CN103463207A - Composition for prevention and treatment of diabetes - Google Patents
Composition for prevention and treatment of diabetes Download PDFInfo
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- CN103463207A CN103463207A CN2012101858453A CN201210185845A CN103463207A CN 103463207 A CN103463207 A CN 103463207A CN 2012101858453 A CN2012101858453 A CN 2012101858453A CN 201210185845 A CN201210185845 A CN 201210185845A CN 103463207 A CN103463207 A CN 103463207A
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Abstract
The present invention provides a composition for prevention and treatment of diabetes, and the composition contains by weight, 1-100 parts of cinnamon, 1-100 parts of plantain seed, 1-100 parts of mulberry leaf and 1-100 parts of balsam pear. The composition has a good hypoglycemic effect, and is especially suitable for the prevention and treatment of spleen-kidney-Yang deficiency type diabetes.
Description
Technical field
The present invention relates to the compositions of prevention and treatment diabetes.Be specifically related to take prevention prepared as primary raw material by Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae and the compositions for the treatment of diabetes.
Background technology
Current global diabetics is 3.66 hundred million, China's diabetics approximately 9,240 ten thousand, and the prediabetes patient 1.48 hundred million, and diabetes have become the fourth-largest disease that causes population in the world death.In view of the significant damage that diabetes are brought to the mankind, World Health Organization (WHO) is referred to as " disaster of 21 century ".The course of disease of diabetes is long, the medical expense costliness, and according to diabetology branch of Chinese Medical Association statistics, the direct medical expenses of diabetes mellitus in China reaches 1,734 hundred million yuan, accounts for 13% of national medical total expenses.Not only affected patient's life and quality of life, also to the country and people, brought heavy financial burden, therefore developed health food or food with auxiliary hyperglycemic function and there are economical, societal benefits widely.
The current prevention for diabetes both at home and abroad and chemicalses such as biguanide drug, sulfonylurea medicine, insulin of the main employing for the treatment of, but there is following problem in these medicines: and the biguanides curative effect is low, and side effect is large, uses for a long time and produces hyperlactacidemia; Sulfonylureas is for a long time with infringement liver, kidney, with sulfa drugs generation cross allergy; Insulin is for a long time with producing antibody, and biological activity reduces, and dosage increases, and produces hyperinsulinemia.
In recent years, along with the research of relevant natural plants hypoglycemic activity deepens continuously, take natural plants or its activity extract as raw material prepares that side effect is less, the research of the medicine that is suitable for long-term prevention and treatment diabetes and health product is increasing.Take the new direction that medicine that natural plants or its activity extract be raw material and health product research becomes exploitation prevention and treatment diabetes medicament and health product gradually.
Chinese patent application CN200710065461.7 discloses a kind of hypoglycemic health product, it is that to take Rhizoma Alismatis, Poria, the Rhizoma Atractylodis Macrocephalae, Folium Mori, Herba Leonuri, Cortex Cinnamomi, Radix Puerariae, Rhizoma Dioscoreae, Semen Plantaginis be raw material, takes decocting, concentrates and is aided with potassium sorbate etc. it is configured to oral liquid formulation.These health product are rich in glucose, volatile oil, organic acid, vitamin, aminoacid and various trace elements, are beneficial to absorption of human body.These health product have promoting diuresis to clear away damp pathogen, and turbid effect is rushed down in spleen invigorating, reduce blood glucose, have determined curative effect, have no side effect, and taking convenience, cheap characteristics.
Chinese patent application CN200810102841.8 discloses a kind of health food with function of blood sugar reduction and preparation method thereof.The active component of this health food mainly by Ganoderma, Radix Panacis Quinquefolii, Cortex Acanthopanacis Sessiliflori, Herba Apocyni veneti, Flos Chrysanthemi Indici, Semen Cuscutae, cover plate, Semen Allii Tuberosi, Rhizoma Polygonati Odorati, Folium Mori, Semen Plantaginis, Poria and form, also contain Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, Herba Apii graveolentis, Fructus Crataegi, Bulbus Allii, Rhizoma Dioscoreae etc. in raw material.The special extracting method according to the characteristics design of every flavor Chinese medicine, to extract gained extractum pulverizes, be aided with certain proportion lecithin and be prepared into soft capsule dosage form, through animal and human's body, experiment shows, this health food has obvious function of blood sugar reduction, and to impaired glucose tolerance, light, poisoning diabetes curative effect is better, the various complication of diabetes (as diabetic nephropathy, diabetes hepatopathy, neuropathy) are had to unique curative effect, can improve life in patients.
Above-mentioned patent application does not all relate to treatment and the prevention of yang deficiency of spleen and stomache diabetes.
Diabetes belong to the diabetes scope in the traditional Chinese medical science, at present the traditional Chinese medical science by diabetes roughly be divided into that the deficiency of YIN is scorching, deficiency of both QI and YIN, deficiency of both YIN and YANG.Diabetes is treated in warming YANG ruling by law, initiates in Zhang Zhongjing.Later age, the doctor often was used for the deficiency of both YIN and YANG stage in diabetes later stage to this method.But along with deepening continuously that diabetes is familiar with, reach the progress to its prevention and treatment of complication, finding quenches one's thirst also factor body yang deficiency, and from the beginning of have the deficiency of vital energy and yang deficiency person concurrently simultaneously, spleen kidney yang QI-insufficiency is the pathogenesis essence of type 2 diabetes mellitus insulin resistant.Spleen kidney yang QI-insufficiency causes the yang deficiency of spleen and stomache diabetes, and its classical symptom comprises that coldness of the body with chills, spiritlessness and weakness, soreness of the waist and knees, limbs edema, numb pain, complexion white, clear urine in large amounts or deficient, nocturia increase, defecate uncomfortable etc.Therefore, for being used for the treatment of and preventing the medicine of yang deficiency of spleen and stomache diabetes and health product to exist demand.
