Calcium supplement and bone strengthening traditional Chinese medicine composition for treating osteoporosis, preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine composition for treating osteoporosis, including its calcium-supplementing and bone-strengthening properties, preparation method, and application. The composition comprises Dipsacus asper, oyster shell, Astragalus membranaceus, Angelica sinensis, Caesalpinia sappan, Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides, Polygonum cuspidatum, and Glycyrrhiza uralensis. Through scientific and rational formulation and preparation methods, this traditional Chinese medicine composition exhibits the effects of invigorating qi and strengthening the spleen, tonifying the liver and kidneys, and supplementing calcium and strengthening bones, significantly improving the effectiveness of treating osteoporosis caused by calcium deficiency. Furthermore, this traditional Chinese medicine composition contains no toxic herbs, has few side effects, and is highly safe.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a calcium-supplementing and bone-strengthening traditional Chinese medicine composition for treating osteoporosis, its preparation method, and its application. Background Technology

[0002] Osteoporosis is a systemic skeletal disease characterized by decreased bone mass, reduced bone strength, and an increased risk of fragility fractures. Clinically, it often manifests as bone pain, fragility fractures, shortened height, general weakness, reduced quality of life, and even paralysis. Risk factors for osteoporosis include unmodifiable factors such as race and age, as well as modifiable factors such as nutritional imbalances in diet, excessive or insufficient protein intake, calcium and / or vitamin D deficiency, and related diseases and medications affecting bone metabolism. Currently, there are over 200 million osteoporosis patients worldwide, and my country is a high-incidence area for osteoporosis. The prevalence rate is 13% in people over 40 years old (11% for men and 14% for women); and 36% in people over 60 years old (23% for men and 49% for women). The most serious consequence of osteoporotic osteoporosis is osteoporotic fractures, which significantly increase disability and mortality rates, making it one of the diseases that seriously affects public health.

[0003] Traditional Chinese medicine categorizes osteoporosis under various terms such as "bone atrophy," "bone numbness," "bone decay," and "bone erosion." For example, the *Suwen* (Plain Questions) states, "The kidneys store essence, govern bones, and produce marrow." The *Suwen* also records, "When kidney qi is hot, the lower back and spine cannot be lifted, bones decay, and marrow decreases, resulting in bone atrophy." The *Rumen Shiqin* (Confucian Family Matters) states, "The symptoms of atrophy... are due to the kidney water's inability to overcome the heart fire... The kidneys govern the two feet, therefore bone marrow depletion occurs due to excessive internal factors." The *Suwen* also states, "If bone numbness persists and is further affected by pathogenic factors, it resides in the kidneys, which is called kidney numbness." Traditional Chinese medicine believes that osteoporosis originates from deficiencies in the spleen, liver, and kidneys. The kidneys are considered the foundation of innate essence and the source of life; the liver stores blood; the kidneys store essence and govern bones; the liver governs tendons; and the spleen governs the entire body. The liver and kidneys share a common origin; when liver blood is abundant, kidney essence is sufficient to nourish the bone marrow. Kidney deficiency is the fundamental pathogenesis of osteoporosis. A lack of kidney essence and an imbalance of kidney yin and yang lead to osteoporosis, while spleen deficiency is key. The spleen and kidneys influence each other, creating a causal relationship. Only when kidney essence is abundant at birth and the spleen is functioning properly after birth can osteoporosis develop. The liver governs the tendons and is the storehouse of blood, responsible for promoting the smooth flow of qi and blood throughout the body. In treating osteoporosis, the holistic approach of traditional Chinese medicine should be followed, focusing on the treatment of the kidneys, liver, and spleen. This involves simultaneously nourishing the liver and kidneys, emphasizing both tendons and bones, and ensuring the generation of essence and blood, thus nourishing the tendons and bones. The treatment principle should be to nourish the liver and kidneys, invigorate qi and strengthen the spleen, and supplement calcium to strengthen bones.

[0004] Currently, chemotherapy drugs for osteoporosis are mainly divided into drugs that inhibit bone resorption and drugs that promote bone formation, such as estrogen, calcitonin, parathyroid hormone, bisphosphonates, and calcium supplements. However, excessive calcium supplementation can increase the incidence of cardiovascular disease and kidney stones. There is a link between calcitonin use and cancer development, and hormone replacement therapy carries the potential risks of stroke and venous thrombosis. Traditional Chinese medicine treatment for osteoporosis largely focuses on tonifying the kidneys and strengthening bones, warming and tonifying kidney yang, nourishing the liver and kidneys, and promoting blood circulation and removing blood stasis.

