A traditional Chinese medicine composition for treating degenerative bone diseases, its preparation method and application

Abstract

This invention discloses a traditional Chinese medicine composition for treating degenerative bone diseases, its preparation method, and its application. It is made from the following raw materials in parts by weight: 30-50 parts Rehmannia glutinosa (processed), 15-30 parts deer antler glue, 20-80 parts Cistanche deserticola, 15-50 parts Morinda officinalis, 15-50 parts tortoise shell glue, 30-80 parts Lycium barbarum, 10-50 parts Curculigo orchioides, 15-50 parts Eucommia ulmoides, 20-80 parts Cuscuta chinensis, and 30-50 parts Dioscorea opposita. 0 parts, Drynaria fortunei 15-50 parts, Achyranthes bidentata 10-50 parts, Taxillus chinensis 20-50 parts, Broussonetia papyrifera 15-30 parts, Clematis chinensis 15-50 parts, Acanthopanax senticosus 15-50 parts; Through the formulation strategy of "regulating the liver and kidneys, nourishing essence and blood, and combining tonification and purging", combined with a specific extraction process, it systematically regulates the balance of bone metabolism, achieves dual prevention and treatment of osteoporosis and bone hyperplasia, and treats both the symptoms and the root cause, and has high safety for long-term use.

Description

Technical Field

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

[0002] Degenerative bone diseases are a general term for chronic diseases characterized by progressive degeneration of bones, joints, and surrounding soft tissues. The most common clinical manifestations include osteoporosis and osteophytes (commonly known as "bone spurs"). With the increasing aging of the global population, the incidence of degenerative bone diseases is rising year by year, becoming a major public health problem that seriously threatens the health and quality of life of middle-aged and elderly people. Osteoporosis is a systemic bone disease characterized by low bone mass and destruction of bone microstructure, leading to increased bone fragility and susceptibility to fractures. Its pathogenesis is complex, mainly involving the disruption of the dynamic balance between osteoblast-mediated bone formation and osteoclast-mediated bone resorption, with the rate of bone resorption consistently exceeding the rate of bone formation, resulting in net bone loss. Osteophytes are bony growths formed at the edges of bones due to long-term uneven stress, wear, or degeneration, often accompanied by local inflammation, soft tissue compression, and chronic intractable pain. The two often coexist in clinical practice, influencing each other and posing great challenges to treatment.

[0003] Existing Western medical treatments (such as calcium supplements, bisphosphonates, and nonsteroidal anti-inflammatory drugs) mostly target single pathological aspects. Long-term use can lead to significant side effects such as gastrointestinal irritation, liver and kidney damage, and cardiovascular risks. Furthermore, they offer limited relief for chronic pain associated with bone hyperplasia. While traditional Chinese medicine (TCM) treatments have the advantage of holistic regulation, existing TCM prescriptions tend to be simplistic, focusing primarily on tonifying the kidneys or promoting blood circulation and relieving pain. This approach fails to deeply address the core pathogenesis of "liver and kidney deficiency, insufficient essence and blood, and malnourishment of tendons and bones," resulting in an excess of tonification and insufficient promotion. Consequently, these treatments are not thorough in regulating bone metabolism balance, protecting cartilage tissue, or relieving chronic bone pain.

[0004] Therefore, a traditional Chinese medicine composition for treating degenerative bone diseases, its preparation method, and its application are proposed to address the problems mentioned above. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating degenerative bone diseases, its preparation method, and its application, in order to solve the problems mentioned in the background art, namely, the large side effects, single target, limited formulation ideas, and failure to fully consider both "tonifying deficiency" and "promoting flow" in the treatment of bone hyperplasia, and the inability to effectively block the core pathogenesis of "deficiency of liver and kidney, insufficiency of essence and blood, and malnourishment of tendons and bones".

[0006] To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition, which is made from the following raw materials in parts by weight: Prepared Rehmannia root 30-50 parts, deer antler glue 15-30 parts, Cistanche deserticola 20-80 parts, Morinda officinalis 15-50 parts, tortoise shell glue 15-50 parts, wolfberry fruit 30-80 parts, Curculigo orchioides 10-50 parts, Eucommia ulmoides 15-50 parts, Cuscuta chinensis 20-80 parts, Dioscorea opposita 30-50 parts, Drynaria fortunei 15-50 parts, Achyranthes bidentata 10-50 parts, Taxillus chinensis 20-50 parts, Broussonetia papyrifera fruit 15-30 parts, Clematis chinensis 15-50 parts, Acanthopanax senticosus 15-50 parts.

