Traditional Chinese medicine compound for preventing or treating osteoporosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine compound for preventing or treating osteoporosis and a preparation method, and relates to the field of traditional Chinese medicine, and the traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 20-30 parts of salted eucommia ulmoides, 15-20 parts of roasted herba epimedii, 15-20 parts of rhizoma drynariae, 15-30 parts of roasted astragalus membranaceus, 12-20 parts of angelica sinensis, 12-20 parts of fructus lycii and 6-9 parts of liquorice. The traditional Chinese medicine compound has a good effect of treating osteoporosis.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine compound for preventing or treating osteoporosis and a preparation method thereof. Background Art

[0002] Osteoporosis (OP) is a systemic bone degenerative disease, a chronic orthopedic disease characterized by decreased bone density, bone microstructure destruction, and increased fracture risk. Due to the hidden and specific nature of osteoporosis, people with osteoporosis usually lack clinical symptoms before a fracture event occurs. Therefore, brittle fractures become the main clinical manifestation. Studies predict that by 2035, the number of osteoporosis-related fractures will double, and by 2050, it will increase to about 6 million fracture patients. Osteoporotic fractures not only cause pain, physical damage and deformity to individuals, but also bring about serious psychological disorders such as depression, anxiety, and fear, reduce the quality of life of patients, and impose a huge economic burden on individuals, families, and society. Therefore, taking effective prevention and intervention measures to improve the bone health of the elderly has become an important public health issue that needs to be addressed.

[0003] At present, the treatment of osteoporosis is mainly based on Western medicine, including bone resorption inhibitors (bisphosphonates, hormone replacement therapy, etc.) and bone formation promoters (parathyroid hormone and its analogs). While these drugs have achieved clinical efficacy, they have disadvantages such as large side effects and high prices. For example, bisphosphonates are a common drug that treats osteoporosis by inhibiting bone resorption, but this type of drug has potential adverse reactions such as gastrointestinal reactions, joint pain, myalgia, and jaw necrosis. Parathyroid hormone is the main traditional hormone for the treatment of OP. It can increase the patient's bone density and reduce the risk of fractures. It is particularly suitable for patients with severe osteoporosis, and there are systemic adverse reactions such as hypercalcemia and arrhythmia. Calcitonin is also a commonly used therapeutic drug. During use, it can cause adverse reactions such as allergic reactions, acute abdominal pain, arrhythmia, and lower limb muscle soreness. Estrogen drugs have long-term and extensive research and application in the treatment of OP. They can induce osteoclast apoptosis, inhibit their differentiation, and reduce bone resorption. Early results in the treatment of OP were significant, but long-term use increases the risk of cardiovascular disease and breast cancer.

[0004] From the perspective of symptomology, OP in modern medicine corresponds to the disease categories of "bone atrophy" and "bone arthritis" in traditional Chinese medicine. Kidney deficiency is considered to be the fundamental pathogenesis of OP. "Suwen·Six-section Zangxiang Theory" says: "The kidney is the master of hibernation, the root of storage, and the place of essence; its beauty is in the hair, and its fullness is in the bones." Traditional Chinese medicine believes that the growth and development of bones is closely related to the fullness of kidney essence. If the kidney essence is full, the bone marrow biochemistry is active and the bones are strong and powerful; if the kidney essence is insufficient, the bone marrow is malnourished, the bones are fragile and weak, and bone atrophy occurs. The clinical manifestations are back pain, soreness of the waist and knees, leg pain and weak feet, and easy fractures. Traditional Chinese medicine has unique advantages in preventing and treating OP. It can prevent OP before it gets sick and prevent changes after it gets sick through syndrome differentiation and treatment. It is moderately priced and has low toxicity. The "Expert Consensus on the Prevention and Treatment of Primary Osteoporosis with Traditional Chinese Medicine (2020)" divides OP into 6 syndrome types. Traditional Chinese medicine compound has the advantages of multiple targets, whole body conditioning, low toxicity and side effects, good quality and low price. In particular, in recent years, kidney-tonifying and bone-strengthening traditional Chinese medicine can improve OP and promote bone health by tonifying the kidney and bones, increasing bone density, regulating yin and yang, replenishing qi and generating blood, strengthening the liver and kidney, etc., and has achieved great success in the treatment of osteoporosis, and has received extensive attention from scholars at home and abroad. With the increasing clinical use of traditional Chinese medicine compound, more and more scholars have analyzed its protective effect and mechanism of osteoporosis, and traditional Chinese medicine treatment has become a new trend in the treatment of OP. Summary of the invention