[0005] Among the existing treatment technologies and patents, there are various publicly disclosed formulations. For example, patent CN 105079403 B discloses a traditional Chinese medicine composition for treating osteoporosis and its preparation method. The components are dragon's blood, licorice, psoralea, drynaria, myrrh, epimedium, peach kernel, eucommia, dipsacus and cynanchum. The preparation method of ultra-fine pulverization can improve the utilization rate of the traditional Chinese medicine composition and treat osteoporosis in middle-aged and elderly people and postmenopausal women. Patent CN 107951932B discloses a traditional Chinese medicine composition for treating osteoporosis and its application. The composition comprises Angelica sinensis, Salvia miltiorrhiza, raw white peony root, red peony root, licorice root, Eucommia ulmoides, Achyranthes bidentata, Epimedium, Lycopodium clavatum, Clematis chinensis, Drynaria fortunei, frankincense, myrrh, and Corydalis yanhusuo for external application. It tonifies both the liver and kidneys, promotes blood circulation and menstruation, invigorates blood and removes blood stasis, dispels wind and cold, reduces swelling and promotes tissue regeneration, and nourishes tendons and bones to treat osteoporosis and lower back pain. Patent CN 111760011B discloses a traditional Chinese medicine composition and its application in preparing a traditional Chinese medicine preparation for treating osteoporosis. The composition comprises Rehmannia glutinosa, bamboo leaves, licorice root, Eucommia ulmoides, Drynaria fortunei, Achyranthes bidentata, Psoralea corylifolia, Cinnamomum cassia, dried ginger, Epimedium brevicornu, Cistanche deserticola, Schisandra chinensis, and Alisma plantago-aquatica, used for various TCM syndrome types of osteoporosis. Patent CN 113491757 B discloses the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and treatment of osteoporosis. The components are prepared aconite, epimedium, dried ginger, licorice, ginseng, salvia miltiorrhiza, polygonum cuspidatum, poria cocos, phellodendron bark and scutellaria baicalensis. It has a good preventive and therapeutic effect on osteoporosis, especially osteoporosis caused by estrogen deficiency.

[0006] Based on years of clinical experience, this invention targets the main pathogenesis of osteoporosis, namely "kidney deficiency, spleen deficiency, qi deficiency and blood stasis." It is a modified version of a classic prescription, focusing on calcium supplementation and kidney tonification while also considering the liver and spleen. The treatment method emphasizes tonifying the kidneys, replenishing essence, and strengthening bones. It employs methods that invigorate qi and spleen, tonify the liver and kidneys, and supplement calcium to strengthen bones. Simultaneously, it maintains yin-yang balance, supporting yang while nourishing yin, and adds qi-tonifying and deficiency-tonifying herbs to nourish the whole body, strengthen bones and generate marrow, thus achieving a calcium-supplementing effect. It is used to treat osteoporosis caused by calcium deficiency, addressing both the root cause and symptoms, with no side effects and significant efficacy. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for treating osteoporosis, its preparation method, and its application. The traditional Chinese medicine composition provided by this invention treats osteoporosis caused by calcium deficiency with the basic principles of invigorating qi and strengthening the spleen, nourishing the liver and kidneys, and supplementing calcium and strengthening bones. It has the characteristics of rapid onset of action, significant efficacy, and few toxic side effects.

[0008] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0009] This invention provides a traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: 200-600 parts of Dipsacus asper, 200-400 parts of Oyster shell, 300-600 parts of Astragalus membranaceus, 100-200 parts of Angelica sinensis, 50-100 parts of Caesalpinia sappan, 200-400 parts of Curculigo orchioides, 100-300 parts of Drynaria fortunei, 200-350 parts of Eucommia ulmoides, 150-450 parts of Polygonum cuspidatum, and 50-200 parts of Glycyrrhiza uralensis.

[0010] Preferably, the above-mentioned traditional Chinese medicine composition comprises the following raw materials in parts by weight: 400-600 parts of Dipsacus asper, 250-350 parts of Oyster shell, 400-500 parts of Astragalus membranaceus, 150-200 parts of Angelica sinensis, 80-100 parts of Caesalpinia sappan, 250-350 parts of Curculigo orchioides, 200-300 parts of Drynaria fortunei, 250-300 parts of Eucommia ulmoides, 200-300 parts of Polygonum cuspidatum, and 100-150 parts of Glycyrrhiza uralensis.

[0011] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0012] (1) The oysters were extracted with edible vinegar, filtered, concentrated and dried to obtain oyster extract powder;

[0013] (2) The Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood and Glycyrrhiza uralensis were extracted with water, filtered, concentrated and dried to obtain water extract powder;

[0014] (3) Extract the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum with ethanol, filter, concentrate and dry to obtain ethanol extract powder;

[0015] (4) Mix oyster powder, water extract powder and alcohol extract powder to obtain the traditional Chinese medicine composition.

[0016] Preferably, in step (1), the ratio of oyster to edible vinegar is 1:4-5, the extraction temperature is 60-80℃, the extraction time is 18-22h, and the extraction is performed 3 times.

[0017] Preferably, in step (2), the ratio of the raw material to the liquid of the extract, astragalus, angelica, sappanwood, licorice and water is 1:8 to 10, the extraction temperature is 100℃, the extraction time is 1.5h, and the extraction is performed 3 times.

[0018] Preferably, in step (3), the ratio of the material to the ethanol solution of the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides, Polygonum cuspidatum, and ethanol solution is 1:8-10, the volume percentage of the ethanol solution is 40-50%, the extraction temperature is 90℃, the extraction time is 2h, and the extraction is performed 3 times.

[0019] The present invention also provides the application of a calcium-supplementing and bone-strengthening traditional Chinese medicine composition for treating osteoporosis in the treatment of osteoporosis caused by calcium deficiency.

