CN114558088B

CN114558088B - Mongolian medicine compound for treating primary osteoporosis and application thereof

Info

Publication number: CN114558088B
Application number: CN202210258747.1A
Authority: CN
Inventors: 肖吉日木图; 郭杨; 马勇; 余自层; 宁吉德玛; 吴七柱; 王布和朝鲁
Original assignee: Inner Mongolia Medical University
Current assignee: Nanjing University of Chinese Medicine; Inner Mongolia Medical University
Priority date: 2022-03-16
Filing date: 2022-03-16
Publication date: 2022-12-27
Anticipated expiration: 2042-03-16
Also published as: CN114558088A

Abstract

The invention discloses a Mongolian medicine compound for treating primary osteoporosis and application thereof, and relates to the field of Mongolian pharmacology. The Mongolian medicine compound comprises the following components in parts by weight: 60-70 parts of (prepared) ten thousand years ash, 6-16 parts of long pepper, 3-13 parts of sal ammoniac, 3-13 parts of sea buckthorn and 3-13 parts of kaempferia galanga. The Mongolian medicine compound provided by the invention follows the formula principle of Mongolian medicine 'monarch, minister, assistant and guide', and all medicine components have synergistic effects, so that the Mongolian medicine compound has the effects of enhancing the digestion function in the stomach, promoting the metabolism of clear and turbid, inhibiting the heyi bone, improving the bone strength and elasticity and the like, and can effectively treat primary osteoporosis.

Description

Mongolian medicine compound for treating primary osteoporosis and application thereof

Technical Field

The invention relates to the field of Mongolian pharmacology, in particular to a Mongolian compound for treating primary osteoporosis and application thereof.

Background

Primary osteoporosis is a common disease in orthopedics, is better developed in postmenopausal women and the elderly, and is a systemic bone chronic disease caused by the imbalance of bone metabolism coupling due to various reasons, such as the reduction of the bone mass and bone density of the whole body, the destruction of bone microstructure, the increase of bone fragility and the increase of fracture risk. The disease is mainly manifested by general muscular and skeletal pain, spinal deformation, thoracic deformity, dwarfing, hunchback, general joint weakness, walking difficulty and increased bone fragility, which easily causes compression fracture of lumbar vertebrae. According to the clinical manifestations of primary osteoporosis, it belongs to the category of Guheyi disease in Mongolian medicine. In the Mongolian medicine theory, food is digested in the stomach to generate food essence, the food essence is delivered to the liver through the hepatic portal vein, the food essence nourishes and generates blood in the liver under the action of the discoloring Hila, the blood essence nourishes muscles, the muscle essence nourishes fat, the fat essence nourishes bones and marrow, the bones and the marrow essence nourishes sperm (menses), the sperm (menses) nourishes vitality element, and the vitality element spreads all over the body through the blood to prolong the life of the body, wherein the circulation process is called a turbid clearing metabolic process. Due to the fact that the stomach is slightly dry in bara and hey and the Hira ratio is reduced, the balance of digestion three energies (adjusting fire, digesting Hira and rotting to be dry) in the stomach is easily lost, food essence cannot nourish and generate blood, muscle essence cannot breed fat essence, fat essence cannot breed bones and bone marrow, or dregs are mixed in the bones and the bone marrow to form osteoporosis. In addition, after people are aged or women are postmenopausal, the body hormone level is reduced, and senile osteoporosis or postmenopausal osteoporosis is easily caused. The Mongolian medicine recorded in the 'four Ganlu' section, the kidney is a functional organ for promoting the metabolism of clear and turbid urine, and the principle of treating osteoporosis by Mongolian medicine is to enhance the digestive function of spleen and stomach, inhibit excessive dryness of Ba Da, promote the Hira characteristic, promote the metabolism of clear and turbid urine, strengthen the kidney function and perform treatment based on syndrome differentiation. At present, a Mongolian medicine compound capable of effectively treating primary osteoporosis is lacked.

Disclosure of Invention

The invention aims to provide a Mongolian medicine compound for treating primary osteoporosis and application thereof, aiming at solving the problems in the prior art.

In order to achieve the purpose, the invention provides the following scheme:

the invention provides a Mongolian medicine compound for treating primary osteoporosis, which comprises the following components in parts by weight: 60-70 parts of (prepared) ten thousand years ash, 6-16 parts of long pepper, 3-13 parts of sal ammoniac, 3-13 parts of sea buckthorn and 3-13 parts of kaempferia galanga.

Preferably, the Mongolian medicine compound comprises the following components in parts by weight: 60 portions of ten thousand years ash (prepared), 6 portions of long pepper, 3 portions of sal ammoniac, 3 portions of sea buckthorn and 3 portions of kaempferia galanga.

The invention also provides application of the Mongolian medicine compound in preparing a medicine for treating primary osteoporosis.

Furthermore, the dosage form of the medicine is granules or decoction.

The invention also provides a preparation method of the Mongolian medicine decoction for treating the primary osteoporosis, which comprises the steps of preparing raw materials according to the Mongolian medicine compound, crushing the raw materials into particles, and adding water for decocting to obtain the Mongolian medicine decoction.

The invention also provides a preparation method of the Mongolian medicine granules for treating primary osteoporosis, which comprises the steps of preparing raw materials according to the Mongolian medicine compound, decocting the raw materials in water to obtain water body fluid, concentrating the water body fluid, adding auxiliary materials, and preparing the granules.

The invention also provides a preparation method of another Mongolian medicine granule for treating primary osteoporosis, which comprises the steps of preparing raw materials according to the Mongolian medicine compound, decocting the raw materials in water to obtain aqueous solution, evaporating the aqueous solution to dryness, crushing, and preparing to obtain the granule.

The pharmaceutical mechanism of the components of the Mongolian medicine compound for treating primary osteoporosis is as follows:

the one-thousand years old gray (processed) has sour, sweet, greasy, dry, sharp, coarse, light, mild and warm properties, and enters spleen and stomach meridians. The functions are as follows: removing the dry skin, increasing bone mass and increasing bone density. The main treatment is as follows: decline of stomach fire, disease of Ba Da gan, dyspepsia, increase of bone density, and inhibition of bone heyi.

Long Pepper, pungent in flavor and warm in nature. Greasy, sharp, light and dry. The functions are as follows: regulating stomach fire, removing Badagan-Heryi, regulating body constitution, tonifying, and improving bone density. The main treatment is as follows: cold diseases such as stomach fire decline, anorexia, indigestion, nausea, asthma, tracheitis, kidney cold, turbid urine, sexual impotence and asthenia, lumbago, skelalgia, arthralgia, insomnia, and cold diarrhea.

