Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating osteoporosis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 15 parts of fructus psoraleae, 10 to 20 parts of herba epimedii, 5 to 10 parts of fructus cnidii, 15 to 20 parts of fructus lycii, 10 to 15 parts of fructus ligustri lucidi and 20 to 30 parts of black beans. , 10-15 parts of rhizoma atractylodis macrocephalae, 5-10 parts of medicated leaven, 10-15 parts of fructus crataegi and 10-12 parts of fructus chaenomelis; the traditional Chinese medicine is prepared from 6-10 parts of rhizoma cyperi, 6-12 parts of fructus aurantii, 10-15 parts of radix paeoniae alba, 10-15 parts of semen ziziphi spinosae, 15-20 parts of radix salviae miltiorrhizae, 10-15 parts of rhizoma corydalis, 5-10 parts of trifolium pretense and 5-8 parts of semen impatientis. , 15-20 parts of oysters, and 10-15 parts of sheep bones. The traditional Chinese medicine composition disclosed by the invention can be used for treating both symptoms and root causes, harmonizing muscles and bones, and remarkably improving the osteoporosis symptom and increasing the bone density by virtue of a multi-way synergistic effect of tonifying kidney and replenishing essence, invigorating spleen and replenishing qi, regulating liver and activating blood, supplementing calcium and the like.

Description

Technical Field

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

[0002] Osteoporosis is a metabolic bone disease characterized by decreased bone mass and deterioration of bone microstructure. Modern medicine primarily treats it with calcium supplements, vitamin D, and antiresorptive drugs, but these are associated with significant side effects and high costs. Traditional Chinese Medicine (TCM) believes that osteoporosis is closely related to kidney deficiency, spleen deficiency, liver depression, and blood stasis, requiring multi-target therapy.

[0003] For example, Chinese patent CN114558047B discloses a Chinese herbal medicine composition for preventing and treating osteoporosis and its preparation method. The composition uses Epimedium, Drynaria Rhizome, and Urolithin A. Through the synergistic combination of the three raw materials, the composition can synergistically regulate bone metabolism, inhibit bone resorption, promote bone formation, and thus increase bone density, thereby preventing and treating osteoporosis in middle-aged and elderly people and promoting bone health in the elderly.

[0004] For example, Chinese patent CN119326832A discloses a Chinese herbal composition, preparation, preparation method, and application for treating osteoporosis. It utilizes Rehmannia root, Eucommia bark, Dipsacus root, Psoralea corylifolia, Angelica sinensis, and White Peony Root. Rehmannia root is used as the main herb to nourish yin and blood, and replenish essence and marrow. Eucommia bark and Dipsacus root are used to nourish the liver and kidneys. Eucommia bark is good at strengthening tendons and bones, and strengthening the waist and spine. Dipsacus root is good at strengthening tendons and bones, and regulating blood vessels. Psoralea corylifolia nourishes the kidneys and strengthens yang, warming the water organs, replenishing fire and generating earth. The three herbs work together to help the main herb replenish essence and marrow to strengthen tendons and bones, and serve as the assistant herb. Angelica sinensis replenishes blood and invigorates blood circulation, assisting the main herb in replenishing blood and nourishing yin. White Peony Root nourishes blood, restrains yin, softens the liver, and relieves pain, thereby relaxing tendons and spasms. The combination of the two herbs invigorates blood circulation and nourishes blood to nourish tendons and bones, serving as the assistant herb.

[0005] However, the above-mentioned traditional Chinese medicine compositions in the prior art mostly focus on single kidney tonification or calcium supplementation, and it is difficult to take into account the pathological characteristics of "deficiency of the root cause and excess of the superficial symptoms". Summary of the Invention

[0006] In order to solve the problems in the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating osteoporosis. The traditional Chinese medicine composition of the present invention can achieve both symptomatic and root treatment, and harmonize tendons and bones. Through the synergistic effects of multiple pathways such as tonifying the kidney and replenishing essence, strengthening the spleen and replenishing qi, regulating the liver and activating blood circulation, and supplementing calcium, it can significantly improve the symptoms of osteoporosis and increase bone density.

