Traditional Chinese medicine composition for treating phlegm-dampness stagnation type femoral head necrosis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating phlegm-dampness stagnation type femoral head necrosis as well as a preparation method and application of the traditional Chinese medicine composition, which can effectively solve the medication problem of phlegm-dampness stagnation type ulcerative femoral head necrosis. The traditional Chinese medicine is prepared from, by weight, 11-19 g of poria cocos, 15-25 g of semen coicis, 7-11 g of rhizoma alismatis, 9-15 g of pericarpium citri reticulatae, 8-13 g of radix ophiopogonis, 11-19 g of angelica sinensis, 9-15 g of ligusticum wallichii, 7-11 g of pinellia ternate, 7-11 g of semen brassicae, 5-8 g of fructus amomi, 5-8 g of rhizoma cyperi, 8-13 g of fructus psoraleae, 9-15 g of radix dipsaci, 5-8 g of black prepared common monkshood daughter root, 9-15 g of rhizoma sparganii, 9-15 g of curcuma zedoary and 5-8 g of liquorice. The traditional Chinese medicine composition is scientific in preparation, has the effects of warming kidney yang, clearing damp and tonifying spleen, has a remarkable effect of treating the phlegm-dampness stagnation type femoral head necrosis, has a good long-term curative effect, is not easy to relapse, is easily accepted by patients, and is an innovation of medicines for treating the phlegm-dampness stagnation type femoral head necrosis.

Description

1. Technical Field

[0001] The invention relates to the field of medicine, in particular to a traditional Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis and a preparation method and application thereof. 2. Background Technology

[0002] Femoral head necrosis is a common clinical orthopedic disease. It is difficult to treat and disabling. It is a pathological evolution process. It often starts in the weight-bearing area of ​​the femoral head. Under the action of force, the necrotic bone structure is damaged, resulting in repeated imperfect repair, resulting in changes in the femoral head structure or collapse and deformation. Femoral head necrosis will cause severe pain and joint mobility dysfunction in patients. Common clinical symptoms include pain, which is mostly located in the hip joint and proximal thigh, resulting in limited hip movement, especially limited rotational movement, or painful and shortened claudication, which seriously endangers the patient's quality of life and even life safety. The current incidence of ONFH is increasing year by year, seriously affecting the quality of life of patients and bringing a considerable economic burden to their families. Studies have shown that patients with ONFH who have not been effectively treated will experience femoral head collapse within 1 to 5 years of onset, which directly affects the function of the hip joint, and ultimately can only be improved through joint replacement surgery. At present, hip preservation treatment is mainly adopted for early and middle-stage ONFH at home and abroad to stabilize the morphology of the femoral head and delay collapse, thereby delaying the time for hip replacement surgery.

[0003] Femoral head necrosis belongs to the category of "bone atrophy" and "bone failure" in traditional Chinese medicine. "The kidney governs bones, the liver governs tendons, and bones produce marrow." Traditional Chinese medicine believes that the main causes of this disease are liver and kidney deficiency, insufficient qi and blood, lack of nourishment to tendons and bones, joint strain, cold and dampness, and blood stasis. The root cause of this disease is liver and kidney deficiency. This disease is prone to recurrence. For this reason, traditional Chinese medicine treatment advocates that this disease is mostly due to deficiency in the root and excess in the superficial, with liver and kidney deficiency and spleen and stomach dysfunction. The kidney-tonifying and bone-strengthening method has the effect of nourishing the liver and kidney and strengthening tendons and bones, which can effectively improve the symptoms of such patients. Chinese herbal decoctions can improve the Harris and JOA scores of patients with femoral head ischemic necrosis, relieve their pain, and are safer. Traditional Chinese medicine conservative treatment has unique therapeutic advantages in preventing and treating femoral head necrosis, and has an improving effect on blood rheology and blood lipids. We believe that femoral head necrosis is not single in terms of pathogenesis, and is related to multiple organs such as the liver, kidney, spleen, bladder, etc., but is most closely related to the liver and kidney. The kidney governs the bones, and bone diseases are treated from the perspective of the kidney. It is in line with the theory of traditional Chinese medicine to take tonifying the kidney as the fundamental way to achieve the treatment goal of strengthening tendons and bones. However, patients with internal obstruction of phlegm and dampness are also part of the treatment in clinical work, but there are few existing studies. In view of this, the inventors proposed phlegm-dampness internal obstruction type femoral head necrosis, and invented a Chinese medicine composition for treating phlegm-dampness internal obstruction type femoral head necrosis, as well as its preparation method and application. III. Summary of the invention

[0004] In view of the above situation, in order to solve the defects of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis and its preparation method and application, which can effectively solve the medication problem of phlegm-dampness internal resistance type ulcerative femoral head necrosis.