Sal ammoniac, sweet in nature, slightly bitter and cool in nature, enters liver meridian. Effective soft, firm, dull and heavy. The functions are as follows: cool blood, lock pulse, regulate menstruation, clear liver, strengthen body, alleviate pain, and relieve swelling. The main treatment is as follows: liver heat, bone pain, muscle pain, irregular menstruation, traumatic bleeding, headache due to blood heat, heart heat, and blood heat.

Sea buckthorn, sweet in property and taste, warm in nature. Mild and soft, entering kidney and bladder meridians. The functions are as follows: nourishing, strengthening body constitution, dispelling kidney cold, invigorating stomach, regulating dryness, and strengthening tendons. The main indications are as follows: body deficiency, kidney cold, lumbago, leg pain, edema, qi stagnation in uterus, cold nature synergestic disease, stomach dryness, impotence, and spermatorrhea.

Kaempferia galanga has sweet, pungent, astringent and slightly salty taste, is warm in nature and enters spleen and stomach meridians. Greasy, light, dry, sharp and superficial in effect. The functions are as follows: dispel cold, alleviate stomach fire, check diarrhea and expel pus. The main treatment is as follows: indigestion, bone-in-heyi, bone-in-kukui, lung abscess, cold-in-heyi diarrhea, dripping menstruation, leukorrhagia, and heyi stasis.

In the Mongolian medicine compound, the perpetual ash (prepared) is a monarch drug, so that stomach fire is conditioned, the bone mass is increased, the bone strength is improved, the disease of dry cold is removed, digestion is promoted, and bone withering is inhibited; the long pepper is used as a ministerial drug, promotes the metabolism of turbid urine and treats pain caused by osteoporosis; sal ammoniac is used as adjuvant drug for dispelling cold and relieving heyi, regulating stomach fire and inhibiting bone withering; seabuckthorn fruit is used as a messenger drug for relieving heyi, regulating stomach fire, promoting digestion and promoting metabolism; rhizoma Kaempferiae has effects of nourishing, tonifying yang, dispelling kidney cold, relieving HEYI, regulating stomach fire, and relieving muscle pain caused by osteoporosis.

The invention discloses the following technical effects:

(1) The Mongolian medicine compound for treating the primary osteoporosis follows the formula principle of monarch, minister, assistant and guide of Mongolian medicine, has the synergistic effect of all medicine components, and has the effects of warming and invigorating kidney yang, promoting turbid metabolism, inhibiting bone heyi, enhancing bone mass and the like;

(2) The Mongolian medicine is rich in protein, glucose, volatile oil, fructose, organic acid, lecithin, vitamins, amino acid, phytosterol and calcium, is beneficial to absorption of a human body, and enhances the bone strength;

(3) The Mongolian medicine has good treatment and prevention effects, definite curative effect, no toxic or side effect, convenient use and low price.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

FIG. 1 shows the results of scanning the trabecular structure of the distal femur on the right side of a rat by Micro-CT;

FIG. 2 shows the results of three-dimensional reconstruction analysis of trabecular bone parameter values BMD, tb.Th, BV/TV, tb.Sp and Th.N, where A is BMD, B is Tb.Th, C is BV/TV, D is Tb.Sp, and E is Th.N;

FIG. 3 is a graph of the effect of the Mongolian drug Armonk-I on the mechanical properties of rat bones, where A is the maximum stiffness, B is the maximum load, and C is the maximum displacement;

FIG. 4 shows the result of staining trabecular bone;

FIG. 5 shows the results of examination of trace elements of sodium (A), calcium (B), phosphorus (C) and zinc (D) in rat serum by the Elisa method;

FIG. 6 shows the results of fluorescence pcr detection of wnt1 (A), BMP-2 (B) and beta-catenin (C) gene transcription in OB with drug-containing serum intervention;

FIG. 7 is ALP staining of BMSC iron accumulation with drug-containing serum intervention;

FIG. 8 is the results of osteogenic mineralization staining of BMSCs with drug-containing serum intervention;

FIG. 9 is a bone marrow smear ferric staining of BMSCs with drug-containing serum intervention;

FIG. 10 shows that drug-containing serum intervention is performed after BMSC is modeled by ferric ammonium citrate, and the drug-containing serum group is found to have a significantly lower ROS level than that of the model group, and the mitochondrial membrane potential level of the medium-high dose drug-containing serum group is found to be significantly higher than that of the model group;

FIG. 11 is a graph showing that the Mongolian drug Arsenimo-1 improves the level of ferric iron in bone marrow in rats with osteoporosis and increases the level of GPR30 and BMP6 protein in rat femur;

FIG. 12 shows that the iron staining of the bone marrow by Prussian blue detection shows that the ferric iron content in the model group is obviously higher than that in the sham operation group, and the medicinal group can effectively reduce the ferric iron content in the bone marrow of the osteoporosis rat; the western blot detects the protein levels of GPR30 (B) and BMP-6 (A), the model group is lower than the sham operation group, and the drug combination can obviously improve the trend;

FIG. 13 shows that drug-containing serum can increase mitochondrial membrane potential levels.

Detailed Description

Reference will now be made in detail to various exemplary embodiments of the invention, the detailed description should not be construed as limiting the invention but as a more detailed description of certain aspects, features and embodiments of the invention.

It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. Further, for numerical ranges in this disclosure, it is understood that each intervening value, between the upper and lower limit of that range, is also specifically disclosed. Every intervening value, to the extent any stated value or intervening value in a stated range, and any other stated or intervening value in a stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference herein for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.

It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification. The description and examples are intended to be illustrative only.

As used herein, the terms "comprising," "including," "having," "containing," and the like are open-ended terms that mean including, but not limited to.

EXAMPLE 1 basic study

The Mongolian medicine used in this example was a compound: 70g of ten thousand years gray (prepared), 16g of long pepper, 13g of sal ammoniac, 13g of sea buckthorn and 13g of kaempferia galanga.

1. In vivo protocol

1.1 modeling

60 SD female rats with the weight of about 250g and the age of 3 months are selected and bred according to the SPF grade. After domestication and feeding for 3 days, ovariectomy operation is carried out, intraperitoneal injection anesthesia is carried out on 40mg/kg body weight of 2% pentobarbital sodium, longitudinal incisions of 1cm are carried out from two sides of lumbar vertebrae of the back, ovaries are found out through shearing layer by layer, ligation, excision and hemostasis are carried out, layer by layer suturing is carried out, each equal division cage is placed to prevent rats from biting each other to cause infection and incomplete healing after awakening, tetracycline tablets (250 mg/250mL drinking water) are fed after operation, infection resistance is carried out for 1 week, wounds heal for 2 weeks, sutures automatically fall off, and the rats are fed in the cages. After 12 weeks, the related indexes of the bone density are detected to verify whether the molding is successful or not.