Summary of the invention
The object of the present invention is to provide a kind of hypoglycemic activity that has, be intended to the compositions of prevention and treatment diabetes.Said composition can reduce the sickness rate of diabetes, and effectively alleviates the various clinical symptoms of diabetes, particularly effective to the control of yang deficiency of spleen and stomache diabetes.
For achieving the above object, the inventor is understanding and the Therapeutic Principle for diabetes and complication mechanism thereof based on the traditional Chinese medical science, in conjunction with the pharmacological research to medicinal plants, animal experiment and clinical trial, through deeply screening for many years, the Cortex Cinnamomi of selecting to contain certain content, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae are as the present composition of essential component.
As the primary raw material for preparing the present composition, Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae have following effect:
1. Cortex Cinnamomi
The dry bark that Cortex Cinnamomi is the canella Cortex Cinnamomi, record the earliest comes from Shennong's Herbal, is clinical drugs for dispelling internal cold commonly used.It is fiery supporing yang that Cortex Cinnamomi has benefit, let the fire back to its origin, dispersing cold for relieving pain, the function of promoting blood circulation to restore menstrual flow.The Cortex Cinnamomi ingredient has volatile oil (cinnamic aldehyde), tannin, sesquiterpene, diterpene-kind compound etc.Many research discoveries in recent years, Cortex Cinnamomi has blood sugar lowering and effect for reducing blood fat.The hypoglycemic mechanism of action of Cortex Cinnamomi comprises: the content that 1. by protection, stimulation beta Cell of islet, increases serum insulin; 2. increase the sensitivity of insulin, improve insulin resistant; 3. remove free radical, anti peroxidation of lipid; 4. promote insulin secretion, increase the content of serum insulin.
2. Semen Plantaginis
Semen Plantaginis is the seed of Plantaginaceae plant Herba Plantaginis or Plantago depressa Willd.The root of Herba Plantaginis, leaf and seed all can be used as medicine.Shennong's Herbal is classified it as in medicine top grade.Semen Plantaginis is sweet in flavor and cold in property, but diuretic, heat clearing away, improving eyesight, eliminates the phlegm.The traditional Chinese medical science is commonly used it and is treated the detumescence distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, the diseases such as phlegm-heat cough.The chemical composition of Semen Plantaginis comprises the materials such as flavone compound (as luteolin, Homoplantaginin etc.), polysaccharide compound (xylose, arabinose, rhamnose, galactose etc.), triterpenoid compound (ursolic acid, oleanolic acid), volatile oil and alkaloid, and modern pharmacological research shows: Semen Plantaginis have antidiarrheal, hepatoprotective, blood pressure lowering, antibacterial, reduce the effect such as serum cholesterol.Foreign study shows that plantago asiatica linne polyoses is a kind of part fermentable dietary fiber, the effect that not only there is whole intestinal relieving constipation, reduce in addition the effect of blood fat, adjusting blood glucose, the diabetic mice oxidative stress that the plantago asiatica linne polyoses of research discovery is recently induced alloxan, the hepatic mitochondria lipid peroxidation that ferrous sulfate-vitamin C is induced have antagonism, and oxidative stress occupies critical role in the genesis of diabetes and chronic complicating diseases thereof.
3. Folium Mori
Folium Mori have the effect of expelling wind and clearing away heat, cooling blood for improving eyesight.Modern study shows: alkaloid 1-DNJ (DNJ) in Folium Mori (content is 0.1 ~ 0.3%) is topmost blood sugar lowering effective ingredient.DNJ is effective inhibitor of mammal alpha-glucosidase activity, alpha-glucosidase main being responsible in human body cut glucose from the non-reducing end of starch and relevant polysaccharide, therefore, after alpha-glucosidase activity is suppressed, thereby slow down the formation speed of intestinal glucose, reduce the regular supply of glucose to intestinal absorption, delayed and reduce blood glucose in the phenomenon raise fast after the meal, reached the purpose for the treatment of and control diabetes.The main component of the medicine " acarbose " of the treatment diabetes that Germany produces is exactly alpha-glucosidase activity inhibitor.
4. Fructus Momordicae charantiae
China since ancient times, just is used as medicinal plants utilization to Fructus Momordicae charantiae.In the ancient Chinese proses such as herbal for Relief of Famines and Compendium of Material Medica are offered, all once mentioned Fructus Momordicae charantiae.Aspect diabetes, all emphasize that it can " quench the thirst ", " curing mainly the excessive thirst taking fluids profusely " etc.The Ming Dynasty's large medicine scholar Li Shizhen (1518-1593 A.D.) is said: " the Fructus Momordicae charantiae nature and flavor are bitter, cold, nontoxic, have except pathogenic heat, separate the effect of tired, the improving eyesight that clears away heart-fire, QI invigorating tonifying YANG." Fructus Momordicae charantiae is very effective in cure for the retinopathy of one of diabetes three large complication.