[0005] The present invention aims at the deficiencies of the existing clinical osteoporosis treatment technology, provides a Chinese medicine compound for preventing or treating osteoporosis and a preparation method thereof, and aims to provide a safe and effective medicine for the prevention and treatment of osteoporosis. The Chinese medicine formula provided in the present invention is an old medicine with a new use. Experimental studies have shown that it can improve the expression level of serum bone turnover markers, femoral bone biomechanical indicators, femoral bone microstructure morphology and trabecular parameters of experimental rats, increase the bone density of experimental rats, and play a role in preventing and treating osteoporosis. At the same time, studies have shown that the Chinese medicine compound has no damage to the body weight, liver function, and kidney function of experimental rats, providing a new medication option for the prevention and treatment of osteoporosis.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: The invention provides a traditional Chinese medicine compound for preventing or treating osteoporosis. The traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 20-30 parts of salt eucommia, 15-20 parts of roasted epimedium, 15-20 parts of drynaria, 15-30 parts of roasted astragalus, 12-20 parts of angelica, 12-20 parts of wolfberry and 6-9 parts of liquorice.

[0007] Furthermore, the Chinese medicine compound is prepared from the following raw materials in parts by weight: 20 parts of salt eucommia, 15 parts of roasted epimedium, 15 parts of drynaria, 15 parts of roasted astragalus, 12 parts of angelica, 12 parts of wolfberry, and 9 parts of licorice.

[0008] Furthermore, the raw material is traditional Chinese medicine granules that do not require decoction or conventional traditional Chinese medicine.

[0009] The present invention also provides a method for preparing the above-mentioned Chinese medicinal compound for preventing or treating osteoporosis, which specifically comprises the following steps: S1: taking salt Eucommia ulmoides, roasted Epimedium, Drynaria fortunei, roasted Astragalus, Chinese Angelica sinensis, Lycium barbarum, and Licorice according to weight proportions, mixing to obtain a drug mixture for later use; S2: Add water to the drug mixture, soak, boil and simmer for 20 minutes, take 300 mL of decoction; add 2000 mL of water again, boil and simmer for 20 minutes, take 300 mL of decoction, mix the two decoctions to obtain the Chinese medicine compound decoction.

[0010] Furthermore, in step S2, the dosage ratio of the drug mixture to water is 1 g:20 mL; and the soaking time is 1 h.

[0011] Furthermore, in step S2, pharmaceutically acceptable excipients may be added to prepare granules or powders.

[0012] In this Chinese medicine compound, the salt of Eucommia ulmoides is a key medicine for tonifying yang, which has the effects of tonifying liver and kidney, strengthening tendons and bones, and is the main medicine; the roasted Epimedium "tonifies waist and knees, strengthens heart strength", has the effects of tonifying kidney yang and strengthening tendons and bones, and Drynaria fortunei, as a classic medicine for tonifying kidney and strengthening bones, has the effects of tonifying kidney and strengthening bones, promoting blood circulation and relieving pain, and mending fractures, and they are combined as ministers; roasted Astragalus membranaceus, as the "king of herbs and qi-tonifying holy medicine", has the effects of "assisting qi and strengthening tendons and bones, growing meat and replenishing blood, and strengthening fur", Angelica sinensis replenishes blood, promotes blood circulation and relieves pain, and Lycium barbarum has the functions of nourishing liver and kidney, nourishing kidney and strengthening bones, and the above medicines are adjuvants; Licorice is a qi-tonifying medicine, which can tonify the middle and replenish qi, and is sweet and moderate, and can regulate other medicines, and is the guiding medicine. The combination of these medicines can play the effects of nourishing liver and kidney, strengthening tendons and bones, replenishing qi and nourishing blood, and relaxing tendons and activating collaterals, and can treat various symptoms caused by osteoporosis.