[0020] The present invention has the following effects:

[0021] This composition is simple in formulation, with Dipsacus asper and Oyster Shell as the principal herbs, Astragalus membranaceus, Curculigo orchioides, Drynaria fortunei, and Eucommia ulmoides as the assistant herbs, Polygonum cuspidatum, Angelica sinensis, and Caesalpinia sappan as adjuvant herbs, and Glycyrrhiza uralensis as the guiding herb. It has the effects of invigorating qi and strengthening the spleen, tonifying the liver and kidneys, and supplementing calcium and strengthening bones. The combination of the principal and assistant herbs synergistically enhances the effect, significantly improving the effectiveness of treating osteoporosis caused by calcium deficiency, with a low recurrence rate. Furthermore, the herbal composition of this invention is convenient to take, has no toxic side effects, is highly safe, and has controllable quality. Detailed Implementation

[0022] This invention provides a traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: 400-600 parts of Dipsacus asper, 250-350 parts of Oyster shell, 400-500 parts of Astragalus membranaceus, 150-200 parts of Angelica sinensis, 80-100 parts of Caesalpinia sappan, 250-350 parts of Curculigo orchioides, 200-300 parts of Drynaria fortunei, 250-300 parts of Eucommia ulmoides, 200-300 parts of Glycyrrhiza uralensis, and 1000-200 parts of Glycyrrhiza uralensis.

[0023] Based on the treatment principle of "tonifying qi and strengthening the spleen, nourishing the liver and kidneys, and supplementing calcium and strengthening bones," the inventors established the formulation of the pharmaceutical composition of this invention. The effects of various traditional Chinese medicines in this invention are as follows:

[0024] The principal herb, Dipsacus asper, enters the liver and kidney meridians, tonifying the liver and kidneys, strengthening tendons and bones, healing fractures, and stopping metrorrhagia. It is used for liver and kidney deficiency, lower back and knee weakness, rheumatic pain, injuries from falls, tendon injuries and fractures, metrorrhagia, and threatened abortion. Wine-processed Dipsacus asper is mainly used for rheumatic pain, injuries from falls, and tendon injuries and fractures. In this invention, the source of the Dipsacus asper is not specifically limited; any product known in the art may be used.

[0025] The principal ingredient: Oyster shell, with its calming and sedative properties, nourishes Yin and subdues Yang, softens hardness and dissipates nodules. It is used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, and abdominal masses. Calcined oyster shell has astringent and consolidating effects, neutralizes acid and relieves pain. It is used for spontaneous sweating, night sweats, seminal emission, metrorrhagia, leukorrhea, stomach pain, and acid reflux. In this invention, oyster shell is extracted with edible vinegar, resulting in organic calcium that is less irritating to the gastrointestinal tract, has better absorption, and is easily absorbed by the human body. The source of the oyster shell is not specifically limited; any product known in the art can be used.

[0026] Ministerial drug: Astragalus membranaceus replenishes qi and promotes yang ascent, consolidates the exterior and stops sweating, promotes diuresis and alleviates edema, generates fluid and nourishes blood, promotes qi circulation to relieve pain, expels toxins and discharges pus, and astringes sores and promotes granulation. It is used for the functions and effects of qi deficiency with weakness, poor appetite and loose stools, middle qi sinking, chronic diarrhea with rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency edema, internal heat with thirst, blood deficiency with sallow complexion, hemiplegia, pain and numbness in arthralgia, carbuncles and ulcers that are difficult to ulcerate, and chronic ulcers that do not heal. In the present invention, the source of the Astragalus membranaceus is not particularly limited, and products well-known in the art can be used.

[0027] Ministerial drug: Curculigo orchioides nourishes the kidney yang, strengthens the muscles and bones, and dispels cold-dampness. It is used for impotence with cold sperm, flaccid muscles and bones, cold pain in the waist and knees, and yang deficiency with cold diarrhea. In the present invention, the source of the Curculigo orchioides is not particularly limited, and products well-known in the art can be used.

[0028] Ministerial drug: Drynaria fortunei relieves pain and heals injuries, nourishes the kidney and strengthens the bones; externally, it dispels wind and removes freckles. It is used for the functions and effects of falls, contusions and strains, tendon and bone fractures, kidney deficiency with low back pain, flaccid muscles and bones, tinnitus and deafness, loose teeth; externally treating alopecia areata and vitiligo. In the present invention, the source of the Drynaria fortunei is not particularly limited, and products well-known in the art can be used.

[0029] Ministerial drug: Eucommia ulmoides nourishes the liver and kidney, strengthens the muscles and bones, and prevents miscarriage. It is used for the functions and effects of liver and kidney deficiency, soreness and pain in the waist and knees, weakness of muscles and bones, dizziness and vertigo, vaginal bleeding during pregnancy, and fetal movement restlessness. In the present invention, the source of the Eucommia ulmoides is not particularly limited, and products well-known in the art can be used.

[0030] Adjuvant drug: Oyster重镇安神,潜阳补阴,软坚散结。用于惊悸失眠,眩晕耳鸣,瘰疬痰核,癥瘕痞块。煅牡蛎收敛固涩,制酸止痛。用于自汗盗汗,遗精滑精,崩漏带下,胃痛吞酸的功能效。在本发明中,所述牡蛎的来源没有特殊限定,采用本领域公知的产品即可。

[0031] Adjuvant drug: Polygonum cuspidatum promotes diuresis and reduces jaundice, clears heat and detoxifies, disperses stasis and relieves pain, and relieves cough and reduces phlegm. It is used for the functions and effects of damp-heat jaundice, gonorrhea, leukorrhea, rheumatic arthralgia, carbuncles and sores, scalds by fire and water, amenorrhea, mass in the abdomen, traumatic injury, and cough due to lung heat. In the present invention, the source of the Polygonum cuspidatum is not particularly limited, and products well-known in the art can be used.

