A Chinese medicine composition for treating knee osteoarthritis and preparation method thereof

Abstract

The invention discloses a Chinese medicine composition for treating knee osteoarthritis. The Chinese medicine composition is prepared by extracting 19 Chinese medicinal pieces in the following weight parts, wherein the weight parts of each Chinese medicinal piece are: 20-30 parts of Sarcandra parasitica, 18-22 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 10-20 parts of Scorpio, 8-12 parts of Pheretima, 20-30 parts of Phellodendron chinense, 15-25 parts of Atractylodes macrocephala, 18-22 parts of Ligusticum chuanxiong, 15-25 parts of Corydalis yanhusuo, 20-30 parts of Angelica sinensis, etc., and discloses a preparation method thereof. The Chinese medicine composition can nourish the liver and kidney, remove wind and phlegm, eliminate stubborn arthralgia, clear away heat and dampness, relieve arthralgia and stop pain, activate blood circulation and remove blood stasis, relieve arthralgia and stop pain, nourish the lung, nourish the spleen and stomach, and nourish the heart, so as to achieve the purpose of treating liver and kidney deficiency and phlegm and blood stasis syndrome of knee osteoarthritis.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating knee osteoarthritis and a preparation method thereof. Background Art

[0002] Knee osteoarthritis is a common chronic disease that mainly occurs in middle-aged and elderly people. Since the knee joint is one of the most important joints in the human body, knee osteoarthritis can cause great pain and inconvenience to patients. Physical therapy for knee osteoarthritis mainly includes cold compress, hot compress, physical therapy, massage, etc. Cold compress can reduce inflammation and pain, while hot compress can promote blood circulation and relieve muscle tension. Physical therapy includes ultrasound, shortwave, magnetic therapy, etc., which can promote inflammation absorption and relieve pain. Massage can relieve muscle fatigue and promote blood circulation. However, the effect of physical therapy is not obvious. Surgical treatment of knee osteoarthritis mainly includes knee arthroscopy and knee replacement. Knee arthroscopy is a minimally invasive surgery that can remove diseased tissue and repair damaged joint surfaces without cutting the joint. Knee replacement surgery is a larger surgery suitable for patients with severe knee osteoarthritis, which can completely relieve the patient's pain and restore joint function. However, surgical treatment is traumatic and recovery is slow. Drug treatment can use non-steroidal anti-inflammatory drugs, glucocorticoids, hyaluronic acid, etc., which can effectively relieve patients' pain and inflammation. Glucocorticoids are mainly used for anti-inflammatory and analgesic purposes in the acute phase, but long-term use will have certain side effects, so the use time should not be too long.

[0003] CN115990218B provides a Yao medicine composition with improved knee osteoarthritis joint function and its preparation method and application, belonging to the field of Yao medicine technology. The present invention follows the treatment principle of "wind deficiency and surplus", compatibility of drug components, and provides a Yao medicine composition that can improve the joint function of knee osteoarthritis. The present invention uses a rat knee osteoarthritis model as an experimental object, and the Yao medicine composition is verified by toxicological tests to have no obvious toxic reaction and skin irritation reaction. Serological detection found that the Yao medicine composition delays the pathological process and inhibits the inflammatory reaction by regulating the iconic inflammatory index. Histopathology shows that the Yao bath composition improves synovial inflammation and cartilage structure destruction. Behavioral observation shows that the Yao medicine composition can relieve the swelling of knee osteoarthritis joints and effectively improve joint mobility and gait. Therefore, the Yao medicine composition can play a role in improving the joint function of knee osteoarthritis and provide a new treatment strategy for knee osteoarthritis. However, there is no classification treatment of syndrome types, and the effect is not obvious.

[0004] CN113230317B discloses a transdermal drug-delivery preparation for treating knee osteoarthritis and a preparation method thereof, wherein the drug is made of raw aconite, white dragon beard, black bone vine, radix scutellariae and safflower. The drug of the present invention has the effects of promoting blood circulation and relieving pain, removing dampness and dispersing blood stasis, relaxing muscles and activating collaterals, and can effectively treat knee osteoarthritis; the prepared microemulsion has a small particle size, improves drug stability, promotes drug absorption, has high biocompatibility, can prolong the drug's action time, and achieves the purpose of prolonging drug efficacy. However, the patent contains toxic drugs and is unsafe to use. Summary of the invention

[0005] The present invention aims to provide a Chinese medicine composition for treating knee osteoarthritis and a preparation method thereof.

