A Chinese medicine composition for improving osteoporosis and its preparation method

Abstract

The invention discloses a Chinese medicine composition for improving osteoporosis and a preparation method thereof, and belongs to the technical field of Chinese medicine composition. The invention comprises the following components: 10 to 30 parts of raw astragalus; 5 to 20 parts of angelica; 10 to 30 parts of codonopsis; 5 to 30 parts of prepared rehmannia root; 5 to 30 parts of dipsacus root; 5 to 30 parts of eucommia bark; 5 to 30 parts of psoralea corylifolia; 5 to 30 parts of bupleurum root; 5 to 30 parts of epimedium; 5 to 30 parts of tortoise shell; 5 to 30 parts of turtle shell; 10 to 30 parts of tuckahoe; 10 to 30 parts of atractylodes macrocephala; 5 to 30 parts of drynaria; 5 to 30 parts of wolfberry. The invention adopts a variety of Chinese herbal medicines with the effects of nourishing liver and kidney, strengthening tendons and bones for compound compatibility. The combination of these medicinal materials can act synergistically to improve the body's disease resistance, thereby effectively improving the symptoms of osteoporosis. Compared with some existing Western medicine treatments, it has no side effects, is safer, has relatively low costs, and can reduce the financial burden on patients.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and particularly relates to a Chinese medicine composition for improving osteoporosis and a preparation method thereof. Background Art

[0002] Osteoporosis is a systemic bone disease characterized by decreased bone mass and destruction of bone microarchitecture, which leads to increased bone fragility and susceptibility to fractures. The condition is particularly common in the elderly, and its incidence increases significantly with age. Osteoporosis and its complications, such as fractures, not only seriously affect the quality of life of patients, but also impose a heavy economic burden on families and society.

[0003] The pathogenesis of osteoporosis is complex, involving multiple factors such as genetics, endocrine, nutrition, and lifestyle. Among them, decreased estrogen levels, insufficient calcium and vitamin D intake, lack of physical activity, smoking, and alcoholism are all important factors that induce osteoporosis. In addition, the natural aging process of bones with age also accelerates the occurrence of osteoporosis.

[0004] At present, the treatment of osteoporosis mainly includes drug therapy and non-drug therapy. In terms of drug therapy, it mainly includes calcium preparations, vitamin D and its derivatives, bisphosphonates, estrogen and its receptor modulators, calcitonin, etc. These drugs promote bone formation, inhibit bone resorption or increase bone density through different mechanisms, thereby achieving the purpose of treating osteoporosis. However, existing drugs often have problems such as limited efficacy, more side effects, and weakened effects after long-term use.

[0005] Non-drug treatment mainly includes lifestyle intervention, such as increasing physical activity, improving eating habits, quitting smoking and limiting alcohol consumption, etc. Although these measures have a positive effect on the prevention and treatment of osteoporosis, their effects are relatively slow and require long-term adherence by patients.

[0006] In recent years, traditional Chinese medicine has gradually gained attention in the treatment of osteoporosis. Traditional Chinese medicine achieves the purpose of treating osteoporosis by regulating the body's yin and yang balance, promoting bone metabolism, and improving bone microstructure. A large number of clinical studies have shown that traditional Chinese medicine has unique advantages in the treatment of osteoporosis, such as the comprehensive effects of multiple components, multiple targets, and multiple pathways, as well as fewer side effects.

[0007] Traditional Chinese medicine has a long history of understanding osteoporosis, classifying it as "bone atrophy" and "bone arthritis", and believes that its main pathogenesis is insufficient kidney essence and empty bone marrow. With the deepening of modern research on traditional Chinese medicine, more and more Chinese herbal compound prescriptions have been confirmed to have multiple mechanisms of action, such as promoting bone formation, inhibiting bone resorption, and increasing bone density. These Chinese herbal compound prescriptions show good prospects for the treatment of osteoporosis through the comprehensive effects of multiple components and multiple pathways.

[0008] However, there are many kinds of traditional Chinese medicine products for osteoporosis on the market, but the efficacy and safety of most products need further verification. Therefore, developing a traditional Chinese medicine product with definite efficacy, high safety and convenient use is of great significance to improve the quality of life of osteoporosis patients. Summary of the invention

[0009] In view of the problem in the prior art of how to develop a traditional Chinese medicine product for treating osteoporosis that has definite efficacy, high safety and is easy to use, the present invention provides a traditional Chinese medicine composition for improving osteoporosis and a preparation method thereof.

[0010] The technical solution adopted by the present invention is as follows:

[0011] A Chinese medicine composition for improving osteoporosis, comprising the following components by weight:

[0012] Raw Astragalus: 10-30 portions;

[0013] Angelica: 5-20 portions;

[0014] Codonopsis pilosula: 10-30 portions;

[0015] Rehmannia root: 5-30 parts;

[0016] Dipsacus asper: 5-30 portions;

[0017] Eucommia ulmoides: 5-30 parts;

[0018] Psoralea corylifolia: 5-20 parts;

[0019] Bupleurum: 5-30 parts;

[0020] Epimedium: 5-30 parts;

[0021] Tortoise shell: 5-30 portions;

[0022] Turtle shell: 5-30 parts;

[0023] Poria: 10-30 portions;

[0024] Atractylodes macrocephala: 10-30 parts;

[0025] Drynaria fortunei: 5-30 portions;

[0026] Wolfberry: 5-30 servings.

[0027] Preferably, the weight ratio of the components is: raw astragalus: angelica: Codonopsis: Rehmannia root: Dipsacus asper: Eucommia bark: Psoralea corylifolia: Bupleurum: Epimedium: Tortoise shell: Carapace of turtle: Poria: Atractylodes macrocephala: Drynaria fortunei: Lycium barbarum is 6:2:4:2:3:2:2:2:2:2:2:4:4:2:4.

[0028] Preferably, the following components are included by weight:

[0029] 30g raw Astragalus;

[0030] Angelica: 10 g;

[0031] Codonopsis pilosula: 20 g;

[0032] Rehmannia root: 10 g;

[0033] Dipsacus asper: 15 g;

[0034] Eucommia ulmoides: 10 g;

[0035] Psoralea corylifolia: 10 g;

[0036] Bupleurum: 10 g;

[0037] Epimedium: 10 g;

[0038] Tortoise shell: 10 g;

[0039] Turtle shell: 10 g;

[0040] Poria: 20 g;

[0041] Atractylodes macrocephala: 20 g;

[0042] Drynaria fortunei: 10g;

[0043] Wolfberry: 20g.

[0044] A method for preparing a traditional Chinese medicine composition for improving osteoporosis comprises the following steps:

[0045] Step 1: Prepare the raw materials according to the Chinese medicinal materials and proportions described in the recipe;

[0046] Step 2: Soak the prepared raw materials;

[0047] Step 3: Decoction the raw materials and soaking liquid together several times;

[0048] Step 4: combining and concentrating the medicinal solutions obtained by decoction for several times to obtain a concentrated medicinal solution;

[0049] Step 5: Prepare the obtained concentrated drug solution into a preparation.

[0050] Preferably, the weight of the soaking liquid added during soaking in step 2 is 10 times the total weight of the raw materials, and the soaking time is 30 minutes.

[0051] Preferably, in step 3, the raw materials and all the soaking liquid are first boiled with high heat, and then the high heat is changed to low heat to continue decocting. After the decoction is completed, the medicinal liquid and the medicinal residue are separated, and water is added to the medicinal residue for the next decoction. The decoction time for each time is between 1 hour and 1 hour and 30 minutes.

[0052] Preferably, the preparation in step 5 is an oral liquid, granules or tablets.

[0053] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0054] 1. The present invention provides a new Chinese medicine composition for improving osteoporosis, which focuses more on improving osteoporosis by replenishing qi and blood and regulating the balance of yin and yang. It is prepared into a formula by carefully selecting and combining a variety of Chinese medicine ingredients with the effects of nourishing the liver and kidneys and strengthening the tendons and bones, providing a new treatment option for patients with osteoporosis.

[0055] 2. The present invention can improve the therapeutic effect of osteoporosis. Through the synergistic effect of multiple components, the formula can more effectively promote bone formation and inhibit bone resorption, thereby significantly improving the therapeutic effect of osteoporosis.

[0056] 3. The present invention can reduce the side effects of treatment: Based on the principles of overall regulation and treatment based on syndrome differentiation in traditional Chinese medicine, the formula is expected to reduce the side effects of drug treatment by regulating the internal environment of the body and improve the patient's treatment experience and quality of life. DETAILED DESCRIPTION

[0057] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the present application will be clearly and completely described below in combination with the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Example

[0058] A Chinese medicine composition for improving osteoporosis, comprising the following components:

[0059] Raw Astragalus: 30g;

[0060] Function: Raw Astragalus is the main drug, which has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood, relieving stagnation and relieving arthritis, expelling toxins and draining pus, and healing sores and promoting tissue regeneration. In the formula, raw Astragalus can enhance the overall function of the body, promote qi and blood circulation, provide sufficient nutrition for bones, and thus improve bone health.