[0032] Adjuvant drug: Angelica sinensis nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes defecation. It is used for the functions and effects of blood deficiency with sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, deficiency-cold abdominal pain, rheumatic arthralgia, traumatic injury, carbuncles and ulcers, and intestinal dryness and constipation. Angelica sinensis processed with wine promotes blood circulation and dredges the meridians. It is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injury. In the present invention, the source of the Angelica sinensis is not particularly limited, and products well-known in the art can be used.

[0033] Adjuvant: Sappanwood invigorates blood circulation, removes blood stasis, reduces swelling, and relieves pain. It is used for traumatic injuries, fractures, muscle strains, swelling and pain due to blood stasis, amenorrhea, dysmenorrhea, postpartum blood stasis, chest and abdominal pain, and carbuncles and boils. In this invention, the source of the sappanwood is not specifically limited; any product known in the art may be used.

[0034] The medicated ingredient, licorice root, is neutral in nature and sweet in taste. It enters the heart, lung, spleen, and stomach meridians, and has the functions 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 used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other medications. In this invention, the source of the licorice root is not specifically limited; any product known in the art may be used.

[0035] The traditional Chinese medicine composition of this invention has the effects of invigorating qi and strengthening the spleen, nourishing the liver and kidneys, and supplementing calcium and strengthening bones. The components in this composition work synergistically to significantly improve the effectiveness of treating osteoporosis caused by calcium deficiency, resulting in rapid cure and a low recurrence rate. Furthermore, the traditional Chinese medicine composition of this invention is convenient to take orally, has no toxic side effects, is highly safe, and has controllable quality.

[0036] This invention uses Dipsacus asper and Oyster Shell as the principal herbs, Astragalus membranaceus, Curculigo orchioides, Drynaria fortunei, and Eucommia ulmoides as the assistant herbs, Polygonum cuspidatum, Angelica sinensis, and Caesalpinia sappan as adjuvant herbs, and Glycyrrhiza uralensis as the guiding herb. Dipsacus asper, as the principal herb, tonifies the liver and kidneys, strengthens tendons and bones, and heals fractures; Oyster Shell strengthens the kidneys and subdues yang, enhancing astringency and simultaneously supplementing calcium; Astragalus membranaceus, among the assistant herbs, tonifies qi to promote circulation and relieve pain; Curculigo orchioides, Drynaria fortunei, and Eucommia ulmoides tonify the liver and kidneys and strengthen tendons and bones, assisting the principal herbs in treating fractures; Angelica sinensis, Polygonum cuspidatum, and Caesalpinia sappan invigorate blood, replenish blood, disperse blood stasis, relieve pain, and strengthen bones; combined with Glycyrrhiza uralensis as the guiding herb, it tonifies the spleen and qi, relieves spasms and pain, and harmonizes the effects of the other herbs. The combined herbs exert a synergistic effect, possessing the therapeutic effects of tonifying qi and spleen, nourishing the liver and kidneys, and supplementing calcium and strengthening bones. It has significant efficacy and few side effects in treating osteoporosis caused by calcium deficiency.

[0037] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0038] (1) The oysters are extracted with edible vinegar, filtered, concentrated and dried to obtain oyster extract powder;

[0039] (2) The Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood and Glycyrrhiza uralensis were extracted with water, filtered, concentrated and dried to obtain a dry extract powder of water extract;

[0040] (3) Extract the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum with ethanol, filter, concentrate and dry to obtain ethanol extract powder;

[0041] (4) Mix oyster extract powder, water extract powder and alcohol extract powder to obtain the traditional Chinese medicine composition.

[0042] The ratio of oysters to edible vinegar is 1:3 to 6, more preferably 1:5, and the extraction temperature is 40 to 80°C, more preferably 60 to 80°C, and even more preferably 70°C.

[0043] The extraction time is 12-24 hours, more preferably 18-22 hours, and even more preferably 16 hours, with 2-4 extractions, and even more preferably 3 extractions.

[0044] The ratio of the ingredients (Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Caesalpinia sappan, Glycyrrhiza uralensis, and water) is 1:6 to 12, more preferably 1:8, and the extraction temperature is 90 to 100°C, more preferably 100°C.

[0045] The extraction time is 1 to 3 hours, more preferably 1.5 hours, and the number of extractions is 2 to 4 times, more preferably 3 times.

[0046] The ratio of the raw material to the ethanol solution of the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides, Polygonum cuspidatum, and ethanol solution is 1:6 to 12, more preferably 1:10. The volume percentage of the ethanol solution is 40 to 80%, more preferably 40 to 60%, and even more preferably 50%. The extraction temperature is 70 to 100°C, more preferably 90°C.

[0047] The extraction time is 1 to 3 hours, more preferably 2 hours, and the number of extractions is 2 to 4 times, more preferably 3 times.

[0048] Based on the properties of the active ingredients contained in medicinal materials, this invention can ensure the extraction of active ingredients through different extraction methods.