1.2 animal groups

The 60 rats were randomly divided into 6 groups of 10 rats each, and there was no statistical difference in body weight between the groups (P)>0.05). Respectively setting Mongolian medicinal decoction at 3.2 g/kg ^-1 、1.6g·kg ^-1 、0.8g·kg ^-1 Dose group, positive control group, model group. The mice in the blank group are cut open the skin, the mesenteric fat is taken out and then the mice are sutured, all the animals are kept under the same condition, and the mice can take food and water freely. After the model is successfully made, the mice in each group are intervened by medication for 4 weeks. The experimental group (high, medium and low dose) was administered with yasimo-I, the positive control group with bone peptide fragments, and the model and blank mice with the same amount of physiological saline.

The Mongolian medicine decoction is prepared by the following method: cleaning the raw materials, removing impurities, air drying, pulverizing into granules, soaking in water, boiling with strong fire, and decocting with slow fire for 40 min for 2 times per dose.

1.3 specimen Collection

The experiment was completed at the end of week 4 after the molding was successful, and the blood was collected from the posterior vein of the rat eye the next day after the last administration. The rats were sacrificed by abdominal aortic exsanguination. Fixing the right tibia in 70% ethanol, and storing the right femur in a refrigerator at 4 deg.C.

1.4 index detection

1.4.1 serum index determination

Centrifuging blood collected from the posterior vein of rat eye at 2500r/min for 10min to separate serum, and measuring inorganic ion content such as serum calcium (Ca), phosphorus (P), copper (Cu), zinc (Zn), magnesium (Mg) and biochemical indexes such as serum alkaline phosphatase and hydroxyproline.

1.4.2 Observation of tissue morphology of the upper tibial segment

Fixing the upper part of the right tibia in 70% ethanol, decalcifying with 5% formic acid, embedding with normal paraffin, HE staining, and observing the morphology of the metaphyseal tissue of the tibia under an optical microscope.

1.4.3 femoral bone Density determination

Bone density (BMD) was measured on the right femur of the rat using a dual energy X-ray bone densitometer. Setting conditions: the step pitch is 0.5mm multiplied by 0.5mm, and the scanning speed is 30mm/s.

1.4.4 measurement of femoral biomechanical indices

Taking the right femur of a rat, removing soft tissues, performing a three-point bending test on a biomechanics tester, and setting test parameters: the span is 22mm, the load range is 0-200N, the test speed is 5mm/min, the load-radius curve is drawn by a data tracking mode load-radius, and the geometric dimension of the section of the fracture part is measured by a microscope and a grid micrometer. And calculating biomechanical indexes according to the load-radius curve and the cross section geometric data obtained by the test.

1.4.5 detection of related molecular indicators

Taking out the femur of the rat after the sacrifice, cutting off epiphyseal ends at two ends, exposing a marrow cavity, scraping marrow tissues, marking, and quickly placing into a liquid nitrogen tank for freezing and storing for later use. Westernblot is adopted to detect the expression conditions of Wnt1, beta-catenin and BMP-2 proteins. And analyzing the expression conditions of the mRNA of Wnt1, beta-catenin and BMP-2 by adopting a fluorescent quantitative PCR method.

2. In vitro experimental study protocol

2.1 in vitro isolation culture and identification of bone marrow mesenchymal Stem cells (BMSCs)

Adopting a secondary enzyme digestion method: taking a newborn 2dSD rat, killing the rat with the neck clamped, cutting the skull into the size of 1mm multiplied by 1mm, adding 0.25% pancreatin, and digesting for 20min at 37 ℃; cutting into pieces with ophthalmic scissors, adding 0.1% collagenase type II, digesting at 37 deg.C under shaking for 1 hr, stopping enzyme reaction, blowing thoroughly, 1000r/min, centrifuging for 5min, re-suspending the culture medium, inoculating into culture flask, standing at 37 deg.C, and reacting with 5% CO ₂ Culturing in an incubator, and changing the culture solution for 1 time every 2-3 days. After 80% of the cells are fused, subculture is carried out. BMSC identification was performed by morphological observation, alkaline phosphatase (ALP) staining method, alizarin red staining method.

2.2 preparation of serum containing drugs

3-month-old female rats were purchased and divided into a blank group (physiological saline), a positive control group (bone peptide tablet), and a Mongolian medicinal decoction of 3.2 g/kg ^-1 、1.6g·kg ^-1 、0.8g·kg ^-1 Dose groups, rats were anesthetized 14 days after each gavage, blood was taken using the abdominal aorta, and serum was isolated and stored.

2.3 Experimental groups

And (3) preparing the 2 nd generation BMSC with good growth state into single cell suspension by using a complete culture medium, randomly dividing the single cell suspension into 5 groups, replacing serum-free culture solution after 24 hours of cell adherence, and respectively adding corresponding conditioned culture solution for culture after the cell cycle is synchronized, wherein the solution is replaced every 2-3 days.

The specific grouping is as follows:

(1) Blank control group: LG-DMEM medium containing 10% FBS.

(2) Positive drug group: the final concentration is 10% bone peptide tablet containing serum LG-DMEM culture solution.

(3) Mongolian high dose drug group: LG-DMEM culture solution with 15% Mongolian medicine-containing serum at final concentration.

(4) Mongolian medicine traditional Chinese dose medicine group: LG-DMEM culture solution with final concentration of 10% Mongolian medicine-containing serum.

(5) Mongolian low dose drug group: LG-DMEM culture solution with final concentration of 5% Mongolian medicine-containing serum.

2.4 index detection

2.4.1 detection of proliferation of BMSC: detecting the cell proliferation condition by referring to a CCK-8 kit; blank control wells without cells were set in parallel with the experiment.

2.4.2 alkaline phosphatase (ALP) Activity assay: detecting the activity expression condition of ALP by referring to an ALP activity detection kit.

2.4.3 osteocalcin detection: osteocalcin content was determined by osteocalcin radioimmunoassay.

2.4.4 mineralization knot number determination: the number of mineralized nodules per group was observed under a light microscope using alizarin red staining.

2.4.5Wnt1, beta-catenin, BMP-2, BMP-6, detection of ROS:

and analyzing the expression conditions of the mRNA of Wnt1, beta-catenin and BMP-2 by adopting a fluorescent quantitative PCR method. Wnt1, beta-catenin and BMP-2 primers are designed according to the Genbank sequence and synthesized. Extracting osteoblast total RNA by a Trizol method, and qualitatively and quantitatively analyzing the RNA by an ultraviolet spectrophotometer. And (3) performing reverse transcription reaction and two-step fluorescence quantitative PCR amplification reaction by referring to a Takara reverse transcription and fluorescence quantitative kit and correcting by using internal reference GAPDH according to the operation instruction of an ABI7500 fluorescence quantitative PCR instrument. Analyzing the expression conditions of Wnt1, beta-catenin and BMP-2 proteins by a Westernblot method, extracting total cell proteins according to a corresponding kit, quantifying and leveling the proteins by a BCA method, and imaging by an ImageQuantLAS4000mini ultrasensitive chemiluminescence imager.