The invention provides following technical scheme:
1, compositions, in weight portion, it contains Cortex Cinnamomi 1-100 part, Semen Plantaginis 1-100 part, Folium Mori 1-100 part and Fructus Momordicae charantiae 1-100 part.
2, according to the compositions of technical scheme 1, in weight portion, it contains Cortex Cinnamomi 20-80 part, preferably contains Cortex Cinnamomi 30-70 part, more preferably contains Cortex Cinnamomi 40-50 part.
3,, according to the described compositions of any one in technical scheme 1-2, in weight portion, it contains Semen Plantaginis 20-80 part, preferably contains Semen Plantaginis 30-70 part, more preferably contains Semen Plantaginis 40-50 part.
4,, according to the described compositions of any one in technical scheme 1-3, in weight portion, it contains Folium Mori 5-50 part, preferably contains Folium Mori 10-40 part, more preferably contains Folium Mori 15-30 part.
5,, according to the described compositions of any one in technical scheme 1-4, in weight portion, it contains Fructus Momordicae charantiae 1-50 part, preferably contains Fructus Momordicae charantiae 1-40 part, more preferably contains Fructus Momordicae charantiae 5-25 part.
6, according to the described compositions of any one in technical scheme 1-5, one or more of can replacement with extract or lyophilized powder separately in Cortex Cinnamomi, Semen Plantaginis, Folium Mori and Fructus Momordicae charantiae wherein.
7, according to the described compositions of technical scheme 6, when using Cortex Cinnamomi extract, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 20-70 weight portion, and more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion; When using Semen Plantaginis extract, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 20-70 weight portion, and more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion; When using Folium Mori extract, in every 100 weight portion compositionss, its content is 1-95 weight portions, is preferably the 5-45 weight portion, and more preferably the 10-35 weight portion, most preferably be the 15-25 weight portion; When using Fructus Momordicae charantiae extract, in every 100 weight portion compositionss, its content, for for the 1-95 weight portion, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion; When using balsam pear freeze-dried powder, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion.
8, according to the described compositions of 1-7 any one in technical scheme, in weight portion, it contains Cortex Cinnamomi powder 20-80 part or Cortex Cinnamomi extract 20-70 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and Fructus Momordicae charantiae extract or balsam pear freeze-dried powder 1-40 part.
9, product, it comprises the described compositions of any one in technical scheme 1-8, and described product is medicine or health product, and preferred described product is granule, tablet, capsule, oral liquid, solid beverage, teabag or powder.
10, in technical scheme 1-8 the described compositions of any one for the preparation for the treatment of or prevent diabetes, the preferably medicine of yang deficiency of spleen and stomache diabetes or the purposes in health product.
The specific embodiment
In the present composition, primary raw material Cortex Cinnamomi, Semen Plantaginis, Folium Mori and Fructus Momordicae charantiae complement each other, and have collaborative hypoglycemic activity, especially are applicable to prevention and treatment yang deficiency of spleen and stomache diabetes.
In weight portion, the present composition contains Cortex Cinnamomi 1-100 part, Semen Plantaginis 1-100 part, Folium Mori 1-100 part and Fructus Momordicae charantiae 1-100 part.In said composition, the content of Cortex Cinnamomi is preferably the 20-80 weight portion, more preferably 30-70 weight portion, more preferably 40-50 weight portion; The content of Semen Plantaginis is preferably the 20-80 weight portion, more preferably 30-70 weight portion, more preferably 40-50 weight portion; The content of Folium Mori is preferably the 5-50 weight portion, more preferably 10-40 weight portion, more preferably 15-30 weight portion; The content of Fructus Momordicae charantiae is preferably the 1-50 weight portion, more preferably 1-40 weight portion, more preferably 5-25 weight portion.
In a kind of preferred implementation, in weight portion, the present composition contains Cortex Cinnamomi 20-80 part, Semen Plantaginis 20-80 part, Folium Mori 5-50 part and Fructus Momordicae charantiae 1-50 part.In another kind of preferred implementation, in weight portion, the present composition contains Cortex Cinnamomi 30-70 part, Semen Plantaginis 30-70 part, Folium Mori 10-40 part and Fructus Momordicae charantiae 1-40 part.In another preferred implementation, in weight portion, the present composition contains Cortex Cinnamomi 40-50 part, Semen Plantaginis 40-50 part, Folium Mori 15-30 part and Fructus Momordicae charantiae 5-25 part.
In above-mentioned composition, raw material Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae can adopt former powder, and former powder can adopt commercially available prod, or utilize conventional pulverizing, the technology of sieving processed and prepared commercially available Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae.Wherein Cortex Cinnamomi, Semen Plantaginis and Folium Mori should meet the corresponding requirements of one one of the Pharmacopoeia of the People's Republic of China (2010 editions).In Fructus Momordicae charantiae powder, the content of total Saponin should be not less than approximately 0.01% of Fructus Momordicae charantiae powder gross weight.In one embodiment, Fructus Momordicae charantiae powder is generally the light green uniform powder, has the distinctive flavour of Fructus Momordicae charantiae and fragrance, preferred mistake 80 mesh sieves.