[0007] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solution:

[0008] A traditional Chinese medicine composition for treating osteoporosis comprises the following raw materials in parts by weight: 10-15 parts of psoralea corylifolia, 10-20 parts of epimedium cordifolia, 5-10 parts of cnidium monnieri, 15-20 parts of wolfberry, 10-15 parts of privet fruit, 20-30 parts of black bean; 10-15 parts of atractylodes macrocephala, 5-10 parts of scutellaria baicalensis, 10-15 parts of hawthorn, 10-12 parts of papaya; 6-10 parts of cyperus rotundus, 6-12 parts of fructus aurantii, 10-15 parts of white peony root, 10-15 parts of spinach seed, 15-20 parts of salvia miltiorrhiza, 10-15 parts of corydalis yanhusuo, 5-10 parts of clover, 5-8 parts of schisandra chinensis; 15-20 parts of oyster, and 10-15 parts of sheep bone.

[0009] Furthermore, the Chinese medicine composition includes the following raw materials in parts by weight: 10 parts of Psoralea corylifolia, 10 parts of Epimedium heartleaf, 5 parts of Cnidium monnieri, 15 parts of Lycium barbarum, 10 parts of Ligustrum lucidum, 20 parts of black beans; 10 parts of Atractylodes macrocephala, 5 parts of Shenqu, 10 parts of Crataegus pinnatifida, 10 parts of Papaya; 6 parts of Cyperus rotundus, 6 parts of Citrus aurantium, 10 parts of White Peony Root, 10 parts of Ziziphus jujuba seeds, 15 parts of Salvia miltiorrhiza, 10 parts of Corydalis yanhusuo, 5 parts of Trifolium pratense, 5 parts of Aconitum carmichaelii; 15 parts of oysters, and 10 parts of sheep bones.

[0010] Furthermore, the Chinese medicine composition includes the following raw materials in parts by weight: 15 parts of psoralea corylifolia, 20 parts of epimedium heartleaf, 10 parts of cnidium monnieri, 20 parts of wolfberry, 15 parts of glossy privet, 30 parts of black beans; 15 parts of atractylodes macrocephala, 10 parts of Shenqu, 15 parts of hawthorn, 12 parts of papaya; 10 parts of cyperus rotundus, 12 parts of fructus aurantii, 15 parts of white peony root, 15 parts of spinach seed, 20 parts of salvia miltiorrhiza, 15 parts of corydalis yanhusuo, 10 parts of red clover, 8 parts of schisandra chinensis; 20 parts of oyster, 15 parts of sheep bone.

[0011] A method for preparing a traditional Chinese medicine composition for treating osteoporosis comprises the following steps:

[0012] Step 1: Calcine the sheep bones and oysters, grind them into fine powder, and pass through a 200-mesh sieve;

[0013] Step 2: Extract Psoralea corylifolia, Epimedium heartleaf, Cnidium monnieri, Cyperus rotundus, and Salvia miltiorrhiza with 95% ethanol three times according to the ratio; decoct Lycium barbarum, Ligustrum lucidum, black bean, Atractylodes macrocephala, Shenqu, Crataegus pinnatifida, Papaya, Citrus aurantium, White Peony Root, Ziziphus jujuba seed, Corydalis yanhusuo, Trifolium pratense, and Fructus australis with water twice according to the ratio, and combine the filtrates and concentrate to an extract with a relative density of 1.2-1.3;

[0014] Step 3: Mix the extract in step 2 with sheep bone powder and oyster powder, and make it into granules, capsules or tablets after drying.

[0015] Furthermore, in step 2, when decocting with water for the first time, 10 times the amount of water is used for decocting for 1.5 hours, and when decocting with water for the second time, 8 times the amount of water is used for decocting for 1 hour, and the filtrates after the two decoctions are combined and concentrated.