[0007] Preferably, the weight parts of the active pharmaceutical ingredient are: Prepared Rehmannia root 35-45 parts, deer antler glue 20-25 parts, Cistanche deserticola 40-60 parts, Morinda officinalis 25-35 parts, tortoise shell glue 25-35 parts, wolfberry fruit 45-65 parts, Curculigo orchioides 20-40 parts, Eucommia ulmoides 25-35 parts, Cuscuta chinensis 40-60 parts, Dioscorea opposita 35-45 parts, Drynaria fortunei 25-35 parts, Achyranthes bidentata 20-40 parts, Taxillus chinensis 30-40 parts, Broussonetia papyrifera fruit 20-25 parts, Clematis chinensis 25-35 parts, Acanthopanax senticosus 25-35 parts.

[0008] Preferably, the traditional Chinese medicine composition is a traditional Chinese medicine extract.

[0009] Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0010] Preferably, the dosage form of the traditional Chinese medicine composition is an oral preparation; more preferably, the oral preparation is selected from capsules, tablets, pills, granules, powders or oral liquids.

[0011] The present invention also provides a method for using the aforementioned traditional Chinese medicine composition, comprising the following steps: (1) Weigh all 16 raw materials according to the proportions and mix them; (2) Add 6-12 times the total mass of the raw material to water, decoct and extract 1-3 times, 1-3 hours each time, combine the decoctions, filter, concentrate and dry the filtrate to obtain the product; or, add 6-12 times the total mass of the raw material to ethanol solution with a volume concentration of 30%-95%, reflux and extract 1-3 times, 1-3 hours each time, combine the extracts, recover the ethanol and concentrate and dry the product to obtain the product.

[0012] Preferably, step (2) is as follows: Add 8-10 times the total mass of the raw materials to water, decoct and extract twice, the first time for 2 hours and the second time for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a thick paste with a relative density of 1.20-1.30, or further dry it into a dry powder.

[0013] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating and / or preventing osteoporosis.

[0014] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating and / or preventing pain caused by bone hyperplasia.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: This traditional Chinese medicine composition for treating degenerative bone diseases, its preparation method, and its application, through the formulation strategy of "harmonizing the liver and kidneys, nourishing essence and blood, and combining tonification and purgation," combined with a specific extraction process, systematically regulates the balance of bone metabolism, achieving dual prevention and treatment of osteoporosis and bone hyperplasia, and addressing both the symptoms and root cause. Furthermore, it has high safety with long-term use. The specific details are as follows: First, this invention addresses the limitations of existing Western medicine treatments, such as single target, long-term use leading to gastrointestinal irritation, liver and kidney damage, and cardiovascular risks, as well as the shortcomings of existing Chinese medicine prescriptions, which often focus on simple tonification or blood-activating and pain-relieving, resulting in "excessive tonification and insufficient facilitation." It innovatively proposes a prescription strategy of "simultaneous regulation of liver and kidney, dual tonification of essence and blood, and combined tonification and facilitation." The formula uses nourishing ingredients such as Rehmannia glutinosa, deer antler glue, tortoise shell glue, wolfberry, and dodder seed, along with kidney-tonifying and essence-boosting herbs, to tonify the liver and kidneys, replenish essence and marrow to treat the root cause. It is combined with herbs such as Cistanche deserticola, Morinda officinalis, Curculigo orchioides, Eucommia ulmoides, Achyranthes bidentata, and Taxillus chinensis to warm the yang, assist the kidneys, strengthen tendons and bones to consolidate the symptoms. It is further supplemented with herbs such as Drynaria fortunei, Clematis chinensis, and Acanthopanax senticosus to dispel wind and dampness, unblock the meridians and relieve pain to treat the acute symptoms. The whole formula tonifies without stagnation and unblocks without harming the body's vital energy. It deeply matches the complex pathogenesis of degenerative bone disease, which is "deficiency of liver and kidney, insufficiency of essence and blood, and malnourishment of tendons and bones", and achieves multi-target and multi-pathway overall regulation of bone metabolism balance.

