Traditional Chinese medicine composition for treating aseptic necrosis of femoral head and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating aseptic necrosis of femoral head. The traditional Chinese medicine decoction piece is prepared by extracting the following traditional Chinese medicine decoction pieces in parts by weight: 20-30 parts of astragalus membranaceus, 15-25 parts of bighead atractylodes rhizome, 20-30 parts of codonopsis pilosula, 15-25 parts of rhizoma polygonati, 10-20 parts of salvia miltiorrhiza, 8-12 parts of corydalis tuber, 8-12 parts of ginger processed pinellia, 15-25 parts of pericarpium citri reticulatae, 12-18 parts of radix ophiopogonis, 12-18 parts of lily, 8-12 parts of tabasheer, 8-12 parts of bryozoatum, 15-25 parts of eclipta, 15-25 parts of dendrobe, 20-30 parts of lucid ganoderma, 20-30 parts of pulp of dogwood fruit, 8-12 parts of cortex acanthopanacis and 15-25 parts of radix achyranthis bidentatae. The traditional Chinese medicine composition is reasonable in compatibility, can tonify spleen and benefit stomach, nourish stomach yin, reduce phlegm and remove stasis, clear metal and moisten dryness, protect lung and promote salivation, nourish yin and clear heat, tonify liver and kidney, and guide medicines to move downwards, and can be used for jointly treating tendon and vessel stasis type aseptic necrosis of femoral head.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating aseptic necrosis of the femoral head, in particular aseptic necrosis of the femoral head of tendon and vein stasis syndrome. Background Art

[0002] Avascular necrosis of the femoral head (AVN), also known as osteonecrosis of the femoral head (ONFH), is a common and intractable disease in orthopedics caused by interrupted or damaged blood supply to the femoral head, leading to the death and subsequent repair of bone cells and bone marrow components, resulting in structural changes, collapse, and joint dysfunction. AVN is a common and intractable disease in orthopedics. It can be divided into two categories: traumatic and non-traumatic. The former is primarily caused by hip trauma, such as femoral neck fracture and hip dislocation, while the latter, in my country, is primarily caused by the use of corticosteroids and alcohol abuse. Early clinical symptoms of aseptic necrosis of the femoral head are atypical, with pain upon internal rotation of the hip being the most common symptom. Following femoral head collapse, limited range of motion may occur. Deep tenderness may be present, including tenderness at the adductor insertion, and in some patients, positive axial percussion. Early symptoms include hip pain, Thomas sign, and a positive figure-of-four test. Later symptoms may be caused by femoral head collapse, hip dislocation, and a positive Allis sign and single-leg independence test. Other physical signs include limited abduction, external rotation, or internal rotation. The affected limb may be shortened, with muscle atrophy and even signs of subluxation. Patients with hip dislocation may also have a shift in the Nelaton line, a base of the Bryant triangle less than 5 cm, and a discontinuous Shenton line.

[0003] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," aseptic necrosis of the femoral head is categorized in Traditional Chinese Medicine (TCM) as either tendon and vein stasis or liver and kidney deficiency. Symptoms of tendon and vein stasis include localized pain, limited mobility, limping, hip and knee stiffness, pain during movement, a red tongue with ecchymosis, a thin yellow fur, and a stringy pulse. Symptoms of liver and kidney deficiency include localized pain, limited mobility, limping, muscle atrophy in the affected limb, soreness of the waist and knees, fatigue walking, dizziness, a red tongue with a thin white fur, and a stringy pulse. Of these, tendon and vein stasis is the most common. Summary of the Invention

[0004] In view of the above-mentioned prior art, the present invention provides a traditional Chinese medicine composition for treating aseptic necrosis of the femoral head, especially for the tendon and vein stasis syndrome.

[0005] The object of the present invention is achieved in the following manner:

[0006] A traditional Chinese medicine composition for treating aseptic necrosis of the femoral head is prepared by extracting the following traditional Chinese medicine slices in parts by weight: 20-30 parts of astragalus, 15-25 parts of white atractylodes, 20-30 parts of codonopsis, 15-25 parts of polygonatum, 10-20 parts of salvia, 8-12 parts of corydalis, 8-12 parts of pinellia, 15-25 parts of tangerine peel, 12-18 parts of ophiopogon, 12-18 parts of lily, 8-12 parts of rhizoma jasminoides, 8-12 parts of pumice, 15-25 parts of eclipta, 15-25 parts of dendrobium, 20-30 parts of ganoderma, 20-30 parts of cornus fruit, 8-12 parts of acanthopanax bark, 15-25 parts of cyperus, 10-20 parts of papaya, 15-25 parts of dipsaci, and 15-25 parts of perilla seed.