[0016] Due to the adoption of the above technical solution, the present invention has the following beneficial effects:

[0017] 1. The Chinese medicine composition of the present invention is based on the core pathogenesis of osteoporosis in traditional Chinese medicine, which is "deficiency of the root and excess of the superficial". It breaks through the single idea of ​​traditional kidney tonification or calcium supplementation, and constructs a multi-dimensional synergistic prescription concept of "tonifying the kidney and replenishing essence, strengthening the spleen and stomach, promoting blood circulation and removing blood stasis, strengthening tendons and bones". It uses kidney tonifying drugs to nourish the essence and consolidate the foundation, uses spleen tonifying drugs to enrich the source of qi and blood biochemistry, and uses blood activating drugs to unclog the bones. Qi and blood are combined to achieve the combination of treating the root cause and treating the symptoms. Compared with conventional prescriptions, it pays more attention to overall conditioning and multi-link improvement.

[0018] 2. Through the combination of sheep bones and oysters, bone supplementation is combined with modern calcium supplementation ideas to directly supplement the material basis of bones; Jijizi is combined with Danshen and Yuanhu to break up blood and soften hard masses and promote blood circulation and qi, thereby enhancing the ability to dredge meridians and disperse blood stasis; Cyperus rotundus and Citrus aurantium soothe the liver and regulate qi, promote blood circulation, and improve local microcirculation of bones. This novel drug combination has expanded the compatibility model of traditional prescriptions.

[0019] 3. Innovation in therapeutic targets: In line with modern medicine's understanding of osteoporosis, the drugs in the prescription can act on multiple targets, namely:

[0020] Kidney-tonifying and Essence-replenishing Group: Psoralea corylifolia, Epimedium heartleaf, Cnidium monnieri, Lycium barbarum, Ligustrum lucidum, and black beans. These ingredients can regulate the hypothalamic-pituitary-gonadal axis, promote osteoblast activity, regulate hormone levels, and affect bone metabolism signaling pathways.

[0021] The spleen-strengthening and qi-invigorating group includes Atractylodes macrocephala, Shenqu, Hawthorn, and Papaya. These ingredients can improve intestinal calcium absorption, increase serum calcium and phosphorus levels, and improve the body's nutritional status by regulating nutrient absorption.

[0022] Liver-regulating and blood-activating group: Cyperus rotundus, Citrus aurantium, White Peony Root, Ziziphus jujuba seed, Salvia miltiorrhiza, Corydalis yanhusuo, Trifolium pratense, and Fructus aconitifolia. These combinations can improve blood circulation in bone tissue, affect cytokine expression, and reduce inflammatory factors (TNF-α, IL-6), thereby regulating the activity of osteoclasts and osteoblasts, and achieving intervention in osteoporosis at the molecular and cellular levels.

[0023] The invention can significantly increase bone density and relieve bone pain. It has an optimized preparation process, high bioavailability, good safety, and is suitable for long-term use. DETAILED DESCRIPTION

[0024] The technical solution of the present invention is further described in detail below with reference to the embodiments.

[0025] A traditional Chinese medicine composition for treating osteoporosis comprises the following raw materials in parts by weight: 10-15 parts of psoralea corylifolia, 10-20 parts of epimedium cordifolia, 5-10 parts of cnidium monnieri, 15-20 parts of wolfberry, 10-15 parts of privet fruit, 20-30 parts of black bean; 10-15 parts of atractylodes macrocephala, 5-10 parts of scutellaria baicalensis, 10-15 parts of hawthorn, 10-12 parts of papaya; 6-10 parts of cyperus rotundus, 6-12 parts of fructus aurantii, 10-15 parts of white peony root, 10-15 parts of spinach seed, 15-20 parts of salvia miltiorrhiza, 10-15 parts of corydalis yanhusuo, 5-10 parts of clover, 5-8 parts of schisandra chinensis; 15-20 parts of oyster, and 10-15 parts of sheep bone.

