Traditional Chinese medicine preparation for strengthening bones and tendons and improving osteoporosis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for strengthening bones and tendons and improving osteoporosis and a preparation method thereof. The traditional Chinese medicine preparation is prepared from the following raw material medicines in parts by weight: 25 to 30 parts of bovine bone, 15 to 20 parts of penis cervi, 10 to 15 parts of fructus mali, 8 to 12 parts of fructus corni, 8 to 10 parts of radix angelicae sinensis, 8 to 12 parts of semen sojae germinatum, 8 to 10 parts of rhizoma dioscoreae, 5 to 10 parts of rhizoma polygonati and 5 to 10 parts of liquorice root. In the formula, bovine bone and penis et testis cervi are taken as monarch drugs, malaytea scallop fruit, dogwood and angelica sinensis are taken as ministerial drugs, semen sojae germinatum, Chinese yam and rhizoma polygonati are taken as adjuvant drugs, and liquorice is taken as a conductant drug. All the components of the traditional Chinese medicine preparation have a synergistic effect, and the purpose of treating osteoporosis is achieved by adjusting the levels of ALP, OC and TRACP-5b, improving bone metabolism, increasing bone mineral density and inhibiting bone resorption.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis, and its preparation method. Background Technology

[0002] Osteoporosis is a systemic skeletal disease characterized by bone loss and destruction of bone microstructure. It has become the third leading chronic disease threatening the health of middle-aged and elderly people, after diabetes and hypertension. Data shows that the prevalence rate is as high as 35.3% in postmenopausal women and 12.5% ​​in men over 65 years of age. As a typical age-related disease, the incidence of osteoporosis increases exponentially with age. Studies indicate that the prevalence of osteoporosis is 24.1% in individuals aged 50-64, rising to 51.8% in those over 80 years of age. Hip fractures are the most serious complication, leading to a mortality rate of 20-24% within one year, significantly higher than the mortality rate of many cancers. Meanwhile, with the increasing aging of the global population, osteoporotic fragility fractures have become a significant public health problem threatening global human health.

[0003] Research data indicates that, guided by a treatment strategy centered on drug intervention, standardized drug therapy can increase lumbar spine bone mineral density (BMD) by 6-8% and reduce the risk of fragility fractures by 40-70%. Although these drugs have shown good clinical efficacy, their side effects remain significant. Studies have shown that 23.7% of patients discontinue treatment due to adverse drug reactions. Therefore, safe and effective alternatives are essential for treating and improving osteoporosis.

[0004] In recent years, with the deepening of basic and clinical research on the intervention of traditional Chinese medicine (TCM) in osteoporosis, TCM has demonstrated immense potential value in the treatment of osteoporosis. The synergistic effects of various TCM components not only significantly improve bone density and enhance the synthesis and secretion capacity of osteocytes, but also regulate calcium ion metabolism and absorption in osteocytes, promoting calcium ion deposition in bones. TCM preparations have proven effective in treating and improving osteoporosis, targeting multiple sites with few side effects. However, existing TCM preparations suffer from poor therapeutic efficacy. Therefore, it is necessary to further explore new TCM formulations to better serve patients. Summary of the Invention

[0005] One of the objectives of this invention is to provide a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis. The components of this preparation work synergistically to improve bone metabolism, increase bone density, and inhibit bone resorption by regulating the levels of ALP, OC, and TRACP-5b, thereby achieving the goal of treating osteoporosis.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following raw materials in parts by weight: 25-30 parts of ox bone, 15-20 parts of deer antler velvet, 10-15 parts of Chinese yam, 8-12 parts of cornus officinalis, 8-10 parts of angelica sinensis, 8-12 parts of soybean curd, 8-10 parts of yam, 5-10 parts of polygonatum sibiricum, and 5-10 parts of licorice.

[0007] Preferably, the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following raw materials in parts by weight: 28 parts of ox bone, 16 parts of deer antler velvet, 12 parts of Chinese yam, 10 parts of cornus officinalis, 9 parts of angelica sinensis, 11 parts of soybean curd, 9 parts of yam, 7 parts of polygonatum sibiricum, and 6 parts of licorice.