[0007] The traditional Chinese medicine composition for treating aseptic necrosis of the femoral head is prepared by extracting the following traditional Chinese medicine pieces in parts by weight: 25 parts of astragalus, 20 parts of white atractylodes, 25 parts of codonopsis, 20 parts of polygonatum, 15 parts of salvia, 10 parts of corydalis, 10 parts of pinellia, 20 parts of dried tangerine peel, 15 parts of ophiopogon, 15 parts of lily, 10 parts of rhizoma dahliae, 10 parts of pumice, 20 parts of eclipta, 20 parts of dendrobium, 25 parts of ganoderma, 25 parts of cornus fruit, 10 parts of acanthopanax bark, 20 parts of cyperus, 15 parts of papaya, 20 parts of dipsacus, and 20 parts of perilla seed.

[0008] The preparation method of the traditional Chinese medicine composition for treating aseptic necrosis of the femoral head comprises the following steps:

[0009] (1) Weigh the raw materials according to the above weight parts;

[0010] (2) firstly prepare volatile oil from salvia miltiorrhiza, corydalis yanhusuo, pinellia ternata and tangerine peel by steam distillation, use cyclodextrin inclusion compound and set aside; after extracting the volatile oil, soak the residue with other Chinese herbal medicine slices in water, decoct twice, filter, concentrate to 25 degrees Celsius to obtain a relative density of 1.15-1.25, add ethanol to adjust the alcohol concentration to 80%, let stand for 24 hours, take the supernatant, recover ethanol, concentrate to 25 degrees Celsius to obtain a relative density of 1.25-1.35, spray dry to obtain extract powder;

[0011] (3) Mixing the volatile oil cyclodextrin inclusion compound with the extract powder prepared in step (2), adding auxiliary materials, and preparing a traditional Chinese medicine preparation.

[0012] In the preparation method of the traditional Chinese medicine composition for treating aseptic necrosis of the femoral head, in step (2), the decoction is preceded by soaking for 2-3 hours, and the decoction time is 1-3 hours.

[0013] In the preparation method step (2) of the traditional Chinese medicine composition for treating aseptic necrosis of the femoral head, the spray drying conditions are as follows: an inlet air temperature of 180-230° C., an exhaust air temperature of 80-90° C., and a moisture content of the final product ≤4%.

[0014] In the preparation method step (2) of the traditional Chinese medicine composition for treating aseptic necrosis of the femoral head, the spray drying condition is an inlet air temperature of 190-210°C.

[0015] The traditional Chinese medicine composition for treating aseptic necrosis of the femoral head is a traditional Chinese medicine preparation selected from the group consisting of tablets, capsules, granules and oral liquids.

[0016] The traditional Chinese medicine composition for treating aseptic necrosis of the femoral head is used in preparing medicine for treating aseptic necrosis of the femoral head.

[0017] The Chinese medicine composition for treating aseptic necrosis of the femoral head is used in the preparation of a medicine for treating aseptic necrosis of the femoral head. Aseptic necrosis of the femoral head belongs to the syndrome of tendon and vessel stasis in traditional Chinese medicine differentiation.

[0018] Tianzhuhuang (Gardenia chinensis) is a dried mass of secretions from the culms of Bambusa tertilis McClure and Schizostachyum chinense Rendle (both species of the Poaceae family). It has the effects of clearing heat and resolving phlegm, soothing the heart and calming nerves. It is primarily used to treat infantile convulsions, stroke, epilepsy, coma due to febrile illness, and cough and asthma caused by phlegm and heat.

[0019] Pumice is a stone formed by volcanic magma. It has the effects of clearing the lungs and resolving phlegm, softening and dispersing lumps, and promoting diuresis and relieving stranguria. It is mainly used to treat phlegm-heat cough and asthma, scrofula, goiter, hematuria, and stranguria with stones.

[0020] Acanthopanax australis is the dried root bark of Acanthopanacis gracilistμlus W.W. Smith, a plant of the Araliaceae family. It dispels wind and dampness, nourishes the liver and kidneys, strengthens tendons and bones, and promotes diuresis and reduces swelling. It is primarily used to treat rheumatic arthritis, weakness of tendons and bones, delayed walking in children, fatigue, edema, and beriberi.