[0026] The Chinese medicine composition of the present invention closely follows the core pathogenesis of osteoporosis in traditional Chinese medicine, namely, "deficiency in the underlying body and excess in the superficial body." It breaks through the traditional single-minded approach of tonifying the kidney or calcium, and constructs a multi-dimensional synergistic formula concept of "tonifying the kidney and replenishing essence, strengthening the spleen and stomach, activating blood circulation and removing blood stasis, and strengthening tendons and bones," namely:

[0027] Kidney-tonifying and Essence-replenishing Group: Psoralea corylifolia, Epimedium heartleaf, Cnidium monnieri, Lycium barbarum, Ligustrum lucidum, and black beans. These ingredients can regulate the hypothalamic-pituitary-gonadal axis, promote osteoblast activity, regulate hormone levels, and affect bone metabolism signaling pathways.

[0028] The spleen-strengthening and qi-invigorating group includes Atractylodes macrocephala, Shenqu, Hawthorn, and Papaya. These ingredients can improve intestinal calcium absorption, increase serum calcium and phosphorus levels, and improve the body's nutritional status by regulating nutrient absorption.

[0029] Liver-regulating and blood-activating group: Cyperus rotundus, Citrus aurantium, White Peony Root, Ziziphus jujuba seed, Salvia miltiorrhiza, Corydalis yanhusuo, Trifolium pratense, and Fructus aconitifolia. These combinations can improve blood circulation in bone tissue, affect cytokine expression, and reduce inflammatory factors (TNF-α, IL-6), thereby regulating the activity of osteoclasts and osteoblasts, and achieving intervention in osteoporosis at the molecular and cellular levels.

[0030] Calcium supplement and bone strengthening group: oysters and sheep bones, bone supplementation combined with modern calcium supplementation ideas, directly replenishing the material basis of bones;

[0031] The present invention uses kidney-tonifying drugs to nourish the essence and strengthen the foundation, uses spleen-tonifying drugs to enrich the source of qi and blood biochemistry, and uses blood-activating drugs to unclog the bones' qi and blood, thereby achieving a combination of treating the root cause and treating the symptoms. Compared with conventional prescriptions, it pays more attention to overall conditioning and multi-link improvement. Compared with the traditional single idea of ​​kidney tonification or calcium supplementation, the present invention can achieve both symptomatic and root cause treatment, and has outstanding creativity.

[0032] Example 1. A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: 10 parts of psoralea corylifolia, 10 parts of epimedium heartleaf, 5 parts of cnidium monnieri, 15 parts of wolfberry, 10 parts of glossy privet fruit, 20 parts of black beans; 10 parts of atractylodes macrocephala, 5 parts of Shenqu, 10 parts of hawthorn, 10 parts of papaya; 6 parts of cyperus rotundus, 6 parts of fructus aurantii, 10 parts of white peony root, 10 parts of spinach seed, 15 parts of salvia miltiorrhiza, 10 parts of corydalis yanhusuo, 5 parts of clover, 5 parts of schisandra chinensis; 15 parts of oyster, 10 parts of sheep bone.

[0033] Example 2. A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: 15 parts of psoralea corylifolia, 20 parts of epimedium heartleaf, 10 parts of cnidium monnieri, 20 parts of wolfberry, 15 parts of glossy privet, 30 parts of black beans; 15 parts of atractylodes macrocephala, 10 parts of lunata ternate, 15 parts of hawthorn, 12 parts of papaya; 10 parts of cyperus rotundus, 12 parts of fructus aurantii, 15 parts of white peony root, 15 parts of spinach seed, 20 parts of salvia miltiorrhiza, 15 parts of corydalis yanhusuo, 10 parts of clover, 8 parts of schisandra chinensis; 20 parts of oyster, 15 parts of sheep bone.

