A traditional Chinese medicine composition for the prevention and treatment of osteoporosis

Abstract

This invention relates to a traditional Chinese medicine composition for the prevention and treatment of osteoporosis. The composition is prepared from Angelica dahurica, Paeonia lactiflora, Lycium barbarum, Ligustrum lucidum, Angelica sinensis, and Gentiana macrophylla in a specific ratio. Based on the principles of traditional Chinese medicine for treating osteoporosis and incorporating the pharmacological characteristics of Chinese herbs, this composition provides a synergistic effect, with the combined effects of the herbs strengthening bones, relieving pain, tonifying the liver and kidneys, and replenishing qi and blood. It is effective in preventing and treating osteoporosis. Furthermore, this invention is a natural pharmaceutical preparation, without the use of organic reagents, with a reasonable formulation, high safety and reliability, low toxicity and side effects, and no adverse reactions observed with long-term use. Its efficacy is well-defined.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to traditional Chinese medicine compositions for the prevention and treatment of osteoporosis. Background Technology

[0002] Osteoporosis is a degenerative skeletal disease characterized by decreased bone mass and deterioration of bone microstructure, leading to increased bone fragility and susceptibility to fractures. It is a systemic metabolic bone disease. Osteoporosis is generally induced by two main factors: one is that in women, starting from menopause, the rate of bone resorption exceeds bone formation, leading to bone loss and osteoporosis. This results in decreased bone mass, a reduction in the number and diameter of trabeculae, and increased bone fragility, making fractures more likely. In addition, disuse osteoporosis caused by reduced or absent mechanical loads is also receiving increasing attention. Examples include prolonged bed rest, spinal cord injury, fracture immobilization, and spaceflight, all of which reduce the stress on bones, decrease bone mass, deteriorate bone microstructure, and cause localized or systemic bone loss. The incidence of osteoporosis under disuse conditions is as high as 81%, with a fracture rate ranging from 1% to 39%. Currently, the mechanisms of osteoporosis in menopausal women and mechanical disuse osteoporosis are quite complex, both characterized by osteoporosis. Among them, the balance between osteoblast and osteoclast differentiation is one of the keys to maintaining normal bone mass. The process of bone metabolism and bone turnover is the process of osteoblasts forming new bone and osteoclasts absorbing old bone.

[0003] Existing Western medicines are widely used in controlling osteoporosis, mainly by inhibiting bone resorption or promoting bone formation to exert their anti-osteoporosis effects. However, most of them have single therapeutic targets, significant side effects, and are expensive, making them unaffordable for many patients. Therefore, finding inexpensive, safe, and effective natural medicines that can be used as both food and medicine is key to solving these problems. Summary of the Invention

[0004] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of osteoporosis and its uses. Its advantages are that the traditional Chinese medicine composition has few toxic side effects, clear effects and reasonable formulation when used for the prevention and treatment of osteoporosis.

[0005] Therefore, the present invention provides a traditional Chinese medicine composition for the prevention and treatment of osteoporosis, wherein the traditional Chinese medicine composition is prepared by angelica dahurica, white peony root, wolfberry, privet fruit, angelica sinensis, and gentian root in a certain proportion.

[0006] Furthermore, the traditional Chinese medicine composition includes, by weight, 15-25 parts of Angelica dahurica, 10-20 parts of Angelica sinensis, 15-25 parts of Paeonia lactiflora, 15-25 parts of Lycium barbarum, 5-15 parts of Ligustrum lucidum, and 10-20 parts of Gentiana macrophylla.

[0007] Furthermore, the traditional Chinese medicine composition comprises, by weight, 25 parts Angelica dahurica, 20 parts Angelica sinensis, 20 parts Paeonia lactiflora, 15 parts Lycium barbarum, 10 parts Ligustrum lucidum, and 10 parts Gentiana macrophylla.

[0008] Furthermore, the traditional Chinese medicine composition includes, by weight, 25g of Angelica dahurica, 20g of Angelica sinensis, 20g of Paeonia lactiflora, 15g of Lycium barbarum, 10g of Ligustrum lucidum, and 10g of Gentiana macrophylla.

[0009] Furthermore, the traditional Chinese medicine composition is in the form of granules, tablets, pills, capsules, powders, or decoctions.

