Traditional Chinese medicine composition for treating spleen-kidney yang deficiency 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 spleen-kidney-yang deficiency type femoral head necrosis as well as a preparation method and application of the traditional Chinese medicine composition, and can effectively solve the medication problem of the spleen-kidney-yang deficiency type femoral head necrosis. The traditional Chinese medicine composition is prepared from the following raw material medicines by weight: 10-20 g of poria cocos, 8-16 g of prepared rehmannia root, 14-26 g of Chinese yam, 7-13 g of dogwood, 7-11 g of cinnamon, 8-16 g of angelica sinensis, 5-7 g of black prepared aconite root, 10-20 g of fructus psoraleae, 7-11 g of eucommia ulmoides, 10-20 g of astragalus membranaceus, 8-16 g of herba epimedii, 7-13 g of vinegar curcuma zedoary, 7-13 g of vinegar rhizoma sparganii, 10-20 g of radix cyathulae and 5-7 g of liquorice. The traditional Chinese medicine composition has the effects of warming kidney yang, clearing damp and tonifying spleen, has a remarkable effect of treating the spleen-kidney yang deficiency type femoral head necrosis, is good in long-term curative effect, not easy to relapse and easy to accept by patients, and is an innovation of medicines for treating the spleen-kidney yang deficiency 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 spleen-kidney yang deficiency 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 or collapse and deformation of the femoral head structure. 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 ONFH patients who have not been effectively treated will experience femoral head collapse within 1-5 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 the disease are liver and kidney deficiency, insufficient qi and blood, malnutrition of tendons and bones, joint strain, cold and dampness, and blood stasis. The root cause of the disease is liver and kidney deficiency. The disease is prone to recurrence. For this reason, traditional Chinese medicine treatment advocates that the disease is mostly due to deficiency in the root and excess in the superficial, with a mixture of deficiency and excess, liver and kidney deficiency, and spleen and stomach dysfunction. The kidney-tonifying and bone-strengthening method has the effects of tonifying the liver and kidney and strengthening tendons and bones, and can effectively improve the symptoms of such patients. Chinese medicine decoctions can improve the Harris and JOA scores of patients with ischemic necrosis of the femoral head and relieve their pain, which is 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. Therefore, it is imperative to invent a Chinese medicine composition for treating spleen and kidney yang deficiency type femoral head necrosis and 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 spleen and kidney yang deficiency type femoral head necrosis and its preparation method and application, which can effectively solve the medication problem of spleen and kidney yang deficiency type femoral head necrosis.

[0005] Femoral head necrosis of spleen and kidney yang deficiency, Chinese medicine dialectical manifestations of spleen and kidney yang deficiency, chills, cold hands and feet, mental depression, clear and long urine, loose stools, backache, fatigue, cold hands and feet, cold stomach, back, waist and knees. Wear more clothes than ordinary people, can't tolerate air conditioning in summer, like quiet, like hot drinks, and feel uncomfortable when eating raw and cold food. Easy to have loose stools, clear urine. The tongue coating is light, fat and tender, with teeth marks on the edge of the tongue coating, and the pulse is deep and slow.

[0006] Based on this, the technical solution solved by the present invention is that the traditional Chinese medicine composition is made of the following raw materials by weight: 10-20g of Poria cocos, 8-16g of Rehmannia glutinosa, 14-26g of Dioscorea opposita, 7-13g of Cornus officinalis, 7-11g of Cinnamon bark, 8-16g of Angelica sinensis, 5-7g of Heishun Pian, 10-20g of Psoralea corylifolia, 7-11g of Eucommia ulmoides, 10-20g of Astragalus membranaceus, 8-16g of Epimedium, 7-13g of Curcuma zedoariae, 7-13g of Trillium wilfordii, 10-20g of Cyathula capitata and 5-7g of Licorice.