[0034] The Chinese medicine composition for treating osteoporosis according to the embodiment of the present invention can be prepared by the following method:

[0035] The specific steps include:

[0036] Step 1: Calcine the sheep bones and oysters, grind them into fine powder, and pass through a 200-mesh sieve;

[0037] Step 2: Extract Psoralea corylifolia, Epimedium heartleaf, Cnidium monnieri, Cyperus rotundus, and Salvia miltiorrhiza with 95% ethanol three times according to the ratio; decoct Lycium barbarum, Ligustrum lucidum, black bean, Atractylodes macrocephala, Shenqu, Crataegus pinnatifida, Papaya, Citrus aurantium, White Peony Root, Ziziphus jujuba seed, Corydalis yanhusuo, Trifolium pratense, and Fructus australis with water twice according to the ratio, and combine the filtrates and concentrate to an extract with a relative density of 1.2-1.3;

[0038] Step 3: Mix the extract in step 2 with sheep bone powder and oyster powder, and make it into granules, capsules or tablets after drying.

[0039] In step 2, when decocting with water for the first time, 10 times the amount of water is used for decocting for 1.5 hours, and when decocting with water for the second time, 8 times the amount of water is used for decocting for 1 hour, and the filtrates after the two decoctions are combined and concentrated.

[0040] The Chinese medicine composition of the present invention can be formulated into various dosage forms, including decoctions, pills, capsules, and granules, breaking through the limitations of traditional decoctions. Each dosage form has its own advantages. For example, capsules are easy to carry and provide accurate dosages, while granules are easily soluble and rapidly absorbed, meeting the needs of different patients and providing more options for clinical application.

[0041] Clinical application effect verification:

[0042] 150 patients with osteoporosis of kidney-qi deficiency were selected and divided into experimental group (75 cases) and control group (75 cases) according to the order of consultation by random number table method. The experimental group took the Chinese medicine composition of the present invention orally, while the control group took Gaitianli orally. The symptoms of kidney-qi deficiency and changes in bone density were observed.

[0043] Table 1 Kidney Qi Deficiency Score Table

[0044]

[0045] Note: Each type of kidney qi deficiency must have two main symptoms and any three of the secondary symptoms, as well as one of the inspection and pulse diagnosis.

[0046] The results showed that the integral value of the experimental group before treatment was 8.1±0.8 and after treatment was 5.1±1.3; the integral value of the control group before treatment was 7.9±1.0 and after treatment was 6.9±1.3. There was a significant difference between the two groups before and after treatment (P<0.05); there was also a significant difference between the two groups after treatment (P<0.05), indicating that the Chinese medicine composition of the present invention is more effective than Gaitianli in improving symptoms such as low back pain in patients with osteoporosis.

[0047] Effect of the Chinese medicine composition of the present invention on the integral value of kidney qi deficiency syndrome

[0048] Table 2 Improvement of kidney qi deficiency symptoms in patients before and after treatment

[0049]

[0050] The results are shown in Table 2. Compared with before and after treatment, the total score of kidney qi deficiency syndrome in the experimental group was significantly different. The difference in the kidney qi deficiency syndrome score between the two groups after treatment (P < 0.05) was significant, indicating that the Chinese medicine composition of the present invention is significantly better than Gaitianli in improving the symptoms of kidney qi deficiency.

[0051] Effect of the Chinese medicine composition of the present invention on the bone density of patients

[0052] Table 3 Comparison of changes in ultrasound bone density values ​​before and after treatment

[0053]

[0054] The results are shown in Table 3. The calcaneal ultrasound bone density values ​​of all patients increased after treatment, but only the female patients in the experimental group showed a statistically significant difference before and after treatment (P < 0.05), indicating that the Chinese herbal composition of the present invention has a significant inhibitory effect on the decrease in bone density in women with osteoporosis.

[0055] Comparison of the overall efficacy of clinical symptoms between the two groups showed that 51 patients (68.00%) in the experimental group showed marked efficacy; 17 patients (22.66%) showed efficacy; and 7 patients (9.33%) showed ineffectiveness, for a total efficacy rate of 90.66%. In the control group, 35 patients (46.66%) showed marked efficacy; 19 patients (25.33%) showed efficacy; and 21 patients (28.00%) showed ineffectiveness, for a total efficacy rate of 72.00%. Ridit analysis showed a significant difference between the two groups (P < 0.05), indicating that the experimental group had superior efficacy. Symptoms of bone pain and weakness in the treatment group were alleviated or resolved in as little as seven days, with an average of approximately one month. After three months of continuous use, the treatment group experienced only a slight dry mouth and no other side effects. Follow-up over one to three years showed a low recurrence rate of bone pain.