[0006] The Chinese medicine composition for treating knee osteoarthritis of the present invention is prepared by extracting 19 Chinese medicinal pieces in the following weight proportions, wherein the weight proportions of the Chinese medicinal pieces are as follows: 20-30 parts of Sarcandra parasitica, 18-22 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 10-20 parts of Scorpio, 8-12 parts of Pheretima, 20-30 parts of Phellodendron chinense, 15-25 parts of Atractylodes macrocephala, 18-22 parts of Ligusticum chuanxiong, 15-25 parts of Corydalis yanhusuo, 20-30 parts of Angelica sinensis, 18-22 parts of Astragalus, 15-25 parts of Schisandra chinensis, 30-40 parts of Dioscorea opposita, 10-20 parts of Chicken's gizzard lining, 15-25 parts of Poria, 18-22 parts of Ginseng, 15-25 parts of Platycladus orientalis, 10-20 parts of Millettia spatholobi, and 15-25 parts of Achyranthes bidentata.

[0007] The Chinese medicine composition for treating knee osteoarthritis is prepared by extracting 19 Chinese medicinal pieces in the following weight proportions, wherein the weight proportions of each Chinese medicinal piece are: 25 parts of Sargassum parasiticum, 20 parts of Eucommia ulmoides, 20 parts of Cuscuta australis, 15 parts of Scorpio, 10 parts of Pheretima, 25 parts of Phellodendron chinense, 20 parts of Atractylodes macrocephala, 20 parts of Ligusticum chuanxiong, 20 parts of Corydalis yanhusuo, 25 parts of Angelica sinensis, 20 parts of Astragalus, 20 parts of Schisandra chinensis, 35 parts of Dioscorea opposita, 15 parts of Chicken's gizzard lining, 20 parts of Poria cocos, 20 parts of Ginseng, 20 parts of Platycladus orientalis, 15 parts of Millettia spatholobi, and 20 parts of Achyranthes bidentata.

[0008] The preparation method of the Chinese medicine composition for treating knee osteoarthritis comprises the following steps:

[0009] (1) Grinding of medicinal materials: weigh and grind the following ingredients according to weight: Herba Mori, Eucommia bark, Cuscuta chinensis, Scorpio ternata, Pheretima chinensis, Atractylodes macrocephala, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis, Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Gallus galli, Poria cocos, Ginseng, Semen Platycladi, Caulis Millettiae and Radix Achyranthis Bidentatae into coarse powder;

[0010] (2) Weigh the coarse powder crushed in step (1) by weight, add water and boil twice, the amount of water added each time is 12 times the total weight of the medicinal materials, the boiling time each time is 1.5 hours, filter, and concentrate the filtrate to an extract with a relative density of 1.15 to 1.25 at 25° C.;

[0011] (3) adding 5 times the volume of 70%-99% ethanol to the extract obtained in step (2) until the alcohol content of the alcohol precipitation solution is 50-80%, stirring evenly, standing for 8-16 hours, and filtering;

[0012] (4) recovering ethanol from the filtrate, concentrating it to an extract having a relative density of 1.3 to 1.4 at 50 to 80° C., and drying it to obtain a dry extract;

[0013] (5) Powdering the dry extract obtained in step (4), adding auxiliary materials, and preparing into one of capsules, pills, tablets or granules.

[0014] The Chinese medicine composition for treating knee osteoarthritis, wherein the concentration method in step (2) of the preparation method is selected from one of vacuum film concentration, direct heating open concentration, single-effect concentrator concentration or double-effect concentrator concentration.

[0015] In the preparation method of the traditional Chinese medicine composition for treating knee osteoarthritis, the concentration method in step (4) is selected from one of vacuum film concentration, direct heating open concentration, single-effect concentrator concentration or double-effect concentrator concentration.

[0016] The traditional Chinese medicine composition for treating knee osteoarthritis, wherein the drying method in step (4) of the preparation method is selected from one of hot air circulation drying, vacuum drying, fluidized bed boiling drying, spray drying or microwave drying.

[0017] The Chinese medicine composition for treating knee osteoarthritis belongs to the syndrome of liver and kidney deficiency and phlegm and blood stasis.

[0018] Mulberry parasite is the dried leafy stems and branches of Taxillus chinensis (DC.) Danser. of the family Loranthaceae. It has the effects of removing rheumatism, nourishing the liver and kidneys, strengthening the tendons and bones, and calming the fetus. It is mainly used to treat rheumatic arthralgia, metrorrhagia, bleeding during pregnancy, restless fetuses, lowering blood pressure, and can be used for hypertension.