[0007] Preferably, the Chinese medicine composition is made of the following raw materials by weight: 15g of Poria, 12g of Rehmannia glutinosa, 20g of Dioscorea opposita, 10g of Cornus officinalis, 9g of Cinnamon bark, 12g of Angelica sinensis, 6g of Heishun Pian, 15g of Psoralea corylifolia, 9g of Eucommia bark, 15g of Astragalus membranaceus, 12g of Epimedium, 10g of Curcuma zedoaria, 10g of Trillium wilfordii, 15g of Cyathula capitata, and 6g of Licorice.

[0008] The preparation method of the Chinese medicine composition can be made into different dosage forms such as decoction, pills, tablets, granules, pastes, etc.

[0009] Furthermore, the preparation method of the water decoction is as follows: add 400-600 ml of water to the above raw material drugs, 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 filter residue, boil over high heat, then turn to low heat, boil for 10-15 minutes, filter, discard the filter residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 2-1 / 3 of the amount of water added twice.

[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 femoral head necrosis of spleen and kidney yang deficiency type, 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 femoral head necrosis of spleen and kidney yang deficiency type. IV. Description of the drawings

[0011] Figure 1 This is the modeling result of the steroid-induced femoral head necrosis model in the animal experiment 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] When the present invention is implemented, the Chinese medicine soup can be prepared from the following raw materials by weight: 10g of Poria, 8g of Rehmannia root, 14g of Chinese yam, 7g of Cornus officinalis, 7g of Cinnamon bark, 8g of Chinese Angelica sinensis, 5g of Heishun Pian, 10g of Psoralea corylifolia, 7g of Eucommia bark, 10g of Astragalus, 8g of Epimedium, 7g of Curcuma zedoariae, 7g of Trigonella ternatae, 10g of Cyathula capitata and 5g of Licorice. 400ml of water is added to the raw materials, and the mixture is soaked at 18°C ​​for 15min, then boiled over high heat, then turned to low heat, decocted for 20min, filtered, and a filtrate is obtained for standby use. 300ml of water is added to the filter residue, and after boiling over high heat, the mixture is turned to low heat, decocted for 10min, filtered, and the filter residue is discarded to obtain a filtrate. The two filtrates are combined and concentrated to 1 / 2 of the amount of water added twice to obtain the product.

[0015] Example 2

[0016] When the present invention is implemented, the Chinese medicine soup can also be prepared from the following raw materials by weight: 15g of Poria, 12g of Rehmannia root, 20g of Chinese yam, 10g of Cornus officinalis, 9g of cinnamon bark, 12g of Chinese angelica, 6g of Heishun Pian, 15g of Psoralea corylifolia, 9g of Eucommia bark, 15g of Astragalus, 12g of Epimedium, 10g of Curcuma zedoariae, 10g of Trigonella argyi, 15g of Cyathula capitata and 6g of Licorice. 500ml of water is added to the raw materials, and the mixture is soaked at 21°C for 20min, then boiled over high heat, then turned to low heat, decocted for 25min, filtered, and a filtrate is obtained for standby use; 350ml of water is added to the filter residue, and after boiling over high heat, the mixture is turned to low heat, decocted for 12min, filtered, and the filter residue is discarded to obtain a filtrate, and the two filtrates are combined and concentrated to 1 / 3 of the amount of water added twice.

[0017] Example 3

[0018] When the present invention is implemented, the Chinese medicine soup can also be prepared from the following raw materials by weight: 20g of Poria, 16g of Rehmannia root, 26g of Chinese yam, 13g of Cornus officinalis, 11g of cinnamon bark, 16g of Chinese angelica, 7g of Heishun Pian, 20g of Psoralea corylifolia, 11g of Eucommia bark, 20g of Astragalus, 16g of Epimedium, 13g of Curcuma zedoariae, 13g of Trigonella argyi, 20g of Cyathula capitata and 7g of Licorice. 600ml of water is added to the raw materials, and the mixture is soaked at 25°C for 25min, then boiled over high heat, then turned to low heat, decocted for 30min, filtered, and a filtrate is obtained for standby use; 400ml of water is added to the filter residue, and after boiling over high heat, the mixture is turned to low heat, decocted for 15min, filtered, and the filter residue is discarded to obtain a filtrate, and the two filtrates are combined and concentrated to 1 / 2 of the amount of water added twice.