[0008] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine preparation that strengthens bones and muscles and improves osteoporosis. The preparation steps are simple and easy to mass-produce.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: The preparation method of the above-mentioned traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following steps: (1) Weigh each raw material according to the formula, grind the bovine bone and deer antler into powder, sieve and mix them evenly with the remaining raw materials to obtain a mixture; (2) Add water to the mixture in step (1) to soak it and obtain a mixture; then boil the mixture and filter it to obtain the first medicinal liquid and the first medicinal residue; (3) The first dregs from step (2) are soaked in water and decocted in sequence, and then filtered to obtain the second medicinal liquid and the second dregs; (4) Combine the medicinal liquids obtained in steps (2) and (3), concentrate them into an extract, add pharmaceutically acceptable excipients, and prepare the corresponding dosage form to obtain the Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis.

[0010] Preferably, the amount of water used in steps (2) and (3) is 5 to 10 times the total weight of the raw materials.

[0011] Preferably, the soaking time in steps (2) and (3) is 1-2 hours; the decocting time is 1.5-2.5 hours.

[0012] Preferably, the concentration temperature in step (4) is 45~55℃.

[0013] Preferably, the relative density of the extract in step (4) is 1.15 to 1.3.

[0014] Preferably, the dosage form in step (4) is an oral preparation.

[0015] Preferably, the oral preparation is one of tablets, granules, or capsules.

[0016] The pharmacological and pharmacodynamic analyses of the active pharmaceutical ingredient used in this invention are as follows: Beef bone: [Properties and Channels Entered] Sweet, warm, non-toxic. Enters the Heart, Kidney, and Large Intestine channels. [Functions and Indications] Has the effects of relieving numbness, stopping malaria, and promoting wound healing. Mainly used to treat arthritis, diarrhea, malaria, and infantile malnutrition sores.

[0017] Deer antler velvet: [Properties and Channels Entered] Sweet and salty in taste, warm in nature. Enters the liver, kidney, and bladder channels. [Functions and Indications] It has the effects of tonifying kidney essence, strengthening kidney yang, and strengthening the waist and knees. It is mainly used to treat kidney deficiency and fatigue, soreness and pain in the waist and knees, deafness and tinnitus, impotence and premature ejaculation, and infertility due to cold uterus.

[0018] Mountain Knife: [Properties and Channels Entered] Bitter in taste, cold in nature. Enters the Lung and Bladder channels. [Functions and Indications] It has the effects of clearing heat and detoxifying, dispelling wind and dampness, promoting blood circulation and relieving pain. It is mainly used to treat colds with fever, sore throat, diphtheria, dysentery, typhoid fever, carbuncles and boils, rheumatic pain, traumatic injuries, and snake bites.

[0019] Cornus officinalis: [Properties and Channels Entered] Sour and astringent in taste, slightly warm in nature. Enters the Liver and Kidney channels. [Functions and Indications] It has the effects of tonifying the Liver and Kidneys, astringing essence and consolidating the body. It is mainly used to treat dizziness, tinnitus, soreness and weakness of the lower back and knees, excessive sweating and collapse, etc.

[0020] Angelica sinensis: [Properties and Channels Entered] Sweet and pungent in taste, warm in nature. Enters the Liver, Heart, and Spleen channels. [Functions and Indications] It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is mainly used to treat blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, constipation due to intestinal dryness, rheumatic pain, traumatic injuries, carbuncles and sores.

[0021] Soybean Curd Rolls:

Properties and Channels Entered

Functions and Indications

[0022] Yam: [Properties and Channels Entered] Sweet in taste, neutral in nature. Enters the Lung, Spleen, and Kidney channels. [Functions and Indications] It has the effects of strengthening the spleen and lungs, benefiting the stomach and kidneys, consolidating the kidneys and replenishing essence, improving hearing and vision, assisting the five internal organs, strengthening muscles and bones, enhancing willpower and calming the mind, and prolonging life. It is mainly used to treat symptoms such as spleen and stomach weakness, fatigue, loss of appetite, chronic diarrhea, lung qi deficiency and dryness, phlegm and cough, kidney qi deficiency, soreness and weakness of the waist and knees, weakness of the lower limbs, thirst and frequent urination, seminal emission and premature ejaculation, leukorrhea, skin redness and swelling, and obesity.