In the present composition, one or more of can the replacement with extract or lyophilized powder separately in the former powder of Cortex Cinnamomi, Semen Plantaginis, Folium Mori and Fructus Momordicae charantiae.Cortex Cinnamomi extract can be commercially available, or by conventional extracting method preparation well known by persons skilled in the art.In Cortex Cinnamomi extract, the content of Cortex Cinnamomi polyphenol should be not less than approximately 10% of Cortex Cinnamomi extract gross weight.In one embodiment, Cortex Cinnamomi extract is generally brown uniform powder, has the distinctive flavour of Cortex Cinnamomi and fragrance, and it preferably crosses 80 mesh sieves.In a kind of embodiment, when using Cortex Cinnamomi extract, in every 100 weight portion compositionss, its content in the present composition is the 1-95 weight portion, is preferably the 20-70 weight portion, and more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion.
Semen Plantaginis extract can be commercially available, or by conventional extracting method preparation well known by persons skilled in the art.In Semen Plantaginis extract, the content of polysaccharide should be not less than approximately 10% of Semen Plantaginis extract gross weight.In one embodiment, Semen Plantaginis extract is generally the grey uniform powder, lightly seasoned, and it preferably crosses 80 mesh sieves.In a kind of embodiment, when using Semen Plantaginis extract, in every 100 weight portion compositionss, its content in the present composition is the 1-95 weight portion, is preferably the 20-70 weight portion, and more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion.
Folium Mori extract can be commercially available, or by conventional extracting method preparation well known by persons skilled in the art.In Folium Mori extract, the content of 1-DNJ should be not less than approximately 1% of Folium Mori extract gross weight.In one embodiment, Folium Mori extract is generally green and brown color uniform powder, has the distinctive abnormal smells from the patient of Folium Mori, and it preferably crosses 80 mesh sieves.In a kind of embodiment, when using Folium Mori extract, in every 100 weight portion compositionss, its content in the present composition is the 1-95 weight portion, is preferably the 5-45 weight portion, and more preferably the 10-35 weight portion, most preferably be the 15-25 weight portion.
Fructus Momordicae charantiae extract can be commercially available, or by conventional extracting method preparation well known by persons skilled in the art.In Fructus Momordicae charantiae extract, the content of total Saponin should be not less than approximately 10% of Fructus Momordicae charantiae extract gross weight.In one embodiment, Fructus Momordicae charantiae extract is generally the yellowish-brown uniform powder, has the distinctive flavour of Fructus Momordicae charantiae and fragrance, and it preferably crosses 80 mesh sieves.In a kind of embodiment, when using Fructus Momordicae charantiae extract, in every 100 weight portion compositionss, its content in the present composition is the 1-95 weight portion, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion.
Balsam pear freeze-dried powder can be commercially available, or by routine well known by persons skilled in the art squeeze the juice, the preparation of filtering and concentrating, freeze-drying method.In balsam pear freeze-dried powder, the content of total Saponin should be not less than approximately 1% of lyophilized powder gross weight.In one embodiment, balsam pear freeze-dried powder is generally the yellowish-brown uniform powder, has the distinctive flavour of Fructus Momordicae charantiae and fragrance, preferred mistake 80 mesh sieves.When using balsam pear freeze-dried powder, in every 100 weight portion compositionss, its content in the present composition is the 1-95 weight portion, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion.
In a kind of preferred implementation, in weight portion, the present composition comprises Cortex Cinnamomi powder 20-80 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and Fructus Momordicae charantiae extract 1-40 part.In another kind of preferred implementation, in weight fraction, the present composition comprises Cortex Cinnamomi powder 20-80 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and balsam pear freeze-dried powder 1-40 part.In another kind of preferred implementation, in weight portion, the present composition comprises Cortex Cinnamomi extract 20-70 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and Fructus Momordicae charantiae extract 1-40 part.In another kind of preferred implementation, in weight portion, the present composition comprises Cortex Cinnamomi extract 20-70 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and balsam pear freeze-dried powder 1-40 part.More preferably, in embodiment, in weight portion, the present composition comprises Cortex Cinnamomi powder 30-70 part, Semen Plantaginis extract 30-65 part, Folium Mori extract 10-35 part and Fructus Momordicae charantiae extract 1-30 part; More preferably, in embodiment, in weight portion, the present composition comprises Cortex Cinnamomi powder 30-70 part, Semen Plantaginis extract 30-65 part, Folium Mori extract 10-35 part and balsam pear freeze-dried powder 1-30 part; More preferably, in embodiment, in weight portion, the present composition comprises Cortex Cinnamomi extract 30-65 part, Semen Plantaginis extract 30-65 part, Folium Mori extract 10-35 part and Fructus Momordicae charantiae extract 1-30 part; More preferably, in embodiment, in weight portion, contain Cortex Cinnamomi extract 30-65 part, Semen Plantaginis extract 30-65 part, Folium Mori extract 10-35 part and balsam pear freeze-dried powder 1-30 part in the present composition.
Can further add acceptable auxiliary additive on pharmaceutically acceptable auxiliary additive or food at the present composition, thereby make the product for prevention and treatment diabetes, this product can be medicine or health product etc.As required, can be by forms such as the agent of described product granulation, tablet, capsule, oral liquid, solid beverage, teabag, powders.
Be applicable to acceptable auxiliary additive on pharmaceutically acceptable auxiliary additive in the present composition or food and include but not limited to binding agent, lubricant, disintegrating agent, correctives, antioxidant etc.
Above-mentioned binding agent includes but not limited to hydroxypropyl cellulose, corn starch, pregelatinized Starch, modified corn starch, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, lactose, arabic gum, ethyl cellulose, cellulose acetate etc.