[0010] The advantages of this invention are: The traditional Chinese medicine composition for the prevention and treatment of osteoporosis provided by this invention is based on the principles of traditional Chinese medicine for the treatment of osteoporosis, combined with the pharmacological characteristics of traditional Chinese medicine. The efficacy of the provided traditional Chinese medicine composition is synergistic, and the combined effects of the various herbs work together to strengthen bones, relieve pain, nourish the liver and kidneys, and replenish qi and blood, thus effectively preventing and treating osteoporosis. Furthermore, this invention is a natural drug preparation, without the use of organic reagents, with a reasonable formulation, safe and reliable, low toxicity and side effects, and no adverse reactions observed with long-term use; its efficacy is clearly defined.

[0011] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. Attached Figure Description

[0012] Figure 1 This is a schematic diagram showing the results of quantitative analysis of femoral tissue bone mineral density in animals undergoing simulated weightlessness osteoporosis using this invention.

[0013] Figure 2 This is a schematic diagram of the micro-CT results of femoral tissue in an animal undergoing simulated weightlessness and osteoporosis using this invention.

[0014] Figure 3 This is a schematic diagram showing the results of quantitative analysis of femoral tissue by micro-CT scan in animals undergoing simulated weightlessness and osteoporosis using this invention.

[0015] Figure 4 This is a schematic diagram showing the three-point bending results of tibial tissue in an animal undergoing weightlessness and osteoporosis, as simulated using this invention.

[0016] Figure 5 This is a schematic diagram showing the HE staining results of femoral tissue sections from animals undergoing simulated weightlessness and osteoporosis using this invention.

[0017] Figure 6 is a schematic diagram of the liver and kidney function index detection results of animals with simulated weightlessness osteoporosis using the present invention. Detailed Implementation

[0018] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the specific implementation methods, structural features and effects of the present invention are described in detail below with reference to the accompanying drawings and embodiments.

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0020] All features disclosed in this specification, or steps in all methods or processes disclosed herein, may be combined in any way, except for mutually exclusive features and / or steps.

[0021] Any feature disclosed in this specification (including any appended claims, abstract, and drawings) may be replaced by other equivalent or similar features, unless specifically stated otherwise. That is, unless specifically stated otherwise, each feature is merely one example of a series of equivalent or similar features.

[0022] Example 1

[0023] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of osteoporosis and its uses. Its advantages are that the traditional Chinese medicine composition has few toxic side effects, clear effects and reasonable formulation when used for the prevention and treatment of osteoporosis.

[0024] Therefore, the present invention provides a traditional Chinese medicine composition for the prevention and treatment of osteoporosis, wherein the traditional Chinese medicine composition is prepared by angelica dahurica, white peony root, wolfberry, privet fruit, angelica sinensis, and gentian root in a certain proportion.

[0025] Among the above-mentioned Chinese medicinal materials, Angelica dahurica is pungent and warm, and enters the lung, spleen, and stomach meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, reducing swelling and draining pus, and dispelling wind and relieving itching.

[0026] Angelica sinensis: Sweet, pungent, and bitter in taste; warm in nature. It enters the liver, heart, and spleen meridians. It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements. The tail of Angelica sinensis is used to invigorate blood and remove blood stasis, and is used for blood stasis obstruction, scanty menstruation or amenorrhea, menstrual cramps, traumatic injuries, stagnation of meridians, carbuncles, and sores.

[0027] White peony root: Enters the liver and spleen meridians. Nourishes blood and softens the liver, relieves pain, astringes yin and stops sweating. According to *Diannan Materia Medica*: It clears spleen heat, stops abdominal pain, stops watery diarrhea, relieves liver qi stagnation and pain, regulates blood in the heart, liver, and spleen meridians, soothes the meridians and lowers qi, and stops liver qi pain.

[0028] Goji berries: Sweet in taste; neutral in nature. They enter the liver, kidney, and lung meridians. They treat liver and kidney yin deficiency, lower back and knee weakness, dizziness, vertigo, blurred vision with excessive tearing, consumptive cough, diabetes, and seminal emission. According to *Dietary Therapy Materia Medica*, they strengthen tendons and bones, dispel wind, benefit the body, and relieve weakness.