3. Results of the experiment

3.1 Mongolian medicine Arsensimo-I can improve bone microstructure of osteoporosis rat and increase bone density

Scanning the far-end trabecular bone structure of the right femur of a rat by using Micro-CT, and three-dimensionally reconstructing and analyzing the trabecular bone parameter value: BMD, tb.Sp, th.N, BV/TV, tb.Th, etc., and the results are shown in FIG. 1 and FIG. 2. The model group showed significant trabecular bone loss in the sham group, whereas oral administration of yasen simo-I significantly increased trabecular bone density in rats and improved bone microarchitectural parameters in the group with the higher and lower doses (p < 0.05, p < 0.01).

3.2 Effect of Mongolian drug Arsensimol-I on the mechanical Properties of rat bone

As shown in FIG. 3 and Table 1, after 12 weeks of administration of Himomo-I, the maximal load, maximal displacement and stiffness of the femurs of the rats in the model group were significantly inhibited, and the differences were statistically significant (P < 0.05) compared with those in the sham-operated group. After the drug combination is used, the three indexes of the femur are increased to different degrees, wherein the maximum load high dose group and the model group have statistical significance (x p is less than 0.001), the maximum displacement and the rigidity have the increasing trend compared with the model group, and the difference has no statistical significance.

TABLE 1

	Maximum stiffness	Maximum load	Maximum displacement
				Blank group	240.81±33.18	144.5±14.97	0.63±0.15
Model set	123.71±23.61	125±21.00	0.98±0.15
				Low dose group	135.71±16.57	115±13.19	0.73±0.09
Middle dose group	182.86±37.06	137.13±20.41	0.75±0.16
				High dose group	193.63±19.05	138.5±16.80	0.67±0.14

3.3 HE staining

As shown in FIG. 4, the trabecular bone in the artificial operation has complete shape, no obvious fracture, normal bone marrow cavity and uniform arrangement of bone cells; the bone trabecula of the model group has fuzzy shape, wide fracture and widened bone marrow cavity; the mode of the trabecular bone of the yasimo-I group is improved compared with that of the model group, and the structure is compact.

3.4 serum assay index

The Elisa method detects trace elements such as zinc, phosphorus, sodium, calcium and the like in the serum of the rat, and the result is shown in figure 5 and table 2, and the result shows that the medicine group can obviously improve the zinc, phosphorus, sodium and calcium in the serum of the rat, wherein the low, medium and high dosage groups of the zinc element have statistical significance (p is less than 0.05 and p is less than 0.0001).

TABLE 2

	Zinc (umol/l)	Phosphorus (mmol/l)	Sodium (mmol/l)	Calcium (mmol/1)
					Blank group	26.33±1.31	1.21±0.07	146.95±3.14	2.41±0.35
Model set	22.58±1.07	1.16±0.14	146.29±4.61	2.3g±0.19
					Low dose group	26.00±1.76	1.46±0.24	148.28±4.66	2.68±0.31
Middle dose group	29.25±0.97	1.48±0.25	150.12+5.20	2.71±0.29
					High dose group	28.77+1.35	1.47±0.25	149.27±5.24	2.61±0.22

3.5 fluorescent pcr detects gene transcription of wnt1, beta-catenin and BMP-2, ALP staining, osteogenic mineralization staining and bone marrow smear ferric iron staining in OB containing drug serum intervention, and the results are respectively shown in FIGS. 7-9.

As shown in FIG. 6, after intervention of yasen simo-I drug-containing serum in primary osteoblasts, wnt1, beta-catenin and BMP-2 were examined, and the corresponding indexes of the low, medium and high dose groups were increased compared with those of the blank group, but the difference was not statistically significant. After the serum containing the medicine intervenes in osteoblasts for 14d, ALP staining and alizarin red staining are carried out. ALP staining results, ALP secretion was significantly higher in the high dose group than in the normal group. Alizarin red staining results show that orange mineralized nodules can be seen in each group, the high dose group is the most, the medium dose group is the next, and the high and low doses are the least.

3.6 Imagin-I medicated serum can reduce ROS of BMSC after ferric ammonium citrate dry prognosis, and increase mitochondrial membrane potential level.

As shown in fig. 10 and 13, after modeling BMSC with ferric ammonium citrate, drug-containing serum intervention is performed, and it is found that ROS levels in the drug-containing serum group are significantly lower than those in the model group, and mitochondrial membrane potential levels in the medium-and high-dose group are significantly improved.

3.7Westernblot to detect GPR30 and BMP-6 protein levels, the model group is lower than the sham operation group, and the drug combination can obviously improve the trend (see figures 11 and 12).

EXAMPLE 2 clinical Observation study for treating Primary osteoporosis

1. Observation object

1.1 diagnostic criteria

Western diagnosis standards: the method is formulated according to WHO osteoporosis standard and Chinese Primary osteoporosis diagnosis Standard formulated by the Chinese society for elderly people.

a. Clinical symptoms: (1) general bone pain mainly refers to pain of the waist and the back, which gradually worsens, and slight trauma can cause fracture; (2) kyphosis deformity, height becoming short, hunchback.

b. Bone density standard: with the DEXA measurement of peak bone mass (M ± SD) for mongolian women as a normal reference value, the criteria can be performed with reference to different nations, regions and genders, in the case where no subdivision is available at present: m-1SD: normal; less than or equal to M-1 SD-2 SD: a decrease in bone mass; < M-2SD or above: is osteoporosis; < M-2SD or above: severe osteoporosis with one or more fractures; < M-3SD or above: no fracture, and severe osteoporosis can also be diagnosed.

The Mongolian medicine diagnosis standard is formulated according to the clinical observation and guidance principle of treating osteoporosis by Mongolian medicine. The main symptoms are: general bone pain, waist and back ache, joint soft pain, frequent cramp, humpback, thoracic deformity, spinal deformation, and dwarfing, which are easy to cause lumbar vertebra fracture, femoral neck fracture, and intertrochanteric fracture. The secondary symptoms are as follows: flaccidity and weakness of lower limbs, lassitude, inability to sustain, aversion to cold, cold limbs, hyperhidrosis, pale and dark or dark red tongue with petechia, ecchymosis, white coating, deep, thready and weak pulse.