[0023] Polygonatum: [Properties and Channels Entered] Sweet in taste, neutral in nature. Enters the spleen, lung, and kidney channels. [Functions and Indications] Nourishes yin and moistens the lungs, tonifies the spleen and replenishes qi, nourishes the kidneys and replenishes essence. It is indicated for spleen and stomach qi deficiency, fatigue, stomach yin deficiency, dry mouth and poor appetite, lung deficiency and dry cough, consumptive cough with hemoptysis, deficiency of essence and blood, soreness and weakness of the lower back and knees, premature graying of hair, and internal heat and thirst.

[0024] Licorice: [Properties and Channels Entered] Sweet in taste, neutral in nature. Enters the Heart, Lung, Spleen, and Stomach channels. [Functions and Indications] It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing other herbs. It is mainly used to treat fatigue, poor appetite, palpitations, shortness of breath, abdominal pain, loose stools, limb pain, cough and wheezing, sore throat, and drug and food poisoning.

[0025] Compared with the prior art, the main advantages of the present invention are as follows: This invention is formulated based on traditional Chinese medicine theory. The formula uses ox bone and deer antler as the principal herbs, *Gnaphalium affine*, *Cornus officinalis*, and *Angelica sinensis* as the assistant herbs, soybean sprouts, yam, and *Polygonatum sibiricum* as the adjuvant herbs, and licorice as the guiding herb. This well-balanced combination of principal, assistant, adjuvant, and guiding herbs, by regulating ALP, OC, and TRACP-5b levels, improves bone metabolism, increases bone density, and inhibits bone resorption, thereby achieving the goal of treating osteoporosis. Detailed Implementation

[0026] The present invention will be further described below with reference to embodiments, but this does not constitute any limitation on the present invention. Any limited modifications made within the scope of the claims of the present invention are still within the scope of the claims of the present invention.

[0027] To illustrate the technical content of the present invention in detail, the following description is provided in conjunction with the embodiments.

[0028] Example 1 This embodiment provides a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis, as well as its preparation method.

[0029] A traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following raw materials in parts by weight: 28 parts of ox bone, 16 parts of deer antler velvet, 12 parts of Chinese yam, 10 parts of cornus officinalis, 9 parts of angelica sinensis, 11 parts of soybean curd, 9 parts of yam, 7 parts of polygonatum sibiricum, and 6 parts of licorice.

[0030] The preparation method of the above-mentioned traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following steps: (1) Weigh each raw material according to the above formula, grind the ox bone and deer antler into powder, pass them through a 200-mesh sieve and mix them evenly with the remaining raw materials to obtain a mixture; (2) Add water to the mixture in step (1) at a rate of 8 times the total weight of the raw materials, soak for 1.5 hours to obtain a mixed solution; boil the mixed solution for 2 hours, filter to obtain the first medicinal liquid and the first medicinal residue; (3) Add water to the first dregs in step (2) according to the amount of water being 8 times the total weight of the raw materials, soak for 1.5 hours, then decoct for 2 hours, filter to obtain the second liquid and the second dregs; (4) Combine the medicinal liquid obtained in steps (2) and (3), concentrate it at 50°C to an extract with a relative density of 1.2, add 2% dextrin by weight of the extract, and make tablets according to conventional methods to obtain the Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis.

[0031] Example 2 This embodiment provides a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis, as well as its preparation method.

[0032] A traditional Chinese medicine preparation for improving osteoporosis includes the following raw materials in parts by weight: 30 parts of ox bone, 20 parts of deer antler velvet, 15 parts of Chinese yam, 12 parts of cornus officinalis, 10 parts of angelica sinensis, 12 parts of soybean curd, 10 parts of yam, 10 parts of polygonatum sibiricum, and 10 parts of licorice.

[0033] The preparation method of the above-mentioned traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following steps: (1) Weigh each raw material according to the above formula, grind the ox bone and deer antler into powder, pass them through a 200-mesh sieve and mix them evenly with the remaining raw materials to obtain a mixture; (2) Add water to the mixture in step (1) at a rate of 10 times the total weight of the raw materials, soak for 1 hour to obtain a mixed liquid; boil the mixed liquid for 1.5 hours, filter to obtain the first medicinal liquid and the first medicinal residue; (3) Add water to the first dregs in step (2) according to the amount of water being 10 times the total weight of the raw materials, soak for 1 hour, then decoct for 1.5 hours, filter to obtain the second liquid and the second dregs; (4) Combine the medicinal liquid obtained in steps (2) and (3), concentrate it at 55°C to an extract with a relative density of 1.15, add 2% dextrin by weight of the extract, and make capsules according to conventional methods to obtain the Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis.