[0049] The traditional Chinese medicine composition prepared by this invention can significantly improve the cure rate of osteoporosis caused by calcium deficiency, with few toxic side effects.

[0050] The present invention also provides an application of a calcium-supplementing and bone-strengthening traditional Chinese medicine composition for the treatment of osteoporosis.

[0051] The drug can be in the form of a solid or liquid preparation, wherein the solid preparation is preferably a tablet, granule, capsule, or pill; and the liquid preparation is preferably a solution, suspension, or syrup. Tablets can be produced mechanically and with a high degree of automation, and their quality is stable and controllable, making them suitable for a wide range of patients. To better realize the social benefits of this drug, we have selected tablets as the preferred dosage form for this prescription, based on a combination of efficacy and quality.

[0052] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0053] Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0054] Example 1

[0055] A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials by weight: 400 parts of Dipsacus asper, 250 parts of oyster shell, 400 parts of Astragalus membranaceus, 180 parts of Angelica sinensis, 100 parts of Sappanwood, 200 parts of Curculigo orchioides, 250 parts of Drynaria fortunei, 300 parts of Eucommia ulmoides, 200 parts of Codonopsis pilosula, and 120 parts of Glycyrrhiza uralensis.

[0056] A. Take oysters and extract them 4 times with 3 times the amount of edible vinegar (80℃), each time for 20 hours. Combine the extracts, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.20-1.30 (65℃), dry under reduced pressure, and pulverize to obtain oyster extract powder for later use.

[0057] B. Take Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood, and Glycyrrhiza uralensis, add 12 times the amount of water and decoct twice, 3 hours each time. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.20-1.40 (80℃), dry under reduced pressure, pulverize, and obtain a dry extract powder of water extract for later use.

[0058] C. Take Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum and reflux extract with 12 times the amount of 80% ethanol 4 times, 2 hours each time. Filter, combine the filtrates, recover the ethanol and concentrate under reduced pressure to a clear extract with a relative density of 1.25-1.30 (70℃). Dry under reduced pressure, pulverize and obtain the alcohol extract dry extract powder for later use.

[0059] D. Mix the above three dry powders to obtain a traditional Chinese medicine powder composition; add excipients to prepare it into an immediate-release tablet, granule, capsule or pill.

[0060] Example 2

[0061] A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials by weight: 500 parts of Dipsacus asper, 280 parts of oyster shell, 500 parts of Astragalus membranaceus, 200 parts of Angelica sinensis, 85 parts of Caesalpinia sappan, 200 parts of Curculigo orchioides, 300 parts of Drynaria fortunei, 245 parts of Eucommia ulmoides, 300 parts of Polygonum cuspidatum, and 150 parts of Glycyrrhiza uralensis.

[0062] A. Take oysters and extract them 4 times with 6 times the amount of edible vinegar (40℃), each time for 24 hours. Combine the extracts, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.25-1.35 (60℃), dry under reduced pressure, and pulverize to obtain oyster extract powder for later use.

[0063] B. Take Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood, and Glycyrrhiza uralensis, add 10 times the amount of water and decoct 3 times, 1.5 hours each time. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.20-1.30 (70℃), dry under reduced pressure, pulverize, and obtain a dry extract powder of water extract for later use.

[0064] C. Take Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum and reflux extract with 8 times the amount of 60% ethanol 3 times, 3 hours each time. Filter, combine the filtrates, recover the ethanol and concentrate under reduced pressure to a clear extract with a relative density of 1.25-1.30 (70℃). Dry under reduced pressure, pulverize and obtain the alcohol extract dry extract powder for later use.

[0065] D. Mix the above three dry powders to obtain a traditional Chinese medicine powder composition; add excipients to prepare it into an immediate-release tablet, granule, capsule or pill.

[0066] Example 3

[0067] A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials by weight: 450 parts of Dipsacus asper, 340 parts of oyster shell, 480 parts of Astragalus membranaceus, 160 parts of Angelica sinensis, 100 parts of Caesalpinia sappan, 250 parts of Curculigo orchioides, 280 parts of Drynaria fortunei, 290 parts of Eucommia ulmoides, 280 parts of Polygonum cuspidatum, and 130 parts of Glycyrrhiza uralensis.

[0068] A. Take oysters and extract them twice with 4 times the amount of edible vinegar (60℃), each time for 12 hours. Combine the extracts, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.08-1.15 (60℃), spray dry to obtain oyster extract powder, and set aside for later use.

[0069] B. Take Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood and Glycyrrhiza uralensis, add 6 times the amount of water and decoct 4 times, 2 hours each time. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.05 to 1.10 (60℃), spray dry to obtain a dry extract powder, and set aside for use.

[0070] C. Take Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum and extract them twice with 10 times the amount of 70% ethanol, each time for 1.5 hours. Filter, combine the filtrates, recover the ethanol and concentrate under reduced pressure to a clear extract with a relative density of 1.05-1.15 (65℃). Spray dry to obtain the alcohol extract powder for later use.

[0071] D. Mix the above three dry powders to obtain a traditional Chinese medicine powder composition; add excipients to prepare it into an immediate-release tablet, granule, capsule or pill.

