Application of traditional Chinese medicine composition in preparation of medicine for femoral head necrosis

Abstract

The invention relates to an application of a traditional Chinese medicine composition in preparation of a medicine for femoral head necrosis, which is characterized in that the traditional Chinese medicine composition is prepared from rehmannia, cistanche, rhizoma cibotii, glossy privet fruit, epimedium, caulis spatholobi, radish seed, rhizoma drynariae and achyranthes bidentata. The composition can obviously promote proliferation of rat bone marrow mesenchymal stem cells and obviously increase the content of BMP-2 and TGF-beta1 in serum, the drug-containing serum can obviously promote proliferation of rabbit bone marrow mesenchymal stem cells, and the composition has a good treatment effect on femoral head necrosis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology and relates to a new use of a traditional Chinese medicine composition, specifically the application of a traditional Chinese medicine composition in the preparation of a drug for femoral head necrosis. Background Technology

[0002] Avascular necrosis of the femoral head is a disease caused by the partial death of bone cells and bone marrow components due to venous stasis, impaired or interrupted arterial blood supply to the femoral head, leading to bone tissue necrosis and subsequent repair. This process results in structural changes and collapse of the femoral head, causing hip pain and functional impairment. Avascular necrosis of the femoral head can be divided into two main categories: traumatic and non-traumatic. The main pathogenic factors of traumatic avascular necrosis of the femoral head include femoral neck fractures, acetabular fractures, hip dislocations, and severe hip sprains or contusions. In my country, the main causes of non-traumatic avascular necrosis of the femoral head include the use of corticosteroids, long-term excessive alcohol consumption, decompression sickness, hemoglobinopathies, autoimmune diseases, and idiopathic diseases. Smoking, obesity, radiation therapy, and pregnancy increase the risk of developing avascular necrosis of the femoral head and are considered to be associated with it.

[0003] Avascular necrosis of the femoral head has a high disability rate, severely impacting patients' work and lives. In advanced stages, it often requires total hip replacement surgery, placing a heavy burden on patients, their families, and society. Due to complications such as dislocation, aseptic loosening of the prosthesis, and infection, as well as the limited lifespan of the prosthesis, patients may need to undergo multiple revision surgeries. Therefore, early diagnosis and treatment of avascular necrosis of the femoral head are crucial. In light of these issues, the field of traditional Chinese medicine should actively participate in the prevention and treatment of avascular necrosis of the femoral head, developing and researching appropriate prescriptions. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for femoral head necrosis. This composition is prepared from Rehmannia glutinosa, Cistanche deserticola, Cibotium barometz, Ligustrum lucidum, Epimedium brevicornu, Spatholobus suberectus, Raphanus sativus, Drynaria fortunei, and Achyranthes bidentata. The term "used for" can refer to any method beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0005] Specifically, the drug for femoral head necrosis includes the ability to significantly promote the proliferation of hormone-induced rat bone marrow mesenchymal stem cells, significantly increase the levels of BMP-2 and TGF-β1 in serum, and the drug-containing serum can significantly promote the proliferation of rabbit bone marrow mesenchymal stem cells.

[0006] Furthermore, the traditional Chinese medicine composition comprises: 150-200 parts of Rehmannia glutinosa, 100-150 parts of Cistanche deserticola, 100-150 parts of Cibotium barometz, 50-100 parts of Ligustrum lucidum, 100-150 parts of Epimedium brevicornu, 100-150 parts of Spatholobus suberectus, 50-100 parts of Raphanus sativus, 100-150 parts of Drynaria fortunei, and 100-150 parts of Achyranthes bidentata. The composition of this invention can be directly ground into powder, or it can be an extract obtained through conventional methods in the art. The traditional Chinese medicines used in the composition of this invention can also be used by directly grinding into powder, extracting, or in other processed forms.

[0007] Furthermore, the traditional Chinese medicine composition includes: 170-180 parts of Rehmannia glutinosa, 110-120 parts of Cistanche deserticola, 110-120 parts of Cibotium barometz, 50-60 parts of Ligustrum lucidum, 110-120 parts of Epimedium brevicornu, 110-120 parts of Spatholobus suberectus, 50-60 parts of Raphanus sativus, 110-120 parts of Drynaria fortunei, and 110-120 parts of Achyranthes bidentata.