[0034] Example 3 This embodiment provides a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis, as well as its preparation method.

[0035] A traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following raw materials in parts by weight: 25 parts of ox bone, 15 parts of deer antler velvet, 10 parts of Chinese yam, 8 parts of cornus officinalis, 8 parts of angelica sinensis, 8 parts of soybean curd, 8 parts of yam, 5 parts of polygonatum sibiricum, and 5 parts of licorice.

[0036] The preparation method of the above-mentioned traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis includes the following steps: (1) Weigh each raw material according to the above formula, grind the ox bone and deer antler into powder, pass them through a 200-mesh sieve and mix them evenly with the remaining raw materials to obtain a mixture; (2) Add water to the mixture in step (1) at a rate of 5 times the total weight of the raw materials, soak for 2 hours to obtain a mixed solution; decoct the mixed solution for 2.5 hours, filter to obtain the first medicinal liquid and the first medicinal residue; (3) Add water to the first dregs in step (2) according to the amount of water being 5 times the total weight of the raw materials, soak for 2 hours, then decoct for 2.5 hours, filter to obtain the second liquid and the second dregs; (4) Combine the medicinal liquid obtained in steps (2) and (3), concentrate it at 45°C to an extract with a relative density of 1.3, add 1% dextrin and 1% sucrose by mass of the extract, and make it into granules according to conventional methods to obtain the Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis.

[0037] Comparative Example 1 Comparative Example 1 is basically the same as Example 1, except that the large knife in Example 1 is omitted.

[0038] Comparative Example 2 Comparative Example 2 is basically the same as Example 1, except that the soybean rolls in Example 1 are omitted.

[0039] Comparative Example 3 Comparative Example 3 is basically the same as Example 1, except that the mountain broadsword in Example 1 is replaced with hawthorn leaves.

[0040] The efficacy of the traditional Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-3 is explained below, with detailed procedures as follows: (1) Selecting experimental model animals Ninety 10-week-old female Wistar rats were selected as the experimental model animals for bilateral ovariectomy-induced osteoporosis. Prior to the experiment, the rats underwent an acclimatization period to ensure their physiological stability. All rats were then randomly divided into four groups: a positive control group, a sham-operated group, a model group, and four groups (Example 1: low, medium, and high doses; Comparative Example 1: low dose; Comparative Example 2: low dose; Comparative Example 3: low dose), with 10 rats in each group.

[0041] (2) Surgical procedure In the sham-operated group, the lower fallopian tubes of rats were ligated and some adipose tissue adjacent to the ovaries was removed, but both ovaries were not removed. In the other groups, rats were anesthetized with 10% chloral hydrate solution at 3 mL / kg via intraperitoneal injection. The skin and muscles were incised below the ribs on the back to expose the abdominal cavity. Both ovaries were located, removed, and sutured. Starting 12 weeks post-operation, rats were administered medication via gavage according to the protocol in Table 1, once daily for 12 consecutive weeks.

[0042] (3) Detection indicators After the last oral administration, the rats were fasted for 24 hours, and then anesthetized by intraperitoneal injection of 10% chloral hydrate solution at a dose of 3 mL / kg, and the rats in each group were sacrificed.

[0043] Bone mineral density: Both intact femurs of rats were collected, and the bone mineral density of the right femur was measured using a dual-energy X-ray absorptiometry (DXA) bone mineral density analyzer. The results are shown in Table 2. Bone weight: The wet weight of the left femur was measured using a 0.01 g electronic balance, and then defatted with a chloroform / methanol (2:1) mixture for 72 h. It was dried at 120 °C to constant weight, cooled, and then weighed to obtain the dry weight. The dry bone was placed in a crucible, and 3 mL of a mixed acid (nitric acid / perchloric acid = 4:1) was added for heating and digestion. It was then ashed in a Moffer furnace at 800 °C for 6 h. After cooling, the ash weight was measured. The results are shown in Table 2. Bone calcium content: The calcium content in the ash of the left femur was determined by EDTA titration. The results are shown in Table 2. Serum bone metabolism biochemical indicators detection: Blood was collected from the abdominal aorta, and after standing for 1 hour, it was centrifuged at 3000 rpm for 15 minutes using a low-temperature centrifuge. Serum was then collected for the detection of serum alkaline phosphatase (ALP), osteocalcin (OC), and tartrate-resistant acid phosphatase 5b (TRACP-5b). The results are shown in Table 3.