[0021] Papaya is the nearly ripe fruit of Chaenomeles speciosa (Sweet) Nakai, a plant of the Rosaceae family. It has the properties of relaxing muscles and tendons, soothing the stomach and eliminating dampness. It is primarily used to treat dampness-induced stiffness and cramps, soreness and pain in the waist and knee joints, vomiting and diarrhea caused by summer heat and dampness, cramps and pain, and beriberi and edema.

[0022] The rest of the medicinal materials are in compliance with the Chinese Pharmacopoeia or local standards.

[0023] Ancient Chinese medical texts contain no direct references to aseptic necrosis of the femoral head. Currently, avascular necrosis of the femoral head is classified as "bone atrophy" in TCM. TCM believes that aseptic necrosis of the femoral head due to tendon and vein stasis syndrome is caused by internal obstruction of phlegm and dampness, leading to obstruction of the meridians. Symptoms include heaviness and pain in the hip, a feeling of heaviness in the limbs, a greasy white tongue coating, and a weak or slippery pulse. The Suwen Treatise on Atrophy states that "treating atrophy should focus solely on the Yangming meridian," emphasizing that the spleen and stomach are the source of qi and blood production, responsible for nourishing the tendons, binding bones, and benefiting joints. Yangming deficiency leads to malnutrition of the tendons, resulting in foot atrophy and ineffectiveness. The pathogenesis of tendon and vein stasis syndrome: In the middle and late stages of aseptic necrosis of the femoral head, liver and kidney deficiency, phlegm and dampness stagnation, and blood stasis obstructing the meridians lead to bone malnutrition and necrosis. Treatments designed to tonify the liver and kidneys often fail to achieve satisfactory results. As Zou Zijiu noted in his Clinical Guide to Medical Cases: Impotence, "Yangming is the meridian of the tendons. A deficiency in the Yangming meridian causes the tendons to become loose, and loose tendons prevent them from binding together and functioning smoothly. This results in inability to walk, and symptoms of impotence and muscle contraction." Therefore, the approach breaks with the traditional approach of simply tonifying the kidneys and activating blood circulation, adopting principles that strengthen the spleen and stomach, nourish stomach yin (targeting the Yangming meridian), and resolve phlegm and blood stasis.

[0024] Zou Zijiu of the Clinical Guide to Medical Cases of Impotence further commented: "The main cause of impotence is nothing more than a disease of the liver, kidney, lung, and stomach meridians. The liver governs the tendons. If the liver is damaged, the limbs will become useless and the tendons and bones will contract. The kidney stores essence, and essence and blood are mutually generated. If the essence is deficient, it cannot irrigate the extremities, and if the blood is deficient, it cannot nourish the tendons and bones. The lung governs qi and is the organ of high and low qi. If the lung is deficient, the high source of qi will be cut off, and if the transformation is cut off, the water will dry up, and if the water dries up, it will not be able to moisten the tendons and bones." That is, lung heat and scorch the leaves, and the fluid is not distributed, then the five internal organs lose moisture, and internal heat arises. Kidney water is deficient, and water cannot control fire, so fire scorches the lung metal, leading to lung heat and fluid damage. Spleen deficiency and damp heat are mutually causal, and damp heat can also flow into the kidney, damaging kidney yin. External epidemic toxins invade the human body and lodge in the Du channel and collateral vessels. At the same time, endogenous dampness, heat, deficiency, phlegm, and blood stasis can also produce turbid toxins, which in turn block the collaterals, sun collaterals, floating collaterals, and entangled collaterals. Blockage of the meridians depletes qi and blood, weakening the body and causing this disease. Zhang Zihe, in his "Rumen Shiqin·Zhifengbiweijue Jinshichaxuanshuo," strongly emphasized the importance of heat in the pathogenesis, explicitly stating that "there is no cold in paralysis." The "Suwen·Wei Lun Pian" states: "The kidneys govern the body's bone marrow... If kidney qi is hot, the waist and spine will become weak, the bones will wither, and the marrow will decrease, leading to bone fistulas." It also states: "Traveling far and being tired, and experiencing extreme heat will cause thirst. Thirst depletes yang qi internally, and this depletion leads to heat in the kidneys. The kidneys are the reservoir of water. If water cannot overcome fire, the bones will wither and the marrow will be deficient, causing the feet to be unable to support the body, leading to bone paralysis." Liver and kidney deficiency prevents nourishment of muscles, tendons, and bones. Therefore, the principles of clearing away metal and moistening dryness, protecting the lungs and promoting fluid production, nourishing yin and clearing heat, and tonifying the liver and kidneys are used.