[0016] Secondly, through specific processes such as water extraction or alcohol extraction, key active ingredients such as citronellol, colloidal peptides, amino acids, naringin, and anemonemin can be fully extracted from the formula. The composition of this invention can systematically and bidirectionally regulate bone metabolism, promoting bone formation and inhibiting bone resorption to increase bone density and improve bone microstructure; simultaneously, it can inhibit cartilage matrix degradation, protect articular cartilage, and effectively relieve chronic inflammatory pain and limb contractures caused by osteophyte formation by inhibiting the release of inflammatory factors and improving local microcirculation. Compared with existing technologies, this invention not only has a dual preventive and therapeutic effect on osteoporosis and osteophyte formation, but also fundamentally improves systemic symptoms such as lower back and knee weakness, achieving both symptomatic and root-cause treatment. Furthermore, it has high safety and low side effects with long-term use, making it particularly suitable for elderly patients with degenerative bone diseases requiring long-term treatment. Detailed Implementation

[0017] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0018] Example 1 Raw material weighing: Weigh each raw material according to the following weight parts: 40 parts Rehmannia glutinosa, 22 parts deer antler glue, 50 parts Cistanche deserticola, 30 parts Morinda officinalis, 30 parts tortoise shell glue, 55 parts Lycium barbarum, 30 parts Curculigo orchioides, 30 parts Eucommia ulmoides, 50 parts Cuscuta chinensis, 40 parts Dioscorea opposita, 30 parts Drynaria fortunei, 30 parts Achyranthes bidentata, 35 parts Taxillus chinensis, 22 parts Broussonetia papyrifera, 30 parts Clematis chinensis, and 30 parts Acanthopanax senticosus.

[0019] Preparation steps: (1) Crush the above 16 raw materials, pass them through a 40-mesh sieve, and mix them evenly to obtain mixed raw material powder; (2) Add 9 times the total mass of distilled water to the mixed raw material powder, decoct and extract twice, the first decoction for 2 hours and the second decoction for 1.5 hours, combine the two decoctions, filter with a 300 mesh filter cloth to remove the dregs and obtain a clear decoction. (3) The clarified decoction was placed in a rotary evaporator and concentrated at 60°C and 0.08 MPa to a thick paste with a relative density of 1.25 (measured at 60°C). Then it was placed in a vacuum drying oven and dried at 65°C and 0.09 MPa to a constant weight. After pulverizing, it was passed through an 80-mesh sieve to obtain the dry extract powder of traditional Chinese medicine, which is the traditional Chinese medicine composition of the present invention.

[0020] Example 2 Raw material weighing: Weigh each raw material according to the following weight parts: 30 parts Rehmannia glutinosa, 15 parts deer antler glue, 20 parts Cistanche deserticola, 15 parts Morinda officinalis, 15 parts tortoise shell glue, 30 parts Lycium barbarum, 10 parts Curculigo orchioides, 15 parts Eucommia ulmoides, 20 parts Cuscuta chinensis, 30 parts Dioscorea opposita, 15 parts Drynaria fortunei, 10 parts Achyranthes bidentata, 20 parts Taxillus chinensis, 15 parts Broussonetia papyrifera, 15 parts Clematis chinensis, and 15 parts Acanthopanax senticosus.

[0021] Preparation steps: (1) Crush the above 16 raw materials, pass them through a 40-mesh sieve, and mix them evenly to obtain mixed raw material powder; (2) Add 6 times the total mass of the mixed raw material powder to an ethanol solution with a volume concentration of 70%, place it in a reflux extraction device, reflux extract 3 times, extract for 1 hour each time, combine the 3 extracts, filter with a 300-mesh filter cloth to remove the residue, and obtain a clear extract. (3) Place the clarified extract in a rotary evaporator and recover ethanol at 55°C and 0.07 MPa until there is no ethanol odor in the extract. Continue to concentrate to a thick paste with a relative density of 1.20 (measured at 60°C). Vacuum dry (60°C and 0.09 MPa) to constant weight. After pulverizing, pass through an 80-mesh sieve to obtain the dry extract powder of the traditional Chinese medicine, which is the traditional Chinese medicine composition of the present invention.