[0044] Table 1 Table 2 Table 3 Table 2 shows that the traditional Chinese medicine preparation of this invention can effectively increase bone mineral density, bone quality, and bone calcium content in the bone tissue of bilaterally ovariectomized osteoporotic rats. Table 3 shows that the traditional Chinese medicine preparation of this invention can effectively increase the levels of osteocalcin and alkaline phosphatase in rat serum, indicating that it can promote bone formation in rats. Furthermore, the traditional Chinese medicine preparation of this invention can also reduce the level of TRACP-5b in rat serum, indicating that it can inhibit bone resorption. The above experimental results show that the traditional Chinese medicine preparation of this invention has a good therapeutic effect on osteoporosis.

[0045] Compared to Example 1, after oral administration of the traditional Chinese medicine preparations of Comparative Examples 1, 2, and 3, the bone mineral density, bone mass, bone calcium content, serum alkaline phosphatase and osteocalcin levels in rats were all reduced, while the serum TRACP-5b level was increased. These results indicate that the traditional Chinese medicine preparation of the present invention has a more rational combination of principal, assistant, and adjuvant herbs, with each component acting synergistically. By regulating ALP, OC, and TRACP-5b levels, it improves bone metabolism, increases bone mineral density, and inhibits bone resorption, thereby achieving the goal of treating osteoporosis.

[0046] The above embodiments are merely illustrative of the concept and technical solution of the present invention and are not intended to limit the present invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis, characterized in that, The raw materials include the following parts by weight: 25-30 parts of ox bone, 15-20 parts of deer antler velvet, 10-15 parts of Chinese yam, 8-12 parts of cornus officinalis, 8-10 parts of angelica sinensis, 8-12 parts of soybean curd, 8-10 parts of yam, 5-10 parts of polygonatum sibiricum, and 5-10 parts of licorice.

2. The traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 1, characterized in that, The raw materials include the following parts by weight: 28 parts of ox bone, 16 parts of deer antler velvet, 12 parts of Chinese yam, 10 parts of cornus officinalis, 9 parts of angelica sinensis, 11 parts of soybean curd, 9 parts of yam, 7 parts of polygonatum sibiricum, and 6 parts of licorice.

3. A method for preparing a traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis as described in claim 1, characterized in that, Includes the following steps: (1) Weigh each raw material according to the formula, grind the bovine bone and deer antler into powder, sieve and mix them evenly with the remaining raw materials to obtain a mixture; (2) Add water to the mixture in step (1) to soak it and obtain a mixture; then boil the mixture and filter it to obtain the first medicinal liquid and the first medicinal residue; (3) The first dregs from step (2) are soaked in water and decocted in sequence, and then filtered to obtain the second medicinal liquid and the second dregs; (4) Combine the medicinal liquids obtained in steps (2) and (3), concentrate them into an extract, add pharmaceutically acceptable excipients, and prepare the corresponding dosage form to obtain the Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis.

4. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 3, characterized in that, In steps (2) and (3), the amount of water used is 5 to 10 times the total weight of the raw materials.

5. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 3, characterized in that, The soaking time in steps (2) and (3) is 1-2 hours; the decocting time is 1.5-2.5 hours.

6. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 3, characterized in that, The concentration temperature in step (4) is 45~55℃.

7. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 3, characterized in that, The relative density of the extract in step (4) is 1.15~1.

3.

8. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 3, characterized in that, The dosage form mentioned in step (4) is an oral preparation.

9. The method for preparing the traditional Chinese medicine preparation for strengthening bones and muscles and improving osteoporosis according to claim 8, characterized in that, The oral preparation is one of tablets, granules, or capsules.

Images