[0072] Example 4

[0073] A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials by weight: 550 parts of Dipsacus asper, 320 parts of oyster shell, 420 parts of Astragalus membranaceus, 190 parts of Angelica sinensis, 90 parts of Caesalpinia sappan, 260 parts of Curculigo orchioides, 230 parts of Drynaria fortunei, 270 parts of Eucommia ulmoides, 290 parts of Polygonum cuspidatum, and 110 parts of Glycyrrhiza uralensis.

[0074] A. Take oysters and extract them three times with 5 times the amount of edible vinegar (50℃), each time for 22 hours. Combine the extracts, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.25-1.35 (65℃), dry under reduced pressure, and pulverize to obtain oyster extract powder for later use.

[0075] B. Take Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood, and Glycyrrhiza uralensis, add 11 times the amount of water and decoct 3 times, 2.5 hours each time. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.20-1.30 (75℃), dry under reduced pressure, pulverize, and obtain a dry extract powder of water extract for later use.

[0076] C. Take Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum and reflux extract twice with 9 times the amount of 40% ethanol, each time for 2.5 hours. Filter, combine the filtrates, recover the ethanol and concentrate under reduced pressure to a clear extract with a relative density of 1.25-1.35 (80℃). Dry under reduced pressure, pulverize and obtain the alcohol extract dry extract powder for later use.

[0077] D. Mix the above three dry powders to obtain a traditional Chinese medicine powder composition; add excipients to prepare it into an immediate-release tablet, granule, capsule or pill.

[0078] Example 5

[0079] A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials by weight: 600 parts of Dipsacus asper, 300 parts of oyster shell, 450 parts of Astragalus membranaceus, 150 parts of Angelica sinensis, 80 parts of Caesalpinia sappan, 350 parts of Curculigo orchioides, 300 parts of Drynaria fortunei, 230 parts of Eucommia ulmoides, 200 parts of Polygonum cuspidatum, and 100 parts of Glycyrrhiza uralensis.

[0080] A. Take oysters and extract them three times with 5 times the amount of edible vinegar (70℃), each time for 16 hours. Combine the extracts, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.10-1.15 (65℃), spray dry to obtain oyster extract powder, and set aside for later use.

[0081] B. Take Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood and Glycyrrhiza uralensis, add 8 times the amount of water and decoct 3 times, 1.5 hours each time. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.05 to 1.08 (65℃), spray dry to obtain a dry extract powder, and set aside for use.

[0082] C. Take Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum and extract them by reflux with 10 times the amount of 50% ethanol 3 times, 2 hours each time. Filter, combine the filtrates, recover the ethanol and concentrate under reduced pressure to a clear extract with a relative density of 1.05 to 1.15 (65℃). Spray dry to obtain dry extract powder, and set aside for later use.

[0083] D. Mix the above three dry powders to obtain a traditional Chinese medicine powder composition; add excipients to prepare it into an immediate-release tablet, granule, capsule or pill.

[0084] Clinical Example 6

[0085] 1. Case selection

[0086] From April 2020 to November 2022, 260 patients with osteoporosis were selected as the study subjects and randomly divided into a control group and a treatment group using a random number table. The control group consisted of 130 patients: 69 males and 61 females; age range 48–69 years, mean (58.04±6.10) years; disease duration 3 months–8 years, mean (6.36±2.38) years. The treatment group consisted of 130 patients: 72 males and 58 females; age range 49–71 years, mean (57.63±7.18) years; disease duration 4 months–9 years, mean (6.20±2.26) years. Statistical analysis showed no significant differences in baseline data such as gender, age, and disease duration between the two groups (P>0.05), indicating comparability. During the study, patients were frequently followed up by telephone and medical staff to closely monitor clinical efficacy, compliance, and safety.

[0087] 2. Diagnostic criteria

[0088] Diagnostic criteria for osteoporosis: All patients were diagnosed according to the Western medicine "Recommended Diagnostic Criteria for Osteoporosis in Chinese (Second Draft)". Symptoms included lower back pain, weakness, progressively worsening pain, fractures from minor injuries, kyphosis, and a bone density reduction of more than two standard deviations. Traditional Chinese medicine diagnostic criteria: Based on the "Technical Guidelines for Clinical Research of New Traditional Chinese Medicines", the diagnosis was kidney deficiency with qi and blood insufficiency, characterized by lower back pain, weakness in the lower back and knees, aversion to cold and preference for warmth (worse when exposed to cold, especially in the lower limbs), frequent urination, chronic diarrhea, or edema, particularly below the waist, with pitting edema; pale tongue with a white coating; and a deep, thready or deep, wiry pulse.

[0089] 3. Inclusion criteria

[0090] All included cases met the Western medicine diagnostic criteria for osteoporosis in the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2017)" and the diagnostic criteria for osteoporosis in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs". (1) Met the diagnostic criteria for osteoporosis in Western medicine. (2) Met the syndrome of liver and kidney deficiency in traditional Chinese medicine. (3) All patients and their families were informed of their participation in this study. (4) Signed informed consent forms.

[0091] 4. Exclusion criteria

[0092] (1) Those who do not meet the diagnostic criteria for osteoporosis. (2) Cases not within the scope of drug action. (3) Those who have been taking other related treatment drugs for a long time and cannot stop immediately. (4) Those with late-stage deformities and loss of labor capacity. (5) Breastfeeding or pregnant women or women preparing for pregnancy. (6) Those with allergic constitutions or allergies to multiple drugs. (7) Patients with severe metabolic bone disease complicated by serious primary diseases of the liver, kidneys, hematopoietic system, endocrine system, etc. (8) Those whose condition is critical and whose efficacy and safety of the drug are difficult to accurately evaluate. (9) Patients with mental disorders or speech disorders who are unable to cooperate in completing the study.