[0019] Example 4

[0020] When the present invention is implemented, the Chinese medicine soup can also be prepared from the following raw materials by weight: 11g of Poria, 9g of Rehmannia root, 15g of Chinese yam, 8g of Cornus officinalis, 8g of Cinnamon bark, 9g of Angelica sinensis, 6g of Heishun Pian, 11g of Psoralea corylifolia, 8g of Eucommia bark, 11g of Astragalus, 9g of Epimedium, 8g of Curcuma zedoariae, 8g of Trigonella ternatae, 11g of Cyathula capitata and 6g of Licorice. 500ml of water is added to the raw materials, and the raw materials are soaked at 25°C for 25min, then boiled over high heat, then turned to low heat, decocted for 25min, filtered, and a filtrate is obtained for standby use; 400ml of water is added to the filter residue, and after boiling over high heat, the mixture is turned to low heat, decocted for 15min, filtered, and the filter residue is discarded to obtain a filtrate, and the two filtrates are combined and concentrated to 1 / 3 of the amount of water added twice.

[0021] In the prescription of the present invention:

[0022] Poria: It can dissipate dampness and promote diuresis, strengthen the spleen and stomach, and calm the mind. It is used for urinary problems, edema, phlegm and cough, vomiting, nausea, diarrhea, spermatorrhea, stranguria, palpitations, and forgetfulness.

[0023] Rehmannia root: nourishes blood and yin, replenishes essence and nourishes marrow. Used for various symptoms of blood deficiency; various symptoms of liver and kidney yin deficiency.

[0024] Chinese yam tastes sweet and neutral. It enters the spleen, lung and kidney meridians. It replenishes qi and nourishes yin, nourishes the spleen, lungs and kidneys, and stops leukorrhea.

[0025] Cornus officinalis tastes sour and astringent, and is slightly warm in nature. It enters the liver and kidney meridians. It nourishes the liver and kidneys, and astringes and consolidates the body.

[0026] Cinnamon bark: replenishes fire and boosts yang, guides fire back to its source, dispels cold and relieves pain, activates blood circulation and dredges menstruation. Warms the spleen and stomach, removes cold accumulation, and dredges blood vessels. Used for fire deficiency at the gate of life, cold limbs and weak pulse, yang deficiency and collapse, abdominal pain and diarrhea, cold hernia and piglet, cold pain in the waist and knees, amenorrhea, lumps in the yin, leukorrhea, and floating of false yang, upper heat and lower cold.

[0027] Angelica: Nature and flavor: warm, sweet and pungent. Enters the liver, heart and spleen meridians. Functions and indications: nourishing blood and activating blood circulation, regulating menstruation and relieving pain, moistening the intestines and relieving constipation. Used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, dry intestines and constipation, rheumatic arthralgia, injuries from falls, carbuncle and ulcer.

[0028] Heishun Tablet: restores yang and rescues adverse conditions, replenishes fire and boosts yang, and expels wind, cold and dampness. It is mainly used to treat yang deficiency, cold limbs and weak pulse, impotence, cold uterus, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, edema due to yin and cold, exogenous infection due to yang deficiency, and pain due to cold and dampness.

[0029] Psoralea corylifolia is pungent, bitter and warm in nature and enters the kidney and spleen meridians. Its functions and indications are warming the kidney and invigorating yang, relieving asthma and warming the spleen to stop diarrhea.

[0030] Eucommia: nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes the fetus. It is used to treat back pain, weakness of the feet and knees, residual urine, itchy genitals, miscarriage, restless fetuses, and high blood pressure.