[0008] Preferably, the traditional Chinese medicine composition includes: 175 parts of Rehmannia glutinosa, 117 parts of Cistanche deserticola, 117 parts of Cibotium barometz, 58 parts of Ligustrum lucidum, 117 parts of Epimedium brevicornu, 117 parts of Spatholobus suberectus, 58 parts of Raphanus sativus, 117 parts of Drynaria fortunei, and 117 parts of Achyranthes bidentata.

[0009] Furthermore, the avascular necrosis of the femoral head can be hormone-induced, or avascular necrosis of the femoral head induced by hormones and lipopolysaccharide. The hormones may be selected from dexamethasone and / or methylprednisolone.

[0010] In some embodiments, the aforementioned medicament further includes a medically acceptable carrier and / or excipient. Specifically, the carrier or excipient may be a commonly used carrier or excipient in the art, including fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices, including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose and methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), tablets, etc., to help improve the stability or activity of the pharmaceutical composition, or to produce an acceptable taste or odor when taken orally.

[0011] In some embodiments, the composition can be prepared into granules, tablets, capsules, pills, oral solutions, oral suspensions, or oral emulsions using existing traditional Chinese medicine preparation methods. This facilitates clinical administration.

[0012] Furthermore, the preparation method of the traditional Chinese medicine composition includes taking 2 / 3 of the above-mentioned Rehmannia glutinosa, Cibotium barometz, and 1 / 2 of the above-mentioned Epimedium brevicornu and pulverizing them into fine powder. Then, the remaining 1 / 3 of the Rehmannia glutinosa, 1 / 2 of the Epimedium brevicornu, Spatholobus suberectus, steamed Cistanche deserticola, Raphanus sativus, Drynaria fortunei, Ligustrum lucidum, and Achyranthes bidentata are decocted twice with water, each time for 1.5 hours. The decoction is filtered, the filtrates are combined, concentrated to an appropriate amount, the above-mentioned fine powder is added, mixed well, dried, and pulverized.

[0013] When the composition of this invention is used as a drug for treating avascular necrosis of the femoral head, it can be administered as an oral solution. For severe cases, one dose is given daily, divided into 2-3 oral or nasal feedings, every 6-8 hours. For critically ill cases, two doses are given daily, divided into morning and evening oral or nasal feedings, every 8-12 hours. For mild cases, one dose is given daily, orally or via nasal feeding. Each dose is 150-250 ml.

[0014] When the drug is in the form of granules or tablets, the dosage is converted to the dosage of the prepared herbal medicine and administered by dissolving in water.

[0015] Clinical trials have demonstrated that the pharmaceutical composition of this invention can significantly reduce the severity of patient deterioration, especially for severely and critically ill patients. Furthermore, it also exhibits a certain therapeutic effect on severely and critically ill patients.

[0016] The composition of this invention can significantly promote the proliferation of rat bone marrow mesenchymal stem cells, significantly increase the content of BMP-2 and TGF-β1 in serum, and the drug-containing serum can significantly promote the proliferation of rabbit bone marrow mesenchymal stem cells, and has a good therapeutic effect on femoral head necrosis. Detailed Implementation

[0017] As mentioned above, the present invention aims to provide an application of a traditional Chinese medicine composition in the preparation of a drug for femoral head necrosis. The following will describe this in detail with reference to specific experiments.

[0018] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight. Unless otherwise specified, the medicinal materials of this invention can be either raw or processed products, provided that the overall effect of the prescription is not significantly affected.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention.

[0020] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0021] Take 175 parts of Rehmannia glutinosa (processed), 117 parts of Cistanche deserticola (processed with wine), 117 parts of Cibotium barometz (processed with salt), 58 parts of Ligustrum lucidum (processed with salt), 117 parts of Epimedium brevicornu, 117 parts of Spatholobus suberectus, 58 parts of Raphanus sativus (fried), 117 parts of Drynaria fortunei, and 117 parts of Achyranthes bidentata. Take 2 / 3 of the above-mentioned Rehmannia glutinosa (processed), Cibotium barometz (processed with salt), and 1 / 2 of the above-mentioned Epimedium brevicornu and grind them into fine powder. Then, take the remaining 1 / 3 of the Rehmannia glutinosa (processed), 1 / 2 of the above-mentioned Epimedium brevicornu, Spatholobus suberectus, Cistanche deserticola (processed with wine), Raphanus sativus (fried), Drynaria fortunei, Ligustrum lucidum (processed with salt), and Achyranthes bidentata and decoct them twice with water, 1.5 hours each time. Filter the decoction, combine the filtrates, concentrate to an appropriate amount, add the above-mentioned fine powder, mix well, dry, and grind into fine powder to obtain the Chinese medicine composition. Add an appropriate amount of maltodextrin, mix well, granulate, and obtain the Chinese medicine composition granules, which are then filled into capsule shells.