[0019] Eucommia ulmoides is the bark of Eucommia ulmoides Oliv., a plant of the Eucommia family. It has the effects of nourishing the liver and kidneys, strengthening the tendons and bones, and calming the fetus. It is mainly used to treat kidney deficiency and various types of back pain, restless fetuses, and habitual abortions.

[0020] Cuscuta chinensis Lam. is a mature seed of Cuscuta chinensis Lam. It has the functions of nourishing the kidney, strengthening the essence, nourishing the liver, improving eyesight, stopping diarrhea, and calming the fetus. It is mainly used to treat soreness of waist and knees, impotence and spermatorrhea, enuresis and frequent urination, liver and kidney deficiency, blurred vision, spleen and kidney yang deficiency, loose stools and diarrhea, restless fetus, and bleeding during pregnancy.

[0021] The whole scorpion is the dried body of the East Asian scorpion Buthus martensii Karsch, which belongs to the genus Scorpionidae. It is mainly distributed in Liaoning, Hebei, Shandong, Anhui, Henan, Hubei and other places. It has the effects of calming wind and relieving spasm, attacking toxins and dispersing knots, unblocking meridians and relieving pain. It is mainly used to treat convulsions, spasms and convulsions caused by various reasons; sores, swellings, scrofula, tuberculosis, gangrene, breast carbuncle; rheumatism, stiffness of tendons and veins; intractable hemiplegia and headache; and it can treat a variety of tumors.

[0022] Pheretima is the dried whole body of Pheretima aspergillum (E.Perrier), Pheretima ulgaris chen, Pheretima guillelmi (Michaelsen) or Pheretima pecvinifera Michaelsen. It has the effects of clearing away heat and calming wind, unblocking meridians, relieving asthma, diuresis and lowering blood pressure. It is mainly used to treat high fever, convulsions, mania; qi deficiency and blood stasis, hemiplegia; arthralgia, joint pain, flexion and extension difficulties; lung heat asthma; heat accumulation in the bladder, urination difficulties or urinary retention; dizziness, headache; traumatic injuries; carbuncle, sore and so on.

[0023] Phellodendron chinense Schneid. is a plant of the Rutaceae family. It has the effects of clearing away heat and dampness, purging fire and detoxifying, and removing bone steaming. It is mainly used to treat damp-heat diarrhea, hot stranguria, damp-heat diarrhea, jaundice, damp-heat beriberi, impotence, bone steaming and fatigue fever, night sweats, spermatorrhea, sores, swelling and poison, and eczema and itching.

[0024] Atractylodes is the dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz. of the Asteraceae family. It has the effects of drying dampness and strengthening the spleen, dispelling wind and dispersing cold. It is mainly used to treat dampness blocking the middle jiao, rheumatic arthralgia, wind-cold dampness with dampness on the surface, night blindness and blurred vision.

[0025] Chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort. of the genus Ligusticum of the Apiaceae family. It has the effects of promoting blood circulation and qi, dispelling wind and relieving pain. It is mainly used for chest pain caused by heart blood stasis, flank pain caused by liver depression and qi stagnation, chest and flank stabbing pain caused by liver blood stasis, injuries caused by falls, sores and swelling caused by blood stasis, irregular menstruation, amenorrhea and dysmenorrhea, postpartum blood stasis and pain, lochia retention, various headaches and rheumatic pain, etc.

[0026] Corydalis yanhusuo is the dried tuber of Corydalis yanhusuo WTWW, a plant of the genus Corydalis in the family Papaveraceae. It has the effects of promoting blood circulation, promoting qi circulation, and relieving pain. It is mainly used for various pain syndromes caused by qi and blood stasis, such as chest pain, liver and stomach qi pain, dysmenorrhea, irregular menstruation, abdominal pain caused by postpartum stasis, abdominal pain caused by cold hernia, traumatic injury, pain caused by bruises and swelling, and rheumatic pain.

[0027] Angelica sinensis is the root of Angelica sinensis (Oliv) Diels. of the Apiaceae family. It has the effects of nourishing blood and regulating menstruation, promoting blood circulation and relieving pain, and moistening the intestines and relieving constipation. It is mainly used to treat chlorosis due to blood deficiency, irregular menstruation, amenorrhea, dysmenorrhea, blood deficiency, blood stasis, pain caused by cold blood, traumatic injuries, rheumatic arthralgia, carbuncle sores, dry intestines and constipation, etc.