1.2 inclusion criteria

(1) Those who meet the criteria for western diagnosis of osteoporosis;

(2) those who meet the criteria for Mongolian medical diagnosis of osteoporosis;

(3) at the age of 45-80 years old, both male and female, and female should be a post-menopausal woman of infertile capacity (at least menopausal for more than one year)

(4) Patients who meet the above standards and receive treatment for primary osteoporosis who are in clinic for osteoporosis in the subsidiary Mongolian medicine medical hospital of Mongolian medical university during the period of 2021-2022-01 month;

(5) volunteered as subjects and signed into study informed consent;

(6) the main medical record data is complete (general condition, induction factors, chief complaints, main physical signs, accompanying symptoms, syndrome differentiation and typing, treatment condition, curative effect and the like);

1.3 exclusion criteria

(1) Secondary osteoporosis: patients with serious primary diseases, including endocrine (such as hyperthyroidism, diabetes, rheumatism, etc.), renal, nutritional, blood, drug disuse, and congenital osteoporosis;

(2) the patients can not be stopped immediately after taking other related treatment medicines for a long time;

(3) those with advanced deformity, disability, or loss of labor force;

(4) allergic constitution and patients allergic to various drugs;

(5) patients with serious primary diseases such as heart, brain, liver, kidney and hemopoietic system, and mental disease;

(6) for various reasons, the patients who are not prescribed, cannot determine the curative effect or have insufficient data;

(7) those who are critically ill and have difficulty in exactly evaluating the effectiveness and safety of the medicine.

40 primary osteoporosis patients are selected from 2021 year 01 month to 2022 year 01 month in the osteoporosis outpatient service of Mongolian traditional Chinese medicine hospital affiliated to the university of medical science of inner Mongolia according to the standards. Of these, 13 males and 27 females aged 52 to 77 years. 40 patients were randomly divided into a treatment group, a control group 1 and a control group 2, wherein 13 patients in the treatment group (oral administration of the formulation of the present invention: armonk-I) were 64.5 years old on average; 14 cases of control group 1 (oral xianlinggubao capsule) with an average age of 66.9 years; control 2 (oral calqi D tablets) 13 cases, the age averaged 65.5 years. The patients in three groups have no obvious difference in factors such as age, sex and the like (P is more than 0.05), and have comparability, which is shown in Table 3.

TABLE 3 two general case comparisons

2 method of treatment

2.1 treatment group

Administering orally the Mongolian drug Argashimoto-I, the following: 60g of (prepared) ten thousand years ash, 6g of long pepper, 3g of sal ammoniac, 3g of sea buckthorn and 3g of kaempferia galangal. The following addition and subtraction are carried out: for instance, 2g of Rohdea japonica Roth and 3g of Long Pepper are added for the disturbance of metabolism of clear and turbid body, 4g of sal ammoniac is added for the disturbance of separation of essence dregs due to deficiency of stomach fire, 2g of sea buckthorn is added for the disturbance of kidney yin deficiency, 2g of rhizoma Kaempferiae is added for the disturbance of kidney yang deficiency, and the like. The Mongolian medicines are all from Mongolian pharmacy of Mongolian medicine hospital of Mongolian medicine university of inner Mongolian medicine. The administration method comprises decocting 1 dose of the above raw materials with 500mL of water for 2 times a day, taking 3 months for 1 treatment course, and stopping taking other calcium supplement medicines during the administration period; control group 1: the Xianlinggubao capsule (capsule, 2 g/granule, provided by Tongji Tang pharmaceutical products GmbH, guizhou, chinese medicine standard Z20025337). The medicine comprises the following components: epimedium, teasel root, red sage root, anemarrhena rhizome, psoralea fruit and rehmannia root. The medication method comprises the following steps: 3 granules/time, 2 times daily with boiled water, 3 months for 1 treatment course, and 3 treatment courses. Control group 2: calqi D tablets (tablets, calcium 600mg, vitamin D3/125 iu/tablet, provided by hui-baigong pharmaceuticals, ltd, usa, approval paper (95) toilet standard X-83) were administered. The medication method comprises the following steps: 1 tablet/time, 1 time before sleep, and 3 months for 1 treatment course, 3 treatment courses.

2.2 treatment course

The Mongolian medicine is taken for 3 courses of treatment, the Xianlinggubao capsule is taken for 3 courses of treatment, the calerqi D tablet is taken for 3 courses of treatment, and patients do not use other medicines and treatments such as acupuncture, physical therapy and the like during the treatment period. The follow-up patients receive treatment of 3 courses of treatment, and the treatment effect is evaluated by repeating the treatment 1 time per course of treatment.

2.3 Observation of indicators

2.3.1 symptom and sign determination

The clinical symptom score refers to the clinical research guideline of treating osteoporosis with Mongolian medicine, and the Mongolian medicine score standard is formulated, wherein pain is scored by VAS, that is, a line with 0-10cm is drawn and is divided into 10 equal parts, and patients can judge where to draw according to their own feeling. No pain: corresponding to a VAS score of 0 (VAS: 0 cm); mild pain: corresponding VAS score 1-3 points (VAS: 1-3 cm); moderate pain: corresponding VAS score of 4-6 (VAS: 4-6 cm); severe pain: corresponding VAS score 7-10 points (VAS: 7-10 cm).

2.3.2 bone Density

Before treatment, 1 course of treatment, 2 courses of treatment, and 3 courses of treatment, and then performing bone densitometry on each row, and using dual-energy X-ray bone Densitometer (DEXA) to test lumbar vertebrae 3-5, intertrochanteric, femoral neck, ward of patients _, s triangular bone density.

2.3.3 related Biochemical examinations

Serum osteocalcin, serum calcitonin and parathyroid hormone are measured before treatment, 1 treatment course, 2 treatment courses and 3 treatment courses respectively.

2.3.4 safety index

Before and after 3 treatment courses, the routine of blood, urine and feces, the function of liver and kidney and electrocardiogram are measured.

2.4 statistical treatment

All data were analyzed using SPSS23.0 software. The data conforming to the normal distribution is represented by + -S, and the counting data adopts chi ² And (5) checking, namely, adopting pairing t-checking for the metering data. The difference is statistically significant when P is less than 0.05, and the difference is not statistically significant when P is more than 0.05.

3 therapeutic results

3.1 clinical symptom score comparisons for each group of treatments for primary osteoporosis are shown in Table 4:

TABLE 4 comparison of clinical symptom score scores before and after three groups of treatments

The clinical symptom scores of 3 groups are integrated, the comparison difference of 1 treatment course before treatment, 1 treatment course after treatment, 2 treatment courses after treatment and 3 treatment courses after treatment has statistical significance (P is less than 0.05), the comparison difference between the treatment group and the control group 1 has no statistical significance (P is more than 0.05), the symptom scores of 1 treatment course, 2 treatment courses and 3 treatment courses after treatment are reduced better than that of the control group 2, and the difference has statistical significance (P is less than 0.05).