Above-mentioned lubricant includes but not limited to magnesium stearate, zinc stearate, calcium stearate, Talcum, stearic acid, silica sol, Palmic acid etc.
Above-mentioned disintegrating agent includes but not limited to cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, starch, potato starch, pregelatinized Starch, corn starch, primojel, microcrystalline Cellulose, hydroxypropyl cellulose etc.
Above-mentioned correctives includes but not limited to fruit essence, aspartame, stevioside etc.
Above-mentioned antioxidant includes but not limited to anti-butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate (PG), ascorbic acid, alpha-tocopherol etc.
Beneficial effect
The present composition can be prepared into medicine or health product, edible safety, health invigorating, effectively prevent diabetes, the especially generation of yang deficiency of spleen and stomache diabetes.
The present composition be comprised of Cortex Cinnamomi powder, Semen Plantaginis powder, powder of Folium Mori and Fructus Momordicae charantiae powder after deliberation has significant collaborative blood sugar decreasing effect to the OLETF rat.Especially the present composition be comprised of Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract and Fructus Momordicae charantiae extract has collaborative blood sugar decreasing effect very significantly to the OLETF rat; With model group relatively, the present composition can significantly reduce blood glucose (
pwhat<0.05), have even is better than positive control rosiglitazone (seeing embodiment 6).
By 30 routine clinical observations, diabetics is taken the present composition, and every day 3 times, each 2, be 30 days the course for the treatment of.Result: produce effects 23 examples, effective 6 examples, invalid 1 example, total effective rate 96.7%(is shown in embodiment 7).
Present composition side effect is little, use safety.The ICR acute toxicity test in mice shows: with 80 times of gastric infusions of clinical dosage (5 g/bags, 1 times/day), Continuous Observation 7 days, none death.Long term toxicity test shows with 40 times of clinical dosage to observe and obvious toxic and side effects within 6 months, not occur to the continuous gavage of SD rat.
Embodiment
By the following examples the present invention is illustrated, following examples limit the invention never in any form.
In following examples, all raw materials and reagent adopt commercially available prod, and wherein Cortex Cinnamomi, Semen Plantaginis, Folium Mori are purchased from hundred primary Chinese herbal medicine company limiteies of Guangxi Yulin; Cortex Cinnamomi extract is purchased from sky, Xi'an one Bioisystech Co., Ltd (batch number TY2011108); Semen Plantaginis extract is purchased from Ningbo Liwah Plant Extract Technology Co., Ltd. (lot number 20111201); Folium Mori extract is purchased from Shaanxi brocade safe biological engineering company limited (batch number JT20111225); Balsam pear freeze-dried powder is purchased from Beihai, Guangxi BAIGUO source fruit juice food company limited (batch number 201117); Fructus Momordicae charantiae extract is purchased from Shaanxi brocade safe biological engineering company limited (batch number JT20111214); Fructus Momordicae charantiae is purchased from Ou Shang Suzhou golden pheasant Hu Dian.
The present composition product that embodiment 1 contains Cortex Cinnamomi powder, Semen Plantaginis powder, powder of Folium Mori and Fructus Momordicae charantiae powder
Capsule preparation method thereof:
Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae are pulverized respectively, crossed 80 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis powder, powder of Folium Mori, Fructus Momordicae charantiae powder and microcrystalline Cellulose mix homogeneously, incapsulate, obtain.
Method for preparing tablet thereof: Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae are pulverized respectively, cross 100 mesh sieves, then take each batching according to formula, by Cortex Cinnamomi powder, Semen Plantaginis powder, powder of Folium Mori, Fructus Momordicae charantiae powder, microcrystalline Cellulose, hydroxypropyl emthylcellulose, PVP K30, carboxymethyl starch receive, mix homogeneously, with 50% appropriate amount of ethanol soft material processed, 20 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate, additional magnesium stearate mix homogeneously, tabletting and get final product.
Method for preparing solid beverage thereof: Cortex Cinnamomi, Semen Plantaginis, Folium Mori, Fructus Momordicae charantiae are pulverized respectively, crossed 60 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis powder, powder of Folium Mori, Fructus Momordicae charantiae powder, maltodextrin, stevioside mix homogeneously, packing and get final product.
Embodiment 2: the present composition product that contains Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract and Fructus Momordicae charantiae extract
Capsule preparation method thereof:
Cortex Cinnamomi is pulverized, cross 80 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, Fructus Momordicae charantiae extract and microcrystalline Cellulose mix homogeneously, incapsulate, obtain.
Method for preparing tablet thereof: Cortex Cinnamomi is pulverized, cross 100 mesh sieves, then take each batching according to formula, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, Fructus Momordicae charantiae extract, microcrystalline Cellulose, hydroxypropyl emthylcellulose, PVP K30, carboxymethyl starch receive, mix homogeneously, with 50% appropriate amount of ethanol soft material processed, 20 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate, additional magnesium stearate mix homogeneously, tabletting and get final product.
Method for preparing solid beverage thereof: Cortex Cinnamomi is pulverized, cross 60 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, Fructus Momordicae charantiae extract, maltodextrin, stevioside mix homogeneously, packing and get final product.
Embodiment 3: the present composition product that contains Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract and balsam pear freeze-dried powder
Capsule preparation method thereof: Cortex Cinnamomi is pulverized, cross 80 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, microcrystalline Cellulose mix homogeneously, incapsulate, obtain.
