Traditional Chinese medicine composition for treating ischemic necrosis of femoral head as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating ischemic necrosis of femoral head as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 to 30 parts of radix angelicae sinensis, 7 to 25 parts of flos carthami, 10 to 20 parts of radix salviae miltiorrhizae, 5 to 20 parts of frankincense, 4 to 18 parts of myrrh, 3 to 9 parts of herba anoectochiae, 10 to 20 parts of radix astragali seu hedysari, 2 to 12 parts of rhizoma corydalis, 2 to 8 parts of acer ginnala and 1 to 5 parts of artificial musk. The traditional Chinese medicine composition disclosed by the invention has a relatively good treatment effect on ischemic necrosis of the femoral head. The traditional Chinese medicine composition is mild in medicine property, free of side effects and wide in application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating avascular necrosis of the femoral head, its preparation method, and its application. Background Technology

[0002] Osteonecrosis is caused by damage to the blood vessels supplying the bone due to various factors, leading to ischemia, degeneration, and necrosis of the bone. Osteonecrosis can occur in many parts of the body; when it occurs in the femoral head, it is called femoral head necrosis. Ischemic necrosis of the femoral head is the most common, severely impacting people's physical and mental health and quality of life. Severe cases can lead to disability and immense suffering. Studies show that most patients with femoral head ischemic necrosis follow a progression from ischemia, necrosis, collapse, to osteoarthritis, with the onset process taking anywhere from months to years, ultimately resulting in complete loss of joint function and walking ability.

[0003] As one of the most difficult and complex diseases in orthopedics, avascular necrosis of the femoral head has always been a major headache, characterized by its difficulty in treatment, long treatment period, and high disability rate. Currently, Western medicine only intervenes in the early stages of avascular necrosis of the femoral head, targeting only the symptoms, which is unlikely to slow down or stop the progression of the disease. As the disease progresses to the middle and late stages of avascular necrosis of the femoral head, after the joint surface collapses, artificial joint replacement surgery is usually unavoidable. However, compared with oral medication, artificial joint replacement surgery is more painful and expensive. 10-15 years after the surgery, the artificial joint will require revision or even replacement due to increased wear and tear, which undoubtedly increases the patient's pain and the difficulty of the surgery, especially for middle-aged and young patients with a longer life expectancy. Therefore, it is not an ideal treatment method. Traditional Chinese medicine (TCM) treatment, based on a holistic approach, treats both internal and external factors, emphasizing both tendons and bones. Currently, although the publicly available TCM compositions have fewer toxic side effects, their drug components are complex, the preparation process is crude, and the effective content is low. They have better therapeutic effects on single symptoms, but their efficacy is relatively singular, and the overall efficacy is not clear.

[0004] To achieve the above objectives, the present invention provides a traditional Chinese medicine composition for treating avascular necrosis of the femoral head, its preparation method, and its application. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for treating avascular necrosis of the femoral head.

[0006] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine composition for treating avascular necrosis of the femoral head.

[0007] A third objective of this invention is to provide the application of a traditional Chinese medicine composition for treating avascular necrosis of the femoral head in the preparation of a drug for treating avascular necrosis of the femoral head.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for treating avascular necrosis of the femoral head, the composition comprising the following raw materials in parts by weight: Angelica sinensis 15-30 parts, Carthamus tinctorius 7-25 parts, Salvia miltiorrhiza 10-20 parts, Boswellia carterii 5-20 parts, Commiphora myrrha 4-18 parts, Anoectochilus roxburghii 3-9 parts, Astragalus membranaceus 10-20 parts, Corydalis yanhusuo 2-12 parts, Acer truncatum 2-8 parts, and artificial musk 1-5 parts.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 22 parts Angelica sinensis, 16 parts Carthamus tinctorius, 15 parts Salvia miltiorrhiza, 12 parts Boswellia carterii, 11 parts Commiphora myrrha, 6 parts Anoectochilus roxburghii, 15 parts Astragalus membranaceus, 7 parts Corydalis yanhusuo, 5 parts Acer truncatum, and 3 parts artificial musk.