[0061] The pharmacological effects of Astragalus on osteoporosis mainly include the following aspects: 1. Promote bone formation. Osteoblast activity: The active ingredients in Astragalus, such as astragaloside, astragaloside IV, etc., can stimulate the proliferation and differentiation of osteoblasts, increase the expression of bone formation-related genes, such as osteocalcin (OCN), alkaline phosphatase (ALP), etc., thereby promoting the synthesis and deposition of bone matrix. Osteoporogen (OPG) / receptor activator of nuclear factor κB ligand (RANKL) system: Astragalus may indirectly promote bone formation by regulating the balance of the OPG / RANKL system and inhibiting the activation of osteoclasts. 2. Inhibition of bone resorption: Osteoclast inhibition: The active ingredients in Astragalus can inhibit the generation and function of osteoclasts, reduce bone resorption, and thus prevent bone loss. This may be related to the inhibitory effect of Astragalus on key factors of osteoclast differentiation such as RANKL. 3. Anti-inflammatory effect: The occurrence of osteoporosis is closely related to inflammatory response. Astragalus has a significant anti-inflammatory effect, which can reduce the level of inflammatory cytokines in the body, such as tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), etc., and reduce the damage of inflammatory response to bones. 4. Regulate hormones related to bone metabolism. Calcium and phosphorus metabolism: Astragalus can affect calcium and phosphorus metabolism, promote calcium absorption and utilization, and increase bone density. This may be related to the regulation of the levels of bone metabolism-related hormones such as vitamin D receptor (VDR) and parathyroid hormone (PTH) by Astragalus. Sex hormones: Astragalus also has a certain effect on sex hormones, especially for estrogen deficiency osteoporosis. Astragalus may indirectly promote bone formation by regulating estrogen levels. 5. Anti-oxidative stress: The occurrence of osteoporosis is closely related to oxidative stress. Astragalus is rich in antioxidants, such as astragalus polysaccharides and flavonoids, which can scavenge free radicals, reduce the damage of oxidative stress to bones, and protect bone health. 6. Immunomodulatory effect: Astragalus can regulate the function of the immune system and enhance the body's immunity, thereby reducing the adverse effects of factors such as infection on bones. At the same time, the balance of the immune system is also an important factor in maintaining bone health. Astragalus extract can significantly increase the bone density, number of trabeculae and bone strength of osteoporosis model animals, while reducing the number and area of ​​bone resorption pits. Astragalus combined with other traditional Chinese medicines can significantly improve the bone density and bone metabolism indicators of osteoporosis patients and reduce the risk of fractures.

[0062] Raw Astragalus: usually refers to Astragalus that has not been specially processed. It is sweet and slightly warm in nature, and enters the spleen and lung meridians. The main effects of raw Astragalus are to tonify qi and consolidate the exterior, promote diuresis and reduce swelling, and promote the production of body fluids and nourish blood. It is suitable for symptoms such as qi deficiency and physical weakness, easy sweating, edema, chronic diarrhea, etc., and has the effect of enhancing the body's immune function and improving the body's disease resistance. And roasted Astragalus: refers to raw Astragalus that has been processed with auxiliary materials such as honey or maltose. It has a milder nature and stronger tonic effect. Roasted Astragalus is mainly used to treat symptoms such as qi and blood deficiency, physical weakness and spontaneous sweating, pale complexion, fatigue, etc. It is particularly suitable for situations where the constitution is weak and warming is needed. In the pharmaceutical composition of the present invention, the choice of using raw Astragalus instead of roasted Astragalus is based on the following considerations:

[0063] Strengthening Qi-tonifying effect: Raw Astragalus has a more obvious Qi-tonifying effect. It is more suitable for osteoporosis patients who need to enhance the body's disease resistance and overall function. Scope of application: Raw Astragalus is suitable for various symptoms caused by Qi deficiency, including but not limited to osteoporosis. Its scope of application is wide. Efficacy characteristics: In addition to replenishing Qi, raw Astragalus also has the effects of strengthening the surface and stopping sweating, promoting diuresis and reducing swelling. These effects have an auxiliary therapeutic effect on some complications of osteoporosis patients.

[0064] Angelica: 10g;

[0065] Function: Angelica sinensis is one of the ministerial drugs, which has the effects of nourishing blood, activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. Angelica sinensis can nourish blood, promote bone marrow hematopoiesis, provide necessary blood support for bone repair, and also has a certain effect on relieving pain caused by bone diseases.

[0066] The pharmacological effects of angelica on osteoporosis mainly include the following aspects: 1. Promoting bone formation and inhibiting bone resorption: Angelica is rich in a variety of active ingredients, including volatile oils, polysaccharides, ferulic acid, vitamins, etc. These ingredients may promote bone formation and inhibit bone resorption through different pathways. For example, angelica polysaccharides have been reported to stimulate osteoblast activity, promote the synthesis and mineralization of bone matrix proteins, and thus increase bone density and bone strength. At the same time, some components in angelica may also regulate the function of osteoclasts, inhibit their overactivation, and reduce bone destruction. 2. Regulating hormone levels: Osteoporosis is closely related to the decline in estrogen levels, especially in postmenopausal women. Angelica has the effect of regulating endocrine, and can indirectly promote the balance of bone metabolism by increasing the content of estrogen-like active substances in the body. Some components in angelica may act as regulators of estrogen receptors, mimic the protective effect of estrogen on bone tissue, and reduce bone loss. 3. Antioxidant and anti-inflammatory effects: Oxidative stress and inflammatory response play an important role in the pathogenesis of osteoporosis. Angelica is rich in antioxidants, such as ferulic acid and flavonoids, which can remove free radicals in the body and reduce the damage of oxidative stress to bone tissue. At the same time, Angelica also has a certain anti-inflammatory effect, which can inhibit the release of inflammatory factors and reduce the damage of inflammatory response to bone. 4. Promote blood circulation: Chinese medicine believes that "if the blood is not prosperous, the bones will not be strong". Angelica has the effect of promoting blood circulation and removing blood stasis, which can improve the blood circulation around the bone tissue, provide sufficient nutrition and oxygen for bone cells, and is conducive to the repair and regeneration of bone. Modern pharmacological research has also found that certain components in Angelica can dilate blood vessels, increase blood flow, and improve microcirculation, thereby having a positive effect on osteoporosis.

[0067] Codonopsis pilosula: 20g;

[0068] Function: Codonopsis is also a ministerial drug, which has the effects of tonifying the spleen and lungs, promoting body fluid and nourishing blood. Codonopsis can enhance the function of the spleen and stomach, promote the absorption and utilization of nutrients, and provide a solid support for bone health.

[0069] Codonopsis contains a variety of active ingredients, such as polysaccharides, saponins, alkaloids and flavonoids, which show a variety of biological activities in pharmacology, including immunomodulatory, antioxidant, and anti-inflammatory effects. The pharmacological effects of Codonopsis on osteoporosis mainly include the following aspects: 1. Promoting bone formation: The polysaccharides and saponins in Codonopsis may promote the proliferation and differentiation of bone cells (such as osteoblasts) and increase the synthesis of bone matrix, thereby contributing to bone formation and repair. This effect may be helpful in preventing and alleviating osteoporosis. 2. Antioxidant and anti-inflammatory effects: The occurrence of osteoporosis is closely related to oxidative stress and inflammatory response. The antioxidant ingredients in Codonopsis (such as flavonoids) can remove free radicals in the body and reduce oxidative stress; while the anti-inflammatory ingredients help reduce inflammatory responses and protect bones from damage. 3. Regulating endocrine: Codonopsis indirectly promotes bone health by regulating the body's endocrine system, especially affecting the secretion and activity of hormones related to bone metabolism (such as estrogen, parathyroid hormone, etc.).

[0070] Rehmannia root: 10g;

[0071] Function: Rehmannia root is a ministerial drug, which has the effects of nourishing blood and yin, replenishing essence and filling marrow. Rehmannia root can nourish kidney yin and promote the formation and transformation of kidney essence. Kidney essence is an important source of bone marrow and plays an important role in the growth, development and repair of bones.

[0072] The pharmacological effects of Rehmannia glutinosa on osteoporosis mainly include the following aspects: Rehmannia glutinosa contains a variety of active ingredients, including polysaccharides, sterols, amino acids, trace elements, etc. These ingredients may play an important role in promoting bone health. For example, polysaccharide components can regulate the immune system, enhance bone cell activity, and promote bone formation; sterol components may have the effect of regulating hormone secretion and indirectly affect bone metabolism. 1. Promote bone formation and inhibit bone resorption: The main characteristics of osteoporosis are bone loss and bone microstructure destruction, which are usually caused by reduced bone formation and increased bone resorption. Modern pharmacological studies have shown that certain components in Rehmannia glutinosa may increase bone density and bone strength by promoting the proliferation and differentiation of osteoblasts and enhancing the synthesis of bone matrix proteins. At the same time, these components may also further protect bone health by inhibiting the activity of osteoclasts and reducing bone resorption. 2. Regulate calcium and phosphorus metabolism: The balance of calcium and phosphorus metabolism is essential for maintaining bone health. Certain active ingredients in Rehmannia glutinosa may regulate calcium and phosphorus metabolism by affecting the intestinal absorption of calcium and phosphorus, the reabsorption of calcium and phosphorus by the kidneys, and the deposition of calcium and phosphorus by the bones. This regulatory effect helps maintain the normal structure and function of bones and prevent the occurrence of osteoporosis. 3. Antioxidant and anti-inflammatory effects: Oxidative stress and inflammatory response play an important role in the occurrence and development of osteoporosis. The antioxidant components in Rehmannia glutinosa (such as flavonoids, polysaccharides, etc.) can remove free radicals and reduce the damage of oxidative stress to bone cells; at the same time, its anti-inflammatory components can inhibit the production and release of inflammatory factors and reduce the damage of inflammatory response to bone tissue. This antioxidant and anti-inflammatory effect helps protect bone health and prevent osteoporosis.

[0073] Both raw rehmannia root and cooked rehmannia root are derived from the same plant, but the different processing methods lead to different medicinal effects. Raw rehmannia root is cold in nature and is mainly used to clear away heat and cool blood, nourish yin and promote the production of body fluid; cooked rehmannia root is sweet and warm in nature after being steamed, and is mainly used to nourish blood and yin, and replenish essence and fill marrow. In the present invention, cooked rehmannia root is selected in order to utilize its effects of nourishing blood and yin, replenishing essence and filling marrow, better nourishing kidney yin, promoting the generation and transformation of kidney essence, and playing an important role in the growth, development and repair of bones.

[0074] Dipsacus asper: 15g;

[0075] Function: As one of the ministerial drugs, Dipsacus root has the effects of nourishing the liver and kidney, strengthening tendons and bones, healing fractures, and stopping metrorrhagia. Dipsacus root directly improves the structure and function of bones and promotes the repair of fractures and osteoporosis by nourishing the liver and kidney and strengthening tendons and bones.