[0013] The pharmacological effects of each Chinese medicinal raw material in the present invention are as follows: Salt Eucommia: Nature and flavor: sweet, slightly pungent, warm. Meridians: Enter the liver and kidney meridians. Functions: nourish the liver and kidney, strengthen the tendons and bones, and stabilize the fetus. Indications: treat soreness of the waist and spine, weakness of the feet and knees, residual urine, wet itching under the genitals, miscarriage, restless fetal movement, and hypertension. Main chemical components: Eucommia bark has always been considered a traditional medicinal part, and its representative components include aucubin, geniposide and niposide acid; modern pharmacology shows that Eucommia, which has lignans, iridoids and flavonoids as the main active ingredients, can directly act on osteoclasts and osteoblasts to affect the absorption and formation of bone matrix, and can also effectively stimulate the osteogenic differentiation of bone marrow mesenchymal stem cells, and can also activate signaling pathways such as Wnt / β-catenin, BMP / Smad, MAPK, OPG / RANKL / RANK and estrogen, to achieve bone protection from multiple aspects.

[0014] Roasted Epimedium: Nature and flavor: pungent, sweet, warm. Meridians: liver and kidney. Function: tonify kidney yang, strengthen tendons and bones, and eliminate rheumatism. Indications: deficiency of kidney yang, impotence and spermatorrhea, weakness of tendons and bones, rheumatic pain, numbness and cramps. Main chemical components: icariin, icariin, dehydrated icariin, epimedium polysaccharide, epimedium total flavonoids, etc. Modern pharmacology shows that epimedium can be used as a promoter of bone healing, and its active ingredient icariin can reduce the occurrence of osteoporosis. It can inhibit the ability of osteoclast differentiation, reduce bone resorption and reduce bone loss, thereby maintaining the integrity of bone structure, as well as the potential effect of promoting bone formation.

[0015] Drynaria: Nature and flavor: bitter, warm. Meridians: liver and kidney. Function: tonifying the kidney and strengthening bones, promoting blood circulation and relieving pain. Indications: low back pain due to kidney deficiency; weakness of the feet and knees; deafness; toothache; chronic diarrhea; enuresis; fractures and alopecia areata. Main chemical components: flavonoids and dihydroflavonoids naringin. Modern pharmacological studies have shown that drynaria extracts can regulate osteoblasts by regulating multiple metabolic pathways and the expression of bone regulatory factors. Different doses of drynaria medicated serum can activate the Wnt / β-catenin pathway to promote the proliferation and osteogenic differentiation of BMSCs, and can also promote the angiogenic activity of endothelial progenitor cells, enhance angiogenesis-osteogenesis coupling, and play a role in preventing and treating osteoporosis.

[0016] Roasted Astragalus: Nature and flavor: bitter; warm. Meridians: liver; kidney. Indications: replenishing qi and strengthening the exterior, astringing sweat and strengthening the body, supporting sores and promoting tissue regeneration, promoting diuresis and reducing swelling. Indications: low back pain due to kidney deficiency, weakness of the feet and knees, deafness, toothache, chronic diarrhea, enuresis, fractures and alopecia areata. Main chemical components: astragaloside, isoastragaloside, acetylastragaloside and cycloastragaloside, etc. Flavonoids mainly include flavonoids, isoflavones, isoflavanes and pteranodones. Modern pharmacology shows that its active ingredients can not only play a role in treating OP by regulating the oxidative stress response of bone cells, inhibiting bone resorption, and promoting bone formation, but also can treat osteoporosis by regulating related MAPK, Wnt / β-catenin, PI3K / AKT, Nrf2 signaling pathways.

[0017] Angelica: Nature and flavor: sweet, pungent, bitter, warm. Meridians: liver, heart, spleen. Function: nourishing blood, activating blood circulation, regulating menstruation and relieving pain. Indications: various pain relief, activating blood circulation and nourishing blood. Main chemical components: including volatile components ligustilide, n-butenylphthalide, n-butenylphthalide and non-volatile angelica polysaccharides, ferulic acid, amino acids, etc. Modern pharmacology shows that its main components can significantly promote cell viability, upregulate cyclin D1 and increase the levels of Runx2, BGP, ALP and BMP-2 proteins in MSCs. Angelica polysaccharides upregulate the relative expression level of H19 in a dose-dependent manner, and can promote osteogenesis and induced osteoblast formation through the Wnt / β-catenin signaling pathway.