[0029] Privet fruit: Sweet; bitter; cool in nature. Meridians: Liver; Kidney. Nourishes the liver and kidneys, strengthens the lower back and knees, improves eyesight and darkens hair. *Ben Cao Zai Xin* states: Nourishes Yin and benefits the kidneys, replenishes Qi and soothes the liver. Treats lower back and leg pain, promotes menstruation and blood circulation.

[0030] Gentiana macrophylla: Enters the stomach, liver, and gallbladder meridians. Pungent, bitter, and neutral in nature. Dispels wind-dampness, clears damp-heat, and relieves pain. Used for rheumatic pain, muscle spasms, and joint pain.

[0031] Furthermore, the traditional Chinese medicine composition includes, by weight, 15-25 parts of Angelica dahurica, 10-20 parts of Angelica sinensis, 15-25 parts of Paeonia lactiflora, 15-25 parts of Lycium barbarum, 5-15 parts of Ligustrum lucidum, and 10-20 parts of Gentiana macrophylla.

[0032] Furthermore, the traditional Chinese medicine composition comprises, by weight, 25 parts Angelica dahurica, 20 parts Angelica sinensis, 20 parts Paeonia lactiflora, 15 parts Lycium barbarum, 10 parts Ligustrum lucidum, and 10 parts Gentiana macrophylla.

[0033] Furthermore, the traditional Chinese medicine composition includes, by weight, 25g of Angelica dahurica, 20g of Angelica sinensis, 20g of Paeonia lactiflora, 15g of Lycium barbarum, 10g of Ligustrum lucidum, and 10g of Gentiana macrophylla.

[0034] Furthermore, the traditional Chinese medicine composition is in the form of granules, tablets, pills, capsules, powders, or decoctions.

[0035] In summary, the traditional Chinese medicine composition for the prevention and treatment of osteoporosis provided in this embodiment is based on the principles of traditional Chinese medicine for treating osteoporosis. Combining the pharmacological characteristics of traditional Chinese medicine, the composition exhibits synergistic effects, with the combined effects of various herbs working together to strengthen bones, relieve pain, tonify the liver and kidneys, and replenish qi and blood. It is effectively used for the prevention and treatment of osteoporosis. Furthermore, this invention is a natural pharmaceutical preparation, without the use of organic reagents, with a reasonable formulation, high safety and reliability, low toxicity and side effects, and no adverse reactions observed with long-term use; its efficacy is clearly defined.

[0036] Example 2

[0037] Preparation of decoction:

[0038] Weigh out 20g each of Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Lycium barbarum, Ligustrum lucidum, and Gentiana macrophylla. Add 2L of purified water, bring to a boil over high heat for 20 minutes, then simmer over low heat for 2 hours. After cooling, filter to remove the dregs and take orally twice a day, morning and evening.

[0039] Example 3

[0040] Pill preparation:

[0041] The following Chinese herbal ingredients were weighed separately: 20g of Angelica dahurica, 20g of Angelica sinensis, 20g of Paeonia lactiflora, 20g of Lycium barbarum, 10g of Ligustrum lucidum, and 10g of Gentiana macrophylla. After soaking in 2L of distilled water for 30 minutes, the herbs were decocted for 2 hours, 1 hour (1.5L of water) for the second decoction, and 1 hour (1L of water) for the third decoction. The three decoctions were combined, concentrated under reduced pressure to a paste-like consistency, and excipients such as cyclodextrin were added to form pills.

[0042] Example 4

[0043] Powder preparation:

[0044] The following Chinese herbal ingredients were weighed separately: 20g of Angelica dahurica, 20g of Angelica sinensis, 20g of Paeonia lactiflora, 20g of Lycium barbarum, 10g of Ligustrum lucidum, and 10g of Gentiana macrophylla. They were soaked in 2L of distilled water for 30 minutes, then decocted for 2 hours, 1 hour (1.5L of water), and 1 hour (1L of water). The three decoctions were combined, concentrated under reduced pressure to a paste, and excipients such as cyclodextrin were added to prepare a powder.