[0076] The pharmacological effects of Dipsacus asper on osteoporosis mainly include the following aspects: 1. Promote bone formation: The active ingredients in Dipsacus asper may promote bone formation by promoting the proliferation and differentiation of osteoblasts and increasing the synthesis of bone matrix. 2. Inhibit bone resorption: The occurrence of osteoporosis is closely related to the increase of bone resorption. Some ingredients in Dipsacus asper may reduce bone resorption by inhibiting the activity and number of osteoclasts, thereby slowing down the process of osteoporosis. 3. Regulate calcium and phosphorus metabolism: The balance of calcium and phosphorus metabolism is essential for maintaining bone health. Dipsacus asper may regulate the absorption and utilization of calcium and phosphorus and promote the mineralization process of bones by affecting the levels of related enzymes and hormones. 4. Antioxidant effect: Oxidative stress is an important pathogenesis of osteoporosis. The antioxidant ingredients in Dipsacus asper can remove free radicals in the body, reduce the damage of oxidative stress to bones, and thus protect bone health. 5. Regulate hormone levels: Changes in certain hormone levels, such as the decline in estrogen levels, are closely related to the occurrence of osteoporosis. Dipsacus may improve osteoporosis by regulating hormone levels, such as increasing estrogen levels or enhancing the sensitivity of estrogen receptors. 6. Anti-inflammatory effect: Inflammation also plays an important role in the pathogenesis of osteoporosis. The anti-inflammatory components in Dipsacus can reduce the inflammatory response around the bones, thereby protecting the bones from damage.

[0077] Eucommia ulmoides: 10g;

[0078] Effect: Eucommia ulmoides is an adjuvant drug. It has the effects of nourishing the liver and kidneys, strengthening the tendons and bones, and calming the fetus. The active ingredients in Eucommia ulmoides can enhance the strength and toughness of bones and reduce the risk of fractures. At the same time, the warming and tonic effect of Eucommia ulmoides can also help improve the symptoms of deficiency and cold caused by bone diseases.

[0079] Eucommia contains a variety of active ingredients, including eucommia gum, chlorogenic acid, flavonoids, polysaccharides, etc. These ingredients show biological activity in many aspects and may have a positive effect on osteoporosis through the following mechanisms: 1. Promote bone formation: Some ingredients in Eucommia may have the effect of promoting osteoblast proliferation and differentiation, thereby increasing bone formation and improving bone density. 2. Inhibit bone resorption: The active ingredients of Eucommia may reduce bone loss by inhibiting the activity of osteoclasts, which helps to maintain the stability of bone mass. 3. Regulate calcium and phosphorus metabolism: Eucommia may promote calcium absorption and utilization by regulating calcium and phosphorus metabolism in the body, provide sufficient calcium for bones, and enhance bone strength and toughness. 4. Antioxidant and anti-inflammatory effects: The active ingredients such as flavonoids and polysaccharides in Eucommia have strong antioxidant and anti-inflammatory effects, which can reduce oxidative stress and inflammatory response in bone tissue and protect bone cells from damage. 5. Immunomodulatory effect: Eucommia may also enhance the body's disease resistance by regulating the body's immune function and reduce the risk of osteoporosis caused by disease or drugs.

[0080] Psoralea corylifolia: 10g;

[0081] Function: Psoralea corylifolia is an adjuvant drug. It has the effects of tonifying the kidney and strengthening yang, consolidating essence and reducing urine, warming the spleen and stopping diarrhea, and promoting qi and relieving asthma. The kidney-tonifying effect of Psoralea corylifolia helps to enhance the generation and transformation of kidney essence and promotes the repair and regeneration of bones.

[0082] Modern pharmacological research on psoralea corylifolia in osteoporosis mainly focuses on its promotion of bone formation, inhibition of bone resorption and enhancement of bone strength. The pharmacological effects of psoralea corylifolia on osteoporosis mainly include the following aspects: 1. Promoting bone formation: The active ingredients in psoralea corylifolia, such as psoralen and isopsoralen, have been shown to promote bone formation. These ingredients can stimulate the activity of osteoblasts, promote the synthesis and mineralization of bone matrix, and thus increase bone density and bone strength. By regulating bone formation-related signaling pathways, such as the Wnt / β-catenin pathway, psoralea corylifolia can enhance the differentiation and function of osteoblasts and promote the formation of new bone. 2. Inhibiting bone resorption: Psoralea corylifolia can also reduce bone resorption by inhibiting the activity of osteoclasts, thereby preventing further bone loss. Osteoclasts are the main cell type responsible for bone resorption, and their excessive activity can lead to osteoporosis. Certain components in psoralea corylifolia can inhibit the differentiation and maturation of osteoclast precursors, reduce the activity of osteoclasts, and reduce the degradation of bone matrix and the loss of bone mass. 3. Antioxidant and anti-inflammatory effects: The occurrence of osteoporosis is often accompanied by oxidative stress and inflammatory response. The various active ingredients in psoralea have significant antioxidant and anti-inflammatory effects, which can remove free radicals in the body, reduce oxidative stress, inhibit inflammatory response, and thus protect bones from damage. These effects help maintain the healthy state of bones and prevent and treat osteoporosis. 4. Regulate estrogen levels: Estrogen plays an important role in maintaining bone health. Certain ingredients in psoralea can regulate estrogen levels, promote the synthesis and secretion of estrogen, and thus enhance the protective effect of estrogen on bones. Estrogen can stimulate the activity of osteoblasts, inhibit the activity of osteoclasts, promote the synthesis and mineralization of bone matrix, and help prevent the occurrence and development of osteoporosis. Psoralea can significantly increase the bone density and bone strength of osteoporotic animals and improve the microstructure of bones. Psoralea has a significant therapeutic effect in the treatment of osteoporosis, can relieve patients' pain and discomfort, and improve their quality of life.

[0083] Bupleurum: 10g;

[0084] Function: Bupleurum is used as a guiding drug. It has the effects of dispersing fever, relieving liver qi and depression, and raising Yang Qi. In the formula, Bupleurum's liver qi and depression-relieving effects help alleviate emotional problems caused by bone diseases, while its Yang Qi-raising effect also helps improve the body's overall condition.

[0085] The pharmacological effects of Bupleurum on osteoporosis mainly include the following aspects: 1. Estrogen-like effect: The occurrence of osteoporosis is closely related to the decline of estrogen levels. Modern pharmacological studies have found that some components in Bupleurum may have estrogen-like effects, which can regulate the levels of related hormones in the bone metabolism process, thereby affecting the balance between bone formation and bone resorption, and help prevent and treat osteoporosis. 2. Antioxidant effect: Oxidative stress is one of the important mechanisms leading to osteoporosis. The various active ingredients in Bupleurum have significant antioxidant effects, which can remove free radicals in the body, reduce the damage of oxidative stress to bone cells, and protect the health of bone tissue. 3. Anti-inflammatory effect: Inflammatory response is also an important factor in the occurrence and development of osteoporosis. Some components in Bupleurum can inhibit inflammatory response, reduce the damage of inflammation to bone tissue, and promote the repair and regeneration of bone tissue. 4. Promote bone cell proliferation and differentiation: Modern studies have shown that some components in Bupleurum may promote the proliferation and differentiation of osteoblasts and increase bone formation, thereby helping to improve the bone density and bone strength of patients with osteoporosis. 5. Regulate bone metabolism-related signal pathways: The active ingredients in Bupleurum may affect the differentiation and function of bone cells by regulating bone metabolism-related signal pathways, such as Wnt / β-catenin, BMP / Smad, etc., thereby exerting a therapeutic effect on osteoporosis.

[0086] Epimedium: 10g;

[0087] Function: Epimedium is an adjuvant drug, which has the effects of tonifying kidney yang, strengthening tendons and bones, and removing rheumatism. The kidney yang tonifying effect of epimedium can enhance the vitality of kidney essence and promote the growth, development and repair of bones; its rheumatism removing effect helps to relieve bone pain caused by rheumatism.

[0088] The pharmacological effects of epimedium on osteoporosis mainly include the following aspects: 1. Promote bone formation: Epimedium contains a variety of active ingredients, such as icariin, icariin and other flavonoid compounds, which have been proven to promote bone formation. Icariin can stimulate the proliferation and differentiation of osteoblasts, increase the synthesis of collagen in the bone matrix, and thus enhance the strength and density of bone tissue. By promoting bone formation, epimedium helps to improve the bone quality of patients with osteoporosis. 2. Inhibit bone resorption: Studies have shown that the active ingredients of epimedium can inhibit the proliferation and differentiation of osteoclasts and reduce the destructive effect of osteoclasts on bone tissue. 3. Regulate hormone levels: Epimedium has been found to have estrogen-like effects and can regulate hormone levels in the body, especially with a certain affinity for estrogen receptors. By regulating hormone levels, epimedium can improve osteoporosis caused by abnormal hormone levels. 4. Antioxidant and anti-inflammatory effects: The various active ingredients in Epimedium have significant antioxidant and anti-inflammatory effects, which can remove free radicals in the body, reduce oxidative stress, and inhibit the occurrence and development of inflammatory reactions. This antioxidant and anti-inflammatory effect helps protect bone tissue from damage and maintain the healthy state of bone tissue.

[0089] Tortoise shell: 10g;

[0090] Function: Tortoise shell is an adjuvant medicine. It has the effects of nourishing yin and suppressing yang, strengthening the kidney and bones, nourishing blood and nourishing the heart. The collagen and various minerals in tortoise shell play an important role in the growth and repair of bones. At the same time, its function of nourishing yin and suppressing yang also helps to improve the body's yin and yang balance.

[0091] The pharmacological effects of tortoise shell on osteoporosis mainly include the following aspects: 1. Promote bone formation and inhibit bone resorption: tortoise shell may contain a variety of active ingredients, such as collagen, minerals (such as calcium, phosphorus, etc.), amino acids, polysaccharides and some bioactive peptides. These ingredients may promote the proliferation and differentiation of bone cells and enhance the activity of osteoblasts through various pathways, thereby facilitating the formation and mineralization of bone matrix. At the same time, some ingredients in tortoise shell may also inhibit the activity of osteoclasts, reduce bone resorption, and maintain the balance of bone mass. 2. Regulate bone metabolism-related hormones: The occurrence of osteoporosis is closely related to the imbalance of various bone metabolism-related hormones, such as parathyroid hormone (PTH), vitamin D, calcitonin, etc. Modern research suggests that some active ingredients in tortoise shell may affect the bone metabolism process by regulating the levels or signal pathways of these hormones, thereby facilitating the prevention and treatment of osteoporosis. 3. Antioxidant and anti-inflammatory effects: the pathogenesis of osteoporosis is often accompanied by oxidative stress and inflammatory reactions. The polysaccharides, amino acids and other ingredients in tortoise shell have significant antioxidant and anti-inflammatory effects, which can remove free radicals in the body, reduce the damage of oxidative stress to the skeletal system, inhibit inflammatory response, and reduce the negative effects of inflammatory factors on bone cells. 4. Improve bone microenvironment: The stability of the bone microenvironment is crucial to maintaining bone health. The active ingredients in tortoise shell may optimize the bone microenvironment by improving the extracellular matrix of bone cells and regulating the interaction between bone cells, providing good conditions for the healthy growth and repair of bones.