[0018] Lycium barbarum: Nature and flavor: sweet, flat. Meridians: liver and kidney meridians. Efficacy: nourishes liver and kidney, improves essence and improves eyesight. Indications: deficiency of essence, soreness of waist and knees, dizziness and tinnitus, internal heat and thirst, blood deficiency and sallow complexion, blurred vision. Main chemical components: Lycium barbarum mainly contains Lycium barbarum polysaccharides, mono-oligosaccharides, organic bases such as betaine, flavonoids and phenolic acids such as rutin, Lycium barbarum pigments such as zeaxanthin dipalmitate, as well as multi-type chemical components such as nucleotides and amino acids. Modern pharmacology shows that the new nucleic acid substance miR162a derived from Lycium barbarum can directly target mouse bone marrow mesenchymal stem cells and promote the differentiation of bone marrow mesenchymal stem cells into osteoblasts. It interprets the principles of traditional Chinese medicine with modern science, explains the scientific connotation of Lycium barbarum "tonifying the kidney and strengthening bones" from the perspective of modern medicine, and provides new ideas for the prevention and treatment of osteoporosis.

[0019] Licorice: Nature and flavor: sweet. Meridians: lung, spleen, heart. Functions: tonify spleen and replenish qi, clear away heat and detoxify, moisten lung and relieve cough, relieve acute pain and harmonize various medicines. Indications: spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough and sputum, acute pain in the abdomen and limbs, carbuncle and sore, relieve drug toxicity and potency. Main chemical components: including glycyrrhizic acid, glycyrrhetinic acid, isoliquiritigenin, etc. Modern pharmacology shows that liquiritin can significantly inhibit the differentiation of osteoclasts induced by nuclear factor κB receptor activator ligand. At the same time, liquiritin can inhibit the expression of osteoclast differentiation-related tissue proteinase K, matrix metalloproteinase 9, c-Fos, nuclear factor of activated T cells c1 gene and protein, and the phosphorylation expression level of MAPK / NF-κB pathway protein. In vivo experiments have shown that liquiritin can alleviate osteoclast-induced osteopenia, suggesting that liquiritin has the potential to inhibit osteoclast differentiation and treat osteoporosis.

[0020] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, the serum of the rat animal model is detected by ELISA method, which confirms that the Chinese medicine compound of the present invention can significantly regulate the expression level of the serum bone turnover marker of the model rat; by dual-energy X-ray detection, it is confirmed that the Chinese medicine compound of the present invention can significantly increase the distal femur bone density of the model rat; by a three-point bending test, it is confirmed that the Chinese medicine compound proposed by the present invention can effectively improve the bone biomechanical indicators such as the femoral breakpoint value, compressive strength and bending strength of the rat; by Micro-CT detection of the distal femur trabecular structure analysis, it is confirmed that the Chinese medicine compound of the present invention can effectively improve the rat bone microstructure and trabecular parameters. In addition, the Chinese medicine compound proposed by the invention has no damage to the body weight, liver function and kidney function of the experimental rats. Based on this, the Chinese medicine compound of the present invention has a good effect in treating osteoporosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 1 is a comparative diagram of the changes in body weight of rats in each group over time in this embodiment; Figure 2 is a comparison chart of organ indexes of rats in various groups in this embodiment; Figure 3 is a comparative diagram of the bone density of rats in each group in this embodiment; Figure 4 is a comparison chart of bone biomechanical indices (breakpoint value, bending strength, compressive strength) of rats in each group in this embodiment; Figure 5 is a three-dimensional scan of the distal femur of each group of rats in this embodiment; Figure 6 is a comparison chart of Micro-CT scan data (BV / TV, BS / TV, Tb.Th, Tb.N, Tb.Sp, (Mean) BMD) of distal femur of rats in each group in this embodiment; Figure 7 is a comparison chart of changes in serum bone turnover markers (PINP, BALP, TRACP, Cath-k) of rats in each group in this example; In the attached figure: Compared with Sham, * P<0.05, ** P<0.01; compared with OVX, # P<0.05, ## P<0.01; compared with LDG, △ P<0.05, △△ P<0.01; compared with the MDG group, ＊ P<0.05, ＊＊ P<0.05. DETAILED DESCRIPTION

[0022] In order to make the purpose and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0023] The instruments, reagents, materials, etc. involved in the following examples, unless otherwise specified, are all conventional instruments, reagents, materials, etc. in the prior art and can be obtained through regular commercial channels. The experimental methods, detection methods, etc. involved in the following examples, unless otherwise specified, are all conventional experimental methods, detection methods, etc. in the prior art.