[0022] Experimental Example 2: The therapeutic effect of a traditional Chinese medicine composition on hormone-induced osteonecrosis of the femoral head in rats. 1. Experimental materials

[0023] 1.1 Animals

[0024] SD rats, SPF grade, female, 20 rats, weighing 160-180g, were purchased from Nantong University for cell isolation and culture.

[0025] 50 male SD rats, SPF grade, weighing 220-250g, were purchased from Nantong University for animal testing.

[0026] Rearing environment: Room temperature 20-26℃, relative humidity controlled at 40-70%.

[0027] 1.2 Drugs

[0028] The traditional Chinese medicine composition capsules prepared in Example 1 were manufactured by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; DMEM / F12 culture medium (Gibco, 11320023); fetal bovine serum (Gibco, A5669701); double antibiotic (Beyotime, C0222); trypsin (Gibco, 27250018); CCK-8 assay kit (Beyotime, C0039); dexamethasone (Beyotime, ST1254); lipopolysaccharide (sigma, L2880); methylprednisolone (Pfizer, USA); chloral hydrate (Shanghai Guoyao Chemical Reagent Co., Ltd., 20150629); rat bone morphogenetic protein 2 (BMP-2) ELISA kit (Shanghai ELISA kit, ml102832); rat transforming growth factor β1 (TGF-β1) ELISA kit (Shanghai ELISA kit, ml002856).

[0029] 1.3 Instruments

[0030] Electronic balance (Sartorius Scientific Instruments, BS224S); animal weight scale (Jetwer, JTS-3CW); low-temperature centrifuge (Eppendorf, 5804R); microplate reader (MD, Flexstation 3).

[0031] 2. Dosage design

[0032] The daily dosage of the traditional Chinese medicine composition is 5.25g of crude drug. Based on the body surface area calculation method, the equivalent dose for rats is 5.25g / 60kg*12.3=0.54g / kg. Designed according to a dosage ratio of 0.5:1:2, the low dose is 0.27g crude drug / kg, the medium dose is 0.54g crude drug / kg, and the high dose is 1.08g crude drug / kg.

[0033] 3. Experimental Methods

[0034] 3.1 Cell isolation and culture

[0035] SD rats were sacrificed via cervical dislocation and immersed in 75% ethanol. Bilateral femurs and tibias were surgically removed in a laminar flow hood. Muscles and connective tissue attached to the bones were separated. The medullary cavity was flushed with a complete culture medium consisting of DMEM / F12, 10% fetal bovine serum, and 1% penicillin-antibiotic mixture to elute intramedullary cells, forming a single-cell suspension. Cells were counted and analyzed at 5 × 10⁻⁶ cells / mL. 7 Seeds were placed in culture dishes at a density of 10 cells / mL and cultured in a 37°C, 5% CO2 incubator, with medium changed every 2-3 days. Bone marrow mesenchymal stem cells (BMSCs) were cultured to 80% confluence, then passaged using 0.25% trypsin, and the third-generation cells were used for experiments.

[0036] 3.2 BMSCs cell proliferation detection

[0037] 100 μL of BMSCs (1 × 10⁻⁶) 5 Cells (100 cells / mL) were seeded in 96-well plates and randomly divided into a blank control group, a dexamethasone (Dex) group, and low-dose, medium-dose, and high-dose groups of the traditional Chinese medicine composition, with 6 replicates per group. Cells were incubated for 24 h. 100 μL of basal medium was added to the blank control group, and 100 μL of Dex solution (300 ng / mL) prepared with basal medium was added to the other groups. Incubation was continued for 48 h. The supernatant was discarded. 100 μL of basal medium was added to the blank control group and the Dex group, and 100 μL of solutions prepared with basal medium (25, 50, and 100 mg / L, respectively) were added to the three dosage groups of the traditional Chinese medicine composition. Cells were incubated for 24 h. 10 μL of CCK-8 solution was added to each well, and incubation was continued for 3 h with shaking for at least 1 min. The absorbance at 450 nm was measured using a microplate reader to calculate cell proliferation. 3.3 Preparation of a hormone-induced femoral head necrosis model