[0092] Turtle shell: 10g;

[0093] Function: Turtle shell is an adjuvant drug. It has the effects of nourishing yin and suppressing yang, reducing fever and removing steam, softening and dispersing nodules. Turtle shell can nourish yin and moisten dryness, improve the symptoms of yin deficiency and hyperactivity of fire, and also has a certain improvement effect on the softening and hardening of bones.

[0094] Modern pharmacological studies on turtle shell in osteoporosis have revealed its positive effects in increasing bone density, improving bone health, regulating immunity and resisting fatigue. The pharmacological effects of turtle shell on osteoporosis mainly include the following aspects: 1. Increase bone density: turtle shell is rich in calcium and other trace elements, such as selenium, which have a good promoting effect on bone growth. Modern pharmacological studies have shown that turtle shell can increase bone density, thereby helping to slow down or prevent the symptoms of osteoporosis. This finding provides a scientific basis for the application of turtle shell in the treatment of osteoporosis. 2. Improve bone health: In addition to increasing bone density, the minerals and trace elements rich in turtle shell can also supplement the body's nutrition and promote bone health. These ingredients help maintain the normal structure and function of bones, thereby reducing the risk of osteoporosis. 3. Regulate immunity and resist fatigue: Modern pharmacological studies have also shown that turtle shell has the effect of regulating immunity. The various trace elements it contains, such as zinc and selenium, can improve the body's immunity and enhance the body's resistance. At the same time, turtle shell also has an anti-fatigue effect. Its ingredients can promote human metabolism and reduce fatigue, which also helps to improve the physical condition of osteoporosis patients. After using turtle shell, patients often feel that bone pain is reduced and bone strength is increased.

[0095] Poria: 20g;

[0096] Function: Poria cocos is a guiding drug, which has the effects of promoting water and removing dampness, strengthening the spleen and calming the mind. Poria cocos can eliminate excess water in the body and relieve edema symptoms. At the same time, its spleen-strengthening effect helps enhance digestion and absorption functions and provide nutritional support for bone health.

[0097] The pharmacological effects of Poria cocos on osteoporosis mainly include the following aspects: 1. Promote osteoblast proliferation and bone formation: The active ingredients in Poria cocos, especially pachycoside, have the activity of promoting osteoblast proliferation. This proliferation effect helps to increase the formation of bone tissue, thereby improving bone density and strength. Pachycoside has also been found to promote bone formation, which is achieved by affecting the relevant signaling pathways of bone metabolism, helping to slow the progression of osteoporosis. 2. Inhibit bone resorption and bone loss: The active ingredients in Poria cocos can inhibit the activity of osteoclasts, thereby reducing bone resorption and maintaining bone integrity. In human studies, adding pachycoside to the treatment regimen of osteoporosis patients can significantly slow down the bone loss of patients after taking it for 12 consecutive months, which is manifested in significant improvements in bone density and trabecular number. 3. Anti-inflammatory and antioxidant effects: Poria cocos has anti-inflammatory effects and can reduce the level of inflammatory factors in osteoporosis patients. Inflammation is an important factor in the occurrence and development of osteoporosis, so this effect of Poria cocos is of great significance for the prevention and treatment of osteoporosis. 4. The antioxidant activity of Poria cocos can remove free radicals in the body, protect bone cells from oxidative damage, and thus maintain bone health. 5. Poria cocos glycosides can effectively improve the symptoms of osteoporosis patients and improve their quality of life.

[0098] Atractylodes macrocephala: 20g;

[0099] Function: Atractylodes macrocephala is an adjuvant drug. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweat and stabilizing pregnancy. Atractylodes macrocephala can enhance the spleen and stomach function, promote the discharge of dampness in the body, and is beneficial to improving systemic symptoms and enhancing the body's immunity.

[0100] Atractylodes macrocephala has a positive preventive and therapeutic effect on osteoporosis through various mechanisms. 1. Promote the proliferation and maturation of bone cells: Studies have found that the active ingredients in Atractylodes macrocephala, such as flavonoids and polysaccharides, can activate the proliferation, differentiation and maturation of bone cells. This mechanism of action helps to increase bone density and reduce the risk of bone damage. Experiments have shown that these ingredients have a direct stimulating effect on bone cells and can promote the formation of new bones. 2. Inhibit bone resorption process: Some ingredients in Atractylodes macrocephala have anti-bone resorption effects, which can interfere with the signaling pathway of bone resorption and reduce the expression of bone resorption-related genes in bone cells, thereby reducing the rate of bone destruction. This finding shows that Atractylodes macrocephala helps to protect bone density and slow down the progression of osteoporosis. 3. Anti-inflammatory effect: Inflammation is an important factor in the occurrence and development of osteoporosis. Polysaccharides and other ingredients in Atractylodes macrocephala can inhibit the production of inflammatory mediators, reduce inflammatory responses, and thus reduce the rate of bone resorption. This anti-inflammatory effect helps to protect bones from inflammation and maintain bone health. 4 Regulate hormone levels: Flavonoids in Atractylodes macrocephala can mimic the effects of estrogen, increase estrogen levels, and thus slow down the process of bone density decline. This hormone regulation effect provides new ideas for Atractylodes macrocephala in preventing and treating osteoporosis.

[0101] Drynaria fortunei: 10g;

[0102] Function: Drynaria is an adjuvant drug. In traditional Chinese medicine theory, it is a good medicine for strengthening the kidney and bones, healing wounds and relieving pain. Traditional Chinese medicine believes that the kidney is responsible for bone and marrow production, and the strength of bones is closely related to the fullness of kidney qi. Drynaria can enhance the growth, development and repair ability of bones by nourishing the kidney and replenishing essence, thereby improving the symptoms of osteoporosis.

[0103] Modern research has found that Drynaria has many modern pharmacological effects. 1. Promote bone formation: The active ingredients in Drynaria can stimulate the proliferation and differentiation of osteoblasts, promote the synthesis and mineralization of bone matrix, and thus increase bone density and bone strength. This helps restore the normal structure and function of bones for patients with osteoporosis. 2. Inhibit bone resorption: Drynaria can also reduce bone loss by inhibiting the activity of osteoclasts. Osteoclasts are the main cells responsible for bone resorption, and their overactivity can lead to osteoporosis. Drynaria helps maintain the balance of bone mass by regulating the function of osteoclasts. 3. Anti-inflammatory effect: The occurrence of osteoporosis is closely related to inflammatory response. The various active ingredients in Drynaria have anti-inflammatory effects, which can reduce the damage to bones caused by inflammatory response and protect bone health. 4. Antioxidant effect: Drynaria is rich in antioxidants, which can scavenge free radicals in the body, reduce the damage of oxidative stress to bone cells, and thus delay the progression of osteoporosis.

[0104] Wolfberry: 20g.

[0105] Function: Lycium barbarum is an adjuvant medicine, and is regarded as a good product for nourishing the liver and kidneys, improving the essence and improving eyesight in traditional Chinese medicine. For patients with osteoporosis, Lycium barbarum can promote the production and transformation of kidney essence by nourishing the yin of the liver and kidneys, providing sufficient nutritional support for bones, thereby improving bone health.

[0106] The modern pharmacological effects of wolfberry mainly include the following aspects: 1. Promote bone metabolism: The various active ingredients in wolfberry can regulate the bone metabolism process, promote bone formation and inhibit bone resorption. This helps to maintain the balance of bone mass and prevent the occurrence and development of osteoporosis. 2. Immunomodulatory effect: Wolfberry has an immunomodulatory effect and can enhance the body's immune function. For patients with osteoporosis, the enhancement of immune function helps to resist the invasion of foreign pathogens and reduce the occurrence of complications such as infection. 3. Antioxidant effect: Wolfberry is rich in antioxidants, such as polysaccharides and betaine. These ingredients can remove free radicals in the body, reduce the damage of oxidative stress to bone cells, and protect bone health. 4. Regulate endocrine: Wolfberry has a certain regulatory effect on the endocrine system. It can indirectly promote bone health by affecting the levels of hormones related to bone metabolism, such as estrogen. This is especially important for postmenopausal women with osteoporosis, because the decline in estrogen levels is one of the important factors leading to osteoporosis.

[0107] The mutual coordination between the components is analyzed from the component aspect and its mechanism of action is as follows:

[0108] 1. Raw Astragalus: As the main drug, raw Astragalus has the effects of replenishing qi and raising yang, strengthening the exterior and stopping sweating, etc. It can enhance the overall function of the body and promote the circulation of qi and blood. It provides a basic support for the entire formula, allowing other drugs to better exert their therapeutic effects. The qi-replenishing effect of raw Astragalus complements other tonic Chinese medicines such as Codonopsis pilosula and Rehmannia glutinosa, and together they enhance the body's qi and blood production and circulation.

[0109] 2. Angelica: As one of the auxiliary drugs, Angelica can replenish blood and promote blood circulation, and promote bone marrow hematopoiesis. It combines with the Qi-replenishing effect of raw Astragalus to form a Qi-replenishing effect, which helps improve the nutritional status of bones and promote bone repair. At the same time, Angelica can also relieve pain caused by bone diseases, and the analgesic effect of raw Astragalus is mutually enhanced.