[0024] Example 1 The present embodiment provides a Chinese herbal compound for preventing or treating osteoporosis, which is prepared from the following raw materials (Chinese herbal granules that do not require decoction) in parts by weight: 30 parts of salt eucommia, 20 parts of roasted epimedium, 20 parts of drynaria, 30 parts of roasted astragalus, 20 parts of angelica, 20 parts of wolfberry, and 6 parts of liquorice.

[0025] The preparation method of the traditional Chinese medicine compound for preventing or treating osteoporosis specifically comprises the following steps: S1: taking salt Eucommia ulmoides, roasted Epimedium, Drynaria fortunei, roasted Astragalus, Chinese Angelica sinensis, Lycium barbarum, and Licorice according to weight proportions, mixing to obtain a drug mixture for later use; S2: Add water to the drug mixture (the ratio of drug mixture to water is 1g:20mL), soak for 1h, boil and simmer for 20min, and take 300mL of decoction; add an equal amount of water again, boil and simmer for 20min, and take 300mL of decoction, mix the two decoctions to obtain the Chinese medicine compound decoction.

[0026] Example 2 The present embodiment provides a Chinese medicinal compound for preventing or treating osteoporosis, which is prepared from the following raw materials (conventional Chinese medicine) in parts by weight: 20 parts of salt eucommia, 15 parts of roasted epimedium, 15 parts of drynaria, 15 parts of roasted astragalus, 12 parts of angelica, 12 parts of wolfberry, and 9 parts of liquorice.

[0027] The preparation method of the traditional Chinese medicine compound for preventing or treating osteoporosis specifically comprises the following steps: S1: taking salt Eucommia ulmoides, roasted Epimedium, Drynaria fortunei, roasted Astragalus, Chinese Angelica sinensis, Lycium barbarum, and Licorice according to weight proportions, mixing to obtain a drug mixture for later use; S2: Add water to the drug mixture (the ratio of drug mixture to water is 1g:20mL), soak for 1h, boil and then simmer for 20min, and take 300mL of decoction; add an equal amount of water again, boil and then simmer for 20min, and take 300mL of decoction, mix the two decoctions, and then add pharmaceutically acceptable excipients to prepare Chinese medicine compound granules.

[0028] Take directly with 300 ml of boiling water.

[0029] Example 3 This embodiment provides a Chinese medicinal compound for preventing or treating osteoporosis, which is prepared from the following raw materials (conventional Chinese medicine) in parts by weight: 25 parts of salt eucommia, 18 parts of roasted epimedium, 18 parts of drynaria, 20 parts of roasted astragalus, 16 parts of angelica, 16 parts of wolfberry, and 8 parts of liquorice.

[0030] The preparation method of the traditional Chinese medicine compound for preventing or treating osteoporosis specifically comprises the following steps: S1: taking salt Eucommia ulmoides, roasted Epimedium, Drynaria fortunei, roasted Astragalus, Chinese Angelica sinensis, Lycium barbarum, and Licorice according to weight proportions, mixing to obtain a drug mixture for later use; S2: Add water to the drug mixture (the ratio of drug mixture to water is 1g:20mL), soak for 1h, boil and then simmer for 20min, and take 300mL of decoction; add an equal amount of water again, boil and then simmer for 20min, and take 300mL of decoction, mix the two decoctions, and then add pharmaceutically acceptable excipients to prepare a Chinese medicine compound powder.

[0031] Take directly with 300 ml of boiling water.

[0032] Experimental Example 1 Animal Experiment 1. Materials and methods 1.1 Experimental animals: 60 9-week-old SPF female SD rats, weighing (220 g ± 20 g), provided by Lanzhou Veterinary Research Institute, Chinese Academy of Agricultural Sciences, animal quality certificate number: SCXK2021- 0013. They were kept in the SPF Animal Experiment Center of Lanzhou Veterinary Research Institute, Chinese Academy of Agricultural Sciences, in an environment with a temperature of 20-25°C, a humidity of 50-70%, and a 12-h light / dark cycle, with free access to food and water.

[0033] 1.2 Experimental drugs: The Chinese medicine compound granules of Example 2, low-, medium- and high-dose groups, were 0.252 g / kg -1 , 0.504g / kg -1 , 1.008g / kg -1 Different concentrations of intragastric fluid.