[0028] Astragalus is the root of Astragalus memeranaceus (Fisch.) Bge. Var. mongholicus (Bge.) Hsiao or A. membranaceus (Fisch.) Bge. of the genus Astragalus in the Leguminosae family. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, strengthening the body's defense system, promoting urination, and removing toxins and promoting tissue regeneration. It is mainly used to treat spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal for a long time, etc.

[0029] Schisandra chinensis is the mature fruit of Schisandra chinesis (Turcz.) Ball or Schisandra sphenanthera rehd.et Wils. of the Schisandra family. It has the effects of astringing, strengthening qi and promoting body fluid, nourishing the kidney and calming the mind. It is mainly used to treat chronic cough, asthma, spontaneous sweating, night sweats, spermatorrhea, spermatorrhea, chronic diarrhea, thirst due to loss of body fluid, polydipsia, palpitations, insomnia and dreaminess.

[0030] Chinese Yam is the rhizome of Dioscorea opposita Thunb., a plant of the Dioscorea family. It has the effects of nourishing qi and yin, tonifying the spleen, lungs and kidneys, consolidating essence and stopping leukorrhea. It is mainly used to treat spleen deficiency, poor appetite, fatigue, loose stools and diarrhea, lung deficiency, wheezing and coughing, kidney deficiency, spermatorrhea, leukorrhea and frequent urination, internal heat and thirst, etc.

[0031] Chicken gizzard lining is the inner wall of the gizzard of Gallus gallus domesticus Brisson, a domesticated chicken of the genus Phasianidae. It has the effects of helping digestion and strengthening the stomach, astringing sperm and stopping nocturnal emission. It is mainly used to treat food stagnation, infantile malnutrition, spermatorrhea and enuresis due to kidney deficiency, sandstone stranguria, and gallstones.

[0032] Poria cocos is the dried sclerotium of the fungus Poriacocos (Schw.) Wolf of the Polyporaceae family. The one produced in Yunnan is called "Yunling" and is of better quality. It has the effects of promoting diuresis and reducing swelling, dispelling dampness, strengthening the spleen, and calming the mind. It is mainly used to treat edema, phlegm and fluid retention, spleen deficiency diarrhea, palpitations, and insomnia.

[0033] Ginseng is the root of Panax ginseng CAMey. It has the effects of replenishing vital energy, tonifying the spleen and lungs, promoting the production of body fluids, calming the mind and improving intelligence. It is mainly used to treat qi deficiency, weak pulse, spleen deficiency, sinking of middle qi, asthma and cough due to lung deficiency, shortness of breath and fatigue, thirst due to loss of body fluids, thirst due to deficiency heat, insomnia and forgetfulness, palpitations, blood deficiency and sallow complexion, impotence and cold uterus, etc.

[0034] Platycladus orientalis (L.) Franco is a dried mature seed kernel of the plant Platycladus orientalis (L.) Franco of the Cupressaceae family. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation. It is mainly used to treat palpitations, insomnia, and constipation caused by dry intestines.

[0035] Millettia reticulata is the dried vine stem of Spatholobus suberectus Dunn, a plant of the Leguminosae family. It is distributed in Fujian, Guangdong, Guangxi, and Yunnan. It has the effects of promoting blood circulation, replenishing blood, regulating menstruation, and relaxing muscles and tendons. It is mainly used to treat irregular menstruation, dysmenorrhea, amenorrhea, rheumatic pain, numbness of hands and feet, paralysis of limbs, and chlorosis due to blood deficiency.

[0036] Achyranthes bidentata is the root of Achyranthes bidentata BI. and Cyathula officinalis Kuan. It has the effects of promoting blood circulation and menstruation, nourishing the liver and kidney, strengthening tendons and bones, promoting diuresis and relieving stranguria, and guiding fire (blood) downward. It is mainly used to treat amenorrhea, dysmenorrhea, abdominal pain during menstruation, retained placenta, traumatic injuries, soreness of waist and knees, paralysis of lower limbs, stranguria, edema, dysuria, headache, dizziness, toothache, oral ulcers, hematemesis, and epistaxis.