[0025] The present invention selects astragalus, white atractylodes, codonopsis, polygonatum to invigorate the spleen and benefit the stomach, and salvia miltiorrhiza, corydalis, pinellia ternata, and tangerine peel to resolve phlegm and remove blood stasis, which are all monarch drugs; ophiopogon, lily, rhizoma dahliae, and pumice stone to clear away lung heat and moisten dryness, protect the lungs and promote fluid production, which are ministerial drugs; eclipta, dendrobium, ganoderma lucidum, cornus fruit, and acanthopanax bark to nourish yin and clear away heat, and tonify the liver and kidneys, which are adjuvant drugs; ox knee, papaya, dipsaccharum officinale, and perilla seed to guide the drugs downward, which are guiding drugs. Among them, polygonatum can not only invigorate the spleen and benefit the qi, but also nourish yin and moisten the lungs, corydalis can not only promote blood circulation and remove blood stasis, but also invigorate the spleen, and acanthopanax bark to nourish the liver and kidneys. The skin can nourish the liver and kidneys, and strengthen the tendons and bones, playing a dual role of one medicine. The whole formula contains astragalus, white atractylodes, codonopsis, polygonatum, salvia miltiorrhiza, corydalis, pinellia, tangerine peel, ophiopogon, lily, gardenia, pumice, Eclipta prostrata, dendrobium, ganoderma lucidum, cornus fruit, acanthopanax bark, Achyranthes bidentata, papaya, dipsacus, and perilla seed. It can treat aseptic necrosis of the femoral head with tendon and vein stasis syndrome by strengthening the spleen and stomach, nourishing stomach yin, resolving phlegm and removing blood stasis, clearing away lung heat and moistening dryness, protecting the lungs and promoting fluid production, nourishing yin and clearing heat, nourishing the liver and kidneys, and guiding the medicine downward. DETAILED DESCRIPTION

[0026] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content of the present invention record, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the application's appended claims equally.

[0027] Example 1:

[0028] Take 25g of Astragalus, 20g of Atractylodes, 25g of Codonopsis, 20g of Polygonatum, 15g of Salvia miltiorrhiza, 10g of Corydalis, 10g of Pinellia ternata, 20g of Tangerine peel, 15g of Ophiopogon japonicus, 15g of Lilium, 10g of Radix Glycyrrhizae, 10g of Pumice, 20g of Ecliptae, 20g of Dendrobium, 25g of Ganoderma lucidum, 25g of Cornus officinalis, 10g of Acanthopanax acanthopanax bark, 20g of Achyranthes bidentata, 15g of Papaya, 20g of Dipsacus asper, and 20g of Perilla seed, and prepare the product by the following steps:

[0029] (1) Weigh the raw materials according to the above weight parts;

[0030] (2) First, volatile oils were prepared from Danshen, Corydalis, Pinellia, and Tangerine peel by steam distillation, and then cyclodextrin was used for inclusion and set aside; after extracting the volatile oils, the residues and other Chinese herbal medicine slices were soaked in water for 2 h, decocted twice, each time for 2 h, filtered, concentrated to a relative density of 1.20 at 25 degrees Celsius, and ethanol was added to adjust the alcohol concentration to 80%, and allowed to stand for 24 hours. The supernatant was taken, ethanol was recovered, and the relative density was 1.30 at 25 degrees Celsius. The extract powder was spray-dried under the following conditions: an inlet air temperature of 210°C and an exhaust air temperature of 85°C. The moisture content of the final product was ≤4%, thereby obtaining an extract powder;

[0031] (3) Mixing the volatile oil cyclodextrin inclusion compound with the extract powder prepared in step (2), adding dextrin, and preparing a Chinese medicine granule.

[0032] Example 2:

[0033] Take 20g of Astragalus, 25g of Atractylodes, 20g of Codonopsis, 25g of Polygonatum, 10g of Salvia miltiorrhiza, 12g of Corydalis, 8g of Pinellia ternata, 25g of Tangerine peel, 12g of Ophiopogon japonicus, 18g of Lilium, 8g of Radix Glycyrrhizae, 12g of Pumice, 15g of Eclipta prostrata, 25g of Dendrobium, 20g of Ganoderma lucidum, 30g of Cornus officinalis, 8g of Acanthopanax acanthopanax bark, 25g of Achyranthes bidentata, 10g of Papaya, 25g of Dipsacus asper, and 15g of Perilla seed, and prepare the product by the following steps:

