WO2023125797A1 - Traditional chinese medicine composition and preparation method and application thereof - Google Patents

Abstract

A traditional Chinese medicine composition for treating thyroid nodules, lipomas, mammary gland hyperplasia and mouth ulcers, the composition comprising as a primary formula of main active ingredients three medicinal/edible source materials consisting of: Lonicera japonica or Lonicera hypoglauca or a mixture of Lonicera japonica and Lonicera hypoglauca, and Taxacum and Prunella vulgaris. The foundation of the primary formula is supplemented by a secondary formula consisting of Scleromitrion diffusa, Hippophae rhamnoides, Poncirus trifoliata and Pholidota, and different preparations are prepared, suitable for different types of thyroid nodules. The traditional Chinese medicine combined formula can be a combined formula of source herbs, and can likewise be a combined formula of extracts thereof, and can likewise be a combined formula of source herbs and extracts. The traditional Chinese medicine composition has a significant therapeutic effect on symptoms of an enlarged thyroid gland caused by inflammation, autoimmunity and new organisms.

Description

A kind of traditional Chinese medicine composition and its preparation method and application technical field

The invention relates to a traditional Chinese medicine composition for thyroid nodule, lipoma, mammary gland hyperplasia and oral ulcer, its preparation method and application, and belongs to the technical field of traditional Chinese medicine.

Background technique

Thyroid nodule is a very common endocrine disease. It is a mass in the thyroid gland. It can move up and down with the thyroid gland when swallowing. It is a common clinical disease. There are many clinical thyroid diseases, such as thyroid degeneration, inflammation , autoimmunity, and neoplasms can all manifest as nodules. Thyroid nodules can be single or multiple. The incidence of multiple nodules is higher than that of single nodules, but the incidence of thyroid cancer in single nodules is higher. Patients with thyroid nodules may experience dyspnea, dysphagia, and hoarseness. Enlarged nodules may compress the trachea, recurrent laryngeal nerve, esophagus, and deep jugular veins, which may cause liver disease, renal tubular acidosis, and diabetes. and serious consequences of cardiovascular disease. Its pathogenesis and etiology are still unclear, and it is likely to be caused by comprehensive stimulation from radiation, immunity, inflammation, chemical stimulation and endocrine changes.

At present, there are many technologies and methods for the treatment of thyroid nodules in medicine. Western medicine mainly includes follow-up observation, thyroid hormone suppression treatment, and surgical treatment in the treatment of benign thyroid nodules. Among them, surgical treatment is widely used clinically, but there are disadvantages of overtreatment or postoperative recurrence. And it may lead to hypothyroidism or loss of normal thyroid function, and hormone replacement is required after surgery, which will also aggravate the anxiety and fear of patients and affect their quality of life. Most western medicines have general curative effect and large side effects, so they cannot achieve good therapeutic effect. The invention provides a pure traditional Chinese medicine composition, and the main prescription medicinal materials constituting the composition are ingredients of the same origin as medicine and food, without toxic and side effects, allowing patients to eliminate patients during the diet therapy process and improve the quality of life.

At present, research papers and patent documents report that the methods of treating thyroid nodules are mostly traditional Chinese medicines, except for surgery, but the relevant research and patents are composed of many kinds of traditional Chinese medicinal materials, including a variety of non-medicine and food homologous Chinese medicinal materials. , even toxic medicinal materials, the safety compatibility between drugs is not clear, quality standards are not easy to establish, and the mechanism of drug action is not clear. . Representative patents include: CN201410293292 Main components: honeysuckle, raw turtle shell, dandelion, forsythia, triangular, rhubarb, black medicine, Cyperus cyperi, angelica, dragon scale grass, seaweed, white glue incense, conch, wulingzhi, pig Heart, loofah, yam, oyster, cicada, snow lotus, prunella, sea pumice. CN201510273093 Main components: honeysuckle, forsythia, mountain conch, green skin, tangerine peel, dandelion, toad skin, melon, wild chrysanthemum, turmeric, grass river car, fritillary fritillary, Patrinia, Sanzi mushroom, salvia miltiorrhiza, xanthophyll, Tortoise shell, seaweed, wood beetle, puffball, gentian, dannan, prunella vulgaris, raw licorice. CN201810994342 Main components: honeysuckle, wild chrysanthemum, dandelion, viola chinensis, geranium, prunella vulgaris, ghost arrow feather, cat's claw, xanthum, panshania, rehmannia glutinosa, red peony root, angelica, chuanxiong, rhubarb, gentian, licorice . Wuhai Yingliu Pills, a Chinese patent medicine listed in China for thyroid-related diseases, patent: CN200510105351.X, composition: kelp, seaweed, octopus, clam shell, kelp, Prunella vulgaris, Angelica dahurica, Chuanxiong, woody fragrance, conch (calcined) . Indications: For thyroid tumors, thyroid nodules, thyroid cysts, lymphatic tuberculosis, lymphitis, breast lumps, lipomas, myofibromas and other body surface masses. Treatment cycle: one course of treatment per month, at least 3 courses of treatment. The composition of Wuhai Yingliu Pills contains non-medicine and food homologous medicinal materials, and the dosage is large and the taking cycle is long.

The Chinese medicinal materials in the above patented prescriptions have many flavors, and the dosage is relatively large, and some medicinal materials have certain liver and kidney toxicity. This patent only has 3-7 flavors of medicinal materials, and the main prescription is composed of medicinal and edible medicinal materials. The medicinal materials for the sub-prescription are also composed of medicinal materials with good safety and long-term taking habits. The overall dosage is small, safe and patient compliance Sex is better. The action mechanism of the patent is clear and has no toxic and side effects. The above patents do not constitute an inspiration to this patent.

Lipoma is a common benign soft tissue tumor composed of mature fat cells that can occur anywhere in the body with fat. It is more common in the shoulders, back, neck, breasts, and abdomen, followed by the proximal extremities (such as upper arms, thighs, buttocks). Mainly under the skin, it is called superficial lipoma, and it can also be found between the deep part of the limb and the muscle belly, called deep lipoma. The texture of the tumor is soft, round or lobulated, located under the skin, and can be pushed; the size of the tumor varies, the small one is as big as a jujube, and can only be felt by hand, and the large one can bulge the skin surface, but the surface skin is normal. Patients are mostly older, more common in middle-aged people aged 40 to 60, and less common in children. Deep lipomas mostly grow along the muscle and can reach the periosteum, but rarely invade the adjacent bones. Lipoma rarely becomes malignant and can be easily removed by surgery. There are many kinds of traditional Chinese medicines for the treatment of lipoma, but the therapeutic effect needs to be improved. Therefore, it is also necessary to develop a drug for the treatment of lipoma with better curative effect.

Mammary gland hyperplasia is a breast disease with abnormal proliferation of breast tissue. Mammary gland hyperplasia is usually the hyperplasia of mammary gland epithelium and fibrous tissue. The abnormalities in the number and shape of mammary gland structure caused by hyperplasia of different degrees and incomplete involution are neither tumor nor A pathological state of inflammation; its main pathological manifestations are typical pregnancy-like changes and tumor-like cystic hyperplasia in the main substance and stroma of the breast, clinical manifestations are breast lumps, unilateral or bilateral breast tenderness or tenderness, accompanied There are menstrual disorders, emotional changes, some patients with nipple discharge, etc., and this disease is one of the breast diseases with the highest incidence rate.

Oral ulcer, commonly known as "oral ulcer", is a common ulcerative injury disease that occurs in the oral mucosa. It is more common in the inner lip, tongue, tongue belly, buccal mucosa, vestibular groove, soft palate and other parts. The mucosa in these parts lacks stratum corneum. or poor keratosis. Tongue ulcers refer to oral ulcers that occur on the tongue and the abdomen of the tongue. When oral ulcers attack, the pain is severe, and the local burning pain is obvious. In severe cases, it will also affect eating and speaking, causing great inconvenience to daily life; Symptoms such as swollen lymph nodes.

Contents of the invention

1. The inventor of the present invention has accumulated rich experience in the pathological mechanism, diagnosis and treatment of thyroid disease during long-term medical research and practice. The mechanism has been researched, summarized and improved for a long period of time, and a prescription of honeysuckle, dandelion and Prunella vulgaris with the same source of medicine and food is proposed to treat typical thyroid nodules, and the effect is remarkable. Combined with modern medical technology, on the basis of continuous experiments and summaries, it is proposed to use Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao as supplementary side prescriptions. Through the differentiation of the proportion, the composition is strengthened to treat the diseases caused by different reasons. The treatment effect of thyroid nodules is significantly shortened compared with the single use of the main prescription three herbs. Such compositions have not been reported prior to the present invention.

2. A traditional Chinese medicine composition, which is a mixture of Flos Lonicerae or Flos Lonicerae or Flos Lonicerae and Flos Lonicerae (the mixing ratio of the two is arbitrary, such as 1:100 to 100:1, for example, 100:1, 90:1, 85:1, 80:1, 70:1, 60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7:1, 6: 1, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:20, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:85, 1:90, 1:100, etc.) The main prescription is the main active ingredients of the three medicinal and edible homologous medicinal materials, dandelion and prunella vulgaris. On the basis of this main prescription, supplemented medicinal materials Hedyotis diffusa, Seabuckthorn, Fructus Aurantii, and Shixiantao are used as secondary prescriptions to prepare different preparations, which are suitable for thyroid nodules caused by inflammation, autoimmunity and neoplasms. The prescription of the traditional Chinese medicine composition may be a prescription of raw medicinal materials, or a prescription composed of its extracts, or a composition of partial extracts and raw medicinal materials.

Among them, A, B, and C respectively represent the raw materials or extracts of honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower, dandelion, and Prunella vulgaris. The unit is weight ratio.

The total content range of active ingredients in the main formula:

10.0% ≤ total flavonoids ≤ 25.0% 5.0% ≤ total polysaccharides ≤ 15.0%

2.0% ≤ total saponins ≤ 10.0% 2.0% ≤ total polyphenols ≤ 10.0%

The selection of the dosage of the main medicinal material or extract equivalent to the main medicinal material is affected by the weight of the user and the degree of disease progression. In some embodiments, the total amount may be about 0.001 to 20 g/kg body weight, about 0.005 to 10 g/kg body weight, about 0.01 to 5 g/kg body weight, about 0.01 to 2.5 g/kg body weight, about 0.02 to 1 g/kg body weight , about 0.02 to 0.3 g/kg body weight, about 0.02 to 0.2 g/kg body weight, about 0.02 to 0.1 g/kg body weight, or about 0.02 to 0.08 g/kg body weight. In some embodiments, the amount is about 0.01 to 0.05 g/kg body weight. In another embodiment, the amount is about 0.05 to 0.10 g/kg body weight.