Method for preparing tablet thereof: Cortex Cinnamomi is pulverized, cross 100 mesh sieves, then take each batching according to formula, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, microcrystalline Cellulose, hydroxypropyl emthylcellulose, PVP K30, carboxymethyl starch receive, mix homogeneously, with 50% appropriate amount of ethanol soft material processed, 20 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate, additional magnesium stearate mix homogeneously, tabletting and get final product.
Method for preparing solid beverage thereof: Cortex Cinnamomi is pulverized, cross 60 mesh sieves, then according to formula, take each batching, by Cortex Cinnamomi powder, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, maltodextrin, stevioside mix homogeneously, packing and get final product.
Embodiment 4: the present composition product that contains Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract and Fructus Momordicae charantiae extract
Capsule preparation method thereof: take each batching according to formula, by Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract, Fructus Momordicae charantiae extract, microcrystalline Cellulose mix homogeneously, incapsulate, obtain.
Method for preparing tablet thereof: according to formula, take each batching, by Cortex Cinnamomi extract, Folium Mori extract, Fructus Momordicae charantiae extract, microcrystalline Cellulose, hydroxypropyl emthylcellulose, PVP K30, carboxymethyl starch receive, mix homogeneously, with 50% appropriate amount of ethanol soft material processed, 20 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate, additional magnesium stearate mix homogeneously, tabletting and get final product.
Method for preparing solid beverage thereof: take each batching according to formula, by Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract, Fructus Momordicae charantiae extract, maltodextrin, stevioside mix homogeneously, packing and get final product.
Embodiment 5: the present composition product that contains Cortex Cinnamomi extract, Semen Plantaginis, Folium Mori extract and balsam pear freeze-dried powder
Capsule preparation method thereof: take each batching according to formula, by Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, microcrystalline Cellulose mix homogeneously, incapsulate, obtain.
Method for preparing tablet thereof: according to formula, take each batching, by Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, microcrystalline Cellulose, hydroxypropyl emthylcellulose, PVP K30, carboxymethyl starch receive, mix homogeneously, with 50% appropriate amount of ethanol soft material processed, 20 mesh sieves are granulated, 60 ℃ of dryings, 20 mesh sieve granulate, additional magnesium stearate mix homogeneously, tabletting and get final product.
Method for preparing solid beverage thereof: take each batching according to formula, by Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract, balsam pear freeze-dried powder, maltodextrin, stevioside mix homogeneously, packing and get final product.
The hypoglycemic activity of 6 pairs of OLETF rats of embodiment
Be prepared as follows test specimen: (1) takes 160g Cortex Cinnamomi extract and 340g microcrystalline Cellulose, makes 1000 capsules; (2) take 160g Semen Plantaginis extract and 340g microcrystalline Cellulose, make 1000 capsules; (3) take 60g Folium Mori extract and 440g microcrystalline Cellulose, make 1000 capsules; (4) take 20g Fructus Momordicae charantiae extract and 480g microcrystalline Cellulose, make 1000 capsules; (5) take 160g Cortex Cinnamomi extract, 160g Semen Plantaginis extract and 180g microcrystalline Cellulose, make 1000 capsules; (6) take 160g Cortex Cinnamomi extract, 60g Folium Mori extract and 280g microcrystalline Cellulose, make 1000 capsules; (7) take 160g Cortex Cinnamomi extract, 20g Fructus Momordicae charantiae extract and 320g microcrystalline Cellulose, make 1000 capsules; (8) take 160g Semen Plantaginis extract, 60g Folium Mori extract and 280g microcrystalline Cellulose, make 1000 capsules; (9) take 160g Semen Plantaginis extract, 20g Fructus Momordicae charantiae extract and 320g microcrystalline Cellulose, make 1000 capsules; (10) take 60g Folium Mori extract, 20g Fructus Momordicae charantiae extract and 420g microcrystalline Cellulose, make 1000 capsules; (11) take 160g Cortex Cinnamomi extract, 160g Semen Plantaginis extract, 60g Folium Mori extract and 120g microcrystalline Cellulose, make 1000 capsules; (12) take 160g Cortex Cinnamomi extract, 160g Semen Plantaginis extract, 20g Fructus Momordicae charantiae extract and 160g microcrystalline Cellulose, make 1000 capsules; (13) take 160g Cortex Cinnamomi extract, 60g Folium Mori extract, 20g Fructus Momordicae charantiae extract and 260g microcrystalline Cellulose, make 1000 capsules; (14) take 160g Semen Plantaginis extract, 60g Folium Mori extract, 20g Fructus Momordicae charantiae extract and 260g microcrystalline Cellulose, make 1000 capsules; (15) take 160g Cortex Cinnamomi powder, 160g Semen Plantaginis powder, 60g powder of Folium Mori, 20g Fructus Momordicae charantiae powder and 100g microcrystalline Cellulose, make 1000 capsules.(16) take 160g Cortex Cinnamomi extract, 160g Semen Plantaginis extract, 60g Folium Mori extract, 20g Fructus Momordicae charantiae extract and 100g microcrystalline Cellulose, make 1000 capsules.