[0034] (1) Weigh the raw materials according to the above weight parts;

[0035] (2) First, volatile oils were prepared from Danshen, Corydalis, Pinellia, and Tangerine peel by steam distillation, and then cyclodextrin was used for inclusion and set aside; after extracting the volatile oils, the residues and other Chinese herbal medicine slices were soaked in water for 2 h, decocted twice, each time for 2 h, filtered, concentrated to a relative density of 1.15 at 25 degrees Celsius, and ethanol was added to adjust the alcohol concentration to 80%, and allowed to stand for 24 hours. The supernatant was taken, ethanol was recovered, and concentrated to a relative density of 1.35 at 25 degrees Celsius, and spray-dried. The spray-drying conditions were as follows: an inlet air temperature of 190°C, an exhaust air temperature of 90°C, and a moisture content of ≤4% in the final product to obtain an extract powder;

[0036] (3) Mixing the volatile oil cyclodextrin inclusion compound with the extract powder prepared in step (2), adding starch, and preparing a Chinese medicine tablet.

[0037] Example 3:

[0038] Take 30g of Astragalus, 15g of Atractylodes, 30g of Codonopsis, 15g of Polygonatum, 20g of Salvia miltiorrhiza, 8g of Corydalis, 12g of Pinellia, 15g of Tangerine peel, 18g of Ophiopogon, 12g of Lilium, 12g of Radix Glehnialids, 8g of Pumice, 25g of Eclipta prostrata, 15g of Dendrobium, 30g of Ganoderma, 20g of Cornus officinalis, 12g of Acanthopanax acanthopanax bark, 15g of Achyranthes, 20g of Papaya, 15g of Dipsacus asper, and 25g of Perilla seed, and prepare the product by the following steps:

[0039] (1) Weigh the raw materials according to the above weight parts;

[0040] (2) First, volatile oils are prepared from Danshen, Yanhusuo, Zingiberis Rhizoma, and Tangerine Peel by steam distillation, and then cyclodextrin is used for inclusion and set aside; after extracting the volatile oils, the residues and other Chinese herbal medicine slices are soaked in water for 3 hours, decocted twice, each time for 1 hour, filtered, concentrated to a relative density of 1.25 at 25 degrees Celsius, and ethanol is added to adjust the alcohol concentration to 80%, and allowed to stand for 24 hours. The supernatant is taken, ethanol is recovered, concentrated to a relative density of 1.25 at 25 degrees Celsius, and spray-dried. The spray-drying conditions are as follows: the inlet air temperature is 190°C, the exhaust air temperature is 90°C, and the moisture content of the final product is ≤4%, thereby obtaining an extract powder;

[0041] (3) The volatile oil cyclodextrin inclusion compound is mixed with the extract powder prepared in step (2), and microcrystalline cellulose is added to prepare a traditional Chinese medicine capsule.

[0042] Example 4:

[0043] Take 25g of Astragalus, 20g of Atractylodes, 25g of Codonopsis, 20g of Polygonatum, 15g of Salvia miltiorrhiza, 10g of Corydalis, 10g of Pinellia ternata, 20g of Tangerine peel, 15g of Ophiopogon japonicus, 15g of Lilium, 10g of Radix Glycyrrhizae, 10g of Pumice, 20g of Ecliptae, 20g of Dendrobium, 25g of Ganoderma lucidum, 25g of Cornus officinalis, 10g of Acanthopanax acanthopanax bark, 20g of Achyranthes bidentata, 15g of Papaya, 20g of Dipsacus asper, and 20g of Perilla seed, and prepare the product by the following steps:

[0044] (1) Weigh the raw materials according to the above weight parts;

[0045] (2) First, volatile oil is prepared from Danshen, Corydalis, Pinellia, and Tangerine Peel by steam distillation and set aside; after extracting the volatile oil, the residue is soaked in water with other Chinese herbal medicine slices for 2 hours, decocted twice, each time for 2 hours, filtered, concentrated to 25 degrees Celsius to obtain a relative density of 1.20, ethanol is added to adjust the alcohol concentration to 80%, and allowed to stand for 24 hours. The supernatant is taken, ethanol is recovered, and concentrated to 25 degrees Celsius to obtain an extract with a relative density of 1.30;

[0046] (3) Mixing the volatile oil ring with the extract prepared in step (2) to prepare a Chinese medicine oral solution.