3. A traditional Chinese medicine composition for the treatment of thyroid nodules, in the mixture of honeysuckle or mountain silver flower or honeysuckle and mountain silver flower (the mixing ratio of the two is arbitrary, such as 1:100 to 100:1, for example, 100:1 , 90:1, 85:1, 80:1, 70:1, 60:1, 50:1, 40:1, 30:1, 20:1, 10:1, 9:1, 8:1, 7 :1, 6:1, 5:1, 4:1, 3:1, 2:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7 , 1:8, 1:9, 1:10, 1:20, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:85, 1:90, 1 : 100, etc.), dandelion, and Prunella vulgaris as the main ingredients, supplemented with Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao as auxiliary ingredients, prepared into different preparations, suitable for different thyroid glands For nodules, the above prescription can be the prescription of the original medicinal material, or a prescription composed of its extract, or a prescription composed of a part of the extract and the original medicinal material.

The ratios are:

Among them, D, E, F, and G represent raw materials or extracts of Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao, respectively. The unit is weight ratio.

The total content range of the active components of the whole formula:

5.0% ≤ total flavonoids ≤ 20.0% 5.0% ≤ total polysaccharides ≤ 20.0%

2.0% ≤ total saponins ≤ 10.0% 2.0% ≤ total polyphenols ≤ 15.0%

The choice of the amount of the above-mentioned auxiliary medicinal materials or extracts equivalent to the auxiliary medicinal materials is affected by the weight of the user and the degree of disease progression. In some embodiments, the total amount may be about 0.001 to 20 g/kg body weight, about 0.005 to 10 g/kg body weight, about 0.01 to 5 g/kg body weight, about 0.01 to 2.5 g/kg body weight, about 0.02 to 1 g/kg body weight , about 0.02 to 0.3 g/kg body weight, about 0.02 to 0.2 g/kg body weight, about 0.02 to 0.1 g/kg body weight, or about 0.02 to 0.08 g/kg body weight. In some embodiments, the amount is about 0.01 to 0.05 g/kg body weight. In another embodiment, the amount is about 0.05 to 0.10 g/kg body weight.

4. The preparation of the traditional Chinese medicine composition can be prepared by directly mixing raw materials, or can be prepared by mixing after crushing.

5. The traditional Chinese medicine composition can be prepared by combining the active substance extracts of various single medicinal materials, or it can be a prescription composed of part of the extracts and the original medicinal materials, or a combination of the active substance extracts after the original medicinal materials are mixed. . The active ingredient extraction method of any medicinal material, including the active ingredient of a single medicinal material or a mixture of multi-flavored medicinal materials, may include but not limited to the following steps:

(1) Herbal medicinal materials of traditional Chinese medicine are crushed;

(2) Soak the Chinese medicinal plant powder overnight with the extractant; the extractant is water or ethanol; when the extractant is ethanol, the ethanol concentration is 30%-95%;

(3) decocting the drug in step (2) or extracting it by low-speed percolation;

(4) Concentrate the extract, including extracting the solution to obtain a dry paste powder by rotary evaporation, spray drying or vacuum drying

6. The traditional Chinese medicine composition can be prepared from the active substance extract of a single medicinal material or a combination of active substance extracts after mixing the original medicinal materials. The active ingredient is extracted by supercritical extraction or macroporous resin separation of active component groups. .

7. The preparation method of the traditional Chinese medicine composition is characterized in that other nutritional ingredients can be added as auxiliary materials of the preparation to make different dosage forms to enhance the above-mentioned effects. These effective excipients are nutritional supplements composed of amino acids (glycine, arginine, leucine, valine, alanine, serine, proline, isoleucine, phenylalanine, lysine, threonine acid, methionine, tryptophan, histidine, tyrosine, aspartic acid, cysteine, glutamic acid), curcumin or turmeric extract, betaine hydrochloride, chlorogenic acid, reduced glutathione Glycerin, Yeast β-glucan, Vitamin B6, B2, GABA, Resveratrol, Polyfructose, Galactooligosaccharide, Chitosan, Sodium Alginate, Aloe Vera Gel at least one or two or more of them.

8. The preparation method of the traditional Chinese medicine composition is characterized in that the dosage forms include: substitute tea, granules, capsules, tablets, powders, oral liquids and other acceptable dosage forms.

9. The traditional Chinese medicine composition can also be used to treat Hashimoto's thyroid inflammation, hypothyroidism, inflammatory hyperthyroidism and the like in patients without surgery or partial thyroidectomy.

10. The traditional Chinese medicine composition can also be used to treat swelling of lymph nodes caused by various inflammations.

11. The traditional Chinese medicine composition can also be used for treating lymphatic tuberculosis (scrofula is also called mouse sore).

12. The traditional Chinese medicine composition can also be used to treat lipoma.

13. The traditional Chinese medicine composition has a good therapeutic effect on mammary gland hyperplasia of nulliparous women, especially the initial effect is more obvious.

14. The traditional Chinese medicine composition has a good therapeutic effect on common oral ulcers, especially recurrent oral ulcers.

15. The above-mentioned traditional Chinese medicine prescriptions for the treatment of thyroid nodules are characterized by utilizing the characteristics of each prescription drug, through the antibacterial, anti-inflammatory, immune-enhancing, and endocrine-improving effects of the following active components of traditional Chinese medicine , Improving cardiovascular function, supplementing vitamins and other essential nutrients for the human body and other mechanisms of action, to achieve overall physical conditioning, to relieve and cure thyroid nodules, hypothyroidism, hyperthyroidism, thyroid inflammation, lymph node enlargement, lymphatic tuberculosis, etc.

(1) Honeysuckle mainly contains organic acids, flavonoids, triterpene saponins, and volatile oils, specifically including active ingredients such as chlorogenic acid, isochlorogenic acid, luteolin, hyperin, and oleanolic acid. Honeysuckle is known as "antibiotics in traditional Chinese medicine", which has anti-inflammatory, antibacterial, antiviral, antioxidative, antitumor, and liver protection effects

(2) Dandelion: The whole herb of dandelion contains dandelion sterol, choline, inulin, pectin, etc. Sterilization, anti-inflammatory, anti-virus, anti-tumor. Liver nourishment, used to "clear blood" and replenish liver blood, enhance human immunity. Dandelion extracts are used to treat liver and gallbladder blockages, improve liver function, stimulate bile secretion and act as a diuretic.

(3) Prunella vulgaris mainly contains Prunella vulgaris polysaccharides, glycosides such as oleanolic acid, rutin, and hyperoside, and organic acids such as ursolic acid, caffeic acid, and free oleanolic acid; it also contains vitamin B1, Vitamin C, vitamin K, carotene, resin, bitter substance, tannin, volatile oil and other ingredients are suitable for lymphatic tuberculosis and goiter, and have the functions of clearing heat and dissipating stagnation, antibacterial and anti-inflammatory.

(4) Hedyotis diffusa, the main components are terpenoids, flavonoids, sterols, organic acids, polysaccharides, etc., all of which have good antitumor activity. Flavonoids have strong DNA cleavage activity, can inhibit the growth of various malignant tumors, and regulate the immune function of the body. Polysaccharides can significantly inhibit the growth of liver cancer cells and cervical cancer cells, inhibit the formation of cell colonies, and induce cell apoptosis. Hedyotis diffusa can regulate the immune function of the body, enhance the inhibitory effect of immune cells such as T cells and natural killer cells on tumor cells, reduce the immune suppression of patients, and finally kill tumor cells. It can also inhibit the formation of blood vessels and lymphatic vessels in tumor tissue, and cut off the nutrient source of tumor cells.

(5) Seabuckthorn is recognized as the king of Vc in the world's plant groups. It is called "longevity fruit" in Japan, "second ginseng" in Russia, "life energy" in the United States, and "magic fruit" in India. China is known as "Holy Fruit" and "King of Vitamin C". It mainly contains isorhamnetin, rutin, astragalin, quercetin, kaempferol, vitamins A, B1, B2, C, E, dehydroascorbic acid, folic acid, carotene, carotenoids, children Tea essence, anthocyanin, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid and other ingredients can remove free radicals in the human body, improve immune function, improve the human body's disease resistance, delay human aging, and antibacterial , anti-inflammatory, anti-cancer, anti-cancer and other effects.

(6) Fructus aurantium, mainly contains volatile oil, orange yellow, mainly contains d-limonene in the oil, and has a small amount of decanal, citric aldehyde, citronellal, methyl anthranilate, linalool. In addition, it contains hesperidin, naringin, neohesperidin, and the bitter ingredient aurinin. It still contains volatile oil and alkaloids. It has the function of regulating gastrointestinal function, cardiovascular system and uterus.

(7) Shixiantao, which mainly contains adoterene alcohol and adoterene ketone, has the effects of anesthesia, analgesia, anti-fatigue, anti-tumor and hypoxia resistance. By inhibiting the central nervous system, it can exert sedation, hypnosis and Anticonvulsant effect. Shixiantao contains 22 kinds of minerals such as K, Na, P, Mg, Ca, Fe, Al, Mn, B, Zn, Cu, Mo, Ti, As, Tl, Cd, Pb, Se, Co, Ni, Cr, V, etc. material element. Among them, the content of constant elements K, Mg, Ca, and P is higher than that of general Chinese medicinal materials; the content of trace elements Fe, Mn, Co, and Se is ten times higher than that of ginseng and astragalus; the content of Cd and Pb is lower than that of heavy metals in the Pharmacopoeia limit standard.

(8) Amino acid is the basic substance that constitutes the protein required for animal nutrition. It is mainly involved in the synthesis of tissue proteins, which are converted into acids, hormones, antibodies, creatine and other ammonia-containing substances, converted into carbohydrates and fats, oxidized into carbon dioxide, water and urea, and generate energy. It is an indispensable nutrient for the human body.