[0093] 5. Treatment methods

[0094] Basic treatment: In accordance with the Guidelines for the Integrated Traditional Chinese and Western Medicine Treatment of Osteoporosis (2019 Edition), all enrolled patients received a balanced diet rich in calcium, low in salt, and with adequate protein, and received appropriate outdoor sunlight exposure. They also underwent appropriate brisk walking, dumbbell exercises, and pedaling exercises weekly. The control group, in addition to basic treatment, received alendronate sodium tablets (Want Pharmaceutical (Hainan) Co., Ltd., National Drug Approval Number H20083481, 10mg / tablet) 30 minutes before breakfast daily on an empty stomach, taken with approximately 200ml of warm water, once daily, 10mg each time. The treatment group, in addition to basic treatment, received oral administration of the traditional Chinese medicine composition of this invention, three times daily, each dose equivalent to 10g of traditional Chinese medicine decoction pieces. Both the control and observation groups received continuous medication for 6 months, and were followed up after 6 months to investigate patients' quality of life.

[0095] 6. Observation Indicators and Methods

[0096] 6.1 Clinical efficacy

[0097] Based on the standards of the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine for the Treatment of Osteoporosis" and the efficacy evaluation criteria for osteoporosis in the literature, the efficacy was assessed in four grades: Clinically cured: disappearance or near-disappearance of TCM clinical symptoms and signs, and a reduction of ≥95% in the syndrome score; Markedly effective: significant improvement in TCM clinical symptoms and signs, a reduction of ≥70% and <95% in the TCM syndrome score, complete disappearance of pain, and an increase of more than 2% in bone mineral density examination; Effective: improvement in both TCM clinical symptoms and signs, a reduction of >30% and <70% in the TCM syndrome score, and an increase of 1% to 2% in the bone mineral density change rate; Ineffective: no significant improvement or even worsening of TCM clinical symptoms and signs, a reduction of less than 30% in the syndrome score, and an increase of <1% in the bone mineral density change rate. The total effective rate was calculated as (cured + markedly effective + effective) / total number of cases × 100%.

[0098] 6.2 Bone mineral density and bone metabolism indicators

[0099] Both groups of patients underwent lumbar spine bone age assessment using a dual-energy X-ray absorptiometry (DEXA) system (Tianjin Medical Device Registration Certificate No. 20192060136, Tianjin Economic-Technological Development Area Shenghong Medical Device Co., Ltd.) before and 6 months after treatment. 2～4 Bone mineral density of the femoral neck, Ward's triangle, and greater trochanter was measured, and changes in bone mineral density before and after treatment were compared. Bone-specific alkaline phosphatase (BALP), bone mineral density, serum calcium, and serum phosphorus levels were measured using a fully automated biochemical analyzer (Guangdong Food and Drug Administration Medical Device Approval No. 20142400152, Shenzhen Mindray Bio-Medical Electronics Co., Ltd.).

[0100] 6.3 Pain Index Assessment

[0101] The Visual Analogue Scale (VAS) was used to assess pain levels in both groups of patients before treatment and at 6, 9, and 12 months after treatment to evaluate the improvement in bone pain. VAS pain scores ranged from 0 to 10, with 0 for no pain, 1–3 for mild (tolerable) pain, 4–6 for moderate pain (somewhat affecting sleep but still tolerable), 7–9 for severe pain (severely affecting sleep and appetite), and 10 for extreme pain.

[0102] 6.4 Health status follow-up evaluation (SF-36)

[0103] To assess the overall health status of patients after treatment, a follow-up questionnaire was conducted on both groups of patients 12 months after the end of treatment. The questionnaire mainly included four aspects of function: social functioning, physical functioning, cognitive functioning, and general health. Each item was scored from 0 to 100, with higher scores indicating relatively higher quality of life. All patients were followed up during this period via telephone or home visits, resulting in a 100% effective follow-up rate.

[0104] 6.5 Statistical Methods

[0105] SPSS 22.0 statistical software was used for data processing. Quantitative data were analyzed using... The t-test was used for comparisons between groups; count data were expressed as effective rate (%), using the x-value. 2 The test was performed, with P < 0.05 considered statistically significant.

[0106] 6.6 Comparison of adverse reactions between the two groups

[0107] During the medication period, the occurrence of adverse reactions such as decreased appetite, stomach discomfort, headache, constipation, nausea, vomiting, anorexia, and high levels of adverse reactions were recorded in both groups of patients.

[0108] 7. Treatment Results

[0109] 7.1 Comparison of clinical efficacy between the two groups of patients

[0110] The effective rate in the observation group was 76.51%, and the effective rate in the control group was 86.15%. The difference in effective rates between the two groups was statistically significant. x 2 =4.25, P <0.05).