[0047] Example 5: Pharmacodynamics Study

[0048] 80 Wistar rats were randomly divided into a normal group, a model group, an alendronate sodium group, and a group according to Example 1 of the present invention, with 20 rats in each group. Method for establishing a rat model of steroid-induced aseptic necrosis of the femoral head: 20 μg·kg of Escherichia coli endotoxin was injected into the rats' peritoneal cavity. -1 , once a day, for 2 consecutive days. 24 hours after the second injection of E. coli endotoxin, 40 mg·kg methylprednisolone was injected into the bilateral gluteal muscles. -1 , once a day, for 3 consecutive days. All model animals were given intraperitoneal injection of sodium penicillin 4×104 U, once daily. The success of the model was determined by pathological observation of the femoral head tissue after modeling, using indicators such as reduced or broken trabeculae, increased adipocytes, and increased empty bone pits as evaluation criteria.

[0049] After the model was successfully established, the first day after the first group of Example 1 of the present invention was treated with 20 g·kg -1 The dose of alendronate sodium group was 1 mg·kg -1 The administration volume was 10 mL·kg -1 , once daily for 6 consecutive weeks. The normal and model control groups were administered the corresponding volume of distilled water for diagnosis. Grip strength, free movement frequency, and tail suspension time were measured on the second day after the end of drug administration. Grip strength was measured by grasping the base of the animal's tail. Once the animal grasped the grip plate, force was applied and the maximum grip force was measured. Five measurements were performed, and the average value was calculated. Spontaneous movement frequency: After the animal was pre-conditioned for 10 minutes on the sprint instrument, the number of movements within 5 minutes was recorded. Tail suspension time: The rats were placed on the tail suspension tester, and the tail suspension time was measured. The results are shown in Table 1.

[0050] Table 1 Pharmacodynamic study of the present invention on the steroid-induced aseptic necrosis of the femoral head model

[0051]

[0052] Compared with the control group, ## P<0.01; compared with the model group * P<0.05, ** P<0.01

[0053] Table 1 shows that compared with the normal group, the gripping force of the rats in the model group was significantly weakened (P<0.01), the number of autonomous activities was significantly reduced (P<0.01), and the tail suspension time was significantly reduced (P<0.01), indicating that the model was successfully established; compared with the model group, the gripping force of the rats in the Example 1 group of the present invention was significantly increased (P<0.01), the number of autonomous activities was significantly increased (P<0.01), and the tail suspension time was significantly prolonged (P<0.01) after administration, indicating that the present invention has the effect of improving the soreness of the waist and knees, mental depression, and mental state of rats with aseptic necrosis of the femoral head, and the effect is better than that of the positive drug alendronate sodium group.

[0054] The main clinical symptoms of aseptic necrosis of the femoral head are lower limb weakness, hip pain, difficulty in flexion and extension, soreness of the waist and knees, mental depression, etc., which seriously affect the quality of life of patients. The present invention can improve the grasping strength of mice, increase the number of independent activities of mice, and significantly prolong the tail suspension time, which may be related to the present invention's ability to strengthen the spleen and stomach, nourish stomach yin, resolve phlegm and remove blood stasis, clear away lung heat and moisten dryness, protect the lungs and promote fluid production, nourish yin and clear away heat, tonify the liver and kidneys, and guide the downward movement of drugs. Pharmacodynamic studies have shown that the present invention can treat aseptic necrosis of the femoral head of tendon and vein stasis syndrome.

[0055] Example 6: Clinical Study

[0056] 1. Clinical cases: This study selected 70 patients with aseptic necrosis of the femoral head of the tendon and vein stasis syndrome type admitted to the orthopedics outpatient clinic of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine, including 37 males and 33 females; aged 35-70 years, with an average age of 47.8 years; the course of disease was 6-24 months, with an average course of disease of 14.3 months. They were randomly divided into two groups, namely, Example 1 group and commercially available Chinese patent medicine group.

[0057] 2. Western medicine diagnostic standards

[0058] 2.1 Main Standards

[0059] (1) Clinical symptoms, signs and medical history: Joint pain mainly in the groin, buttocks and thighs, limited internal rotation of the hip joint, history of hip trauma, history of corticosteroid use, and history of alcoholism.

[0060] (2) X-ray changes: collapse of the femoral head without narrowing of the joint space; a demarcated sclerotic zone within the femoral head; and a radiolucent zone in the subchondral bone (crescent sign, subchondral fracture).

[0061] (3) Radionuclide scanning showed a cold area within the hot area in the femoral head.

[0062] (4) The T1-weighted image of the femoral head MRI shows a band-like low signal (band-like type) or the T2-weighted image has a double-line sign.