Curcumin, a natural compound, is a rare pigment with a diketone structure in the plant kingdom. It has the effects of lowering blood fat, anti-tumor, anti-inflammatory, choleretic, and anti-oxidation. In addition, some scientists have found that curcumin can help treat drug-resistant tuberculosis.

Betaine hydrochloride, participates in fat metabolism, promotes protein synthesis, appetizer, has buffering effect, can play a synergistic effect with anti-evil insect drugs, protect vitamins, can be used for gastric acid deficiency, arteriosclerosis and liver diseases, and can increase fat metabolism , Inhibit the deposition of fat in the liver.

Chlorogenic acid is an important biologically active substance, which has the functions of antibacterial, antiviral, increasing white blood cells, protecting liver and gallbladder, antitumor, lowering blood pressure, lowering blood fat, scavenging free radicals and stimulating the central nervous system.

Reduced glutathione can activate a variety of enzymes and promote the metabolism of carbohydrates, fats and proteins. It can also affect the metabolic process of cells and is an important regulatory metabolic substance in cells.

Yeast β-glucan is the first glucan found to have immune activity. It has antibacterial and immunoregulatory effects, removes toxins, resists radiation, repairs cells, and improves intestinal function. It has unique biological activities on tumors, hepatitis, cardiovascular, diabetes, blood lipid lowering, anti-aging and other aspects.

Vitamin B6, participates in the metabolism of neurotransmitters, glycogen, sphingomyelin, heme, steroids and nucleic acids, participates in the metabolism of all amino acids, reduces chronic diseases, treats anemia, treats leukopenia, enhances immunity and fights cancer.

Vitamin B2 mainly participates in biological oxidation and energy metabolism in the body, promotes development and cell regeneration, and affects biological oxidation and energy metabolism.

γ-aminobutyric acid is a naturally occurring non-protein amino acid that participates in a variety of metabolic activities and has extremely important physiological functions. It can promote the balance of amino acid metabolism in the human body, regulate immune function, delay brain aging, and supplement Inhibitory neurotransmitter in the human body, promotes the improvement and protection of kidney function.

Resveratrol, a non-flavonoid polyphenolic organic compound, is an antitoxin produced by many plants when stimulated. It has anti-inflammatory, anti-aging, anti-tumor, anti-cancer, and cardiovascular disease prevention effects.

Polyfructose is an excellent water-soluble dietary fiber and a good "prebiotic". It has health functions such as regulating intestinal flora, proliferating bifidobacteria, promoting calcium absorption, and promoting immune regulation. It can reduce liver toxins, generate anti-cancer organic acids in the intestines, and has significant anti-cancer functions.

Galacto-oligosaccharide is a new functional food, through the highly selective proliferation of bifidobacteria, it can balance the largest micro-ecosystem of the human body - the intestinal micro-ecosystem, thereby affecting the nutrition, immunity and disease prevention of the host. Prevention and treatment play an active role, which can promote the synthesis of B vitamins, improve the absorption and utilization of protein, promote the absorption of minerals, and inhibit endotoxin.

Chitosan is a functional food that can nourish cells, activate inactive cells, and repair damaged cells. The ability to age and unleash the natural healing power in the body.

Sodium alginate is a natural polysaccharide and an indispensable dietary fiber for the human body. It has unique nutrition, can combine with organic matter, reduce cholesterol in serum and liver, inhibit the increase of total fat and total fatty acid concentration, and improve the absorption of nutrients. Digestion and absorption, long-term consumption will help treat hypertension, coronary heart disease, diabetes and intestinal system diseases.

Curacao aloe vera gel is a new resource food, which can improve human immunity, remove free radicals, and relieve inflammation.

16. Compared with the patent CN201410293292, which is a traditional Chinese medicine for treating thyroid tumors, which consists of 22 medicinal materials, this patent only consists of 3-7 medicinal materials, which have obvious therapeutic effects for thyroid nodules, and the traditional Chinese medicine composition It can also be used to treat lymph node enlargement and lymph node nucleus (scrofula, also known as mouse sore) caused by various inflammations, as well as lipoma and mammary gland hyperplasia of nulliparous women, especially in the early stage, with good therapeutic effect. Mouth ulcers also have a good effect.

The composition of this patented formula is not based on the traditional Chinese medicine theory, but based on the modern medical research on the pathological mechanism of the above-mentioned diseases. The formula is formulated on the basis of a large number of active components and their functional studies of the medicinal materials in the formula. The Chinese medicine composition contains active ingredients such as polysaccharides, flavonoids, polyphenols, saponins, sterols, vitamin B, vitamin C, various amino acids, trace elements, minerals and other nutrients that can regulate the body's own Immunity, regulating endocrine level, increasing antibacterial ability, anti-inflammation, improving microcirculation, supplementing nutrition. Based on this, this patent starts from the treatment mechanism of thyroid nodules, the main active components of the drug and its mechanism of action, nutritional efficacy, etc., to relieve the pain of patients with thyroid nodules, reduce the volume of the tumor until it disappears, and the effect is remarkable.

Antibacterial effect: Honeysuckle contains organic acids such as chlorogenic acid, isochlorogenic acid, caffeic acid, and luteolin, which are antibacterial components; flavonoids, polysaccharides, alkaloids, organic acids, and sterols in dandelion have strong Antibacterial effect, the triterpenoid component ursolic acid contained in the fruit ears of Prunella vulgaris has good antibacterial and antiviral effects, and the polyphenolic compounds contained in seabuckthorn include ursolic acid, coumarin, β-coumarin, phenol Acid and other antibacterial components, the above several medicinal materials synergistically strengthen the therapeutic effect.

Anti-inflammatory effect: Honeysuckle, honeysuckle and loganin and other components can inhibit the synthesis and release of inflammatory mediators (prostaglandins, histamine, 5-hydroxytryptamine, malondialdehyde), inhibit the expression of COX-2, and inhibit the expression of COX -1 and COX-2 activity. Flavonoids such as luteolin and quercetin in dandelion mediate the production of tumor necrosis factor TNF-α by inhibiting the production of interleukin-1, thereby inhibiting the occurrence of inflammation; the triterpenoids in the ears of Prunella vulgaris Ursolic acid, oleanolic acid, betulinic acid, carotene, etc.

Regulating the body's immunity: the polysaccharide (Tof-CFr) extracted from dandelion can strongly stimulate sugar energy, and can significantly reduce the phagocytosis index of T cells with low immunity; dandelion water extract can promote cell growth factors IL-2, FIN-γ, IL The secretion of -4 can significantly increase the immunoglobulin on the surface of B cell membrane, thereby improving the immune function of the body; polysaccharides, ursolic acid, oleanolic acid, etc. in Prunella vulgaris can improve the immunity of the body, among which Prunella vulgaris polysaccharides have significant antioxidant properties And immune activity, can significantly scavenge DPPH free radicals, ABTS free radicals and HOO free radicals, and stimulate macrophages to secrete cellular immune factors.

Improve microcirculation: The organic acid contained in honeysuckle can improve local blood circulation and vascular permeability. Seabuckthorn stem bark, fruit, and leaves contain a rare ingredient in the plant world - 5-hydroxytryptamine. It exists in free state and compound state. As a neurotransmitter, it has an important regulatory effect on human emotional state, blood pressure, body temperature, internal environment of the body, hormones, etc. It also has anti-radiation, anti-infectious disease, anti-cancer It can accelerate the conversion of fibrinogen into fibrin, which is helpful for blood coagulation and so on.

Nutritional efficacy: the formula is rich in vitamin B, vitamin C and various amino acids, as well as trace amounts of manganese, zinc, potassium, sodium, calcium, magnesium, phosphorus, iron, copper and other elements. Dandelion whole herb contains glucose, glucoside, resin, rubber and so on. The leaves contain lutein, phylloxanthin, phylloquinone, vitamin C (50-70 mg/100 g) and vitamin D (5-9 mg/100 g), and dandelion is also a rare selenium-rich plant in nature. The content of vitamin C in seabuckthorn is extremely high. Per 100 grams of fruit juice, the content of vitamin C can reach 825-1100 mg. There are also active ingredients of vitamin E, vitamin A, flavonoids and SOD, which can effectively prevent free radicals and achieve anti-aging effects.

Description of drawings

Figure 1 is a typical case 9 pre-medication inspection report.

Figure 2 is a typical case 9 inspection report after taking the medicine.

Detailed ways

Honeysuckle is the dry flower bud or the first flower of Lonicera japonica Thunb. (Anhui Jiancheng 170809)

Mountain silver flower is the dry flower bud or the first opening of Lonicera macranthoides Hand.-Mazz., Lonicera hypoglauca Miq., Lonicera confusa DC. or Lonicera fulvotomentosa Hsu et S.C.Cheng flowers.

Dandelion is the dry whole plant of Taraxacum mongolicum Hand.-Mazz. (Anhui Jiancheng 171002)

Prunella vulgaris is the dried fruit ear of Prunella vulgaris L., a plant of Lamiaceae. (Anhui Jiancheng 180201)

Hedyotis diffusa is the whole plant of Hedyotis diffusa Willd. [Oldenlandia diffusa (Willd.) Roxb.], a plant of Rubiaceae Auricularia. (Anhui Jiancheng 180102)

Seabuckthorn is the dry ripe fruit of Hippophae rhamnoides L. (Anhui Jiancheng 170904)

Citrus aurantii is the dry immature fruit of Citrus aurantium L. and its cultivars of the Rutaceae plant. (Anhui Jiancheng 180307)

Shixiantao is a plant of the genus Shixiantao in the family Orchidaceae, Pholidota chinensis Lindl. It is used as medicine with pseudobulbs or whole plants. (Anhui Tengxin 180103)

In the following examples, A represents honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower; B represents dandelion; C represents Prunella vulgaris; D represents Hedyotis diffusa; E represents seabuckthorn;

The ratios mentioned in the following examples refer to weight ratios.

Example 1

Fully dried honeysuckle, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao raw medicinal materials or processed medicinal materials, according to the formula ratio (A/B/C=1:1:1; A/E= 2:1; D/E/F/G=1:1:1:1) weighed, superfinely pulverized, mixed, made into bags, or added with honey to make pills, bagged and stored in a dry environment.