[0110] 3. Codonopsis and Rehmannia root: Codonopsis and Rehmannia root are also used as ministerial drugs, which have the effects of tonifying the spleen and lungs, promoting the production of body fluids and nourishing blood, and tonifying blood and nourishing yin, and replenishing essence and filling marrow. Together with raw astragalus and angelica, they form a basic framework for tonifying qi and nourishing blood, and provide solid nutritional support for bone health by tonifying the liver and kidneys, nourishing yin and nourishing blood. In traditional Chinese medicine theory, the spleen is the foundation of acquired constitution, and the lungs are the master of qi. Codonopsis, by tonifying the spleen and lungs, enhances the body's ability to absorb and transform nutrients, and at the same time promotes the generation of qi and blood. This is crucial for patients with osteoporosis, because a good circulation of qi and blood can provide the necessary nutrition for bones and promote the repair and reconstruction of bones. Codonopsis and astragalus and other qi-tonifying herbs work synergistically to form a double-tonifying effect of qi and blood. Adequate Qi and blood are the basis for maintaining normal physiological functions of the body. For patients with osteoporosis, replenishing both Qi and blood can help improve bone malnutrition and decreased bone density caused by insufficient Qi and blood. The various active ingredients contained in Codonopsis can regulate the body's metabolic process, including promoting protein synthesis, regulating sugar and lipid metabolism, etc., which are important for maintaining bone health and delaying the progression of osteoporosis. The polysaccharide components in Codonopsis have the effect of promoting osteoblast proliferation and differentiation, helping to enhance the activity of bone cells and promote the synthesis of bone matrix, thereby counteracting the decrease in bone mass caused by osteoporosis; Codonopsis has the effect of enhancing the body's immune function, can improve the body's resistance to external pathogens, and reduce the occurrence of complications such as infection, which is of positive significance for the overall health maintenance of patients with osteoporosis; the antioxidant content of Codonopsis is Chemical components can remove free radicals, reduce the damage of oxidative stress to bones, protect bone cells from oxidative damage, and maintain the healthy state of bones; Codonopsis has anti-inflammatory effects, can reduce the activity of inflammatory factors, and reduce the damage of inflammation to bones, which has a positive effect on relieving the pain of osteoporosis patients and improving the bone microenvironment; Codonopsis regulates the endocrine system and affects the hormone levels related to bone metabolism, such as estrogen, growth hormone, etc., thereby indirectly promoting bone health; The effective ingredients in Codonopsis can promote the absorption and utilization of minerals such as calcium and phosphorus, help increase bone density, and fight against osteoporosis caused by bone loss; The role of Codonopsis in the formula is not limited to a single aspect, but through the comprehensive effects of multiple pathways and multiple targets, it cooperates with other medicinal materials to form a comprehensive therapeutic effect on osteoporosis. It can be seen from the above that Codonopsis has a unique role and importance in the formula of the present invention, and these effects help to reflect the difference in the mechanism of action between this formula and the existing formula. The addition of Codonopsis provides a more comprehensive therapeutic effect for this formula, especially in terms of spleen and lung double supplementation, qi and blood double supplementation, immune regulation, and endocrine balance.

[0111] 4. Dipsacus asper, Eucommia ulmoides, and Psoralea corylifolia: These three herbs all have the effect of nourishing the liver and kidneys and strengthening the tendons and bones. They work synergistically with raw astragalus and angelica to directly improve the structure and function of bones and promote the repair of fractures and osteoporosis. By enhancing the strength and toughness of bones, the risk of fractures is reduced.

[0112] 5. Bupleurum: Bupleurum has the effects of soothing the liver and relieving depression, and raising Yang Qi. In the formula, Bupleurum's soothing liver and relieving depression helps alleviate emotional problems caused by bone diseases. At the same time, its role in raising Yang Qi also helps improve the overall state of the body and create better conditions for the absorption and utilization of other drugs. Bupleurum is believed to have the effects of soothing the liver and relieving depression, and raising Yang Qi in traditional Chinese medicine. In the pharmaceutical composition of the present invention, it can be used in combination with other components to play the following unique roles:

[0113] Soothing the liver and relieving depression: Bupleurum can regulate liver qi and relieve various symptoms caused by liver qi stagnation, such as depression and flank pain. In osteoporosis patients, Bupleurum can help improve the patient's emotional state and quality of life by soothing the liver and relieving depression, which is especially important for patients with chronic diseases.

[0114] Raising Yang Qi: Bupleurum has the effect of raising Yang, which can enhance the body's Yang Qi and counteract the common symptoms of Yang deficiency in osteoporosis patients, such as fatigue, chills, etc.

[0115] Promote the circulation of Qi and blood: Bupleurum can promote the circulation of Qi and blood and improve blood circulation, which is essential for the supply of nutrients to bones and the elimination of metabolic waste, and helps maintain bone health.

[0116] Regulating endocrine: Modern pharmacological research shows that certain components in Bupleurum may have hormone-like effects, which can regulate the endocrine system and affect the hormone levels related to bone metabolism, thereby having a positive therapeutic effect on osteoporosis.

[0117] Synergistically enhance immunity: Bupleurum is used in combination with immune-enhancing herbs such as Astragalus and Codonopsis to synergistically improve the body's immunity and enhance resistance to disease.

[0118] Anti-inflammatory effect: Bupleurum has anti-inflammatory effects, can reduce inflammatory responses, and has an auxiliary therapeutic effect on joint inflammation that may accompany osteoporosis patients.

[0119] Promote bone metabolism: The active ingredients in Bupleurum may help improve bone density by affecting bone metabolism-related signaling pathways, promoting the proliferation and differentiation of osteoblasts and inhibiting the activity of osteoclasts.

[0120] Synergistic effects with other herbs:

[0121] - Combined with Astragalus: Enhances the Qi-replenishing effect and improves the body's overall disease resistance.

[0122] - Combined with Chinese Angelica: Enhances the blood-tonifying and blood-activating effects, improves blood circulation, and promotes bone nutrition.

[0123] - Combined with Codonopsis pilosula: they can jointly enhance the spleen and stomach functions and promote the absorption and utilization of nutrients.

[0124] - Combined with Dipsacus asper and Eucommia ulmoides, etc.: Together they can strengthen the liver and kidney, strengthen tendons and bones, and promote bone health.

[0125] Comprehensive regulatory effect: Bupleurum has many functions in the formula. It can not only directly play a role in the treatment of osteoporosis, but also work synergistically with other medicinal materials through indirect pathways such as regulating emotions, promoting the circulation of qi and blood, and enhancing immunity, thus forming a comprehensive therapeutic effect on osteoporosis. From the above, we can see the unique role and importance of Bupleurum in the formula of the present invention, especially the special role of Bupleurum in soothing the liver and relieving depression, raising yang qi, regulating endocrine and emotions, etc., which provides a new perspective and method for the comprehensive treatment of osteoporosis.

[0126] 6. Epimedium and tortoise shell: Epimedium has the effect of tonifying kidney yang and strengthening tendons and bones, while tortoise shell has the effect of nourishing yin and suppressing yang, benefiting kidney and strengthening bones. They cooperate with raw astragalus, angelica and other drugs to promote the generation and transformation of kidney essence by regulating the body's yin and yang balance, thereby further improving bone health. The combined use of epimedium and tortoise shell in the formula of the present invention embodies the principle of syndrome differentiation and overall conditioning of traditional Chinese medicine.

[0127] Yin and Yang Supplementation: Epimedium has the effect of replenishing kidney yang and strengthening tendons and bones, while tortoise shell has the effect of nourishing yin, suppressing yang, benefiting kidney and strengthening bones. This combination of use can nourish kidney yin while replenishing kidney yang, achieving a balance between yin and yang, which is essential for maintaining bone health for patients with osteoporosis.

[0128] Strengthen bones: The active ingredients in Epimedium can promote bone formation and increase bone density, while the collagen and minerals in Tortoise Shell help bone growth and repair. The combination of the two can enhance bone strength and toughness and reduce the risk of fractures.

[0129] Regulating bone metabolism: Epimedium may regulate bone metabolism by promoting the activity of osteoblasts and inhibiting the function of osteoclasts, while the polysaccharides and bioactive peptides in tortoise shell may optimize the bone microenvironment by improving the extracellular matrix of bone cells and regulating the interaction between bone cells. This dual effect helps maintain the balance of bone metabolism.

[0130] Antioxidant and anti-inflammatory effects: Both Epimedium and Tortoise Shell contain antioxidant ingredients that can remove free radicals in the body and reduce the damage of oxidative stress to bones. At the same time, they also have anti-inflammatory effects, which can inhibit inflammatory responses and reduce the negative effects of inflammatory factors on bone cells.

[0131] Regulating hormone levels: Epimedium has estrogen-like effects and can regulate hormone levels in the body. In particular, it has a certain affinity for estrogen receptors, which helps improve osteoporosis caused by abnormal hormone levels. Tortoise shell may affect the bone metabolism process by regulating hormone levels or signal pathways related to bone metabolism.

[0132] Mental and emotional regulation: In addition to its direct effects on bones, epimedium may also improve mental state and alleviate emotional fluctuations caused by chronic diseases through its role in tonifying kidney yang.

[0133] Comprehensive effect: The combination of epimedium and tortoise shell not only plays a role in the pathological mechanism of osteoporosis, but also achieves a holistic treatment of osteoporosis by regulating the overall state of the body, such as enhancing immunity, improving endocrine balance, and anti-oxidation. This formula, through the combination of epimedium and tortoise shell, pays more attention to the balanced regulation of kidney yin and yang, and strengthens the overall health of bones by tonifying the kidney. The combination of epimedium and tortoise shell in this formula also reflects the treatment principle of traditional Chinese medicine in the treatment of chronic diseases, which focuses on the harmony of yin and yang, qi and blood, and the combination of the whole and the local.

[0134] 7. Turtle Shell and Poria: Turtle Shell and Poria have the effects of nourishing yin and moistening dryness, softening and dispersing nodules, promoting water and removing dampness, and strengthening the spleen and calming the mind. They not only enhance the overall nourishing effect in the formula, but also provide a better internal environment for bone health by regulating water metabolism in the body and alleviating symptoms such as edema.

[0135] The synergistic effect of turtle shell and Poria cocos in the formula of the present invention embodies the compatibility theory and treatment principle of traditional Chinese medicine:

[0136] Combination of nourishing yin and strengthening the spleen: Turtle shell has the effects of nourishing yin and suppressing yang, reducing fever and removing steam, while Poria cocos has the effects of promoting water and eliminating dampness, strengthening the spleen and calming the mind. In this formula, turtle shell strengthens bones by nourishing kidney yin, while Poria cocos enhances digestion and absorption by strengthening the spleen. The two work synergistically, replenishing the yin fluid needed by the body, promoting the generation of qi and blood, and jointly maintaining bone health.