[0005] The inventor found that the body shape of patients with TCM syndrome differentiation of phlegm-dampness obstruction is often obese, the flesh of the abdomen is plump and soft, the mouth is sticky and white and greasy, the stool is often sticky but not smelly, and there is often a feeling of heaviness and soreness of the limbs. The tongue is red, the tongue coating is white and greasy, and the pulse is often slippery. Based on this, the technical solution solved by the present invention is a traditional Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis, which is made of the following raw materials by weight: Poria 11-19g, Coix seed 15-25g, Alisma orientalis 7-11g, Tangerine peel 9-15g, Ophiopogon japonicus 8-13g, Angelica sinensis 11-19g, Ligusticum chuanxiong 9-15g, Pinellia 7-11g, Sinapis alba 7-11g, Amomum villosum 5-8g, Cyperus rotundus 5-8g, Psoralea corylifolia 8-13g, Dipsacus asper 9-15g, Heishun Pian 5-8g, Trillium 9-15g, Curcuma 9-15g and Licorice 5-8g.

[0006] Preferably, the Chinese medicine composition is made of the following raw materials by weight: 15g Poria, 20g Coix Seed, 9g Alisma, 12g Tangerine Peel, 10g Ophiopogon, 15g Angelica, 12g Chuanxiong, 9g Pinellia, 9g Sinapis, 6g Amomum, 6g Cyperus, 10g Psoralea, 12g Dipsacus, 6g Heishun, 12g Trillium, 12g Curcuma and 6g Licorice.

[0007] Furthermore, the Chinese medicine composition can be prepared into different dosage forms such as decoctions, pills, granules, tablets, ointments, etc. with medically acceptable excipients.

[0008] Furthermore, the preparation method of the Chinese medicine composition is as follows: add 400-600 ml of water to the raw material medicine, soak for 15-25 minutes at 18-25°C, then boil over high heat, then turn to low heat, boil for 20-30 minutes, filter, obtain filtrate, and set aside; add 300-400 ml of water to the residue, boil over high heat, then turn to low heat, boil for 10-15 minutes, filter, discard the residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 2-1 / 3 of the amount of water added twice.

[0009] Furthermore, the Chinese medicine composition is used in the preparation of a drug for treating phlegm-dampness internal resistance type femoral head necrosis.

[0010] The invention has abundant raw materials, simple preparation method, effective combination of prescription drugs, mutual support, and scientific preparation, and has the effects of warming kidney yang, removing dampness and strengthening spleen. It has significant effect in treating phlegm-dampness internal resistance type femoral head necrosis, and has good long-term efficacy, is not easy to recur, and is easily accepted by patients. It is an innovation in drugs for treating phlegm-dampness internal resistance type femoral head necrosis. IV. Description of the drawings

[0011] Figure 1 These are the results of the in vitro cell experiments of the present invention. V. Specific implementation methods

[0012] The specific implementation modes of the present invention are further described in detail below in conjunction with the embodiments.

[0013] Example 1

[0014] In the specific implementation of the present invention, the Chinese medicine soup can be made from the following raw materials by weight: it is made from the following raw materials by weight: 11g of Poria cocos, 15g of Coix seed, 7g of Alisma orientalis, 9g of dried orange peel, 8g of Ophiopogon japonicus, 11g of Angelica sinensis, 9g of Ligusticum chuanxiong, 7g of Pinellia ternata, 7g of Sinapis alba, 5g of Amomum villosum, 5g of Cyperus rotundus, 8g of Psoralea corylifolia, 9g of Dipsacus asper, 5g of Heishun Pian, 9g of Trillium, 9g of Curcuma zedoaria and 5g of Licorice.

[0015] The preparation method is as follows: add 400 ml of water to the above raw material drugs, soak for 15 minutes at 18°C, then boil over high heat, then turn to low heat, boil for 20 minutes, filter, obtain filtrate, and set aside; add 300 ml of water to the residue, boil over high heat, then turn to low heat, boil for 10 minutes, filter, discard the residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 2 of the amount of water added twice.