Example 2

Raw or processed medicinal materials of mountain silver flower, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao after fully drying, according to the formula ratio (A/B/C=1:1:1; A/B/C=1:1:1; A/B/C=1:1:1; E=2:1; D/E/F/G=1:1:1:1) Weigh it, add water 10 times the total weight of the drug, soak it overnight, decoct twice, each time for 2 hours, filter, The filtrate was evaporated to remove water under reduced pressure at 70°C to obtain a concentrated solution with a density of 1.1-1.2, which was bottled or made into an oral solution.

Example 3

Weigh the 1:1 mixture of fully dried honeysuckle and mountain silver flower, dandelion, and Prunella vulgaris according to the formula ratio (A/B/C=1:1:1), ultrafinely pulverize, add 10 times the total weight of the medicine Soak in water overnight, decoct twice for 2 hours each time, filter, and distill the filtrate to remove water under reduced pressure at 70°C to obtain a concentrated solution with a density of 1.1-1.2, bottle it or make it into an oral solution, or fully concentrate , Dried into powder.

The fully dried Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao raw or processed medicinal materials are weighed according to the formula ratio (D/E/F/G=1:1:1:1), ultrafinely pulverized, Add water 10 times the total weight of the drug, soak it overnight, decoct twice, each time for 2 hours, filter, and distill the filtrate to remove water under reduced pressure at 70°C to obtain a concentrated solution with a density of 1.1-1.2, bottle or make Oral solution, or fully concentrated and dried into powder.

The two extracts obtained above are mixed and further processed to prepare tablets, capsules, granules or oral liquids.

Example 4

Raw or processed medicinal materials of honeysuckle, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium and Shixiantao that have been fully dried are superfinely pulverized.

Take the crushed honeysuckle medicinal material, add 20 times of water to heat and extract twice, each time for 1.5 hours, the extraction temperature is 95°C, add ethanol to the extract to make the alcohol concentration reach 75%, and concentrate the alcohol precipitation solution to a certain density. Spray dried powder.

Take the pulverized dandelion medicinal material, add 3% biological enzyme, adjust the pH value to 8.7, enzymolyze for 120min, and the temperature is 48°C. After the enzymolysis, add water 10 times the total weight of the drug to heat and extract twice, each time 2 hours, the extraction temperature is 90°C, the filtrates are combined, the filtrate is evaporated to remove water under reduced pressure at 70°C, and spray-dried to obtain a dry powder.

Take the pulverized Prunella vulgaris medicinal material, add 15 times of water to heat and extract twice, each time for 2 hours, the extraction temperature is 90°C, add 2 times the amount of 95% ethanol to the extract, and concentrate the alcohol precipitation solution to 1.07-1.12 (30°C ) followed by spray drying to obtain a dry powder.

Take the pulverized Hedyotis diffusa medicinal material, add 2.4% biological enzyme, adjust the pH value to 7.9, the temperature is 58°C, the extraction time is 2 hours, extract twice, combine the filtrate, and concentrate the filtrate to a certain level under reduced pressure at 70°C Concentration, spray-dried to obtain dry powder.

Take the pulverized seabuckthorn medicinal material, add 5% bio-enzyme, adjust the pH value to 5.2, enzymolysis temperature is 52°C, and enzymolysis time is 2 hours, then add 70% ethanol with 20 times the amount of medicinal material and heat extraction, the extraction temperature is 55°C, the extraction time is 2 hours, and the number of extractions is 2 times. The extract is concentrated to a certain concentration and then spray-dried to obtain a dry powder.

Take the pulverized Fructus Aurantii medicinal material, add 10 times the amount of 50% ethanol, heat and reflux extraction for 3 times, each time for 2 hours, combine the extracts, concentrate to a certain concentration, and then spray dry to obtain a dry powder.

Take the crushed Shixiantao medicinal material, add 30 times of water to heat and extract twice, each time for 3 hours, the extraction temperature is 80°C, add ethanol to the extract to make the alcohol concentration reach 80%, and concentrate the alcohol precipitation solution to a certain density Spray-dried to obtain a dry powder.

The above medicinal material dry cream powder is packaged after being mixed according to the formula ratio (A/B/C=1:1:1; A/E=2:1; D/E/F/G=1:1:1:1), Or add auxiliary materials to prepare different dosage forms for packaging.

Example 5

Take the extract dry powder of Example 4 and add or not add the corresponding superfine powder of raw medicinal materials, mix evenly, pack in bags, or make pills, and pack.

Example 6

Raw or processed medicinal materials of mountain silver flower, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao after fully drying, according to the formula ratio (A/B/C=1:1:1; A/B/C=1:1:1; A/B/C=1:1:1; E=2:1; D/E/F/G=1:1:1:1) Weighing, add specific microorganisms (including Monascus, yeast) for microbial fermentation treatment or weigh and mix the above medicinal materials in proportion Then add microbial fermentation treatment, sterilize the medicinal material after treatment, add water 10 times the total weight of the drug, soak it overnight, decoct it twice, each time for 2 hours, filter, and distill the filtrate to remove water under reduced pressure at 70°C to obtain Concentrated solution with a density of 1.1-1.2, bottled or made into oral solution. Or the concentrated solution of single medicinal material is directly spray-dried to obtain a dry powder, which is mixed evenly with or without the corresponding superfine powder of raw medicinal material, and then packed into a bag, or made into a pill, and packaged. Or the concentrated solution of single medicinal material can be directly spray-dried to obtain dry powder, according to the formula ratio (A/B/C=1:1:1; A/E=2:1; D/E/F/G=1:1:1 : 1) Weighing, adding auxiliary materials and preparing into different dosage forms for packaging.

Example 7

The 1:1 mixture of fully dried honeysuckle and mountain silver flower, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixian peach raw or processed medicinal materials, according to the formula ratio (A/B/C=1 :1:1; A/E=2:1; D/E/F/G=1:1:1:1) Weighing, adding specific biological enzymes (cellulase, pectinase) for enzyme treatment or Weigh and mix the above medicinal materials in proportion (A/B/C=1:1:1; A/E=2:1; D/E/F/G=1:1:1:1) and add biological enzyme treatment , after treatment, sterilize the medicinal material, add water 10 times the total weight of the drug, soak it overnight, decoct twice, each time for 2 hours, filter, and distill the filtrate under reduced pressure at 70 ° C to obtain a density of 1.1-1.2 Concentrated solution, bottled or made into oral solution. Or the concentrated solution of single medicinal material is directly spray-dried to obtain a dry powder, which is mixed evenly with or without the corresponding superfine powder of raw medicinal material, and then packed into a bag, or made into a pill, and packaged. Or the concentrated solution of single medicinal material can be directly spray-dried to obtain dry powder, according to the formula ratio (A/B/C=1:1:1; A/E=2:1; D/E/F/G=1:1:1 : 1) Weighing, adding auxiliary materials and preparing into different dosage forms for packaging.

Example 8

Extract dry powder or raw medicinal material superfine powder also can add different adjuvants to make different dosage forms in above embodiment 4,6,7, and added adjuvants and dosage forms are respectively:

The superfine powder of raw medicinal materials is added with silicon dioxide, mixed evenly and packed into bags, or prepared into pills by adding water, honey or other binders.

Mixed herbal extract dry powder, added nutritional supplements betaine hydrochloride, chlorogenic acid, yeast β-glucan, γ-aminobutyric acid, resveratrol, polyfructosaccharide, galactooligosaccharide, chitosan, seaweed Add honey, isomaltose oligosaccharide powder and powdered sugar to the sodium nitrate to make oral liquid or ointment.

Mix medicinal herb extract dry powder, add nutritional supplement curcumin or turmeric extract, amino acid, betaine hydrochloride, chlorogenic acid, reduced glutathione, vitamin B6, B2, γ-aminobutyric acid, resveratrol, Chitosan, sodium alginate, aloe vera gel;

Adding excipients for preparation: fillers are selected from dextrin, starch, sucrose, lactose, microcrystalline cellulose, mannose, xylitol, bifidosaccharide, and trehalose.

The binder is selected from sodium carboxymethylcellulose, povidone, sodium alginate and polyethylene glycol.

The disintegrating agent is selected from dry starch, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, and low-substituted hydroxypropyl cellulose.

Lubricants are selected from magnesium stearate, micronized silica gel, talcum powder, and polyethylene glycols.

The wetting agent is water, different concentrations of ethanol or a mixture thereof.

The above raw and auxiliary materials are mixed to make dosage forms such as granules, tablets or capsules.

The dosage forms described in this patent are not limited to several in the examples, but also include various clinically acceptable dosage forms.

Example 9

Weigh honeysuckle, dandelion, Prunella vulgaris, white flower Dry powder of extracts of Hedyotis, seabuckthorn, citrus aurantium and shixiantao, mix, add 0.5 part of betaine hydrochloride, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.5 part of polyfructose, 0.1 part of silicon dioxide, add The honey is made into pills, packed in bags and stored in a dry environment.

Example 10

According to the formula ratio (A/B/C=1:1:1; A/E=2:1; D/E/F/G=1:1:1:1), weigh mountain silver flower, dandelion and Prunella vulgaris , Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantii, Shixiantao extract dry powder, mix, and then add mountain silver flower, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides according to the proportion of the above formula , Aurantii Fructus Fructus Fructus, Shixiantao raw medicinal material superfine powder, 0.3 part of betaine hydrochloride, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.3 part of polyfructose, make powder into bags, or add honey to make pills, pack Store in a dry environment after bagging.

Example 11

According to the formula ratio (A/B/C=1:1:1:1), weigh the 1:1 mixture of honeysuckle and mountain silver flower, dandelion, and dry powder of Prunella vulgaris extract, mix them, and then add the weight of the respective medicinal materials according to the above formula ratio 1/3 of honeysuckle and mountain silver flower 1:1 mixture, dandelion, Prunella vulgaris superfine powder, 0.5 part of betaine hydrochloride, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, galacto-oligosaccharide 0.5 part, 0.2 part of sodium alginate, made into bags, or added honey to make pills, bagged and stored in a dry environment.