180 OLETF rats (purchased from Japan's large tomb pharmacy Tokushima institute, 20 week age, male and female half and half) are raised under no-special pathogen level (SPF level) condition, raised with standard feed (purchased from the western pul in Shanghai-Bi Kai laboratory animal company limited).In raising to 32 week, be divided at random 18 groups.Gastric infusion 3 weeks, once a day.Wherein respectively organizing dosage is respectively: model group: normal saline 10 mL/kg body weight; Rosiglitazone group: 2.5mg/kg body weight; Cortex Cinnamomi extract group: 160 mg/kg body weight; Semen Plantaginis extract group: 160mg/kg body weight; Folium Mori extract group: 60 mg/kg body weight; Fructus Momordicae charantiae extract group: 20mg/kg body weight; Cortex Cinnamomi extract+Semen Plantaginis extract group: 160mg Cortex Cinnamomi extract/kg body weight+160mg Semen Plantaginis extract/kg body weight; Cortex Cinnamomi extract+Folium Mori extract group: 160mg Cortex Cinnamomi extract/kg body weight+60mg Folium Mori extract/kg body weight; Cortex Cinnamomi extract+Fructus Momordicae charantiae extract group: 160mg Cortex Cinnamomi extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight; Semen Plantaginis extract+Folium Mori extract group: 160mg Semen Plantaginis extract/kg body weight+60mg Folium Mori extract/kg body weight; Semen Plantaginis extract+Fructus Momordicae charantiae extract group: 160mg Semen Plantaginis extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight; Folium Mori extract+Fructus Momordicae charantiae extract group: 60mg Folium Mori extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight; Cortex Cinnamomi extract+Semen Plantaginis extract+Folium Mori extract group: 160mg Cortex Cinnamomi extract/kg body weight+160mg Semen Plantaginis extract/kg body weight+60mg Folium Mori extract/kg body weight; Cortex Cinnamomi extract+Semen Plantaginis extract+Fructus Momordicae charantiae extract group: 160mg Cortex Cinnamomi extract/kg body weight+160mg Semen Plantaginis extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight; Cortex Cinnamomi extract+Folium Mori extract+Fructus Momordicae charantiae extract group: 160mg Cortex Cinnamomi extract/kg body weight+60mg Folium Mori extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight.Semen Plantaginis extract+Folium Mori extract+Fructus Momordicae charantiae extract group: 160mg Semen Plantaginis extract/kg body weight+60mg Folium Mori extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight; Cortex Cinnamomi powder+Semen Plantaginis powder+powder of Folium Mori+Fructus Momordicae charantiae powder group: 160mg Cortex Cinnamomi powder/kg body weight+160mg Semen Plantaginis powder/kg body weight+60mg powder of Folium Mori kg body weight+20mg Fructus Momordicae charantiae powder/kg body weight.Cortex Cinnamomi extract+Semen Plantaginis extract+Folium Mori extract+Fructus Momordicae charantiae extract group: 160mg Cortex Cinnamomi extract/kg body weight+160mg Semen Plantaginis extract/kg body weight+60mg Folium Mori extract/kg body weight+20mg Fructus Momordicae charantiae extract/kg body weight.After finishing, administration detects the fasting glucose of each group.
The data of table 1 show, with model group, compare, and Cortex Cinnamomi powder+Semen Plantaginis powder+powder of Folium Mori+Fructus Momordicae charantiae powder group has significant blood sugar decreasing effect.In addition, Cortex Cinnamomi extract+Semen Plantaginis extract+Folium Mori extract+Fructus Momordicae charantiae extract group has very significant blood sugar decreasing effect, and its effect even is better than the rosiglitazone positive controls.Than only give in Cortex Cinnamomi extract, Semen Plantaginis extract, Folium Mori extract and Fructus Momordicae charantiae extract any one, two or three group
,cortex Cinnamomi extract+Semen Plantaginis extract+Folium Mori extract+Fructus Momordicae charantiae extract group has significant collaborative blood sugar decreasing effect.Visible, with model group relatively, the present composition can significantly reduce blood glucose (
p<0.05), extractive composition of the present invention even is better than the positive control rosiglitazone.
Embodiment 7 effect of lowering blood sugar experiments
Sample is selected the capsule in embodiment 4.
(1) the routine deficiency of spleen-YANG and kidneyYANG diabetes mellitus type of clinical data 60 is divided into two groups at random, treatment group 30 examples, male 15 examples wherein, female's 15 examples, 65 years old ± 7.2 years old age, the course of disease 7.52 ± 5.12 years; Matched group 30 examples, male 15 examples wherein, female's 15 examples, 66 years old ± 7.7 years old age, the course of disease 7.45 ± 4.91.Learn and process by statistics, between two groups, the equal not statistically significant of indices difference, have comparability.
(2) the oral capsule of the present invention of Therapeutic Method treatment group, every day 3 times, each 2, be 30 days the course for the treatment of.Oral SHENQI JIANGTANG KELI 3 grams of matched group, every day 3 times, be 30 days the course for the treatment of.
(3) observation index
1. curative effect index
Fasting glucose, after the meal 2 hours blood glucoses, glycolated hemoglobin all before treatment and when end treatment respectively survey 1 time.
2. tcm symptom
Observe following symptom variation: coldness of the body with chills, spiritlessness and weakness, soreness of the waist and knees, limbs edema, numb pain, complexion white, clear urine in large amounts or deficient, nocturia increase, defecate uncomfortable.By above-mentioned symptom basis " guideline of clinical investigations of new Chinese medicine treatment diabetes " (2002 editions) " tcm symptom scalar quantization standard ", be divided into without, light, in, weigh four grades, adopt sxemiquantitative grade score evaluation methodology, count 0,2,4,6 minute, respectively at before treatment, the registration of score after treatment, observe the integration variation for the treatment of front and back.