[0022] Example 3 Take 100 parts of the dried herbal extract powder prepared in Example 1, add pharmaceutically acceptable excipients (20 parts starch and 2 parts magnesium stearate), mix evenly, and fill into empty capsules using a capsule filling machine. Each capsule contains 0.5g of dried herbal extract powder, thus obtaining the herbal composition capsule of the present invention.

[0023] To verify the therapeutic effect and safety of the traditional Chinese medicine composition of the present invention on pain caused by osteoporosis and bone hyperplasia, the following small animal experiments were conducted. All experimental animals were SPF-grade rats, and the breeding environment met the standards of "Experimental Animal Environment and Facilities" (GB14925-2023).

[0024] Experiment 1: Therapeutic effect of traditional Chinese medicine composition on osteoporosis rats Experimental materials: 60 SPF-grade female SD rats, weighing 220±20g and aged 6-8 months; the herbal composition of this invention (the dry powder prepared in Example 1, which was prepared into suspensions of different concentrations with physiological saline); positive control drug (alendronate sodium tablets, which were crushed and prepared into suspensions with physiological saline); physiological saline; bone densitometer; serum bone metabolism marker detection kit (P1NP, CTX); Micro-CT scanner.

[0025] Model establishment: A rat osteoporosis model was established using ovariectomy. The specific procedure was as follows: rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 ml / kg), a midline abdominal incision was made, both ovaries were exposed and removed, and the incision was sutured layer by layer. In the sham-operated group, only the abdominal cavity was opened, the ovaries were exposed but not removed, and the incision was directly sutured. After two months of routine feeding, the model was confirmed by measuring lumbar vertebral bone mineral density (BMD) (the model group had lower BMD than the sham-operated group, P < 0.01).

[0026] Experimental grouping: Rats with successfully established models were randomly divided into 5 groups of 10 each. An additional sham-operated group of 10 rats and a normal control group of 10 rats (no treatment) were also included. The specific groupings are as follows: Normal control group: fed normally, and administered 10ml / kg of physiological saline by gavage daily; Sham surgery group: Normal feeding, daily gavage administration of 10ml / kg of physiological saline; Model control group: Normal feeding, daily gavage administration of 10ml / kg of physiological saline; Positive control group: fed normally, and administered alendronate sodium suspension by gavage daily (dose of 0.2 mg / kg). Low-dose group of the present invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 1.0g / kg, calculated as dry powder); The medium-dose group of this invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of this invention (dose of 2.0 g / kg, calculated as dry powder); High-dose group of the present invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 4.0g / kg, calculated as dry powder).

[0027] Administration method: once daily by gavage for 12 consecutive weeks. During the administration period, the rats in each group were kept in the same feeding conditions and had free access to water and food.

[0028] Test indicators and results: Bone mineral density testing: Twelve weeks after administration, rats were anesthetized in the abdominal cavity, and bone mineral density (BMD) of the lumbar vertebrae (L3-L5) was measured using a bone mineral density analyzer. The results are shown in Table 1 below.

[0029] Table 1 Results of lumbar spine bone mineral density detection in each group of rats ; As shown in Table 1, the bone mineral density of the model control group rats was lower than that of the normal control group and the sham-operated group (P<0.01), indicating that the osteoporosis model was successfully established. Compared with the model control group, the bone mineral density of rats in each dosage group of the present invention was increased (P<0.05 for the low-dose group, P<0.01 for the medium and high-dose groups), and the bone mineral density of the high-dose group was close to that of the sham-operated group, which was better than that of the positive control group. This indicates that the traditional Chinese medicine composition of the present invention can increase the bone mineral density of osteoporotic rats, improve bone metabolism, and has a good therapeutic effect on osteoporosis.

[0030] Serum bone metabolism marker detection: After 12 weeks of drug administration, blood was collected from the orbital cavity of rats, and serum was separated by centrifugation. The bone formation marker P1NP (type I procollagen N-terminal propeptide) and the bone resorption marker CTX (type I collagen cross-linked C-terminal peptide) in the serum were detected by ELISA. The results are shown in Table 2 below.