According to the formula ratio (D/E/F/G=1:1:1:1), weigh the dry powder of Hedyotis diffusa, Hippophae rhamnoides, Fructus Citrifolia, and Shixiantao extracts, mix them, and then add One-third of the amount of Hedyotis diffusa, seabuckthorn, citrus aurantium, and Shixiantao raw medicinal materials are superfine powder, 0.5 parts of betaine hydrochloride, 0.1 parts of chlorogenic acid, 0.1 parts of resveratrol, and 0.5 parts of polyfructose. Bag, or add honey to make pills, and store in a dry environment after bagging.

The two mixtures obtained above can be further processed to be prepared into tablets, capsules, granules or oral liquids and the like.

Example 12

Weigh honeysuckle, dandelion, Prunella vulgaris, white flower Dry powder of hedyotis, seabuckthorn, citrus aurantii, shixiantao extracts, mixed, add 0.1 part of L-tyrosine, 0.1 part of curcumin, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.1 part of galacto-oligosaccharide , add povidone K30, sodium carboxymethyl cellulose, sodium carboxymethyl starch, mix evenly, prepare granules with 90% ethanol, dry, compress into tablets, bag or bottle for storage.

Example 13

Raw or processed medicinal materials of mountain silver flower, dandelion, Prunella vulgaris, Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao after fully drying, according to the formula ratio (A/B/C=1:1:1; A/B/C=1:1:1; A/B/C=1:1:1; E=2:1; D/E/F/G=1:1:1:1) weighed, ultrafinely pulverized, added water 10 times the total weight of the drug, soaked overnight, decocted twice, each time 2 hours, filtered, and the filtrate was evaporated to remove water under reduced pressure at 70°C to obtain a concentrated solution with a density of 1.1-1.2, which was dried to obtain a dry cream powder. Add 0.1 part of L-tyrosine, 0.1 part of curcumin, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.1 part of γ-aminobutyric acid, 0.1 part of galacto-oligosaccharide into the dry cream powder, and add povidone K30 , sodium carboxymethyl cellulose, sodium carboxymethyl starch, after mixing evenly, prepare granules with 90% ethanol, dry, fill capsules or compress tablets, pack into bags or bottle for preservation.

Example 14

Weigh the fully dried 1:1 mixture of honeysuckle and mountain silver flower, dandelion, Prunella vulgaris or processed medicinal materials according to the formula ratio (A/B/C=1:1:1), ultrafinely pulverize, and add the medicine Soak 10 times the total weight in water overnight, decoct twice for 2 hours each time, filter, and distill the filtrate to remove water under reduced pressure at 70°C to obtain a concentrated solution with a density of 1.1-1.2, and dry to obtain a dry cream powder. Add 0.1 part of lysine, 0.5 part of curcumin extract, 0.1 part of chlorogenic acid, 0.01 part of vitamin B2, 0.1 part of reduced glutathione, 0.1 part of polyfructose into dry paste powder, add povidone K30, carboxylate Sodium methyl cellulose and sodium carboxymethyl starch are uniformly mixed and 90% ethanol is used to prepare granules, dried, pressed into tablets, packed into bags or bottled for preservation.

The fully dried Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, Shixiantao raw medicinal materials or processed medicinal materials, according to the formula ratio (D/E=1:1; D/F=2:1; F/G=1:1 ), weighed, ultrafinely pulverized, soaked in water 10 times the total weight of the drug and left overnight, decocted in water twice, each time for 2 hours, filtered, and the filtrate was evaporated to remove water under reduced pressure at 70 ° C to obtain a density of 1.1-1.2 Concentrate, dried to obtain dry cream powder. Add 0.1 part of histidine, 0.1 part of curcumin extract, 0.1 part of chlorogenic acid, 0.1 part of resveratrol, 0.01 part of vitamin B6, 0.1 part of polyfructose, 0.1 part of sodium alginate into the dry cream powder, add polyvinyl chloride Ketone K30, sodium carboxymethyl cellulose, sodium carboxymethyl starch, and crospovidone are mixed evenly, and the granules are prepared by a dry granulator, dried, compressed into tablets, packed into bags or bottled for storage.

The two mixtures obtained above can be further processed to be prepared into tablets, capsules, granules or oral liquids and the like.

The prescriptions or products combined according to the patent formula have been used for the prevention or treatment of inflammatory diseases affected by certain immune mechanisms. Observational clinical studies, or in vivo and in vitro experiments have been carried out. The results show that the patented product has a strong anti-inflammatory effect and can improve the body's immunity.

This patent project uses carrageenan-induced rat inflammation model for anti-inflammatory verification, and uses subacute aging mouse thymus index, in vitro spleen lymphocyte proliferation, mouse spleen lymphocyte proliferation and other experiments to observe the effects of this patent product on the body Effects on immune function.

1. Anti-inflammatory experiment of carrageenan-induced inflammation model in rats

Choose 60 male rats of 180-220g, after environmental adaptation and feeding for 3 days, they are randomly divided into 4 groups, 15 in each group, respectively blank control group (give equal amount of normal saline), aspirin group (oral aspirin 0.5g/kg ), drug low-dose group (oral embodiment 13 group of drugs 10g/kg), drug high-dose group (oral embodiment 13 group of drugs 20g/kg). The temperature in the laboratory was controlled at 18-26°C, and the animals were fed with purchased standard feed, and they had free access to food and water. Continuous intragastric administration according to body weight for 7 days, once a day, 2 hours after the last administration, subcutaneously inject 1% carrageenan 0.1mL/rat into the right hind paw of the rat, 1.0h after inflammation, At 2.0h, 3.0h, and 6.0h, the volume of the paws of the rats was measured respectively, and the swelling value was calculated.

Swelling value = the volume of the inflamed rear paw - the volume of the inflamed anterior paw

Effects of different swelling values after carrageenan-induced inflammation in rats

Note: Compared with normal saline group, * means P<0.05

It can be seen from the table that, compared with the blank control group, the low-dose drug group slightly reduced the degree of swelling after inflammation, but the effect was not obvious, while the high-dose group decreased significantly, and was significantly better than the aspirin group. Illustrate that this patented product has better anti-inflammatory effect.

2. Experiments on the influence of the immune function of the body

(1) Effect test of thymus index in subacute aging mice induced by D-galactose

40 male mice, body weight (16-20g) were divided into 5 groups at random: normal control group (equal dose of normal saline), subacute mouse model group, low dose of medicine group (embodiment 2 oral gavage 0.1g/kg) , the middle dose group of medicine (Example 2 orally gavaged 0.25g/kg), the high dose group of medicine (Example 2 Orally gavage 0.5g/kg). The same volume of distilled water was given, and at the same time, except for the normal control group with the same volume of sterile saline, the other groups were given 0.1mL/10g of D-galactose per day for 42 consecutive days. One hour after the last administration, they were executed by decapitation and decapitated. Take the thymus, weigh it and calculate the thymus index.

Effects on Thymus Index in Subacute Aging Mice

group	Dose (g/Kg)	Thymus index (mg/Kg)
control group	the	19.1±4.7
model group	the	13.2±3.8
drug low dose group	0.1	18.5±4.5
drug middle dose group	0.25	21.2±3.7
drug high dose group	0.5	23.1±3.8

It can be seen from the table that compared with the control group, the mouse thymus index in the low-dose drug group does not increase significantly, and both the middle-dose and high-dose groups of the drug can increase the thymus index in mice, especially the high-dose group. The most obvious.

(2) Influence test on mouse splenic lymphocyte proliferation response

24 ICR female mice were taken, decapitated and aseptically obtained spleens, prepared spleen cell suspension according to the literature, adjusted the cell concentration to 4*106/mL, and inoculated them in 96-well flat-bottomed cell culture plates. 100 μL per hole, then add 100 μL of phytohemagglutinin Concanavalin A and drug groups I-IV (the products in Example 3 are respectively configured to 25, 50, 100, and 125 μg/mL concentration) liquid medicine, and each group is repeated three times, and cultured Incubate for 72 hours. Before the end, the supernatant was aspirated from each well, and 100 μL of 1 mg/mL MTT was added. At the end, the clear night was collected by centrifugation, and 100 μL of dimethyl sulfoxide was added to each well. The A570 was measured by a microplate reader, and the cell proliferation index was calculated.

Effects on Proliferative Response of Mouse Lymphocytes

group	Dose (μg/mL)	A570	proliferation index
Blank control group	the	0.14±0.01	the
Concanavalin Group A	4.0	0.24±0.02	1.71
Drug Group I	25	0.15±0.02	1.06
Drug Group II	50	0.16±0.02	1.14
Drug Group III	100	0.20±0.02	1.42
Drug Group IV	125	0.22±0.03	1.56

Conclusion: This patented product can directly promote the proliferation index of mouse spleen lymphocytes in vitro, which is equivalent to that of phytohemagglutinin Concanavalin A (4.0 μg/mL).

(3) Effect test on mouse lymphocyte transformation

Choose 50 mice of Kunming kind and be divided into 5 groups at random: blank control group (normal saline), medicine low dosage group (embodiment 5 oral gavage 0.05g/kg), medicine low dosage group (embodiment 5 oral gavage 0.1 g/kg), the low-dose drug group (0.2 g/kg orally administered orally in Example 5), and the positive control group (0.025 g/kg body weight of mannan peptide). The drug was dissolved in normal saline, administered orally by gavage according to body weight, once a day, for 8-10 days in a row. In each group, 10 mg/kg of PHA was intramuscularly injected into each mouse every day for the first 3 days of administration. On the 8th day, 2 hours after the administration, the tails of the mice were cut to collect blood, and the percentage of lymphocyte transformation was calculated according to the literature method.

group	Dose (g/Kg)	Lymphocyte transformation rate (%)
control group	-	40.15±1.43
Mannan peptide positive group	0.025	53.1±7.61
drug low dose group	0.05	47.3±2.31
drug middle dose group	0.1	57.1±3.21
drug high dose group	0.2	67.8±2.54

Conclusion: Compared with the control group, the drug group can increase the lymphocyte transformation rate of mice, especially the middle-dose group and high-dose group have more obvious effects, and are better than the positive control group.

Animal experiment conclusion:

This patented product can significantly reduce the paw swelling value of rats caused by carrageenan, indicating that it has a good anti-inflammatory effect; it can significantly increase the thymus index of subacute aging mice caused by D-galactose; The proliferation of spleen lymphocytes has a certain promoting effect; it can obviously promote the transformation rate of T lymphocytes in mice, and enhance the cellular immune function of mice.