[0038] Rats were randomly divided into three groups according to body weight: a blank control group, a model control group, and low-, medium-, and high-dose groups of the traditional Chinese medicine composition, with 10 rats in each group. Except for the blank control group, all other groups received intraperitoneal injections of lipopolysaccharide (LPS, 0.2 mg / kg) and intramuscular injections of methylprednisolone (MP, 40 mg / kg) for 3 consecutive days. The low-, medium-, and high-dose groups of the traditional Chinese medicine composition were administered the medicine on the first day of modeling, with each group receiving 20 mL / kg of the corresponding concentration of the traditional Chinese medicine composition via gavage once daily for 4 weeks. The blank control group received an intraperitoneal injection of the corresponding volume of physiological saline, an intramuscular injection of the corresponding concentration of physiological saline, and a gavage of the corresponding volume of purified water. One hour after the last administration, the rats were anesthetized, and blood was collected from the abdominal aorta. After standing for 30 minutes, the blood was centrifuged at 3000 rpm for 10 minutes at 4°C, and the supernatant was collected and stored at -20°C for later use. BMP-2 and TGF-β were detected according to the manufacturer's instructions.

[0039] 4. Statistical Methods

[0040] The results were statistically analyzed using t-tests.

[0041] 5. Experimental Results

[0042] 5.1 Detection of BMSCs cell proliferation

[0043] After dexamethasone induction of BMSCs, cell proliferation was significantly inhibited compared with the blank control (**P<0.01), showing a statistically significant difference. After administration of drug-containing serum to the low, medium, and high concentrations of the traditional Chinese medicine composition, cell proliferation was significantly promoted compared with the Dex group, showing a statistically significant difference (**P<0.01). See Table 1.

[0044] Table 1: Therapeutic effects on hormone-induced apoptosis of bone marrow mesenchymal stem cells

[0045]

[0046] Note: Compared with the model control group (Dex group), **P<0.01.

[0047] 5.2 Cytokine Detection

[0048] Compared with the blank control group, the levels of BMP-2 and TGF-β1 in the model control group were significantly reduced (**P<0.01), showing a statistically significant difference. Compared with the model control group, the levels of BMP-2 and TGF-β1 in the medium and high doses of the traditional Chinese medicine composition were significantly increased, showing a statistically significant difference (**P<0.01, *P<0.01). See Table 2.

[0049] Table 2: Effects on cytokines

[0050]

[0051] Note: Compared with the model control group, **P<0.01, *P<0.05.

[0052] 6. Experimental Conclusions

[0053] The traditional Chinese medicine composition promoted the proliferation of Dex-induced BMSCs; the content of BMP-2 and TGF-β1 in the traditional Chinese medicine composition was significantly increased, suggesting that the traditional Chinese medicine composition has a certain therapeutic effect on hormone-induced femoral head necrosis.

[0054] Experimental Example 3: Therapeutic Effect of Traditional Chinese Medicine Composition on Hormone-Induced Apoptosis of Rabbit Bone Marrow Mesenchymal Stem Cells 1. Experimental Materials

[0055] 1.1 Animals

[0056] New Zealand rabbits, female, weighing 2.0–2.5 kg, were purchased from Laifu Rabbit Breeding Farm in Pukou District, Nanjing City, for cell isolation and culture.

[0057] New Zealand rabbits, male, weighing 2.0–2.5 kg, were purchased from Laifu Farm in Pukou District, Nanjing City, for use in animal model preparation.

[0058] Rearing environment: Room temperature 20-26℃, relative humidity controlled at 40-70%. Individual cage rearing.