3.2 bone density comparison for each group of treatments for primary osteoporosis is shown in Table 5:

TABLE 5 comparison of bone Density before and after three groups of treatments

3 groups of femoral neck and Ward _, The indexes of the two bone mineral densities of the s triangle before treatment, 1 treatment course after treatment, 2 treatment courses after treatment and 3 treatment courses after treatment have no obvious difference (P is more than 0.05); 1 lumbar vertebra 3-5 of the treatment group and the control group, the bone density index between tuberosity has no significant difference (P is more than 0.05) after 1 treatment course and 2 treatment courses before and after treatment, and has significant difference (P is less than 0.05) after 3 treatment courses before and after treatment, 2 groupsThe comparison between the two groups has no statistical significance (P is more than 0.05), and after 3 treatment courses of treatment of the treatment group and the control group 1, the change of the bone density index between the tuberosity is 3-5 and is better than that of the control group 2, and the obvious difference is realized (P is less than 0.05).

3.3 Biochemical examination results for various groups of treatments for primary osteoporosis are compared as shown in Table 6:

TABLE 6 comparison of results of biochemical examination before and after three groups of treatments

Before and after 1 treatment course, 2 treatment courses and 3 treatment courses, the comparison difference of serum calcitonin in the treatment groups has no statistical significance (P is more than 0.05), the comparison difference of serum calcitonin and parathyroid hormone in the treatment groups has statistical significance (P is less than 0.05) after 1 treatment course, 2 treatment courses and 3 treatment courses after treatment (P is more than 0.05), the comparison between the groups is superior to that of the control group 1 and the control group 2, and the difference has statistical significance (P is less than 0.05).

3.4 evaluation of safety

No adverse reactions such as abnormality of indexes such as liver and kidney functions, diarrhea, abdominal pain and the like are reported in all groups, and the results show that the Mongolian medicine compound disclosed by the invention is good in safety and free of adverse reactions after being taken for a long time.

Clinical observation results show that the Mongolian medicine compound disclosed by the invention has an obvious improvement effect on symptoms and physical signs of patients with primary osteoporosis, and is exact in clinical curative effect, and the Mongolian medicine compound disclosed by the invention has a benign regulation effect on relieving and improving the primary osteoporosis, does not have any adverse reaction after being taken for a long time, and is worthy of being further developed into a new generation of medicine for treating the primary osteoporosis.

Example 3

The Mongolian medicine for treating primary osteoporosis comprises the following components in parts by weight: 64g of (prepared) ten thousand years ash, 10g of long pepper, 7g of sal ammoniac, 7g of sea buckthorn and 7g of kaempferia galangal. Wherein the fructus Piperis Longi is used as monarch drug for regulating stomach fire, eliminating pathogenic wind and dampness, promoting digestion, and inhibiting bone withering; sal ammoniac is used as a ministerial drug, promotes the metabolism of clear and turbid urine, and inhibits the pain caused by osteoporosis; the sea buckthorn is an adjuvant drug, and has the effects of dispelling cold and relieving HEYI, regulating stomach fire and inhibiting bone withering; rhizoma kaempferiae is used as a guiding drug, can relieve heyi, regulate stomach fire, promote digestion and promote metabolism of turbid and clear; the product has effects in tonifying yang, dispelling kidney cold, relieving heryi, regulating stomach fire, and relieving muscle pain and osteodynia caused by osteoporosis. The Mongolian compound medicine is a decoction, and the decoction is prepared by the following method: cleaning the raw materials, removing impurities, air drying, pulverizing into granules, soaking in water, boiling with strong fire, and decocting with slow fire for 40 min for 2 times per dose.

Effect verification: clinical observations study of the treatment of Primary osteoporosis Using the formulation of example 3

1. Observation object

40 patients with primary osteoporosis were selected from the osteoporosis clinic of the subsidiary Mongolian medical science hospital of the university of medical Endomastol, from the year 2020, month 01 to the year 2021, month 01, according to the criteria of section 1.1 to section 1.3 in example 2. Of these, 13 men and 27 women aged 52 to 77 years. 40 patients were randomly divided into a treatment group, a control group 1 and a control group 2, wherein 13 patients in the treatment group (oral administration of the formulation of the present invention: armonk-I) were 64.5 years old on average; 14 cases of control group 1 (oral xianlinggubao capsule) with an average age of 66.9 years; control 2 (oral calqi D tablets) 13 cases, the age averaged 65.5 years. The patients in three groups have no obvious difference in factors such as age, sex and the like (P is more than 0.05), and have comparability, which is shown in Table 7.

TABLE 7 comparison of two general cases

2 method of treatment

2.1 treatment group

The decoction prepared in the embodiment 3 is orally taken by a treatment group, the administration method is 1 dose per day, the decoction is warmly taken with boiled water for 2 times per day, 3 months are 1 treatment course, 3 treatment courses are taken totally, and other calcium supplement medicines are stopped to be taken during the administration period; control group 1: the Xianlinggubao capsule (capsule, 2 g/capsule, provided by Tongji Tang pharmaceutical products GmbH of Guizhou, chinese medicine standard character Z20025337). The medicine comprises the following components: epimedium, teasel root, red sage root, anemarrhena rhizome, psoralea fruit and rehmannia root. The medication method comprises the following steps: 3 granules/time, 2 times daily with boiled water, 3 months for 1 treatment course, and 3 treatment courses. Control group 2: calrgin D tablets (tablets, calcium 600mg, vitamin D3/125 iu/tablet, provided by wecker baigong pharmaceutical limited, usa, approval document No. (95) satellite drug standard X-83) were administered. The medication method comprises the following steps: 1 tablet/time, 1 time before sleep, and 3 months for 1 treatment course, 3 treatment courses.

2.2 treatment course

The Mongolian medicine is taken for 3 courses of treatment, the Xianlinggubao capsule is taken for 3 courses of treatment, the calerqi D tablet is taken for 3 courses of treatment, and patients do not use other medicines and treatments such as acupuncture, physical therapy and the like during the treatment period. The follow-up patients received 3 treatment courses of treatment, and the treatment effect was evaluated by 1-time double visit per treatment course.

2.3 Observation of indicators

The same as in example 2.

2.4 statistical treatment

The same as in example 2.

3 therapeutic results

3.1 clinical symptom score comparison for each group of treatments of primary osteoporosis is shown in Table 8:

TABLE 8 comparison of clinical symptom score scores before and after three groups of treatments

3.2 bone density comparison for each group of treatments for primary osteoporosis is shown in Table 9:

TABLE 9 comparison of bone Density before and after three groups of treatments

3 groups of femoral neck and Ward _, The indexes of the two bone mineral densities of the s triangle before treatment, 1 course after treatment, 2 courses after treatment and 3 courses after treatment have no significant difference (P is more than 0.05); 3-5 lumbar vertebrae and bone density indexes between tuberosities of the treated group and the control group 1 have no significant difference (P is more than 0.05) after 1 treatment course and 2 treatment courses before and after treatment, have significant difference (P is less than 0.05) after 3 treatment courses before and after treatment, have no statistical significance (P is more than 0.05) by comparison between 2 groups, and 3-5 lumbar vertebrae and bone density indexes between tuberosities of the treated group and the control group 1 have significant difference (P is less than 0.05) after 3 treatment courses.