[0031] Astragalus: replenishes qi and strengthens the exterior, stops sweating and stops falling, supports sores and promotes tissue regeneration, and promotes diuresis and reduces swelling. It is used to treat qi deficiency and fatigue, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, carbuncle that is difficult to ulcerate, long-term ulcer that does not heal, blood deficiency and sallow complexion, internal heat and thirst, chronic nephritis, proteinuria, diabetes, etc.

[0032] Epimedium: nourishes kidney yang, strengthens tendons and bones, and removes rheumatism. Used for impotence and spermatorrhea, weakness of tendons and bones, rheumatic pain, numbness and cramps; and menopausal hypertension.

[0033] Vinegar-scented Curcuma has the effects of breaking blood, dispersing blood stasis, eliminating symptoms, promoting qi circulation and relieving pain.

[0034] Vinegar Trillium: bitter, flat, enters the liver and spleen meridians, has the effects of breaking blood, promoting qi, eliminating accumulation and relieving pain.

[0035] Rhizoma Cynoglossi: removes blood stasis and promotes menstruation, clears joints, promotes diuresis and relieves stranguria. It is used for amenorrhea, retained placenta, joint pain, foot paralysis and muscle spasm, hematuria and stranguria, and injuries from falls.

[0036] Licorice: Sweet in taste, mild in nature, enters the heart, spleen, lung, and stomach meridians. When used raw, it is cool, can purge fire and detoxify, relieve pain; when roasted, it is warm, can dissipate surface cold, replenish the middle and benefit qi. In addition, licorice is good at harmonizing the properties of medicines and detoxifying hundreds of medicines.

[0037] Traditional Chinese medicine believes that the pathogenesis of femoral head necrosis is not single, and it is related to multiple organs such as the liver, kidney, spleen, bladder, etc., but it is most closely related to the liver and kidney. The kidney controls the bones, and treating bone diseases 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 treatment goal to strengthen the tendons and bones. Traditional Chinese medicine conservative treatment has unique therapeutic advantages in preventing and treating femoral head necrosis. The effective combination of the above-mentioned drugs supports each other and is scientifically prepared, with the function of strengthening the spleen and kidney. In the formula, Poria cocos and Rehmannia root strengthen the spleen and kidney, and are the main drugs; Chinese yam, Cornus officinalis, Angelica sinensis, Psoralea corylifolia, Eucommia bark, Astragalus membranaceus, Cyathula officinalis, and Epimedium nourish yin and replenish qi, nourish the liver and kidney, and help the main drugs to replenish kidney essence, and are the minister drugs; Curcuma zedoaria and Tripterygium wilfordii promote blood circulation and dissipate blood stasis, promote qi and relieve pain, and are the adjuvant drugs; Cinnamon bark and Heishun tablets promote yang and invigorate qi, and are the guiding drugs. The whole formula has the effects of warming kidney yang, removing dampness and strengthening spleen, and is effective in treating spleen and kidney yang deficiency type femoral head necrosis, and has achieved very good beneficial technical results through experiments. The relevant experimental data are as follows:

[0038] 1Case Source

[0039] 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, random numbers were generated using SPSS27.0, and patients were divided into treatment group and control group according to the random grouping principle, with 30 cases in each group.

[0040] 2 Diagnostic criteria

[0041] 2.1 Diagnostic criteria The diagnostic criteria were formulated based on the 2012 edition of the Expert Consensus on Diagnosis and Treatment Standards for Femoral Head Necrosis in Adults.

[0042] (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;

[0043] (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;

[0044] (3) CT scan changes: sclerotic bands surrounding necrotic bone, repaired bone, or subchondral bone fractures can be seen in the femoral head;

[0045] (4) MRI signs: T1WI shows a band-like low signal in the necrotic area or T2WI shows a double-line sign;

[0046] (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;

[0047] (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.

[0048] 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.

[0049] 2.2 Staging criteria are based on the 2019 Association Research Circulation Osseuse (ARCO) osteonecrosis staging criteria.