[0137] Regulate the body's water balance: Both turtle shell and Poria cocos have the function of regulating the body's water balance. Turtle shell reduces the internal heat caused by yin deficiency by nourishing yin, while Poria cocos relieves edema symptoms by promoting water and removing dampness. This synergistic effect helps improve the water metabolism disorder that may occur in osteoporosis patients.

[0138] Enhance immune function: Turtle shell contains a variety of trace elements, such as zinc and selenium, which can improve the body's immunity, and Poria cocos also has a certain immune regulation effect. The combination of the two can enhance the body's resistance and reduce the risk of infection caused by decreased immunity in osteoporosis patients.

[0139] Anti-fatigue effect: Turtle shell has an anti-fatigue effect, which can promote metabolism and reduce fatigue. Poria cocos can also help improve the body's energy utilization efficiency by strengthening the spleen. This synergistic effect helps improve the overall physical strength and mental state of osteoporosis patients.

[0140] Promote bone health: Turtle shell increases bone density and improves bone health, while Poria cocos promotes bone cell proliferation and bone formation. The two work together to help improve bone density and bone quality and slow down the progression of osteoporosis.

[0141] Antioxidant and anti-inflammatory effects: Both turtle shell and Poria cocos have antioxidant and anti-inflammatory effects, which can scavenge free radicals, reduce the damage to bones caused by oxidative stress and inflammatory response, and protect bone cells from damage.

[0142] Regulating hormone levels: Turtle shell may improve osteoporosis by regulating hormone levels, such as increasing estrogen levels or enhancing the sensitivity of estrogen receptors. Although Poria cocos does not directly regulate hormone levels, its spleen-strengthening effect helps maintain the balance of the endocrine system.

[0143] Comprehensive regulatory effect: The synergistic effect of turtle shell and Poria in the formula not only plays a role in the pathological mechanism of osteoporosis, but also achieves overall treatment of osteoporosis by regulating the overall state of the body, such as enhancing immunity, improving endocrine balance, and anti-oxidation.

[0144] This formula, through the synergistic effect of turtle shell and Poria cocos, pays more attention to the combination of nourishing yin and strengthening the spleen, and comprehensively improves the symptoms of osteoporosis by regulating the body's water balance and enhancing immune function. This different emphasis on the mechanism provides a more comprehensive and in-depth method for the treatment of osteoporosis, and reflects the treatment principle of traditional Chinese medicine in the treatment of chronic diseases, which focuses on the harmony of yin and yang, qi and blood, and the combination of the whole and the local.

[0145] 8. Atractylodes: Atractylodes has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. It cooperates with drugs such as Codonopsis pilosula and Poria cocos to strengthen the spleen and stomach functions, promote the absorption and utilization of nutrients, and provide more energy and raw materials for bone repair.

[0146] 9. Dipsacus asper: As an important Chinese medicinal material, Dipsacus asper plays a unique role in the pharmaceutical composition of the present invention, and its synergistic effects with other components are as follows:

[0147] Nourishes the liver and kidneys, and strengthens the tendons and bones: In traditional Chinese medicine, Dipsacus asper is believed to have the effect of nourishing the liver and kidneys, and strengthening the tendons and bones. Working together with other medicinal materials such as Epimedium and Eucommia, it can enhance the strength and toughness of bones, and fight against bone loss caused by osteoporosis.

[0148] Promote bone formation: The active ingredients contained in Dipsacus asper may promote the proliferation and differentiation of osteoblasts, increase the synthesis of bone matrix, and combine with the blood-enriching effects of medicinal materials such as Astragalus and Angelica sinensis to provide sufficient nutrition for bones and jointly promote bone formation.

[0149] Inhibit bone resorption: Dipsacus asper can reduce bone resorption by inhibiting the activity and number of osteoclasts. Combined with the kidney-tonifying effects of herbs such as Psoralea corylifolia, it helps slow down the progression of osteoporosis.

[0150] Regulating calcium and phosphorus metabolism: Dipsacus asper can regulate the absorption and utilization of calcium and phosphorus by affecting the levels of related enzymes and hormones. Combined with the spleen-strengthening effects of medicinal materials such as Poria cocos, it can promote the mineralization process of bones.

[0151] Antioxidant effect: The antioxidant ingredients in Dipsacus asper can eliminate free radicals in the body and reduce the damage of oxidative stress to bones. They complement the antioxidant effects of medicinal materials such as Astragalus and Angelica sinensis to protect bone health together.

[0152] Regulating hormone levels: Dipsacus asper can improve osteoporosis by regulating hormone levels, such as increasing estrogen levels or enhancing the sensitivity of estrogen receptors, when combined with herbs with estrogen-like effects such as Epimedium.

[0153] Anti-inflammatory effect: The anti-inflammatory ingredients in Dipsacus can reduce the inflammatory response around the bones, and combined with the anti-inflammatory effects of herbs such as Bupleurum, protect the bones from damage.

[0154] Comprehensive regulatory effect: The role of Dipsacus asper in the formula is not limited to a single aspect, but through the comprehensive effects of multiple pathways and multiple targets, it synergizes with other medicinal materials to form a comprehensive therapeutic effect on osteoporosis.

[0155] Promote blood circulation: Combining Dipsacus asper with other medicinal materials such as Astragalus and Angelica sinensis can not only strengthen bones, but also promote blood circulation, improve the body's disease resistance and overall health level.

[0156] These effects help to reflect the differences in the mechanism of action between this formula and existing formulas, especially the special effects of Dipsacus asper in nourishing the liver and kidneys, strengthening tendons and bones, and regulating bone metabolism.

[0157] Drynaria fortunei

[0158] Synergy with Astragalus and Codonopsis:

[0159] Tonifying Qi and Nourishing Blood: Astragalus and Codonopsis are Qi-tonifying herbs that can enhance the body's Qi and blood production and circulation. Drynariae can strengthen the kidneys and bones, complementing the Qi-tonifying effects of Astragalus and Codonopsis, and jointly promoting the nutritional supply and repair of bones.

[0160] Promote bone metabolism: Astragalus and Codonopsis have a regulatory effect on the endocrine system and can promote the secretion of hormones related to bone metabolism, such as growth hormone, etc. Drynaria directly acts on bones, promoting bone formation and inhibiting bone resorption. The combination of the two can more effectively regulate the bone metabolism process.

[0161] Synergy with Angelica sinensis and Rehmannia glutinosa:

[0162] Blood-tonifying and blood-activating: Chinese angelica and Rehmannia glutinosa are important blood-tonifying herbs that can promote bone marrow hematopoiesis and provide sufficient blood support for bones. The kidney-tonifying effect of Drynaria fortunei combined with the blood-tonifying effect of Chinese angelica and Rehmannia glutinosa form a good combination of kidney-tonifying and blood-nourishing, which helps improve the nutritional status of bones.

[0163] Synergistic promotion of bone formation: The active ingredients in Angelica sinensis can promote the proliferation and differentiation of osteoblasts, while Rehmannia glutinosa has the effect of promoting the synthesis of bone matrix proteins. Drynaria fortunei further enhances the effect of promoting bone formation on this basis. The three work synergistically to significantly improve bone density and bone strength.

[0164] Synergy with Eucommia ulmoides and Dipsacus asper:

[0165] Nourishing the kidney and strengthening bones: Eucommia ulmoides and Dipsacus asper also have the effect of nourishing the kidney and strengthening bones. They form a superimposed effect with Drynaria fortunei in nourishing the kidney, and together enhance the strength and toughness of bones.

[0166] Synergistic inhibition of bone resorption: The active ingredients in Eucommia ulmoides and Dipsacus asper can inhibit the activity of osteoclasts and reduce bone resorption. Drynaria fortunei also has this effect. The three work synergistically to more effectively prevent bone loss.

[0167] Synergy with Bupleurum and Epimedium:

[0168] Regulate endocrine: Bupleurum and Epimedium have a regulating effect on the endocrine system and can affect the hormone levels related to bone metabolism. Drynaria indirectly regulates the endocrine system by tonifying the kidney. The combination of the three can more comprehensively regulate the endocrine system and promote bone health.

[0169] Improve mood: Bupleurum has the effect of soothing the liver and relieving depression, while Epimedium can nourish the kidney and strengthen yang, and relieve fatigue. Drynaria can indirectly improve the patient's quality of life by improving osteoporosis symptoms. The synergistic effect of the three helps to improve the patient's emotional state and mental outlook.

[0170] Wolfberry

[0171] Synergy with Astragalus and Codonopsis:

[0172] Enhance immunity: Astragalus and Codonopsis can enhance the body's immune function, while Lycium barbarum has an immunomodulatory effect. The combination of the three can significantly improve the patient's immunity and reduce the occurrence of complications such as infection.

[0173] Antioxidant: The antioxidant components in Astragalus and Codonopsis work synergistically with antioxidant substances such as polysaccharides and betaine in Lycium barbarum to more effectively remove free radicals in the body and reduce the damage of oxidative stress to bones.

[0174] Synergy with Angelica sinensis and Rehmannia glutinosa:

[0175] Nourishing blood and yin: Angelica and Rehmannia root can nourish blood, nourish yin and relieve dryness. Lycium barbarum enhances this effect by nourishing the yin of the liver and kidney. The three work synergistically to help improve the symptoms of osteoporosis caused by liver and kidney yin deficiency.

[0176] Promote bone marrow hematopoiesis: Angelica and Rehmannia root can promote bone marrow hematopoiesis, while wolfberry can enhance the body's ability to absorb and utilize nutrients. The combination of the three can more effectively promote bone marrow hematopoiesis and bone repair.

[0177] Synergy with Eucommia ulmoides and Dipsacus asper:

[0178] Tonify the kidney and replenish essence: Eucommia ulmoides and Dipsacus asper have the effect of tonifying the kidney and strengthening bones, while Lycium barbarum promotes the production and transformation of kidney essence by nourishing the yin of the liver and kidney. The three work synergistically to enhance kidney function and provide adequate nutritional support for bones.

[0179] Synergistic promotion of bone formation: The active ingredients in Eucommia ulmoides and Dipsacus asper can promote bone formation, while Lycium barbarum indirectly promotes bone metabolism by regulating the endocrine system. The combination of the three can more effectively promote bone formation and inhibit bone resorption.