[0010] The preparation method of the traditional Chinese medicine composition for treating avascular necrosis of the femoral head described above includes the following steps: (1) Weigh out each raw material according to the weight proportions: Angelica sinensis, safflower, Salvia miltiorrhiza, frankincense, myrrh, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, Acer truncatum, artificial musk, pulverize and sieve to obtain Chinese medicine powder for later use; (2) Soak the Chinese herbal powders of Angelica sinensis, Carthamus tinctorius, Salvia miltiorrhiza, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo and Acer truncatum prepared in step (1) in water, bring to a boil over high heat, then simmer over low heat, and filter to obtain the first filtrate and residue. (3) Soak the filter residue obtained in step (2) in water, bring it to a boil over high heat, then simmer over low heat, filter to obtain the second filtrate and filter residue, combine the first filtrate and the second filtrate to obtain a mixture; concentrate the mixture to extract. (4) Add ethanol to extract the frankincense and myrrh powders prepared in step (1), combine the filtrates and concentrate them into an extract; add anhydrous ethanol to the artificial musk powders prepared in step (1) and disperse them into an artificial musk suspension. (5) The extract obtained in step (4) and the artificial musk suspension are slowly added to the extract in step (3) under certain conditions and then homogenized under vacuum to obtain the traditional Chinese medicine composition.

[0011] Furthermore, the mesh size of the sieve in step (1) is 60-80.

[0012] Furthermore, in step (2), the amount of water added is 3-5 times the total weight of the medicinal powder in each raw material, the soaking time is 40-50 minutes, and the simmering time is 50-70 minutes.

[0013] Furthermore, in step (3), the amount of water added is 2-4 times the total weight of the filter residue, the soaking time is 30-40 minutes, the simmering time is 30-40 minutes, and the extract is an extract with a relative density of 1.0-1.2.

[0014] Furthermore, in step (4), the amount of ethanol added is 6-8 times the total weight of the frankincense and myrrh powder; the reflux extraction time is 0.5-1h; the extract is an extract with a relative density of 1.0-1.2; and the ratio of the amount of artificial musk powder to ethanol is 1g:(5-7)mL.

[0015] Furthermore, the conditions in step (5) are ≤45 ℃, vacuum -0.06 MPa, and closed nitrogen filling; the time for vacuum homogenization is 10-15 min.

[0016] The above-described traditional Chinese medicine composition for treating avascular necrosis of the femoral head is used in the preparation of drugs for treating avascular necrosis of the femoral head.

[0017] To facilitate a better understanding of this invention, the effects of each ingredient are explained below: Angelica sinensis: Sweet and pungent in taste, warm in nature; enters the liver, heart, and spleen meridians. Functions and indications: Nourishes blood and promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movement. Safflower: Pungent in taste, warm in nature; enters the heart and liver meridians. Functions and indications: Promotes blood circulation and regulates menstruation, disperses blood stasis and relieves pain. The *Shennong Bencao Jing* records: Treats cough, shortness of breath, malaria, chills and fever, and can be washed on the skin. Also treats leukorrhea and infertility in women, and various malignant sores and wounds. Boil and drink. Also known as dried angelica. Grows in valleys.

[0018] Safflower: Pungent in taste, warm in nature; enters the heart and liver meridians. Functions and indications: invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain. The Chinese Pharmacopoeia records: invigorates blood circulation, regulates menstruation, disperses blood stasis, and relieves pain.

[0019] Danshen (Salvia miltiorrhiza): Bitter in taste, slightly cold in nature; enters the heart and liver meridians. Functions and indications: Invigorates blood circulation and removes blood stasis, unblocks menstruation and relieves pain, clears the heart and eliminates irritability, cools the blood and reduces swelling. The Compendium of Materia Medica records: Invigorates blood circulation, unblocks the pericardium, and treats hernia pain.

[0020] Frankincense: pungent and bitter in taste, warm in nature; enters the heart, liver, and spleen meridians. Functions and indications: invigorates blood circulation, promotes qi flow, relieves pain, reduces swelling, and promotes tissue regeneration. The *Compendium of Materia Medica* records: Frankincense is a medicine that invigorates blood circulation, dispels wind, relaxes muscles, and relieves pain.

[0021] Myrrh: pungent and bitter in taste, neutral in nature; enters the heart, liver, and spleen meridians. Functions and indications: disperses blood stasis and relieves pain, reduces swelling and promotes tissue regeneration.

[0022] Golden thread wind: Tasteless and astringent, neutral in nature; enters the liver and lung meridians. Functions and indications: Clears heat and detoxifies, invigorates blood circulation and removes blood stasis, disperses blood stasis and relieves pain. The *Compendium of Materia Medica Supplement* records: Treats jaundice, urinary tract infections, and sores.