[0016] Example 2

[0017] In the specific implementation of the present invention, the Chinese medicine soup can also be made from the following raw materials by weight: it is made from the following raw materials by weight: 15g of Poria, 20g of Coix Seed, 9g of Alisma, 12g of Tangerine Peel, 10g of Ophiopogon, 15g of Angelica, 12g of Chuanxiong, 9g of Pinellia, 9g of White Sinapis, 6g of Amomum, 6g of Cyperus, 10g of Psoralea, 12g of Dipsacus, 6g of Heishun Pian, 12g of Trillium, 12g of Curcuma and 6g of Licorice.

[0018] The preparation method is as follows: add 500 ml of water to the above raw material drugs, soak for 20 minutes at 21°C, then boil over high heat, then turn to low heat, boil for 25 minutes, filter, obtain filtrate, and set aside; add 350 ml of water to the residue, boil over high heat, then turn to low heat, boil for 12 minutes, filter, discard the residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 3 of the amount of water added twice.

[0019] Example 3

[0020] When the present invention is implemented, the Chinese medicine soup can also be made from the following raw materials by weight: 19g of Poria, 25g of Coix Seed, 11g of Alisma, 15g of Tangerine Peel, 13g of Ophiopogon, 19g of Angelica, 15g of Ligusticum chuanxiong, 11g of Pinellia, 11g of White Sinapis, 8g of Amomum, 8g of Cyperus, 13g of Psoralea, 15g of Dipsacus, 8g of Heishun Pian, 15g of Trillium, 15g of Curcuma and 8g of Licorice.

[0021] The preparation method is as follows: add 600 ml of water to the above raw material drugs, soak for 25 minutes at 25°C, then boil over high heat, then turn to low heat, boil for 30 minutes, filter, obtain filtrate, and set aside; add 400 ml of water to the residue, boil over high heat, then turn to low heat, boil for 15 minutes, filter, discard the residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 2 of the amount of water added twice.

[0022] In the prescription of the present invention:

[0023] Poria cocos tastes sweet and mild, and is neutral in nature. It enters the spleen, kidney, heart, and lung meridians. It strengthens the spleen and calms the heart, and promotes diuresis and eliminates dampness.

[0024] Coix seeds are sweet, light, and cool in nature. They enter the spleen, stomach, and lung meridians. They can promote diuresis and eliminate dampness, strengthen the spleen and stop diarrhea, and eliminate numbness.

[0025] Alisma orientalis is sweet and light in taste, and cold in nature. It enters the kidney and bladder meridians. It can promote diuresis, dissipate dampness, relieve heat, clear turbidity and reduce fat.

[0026] Tangerine peel tastes bitter and spicy, and is warm in nature. It enters the spleen and lung meridians. It regulates qi and strengthens the spleen, dries dampness and resolves phlegm.

[0027] Ophiopogon japonicus tastes sweet, slightly bitter, and slightly cold. It enters the heart, stomach, and lung meridians. It benefits the stomach and produces body fluid, nourishes yin and moistens the lungs, and clears the heart and relieves restlessness.

[0028] Angelica sinensis is sweet, spicy and warm in nature. It enters the spleen, liver and heart meridians. It nourishes blood, promotes blood circulation, removes blood stasis and relieves pain.

[0029] Chuanxiong is pungent and warm in nature. It enters the liver, gallbladder and pericardium meridians. It promotes blood circulation, qi circulation, dispels wind and relieves pain.

[0030] Pinellia tuber is pungent in taste and warm in nature. It enters the spleen, stomach and lung meridians. It dries dampness and resolves phlegm, relieves adverse reactions and stops vomiting, and eliminates lumps and resolves masses.

[0031] White mustard seeds are pungent and warm in nature. They enter the lung and stomach meridians. They warm the lungs and resolve phlegm, promote qi and resolve stagnation, and relieve pain.

[0032] Amomum villosum is pungent and warm in nature. It enters the spleen, stomach and kidney meridians. It regulates qi, eliminates dampness, stimulates appetite, warms the spleen and stops diarrhea.

[0033] Cyperus rotundus is pungent, slightly bitter, slightly sweet, and neutral in nature. It enters the liver, spleen, and triple burner meridians. It soothes the liver and relieves depression, regulates qi, and relieves fullness.

[0034] Psoralea corylifolia tastes pungent and bitter, and is warm in nature. It enters the spleen and kidney meridians. It nourishes the kidney and strengthens yang, warms the spleen and stops diarrhea, consolidates semen and reduces urine.