Clinical Trial Data

The main points of asking the medical history of patients with thyroid nodules include the patient's age, gender, long-term insufficient or excessive iodine intake, whether there is a head and neck or whole body radiological examination or treatment history or family history, and the size of the thyroid nodule and its changes and growth. Speed and presence or absence of local symptoms, etc. The size, number, activity, texture, tenderness, and cervical lymphadenopathy of nodules.

(1) Clinical application of thyroid nodules:

1. Materials and methods

1.1 General information: From October 2018 to October 2019, 80 patients were screened in 3 formal medical institutions. Two weeks before the test, the group was continuously observed, symptoms and changes were recorded, and they were randomly divided into two groups, the treatment group and the control group, and the differences in gender, age, onset time, pain degree, nodule size, etc. There was no statistical significance (P>0.05), comparable.

1.2 Diagnostic criteria: Diagnosis of thyroid nodules: Refer to the 2012 "Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer": ① Imaging examination: Thyroid color ultrasound shows ≥1 thyroid nodule. ② Serum TSH is lower than 0.35mIU/L; ③ Palpation of cervical goiter; the diagnosis can be made if the above conditions are met.

Imaging examination: Ultrasound examination is required for all patients to determine the location, shape, size, number, edge status of nodules, internal structure, echo pattern, blood flow status and lymph node condition.

Serological examination: mainly to measure serum TSH and thyroid hormone levels. Serum thyroid hormone levels increased, TSH decreased, and most of them were benign nodules.

Cytological examination: Cytological examination may be considered for thyroid nodules with a diameter ≥ 1 cm to differentiate benign from malignant nodules. The most commonly used method is thyroid fine needle aspiration. During the puncture, the patient should be in the supine position and the neck should be raised , to fully expose the thyroid gland. 75% alcohol disinfection twice, the operator fixed the thyroid gland or thyroid nodule on the punctured side with the index finger and middle finger of the left hand, held an empty needle in the right hand, left 5-7ml of air in the needle barrel, and quickly pierced the thyroid gland (or nodule) with the puncture needle percutaneously. inside), draw 2-5ml of negative pressure with an empty needle, then puncture back and forth 2-3 times in different directions, quickly eliminate the negative pressure, pull out the needle, and puncture the local cotton ball for 10 minutes. Inject the aspirate on the glass slide, push it away evenly, fix the smear with 95% alcohol after drying, and send it for inspection. Only when there are at least 6 groups of intact thyroid epithelial cells in the submitted biopsy specimens, and each group has at least 10 cells, can it be of diagnostic value.

Cytological diagnosis classification: divided into benign, difficult to determine benign and malignant or suspected malignant, malignant and unsatisfactory smear. The criteria for a satisfactory smear are: at least 5-6 follicular epithelial cell clusters on each smear, and at least 10 follicular epithelial cells per cluster.

Test results:

Benign: A nodule is benign if cytology includes colloid nodules, hyperplastic nodules, lymphocytic or granulomatous thyroiditis, and benign cysts.

Suspicious malignancy: the cytological features in the specimen suggest malignancy, but do not fully meet the diagnostic criteria for malignancy; the cell structure is incomplete and/or the specimen is not fixed and well preserved, but there are clear signs suggesting malignancy.

Malignant: The specimen has the cytological features of a malignant tumor. The most common is PTC, but also includes MTC, anaplastic carcinoma, lymphoma, and other thyroid malignancies and metastatic carcinomas.

1.3 Exclusion criteria: Those who are confirmed as malignant nodules, the volume of nodules has increased by more than 40% in a short period of time; those with hyperthyroidism or hypothyroidism; those who are allergic to the prescription drugs; those with infectious diseases, severe cardiovascular and cerebrovascular diseases, or Patients with severe hepatic and renal insufficiency; pregnant women; patients with incomplete data collection.

1.4 Treatment method: the treatment group took the granule product of Example 13, 3 times a day, 10g once a time (infused with 200mL boiled water), the control group took Wuhaiyingliu Pill, 5g once a day, 2 times a day, and other hormones were prohibited during the test with immunosuppressants. The method of use is: a course of treatment for 7 days.

1.5 Observation indicators: relief of discomfort symptoms, softer and smaller lumps, disappearance of lumps, recurrence rate.

1.6 Judgment criteria for curative effect: cure: take this product for four courses of treatment, discomfort symptoms disappear, breathing is smooth, nodules and lumps disappear; effective: take this product for four courses of treatment, discomfort symptoms are alleviated or partially disappeared, and energy status is improved; invalid: take Four courses of treatment of this product, no change in discomfort symptoms.

2. Results

Table 1: Comparison of clinical comprehensive curative effect of two groups of patients

Therapeutic effect: 30 cases (75.0%) were cured, 8 cases (20.0%) were effective, 2 cases (5%) were ineffective, and the total effective rate was 95%. The effect was significantly better than that of the control group.

Table 2: Comparison of the improvement time (days) of symptoms and signs in the two groups of patients

Conclusion: Both the treatment group and the control group were relieved after taking the medicine, but the treatment group was significantly lower than the control group, and the data of the two groups were statistically significant (P<0.05); The comparison was statistically significant (P<0.05), and the treatment group was significantly lower than the control group; the thyroid nodule regression time of the treatment group was significantly lower than that of the control group (P<0.05), and the treatment group was significantly lower than the control group.

Table 3. Comparison of the recurrence rate after drug withdrawal in the two groups

Conclusion: The recurrence rate of the treatment group and the control group was statistically significant (*P<0.01), and the treatment group was significantly lower than the control group.

The results showed that the improvement of symptoms and the reduction and regression of thyroid nodules in the treatment group were significantly better than those in the Jiakangling control group. The total improvement rate of common symptoms in the treatment group was 95%, which was significantly higher than 70% in the control group; the time for the patients in the treatment group to become soft and smaller was lower than that in the control group (P<0.05); the patients in the treatment group had thyroid nodules after treatment The regression time was significantly lower than that of the control group (P<0.05).

It can be seen that the medicine of the present invention can effectively improve the postoperative clinical symptoms of patients with thyroid nodules, reduce the diameter of thyroid nodules and even disappear, relieve the pain of patients, improve the quality of life, have high safety, and are suitable for clinical promotion and application.

(2) Clinical application of lymphoma

Therapeutic method: choose the patient with relevant clinical indication to carry out relevant data collection, take the product of embodiment 6 gained by the present invention, take 3 times every day, once 10g (200mL boiling water brews), using method is: 30 days a course of treatment.

Lymphadenopathy Data Collection Results

The data in the above table shows that this patented product has a good therapeutic effect on single or multiple lymphadenopathy.

(3) Clinical application of lipoma

Therapeutic method: select the patient with relevant clinical indication to carry out relevant data collection, take the product of the gained embodiment 7 of the present invention, take 3 times every day, once 10g (200mL boiled water brewing), using method is: 30 days a course of treatment.

Results of lipoma data collection

The data in the above table shows that the patented product has a good therapeutic effect on single or multiple lipomas.

(4) Clinical application of mammary gland hyperplasia

1. Therapeutic method: collect 30 20-40 year old unmarried and childless female patients and carry out relevant data collection, the treatment group takes the granule product prepared based on embodiment 4 in the embodiment of the present invention 8, takes 3 times every day, once 10g ( 200mL boiling water), the control group took Xiaoyao Pills, 3 times a day, 8 pills each time.

2. Observation indicators: relief of discomfort symptoms, softer and smaller lumps, and disappearance of lumps.

3. Criteria for judging the curative effect: cure: taking this product for four courses of treatment, discomfort symptoms disappear, breathing is smooth, and hyperplasia and mass disappear; effective: taking this product for four courses of treatment, discomfort symptoms are alleviated or partially disappeared, and energy status is improved; invalid: taking this product Four courses of treatment of this product, no change in discomfort symptoms.

4. Results

Table 1: Comparison of clinical comprehensive curative effect of two groups of patients

Therapeutic effect: 10 cases (66.7%) were cured, 3 cases (20.0%) were effective, 2 cases (13.3%) were ineffective, and the total effective rate was 86.7%. The effect was significantly better than that of the control group.

Table 2: Comparison of the improvement time (days) of symptoms and signs in the two groups of patients

Conclusion: The discomfort symptoms of the treatment group and the control group were improved after taking the medicine, but the treatment group was significantly lower than the control group.

The results showed that the improvement of symptoms and the reduction and regression of breast lumps in the treatment group were significantly better than those in the Xiaoyao Pill control group. The time for the tumor to become soft and smaller in the treatment group was lower than that in the control group (P<0.05); the time for the tumor to subside in the treatment group was significantly lower than that in the control group (P<0.05).

(5) Clinical application of oral ulcer

1. Therapeutic method: choose 20 routine patients who have recurrent oral ulcers all the year round to carry out relevant data collection, the treatment group takes the product of embodiment 10 gained by the present invention, takes 3 times a day, 10g (200mL boiled water for brewing); the control group uses acetic acid Dexamethasone sticky patch, use one patch every day, once a day.

2. Observation indicators: relief of discomfort symptoms, reduction of ulcer surface, and relief of pain.

3. Criteria for judging the curative effect: cured: the symptoms of discomfort are alleviated, and the ulcer surface disappears; effective: the symptoms of discomfort are alleviated or partially disappeared, the ulcer surface is reduced, and the pain is alleviated; invalid: the symptoms of discomfort are not improved.

4. Results

Table 1: Comparison of clinical comprehensive curative effect of two groups of patients

Therapeutic effect: 8 cases (80.0%) were cured, 1 case (10.0%) was effective, 1 case (10.0%) was ineffective, and the total effective rate was 90%. The effect was significantly better than that of the control group.

Table 2: Comparison of the recurrence rate after drug withdrawal in the two groups

Conclusion: The recurrence rate of the treatment group and the control group was statistically significant (*P<0.01), and the treatment group was significantly lower than the control group.

Typical case report:

1. Typical case one Mr. Yi, age: 52 years old. The patient reported that there had been small granular thyroid nodules near the clavicle at the bottom of the throat for more than 5 years, which suddenly swelled and developed into spherical hard lumps, and it took a long time to fall asleep every day. Two weeks later, I felt dysphagia, and my work and life were seriously affected. I went to the hospital for B-ultrasound examination and found a 12*7mm thyroid nodule in the thyroid gland. Take the granule product of Example 13, 3 times a day, 10 g each time, for 7 days, the patient's discomfort symptoms are alleviated, and the nodules become smaller; after 14 days, the thyroid nodules completely disappear. After continuing to take for a week, check, thyroid nodule disappears completely. The imaging review was carried out for three consecutive years, and there was no recurrence.