[0045] Example 5

[0046] Capsule preparation:

[0047] The following traditional Chinese medicine ingredients were weighed: 10g each of Angelica dahurica, Angelica sinensis, Paeonia lactiflora, Lycium barbarum, Ligustrum lucidum, and Gentiana macrophylla. After soaking in 2L distilled water for 30 minutes, the ingredients were decocted for 2 hours, 1 hour (1.5L water), and 1 hour (1L water). The mixture was then spray-dried, wet-granulated with cyclodextrin, and filled into #1 capsule shells to produce capsules.

[0048] Example 6

[0049] Effects of Traditional Chinese Medicine Compositions on Bone Mineral Density in Osteoporosis Model Animals

[0050] Seventy-two 8-week-old female C57BL / 6 (18-24g) mice were purchased from the Experimental Animal Center of Air Force Medical University. The mice were randomly divided into a normal control group, a model group, and a treatment group using the traditional Chinese medicine composition prepared in Example 4.

[0051] Experimental methods: Eight-week-old C57BL / 12 ovariectomized mice were selected as an animal model of osteoporosis. The group was administered the herbal composition (2g / kg) by gavage for 8 weeks, while the control group was administered an equal volume of 0.5% CMCNa solution by gavage. After the administration, the mice were anesthetized with sodium pentobarbital, and the bone mineral density and other indicators of the osteoporosis model animals were detected by a high-resolution dual-energy X-ray imaging system (MEDIKORS, InAlyzer, 55KeV / 80KeV).

[0052] Experimental results:

[0053] Figure 1 The results showed that the bone mineral density and bone mineral index of the femur in osteoporosis model mice were significantly lower than those in the normal control group. However, after oral administration of the traditional Chinese medicine composition, the bone mineral density of the femur in osteoporosis model mice was significantly increased (*: p < 0.05; **: p < 0.01; ***: p < 0.001), indicating that the traditional Chinese medicine composition can significantly improve the bone mineral density of osteoporosis model animals.

[0054] Example 7

[0055] Effects of Traditional Chinese Medicine Combinations on Bone Microstructure in Osteoporosis Model Animals

[0056] Experimental methods: After 8 weeks of oral administration, the osteoporosis model mice in Example 6 were euthanized by cervical dislocation after blood was drawn by cardiac puncture. The femur was dissected and the soft tissue on the bone surface was removed. After fixation with 4% paraformaldehyde, the femur was scanned using a micro CT scanner. After reconstruction, the following parameters were analyzed using micro-CT analysis software: bone volume fraction (BV / TV%), number of trabeculae (Tb.N), trabecular separation (Tb.Sp), etc.

[0057] Experimental results: Figure 2 The results showed that after 8 weeks of oral administration of the traditional Chinese medicine composition to osteoporosis model mice, micro-CT scans of the femur were performed. Compared with the normal control group, the osteoporosis model mice had sparse distribution of femoral trabeculae and thinner cortical bone. However, after oral administration of the traditional Chinese medicine composition, the number of femoral trabeculae and the thickness of cortical bone increased in the osteoporosis model mice. Figure 3 This is a schematic diagram of the software quantitative analysis results after femoral micro-CT scan. Compared with normal control mice, the osteoporosis model group mice showed significantly reduced trabecular bone number, bone volume fraction, trabecular bone thickness, and cortical bone thickness, and significantly increased trabecular bone separation. However, after oral administration of the traditional Chinese medicine composition, the bone volume fraction, trabecular bone thickness, trabecular bone number, cortical bone thickness, and trabecular bone separation of the mice were significantly restored (*: p < 0.05; **: p < 0.01; ***: p < 0.001), indicating that the traditional Chinese medicine composition can increase femoral bone mineral density and improve bone microstructure in osteoporosis model mice.

[0058] Example 8

[0059] Effects of Traditional Chinese Medicine Composition on Femoral Tissue Morphology in Osteoporosis Model Mice

[0060] Experimental methods: The traditional Chinese medicine composition was administered by gavage for 8 weeks. Mice with osteoporosis (as described in Example 6) were sacrificed by cervical dislocation after blood was aspirated via cardiac puncture. The femur was dissected, fixed with 4% paraformaldehyde, and then decalcified with 14% EDTA solution for 28 days. Tissue embedding and paraffin sectioning were performed, and the morphological changes of the femur tissue were observed under a microscope using H&E staining.