[0035] Dipsacus root tastes bitter and pungent, and is slightly warm in nature. It enters the liver and kidney meridians. It nourishes the liver and kidneys, strengthens the tendons and bones, regulates qi and blood, and warms the kidneys and strengthens yang.

[0036] Heishun tablets are pungent and sweet, and very hot in nature. They enter the spleen, kidney, and heart meridians. They replenish fire, boost yang, dispel cold, and relieve pain.

[0037] Trigonum multiflorum is bitter in taste and neutral in nature. It enters the liver and spleen meridians. It can promote blood circulation, relieve swelling and relieve pain.

[0038] Curcuma zedoaria is pungent and bitter in taste and warm in nature. It enters the liver, spleen and stomach meridians. It promotes qi and resolves blood, eliminates stagnation and relieves pain.

[0039] Licorice root is sweet and neutral in nature. It enters the spleen, stomach, heart and lung meridians. It nourishes the spleen and replenishes qi, relieves pain and harmonizes various medicines.

[0040] The effective combination of the above-mentioned drugs supports each other and is scientifically prepared, and has the function of removing dampness and resolving phlegm. In the prescription, Poria cocos and Coix seed are the main drugs for strengthening the spleen, promoting diuresis and eliminating dampness, while Tangerine peel is used to dry dampness and resolve phlegm. Angelica sinensis, Chuanxiong rhizome, Trillium and Curcuma zedoaria are used to promote blood circulation and promote qi, Ophiopogon japonicus is used to benefit the stomach and promote body fluid, Psoralea corylifolia and Dipsacus asper are used to nourish the liver and kidney, and strengthen the tendons and bones, which enhance the effects of removing dampness and resolving phlegm, nourishing the liver and kidney, and strengthening the tendons and bones; Alisma orientalis is used to promote diuresis and eliminate dampness, Pinellia ternata is used to dry dampness and resolve phlegm, Sinapis alba is used to resolve phlegm and promote qi, Amomum villosum is used to harmonize the stomach and eliminate dampness, Cyperus rotundus is used to soothe the liver and regulate qi, Heishun tablets are used as adjuvants, and Licorice is used to nourish the spleen and replenish qi and harmonize the various drugs. The mutual compatibility in the treatment of phlegm-damp internal resistance type femoral head necrosis is effective, and experiments have achieved very good beneficial technical effects. The relevant experimental data are as follows:

[0041] 1Case Source

[0042] This study selected 60 patients with phlegm-dampness internal resistance type femoral head necrosis who visited the inpatient department of osteonecrosis at Luoyang Orthopedic Hospital of Henan Province from January 2022 to October 2023 as the research subjects.

[0043] 2 Diagnostic criteria

[0044] The diagnostic criteria were developed based on the 2012 edition of the Expert Consensus on Diagnosis and Treatment Standards for Femoral Head Necrosis in Adults.

[0045] (1) Clinical symptoms, signs and medical history: joint pain mainly in the groin, buttocks and thighs, occasionally accompanied by knee pain, limited hip flexion, internal rotation and external rotation, often with a history of hip trauma, corticosteroid use, alcoholism and occupational history such as diving;

[0046] (2) X-ray changes: In the early stage of femoral head necrosis, the femoral head will show increased density (sclerosis) and translucent areas (cystic changes); as the disease progresses, a typical crescent sign will appear; in the late stage, the femoral head may collapse, the joint space may narrow, and severe bone and joint changes may occur, with sclerosis and cystic changes in the acetabulum being common;

[0047] (3) CT scan changes: sclerotic bands surrounding necrotic bone, repaired bone, or subchondral bone fractures can be seen in the femoral head;

[0048] (4) MRI signs: T1WI shows a band-like low signal in the necrotic area or T2WI shows a double-line sign;

[0049] (5) Radionuclide bone scan: In the early stage of necrosis, there is a perfusion defect (cold area); as the disease progresses, there is a cold area in the hot area, which is a "doughnut-like" change;

[0050] (6) Bone biopsy: showed that the empty pits of osteocytes in trabeculae accounted for more than 50% and involved multiple adjacent trabeculae, with bone marrow necrosis.

[0051] The diagnosis can be confirmed if two or more of the above six criteria are met. Except for (1) and (5), the diagnosis can be confirmed if one of (2, 3, 4, 6) is met.