2. Typical case 2 Ms. Chen, female, 29 years old, was found to have thyroid nodules during the physical examination of the company in 2015. She did not pay much attention to it, and then gradually developed symptoms such as sore throat and dysphagia, accompanied by multiple nodules , After B-ultrasound examination, the larger one on the right thyroid was a 29×15mm nodule, which was diagnosed as a benign thyroid nodule by cytology thyroid fine needle aspiration, and the effect of multiple treatments was not good. Taking the product of Example 13 of this prescription, 3 times a day, 10g each time, after one course of treatment, the patient's breathing was smoother than before, and the discomfort symptoms were alleviated; after continuing to take 5 courses of treatment, the swelling and pain in the patient's thyroid disappeared, and the discomfort symptoms disappeared obviously. get well.

3. Ms. San Zhang, a typical case, age: 36 years old. The patient reported that 2 years ago, a painless mass was found in the right neck, and he had no symptoms of hyperthyroidism. Color ultrasound prompt: the left lobe of the thyroid gland is 0.1cm×0.2cm, and the size is 2.7cm×1.6cm and 0.3cm×0.5cm respectively. There is a dark red lump under the right thyroid gland with a size of about 2.0cm×3.0cm, which was diagnosed as a benign thyroid nodule by cytology thyroid fine needle aspiration. The patient didn't want to be treated with surgery, and was later introduced by someone to use the granule product of Example 13 of this prescription, 3 times a day, 10g each time. After one course of treatment, the mass shrank. Take two courses of treatment to consolidate, follow up a case by regular visits to 1 year without recurrence.

4. Typical case four Ms. Yang, age: 50 years old. The patient reported a painless mass in the right neck 1 year ago, with a smooth surface and no nodules, which could move up and down with swallowing. B-ultrasound examination showed a mass of 20*30mm, which was diagnosed as benign thyroid nodules after cytology thyroid fine needle aspiration Festival. He often felt foreign body sensation in the throat, dyspnea, and hoarse voice. The patient refused surgical treatment, and was recommended to take the thyroid nodule granules obtained in Example 13, 3 times a day, 10g each time, for 7 days, and the patient's mass changed. Small, discomfort symptoms improved; taking 1 month, the patient's lump disappeared, and discomfort symptoms disappeared.

5. Typical case five Mr. Xu, age: 33 years old. Some time ago, the patient felt that his throat was uncomfortable. He thought it was caused by the fire and did not care about it. Until a severe cold, two lumps the size of thumb belly appeared in the throat. It was very uncomfortable, as if there was something blocked, and I felt a foreign body sensation when eating and drinking, and I couldn't swallow it. The B-ultrasound examination showed thyroid nodules of 15*10mm and 12*8mm. Take the granule product of Example 13 of this prescription, 3 times a day, 10g each time, for 14 days, the patient's neck swelling alleviated, and the lump became smaller; after taking it for 1 month, the patient's neck swelling basically disappeared, and the breathing, eating and drinking It is normal, and the discomfort symptoms basically disappear; continue to take it for 2 weeks, the lump completely disappears, and the patient feels healed.

6. Typical case Ms. Jiang, age: 34 years old, after partial surgical resection for multiple thyroid nodules 5 years ago, she insisted on taking euthyrox and could not stop using euthyrox, and hypothyroidism occurred after stopping euthyrox. One week after taking this prescription, euthyrox was stopped, and insisted on taking the 13 granules of this prescription for three months, 3 times a day, 10g each time, no longer taking it, and continuously monitoring the thyroid specific indicators within half a year to keep it normal .

7. Typical case Mr. Liu, 47 years old, began to develop multiple lymphatic tuberculosis in the neck at the age of five. Before taking this prescription, the largest lymphatic tuberculosis was 30*20mm, and multiple lymphatic tuberculosis was 10*20mm. Take this prescription embodiment 6 pills, 3 times a day, each 5g, after two months of the product, most lymphoid tuberculosis disappears, remaining lymphatic tuberculosis is 10*5mm (due to the shrinkage of the largest lymphatic tuberculosis).

8. Typical case Ms. Tang, 40 years old, multiple thyroid nodules were found in the unit physical examination in 17 years, a hypoechoic nodule about 3*5mm in size in the lower part of the left lobe of the thyroid gland, aspect ratio > 1, clear boundary, internal echo Irregularity, rich blood color can be seen inside, and the ultrasonic prompt is TI-RADS: 4a category. Multiple hypo-anechoic nodules can be seen in the right lobe of the thyroid gland, with clear borders and no obvious blood color in the nodules. The larger ones are about 5*3mm, and the ultrasound prompts TI-RADS: 3 categories. The doctor suggested surgical resection, but the patient did not want surgery or cytological examination, and wanted conservative treatment. Therefore, taking the traditional Chinese medicine for eliminating nodules from time to time, the effect was not satisfactory. Later, someone introduced him to take the granules of Example 13 of the patent, every day 3 times, 10g each time, after taking it continuously for one month, the nodules became soft and shrunk, the larger one on the right lobe became 2*3mm, and the number of nodules became less, and all the nodules disappeared after taking it for three months. There was no recurrence for the following year.

9. Typical case Mr. Huang, 38 years old, physical examination in August 2020 found a large lymph node in the left neck, the size was 25mm*5mm, and a large lymph node in the right neck, the size was 27mm*10mm. Ultrasound diagnosis: the right side of the thyroid gland Lobar hypoechoic nodules near the trachea (TI-RADS category 4); bilateral cervical lymph nodes. Take this project embodiment 6 pill product, every day 3 times, each 5g, after one month, bilateral cervical lymph nodes are eliminated, and right lobe of thyroid is mixed echo, hypoechoic nodules (TI-RADS 3 classes). Continue to take the product for two months, the nodules become softer and smaller.

10. Typical case Mr. Luo, 38 years old, physical examination in May 2020 found large lymph nodes in the left neck, with a size of 16mm*7mm, and large lymph nodes in the right neck, with a size of 17mm*6mm. Ultrasound diagnosis: bilateral neck multiple lymph nodes. Take this item embodiment 6 pill product, every day 3 times, each 5g, after one month, multiple bilateral cervical lymph nodes disappear.

11. A typical case, Mr. Zhang, 50 years old, went to the doctor in December 2019 because of swallowing and neck discomfort. Examination revealed bilateral thyroid nodules. Ultrasound showed that the size of the nodule in the right lobe of the thyroid gland was 1.37cm*0.61cm, graded by TI-RADS : Grade 4a; the size of the left lobe of the thyroid gland is 1.07cm*0.58cm, TI-RADS classification: Grade 3a, multiple lymph nodes in the bilateral neck, the largest lymph node on the right side of the neck is 1.63cm*0.50cm, the largest on the left side of the neck The lymph node size is 1.90cm*0.54cm. Take the 13 granule products of this project embodiment, 3 times a day, 10g each time, after 1 month: the bilateral thyroid nodules are obviously reduced, and both sides become 0.5cm*0.3cm, and the lymph nodes on the right side of the neck are obviously reduced and become It is 0.6cm*0.7cm, and the lymph nodes on the left side of the neck disappear. Taking the medicine for 2 months: the bilateral lymph nodes in the neck were all eliminated. After taking the medicine for 3 months: the right thyroid nodule changed from grade 4a to thyroid inflammation, the left thyroid nodule remained grade 3a, and all bilateral lymph nodes in the neck were eliminated.

12. Typical case 12. Mr. Zhu, 48 years old, had a physical examination in October 20 due to neck induration. The examination revealed bilateral axillary lymph nodes and multiple lymph nodes in both sides of the neck. Ultrasound showed that the size of the left neck nodule was 7mm* 3mm, the size of the left axillary nodule is 12mm*6mm, and the size of the right axillary nodule is 9*8mm. Take the pill product of Example 6 of this project, 3 times a day, 5g each time, for 2 months: various nodules are all significantly reduced, and continue to take the medicine for 3 months: except for the large nodules in the left armpit, the other neck All bilateral lymph nodes were eliminated.

13. Typical case Thirteen Ms. Peng, 54 years old, had a physical examination in November 21, the report showed: a single nodule on the left side of the thyroid gland, size 3.4*3.2.*4.1mm, regular shape, clear border, classified as TI-RADS: Category 4a; multiple nodules on the right side, ranging in size from 3.0*3.0*2.7mm to 8.5*6.0*5.5mm, regular shape, clear boundary, classified as TI-RADS: category 4a; left breast nodules 4.0*2.0mm , Regular shape, clear border, classified as TI-RADS: 3 categories; right cystic dark area 4.4*2.5mm, clear border, classified as TI-RADS: 2, left axillary lymph node 21*6.0mm, regular shape , clear boundary; right axillary lymph node 18*5.0mm, regular shape, clear boundary, taking the 13 granule product of this project embodiment, 3 times a day, 10g each time, after 3 months, all the above indicators have decreased to varying degrees , the left solitary nodule became TI-RADS: 4b, the grade classification of the right nodule decreased, breast nodules and cysts disappeared, and the size of the left and right cervical lymph nodes decreased to 12*6mm, respectively. *4mm; continue to take the product for 3 months, the single nodule on the left side still exists, the multiple nodules on the right side are small, the large ones are semi-soft and become smaller, and the cervical lymph nodes have all disappeared.

14. Typical Case Fourteen Mr. Wang, 42 years old, found several small bumps on his right forearm a year ago, the big one was 3*4, and the small one was 1*2. The hospital diagnosed it as a lipoma. After a year, it recurred again, and the same hard lump appeared in other parts, and it was unwilling to undergo surgery again. Therefore, it sought treatment with traditional Chinese medicine. After being introduced by others, it took the 7 tablet products of this project embodiment, 3 times a day, 3 tablets each time, and took 45 minutes. Days later, the big lumps began to soften and become smaller, and the small lumps became soft and some disappeared. After taking this product for 3 months, all the lumps disappeared, and there was no recurrence in the later period.