[0063] (5) Bone biopsy showed that the trabeculae contained more than 50% empty pits of osteocytes, involving multiple adjacent trabeculae and bone marrow necrosis.

[0064] 2.2 Secondary standards

[0065] (1) X-rays show collapse of the femoral head with narrowing of the joint space, cystic changes or spotty sclerosis in the femoral head, and flattening of the outer upper part of the femoral head.

[0066] (2) Radionuclide bone scan shows cold or hot areas.

[0067] (3) MRI shows isotropic or heterogeneous low signal intensity without T1 image banding type.

[0068] The diagnosis can be confirmed if two or more main criteria are met.

[0069] 2.3 Others

[0070] Aseptic necrosis of the femoral head can be diagnosed through medical history taking, clinical examination, X-rays, magnetic resonance imaging (MRI), radionuclide scanning, computed tomography (CT), etc.

[0071] 3. Traditional Chinese Medicine Diagnostic Criteria

[0072] The patient was diagnosed with aseptic necrosis of the femoral head due to tendon and vein stasis by Traditional Chinese Medicine. The clinical manifestations included local pain, limited movement, lameness, hip and knee stiffness, pain during movement, red tongue or ecchymosis, dark purple tongue, thin yellow tongue coating, and stringy pulse.

[0073] 4. Administration method: The granules prepared by the method of Example 1 of the present invention were administered to the group 1 of Example 1, with a daily dosage of 25 g of Astragalus, 20 g of Atractylodes, 25 g of Codonopsis, 20 g of Polygonatum, 15 g of Salvia, 10 g of Corydalis, 10 g of Pinellia, 10 g of Tangerine peel, 20 g of Radix Ophiopogonis, 15 g of Lilium, 10 g of Radix Glycyrrhizae, 10 g of Pumice, 20 g of Eclipta, 20 g of Dendrobium, 25 g of Ganoderma, 25 g of Cornus officinalis, 10 g of Acanthopanax acanthopanax, 20 g of Achyranthes, 15 g of Papaya, 20 g of Dipsacus asper. The patients were treated with 0g of granules and 20g of Perilla seeds, taken three times a day for 6 months. The commercially available Chinese medicine group received Xianling Gubao Capsules (National Medicine Approval No. Z20025337, manufactured by Sinopharm Tongjitang (Guizhou) Pharmaceutical Co., Ltd.), 3 capsules twice a day for 6 months, and Xuefu Zhuyu Capsules (National Medicine Approval No. Z12020223, manufactured by Tianjin Hongrentang Pharmaceutical Co., Ltd.), 6 capsules twice a day for 6 months. During treatment, the patients stopped taking hormonal medications, abstained from alcohol, used a walker to reduce weight when walking, and strictly avoided any form of weight-bearing activity.

[0074] 5. Efficacy evaluation indicators

[0075] 5.1 VAS score: All patients were compared before treatment, 3 months after treatment, and 6 months after treatment. VAS scores range from 0 to 10, with higher scores indicating more severe pain. The results are shown in Table 2.

[0076] 5.2 Harris Scores: Harris scores were compared among all patients before treatment, 3 months after treatment, and 6 months after treatment. The score includes joint pain (44 points), joint function (47 points), joint deformity (4 points), and range of motion (5 points). Scores range from 0 to 100, with scores greater than 90 considered excellent, 80-89 good, 70-79 acceptable, and less than 70 poor. Results are shown in Table 2.

[0077] 5.3 Traditional Chinese Medicine Symptom Score: The primary symptom is hip pain and heaviness in the joints, with a score range of 0-6, with higher scores indicating more severe symptoms. Secondary symptoms include soreness and weakness in the waist and knees, a dark purple tongue, and a stringy pulse, with a score range of 0-4, with lower scores indicating more severe symptoms. Results are shown in Table 3.

[0078] 5.4 Criteria for determining efficacy of syndromes: (1) Clinically cured: TCM clinical symptoms and signs disappear or almost disappear, and the syndrome score decreases by >95%. (2) Markedly effective: TCM clinical symptoms and signs significantly improve, and the syndrome score decreases by >70% to <95%. (3) Effective: TCM clinical symptoms and signs improve, and the syndrome score decreases by >30% to <70%. (4) Ineffective: TCM clinical symptoms and signs do not improve significantly, or even worsen, and the syndrome score decreases by less than 30%. Note: The calculation formula (nimodipine method) is: [(pre-treatment score - post-treatment score) + pre-treatment score] × 100%. The results are shown in Table 4.