[0050] Table 1 ARCO staging of femoral head necrosis

[0051]

[0052] 2.3 TCM Syndrome Differentiation Standards Symptoms of femoral head necrosis of spleen and kidney yang deficiency type include: fear of cold, cold hands and feet, listlessness, clear and long urine, loose stools, backache and fatigue, cold hands and feet, cold stomach, back, waist and knees. Wear more clothes than ordinary people, can't tolerate air conditioning in summer, like quiet, like hot drinks, and feel uncomfortable when eating raw and cold food. Easy to have loose stools, clear urine color and large volume. The tongue coating is light, fat and tender, with teeth marks on the edge of the tongue coating, and the pulse is deep and slow.

[0053] 2.4 Inclusion criteria

[0054] (1) Meet the diagnostic criteria for femoral head necrosis of spleen and kidney yang deficiency type;

[0055] (2) those receiving conservative treatment;

[0056] (3) The primary disease is cured or in a stable stage;

[0057] (4) Those who are not accompanied by bone metabolic diseases, ankylosing spondylitis, bone tumors, various arthritis and other bone diseases;

[0058] (5) Be at least 18 years old and have the capacity to act independently;

[0059] (6) Patients who voluntarily participate in clinical research and sign the informed consent form.

[0060] 2.5 Exclusion criteria

[0061] (1) The primary disease has not been effectively controlled or is in the active stage;

[0062] (2) Patients with femoral head necrosis who refuse conservative treatment;

[0063] (3) Patients with other internal and external diseases other than the primary disease who require long-term medication;

[0064] (4) Pregnant or lactating women;

[0065] (5) Those who are currently participating in clinical trials of other drugs;

[0066] (6) Those who dropped out of the study or were lost to follow-up due to various reasons.

[0067] 3 Treatment options

[0068] Treatment duration: 12 weeks

[0069] Control group: Xianling Gubao.

[0070] Treatment group: Xianling Gubao (specific usage is the same as the control group) combined with the Chinese medicine soup prepared in Example 4 of the present invention, 200 ml each time, once in the morning and once in the evening.

[0071] 4. Efficacy evaluation criteria

[0072] 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.

[0073] 5 Clinical efficacy evaluation

[0074] 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.

[0075] Table 2 Comparison of Harris score and VAS pain score

[0076]

[0077] 6 Animal Experiment Evaluation

[0078] Twenty-four 8-week-old SD rats were injected intravenously with lipopolysaccharide (0.2 mg / kg) combined with 7-day continuous gluteal muscle injection of methylprednisolone (40 mg / kg) to establish a steroid-induced femoral head necrosis model. After 8 weeks, the 24 rats were randomly divided into 3 groups, including a model group (8 rats), a control group (8 rats), and a treatment group (8 rats). The model group was given normal saline by gavage, the control group was given Xianling Gubao solution by gavage, and the treatment group was given Xianling Gubao combined with Pishen Yangxu decoction by gavage. Micro-CT was performed after 6 weeks of intervention. The trabeculae of the rats in the model group were sparse, disordered, and had trabecular fractures; the trabeculae of the rats in the control group were sparse, and some trabeculae were broken; the trabeculae of the rats in the treatment group were neatly arranged. The spleen and kidney yang deficiency Chinese herbal decoction has a protective effect on the bone destruction of rats with steroid-induced femoral head necrosis, such as Figure 1 shown.

[0079] 7 Safety Assessment

[0080] 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.

[0081] After repeated tests and practices, other embodiments all obtained the same or similar test results as Embodiment 4, which will not be described in detail one by one.

[0082] 8 Conclusion

[0083] 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 kidney yang, removing dampness and strengthening spleen. The whole prescription not only has stable efficacy, but also good long-term efficacy, is not easy to relapse, is easily accepted by patients, and is effectively used to treat spleen and kidney yang deficiency 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 spleen and kidney in traditional Chinese medicine. It is an innovation in medicine for treating femoral head necrosis, and has huge economic and social benefits.