[0023] Astragalus: Bitter in taste, slightly warm in nature; enters the lung and spleen meridians. Functions and indications: Tonifies qi and raises yang, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes pus drainage and detoxification, and astringes sores and promotes tissue regeneration. The *Medical Records of Integrating Chinese and Western Medicine* states: Astragalus has the best qi-tonifying effect, can help blood circulation, and relieves obstruction.

[0024] Corydalis Rhizome: pungent and bitter in taste, warm in nature; enters the liver and spleen meridians. Functions and indications: invigorates blood circulation, removes blood stasis, regulates qi, and relieves pain. The Pharmacopoeia of the People's Republic of China records: invigorates blood circulation, promotes qi flow, and relieves pain.

[0025] Tea-leaf maple: Bitter in taste and cold in nature, it enters the liver meridian. Functions and indications: It has the effects of dispelling wind and dampness, clearing heat and improving eyesight, and promoting blood circulation and unblocking collaterals. According to "Commonly Used Folk Herbs of Zhejiang," it disperses blood stasis and reduces swelling, dispels wind and relieves pain.

[0026] Artificial musk: Its functions and indications are the same as those of musk, and it has the effects of opening the orifices and refreshing the mind, promoting blood circulation and regulating menstruation, and reducing swelling and relieving pain.

[0027] The beneficial technical effects of this invention are as follows: This invention provides a traditional Chinese medicine composition for treating avascular necrosis of the femoral head, its preparation method, and its application. The composition uses Angelica sinensis, Carthamus tinctorius, and Boswellia carterii as the principal herbs, which have the effects of promoting blood circulation and removing blood stasis. It uses Aristolochia debilis, Salvia miltiorrhiza, and Commiphora myrrha as the assistant herbs, which have the effects of promoting blood circulation, removing blood stasis, clearing heat, and detoxifying. It uses Astragalus membranaceus, Acer palmatum, and Corydalis yanhusuo as adjuvant herbs, which have the effects of promoting blood circulation, relieving pain, tonifying qi, and assisting yang. Artificial musk is used as the guiding herb, which has the effects of opening the orifices, waking the mind, reducing swelling, and relieving pain. The traditional Chinese medicine composition of this invention has a reasonable formulation, and its use has a good therapeutic effect on avascular necrosis of the femoral head. Furthermore, this traditional Chinese medicine composition has mild medicinal properties, no side effects, and broad application prospects. Attached Figure Description

[0028] Figure 1 The figure shows the effect of different traditional Chinese medicine combinations on bone mineral density in Wistar rats with avascular necrosis of the femoral head. Detailed Implementation

[0029] The following is a further detailed description of the present invention in conjunction with specific preferred embodiments, and 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. Specific conditions not specified in the embodiments are performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, all reagents or instruments used are conventional products obtained through commercial channels.

[0030] Example 1 A traditional Chinese medicine composition for treating avascular necrosis of the femoral head, the composition comprising the following raw materials in parts by weight: 22 parts Angelica sinensis, 16 parts Carthamus tinctorius, 15 parts Salvia miltiorrhiza, 12 parts Boswellia carterii, 11 parts Commiphora myrrha, 6 parts Anoectochilus roxburghii, 15 parts Astragalus membranaceus, 7 parts Corydalis yanhusuo, 5 parts Acer truncatum, and 3 parts artificial musk.

[0031] The preparation method of the traditional Chinese medicine composition for treating avascular necrosis of the femoral head specifically includes the following steps: (1) Weigh out each raw material according to the following weight proportions: 22 parts Angelica sinensis, 16 parts Carthamus tinctorius, 15 parts Salvia miltiorrhiza, 12 parts Boswellia carterii, 11 parts Myrrha, 6 parts Aristolochia debilis, 15 parts Astragalus membranaceus, 7 parts Corydalis yanhusuo, 5 parts Acer truncatum, and 3 parts artificial musk. After pulverizing, pass through a 70-mesh sieve to obtain Chinese medicine powder for later use.

[0032] (2) Add the Chinese herbal powders of Angelica sinensis, Carthamus tinctorius, Salvia miltiorrhiza, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, and Acer truncatum prepared in step (1) to water with a total weight of 4 times the Chinese herbal powder, soak in water for 45 min, bring to a boil over high heat, then simmer over low heat for 60 min, and filter to obtain the first filtrate and residue.

[0033] (3) Add water to the filter residue obtained in step (2) in three times the total weight of the filter residue, soak for 35 minutes, bring to a boil over high heat and then simmer over low heat for 35 minutes, then filter to obtain the second filtrate and filter residue, combine the first filtrate and the second filtrate to obtain a mixture; concentrate the mixture into an extract with a relative density of 1.1.