[0034] 1.3 Modeling: Rats were fed adaptively for 1 week and then divided into a sham operation group (n=10) and a model group (n=50) according to the random number table method. The model group was subjected to bilateral ovariectomy (OVX) to establish an OP rat model, while the sham operation group only removed the same volume of fat tissue around the ovaries. The rats were fasted for 24 h and deprived of water for 12 h before surgery. 3% sodium pentobarbital (30 mg / kg) was used for intraperitoneal anesthesia. When the rats were completely asleep, they were fixed on the operating table in a prone position. The hair on both sides of the lumbar spine was removed. The operating table was wiped with wet gauze and disinfected with 1% iodine. A longitudinal incision of about 1 cm was made along the left and right sides of the lumbar spine. The subcutaneous tissue was cut open in sequence, and a large amount of fat tissue appeared. There was a light pink cauliflower-like tissue surrounded by the fat tissue, which was the rat ovary. After separating the ovary from the fat, it was ligated about 0.5 cm below the ovary, and the ovary was removed. After no bleeding, the incision was closed layer by layer, sutured, and disinfected. After surgery, each rat was injected with penicillin 400,000 IU / kg to prevent infection, once a day for 3 consecutive days. After surgery, the rats were placed in a spacious and warm environment. After all rats woke up, they were put back into the breeding cage and continued to be observed and fed for 1 week. The rats in the model group entered the estrus state from the 8th day, indicating that castration was successful.

[0035] 1.4 Grouping and drug intervention: 4 weeks after successful modeling, except for the 10 sham operation (Sham) groups, the 50 first model groups were again divided into the model (OVX) group, the western medicine control (alendronate sodium / WMCG) group and the low (LDG), medium (MDG) and high (HDG) dose groups of the Chinese medicine compound of Example 2 according to the random number table, with 10 rats in each group. The low, medium and high dose groups of the Chinese medicine compound were 0.252 g / kg -1 , 0.504g / kg -1 , 1.008g / kg -1 Different concentrations of Chinese herbal compound decoction-free granules were administered orally. The Western medicine control group was given 0.18 mg / kg-1 The mice in the sham operation group and the model group were gavaged with an equal amount of 0.9% saline once a day. After 8 weeks of continuous intervention according to the above method, samples were collected to detect relevant indicators.

[0036] 1.5 Sampling: After the in vivo bone density test, blood was collected from the heart, and the blood was centrifuged at (3000rpm, 10min). The upper serum was collected, packaged in EP tubes and labeled, and stored in a -80℃ refrigerator for Elisa testing. The muscle tissue around the bilateral femurs of the rats was separated and removed, and the right femur was fixed in 4% paraformaldehyde solution and stored in a -20℃ refrigerator. The left femur was placed in a cryopreservation tube and stored in a -80℃ refrigerator for subsequent experimental testing.

[0037] 1.6 Statistical methods: SPSS26.0 and GraphPad Prism 8.0.1 statistical software were used. All data were expressed as mean ± standard deviation (x ± s). If the data conformed to normal distribution, independent sample t test was used between two groups. One-way analysis of variance test was used for comparison between multiple groups, and non-parametric rank sum test was used for non-normal distribution. P < 0.05 was considered statistically significant, and P < 0.01 was considered statistically significant.

[0038] 2. Experimental results (1) Effects on body weight changes in rats There was no significant difference in the body weight of rats in each group before modeling (P>0.05). The body weight of rats in each group showed a rapid growth trend from 0 to 4 weeks after modeling. After drug intervention, the weight gain of rats in each group was positively correlated with time. The trend from fast to slow was OVX group>LDG group>HDG group>MDG group>WMCG group>Sham group. The results showed that the Chinese medicine compound had no side effects on the body weight of rats. Figure 1 .

[0039] (2) Changes in organ indexes of rats After 8 weeks of drug intervention, rats in each group were dissected, and the liver and kidney (both) were taken and weighed. The organ coefficient of each group of rats was calculated by (organ weight / body weight) to reflect whether the organ was damaged. The results showed that there was no statistical difference between the groups (P>0.05), indicating that the Chinese medicine compound of this example had no toxic side effects on the liver and kidney of rats. Figure 2 shown.