[0052] 3 The staging criteria are based on the 2019 Association Research Circulation Osseuse (ARCO) osteonecrosis staging criteria, as shown in Table 1.

[0053] Table 1 ARCO staging of femoral head necrosis

[0054]

[0055] People with phlegm-dampness obstruction are usually obese, with plump and soft abdominal flesh, sticky white and greasy mouth coating, sticky but not smelly stools, and often feel sore, tired and heavy in the limbs. The tongue is red, with a white and greasy coating, and the pulse is often slippery.

[0056] 4 Inclusion criteria

[0057] (1) Meet the diagnostic criteria for femoral head necrosis;

[0058] (2) those receiving conservative treatment;

[0059] (3) The primary disease is cured or in a stable stage;

[0060] (4) Those who are not accompanied by bone metabolic diseases, ankylosing spondylitis, bone tumors, various arthritis and other bone diseases;

[0061] (5) Be at least 18 years old and have the capacity to act independently;

[0062] (6) Patients who voluntarily participate in clinical research and sign the informed consent form.

[0063] 5 Exclusion criteria

[0064] (1) The primary disease has not been effectively controlled or is in the active stage;

[0065] (2) Patients with femoral head necrosis who refuse conservative treatment;

[0066] (3) Patients with other internal and external diseases other than the primary disease who require long-term medication;

[0067] (4) Pregnant or lactating women;

[0068] (5) Those who are currently participating in clinical trials of other drugs;

[0069] (6) Those who dropped out of the study or were lost to follow-up due to various reasons.

[0070] 6 Research Groups

[0071] Patients with femoral head necrosis who received conservative treatment in Luoyang Orthopedic Hospital of Henan Province from January 2022 to October 2023 were selected as the research subjects. Patients were numbered from 1 to 60 according to the order of visit, and random numbers were generated using SPSS27.0. Patients were divided into treatment group and control group according to the random grouping principle, with 30 cases in each group.

[0072] 7. Medication

[0073] Treatment duration: 12 weeks

[0074] Control group: Xianling Gubao.

[0075] Treatment group: Xianling Gubao (specific usage is the same as the control group) combined with the Chinese medicine soup prepared in Example 2 of the present invention, 200 ml each time, once in the morning and once in the evening.

[0076] 8. Efficacy evaluation criteria

[0077] Harris score of hip joint function and visual analogue scale (VAS pain score) were observed in the two groups before treatment and 12 weeks after treatment, and the differences between the two groups before and after treatment were compared and analyzed.

[0078] 9 Clinical efficacy evaluation

[0079] After treatment, the P values ​​of Harris score and VAS pain score were less than 0.05, and the difference between the two groups was statistically significant. The therapeutic effect of the treatment group was better than that of the control group. The clinical efficacy evaluation is shown in Table 2.

[0080] Table 2 Comparison of Harris score and VAS pain score

[0081]

[0082] 10 In vitro cell experiments

[0083] Twelve 4-week-old SD rats were randomly divided into two groups, a control group and an experimental group. The control group was given Xianlinggubao solution by gavage, and the experimental group was given Xianlinggubao and the mixed solution of the Chinese medicine decoction of the present invention by gavage, once a day, for a total of 14 days. Two hours after the last gavage intervention, the abdominal aorta blood of the rats was collected, centrifuged, inactivated, sterilized, and then packaged, and the serum was stored at -20°C for later use.

[0084] Four SD rats were anesthetized with 20% urethane and then killed. The femoral and tibia bone marrows of the rats were taken out for BMSCs culture. The cells were passaged when the confluence reached 80% to 90%, and the cell morphology and growth were observed under an inverted microscope. The third-generation rat BMSCs were made into a single cell suspension, and the cells were inoculated into a 6-well plate and divided into a control group and an experimental group. The control group was cultured with an osteogenic induction agent containing rat serum containing Xianling Gubao, and the experimental group was cultured with an osteogenic induction agent containing rat serum containing Xianling Gubao and Chinese herbal decoction. After 21 days of culture, alizarin red staining was performed to observe the cell osteogenesis. The results showed that the formation and deposition of extracellular mineralized nodules occurred in each group, among which the positive staining area in the experimental group was larger and the mineralized nodules were obvious. This suggests that the Chinese herbal decoction of the present invention can enhance the osteogenic differentiation of BMSCs. Figure 1 shown.