3.3 Biochemical examination results for various groups of treatments for primary osteoporosis are compared as shown in Table 10:

TABLE 10 comparison of results of biochemical examination before and after three groups of treatments

Before treatment, 1 treatment course after treatment, 2 treatment courses after treatment and 3 treatment courses after treatment, the comparison difference of serum calcitonin in the treatment groups has no statistical significance (P is more than 0.05), the comparison difference of serum calcitonin and parathyroid hormone in the treatment groups has statistical significance (P is less than 0.05) after treatment, 2 treatment courses after treatment and 3 treatment courses after treatment (P is more than 0.05), the comparison between the groups is superior to that of the control group 1 and the control group 2, and the difference has statistical significance (P is less than 0.05).

3.4 evaluation of safety

All groups do not report any adverse reactions such as abnormality of indexes such as liver and kidney functions, diarrhea, abdominal pain and the like, and the results indicate that the Mongolian medicine compound disclosed by the invention is good in safety and free of adverse reactions after being taken for a long time.

Example 4

The Mongolian medicine for treating primary osteoporosis comprises the following components in parts by weight: 62g of Romannian ash (prepared), 8g of Piper longum, 5g of sal ammoniac, 5g of sea buckthorn and 10g of Kaempferia galanga, wherein the Romannian ash (prepared) is a monarch drug; rhizoma kaempferiae is used as a ministerial drug; the long pepper is used as an adjuvant drug; sal ammoniac is used as a messenger drug; perpetual grey (processed), regulating stomach fire, removing pathogenic wind, relieving symptoms of dryness and cold, promoting digestion, and inhibiting bone heyi and bone withering; the long pepper promotes the metabolism of clear turbidity and inhibits the pain caused by osteoporosis; the sea buckthorn can dispel cold and relieve heyi, regulate stomach fire and inhibit bone withering; sal ammoniac is used for relieving heyi, regulating stomach fire, promoting digestion and promoting turbid metabolism; rhizoma Kaempferiae has effects of nourishing and tonifying yang, dispelling kidney cold, relieving Heryi, regulating stomach fire, and relieving muscle pain and bone pain caused by osteoporosis. The Mongolian medicine compound preparation is granules, and the granules are prepared by the following method: decocting with 7 times of clear water for 2 times, each for 45 min, mixing water extractive solutions, concentrating at 60 deg.C under reduced pressure to obtain extract, adding appropriate amount of sugar powder and stabilizer, sieving with 40 mesh sieve to obtain granule, and packaging.

Effect verification: clinical observations study of the treatment of Primary osteoporosis Using the formulation of example 4

1. Observation object

Based on the criteria in section 1.1-1.3 of example 2, 40 patients with primary osteoporosis were selected from the osteoporosis clinic of the Mongolian medicine Hospital, department of medical university of inner Mongolia, from month 01 to month 01 of 2019, and 2020. Of these, 13 men and 27 women aged 52 to 77 years. 40 patients were randomly divided into a treatment group, a control group 1 and a control group 2, wherein 13 patients in the treatment group (oral administration of the formulation of the present invention: arsensimo-I) were 64.5 years old on average; 14 control group 1 (oral Xianlinggubao capsules) with an average age of 66.9 years; control 2 (oral calqi D tablets) 13 cases, the age averaged 65.5 years. The patients in three groups have no obvious difference in factors such as age, sex and the like (P is more than 0.05), and have comparability, which is shown in a table 11.

TABLE 11 comparison of two general cases

2 method of treatment

2.1 treatment group

The granules prepared in the embodiment 4 are orally taken by a treatment group, the taking method is 1 dose per day, 2 times of warm water is taken each day, 3 months are taken as 1 treatment course, 3 treatment courses are taken totally, and other calcium supplement medicines are stopped taking during the taking period; control group 1: the Xianlinggubao capsule (capsule, 2 g/granule, provided by Tongji Tang pharmaceutical products GmbH, guizhou, chinese medicine standard Z20025337). The medicine comprises the following components: epimedium, teasel root, red sage root, anemarrhena rhizome, psoralea fruit and rehmannia root. The medication method comprises the following steps: 3 granules/time, 2 times daily with boiled water for warm-taking, 3 months for 1 treatment course, and 3 treatment courses. Control group 2: calrgin D tablets (tablets, calcium 600mg, vitamin D3/125 iu/tablet, provided by wecker baigong pharmaceutical limited, usa, approval document No. (95) satellite drug standard X-83) were administered. The medication method comprises the following steps: 1 tablet/time, 1 time before sleep, and 3 months for 1 treatment course, 3 treatment courses.

2.2 treatment course

The Mongolian medicine of the embodiment 4 is taken for 3 courses, the Xianlinggubao capsule is taken for 3 courses, the Callqi D tablet is taken for 3 courses, and patients do not use other medicines, acupuncture, physical therapy and other treatments during the treatment period. The follow-up patients receive treatment of 3 courses of treatment, and the treatment effect is evaluated by repeating the treatment 1 time per course of treatment.

2.3 Observation of indicators

The same as in example 2.

2.4 statistical treatment

The same as in example 2.

3 therapeutic results

3.1 clinical score comparison for treatment of primary osteoporosis in each group is shown in Table 12:

TABLE 12 comparison of clinical symptom score scores before and after three groups of treatments

3.2 bone density comparison for each group of treatments for primary osteoporosis is shown in table 13:

TABLE 13 comparison of bone Density before and after three groups of treatments

The indexes of the 3 groups of femoral neck and Ward, s triangle before and after treatment for two bone densities have no significant difference (P is more than 0.05); 3-5 lumbar vertebrae and bone density indexes between tuberosities of the treated group and the control group 1 have no significant difference (P is more than 0.05) after 1 treatment course and 2 treatment courses before and after treatment, have significant difference (P is less than 0.05) after 3 treatment courses before and after treatment, have no statistical significance (P is more than 0.05) by comparison between 2 groups, and 3-5 lumbar vertebrae and bone density indexes between tuberosities of the treated group and the control group 1 have significant difference (P is less than 0.05) after 3 treatment courses.