[0034] (4) Add 90 v / v% ethanol, which is 7 times the total weight of the frankincense and myrrh powders prepared in step (1), to the frankincense and myrrh powders, and reflux extract at 80°C for 0.7 h. Combine the filtrates and concentrate to an extract with a relative density of 1.1. Add anhydrous ethanol to the artificial musk powders prepared in step (1) and disperse them into an artificial musk suspension. The ratio of the artificial musk powders to ethanol is 1 g: 6 mL.

[0035] (5) The extract obtained in step (4) and the artificial musk suspension are slowly added to the extract in step (3) under the conditions of ≤45 ℃, vacuum -0.06 MPa and closed nitrogen filling, and the mixture is homogenized under vacuum for 12 min to obtain the traditional Chinese medicine composition.

[0036] Example 2 A traditional Chinese medicine composition for treating avascular necrosis of the femoral head, the composition comprising the following raw materials in parts by weight: 15 parts Angelica sinensis, 7 parts Carthamus tinctorius, 10 parts Salvia miltiorrhiza, 5 parts Boswellia carterii, 4 parts Commiphora myrrha, 3 parts Anoectochilus roxburghii, 10 parts Astragalus membranaceus, 2 parts Corydalis yanhusuo, 2 parts Acer truncatum, and 1 part Musk.

[0037] The preparation method of the traditional Chinese medicine composition for treating avascular necrosis of the femoral head specifically includes the following steps: (1) Weigh out each raw material according to the following weight proportions: 15 parts Angelica sinensis, 7 parts Carthamus tinctorius, 10 parts Salvia miltiorrhiza, 5 parts Boswellia carterii, 4 parts Myrrha, 3 parts Aristolochia debilis, 10 parts Astragalus membranaceus, 2 parts Corydalis yanhusuo, 2 parts Acer truncatum, and 1 part Musk. After pulverizing, pass through a 60-mesh sieve to obtain Chinese medicine powder for later use.

[0038] (2) Add the Chinese herbal powders of Angelica sinensis, Carthamus tinctorius, Salvia miltiorrhiza, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, and Acer truncatum prepared in step (1) to water with a total weight of 3 times the Chinese herbal powder, soak in water for 40 min, bring to a boil over high heat, then simmer over low heat for 50 min, and filter to obtain the first filtrate and residue.

[0039] (3) Add water twice the total weight of the filter residue obtained in step (2), soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes, and then filter to obtain the second filtrate and filter residue. Combine the first filtrate and the second filtrate to obtain a mixture. Concentrate the mixture into an extract with a relative density of 1.0.

[0040] (4) Add 90v / v% ethanol, which is 6 times the total weight of the frankincense and myrrh powders prepared in step (1), to the frankincense and myrrh powders, and reflux at 80°C for 0.5h. Combine the filtrates and concentrate them to an extract with a relative density of 1.0. Add anhydrous ethanol to the artificial musk powders prepared in step (1) and disperse them into an artificial musk suspension. The ratio of the artificial musk powders to ethanol is 1g:5mL.

[0041] (5) The extract obtained in step (4) and the artificial musk suspension are slowly added to the extract in step (3) under the conditions of ≤45 ℃, vacuum -0.06 MPa and closed nitrogen filling, and the mixture is homogenized under vacuum for 10 min to obtain the traditional Chinese medicine composition.

[0042] Example 3 A traditional Chinese medicine composition for treating avascular necrosis of the femoral head, the composition comprising the following raw materials in parts by weight: 30 parts Angelica sinensis, 25 parts Carthamus tinctorius, 20 parts Salvia miltiorrhiza, 20 parts Boswellia carterii, 18 parts Commiphora myrrha, 9 parts Anoectochilus roxburghii, 20 parts Astragalus membranaceus, 12 parts Corydalis yanhusuo, 8 parts Acer truncatum, and 5 parts Musk.

[0043] The preparation method of the traditional Chinese medicine composition for treating avascular necrosis of the femoral head specifically includes the following steps: (1) Weigh out each raw material according to the following weight proportions: 30 parts Angelica sinensis, 25 parts Carthamus tinctorius, 20 parts Salvia miltiorrhiza, 20 parts Boswellia carterii, 18 parts Myrrha, 9 parts Aristolochia debilis, 20 parts Astragalus membranaceus, 12 parts Corydalis yanhusuo, 8 parts Acer truncatum, and 5 parts artificial musk. After pulverizing, pass through an 80-mesh sieve to obtain Chinese medicine powder for later use.