[0180] Synergy with Bupleurum and Epimedium:

[0181] Regulate endocrine and emotions: Bupleurum and Epimedium have a regulating effect on the endocrine system and can improve the patient's emotional state. Lycium barbarum enhances this effect by nourishing the yin of the liver and kidney. The synergistic effect of the three helps to fully regulate the patient's endocrine system and emotional state and improve the quality of life.

[0182] Antioxidant and anti-inflammatory: The antioxidants in wolfberry work synergistically with the anti-inflammatory components in bupleurum and epimedium to more effectively reduce the damage to bones caused by inflammation and oxidative stress.

[0183] The mechanism of action of the components in cooperation with each other is as follows:

[0184] 1. Mutual generation of Qi and blood:

[0185] In traditional Chinese medicine theory, Qi can generate blood, and blood can carry Qi. Raw Astragalus can replenish Qi and help promote blood circulation, while Angelica and Codonopsis can replenish blood and provide a material basis for the generation of Qi and blood. The combination of the two can enhance the effect of Qi and blood mutual generation and improve the symptoms caused by Qi and blood deficiency.

[0186] 2. Mutual assistance between spleen and kidney:

[0187] The spleen is the foundation of acquired constitution, while the kidney is the foundation of innate constitution. Codonopsis and Atractylodes macrocephala strengthen the spleen and replenish Qi, promote digestion and absorption, and provide energy for the body; Rehmannia root, Eucommia bark, and Psoralea corylifolia nourish the kidney, strengthen the innate constitution, and promote bone marrow production. The two work together to maintain the health of the body.

[0188] 3. Yin and Yang are interdependent:

[0189] Turtle shell and turtle shell nourish yin and suppress yang, which helps to balance yin and yang in the body, prevent internal heat caused by yin deficiency and cold caused by yang deficiency, and play an important role in the overall conditioning of osteoporosis patients.

[0190] 4. Muscles and bones have the same origin:

[0191] In traditional Chinese medicine theory, the liver governs the tendons and the kidneys govern the bones. Dipsacus asper and Eucommia ulmoides have the function of nourishing the liver and kidneys, strengthening tendons and bones, promoting the health of tendons and bones, and improving the pain and limited mobility caused by osteoporosis.

[0192] 5. Water and moisture transportation:

[0193] Poria and Atractylodes macrocephala can promote diuresis and eliminate dampness, help regulate the body's water balance, reduce swelling and discomfort caused by stagnant water and dampness, while also strengthening the spleen and enhancing the body's ability to transport and transform water and dampness.

[0194] 6. Immunomodulation and anti-inflammation:

[0195] Raw astragalus, codonopsis, etc. have the effect of enhancing immune function and improving the body's resistance; while angelica, bupleurum, etc. have anti-inflammatory effects, can reduce inflammatory responses and protect bones from inflammatory damage.

[0196] 7. Antioxidation and bone metabolism regulation:

[0197] Antioxidant ingredients such as astragalus, angelica, rehmannia root, bupleurum, etc. can scavenge free radicals and reduce the damage of oxidative stress to bones; at the same time, these medicinal materials can promote bone formation and inhibit bone resorption by regulating bone metabolism-related hormones and signal pathways.

[0198] 8. Hormone level regulation:

[0199] Epimedium, Psoralea corylifolia, etc. have estrogen-like effects and can regulate hormone levels in the body. They have an improving effect on osteoporosis caused by a decrease in estrogen, while also enhancing the protective effect of estrogen on bones.

[0200] 9. Bidirectional effect of promoting bone formation and inhibiting bone resorption:

[0201] Raw astragalus, angelica, etc. promote bone formation by promoting the proliferation and differentiation of osteoblasts, increasing the synthesis and mineralization of bone matrix; while Dipsacus asper and Eucommia ulmoides, etc. inhibit the activity of osteoclasts and reduce bone resorption. The two work synergistically to achieve a balance in bone metabolism.

[0202] 10. Mental and emotional regulation:

[0203] Bupleurum's effect of soothing the liver and relieving depression helps alleviate mood swings caused by chronic diseases and improve patients' mental state and quality of life.

[0204] 11. Interactions of drug-effective substances:

[0205] The active ingredients in each medicinal material, such as astragalus polysaccharides, astragaloside I, ferulic acid, flavonoids, etc., may interact with each other in the body to enhance efficacy and reduce side effects.

[0206] 12. Combination of overall regulation and local treatment:

[0207] This formula not only focuses on the treatment of local osteoporosis, but also achieves overall treatment of osteoporosis by regulating the body's functions as a whole, such as enhancing immunity, regulating endocrine, and anti-oxidation.

[0208] In summary, the components in this formula, through their synergistic effects, form a multi-component, multi-target, and multi-pathway comprehensive action system. They work together on multiple aspects of the body, and achieve the purpose of treating osteoporosis through multiple mechanisms such as tonifying the liver and kidneys, strengthening tendons and bones, and regulating qi and blood circulation. This comprehensive therapeutic effect embodies the holistic concept and principle of syndrome differentiation and treatment in traditional Chinese medicine, making the formula have significant efficacy and advantages in treating osteoporosis.

[0209] A preparation method of a Chinese medicine composition for improving osteoporosis:

[0210] (1) Raw material preparation

[0211] According to the weight ratio of Example 1, accurately weigh the raw material.

[0212] (2) Extraction and concentration

[0213] Soaking: Place all the weighed APIs into a suitable container, add 10 times the amount of water as the total amount of the medicinal materials, and ensure that all the medicinal materials are completely immersed in the water. Soak for about 30 minutes to allow the medicinal materials to fully absorb water and swell.

[0214] Decoction: Put the soaked herbs together with the soaking liquid in the decoction pot, boil them over high heat, then use low heat to decoct. Each decoction takes 1 hour, and the decoction is three times in total. After each decoction, filter the liquid with gauze or filter, keep the filtrate, and discard the residue.

[0215] Combine the filtrates: Combine the filtrates obtained from the three decoctions, place them in a decoction pot and continue to heat them over a low fire to concentrate them. Stir constantly during the concentration process to prevent the liquid from sticking to the bottom. Concentrate to an appropriate volume, which can be adjusted according to the requirements of subsequent preparations.

[0216] (3) Preparation

[0217] Oral solution preparation:

[0218] Continue to heat the concentrated medicine solution to the appropriate temperature, add appropriate amount of flavoring agent (such as honey, sucrose, etc., optional), and stir evenly.

[0219] The liquid medicine is dispensed into clean oral liquid bottles, sealed, and sterilized (such as by high-temperature steam sterilization) to obtain the formulated oral liquid.

[0220] Granule preparation:

[0221] Add appropriate amount of starch or other suitable excipients to the concentrated drug solution and stir it thoroughly to form a soft material.

[0222] The soft material is sieved and granulated, dried to a suitable moisture content, granulated, and packaged to obtain the formulated granules.

[0223] Tablet preparation:

[0224] The concentrated medicinal solution is mixed with appropriate amounts of starch, dextrin and other auxiliary materials to form a soft material, which is then sieved and granulated.

[0225] After the wet granules are dried, a suitable lubricant (such as magnesium stearate) is added, mixed evenly, and compressed to obtain the formulated tablets.

[0226] (4) Quality inspection

[0227] Carry out quality inspection on the prepared formula preparations, including appearance, properties, content determination, microbial limit inspection and other items, to ensure that the quality of the preparations meets the relevant standards.

[0228] (5) Packaging and storage

[0229] Formula preparations that pass the inspection will be packaged, with information such as the drug name, specifications, usage and dosage, expiration date, storage conditions, etc. indicated, and stored in accordance with the prescribed storage conditions to ensure stable drug quality.

[0230] Through the above steps, a formula preparation that meets the requirements can be prepared. In actual operation, the requirements of Good Manufacturing Practice (GMP) should be strictly followed to ensure the safety and effectiveness of the drug.

[0231] In order to reflect the compatibility between the components in this formula, the present invention has made relevant embodiments (S1-10) and comparative examples (D1-12). The differences between the relevant embodiments and comparative examples and the formula of Example 1 are shown in Table 1. In order to highlight the differences, only the differences from Example 1 are filled in:

[0232]

[0233] In order to further verify the efficacy of the present invention in treating osteoporosis, we conducted animal experiments on the formulations of Example (S1-10) and Comparative Example (D1-12), and the experimental steps are as follows:

[0234] 1. Selection of experimental mice: Usually healthy, non-pregnant female C57BL / 6 mice are selected, aged 6-8 weeks and weighing about 18g-20g. Before the experiment, the mice undergo a certain adaptation period to ensure that their physiological state is stable.

[0235] 2. Surgical operation: The mice are first anesthetized by intraperitoneal injection of sodium pentobarbital (usually 3% concentration, 40 mg / kg dose). After the anesthesia takes effect, the mice are placed in a supine position on the surgical board and the back is depilated. A skin incision about 0.5~1 cm long is made on the midline of the back, and the skin and muscle are bluntly separated to expose the location of the ovaries. The psoas muscle is cut about 1 cm away from the spine to find the adipose tissue surrounding the ovaries and the closely connected uterine horns. Gently clamp the adipose tissue and pull it out of the wound to reveal the ovaries. Ligate the fallopian tubes at the upper and lower parts of the uterine horns. Peel off the adipose tissue surrounding the ovaries, cut off the uterine horns, and remove the ovaries. Push the adipose tissue back into the abdominal cavity, suture the covering membrane and muscle layer, and then suture the skin.

[0236] 3. Postoperative care: Mice need proper care after surgery, including regular observation of the mice's condition and recording of deaths. To prevent infection, each mouse receives a daily injection of 40,000 units of penicillin within a few days after surgery (such as 3 days after surgery), and the bone condition of the mice is tested. Subsequent experiments will begin after osteoporosis is formed.

[0237] 4. Experimental Grouping:

[0238] The invention includes a normal control group (only the fat around the ovaries is removed and the ovaries are retained), a model group (only the ovaries are removed to simulate osteoporosis caused by estrogen deficiency, and no medication is used), and a test drug group (the ovaries are removed to simulate osteoporosis caused by estrogen deficiency, and the prescription of the embodiment or comparative example is used for intervention). The positive control group is intervened with alendronate sodium. According to the instructions, the mice are treated with (Gubang) alendronate sodium tablets at a dose of 0.966 g / kg.d. There are 22 test drug groups, which respectively use the prescriptions of embodiments 1-10 and comparative examples 1-12.

