A traditional Chinese medicine composition for preventing and treating 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, Salvia miltiorrhiza, thyme, Polygonatum sibiricum, Astragalus membranaceus, and Eucommia ulmoides 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 herbs working together to strengthen bones, relieve pain, tonify the liver and kidneys, and replenish 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 clearly 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, salvia miltiorrhiza, thyme, polygonatum sibiricum, astragalus membranaceus and eucommia ulmoides in proportion.

[0006] Furthermore, the traditional Chinese medicine composition includes, by weight, 10-30 parts of Angelica dahurica, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of thyme, 5-15 parts of Polygonatum sibiricum, 5-15 parts of Astragalus membranaceus, and 5-15 parts of Eucommia ulmoides.

[0007] Furthermore, the traditional Chinese medicine composition comprises, by weight, 30 parts Angelica dahurica, 30 parts Salvia miltiorrhiza, 5 parts Thyme, 10 parts Polygonatum sibiricum, 15 parts Astragalus membranaceus, and 10 parts Eucommia ulmoides.

[0008] Furthermore, the traditional Chinese medicine composition includes, by weight, 30g of Angelica dahurica, 30g of Salvia miltiorrhiza, 5g of thyme, 10g of Polygonatum sibiricum, 20g of Astragalus membranaceus, and 10g of Eucommia ulmoides.

[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 illustrating the effect of a traditional Chinese medicine composition on bone density in an osteoporosis model animal.

[0013] Figure 2 This is a schematic diagram illustrating the effects of a traditional Chinese medicine composition on the bone microstructure of an osteoporosis model animal.

[0014] Figure 3 This is a schematic diagram showing the quantitative analysis results of the effects of traditional Chinese medicine composition on the bone microstructure of osteoporosis model animals.

[0015] Figure 4 This is a schematic diagram illustrating the effect of a traditional Chinese medicine composition on the morphology of femoral tissue in an osteoporosis model mouse.

[0016] Figure 5 This is a schematic diagram illustrating the effect of a traditional Chinese medicine composition on the mechanical properties of femoral tissue in an osteoporosis model mouse.

[0017] Figure 6 shows the levels of liver and kidney function indicators before and after treatment in the control group and the observation group. 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, salvia miltiorrhiza, thyme, polygonatum sibiricum, astragalus membranaceus and eucommia ulmoides in 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] Danshen (Salvia miltiorrhiza): Slightly cold in nature, bitter in taste. It enters the Heart and Liver meridians. Its functions include removing blood stasis and relieving pain, promoting blood circulation and alleviating menstrual cramps, clearing the heart and relieving irritability. It belongs to the category of blood-activating and menstruation-regulating drugs under the subclass of blood-activating and stasis-removing drugs. It also promotes blood circulation and removes blood stasis; enhances hypoxia tolerance; enhances immune function; has anti-inflammatory effects; protects the liver; has anti-tumor effects; has sedative and analgesic effects; improves kidney function; has antibacterial effects; promotes the healing of skin wounds and fractures; and has hormone-like effects.

[0027] Thyme: Warms the middle burner and dispels cold, strengthens the spleen and aids digestion, dispels wind and relieves pain. It has the effects of dispelling wind and releasing the exterior, regulating qi and relieving pain.

[0028] Polygonatum: Enters the Spleen, Lung, and Kidney meridians. It nourishes Yin and moistens the lungs, tonifies the spleen and replenishes Qi, and nourishes the kidneys and replenishes essence. It is primarily used for Yin deficiency cough, dry cough due to lung dryness, and weakness due to spleen deficiency. According to *Rihuazi Materia Medica*, it replenishes the five types of fatigue and seven types of injury, and strengthens muscles and bones.

[0029] Astragalus: Enters the Lung and Spleen meridians. It is sweet and warm in nature. It tonifies Qi and strengthens the exterior, promotes diuresis and eliminates toxins, drains pus, and promotes wound healing and tissue regeneration.

[0030] Eucommia ulmoides: Liver meridian; Kidney meridian; Sweet; Slightly pungent; Warm in nature. It tonifies the liver and kidneys, strengthens tendons and bones. According to *Yuqiu Yaoxie*: It benefits the liver and kidneys, nourishes tendons and bones, and removes dampness from the joints. It treats lower back and knee pain, and leg and foot cramps.

[0031] Furthermore, the traditional Chinese medicine composition includes, by weight, 10-30 parts of Angelica dahurica, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of thyme, 5-15 parts of Polygonatum sibiricum, 5-15 parts of Astragalus membranaceus, and 5-15 parts of Eucommia ulmoides.

[0032] Furthermore, the traditional Chinese medicine composition comprises, by weight, 30 parts Angelica dahurica, 30 parts Salvia miltiorrhiza, 5 parts Thyme, 10 parts Polygonatum sibiricum, 15 parts Astragalus membranaceus, and 10 parts Eucommia ulmoides.

[0033] Furthermore, the traditional Chinese medicine composition includes, by weight, 30g of Angelica dahurica, 30g of Salvia miltiorrhiza, 5g of thyme, 10g of Polygonatum sibiricum, 20g of Astragalus membranaceus, and 10g of Eucommia ulmoides.

[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] The following Chinese herbal ingredients were weighed separately: 30g of Angelica dahurica, 30g of Salvia miltiorrhiza, 5g of Thyme, 10g of Polygonatum sibiricum, 20g of Astragalus membranaceus, and 10g of Eucommia ulmoides. 2L of purified water was added, and the mixture was brought to a boil over high heat for 20 minutes, then simmered over low heat for 2 hours. After cooling, the mixture was filtered to remove the dregs and taken orally twice daily, morning and evening.

[0039] Example 3

[0040] Pill preparation:

[0041] The following Chinese herbal ingredients were weighed separately: 30g of Angelica dahurica, 30g of Salvia miltiorrhiza, 5g of Thyme, 10g of Polygonatum sibiricum, 20g of Astragalus membranaceus, and 10g of Eucommia ulmoides. 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, 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: 30g of Angelica dahurica, 30g of Salvia miltiorrhiza, 5g of Thyme, 10g of Polygonatum sibiricum, 20g of Astragalus membranaceus, and 10g of Eucommia ulmoides. 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, 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 separately: 15g of Angelica dahurica, 15g of Salvia miltiorrhiza, 2.5g of Thyme, 5g of Polygonatum sibiricum, 10g of Astragalus membranaceus, and 5g of Eucommia ulmoides. After soaking in 2L of distilled water for 30 minutes, the ingredients were decocted for 2 hours, 1 hour (1.5L of water), and 1 hour (1L of 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 Combinations 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 mice were administered the traditional Chinese medicine composition by gavage for 8 weeks, while the control group was administered an equal volume of 0.5% CMCNa solution. 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 4The 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 10-30 parts of Angelica dahurica, 10-30 parts of Salvia miltiorrhiza, 5-15 parts of thyme, 5-15 parts of Polygonatum sibiricum, 5-15 parts of Astragalus membranaceus, and 5-15 parts of Eucommia ulmoides.

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 30 parts Angelica dahurica, 30 parts Salvia miltiorrhiza, 5 parts Thyme, 10 parts Polygonatum sibiricum, 15 parts Astragalus membranaceus, and 10 parts Eucommia ulmoides.

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 30g Angelica dahurica, 30g Salvia miltiorrhiza, 5g Thyme, 10g Polygonatum sibiricum, 20g Astragalus membranaceus, and 10g Eucommia ulmoides.

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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