[0044] (2) Add the Chinese herbal powders of Angelica sinensis, Carthamus tinctorius, Salvia miltiorrhiza, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, and Acer truncatum prepared in step (1) to water at a ratio of 5 times the total weight of the Chinese herbal powders, soak in water for 50 min, bring to a boil over high heat, then simmer over low heat for 70 min, and filter to obtain the first filtrate and residue.

[0045] (3) Add water to the filter residue obtained in step (2) in 4 times the total weight of the filter residue, soak for 40 minutes, bring to a boil over high heat and then simmer over low heat for 40 minutes, then filter to obtain the second filtrate and filter residue, mix the first filtrate and the second filtrate to obtain a mixture; concentrate the mixture to an extract with a relative density of 1.2.

[0046] (4) Add 8 times the total weight of the frankincense and myrrh powders prepared in step (1) to 90 v / v% ethanol, and reflux extract at 80°C for 1 h. Combine the filtrates and concentrate to an extract with a relative density of 1.2. Add anhydrous ethanol to the artificial musk powders prepared in step (1) and disperse to form an artificial musk suspension. The ratio of the amount of artificial musk powder to ethanol is 1 g: 7 mL.

[0047] (5) The extract obtained in step (4) and the artificial musk suspension are slowly added to the extract in step (3) under the conditions of ≤45 ℃, vacuum -0.06 MPa and closed nitrogen filling, and the mixture is homogenized under vacuum for 15 min to obtain the traditional Chinese medicine composition.

[0048] Comparative Example 1 The difference between Comparative Example 1 and Example 1 is that the tea-leaf maple is omitted, while everything else is the same as in Example 1.

[0049] Comparative Example 2 The difference between Comparative Example 2 and Example 1 is that the gold thread wind is omitted, while everything else is the same as Example 1.

[0050] Comparative Example 3 The difference between Comparative Example 2 and Example 1 is that the golden thread wind is replaced with Panax notoginseng, and everything else is the same as Example 1.

[0051] Experimental Example 1 Animal model bone mineral density test results: Ninety Wistar rats were selected as research subjects in this experiment. After one week of acclimatization, they were randomly divided into a blank control group, a model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and a positive group, with 10 rats in each group. Except for the blank control group, the other groups were used to establish a hormone-induced femoral head necrosis model according to the modified Yamamoto method: a single intramuscular injection of lipopolysaccharide 10 μg / kg, followed by an intramuscular injection of methylprednisolone 20 mg / kg 24 h later, for three consecutive times, with an interval of 24 h between each injection. After successful modeling, the rats were administered the traditional Chinese medicine composition prepared in Examples 1-3 and Comparative Examples 1-3 of this invention by gavage (based on crude drug, 2.0 g / kg body weight per Wistar rat, once a day). The positive control group was administered Qianggu capsules by gavage (2.0 g / kg, once a day). The model group and the blank control group were given an equal volume of physiological saline. The administration was continued for 12 weeks.

[0052] (1) After 12 weeks, the animals in each group were sacrificed, and the femoral head of one side of the animal was harvested. Soft tissue was removed, and bone mineral density was measured. The effect of the traditional Chinese medicine composition on bone mineral density in rats with avascular necrosis of the femoral head is as follows: Figure 1 As shown.

[0053] The results are as follows Figure 1 The image shows the effect of a traditional Chinese medicine composition on bone mineral density (BMD) in Wistar rats with avascular necrosis of the femoral head. BMD is a core pathological feature of avascular necrosis of the femoral head and a key indicator for assessing its progression. Figure 1 It can be seen that the bone mineral density of rats in the femoral head necrosis model group was significantly lower than that in the blank control group, indicating that methylprednisolone successfully induced the femoral head ischemic necrosis model. Compared with comparative groups 1-3, the traditional Chinese medicine composition for treating femoral head ischemic necrosis prepared in Examples 1-3 of this invention can significantly increase the bone mineral density of rats, significantly improve and approach the normal level.

[0054] (2) Then remove the femoral head on the other side of the animal, fix it in 70% ethanol for 24 hours, freeze it, section it, stain it with Lillie Oil Red O, observe the distribution of fat, and calculate the proportion of fat-stained chondrocytes and osteocytes. The results are shown in Table 1.