[0079] Table 2 Comparison of VAS scores and Harris scores before and after treatment

[0080]

[0081] Note: Compared with before treatment, * P<0.05; compared with the commercial Chinese patent medicine group, # P<0.05.

[0082] Table 3 Comparison of TCM syndrome scores before and after treatment

[0083]

[0084] Note: Compared with before treatment, * P<0.05; compared with the commercial Chinese patent medicine group, # P<0.05.

[0085] Table 4 Comparison of treatment effects

[0086]

[0087] Tables 2-4 show that 3 months and 6 months after the patients received the granules prepared in Example 1 of the present invention, their VAS pain visual analogue score, Harris hip joint function score, and TCM symptom score were significantly improved, and the effect was better than that of the commercially available Chinese patent medicine group, indicating that the present invention has a reasonable combination and can effectively treat aseptic necrosis of the femoral head with phlegm and blood stasis.

[0088] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating aseptic necrosis of the femoral head, characterized in that: The invention is prepared by extracting the following Chinese medicinal pieces in parts by weight: 20-30 parts of astragalus, 15-25 parts of white atractylodes, 20-30 parts of codonopsis, 15-25 parts of polygonatum, 10-20 parts of salvia, 8-12 parts of corydalis, 8-12 parts of pinellia, 15-25 parts of tangerine peel, 12-18 parts of ophiopogon, 12-18 parts of lily, 8-12 parts of rhizoma jasminoides, 8-12 parts of pumice, 15-25 parts of eclipta, 15-25 parts of dendrobium, 20-30 parts of ganoderma, 20-30 parts of cornus fruit, 8-12 parts of acanthopanax bark, 15-25 parts of cyperus, 10-20 parts of papaya, 15-25 parts of dipsaci, and 15-25 parts of perilla seed.

2. The Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 1, wherein The preparation method is prepared by extracting the following Chinese medicinal pieces in parts by weight: 25 parts of astragalus, 20 parts of atractylodes, 25 parts of codonopsis, 20 parts of polygonatum, 15 parts of salvia, 10 parts of corydalis, 10 parts of pinellia, 20 parts of dried tangerine peel, 15 parts of ophiopogon, 15 parts of lily, 10 parts of rhizoma damias, 10 parts of pumice, 20 parts of eclipta, 20 parts of dendrobium, 25 parts of ganoderma, 25 parts of cornus fruit, 10 parts of acanthopanax bark, 20 parts of cyperus, 15 parts of papaya, 20 parts of dipsacus, and 20 parts of perilla seed.

3. The Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 1, wherein The preparation method comprises the following steps: (1) Weigh the raw materials according to the above weight parts; (2) firstly prepare volatile oil from salvia miltiorrhiza, corydalis yanhusuo, pinellia ternata and tangerine peel by steam distillation, use cyclodextrin inclusion compound and set aside; after extracting the volatile oil, soak the residue with other Chinese herbal medicine slices in water, decoct twice, filter, concentrate to 25 degrees Celsius to obtain a relative density of 1.15-1.25, add ethanol to adjust the alcohol concentration to 80%, let stand for 24 hours, take the supernatant, recover ethanol, concentrate to 25 degrees Celsius to obtain a relative density of 1.25-1.35, spray dry to obtain extract powder; (3) Mixing the volatile oil cyclodextrin inclusion compound with the extract powder prepared in step (2), adding auxiliary materials, and preparing a traditional Chinese medicine preparation.

4. The Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 3, wherein In step (2) of the preparation method, the decoction is preceded by soaking for 2-3 hours, and the decoction time is 1-3 hours.

5. The Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 3, characterized in that: In step (2) of the preparation method, the spray drying conditions are as follows: the inlet air temperature is 180-230°C, the exhaust air temperature is 80-90°C, and the moisture content of the final product is ≤4%.

6. The Chinese medicine composition for treating aseptic necrosis of the femoral head according to claim 5, wherein In step (2) of the preparation method, the spray drying condition is an inlet air temperature of 190-210°C.

7. The Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 3, characterized in that: Chinese medicine preparations are tablets, capsules, granules, and oral liquids.

8. Use of the Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 1 in preparing a medicament for treating aseptic necrosis of the femoral head.

9. The use of a Chinese medicine composition for treating aseptic necrosis of the femoral head as claimed in claim 1 in preparing a medicament for treating aseptic necrosis of the femoral head, characterized in that : Aseptic necrosis of the femoral head belongs to the type of phlegm and blood stasis in traditional Chinese medicine.

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