(4) criterion of therapeutical effect is worked out with reference to the guideline of clinical investigations of the treatment of the new Chinese medicine in new Chinese medicine guideline of clinical investigations diabetes.
1. produce effects: fasting glucose and after the meal 2 hours blood glucoses drop to normal range; Or fasting glucose and after the meal 2 hours blood glucose values descend to surpass 40% before treatment, the glycolated hemoglobin value drops to normally, or descend surpass treatment front 30%.
2. effective: fasting glucose and after the meal 2 hours blood glucoses descend to surpass 20% before treatment, but do not reach the produce effects standard, the glycolated hemoglobin value descends and surpasses 10% before treatment, but does not reach the produce effects standard.
3. tcm symptom all is not improved, even increase the weight of, the disease integration reduces less than 30%; Fasting glucose and after the meal 2 hours blood glucoses without decline, or descend and not reach effective standard, the glycolated hemoglobin value is without decline, or descends and do not reach effective standard.
(5) in efficacy result treatment group 30 examples, produce effects 23 examples, effective 6 examples, invalid 1 example, total effective rate 96.7%, matched group 30 examples, produce effects 17 examples, effective 6 examples, invalid 6 examples, total effective rate 76.7%.
(6) two groups of patient of therapeutic evaluation are after 30 days, aspect curative effect, there were significant differences (
p<0.05), from leading indicators such as glucose, tcm symptoms, improve the aspect analysis, treatment group has preferably effect, the results are shown in Table 2 and table 3.
Comprehensive clinical observation result can draw to draw a conclusion:
1. invent related prevention and treatment diabetes especially the compositions of yang deficiency of spleen and stomache diabetes there is good blood sugar reducing function, be no matter fasting glucose or 2 hours blood glucoses after the meal, all have clear improvement.
2. the compositions of inventing related prevention and treatment diabetes is significantly improved effect for the coldness of the body with chills of yang deficiency of spleen and stomache diabetes, spiritlessness and weakness, soreness of the waist and knees, limbs edema, numb pain, complexion white, clear urine in large amounts or deficient, the nocturia clinical symptoms such as uncomfortable that increases, defecates.
The description of the above-described embodiment and examples of the present invention only, for the purpose of explaination and explanation, not limits the present invention by any way.Clearly, those skilled in the art can carry out multiple change and variation according to the instruction of the context of the invention.These changes and change all drop in the spirit and scope of the invention that claim limits.
Claims (10)
1. compositions, in weight portion, it contains Cortex Cinnamomi 1-100 part, Semen Plantaginis 1-100 part, Folium Mori 1-100 part and Fructus Momordicae charantiae 1-100 part.
2. according to the compositions of claim 1, in weight portion, it contains Cortex Cinnamomi 20-80 part, preferably contains Cortex Cinnamomi 30-70 part, more preferably contains Cortex Cinnamomi 40-50 part.
3. according to the described compositions of any one in claim 1-2, in weight portion, it contains Semen Plantaginis 20-80 part, preferably contains Semen Plantaginis 30-70 part, more preferably contains Semen Plantaginis 40-50 part.
4. according to the described compositions of any one in claim 1-3, in weight portion, it contains Folium Mori 5-50 part, preferably contains Folium Mori 10-40 part, more preferably contains Folium Mori 15-30 part.
5. according to the described compositions of any one in claim 1-4, in weight portion, it contains Fructus Momordicae charantiae 1-50 part, preferably contains Fructus Momordicae charantiae 1-40 part, more preferably contains Fructus Momordicae charantiae 5-25 part.
6. according to the described compositions of any one in claim 1-5, one or more of can replacement with extract or lyophilized powder separately in Cortex Cinnamomi, Semen Plantaginis, Folium Mori and Fructus Momordicae charantiae wherein.
7. compositions according to claim 6, when using Cortex Cinnamomi extract, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 20-70 weight portion, more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion; When using Semen Plantaginis extract, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 20-70 weight portion, and more preferably the 30-65 weight portion, most preferably be the 35-45 weight portion; When using Folium Mori extract, in every 100 weight portion compositionss, its content is 1-95 weight portions, is preferably the 5-45 weight portion, and more preferably the 10-35 weight portion, most preferably be the 15-25 weight portion; When using Fructus Momordicae charantiae extract, in every 100 weight portion compositionss, its content, for for 1-95 weight portions, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion; When using balsam pear freeze-dried powder, in every 100 weight portion compositionss, its content is the 1-95 weight portion, is preferably the 1-40 weight portion, and more preferably the 1-30 weight portion, most preferably be the 5-20 weight portion.
8. according to the described compositions of any one in claim 1-7, in weight portion, it contains Cortex Cinnamomi powder 20-80 part or Cortex Cinnamomi extract 20-70 part, Semen Plantaginis extract 20-70 part, Folium Mori extract 5-45 part and Fructus Momordicae charantiae extract or balsam pear freeze-dried powder 1-40 part.
9. product, it comprises the described compositions of any one in claim 1-8, and described product is medicine or health product, and preferred described product is granule, tablet, capsule, oral liquid, solid beverage, teabag or powder.
In claim 1-8 the described compositions of any one for the preparation for the treatment of or prevent diabetes, the preferably medicine of yang deficiency of spleen and stomache diabetes or the purposes in health product.
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