[0055] Table 1. Effects of Traditional Chinese Medicine Composition on Fat Deposition in Bone Tissue of Wistar Rats with Avascular Necrosis of the Femoral Head The results are shown in Table 1, which illustrates the effect of the traditional Chinese medicine composition on fat deposition in the bone tissue of Wistar rats with avascular necrosis of the femoral head. As shown in Table 1, compared with comparative groups 1-3, the traditional Chinese medicine compositions for treating avascular necrosis of the femoral head prepared in Examples 1-3 of this invention significantly reduced the fat staining rate of necrotic chondrocytes and osteocytes in the femoral head, significantly improving and approaching normal levels. Among them, the traditional Chinese medicine composition prepared in Example 1 had the lowest fat staining rate.

[0056] In conclusion, the traditional Chinese medicine composition made from Angelica sinensis, safflower, Salvia miltiorrhiza, frankincense, myrrh, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, Acer truncatum, and artificial musk has a significant effect on improving avascular necrosis of the femoral head.

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. The basic principles and main features of the present invention have been described above with specific implementation schemes. Based on the present invention, some modifications or substitutions can be made, but these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating avascular necrosis of the femoral head, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica sinensis 15-30 parts, Carthamus tinctorius 7-25 parts, Salvia miltiorrhiza 10-20 parts, Boswellia carterii 5-20 parts, Commiphora myrrha 4-18 parts, Anoectochilus roxburghii 3-9 parts, Astragalus membranaceus 10-20 parts, Corydalis yanhusuo 2-12 parts, Acer truncatum 2-8 parts, and Artificial musk 1-5 parts.

2. The traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 22 parts Angelica sinensis, 16 parts Carthamus tinctorius, 15 parts Salvia miltiorrhiza, 12 parts Boswellia carterii, 11 parts Commiphora myrrha, 6 parts Anoectochilus roxburghii, 15 parts Astragalus membranaceus, 7 parts Corydalis yanhusuo, 5 parts Acer truncatum, and 3 parts artificial musk.

3. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh out each raw material according to the weight proportions: Angelica sinensis, safflower, Salvia miltiorrhiza, frankincense, myrrh, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo, Acer truncatum, artificial musk, pulverize and sieve to obtain Chinese medicine powder for later use; (2) Soak the Chinese herbal powders of Angelica sinensis, Carthamus tinctorius, Salvia miltiorrhiza, Aristolochia debilis, Astragalus membranaceus, Corydalis yanhusuo and Acer truncatum prepared in step (1) in water, bring to a boil over high heat, then simmer over low heat, and filter to obtain the first filtrate and residue. (3) Soak the filter residue obtained in step (2) in water, bring it to a boil over high heat, then simmer over low heat, filter to obtain the second filtrate and filter residue, combine the first filtrate and the second filtrate to obtain a mixture; concentrate the mixture to extract. (4) Add ethanol to extract the frankincense and myrrh powders prepared in step (1), combine the filtrates and concentrate them into an extract; add anhydrous ethanol to the artificial musk powders prepared in step (1) and disperse them into an artificial musk suspension. (5) The extract obtained in step (4) and the artificial musk suspension are slowly added to the extract in step (3) under certain conditions and then homogenized under vacuum to obtain the traditional Chinese medicine composition.

4. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 3, characterized in that, The mesh size of the sieve in step (1) is 60-80.

5. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 3, characterized in that, In step (2), the amount of water added is 3-5 times the total weight of the raw materials and powders, and the soaking time is 40-50 minutes; the simmering time is 50-70 minutes.

6. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 3, characterized in that, In step (3), the amount of water added is 2-4 times the total weight of the filter residue, the soaking time is 30-40 minutes, the simmering time is 30-40 minutes, and the extract is an extract with a relative density of 1.0-1.

2.

7. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 3, characterized in that, In step (4), the amount of ethanol added is 6-8 times the total weight of the frankincense and myrrh powder; the reflux extraction time is 0.5-1h; the extract is an extract with a relative density of 1.0-1.2; the ratio of the amount of artificial musk powder to ethanol is 1g:(5-7)mL.

8. The method for preparing the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 3, characterized in that, The conditions in step (5) are ≤45 ℃, vacuum -0.06 MPa, and closed nitrogen filling; the time for vacuum homogenization is 10-15 min.

9. The use of the traditional Chinese medicine composition for treating avascular necrosis of the femoral head according to claim 1 or 2 in the preparation of a drug for treating avascular necrosis of the femoral head.

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