[0040] (3) Effect on bone mineral density (BMD) in rats Dual-energy X-ray is one of the most common methods for detecting bone density. It has the advantages of sensitive detection, accurate test results and good reproducibility. All rats were fasted for 12 hours one day before the end of the intervention period. After the rats were weighed and anesthetized, a disposable medium was laid on the dual-energy X-ray bone densitometer. The results showed that after treatment, compared with the Sham group, the bone density of the distal femur of the OVX group rats was significantly reduced (P<0.001), and the difference was statistically significant; compared with the OVX group, the bone density of the LDG, MDG, HDG and WMCG groups was significantly increased (P<0.05); compared with the LDG group, the MDG group was significantly increased (P<0.05), and the difference was statistically significant. Figure 3 The experimental results are shown in Table 1. It can be seen that the Chinese medicinal compound of the present invention can significantly increase the distal femoral bone density of the model rats.

[0041] Table 1 Comparison of bone density in rats (x±s)

[0042] Note: Compared with Sham, * P<0.05, ** P<0.01; compared with OVX, # P<0.05, ## P<0.01; compared with LDG, △ P<0.05, △△ P<0.01. (4) Effect on bone strength in rats Bone strength is an important indicator of bone biomechanics. The maximum breakpoint value reflects the maximum external force that the bone can withstand, while the bending strength and compressive strength reflect the external force and toughness that must be applied to make the bone bend. A three-point bending test was performed on the cortical bone of the mid-section of the rat femur to detect its breakpoint value, bending strength and compressive strength, and to analyze the changes in the biomechanical properties of the rat femur. The results showed that compared with the Sham group, the breakpoint value, bending strength and compressive strength of the femur of the rats in the OVX group were significantly decreased (P<0.01); compared with the LDG group, the breakpoint value and compressive strength of the femur of the rats in the MDG group were increased (P<0.05), and the difference was statistically significant. Figure 4 The experimental results are shown in Table 2. It can be seen that the Chinese medicinal compound of this embodiment can effectively improve the bone biomechanical indicators such as the breaking point value, compressive strength and bending strength of rat femur.

[0043] Table 2 Comparison of biomechanical parameters of rat femur (x±s)

[0044] Note: Compared with Sham, * P<0.05, ** P<0.01; compared with OVX,# P<0.05, ## P<0.01; compared with LDG, △ P<0.05, △△ P<0.01. (5) Effects on rat bone microstructure and trabecular parameters Micro-CT was used to reconstruct the 3D structure of the distal femoral trabeculae. The results showed that the number of trabeculae in the OVX group was severely reduced, the arrangement was sparse, the trabecular spacing was the largest, the bone lacuna was obvious, and the bone was irregular. Compared with the LDG group, the number of trabeculae in the MDG and HDG groups increased, and the gaps decreased, which was more obvious in the MDG group. Figure 5 shown.

[0045] Bone analysis parameters were calculated based on CT images: bone volume (BV), tissue volume (TV), bone surface area (BS), bone volume fraction (BV / TV), bone surface area to tissue volume ratio (BS / TV), trabecular thickness (Tb.Th), trabecular number (Tb.N), trabecular separation (Tb.Sp), and bone mineral density ((Mean) BMD). The results showed that compared with the Sham group, the BV / TV, BS / TV, Tb.Th, Tb.N, and (Mean) BMD values ​​of the OVX group were significantly decreased (P<0.01), and Tb.Sp was significantly increased (P<0.01); compared with the LDG group, the BV / TV, BS / TV, Tb.Th, and (Mean) BMD values ​​of the MDG group were increased (P<0.05), Tb.N was significantly increased (P<0.01), and Tb.Sp had no difference (P>0.05); compared with the MDG group, the BS / TV and Tb.Th values ​​of the HDG group were decreased (P<0.05), and Tb.N was increased (P<0.05), and BV / TV, Tb.Sp, and (Mean) BMD had no difference (P>0.05). Figure 6 The experimental results are shown in Table 3. It can be seen that the Chinese medicinal compound of the present invention can effectively improve the bone microstructure and trabecular parameters of rats.

[0046] Table 3 Comparison of Micro-CT scan data of rat distal femur (x±s)

[0047] Note: Compared with Sham, * P<0.05, ** P<0.01; compared with OVX, # P<0.05, ## P<0.01; compared with LDG, △ P<0.05, △△ P<0.01; compared with the MDG group, ＊ P<0.05,＊＊ P<0.05.