Claims

1. A Chinese medicine composition for treating osteoporosis, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of psoralea corylifolia, 10-20 parts of epimedium heartleaf, 5-10 parts of cnidium monnieri, 15-20 parts of wolfberry, 10-15 parts of privet fruit, 20-30 parts of black bean; 10-15 parts of atractylodes macrocephala, 5-10 parts of scutellaria baicalensis, 10-15 parts of hawthorn, 10-12 parts of papaya; 6-10 parts of cyperus rotundus, 6-12 parts of fructus aurantii, 10-15 parts of white peony root, 10-15 parts of spinach seed, 15-20 parts of salvia miltiorrhiza, 10-15 parts of corydalis yanhusuo, 5-10 parts of clover, 5-8 parts of schisandra chinensis; 15-20 parts of oyster, and 10-15 parts of sheep bone.

2. The Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of psoralea corylifolia, 10 parts of epimedium heartleaf, 5 parts of cnidium monnieri, 15 parts of wolfberry, 10 parts of glossy privet fruit, 20 parts of black bean; 10 parts of atractylodes macrocephala, 5 parts of scutellaria baicalensis, 10 parts of hawthorn, 10 parts of papaya; 6 parts of cyperus rotundus, 6 parts of fructus aurantii, 10 parts of white peony root, 10 parts of spinach seed, 15 parts of salvia miltiorrhiza, 10 parts of corydalis yanhusuo, 5 parts of clover, 5 parts of schisandra chinensis; 15 parts of oyster, and 10 parts of sheep bone.

3. The Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of psoralea corylifolia, 20 parts of epimedium heartleaf, 10 parts of cnidium monnieri, 20 parts of wolfberry fruit, 15 parts of glossy privet fruit, 30 parts of black bean; 15 parts of atractylodes macrocephala, 10 parts of scutellaria baicalensis, 15 parts of hawthorn fruit, 12 parts of papaya; 10 parts of cyperus rotundus, 12 parts of fructus aurantii, 15 parts of white peony root, 15 parts of spinach seed, 20 parts of salvia miltiorrhiza, 15 parts of corydalis yanhusuo, 10 parts of clover, and 8 parts of schisandra chinensis. 20 parts of oysters and 15 parts of lamb bones.

4. A method for preparing a Chinese medicine composition for treating osteoporosis according to any one of claims 1 to 3, characterized in that: The specific steps include: Step 1: Calcine the sheep bones and oysters, grind them into fine powder, and pass through a 200-mesh sieve; Step 2: Extract Psoralea corylifolia, Epimedium heartleaf, Cnidium monnieri, Cyperus rotundus, and Salvia miltiorrhiza with 95% ethanol three times according to the ratio; decoct Lycium barbarum, Ligustrum lucidum, black bean, Atractylodes macrocephala, Shenqu, Crataegus pinnatifida, Papaya, Citrus aurantium, White Peony Root, Ziziphus jujuba seed, Corydalis yanhusuo, Trifolium pratense, and Fructus australis with water twice according to the ratio, and combine the filtrates and concentrate to an extract with a relative density of 1.2-1.3; Step 3: Mix the extract in step 2 with sheep bone powder and oyster powder, and make it into granules, capsules or tablets after drying.

5. The method for preparing the Chinese medicine composition for treating osteoporosis according to claim 4, wherein: In step 2, when decocting with water for the first time, 10 times the amount of water is used for decocting for 1.5 hours, and when decocting with water for the second time, 8 times the amount of water is used for decocting for 1 hour, and the filtrates after the two decoctions are combined and concentrated.

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