[0111] Table 1 Comparison of clinical efficacy between the two groups [cases (%)]

[0112]

[0113] 7.2 Comparison of bone mineral density levels before and after treatment in the two groups of patients

[0114] After 6 months of treatment, the L1 lumbar spine of both groups of patients... 2～4 Bone mineral density in the femoral neck, Ward's triangle, and femoral trochanter all increased significantly compared to before treatment. * P <0.05). After treatment, the bone mineral density in the treatment group was significantly higher than that in the control group. ▲ P <0.05).

[0115] Table 2 Comparison of bone mineral density levels between the two groups ( g / cm 2 )

[0116]

[0117] 7.3 Comparison of serum bone-related marker levels before and after treatment in the three groups

[0118] After 6 months of treatment, BALP levels in both groups of patients were significantly lower than before treatment. * P <0.05), serum calcium and serum phosphorus levels were significantly increased compared to before treatment ( ▲ P <0.05). Compared with the control group after treatment, the BALP level in the treatment group was significantly lower ( * P <0.05), serum calcium and serum phosphorus levels were significantly increased compared to before treatment ( ▲ P <0.05).

[0119] Table 3 Comparison of serum bone marker levels between the two groups of patients ( )

[0120]

[0121] 7.4 Comparison of VAS pain index between the two groups of patients before and after treatment:

[0122] The VAS pain index of both groups of patients was significantly lower than that before treatment at 6 and 12 months after treatment. * P <0.05), the VAS pain index in the treatment group was lower than that in the control group after treatment. ▲ P <0.05).

[0123] Table 4 Comparison of VAS pain index before and after treatment in the two groups of patients ( )

[0124]

[0125] 7.5 Comparison of health status follow-up evaluation (SF-36) before and after treatment between the two groups of patients.

[0126] After treatment, the efficacy of the treatment group and the control group was observed. The results showed that the health status scores of both groups improved significantly. * P <0.05), the health score of the observation group after treatment was higher than that of the control group ( ▲ P <0.05) indicates that the observation group showed better improvement in both physical and mental aspects than the control group.

[0127] Table 5. Comparison of SF-36 scores before and after treatment in the two groups ( )

[0128]

[0129] 7.6 Comparison of adverse reactions between the two groups:

[0130] No significant adverse effects were observed on vital signs or general condition in either the experimental or control groups. No abnormalities were found in renal function or blood routine tests in either group, and no serious adverse events occurred. In the control group, 4 patients experienced vomiting, 2 experienced decreased appetite, and 2 experienced upper abdominal discomfort; in the observation group, 1 patient experienced decreased appetite and 1 patient experienced upper abdominal discomfort.

[0131] The present invention has been partially described above using general descriptions, specific embodiments, and clinical trials. However, modifications or improvements can be made to the present invention, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made to the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating osteoporosis, characterized in that, It is made from the following ingredients in parts by weight: Dipsacus asper 200-600 parts, Oyster shell 200-400 parts, Astragalus membranaceus 300-600 parts, Angelica sinensis 100-200 parts, Caesalpinia sappan 50-100 parts, Curculigo orchioides 200-400 parts, Drynaria fortunei 100-300 parts, Eucommia ulmoides 200-350 parts, Polygonum cuspidatum 150-450 parts, and Glycyrrhiza uralensis 50-200 parts.

2. The calcium-supplementing and bone-strengthening traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Dipsacus asperoides 400-600 parts, oyster shell 250-350 parts, Astragalus membranaceus 400-500 parts, Angelica sinensis 150-200 parts, Sappanwood 80-100 parts, Curculigo orchioides 250-350 parts, Drynaria fortunei 200-300 parts, Eucommia ulmoides 250-300 parts, Polygonum cuspidatum 200-300 parts, and Glycyrrhiza uralensis 100-150 parts.

3. A method for preparing a calcium-supplementing and bone-strengthening traditional Chinese medicine composition for treating osteoporosis as described in claim 1 or 2, characterized in that, Includes the following steps: (1) The oysters are extracted with edible vinegar, filtered, concentrated and dried to obtain oyster extract powder; (2) The Dipsacus asper, Astragalus membranaceus, Angelica sinensis, Sappanwood and Glycyrrhiza uralensis were extracted with water, filtered, concentrated and dried to obtain a dry extract powder of water extract; (3) Extract the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides and Polygonum cuspidatum with ethanol, filter, concentrate and dry to obtain ethanol extract powder; (4) Mix oyster extract powder, water extract powder and alcohol extract powder to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, In step (1), the ratio of oyster to edible vinegar is 1:3 to 6, the extraction temperature is 40 to 80°C, the extraction time is 12 to 24 hours, and the extraction is performed 2 to 4 times.

5. The preparation method according to claim 3, characterized in that, In step (2), the ratio of the raw material to water of Dipsacus asperoides, Astragalus membranaceus, Angelica sinensis, Sappanwood, Glycyrrhiza uralensis and water is 1:6 to 12, the extraction temperature is 90 to 100℃, the extraction time is 1 to 3 hours, and the extraction is performed 2 to 4 times.

6. The preparation method according to claim 3, characterized in that, In step (3), the ratio of the material to the ethanol solution of the Curculigo orchioides, Drynaria fortunei, Eucommia ulmoides, Polygonum cuspidatum and the ethanol solution is 1:6 to 12, the volume percentage of the ethanol solution is 40 to 80%, the extraction temperature is 70 to 100°C, the extraction time is 1 to 3 hours, and the extraction is performed 2 to 4 times.

7. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating osteoporosis.

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