3.3 Biochemical examination results for various groups of treatments for primary osteoporosis are compared as shown in Table 14:

TABLE 14 comparison of Biochemical examination results before and after three groups of treatments

3.4 evaluation of safety

Example 5

The Mongolian medicine for treating primary osteoporosis comprises the following components in parts by weight: 70g of (prepared) ten thousand years ash, 16g of long pepper, 13g of sal ammoniac, 13g of sea buckthorn and 13g of kaempferia galangal.

Wherein, the ten thousand years of ashes (prepared) is a monarch drug, which regulates stomach fire, dispels the bara and prevents the symptoms of cold, promotes digestion, improves bone strength and bone density, and inhibits bone withering; rhizoma kaempferiae is a ministerial drug, promotes metabolism of turbid urine, and inhibits pain caused by osteoporosis; the sea buckthorn is used as an adjuvant drug, dispels cold and is heiyi, regulates stomach fire and inhibits bone withering; sal ammoniac is used as a messenger drug to suppress heyi, regulate stomach fire, promote digestion and promote the metabolism of turbid and clear liquid; the long pepper has the effects of nourishing and tonifying yang, dispelling kidney cold, relieving heci, regulating stomach fire, and relieving muscle pain and bone pain caused by osteoporosis. The Mongolian medicine compound preparation is granules, and the granules are prepared by the following method: decocting the raw materials in 8 times of clear water for 30 min for 2 times, mixing water extractive solutions, concentrating under reduced pressure at 60 deg.C to obtain Mongolian compound extract, pulverizing, and sieving with 60 mesh sieve.

Effect verification: clinical observations study of the treatment of Primary osteoporosis Using the formulation of example 5

1. Observation object

The primary osteoporosis patients were selected from the study of the clinical study of osteoporosis of department 1.1 to 1.3 of example 2 from month 01 of 2018 to month 01 of 2019, and from 40 out-patients with primary osteoporosis in the osteoporosis clinic of the subsidiary Mongolian medical science hospital of the university of medical Endomastment. Of these, 13 males and 27 females aged 52 to 77 years. 40 patients were randomly divided into a treatment group, a control group 1 and a control group 2, wherein 13 patients in the treatment group (oral administration of the formulation of the present invention: arsensimo-I) were 64.5 years old on average; 14 cases of control group 1 (oral xianlinggubao capsule) with an average age of 66.9 years; control 2 (oral calqi D tablets) 13 cases, the age averaged 65.5 years. The patients in three groups have no obvious difference in factors such as age, sex and the like (P is more than 0.05), and have comparability, which is shown in Table 15.

TABLE 15 two general case comparisons

2 method of treatment

2.1 treatment group

Treatment groups the formulation prepared in example 5 was administered orally. The administration method comprises 1 dose per day, warm-taking with boiled water for 2 times per day, taking 3 months as 1 treatment course, and stopping taking other calcium supplement medicines during administration; control group 1: the Xianlinggubao capsule (capsule, 2 g/capsule, provided by Tongji Tang pharmaceutical products GmbH of Guizhou, chinese medicine standard character Z20025337). The medicine comprises the following components: epimedium, teasel root, red sage root, anemarrhena rhizome, psoralea fruit and rehmannia root. The medication method comprises the following steps: 3 granules/time, 2 times daily with boiled water, 3 months for 1 treatment course, and 3 treatment courses. Control group 2: calqi D tablets (tablets, calcium 600mg, vitamin D3/125 iu/tablet, provided by hui-baigong pharmaceuticals, ltd, usa, approval paper (95) toilet standard X-83) were administered. The medication method comprises the following steps: 1 tablet/time, 1 time before sleep, and 3 months for 1 treatment course, 3 treatment courses.

2.2 treatment course

In the embodiment, the Mongolian medicine is taken for 3 courses, the Xianlinggubao capsule is taken for 3 courses, the Callqi D tablet is taken for 3 courses, and during the treatment period, patients do not use other medicines and treatments such as acupuncture and physical therapy. The follow-up patients received 3 treatment courses of treatment, and the treatment effect was evaluated by 1-time double visit per treatment course.

2.3 Observation of indicators

The same as in example 2.

2.4 statistical treatment

The same as in example 2.

3 results of the treatment

3.1 clinical score comparison for treatment of primary osteoporosis in each group is shown in Table 16:

TABLE 16 comparison of clinical symptom score scores before and after three groups of treatments

3.2 bone density comparison for each group of treatments for primary osteoporosis is shown in table 17:

TABLE 17 comparison of bone Density before and after three groups of treatments

3 groups of femoral neck and Ward _, The indexes of the two bone mineral densities of the s triangle before treatment, 1 treatment course after treatment, 2 treatment courses after treatment and 3 treatment courses after treatment have no obvious difference (P is more than 0.05); 3-5 lumbar vertebrae of the treatment group and the control group 1, bone density index between tuberosity, no significant difference (P is more than 0.05) exists after 1 treatment course and 2 treatment courses before and after treatment, significant difference (P is less than 0.05) exists after 3 treatment courses before and after treatment, and 2 groups have no differenceThe significance of the study (P is more than 0.05), 3-5 lumbar vertebrae and the change of the bone density index between tuberosity is better than that of the control group 2 after the treatment of the treatment group and the control group 1 for 3 courses of treatment, and the difference is obvious (P is less than 0.05).

3.3 Biochemical examination results for various groups of treatments for primary osteoporosis are compared as shown in Table 18:

TABLE 18 comparison of Biochemical examination results before and after three groups of treatments

3.4 evaluation of safety

The above-described embodiments are only intended to illustrate the preferred embodiments of the present invention, and not to limit the scope of the present invention, and various modifications and improvements made to the technical solution of the present invention by those skilled in the art without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. The application of a Mongolian medicine compound in preparing a medicine for treating primary osteoporosis is characterized in that the Mongolian medicine compound comprises the following components in parts by weight: 60-70 parts of ten-thousand-year-old ash, 6-16 parts of long pepper, 3-13 parts of sal ammoniac, 3-13 parts of sea buckthorn and 3-13 parts of kaempferia galanga.

2. The use of claim 1, wherein the Mongolian medicine compound comprises the following components in parts by weight: 60 parts of ten thousand years ash, 6 parts of long pepper, 3 parts of sal ammoniac, 3 parts of sea buckthorn and 3 parts of kaempferia galanga.

3. The use of claim 1 or 2, wherein the medicament is in the form of granules or decoction.

4. The use of claim 3, wherein the decoction is prepared by a method comprising: preparing raw materials according to the Mongolian medicine compound, crushing the raw materials into granules, and decocting the granules in water to obtain the decoction.

5. The use according to claim 3, wherein the granules are prepared by a process comprising: preparing the raw materials according to the Mongolian medicine compound, decocting the raw materials in water to obtain aqueous liquid, concentrating the aqueous liquid, adding auxiliary materials, and preparing the granules.