[0084] It should be pointed out that the above is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any technician familiar with the profession can make changes or modify the technical contents disclosed above into equivalent embodiments with equivalent changes without departing from the scope of the technical solution of the present invention, which all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis, characterized in that: The Chinese medicine soup is prepared from the following raw materials by weight: 10-20g of Poria cocos, 8-16g of Rehmannia glutinosa, 14-26g of Chinese yam, 7-13g of Cornus officinalis, 7-11g of Cinnamon bark, 8-16g of Chinese Angelica sinensis, 5-7g of Heishun Pian, 10-20g of Psoralea corylifolia, 7-11g of Eucommia bark, 10-20g of Astragalus membranaceus, 8-16g of Epimedium, 7-13g of Curcuma zedoariae with vinegar, 7-13g of Trigonosciadium japonicum with vinegar, 10-20g of Cyathula officinalis and 5-7g of Licorice root.

2. The Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: 10g of Poria, 8g of Rehmannia glutinosa, 14g of Dioscorea opposita, 7g of Cornus officinalis, 7g of Cinnamon bark, 8g of Angelica sinensis, 5g of Heishun Pian, 10g of Psoralea corylifolia, 7g of Eucommia bark, 10g of Astragalus membranaceus, 8g of Epimedium, 7g of Curcuma zedoariae, 7g of Vinegar Trillium, 10g of Cyathula officinalis and 5g of Licorice.

3. The Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to claim 1, characterized in that, It is made from the following raw materials by weight: 15g of Poria, 12g of Rehmannia glutinosa, 20g of Dioscorea opposita, 10g of Cornus officinalis, 9g of Cinnamon bark, 12g of Angelica sinensis, 6g of Heishun Pian, 15g of Psoralea corylifolia, 9g of Eucommia bark, 15g of Astragalus membranaceus, 12g of Epimedium, 10g of Curcuma zedoaria, 10g of Vinegar Trillium, 15g of Cyathula capitata and 6g of Licorice.

4. The Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: 20g of Poria, 16g of Rehmannia glutinosa, 26g of Dioscorea opposita, 13g of Cornus officinalis, 11g of Cinnamon bark, 16g of Angelica sinensis, 7g of Heishun Pian, 20g of Psoralea corylifolia, 11g of Eucommia ulmoides, 20g of Astragalus membranaceus, 16g of Epimedium, 13g of Curcuma zedoariae, 13g of Trigonosciadium japonicum, 20g of Cyathula capitata and 7g of Licorice.

5. The Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to claim 1, characterized in that: It is made from the following raw materials by weight: Poria 11g, Rehmannia glutinosa 9g, Chinese yam 15g, Cornus officinalis 8g, Cinnamon bark 8g, Angelica sinensis 9g, Heishunpian 6g, Psoralea corylifolia 11g, Eucommia ulmoides 8g, Astragalus 11g, Epimedium 9g, Curcuma 8g, Vinegar Tripterygium wilfordii 8g, Cyathula officinalis 11g and Licorice 6g.

6. The method for preparing the Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to any one of claims 1 to 5, characterized in that: It can be made into decoction, pills, tablets, granules and ointments.

7. The method for preparing the Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to claim 6, characterized in that: The preparation method of the water decoction is as follows: add 400-600 ml of water to the above raw material medicine, soak at 18-25°C for 15-25 minutes, 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 filter residue, boil over high heat, then turn to low heat, boil for 10-15 minutes, filter, discard the filter residue, obtain filtrate, combine the two filtrates, and concentrate to 1 / 2-1 / 3 of the amount of water added twice to obtain the decoction.

8. Use of the Chinese medicine composition for treating spleen-kidney yang deficiency type femoral head necrosis according to any one of claims 1 to 5 in the preparation of drugs for treating spleen-kidney yang deficiency type femoral head necrosis.

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