[0059] 1.2 Drugs

[0060] The traditional Chinese medicine composition capsules prepared in Example 1 were manufactured by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; DMEM / F12 culture medium (Gibco, 11320023); fetal bovine serum (Gibco, A5669701); double antibiotic (Beyotime, C0222); trypsin (Gibco, 27250018); CCK-8 assay kit (Beyotime, C0039); lipopolysaccharide (Sigma, L2880); methylprednisolone sodium succinate (Shanghai Aladdin Biochemical Technology Co., Ltd., M168895).

[0061] 1.3 Instruments

[0062] Electronic balance (Sartorius Scientific Instruments, BS224S); animal weight scale (Jetwer, JTS-3CW); low-temperature centrifuge (Eppendorf, 5804R); microplate reader (MD, Flexstation 3).

[0063] 1.3 Instruments

[0064] Electronic balance (Sartorius Scientific Instruments, model BS224S); Electronic balance (G&G, model TC3K); Low-temperature centrifuge (Eppendorf, Germany, model 5804R); Microplate reader (McGen, USA, model Flexstation 3).

[0065] 2. Dosage design

[0066] The daily dosage of the traditional Chinese medicine composition is 5.25g of crude drug. Based on the body surface area conversion method, the equivalent dose for rabbits is 5.25g / 60kg*3.3=0.29g / kg. Designed according to a dosage ratio of 0.5:1:2, the low dose is 0.14g crude drug / kg, the medium dose is 0.29g crude drug / kg, and the high dose is 0.58g crude drug / kg. Administered by gavage, 10mL / kg, once daily.

[0067] 3. Experimental Methods

[0068] 3.1 Cell isolation and culture

[0069] New Zealand rabbits were euthanized via embolization. The thoracolumbar spine was surgically removed in a clean bench, and two vertebral bodies were harvested. The attached muscle and connective tissue were separated, and the bone fragments were cut into smaller pieces using bone shears. These smaller pieces were then washed with a complete culture medium consisting of DMEM / F12, 15% fetal bovine serum, and 1% penicillin-dextrose antibiotics, and the washings were collected. Cell suspensions were seeded into cell culture flasks and cultured in a 37°C, 5% CO2 incubator, with the medium changed every 2-3 days. When BMSCs reached 80% confluence, they were passaged using 0.25% trypsin, and the third-generation cells were used for experiments.

[0070] 3.2 Preparation of drug-containing serum

[0071] Five New Zealand rabbits were randomly selected as the blank control group. The remaining rabbits in each group received LPS (10 μg / kg) via the marginal ear vein for two consecutive days. On the second day, methylprednisolone sodium succinate (25 mg / kg) was injected intramuscularly into the buttocks every other day for a total of three times. The blank control group received an equal volume of physiological saline intramuscularly. During this period, 800,000 units of penicillin sodium were injected twice a week for two weeks. After modeling, surviving New Zealand rabbits were randomly divided into four groups based on body weight: a model control group, and low, medium, and high dose groups of the traditional Chinese medicine composition, with six rabbits in each group. The medicine was administered via gavage at a volume of 10 mL / kg once daily for four consecutive weeks. The blank control group received pure water via gavage, while the low, medium, and high dose groups of the traditional Chinese medicine composition received the corresponding concentrations. Blood was collected from the heart, allowed to stand for 30 minutes, and then centrifuged at 3000 rpm for 10 minutes at 4°C. The supernatant was collected and filtered through a 0.45 μm filter for sterilization. The serum from each group was mixed with the basal culture medium to prepare complete culture media containing 15% serum, namely blank control group, model control group, and low, medium and high dose groups of traditional Chinese medicine composition.

[0072] 3.3 BMSCs cell proliferation detection

[0073] 100 μL of BMSCs (1 × 10⁻⁶) 5 Cells (10 cells / mL) were seeded in 96-well plates and randomly divided into a blank control group, a model control group, and low, medium, and high dose groups of the traditional Chinese medicine composition, with 6 replicates per group. Cells were incubated for 24 h. The corresponding complete culture medium collected in section 3.2 was added to each group. Cells were incubated for 24 h. 10 μL of CCK-8 solution was added to each well, and the cells were incubated for 3 h with shaking for at least 1 min. The absorbance at 450 nm was measured using a microplate reader to calculate cell proliferation.

[0074] 4. Statistical Methods

[0075] The results were statistically analyzed using t-tests.