[0061] Experimental results: such as Figure 4 The results showed that, compared with the normal control group, the osteoporosis model group mice had a significantly reduced number of trabeculae, blank areas in the medullary cavity, and a large number of fat cells. After treatment with the traditional Chinese medicine composition, the trabeculae in the femur of the mice were significantly thicker and their number increased significantly. This indicates that the traditional Chinese medicine composition can significantly improve the bone microstructure of the femur in mice with weightlessness-induced osteoporosis.

[0062] Example 9

[0063] Effects of Traditional Chinese Medicine Composition on the Mechanical Properties of Femoral Tissue in Osteoporosis Model Mice

[0064] Experimental methods: The traditional Chinese medicine composition was administered by gavage at a dose of 2g / kg for 8 weeks. The osteoporosis model mice in Example 6 were euthanized by cervical dislocation after blood was extracted by cardiac puncture. The tibia was wrapped with gauze soaked in physiological saline, and the hardness, elastic modulus and maximum bearing capacity of the tibia were measured using a mechanical loading instrument.

[0065] Experimental results: such as Figure 5 The results showed that compared with the normal control group, the osteoporosis model group mice had significantly reduced maximum tibial load-bearing capacity, elastic modulus, and hardness coefficient. However, after treatment with the traditional Chinese medicine composition, the maximum tibial load-bearing capacity, elastic modulus, and hardness coefficient of the osteoporosis model group mice were significantly improved (*: p < 0.05; **: p < 0.01; ***: p < 0.001). This indicates that the traditional Chinese medicine composition can improve the biomechanical properties of the tibia caused by osteoporosis and restore the values ​​of maximum tibial load-bearing capacity, elastic modulus, and hardness coefficient.

[0066] Example 10

[0067] Effects of Traditional Chinese Medicine Combinations on Liver and Kidney Toxicity in Osteoporosis Model Mice

[0068] Experimental methods: The traditional Chinese medicine composition was administered by gavage at a dose of 2g / kg for 8 weeks. Blood was extracted from the heart of the osteoporosis model mice in Example 6, and serum was separated. The levels of liver and kidney function indicators such as ALT, AST, r-GT and BUN in the serum were detected by an automated biochemical analyzer.

[0069] Experimental Results: As shown in Figure 6, after 8 weeks of treatment with the traditional Chinese medicine composition, the levels of liver and kidney function indicators ALT, AST, γ-GT, and BUN in mice showed no significant changes. This indicates that long-term (8 weeks) treatment with the traditional Chinese medicine composition did not have significant liver and kidney toxicity, and its safety is reliable.

[0070] In summary, the traditional Chinese medicine composition provided by this invention can effectively prevent and improve osteoporosis symptoms, effectively alleviate osteoporosis symptoms, significantly increase bone density, restore bone microstructure, and has no obvious toxic side effects.

[0071] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and treatment of osteoporosis, characterized in that: The traditional Chinese medicine composition is prepared by weight proportioning 15-25 parts of Angelica dahurica, 10-20 parts of Angelica sinensis, 15-25 parts of Paeonia lactiflora, 15-25 parts of Lycium barbarum, 5-15 parts of Ligustrum lucidum, and 10-20 parts of Gentiana macrophylla.

2. The traditional Chinese medicine composition for the prevention and treatment of osteoporosis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared by weight proportioning 25 parts Angelica dahurica, 20 parts Angelica sinensis, 20 parts Paeonia lactiflora, 15 parts Lycium barbarum, 10 parts Ligustrum lucidum, and 10 parts Gentiana macrophylla.

3. A traditional Chinese medicine composition for the prevention and treatment of osteoporosis according to claim 2, characterized in that: The traditional Chinese medicine composition is prepared by weight ratio of 25g Angelica dahurica, 20g Angelica sinensis, 20g Paeonia lactiflora, 15g Lycium barbarum, 10g Ligustrum lucidum, and 10g Gentiana macrophylla.

4. A traditional Chinese medicine composition for the prevention and treatment of osteoporosis according to claim 2, characterized in that: The traditional Chinese medicine composition is in the form of granules, tablets, pills, capsules, powders, or decoctions.

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