[0048] (6) Effects on serum bone turnover markers in rats ELISA method was used to detect the levels of type I procollagen amino-terminal propeptide (PINP), bone-specific alkaline phosphatase (BALP), tartrate-resistant acid phosphatase (TRACP), and cathepsin K (Cath-K) in rat serum. The results showed that compared with the Sham group, the PINP level in the OVX group was significantly decreased (P<0.01), and the BALP, TRACP, and Cath-k levels were significantly increased (P<0.01); compared with the LDG group, the BALP level in the MDG group was increased (P<0.05), and the TRACP level was decreased (P<0.05); the PINP level in the HDG group was increased (P<0.05), and there was no difference in the changes in the levels of BALP, TRACP, and Cath-K (P>0.05). Figure 7 The experimental results are shown in Table 4. It can be seen that the Chinese medicine compound of this embodiment can significantly regulate the expression level of serum bone turnover markers in model rats.

[0049] Table 4 Changes of serum bone turnover markers in rats (x±s)

[0050] Note: Compared with Sham, * P<0.05, ** P<0.01; compared with OVX, # P<0.05, ## P<0.01; compared with LDG, △ P<0.05. In some experimental examples of the present invention, the Chinese herbal compound of Example 1 and Example 3 were used to carry out the animal experiment of the above-mentioned Experimental Example 1, and the same experimental results as those of the Chinese herbal compound of Example 2 were obtained.

[0051] In this embodiment, the serum of the rat animal model was detected by ELISA method, which confirmed that the Chinese medicine compound of this embodiment can significantly regulate the expression level of serum bone turnover markers in the model rats; by dual-energy X-ray detection, it was confirmed that the Chinese medicine compound of this embodiment can significantly increase the distal femoral bone density of the model rats; by three-point bending test, it was confirmed that the Chinese medicine compound proposed in this embodiment can effectively improve the bone biomechanical indicators such as the femoral breakpoint value, compressive strength and bending strength of the rats; by Micro-CT detection of the distal femoral trabecular structure analysis, it was confirmed that the Chinese medicine compound of this embodiment can effectively improve the rat bone microstructure and trabecular parameters. In addition, the Chinese medicine compound proposed in this embodiment has no damage to the body weight, liver function, and renal function of the experimental rats. Based on this, the Chinese medicine compound of this embodiment has a good effect on the treatment of osteoporosis.

[0052] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicinal compound for preventing or treating osteoporosis, characterized in that: The traditional Chinese medicine compound is prepared from the following raw materials in parts by weight: 20-30 parts of salt eucommia, 15-20 parts of roasted epimedium, 15-20 parts of drynaria, 15-30 parts of roasted astragalus, 12-20 parts of angelica, 12-20 parts of wolfberry and 6-9 parts of liquorice.

2. A Chinese medicinal compound for preventing or treating osteoporosis according to claim 1, characterized in that: The Chinese medicinal compound is prepared from the following raw materials in parts by weight: 20 parts of salt eucommia, 15 parts of roasted epimedium, 15 parts of drynaria, 15 parts of roasted astragalus, 12 parts of angelica, 12 parts of wolfberry and 9 parts of liquorice.

3. A Chinese medicinal compound for preventing or treating osteoporosis according to claim 1, characterized in that: The raw materials are Chinese medicine granules that do not require decoction or conventional Chinese medicine; the administration method of the Chinese medicine compound is an oral administration dosage form.

4. A method for preparing a Chinese medicinal compound for preventing or treating osteoporosis according to any one of claims 1 to 3, characterized in that: The specific steps include: S1: taking salt Eucommia ulmoides, roasted Epimedium, Drynaria fortunei, roasted Astragalus, Chinese Angelica sinensis, Lycium barbarum, and Licorice according to weight proportions, mixing to obtain a drug mixture for later use; S2: Add water to the drug mixture, soak, boil, and simmer for 20 minutes, and take 300 mL of the decoction; add an equal amount of water again, boil, and simmer for 20 minutes, and take 300 mL of the decoction, mix the two decoctions, and obtain the Chinese medicine compound decoction.

5. The method for preparing a Chinese medicinal compound for preventing or treating osteoporosis according to claim 4, characterized in that: In step S2, the dosage ratio of the drug mixture to water is 1 g:20 mL; and the soaking time is 1 h.

6. The method for preparing a Chinese medicinal compound for preventing or treating osteoporosis according to claim 4, characterized in that: In step S2, pharmaceutically acceptable excipients may be added to prepare granules or powders.

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