[0031] Table 2 Results of serum bone metabolism markers in rats of each group ; As shown in Table 2, the serum P1NP level of rats in the model control group was decreased and the CTX level was increased (P<0.01), indicating that the rats had reduced bone formation, increased bone resorption, and an imbalance in bone metabolism. Compared with the model control group, the serum P1NP level of rats in each dose group of the present invention was increased and the CTX level was decreased (P<0.05 or P<0.01), and there was no difference between the high-dose group and the sham-operated group. This indicates that the traditional Chinese medicine composition of the present invention can bidirectionally regulate bone metabolism, promote bone formation, and inhibit bone resorption, thereby improving osteoporosis from the root cause. This is consistent with the formulation strategy of "harmonizing the liver and kidneys and nourishing essence and blood", which can effectively repair bone microstructure damage.

[0032] Bone microstructure detection: 12 weeks after drug administration, the L4 vertebral body of rats was taken and scanned using a Micro-CT scanner (voltage 80kV, current 500μA, resolution 13μm) to analyze trabecular thickness (Tb.Th), number of trabecular bones (Tb.N), and trabecular separation (Tb.Sp). The results are shown in Table 3 below.

[0033] Table 3 Results of lumbar vertebral microstructure detection in each group of rats ; As shown in Table 3, the trabecular bone thickness of the rats in the model control group was thinner, the number of trabeculae decreased, and the separation was increased (P<0.01), indicating severe damage to the bone microstructure. Compared with the model control group, the trabecular bone thickness and number of rats in each dose group of the present invention increased, and the separation was decreased (P<0.05 or P<0.01). Among them, the bone microstructure index of the high dose group was close to that of the sham-operated group, indicating that the traditional Chinese medicine composition of the present invention can effectively improve the bone microstructure of osteoporotic rats, enhance bone strength, and reduce the risk of fracture.

[0034] Experiment 2: Therapeutic effect of traditional Chinese medicine composition on osteoproliferative pain in rats Experimental materials: 60 SPF-grade SD rats, half male and half female, weighing 200±20g, aged 6-8 months; the herbal composition of this invention (the dry powder prepared in Example 1, which was prepared into suspensions of different concentrations with physiological saline); positive control drug (ibuprofen suspension); physiological saline; Von Freyfilaments (pain threshold detection tool); ELISA kit (IL-6, TNF-α); Safranin O-Fix Green staining kit; optical microscope.

[0035] Model establishment: A rat model of osteoarthritis was established using the medial meniscus tear (MMT) method. The procedure was as follows: rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 ml / kg). The right knee joint was shaved, disinfected, and a medial incision was made to expose the knee joint. The medial collateral ligament was severed, and the medial meniscus was torn. The incision was then sutured layer by layer. In the sham-operated group, only the knee joint was opened to expose the medial collateral ligament and meniscus without damage, and then sutured directly. Rats were fed routinely for 4 weeks post-surgery. The successful establishment of the model was confirmed by Von Freyfilaments assay of the right hind limb pain threshold and X-ray examination of the knee joint (the model group showed a decreased pain threshold, osteophyte formation, and joint space narrowing in the knee joint, P < 0.01).

[0036] Experimental grouping: Rats with successfully established models were randomly divided into 5 groups of 10 each. An additional sham-operated group of 10 rats and a normal control group of 10 rats (no treatment) were also included. The specific groupings are as follows: Normal control group: fed normally, and administered 10ml / kg of physiological saline by gavage daily; Sham surgery group: Normal feeding, daily gavage administration of 10ml / kg of physiological saline; Model control group: Normal feeding, daily gavage administration of 10ml / kg of physiological saline; Positive control group: Normal feeding, daily gavage administration of ibuprofen suspension (dose of 20 mg / kg). Low-dose group of the present invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 1.0g / kg, calculated as dry powder); The medium-dose group of this invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of this invention (dose of 2.0 g / kg, calculated as dry powder); High-dose group of the present invention: normal feeding, daily gavage administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 4.0g / kg, calculated as dry powder).

[0037] Administration method: once daily by gavage for 8 consecutive weeks. During the administration period, the rats in each group were kept in the same feeding conditions and had free access to water and food.