[0239] There were 25 groups of experimental animals, each with 6 mice. There were 22 groups of experimental animals in the test drug group, and the 22 groups of experimental animals were gavaged with one of the formulas in Example 1-10 or Comparative Example 1-12, respectively, using the human-mouse surface area conversion, Meeh-Rubner formula: A = k * (W^(2 / 3)) / 10000, where k is a constant, and the k value of mice is 9.1. Determine the initial dose (D0). Assuming that the standard body surface area of ​​a person is 1.73m², the equivalent dose (Deq) of mice can be calculated by the following formula: Deq = (A mouse / 1.73m²) * D0. After calculation, the drug mass range of mice is 0.2580g to 1.1224g, and this experiment is set to 1g / kg.d. The model group (1 group of 6) and the normal control group (1 group of 6) were gavaged with equal volumes of sterile pure water, and gavaged once a day at regular intervals. The positive control group (1 group, 6 rats) was gavaged with an equal volume of drug solution prepared by dissolving (Gubang) sodium alendronate tablets in water, with a dosage of 0.966 g / kg.d. It should be noted that the volume of gavage liquid in the test drug group, positive control group, model group and normal control group was equal.

[0240] 5. Detect bone density, activity level, activity level, and hair condition:

[0241] The experimental period was 12 weeks, in order to observe the development of osteoporosis and evaluate the treatment effect, the mice were evaluated every 4 weeks. For bone density testing, mice were anesthetized with anesthetics such as isoflurane or chloral hydrate to ensure that the mice remained still during the measurement. The anesthetized mice were placed on the measurement table, ensuring that their trunks were straight for accurate measurement. The bone density (BMD) of mice was measured using a dual-energy X-ray absorptiometry system (DEXA).

[0242] 6. Record the measurement data of each mouse in detail, enter the test data into an Excel table, and then use Graphpadprism 10.0 software for statistical analysis. Import the measured data into the analysis software for further data processing and analysis to evaluate the degree of osteoporosis and the treatment effect.

[0243] Bone density of mice in each group The test results are shown in Table 2:

[0244]

[0245] As can be seen from Table 2, the various components of this formula have a good improvement effect on osteoporosis caused by abnormal estrogen after being used in a specific ratio. And the mice in the test drug group showed good physical condition during the experiment, with shiny hair and flexible movements. The hair of the osteoporotic mice in the model group may lack luster and appear gray, which may be caused by malnutrition, endocrine disorders or physical discomfort caused by osteoporosis. The mobility of mice in the osteoporosis model group will be significantly reduced, showing symptoms such as reduced activity, unstable gait or difficulty walking. These symptoms are related to bone pain, joint stiffness and increased risk of fractures caused by osteoporosis. The hair condition and mobility of osteoporotic mice intervened using this formula are improved compared to the mice in the model group. It can be seen that the present invention has a significant effect of improving osteoporosis for osteoporotic animals.

[0246] The therapeutic effect data of this Chinese medicine composition on the human body are as follows:

[0247] 1. General information:

[0248] A total of 120 osteoporosis patients from the orthopedic outpatient clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine were selected for this study, including 40 male patients and 80 female patients, with an age range of 50 to 80 years old, and an average age of 65 years old. All patients were diagnosed with osteoporosis by dual-energy X-ray absorptiometry (DEXA).

[0249] 2. Case inclusion criteria:

[0250] It meets the diagnostic criteria for osteoporosis established by the World Health Organization (WHO).

[0251] Aged 50 and above.

[0252] Sign the informed consent form and voluntarily participate in this study.

[0253] No other osteoporosis medications or therapies have been received for at least 3 months.

[0254] 3. Case exclusion criteria:

[0255] Those with serious diseases of heart, liver, kidney and other important organs.

[0256] Those who are allergic to any ingredient in this Chinese medicine composition.

[0257] Patients who are receiving other medications that may affect bone metabolism.

[0258] Patients with malignant tumors or other serious diseases.

[0259] 4. Treatment methods:

[0260] The selected patients were randomly divided into two groups: a control group (60 cases) and an observation group (60 cases). The patients in the control group received conventional treatment, including basic treatments such as calcium supplementation and vitamin D; the patients in the observation group took the Chinese medicine composition (prepared according to the preferred ratio in Example 1) on this basis, one dose per day, twice a day, morning and evening, for a course of 6 months.

[0261] 5. Observation indicators:

[0262] Bone mineral density (BMD): DEXA was used to measure the BMD of the lumbar spine (L1-L4) and femoral neck before and after treatment.

[0263] TCM syndrome scoring: Based on the TCM syndrome differentiation of osteoporosis, a TCM syndrome scoring scale was developed (as shown in Table 3) to evaluate the improvement of patients' symptoms.

[0264]

[0265] 6. Criteria for determining efficacy

[0266] Markedly effective: bone density increased by ≥2%.

[0267] Effective: Bone density increase <2% but >0%.

[0268] Ineffective: No increase or even decrease in bone density.

[0269] 7. Statistical methods

[0270] SPSS 22.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (xˉ±s), and the t test was used for comparison between groups; count data were expressed as rate (%), and the χ² test was used for comparison between groups. P < 0.05 indicated that the difference was statistically significant.

[0271] 8. Typical Cases

[0272] Patient, male, 72 years old, suffered from osteoporosis due to long-term smoking and lack of exercise. Before treatment, the femoral neck bone density was 0.68 g / cm², and the TCM syndrome score was 18 points. After 6 months of treatment with the formula of Example 1, the femoral neck bone density increased to 0.71 g / cm², and the TCM syndrome score dropped to 10 points, which was judged to be significantly effective.

[0273] 9. Results:

[0274]

[0275] As can be seen from Table 4, the effective rate of this formula can reach 100%.

[0276]

[0277] Note: Comparison between observation group and control group: *P<0.05, **P<0.01.

[0278] As can be seen from Table 5, the TCM syndrome score of the observation group improved more significantly, and the difference was statistically significant compared with the control group (P < 0.01). This shows that the TCM syndrome improvement of the observation group patients who took the TCM composition on the basis of conventional treatment was significantly better than that of the control group patients who only received conventional treatment. This further verifies the effectiveness of the TCM composition in treating osteoporosis and improving TCM syndrome.

[0279]

[0280] Note: Comparison of bone density between the observation group and the control group at the same stage: *P<0.05, **P<0.01; Comparison of bone density between before and after treatment in the same group: # P<0.05, ## P<0.01.

[0281] As can be seen from Table 6, the bone density levels of the two groups of patients were similar before treatment, with no significant difference. After 6 months of treatment, the bone density levels of both groups of patients increased, but the bone density of the observation group increased more significantly, and the difference was statistically significant compared with the control group (P < 0.01). This shows that the improvement in bone density levels of the observation group patients who took the Chinese medicine composition on the basis of conventional treatment was significantly better than that of the control group patients who only received conventional treatment. This further proves the effectiveness of the Chinese medicine composition in treating osteoporosis and improving bone density.

[0282] The above-mentioned embodiments only express the specific implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the protection scope of the present application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the technical solution concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A Chinese medicine composition for improving osteoporosis, characterized in that: By weight, it is composed of the following components: Raw Astragalus: 10-30 portions; Angelica: 5-20 portions; Codonopsis pilosula: 10-30 portions; Rehmannia root: 5-30 parts; Dipsacus asper: 5-30 portions; Eucommia ulmoides: 5-30 parts; Psoralea corylifolia: 5-20 parts; Bupleurum: 5-30 parts; Epimedium: 5-30 parts; Tortoise shell: 5-30 portions; Turtle shell: 5-30 parts; Poria: 10-30 portions; Atractylodes macrocephala: 10-30 parts; Drynaria fortunei: 5-30 portions; Wolfberry: 5-30 servings; The weight ratio of each component is: raw astragalus: angelica: Codonopsis pilosula: Rehmannia root: Dipsacus asper: Eucommia ulmoides: Psoralea corylifolia: Bupleurum chinense: Epimedium brevicornum: Tortoise shell: Turtle shell: Poria cocos: Atractylodes macrocephala: Drynaria fortunei: Lycium barbarum is equal to 6:2:4:2:3:2:2:2:2:2:2:4:4:2:

4.

2. A Chinese medicine composition for improving osteoporosis according to claim 1, characterized in that: By weight, it is composed of the following components: Raw Astragalus: 30g; Angelica: 10 g; Codonopsis pilosula: 20 g; Rehmannia root: 10 g; Dipsacus asper: 15 g; Eucommia ulmoides: 10 g; Psoralea corylifolia: 10 g; Bupleurum: 10 g; Epimedium: 10 g; Tortoise shell: 10 g; Turtle shell: 10 g; Poria: 20 g; Atractylodes macrocephala: 20 g; Drynaria fortunei: 10g; Wolfberry: 20g.

3. A method for preparing a Chinese medicine composition for improving osteoporosis, characterized in that: The following steps are involved: Step 1: Prepare raw materials according to the Chinese medicinal raw materials and proportions described in any one of claims 1-2; Step 2: Soak the prepared raw materials; Step 3: Decoction the raw materials and soaking liquid together several times; Step 4: combining and concentrating the medicinal solutions obtained by decoction for several times to obtain a concentrated medicinal solution; Step 5: Prepare the obtained concentrated drug solution into a preparation.

4. A method for preparing a Chinese medicine composition for improving osteoporosis according to claim 3, characterized in that: The weight of the soaking liquid added during soaking in step 2 is 10-12 times the total weight of the raw materials, and the soaking time is 30-40 minutes.

5. The method for preparing a Chinese medicine composition for improving osteoporosis according to claim 3, characterized in that: In step 3, the raw materials and all the soaking liquid are first boiled with high heat, and then the high heat is changed to low heat to continue decocting. After the decoction is completed, the medicinal liquid and the medicinal residue are separated, and water is added to the medicinal residue for the next decoction. The decoction time for each time is between 1 hour and 1 hour and 30 minutes.

6. A method for preparing a Chinese medicine composition for improving osteoporosis according to any one of claims 3 to 5, characterized in that: The preparation in step 5 is oral liquid, granules or tablets.

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