15. Typical case 15. Mr. Feng, 36 years old, found a hard lump the size of a thumb belly on the back of his neck many years ago, with a clear boundary. The hospital diagnosed it as a lipoma, 2*3cm. He was afraid of surgery and the doctor said he would not continue. Don't worry about the length. One year later, the hard lump tended to grow up. Because I didn't want surgery, I ate a lot of traditional Chinese medicine products, but no effect was found. After being introduced by someone, I took the 7 tablet products of this project embodiment for 1 month, 3 times a day, 3 tablets each time, The hard lumps began to soften. After taking it for 1 month, the hard lumps began to shrink. After taking it for another two months, the hard lumps disappeared. There is no recurrence at present.

16. Typical Case 16 Ms. Huang, 25 years old, unmarried and childless, has just graduated and entered the society, and the work pressure is relatively high. In addition, her parents urged her to go on a blind date. If there is a hard lump, it will be worse during menstruation. I went to the hospital for an examination and was diagnosed with breast hyperplasia. The doctor prescribed western medicine orally, but taking it for a period of time had no effect. Instead of taking traditional Chinese medicine, I took the granule product prepared based on Example 6 in Example 8 of this patent, 3 times a day, 10g each time, after being introduced by others, there was no discomfort at the beginning of taking it, and the hard lumps softened after taking it for 1 month. Trend, the lumps disappeared after continuing to take for 1 month, and the symptoms of previous menstrual disorders also improved. After the lump disappeared, I adjusted my mentality, and there was no recurrence for the time being.

17. Typical case Seventeen Ms. Wei, 28 years old, unmarried and childless, has been working for two years. During the physical examination two years ago, the right breast was found to have induration, which was painless to the touch. The diagnosis was mammary gland hyperplasia. The doctor told me that no special treatment was needed. Periodic reexamination is enough. Recently, due to the relatively high work pressure, the induration has a tendency to increase, and it is painful to touch, and the menstrual pain is aggravated. Introduced by someone to take the granule product prepared in Example 7 in Example 8 of this patent, 3 times a day, 10g each time, after taking it for 1 month, the symptoms were relieved, the pain was weakened, and the induration was still there. Continue to take 2 After one month, the induration softened, and the hard lump disappeared after continuing to take it for two months, and there was no recurrence in a follow-up visit in the later period.

18. Typical Case Eighteen Ms. Zheng, 34 years old, is prone to oral ulcers all the year round, and basically heals without treatment in the early stage. Recently, the seizures were frequent before, and each time the pain was unbearable, and the cycle was long, which seriously affected his work and life. He also tried to go to the hospital for stomatology treatment. The doctor suggested gargling with salt water, adding more VC, or To prescribe some hormonal drugs, there is no particularly good other treatment. Take the powder product of Example 10 of this patent, 3 times a day, 10g each time, you can obviously feel that the pain is not as unbearable as before when the recurrence occurs, and the recovery period is obviously shortened, the ulcer surface is very small, does not continue to expand, and 3-4 Ulcerativeness gradually disappeared. There has been no recurrence for nearly half a year.

19. Typical case 19 Yang shows that he is 36 years old and engaged in sales work. He is a victim of recurrent oral ulcers. Basically, oral ulcers will recur when he gets angry. Because of work needs, he often needs to communicate with customers face to face. At this time The bad breath caused by the mouth ulcers made her miserable and had a huge impact on her work. I have found various ways to treat it, and I have also eaten traditional Chinese medicine, but the effect is not ideal. After being recommended by others, I took the powder product of Example 10 of this patent, 3 times a day, 10g each time, and the number of oral ulcer recurrences decreased after taking it for 3 months. , and each time the ulcer surface has slowly healed before it has extended to a large size, and the drug has been stopped after continuing to take it for a month, and there has been no recurrence for more than 4 months after stopping the drug.

Claims (13)

1. A traditional Chinese medicine composition, characterized in that the composition is a main prescription with honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower, dandelion and Prunella vulgaris as the main active ingredients;

   Optionally, on the basis of the main prescription, medicinal materials such as Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium and Shixiantao are supplemented as auxiliary prescriptions;

   Optionally, the prescription of the traditional Chinese medicine composition is a prescription of raw medicinal materials, or a prescription composed of its extracts, or a prescription composed of raw medicinal materials and extracts;

   Ratio of the main formula of raw medicinal materials or formula extracts:

   

   Among them, A, B, and C respectively represent the raw materials or extracts of honeysuckle or mountain silver flower or a mixture of honeysuckle and mountain silver flower, dandelion, and Prunella vulgaris, and the unit is weight ratio;

   The total content range of active ingredients in the main formula:

   10.0% ≤ total flavonoids ≤ 25.0% 5.0% ≤ total polysaccharides ≤ 15.0%

   2.0%≤total saponins≤10.0% 2.0%≤total polyphenols≤10.0%;

   The choice of the amount of the main medicinal material or extract equivalent to the main medicinal material; preferably, the total amount may be about 0.001 to 20 g/kg body weight, about 0.005 to 10 g/kg body weight, about 0.01 to 5 g/kg body weight, about 0.01 to 2.5 g/kg body weight, about 0.02 to 1 g/kg body weight, about 0.02 to 0.3 g/kg body weight, about 0.02 to 0.2 g/kg body weight, about 0.02 to 0.1 g/kg body weight, or about 0.02 to 0.08 g/kg body weight or, preferably, the dosage is about 0.01 to 0.05 g/kg body weight; or, preferably, the dosage is about 0.05 to 0.10 g/kg body weight.
2. The traditional Chinese medicine composition according to claim 1, wherein the main prescription is supplemented with medicinal materials Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao as secondary prescriptions, which are prepared into different preparations, and the above prescriptions are the prescriptions of the original medicinal materials , or a composition composed of its extracts,

   The ratios are:

   

   

   Among them, D, E, F, and G represent the raw materials or extracts of Hedyotis diffusa, Hippophae rhamnoides, Citrus aurantium, and Shixiantao, respectively, and the unit is weight ratio;

   The total content range of the active components of the whole formula:

   5.0% ≤ total flavonoids ≤ 20.0% 5.0% ≤ total polysaccharides ≤ 20.0%

   2.0% ≤ total saponins ≤ 10.0% 2.0% ≤ total polyphenols ≤ 15.0%

   The selection of the amount of the above-mentioned secondary medicinal materials or extracts equivalent to the secondary medicinal medicinal materials; preferably, the total amount may be about 0.001 to 20 g/k user g body weight, about 0.005 to 10 g/kg user body weight, about 0.01 to 5 g/kg body weight kg user body weight, approximately 0.01 to 2.5 g/kg user body weight, approximately 0.02 to 1 g/kg user body weight, approximately 0.02 to 0.3 g/kg user body weight, approximately 0.02 to 0.2 g/kg user body weight, approximately 0.02 to 0.1 g/kg body weight of the user, or about 0.02 to 0.08 g/kg body weight of the user; or, preferably, an amount of about 0.01 to 0.05 g/kg body weight of the user; or, preferably, an amount of about 0.05 to 0.10 g/kg user body weight.
3. Chinese medicine composition according to claim 1 and 2, is characterized in that, the preparation of described Chinese medicine composition can directly form with raw material mixing, also can mix after pulverizing.
4. According to the Chinese medicine composition according to any one of claims 1-3, it is characterized in that the Chinese medicine composition is a dosage form, and the preparation includes: substitute tea, granules, capsules, tablets, powders, oral liquids and other acceptable dosage forms.
5. The method for preparing the Chinese medicine composition described in any one of claims 1-3, characterized in that, the Chinese medicine composition can be composed of active substance extracts of various single medicinal materials, or the original medicinal materials are mixed The final active substance extract is prepared by combination; the active ingredient extraction method of any medicinal material, including the active substance of a single herbal medicine or a mixture of multi-flavor medicinal materials, may include but not limited to the following steps:

   (1) Herbal medicinal materials of traditional Chinese medicine are crushed;

   (2) Soak the Chinese medicinal plant powder overnight with the extractant; the extractant is water or ethanol; when the extractant is ethanol, the ethanol concentration is 30%-95%;

   (3) decocting the drug in step (2) or extracting it by low-speed percolation;

   (4) Concentrating the extract, including obtaining a dry paste powder by rotating the extracted solution through rotary evaporation, spray drying or vacuum drying.
6. The method according to claim 5, characterized in that, the Chinese medicine composition can be prepared by combining the active substance extract of a single medicinal material or the active substance extract after mixing the original medicinal materials, and the active ingredient is extracted by supercritical extraction. Or it is prepared by the method of separating the active component group by macroporous resin.
7. The method according to claim 5 or 6, characterized in that other nutritional ingredients can be added as auxiliary materials of the preparation to make different dosage forms to enhance the above-mentioned effects. These effective excipients are nutritional supplements composed of amino acids (glycine, arginine, leucine, valine, alanine, serine, proline, isoleucine, phenylalanine, lysine, threonine acid, methionine, tryptophan, histidine, tyrosine, aspartic acid, cysteine, glutamic acid), curcumin or turmeric extract, betaine hydrochloride, chlorogenic acid, reduced glutathione Glycerin, Yeast β-glucan, Vitamin B6, B2, GABA, Resveratrol, Polyfructose, Galactooligosaccharide, Chitosan, Sodium Alginate, Aloe Vera Gel at least one or two or more of them.
8. The purposes of the traditional Chinese medicine composition described in any one in claim 1-4 in the preparation medicine, described medicine is used for the treatment of Hashimoto's thyroid inflammation, the hypothyroidism disease of unoperated or partial thyroidectomy patient, inflammatory hyperthyroidism disease.
9. The use of the traditional Chinese medicine composition described in any one of claims 1-4 in the preparation of medicines, which are used to treat lymph node enlargement caused by various inflammations.
10. The use of the traditional Chinese medicine composition described in any one of claims 1-4 in the preparation of medicine, and the medicine is used for treating lymphatic tuberculosis.
11. The use of the traditional Chinese medicine composition described in any one of claims 1-4 in the preparation of medicines, and the medicines are used for the treatment of lipoma.
12. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of medicine, which is used to treat hyperplasia of mammary glands in nulliparous women.
13. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of medicines for treating common oral ulcers, especially recurrent oral ulcers.

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