[0085] 11. Safety Assessment

[0086] No adverse reactions occurred in the 60 patients during the treatment period, and no obvious abnormalities were found in vital signs, blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, and coagulation function after taking the medicine, indicating that the Chinese medicine of the present invention has good safety.

[0087] After repeated tests and practices, other embodiments all obtained the same or similar test results as Embodiment 2, which will not be described in detail one by one.

[0088] 12 Conclusion

[0089] It can be seen from the above that the present invention has abundant raw materials, simple preparation method, easy to take, low cost, good effect, and the components support each other. It has the effects of warming the kidney yang and tending to strengthen the spleen. The whole prescription not only has stable efficacy, but also good long-term efficacy, is not easy to recur, and is easily accepted by patients. It is effectively used to treat phlegm-dampness internal resistance type femoral head necrosis. The Chinese medicine soup of the present invention, which is characterized by simplicity, convenience, low cost and effectiveness, not only conforms to the pathogenesis of femoral head necrosis, but also conforms to the theory of warming and tonifying the spleen and kidney in traditional Chinese medicine. It is an innovation in drugs for treating femoral head necrosis, and has huge economic and social benefits.

[0090] Although the present invention has been described above through embodiments, those skilled in the art should understand that without departing from the spirit and substance of the present invention, all improvements and modifications made to the present invention should fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis, characterized in that: The invention is prepared from the following raw materials by weight: 11-19g of Poria cocos, 15-25g of Coix seed, 7-11g of Alisma orientalis, 9-15g of dried orange peel, 8-13g of Ophiopogon japonicus, 11-19g of Angelica sinensis, 9-15g of Ligusticum chuanxiong, 7-11g of Pinellia ternata, 7-11g of Sinapis alba, 5-8g of Amomum villosum, 5-8g of Cyperus rotundus, 8-13g of Psoralea corylifolia, 9-15g of Dipsacus asper, 5-8g of Heishun Pian, 9-15g of Trillium gracile, 9-15g of Curcuma zedoaria and 5-8g of Licorice root.

2. The Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: 15g of Poria, 20g of Coix Seed, 9g of Alisma, 12g of Tangerine Peel, 10g of Ophiopogon, 15g of Angelica, 12g of Chuanxiong, 9g of Pinellia, 9g of White Sinapis, 6g of Amomum, 6g of Cyperus, 10g of Psoralea, 12g of Dipsacus, 6g of Heishun, 12g of Tripterygium, 12g of Curcuma and 6g of Licorice.

3. The Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: 11g of Poria cocos, 15g of Coix seed, 7g of Alisma orientalis, 9g of dried orange peel, 8g of Ophiopogon japonicus, 11g of Angelica sinensis, 9g of Ligusticum chuanxiong, 7g of Pinellia ternata, 7g of Sinapis alba, 5g of Amomum villosum, 5g of Cyperus rotundus, 8g of Psoralea corylifolia, 9g of Dipsacus asper, 5g of Heishun Pian, 9g of Trillium, 9g of Curcuma zedoaria and 5g of Licorice.

4. The Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: 19g of Poria cocos, 25g of Coix seed, 11g of Alisma orientalis, 15g of dried tangerine peel, 13g of Ophiopogon japonicus, 19g of Angelica sinensis, 15g of Ligusticum chuanxiong, 11g of Pinellia ternata, 11g of Sinapis alba, 8g of Amomum villosum, 8g of Cyperus rotundus, 13g of Psoralea corylifolia, 15g of Dipsacus asper, 8g of Heishun Pian, 15g of Trillium, 15g of Curcuma zedoaria and 8g of Licorice.

5. The method for preparing the Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis according to any one of claims 1 to 4, characterized in that: It can be prepared into decoction, pills, granules, tablets and ointments with medically acceptable auxiliary materials.

6. The method for preparing the Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis according to claim 5, characterized in that: Add 400-600ml of water to the raw material medicine, soak for 15-25min at 18-25℃, then boil over high heat, then turn to low heat, boil for 20-30min, filter, and obtain the filtrate for later use; add 300-400ml of water to the residue, boil over high heat, then turn to low heat, boil for 10-15min, filter, discard the residue, and obtain the filtrate, combine the two filtrates, and concentrate to 1 / 2-1 / 3 of the amount of water added twice.

7. Use of the traditional Chinese medicine composition for treating phlegm-dampness internal resistance type femoral head necrosis as described in any one of claims 1 to 4 in the preparation of drugs for phlegm-dampness internal resistance type femoral head necrosis.

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