[0038] Test indicators and results: Pain threshold detection: The mechanical pain threshold of the right hind limb of rats was detected by Von Freyfilaments before administration, 4 weeks after administration, and 8 weeks after administration (the minimum pressure value at which the rat exhibited a foot withdrawal response was the pain threshold). The results are shown in Table 4 below.

[0039] Table 4. Results of mechanical pain threshold detection in the right hind limb of rats in each group. ; As shown in Table 4, there was no difference in pain threshold among the model rats in each group before administration (P>0.05), and the pain threshold was lower than that of the normal control group and the sham-operated group (P<0.01). After administration, the pain threshold of rats in each dose group of the present invention gradually increased with the extension of administration time. After 8 weeks of administration, compared with the model control group, the pain threshold of each dose group increased (P<0.01). Among them, the pain threshold of the high dose group of the present invention was close to that of the sham-operated group and better than that of the positive control group. This indicates that the traditional Chinese medicine composition of the present invention can effectively relieve pain caused by bone hyperplasia and the effect is sustained and stable. This is consistent with the effects of Clematis chinensis, Acanthopanax senticosus, and Drynaria fortunei in the formula in dispelling wind and dampness, clearing the meridians and relieving pain.

[0040] Serum inflammatory factor detection: Eight weeks after administration, blood was collected from the orbital cavity of rats, and serum was separated by centrifugation. The levels of inflammatory factors IL-6 (interleukin-6) and TNF-α (tumor necrosis factor-α) in the serum were detected by ELISA. The results are shown in Table 5 below.

[0041] Table 5. Results of serum inflammatory factors in rats in each group (x±s, n=10, pg / ml) ; As shown in Table 5, the serum IL-6 and TNF-α levels in the model control group were elevated (P<0.01), indicating that the osteoproliferative model rats had a significant chronic inflammatory response. Compared with the model control group, the serum IL-6 and TNF-α levels in rats of each dose group of the present invention were decreased (P<0.05 or P<0.01). Among them, the inflammatory factor levels in the high-dose group were close to those in the sham-operated group, indicating that the traditional Chinese medicine composition of the present invention can effectively inhibit the release of inflammatory factors, reduce joint inflammation, and thus relieve pain. This is consistent with the mechanism of action of the composition by improving local microcirculation and inhibiting inflammatory response.

[0042] Histological examination of articular cartilage: Eight weeks after drug administration, rats were sacrificed, and the right knee joint was taken, decalcified, embedded in paraffin, sectioned, stained with Safranin O-Fix Green, and the morphology of articular cartilage was observed under an optical microscope. The degree of cartilage damage was assessed using the modified Mankin score (0-14 points, the higher the score, the more severe the cartilage damage). The results are shown in Table 6 below.

[0043] Table 6. Modified Mankin scores of knee cartilage in rats of each group (x±s, n=10, points) ; As shown in Table 6, the Mankin score of the knee joint cartilage in the model control group was increased (P<0.01). The staining results showed that the cartilage surface was damaged, chondrocytes were detached, and proteoglycans were severely lost (Safranin O staining was weakened). Compared with the model control group, the Mankin scores of each dosage group of the present invention were decreased (P<0.05 or P<0.01). Among them, the high-dose group had a score close to that of the sham-operated group. The staining results showed that the cartilage surface was more intact, the chondrocytes were more neatly arranged, and the loss of proteoglycans was reduced. This indicates that the traditional Chinese medicine composition of the present invention can inhibit the degradation of cartilage matrix, protect articular cartilage, delay the progression of bone hyperplasia, and achieve both symptomatic and radical treatment.

[0044] Experiment 3: Long-term safety test of traditional Chinese medicine composition Experimental materials: 40 SPF-grade SD rats, half male and half female, weighing 200±20g, aged 6-8 months; the herbal composition of this invention (the dry powder prepared in Example 1, which was prepared into a suspension with physiological saline); physiological saline; fully automated biochemical analyzer; blood routine test kit.

[0045] Experimental grouping: Rats were randomly divided into 4 groups of 10 each, as follows: Normal control group: 10 ml / kg of normal saline was administered by gavage daily; Low-dose group of the present invention: daily oral administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 2.0 g / kg, calculated as dry powder); The dosage group of this invention: daily oral administration of the suspension of the traditional Chinese medicine composition of this invention (dosage is 4.0 g / kg, calculated as dry powder). High-dose group of the present invention: daily oral administration of the suspension of the traditional Chinese medicine composition of the present invention (dose of 8.0 g / kg, calculated as dry powder, which is 10 times the clinically intended dose).