[0076] 5. Experimental Results

[0077] BMSCs treated with drug-containing serum showed significantly inhibited cell proliferation compared to the blank control group (**P<0.01), indicating a statistically significant difference. After treatment with drug-containing serum in the low, medium, and high concentrations of the traditional Chinese medicine composition, cell proliferation was significantly promoted compared to the model control group (**P<0.01). See Table 3.

[0078] Table 3: Therapeutic effects on hormone-induced apoptosis of bone marrow mesenchymal stem cells

[0079]

[0080] Note: Compared with the model control group, **P<0.01.

[0081] 6. Experimental Conclusions

[0082] The traditional Chinese medicine composition promotes the proliferation of BMSCs, suggesting that the traditional Chinese medicine composition has a certain therapeutic effect on hormone-induced femoral head necrosis.

[0083] The above embodiments of the present invention are merely examples to clearly illustrate the present invention and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for avascular necrosis of the femoral head, characterized in that, The traditional Chinese medicine composition is made from the following components: 150-200 parts of Rehmannia glutinosa, 100-150 parts of Cistanche deserticola, 100-150 parts of Cibotium barometz, 50-100 parts of Ligustrum lucidum, 100-150 parts of Epimedium brevicornu, 100-150 parts of Spatholobus suberectus, 50-100 parts of Raphanus sativus, 100-150 parts of Drynaria fortunei, and 100-150 parts of Achyranthes bidentata.

2. The application according to claim 1, characterized in that, The traditional Chinese medicine composition, by weight, is made from the following components: 170-180 parts of Rehmannia glutinosa, 110-120 parts of Cistanche deserticola, 110-120 parts of Cibotium barometz, 50-60 parts of Ligustrum lucidum, 110-120 parts of Epimedium brevicornu, 110-120 parts of Spatholobus suberectus, 50-60 parts of Raphanus sativus, 110-120 parts of Drynaria fortunei, and 110-120 parts of Achyranthes bidentata.

3. The application according to claim 1, characterized in that, The traditional Chinese medicine composition, by weight, is made from the following components: 175-180 parts of Rehmannia glutinosa, 115-120 parts of Cistanche deserticola, 115-120 parts of Cibotium barometz, 55-60 parts of Ligustrum lucidum, 115-120 parts of Epimedium brevicornu, 115-120 parts of Spatholobus suberectus, 55-60 parts of Raphanus sativus, 115-120 parts of Drynaria fortunei, and 115-120 parts of Achyranthes bidentata.

4. The application according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components: 175 parts Rehmannia glutinosa, 117 parts Cistanche deserticola, 117 parts Cibotium barometz, 58 parts Ligustrum lucidum, 117 parts Epimedium brevicornu, 117 parts Spatholobus suberectus, 58 parts Raphanus sativus, 117 parts Drynaria fortunei, and 117 parts Achyranthes bidentata.

5. The application according to claim 1, characterized in that, The aforementioned femoral head necrosis is hormone-induced femoral head necrosis.

6. The application according to any one of claims 1-5, characterized in that, Drugs used for avascular necrosis of the femoral head include pharmaceutically acceptable excipients or additives.

7. The application as described in claim 6, characterized in that, Pharmaceutically acceptable excipients or additives include fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices.

8. The application according to claim 7, characterized in that, The dosage forms of the drugs for avascular necrosis of the femoral head include oral dosage forms, injectable dosage forms, or topical dosage forms.

9. The application according to claim 8, characterized in that, The dosage forms of the drugs for avascular necrosis of the femoral head include tablets, granules, capsules, pills, or drop pills.

10. The application according to any one of claims 1-5, characterized in that, The preparation method of the traditional Chinese medicine composition includes taking 2 / 3 of the above-mentioned Rehmannia glutinosa, Cibotium barometz, and 1 / 2 of the above-mentioned Epimedium brevicornu and pulverizing them into fine powder. Then, the remaining 1 / 3 of the Rehmannia glutinosa, 1 / 2 of the Epimedium brevicornu, Spatholobus suberectus, steamed Cistanche deserticola, Raphanus sativus, Drynaria fortunei, Ligustrum lucidum and Achyranthes bidentata are decocted twice with water, each time for 1.5 hours. The decoction is filtered, the filtrates are combined, concentrated to an appropriate amount, the above-mentioned fine powder is added, mixed well, dried and pulverized.

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