[0046] Administration method: once daily by gavage for 24 consecutive weeks. During the administration period, observe the general condition of the rats (diet, water intake, activity, weight, fur, etc.) and record the mortality of the rats.

[0047] Test indicators and results: General observation: During the administration period, the rats in each group had normal diet, water intake and activity, their weight gradually increased with the feeding time, their fur was smooth, there was no abnormal behavior, and no rats died, indicating that the traditional Chinese medicine composition of the present invention has no obvious acute toxicity or long-term toxicity to rats.

[0048] Blood routine and liver and kidney function tests: After 24 weeks of administration, blood was collected from the orbital cavity of rats, and serum was separated by centrifugation. Blood routine (white blood cell count, red blood cell count, hemoglobin Hb, platelet count, PLT) and liver and kidney function indicators (alanine aminotransferase ALT, aspartate aminotransferase AST, serum creatinine Cr, blood urea nitrogen BUN) were detected using a fully automated biochemical analyzer. The results showed that the blood routine and liver and kidney function indicators of rats in each group were within the normal range, and there was no difference compared with the normal control group (P>0.05). This indicates that the traditional Chinese medicine composition of the present invention will not cause damage to the liver and kidney function or blood system of rats in the long term, and has high safety and is suitable for long-term conditioning.

[0049] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is made from the following parts by weight of raw materials: Prepared Rehmannia root 30-50 parts, deer antler glue 15-30 parts, Cistanche deserticola 20-80 parts, Morinda officinalis 15-50 parts, tortoise shell glue 15-50 parts, wolfberry fruit 30-80 parts, Curculigo orchioides 10-50 parts, Eucommia ulmoides 15-50 parts, Cuscuta chinensis 20-80 parts, Dioscorea opposita 30-50 parts, Drynaria fortunei 15-50 parts, Achyranthes bidentata 10-50 parts, Taxillus chinensis 20-50 parts, Broussonetia papyrifera fruit 15-30 parts, Clematis chinensis 15-50 parts, Acanthopanax senticosus 15-50 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The weight parts of the active pharmaceutical ingredient are: Prepared Rehmannia root 35-45 parts, deer antler glue 20-25 parts, Cistanche deserticola 40-60 parts, Morinda officinalis 25-35 parts, tortoise shell glue 25-35 parts, wolfberry fruit 45-65 parts, Curculigo orchioides 20-40 parts, Eucommia ulmoides 25-35 parts, Cuscuta chinensis 40-60 parts, Dioscorea opposita 35-45 parts, Drynaria fortunei 25-35 parts, Achyranthes bidentata 20-40 parts, Taxillus chinensis 30-40 parts, Broussonetia papyrifera fruit 20-25 parts, Clematis chinensis 25-35 parts, Acanthopanax senticosus 25-35 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition is a traditional Chinese medicine extract.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition also contains pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition according to claim 4, characterized in that: The dosage form of the traditional Chinese medicine composition is an oral preparation; preferably, the oral preparation is selected from capsules, tablets, pills, granules, powders or oral liquids.

6. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that: Includes the following steps: (1) Weigh all 16 raw materials according to the proportions and mix them; (2) Add 6-12 times the total mass of the raw material to water, decoct and extract 1-3 times, 1-3 hours each time, combine the decoctions, filter, concentrate and dry the filtrate to obtain the product; or, add 6-12 times the total mass of the raw material to ethanol solution with a volume concentration of 30%-95%, reflux and extract 1-3 times, 1-3 hours each time, combine the extracts, recover the ethanol and concentrate and dry the product to obtain the product.

7. The method according to claim 6, characterized in that: Step (2) is as follows: Add 8-10 times the total mass of the raw materials to water, decoct and extract twice, the first time for 2 hours and the second time for 1.5 hours. Combine the decoctions, filter, and concentrate the filtrate to a thick paste with a relative density of 1.20-1.30, or further dry it into a dry powder.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating and / or preventing osteoporosis.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating and / or preventing pain caused by bone hyperplasia.