[0037] According to the "Diagnostic Criteria for Knee Osteoarthritis" in the 2002 edition of "Principles for Clinical Guidance and Research on New Chinese Medicines", it is believed that knee osteoarthritis can be divided into liver and kidney deficiency and tendon and vein stasis syndrome, spleen and kidney deficiency and dampness in the joints syndrome, and liver and kidney deficiency and phlegm and blood stasis syndrome. Among them, liver and kidney deficiency and phlegm and blood stasis syndrome are the most common in knee osteoarthritis. The main symptoms are joint pain, swelling and hypertrophy, weakness and lack of strength. Secondary symptoms are hypertrophy of joints, limited movement, red tongue, or fat and pale tongue, thin or thin and greasy fur, and slippery or stringy pulse.

[0038] Osteoarthritis of the knee joint belongs to arthralgia. The lesions of osteoarthritis of the knee joint with liver and kidney deficiency and phlegm and blood stasis are located in the tendons and bones. The tendons and bones rely on the nourishment of the essence and blood in the liver and kidney, and the warmth of the yang in the kidney. Kidney deficiency will result in a weak innate foundation and the breeding of all kinds of diseases. The original yang in the kidney is the root of all yang in the human body. Wind-cold-damp arthralgia is often manifested as pain, soreness, and heaviness, which can be resolved when the yang is invigorated. The original yin in the kidney is the root of all yin in the human body. Wind-rheumatic-heat arthralgia often turns into heat and damages yin, which can only be relieved by the nourishment of yin essence. Therefore, this disease is related to liver and kidney deficiency, malnutrition of tendons and bones, invasion of wind-cold-damp evil, stagnation of phlegm and blood stasis, and belongs to the syndrome of deficiency in the root and excess in the superficial. Insufficiency of the liver and kidney leads to malnutrition of tendons and bones, poor circulation of qi and blood, and thus a series of symptoms such as joint pain, muscle soreness, and weakness in the waist and knees. Therefore, mistletoe, Eucommia ulmoides, and Cuscuta chinensis are used to nourish the liver and kidneys; at the same time, "Suwen·Bi Lun" says: "The so-called Bi is that each is affected by the wind, cold and dampness at its own time." "The three qi of wind, cold and dampness are mixed together and form Bi. The wind qi is stronger than the cold qi, which is painful Bi, and the dampness is stronger than the dampness." "If the Bi is in the bones, it is heavy; if it is in the veins, the blood will coagulate and not flow; if it is in the tendons, it will bend and not stretch; if it is in the flesh, it will be numb; if it is in the skin, it will be cold." It points out that the cause of the disease is mainly affected by wind, cold and dampness, which reflects the idea that Bi syndrome can be classified according to the prevalence of pathogenic factors. Liver and kidney deficiency and phlegm and blood stasis syndrome often occur in the late stage of Bi syndrome. Phlegm and blood stasis are intertwined and turn into heat over time. Therefore, scorpion and earthworm are used to search for wind and phlegm and eliminate stubborn Bi, Phellodendron chinense and Atractylodes macrocephala are used to clear heat and dampness, relieve Bi and relieve pain. Mulberry, Eucommia ulmoides, Cuscuta chinensis, scorpion, earthworm, Phellodendron chinense, and Atractylodes macrocephala are all the main drugs.

[0039] "Treatise on the Causes and Symptoms of Various Diseases·Rheumatic Arthritis Body Hands and Feet Symptoms": "If a person's body is weak, it is due to rheumatism, which attacks the qi and blood. If the blood and qi do not flow, it will be unhealthy. The true evil strikes each other between the muscles, so the skin is all painful." "Medical Essential Reading·Arthritis": "For the treatment of arthritis, dispersing wind is the main method, and resisting cold and removing dampness cannot be abandoned. Generally, blood-tonifying agents are used. Treating wind starts with treating blood, and wind will disappear when blood circulates." The present invention adopts Chuanxiong, Corydalis, and Angelica to promote blood circulation, remove blood stasis, relieve arthritis and relieve pain, as assistant drugs.

[0040] The lungs give birth to the kidneys, which means that metal gives birth to water. For example, the lung's essence and fluid descend to nourish the kidney essence, and the lung qi descends to help the kidney absorb qi. Astragalus, Schisandra chinensis, and Chinese yam are used to nourish the lungs and achieve the purpose of nourishing the kidneys. At the same time, it is believed that liver and kidney deficiency and phlegm and blood stasis syndrome belong to the transition stage from Taiyin to Shaoyin. Taiyin disease is caused by wind and cold evil that damages the spleen and stomach, while Shaoyin disease leads to deficiency of both the heart and kidneys and excessive yin and cold inside the body. Therefore, chicken's gizzard lining and Poria cocos are used to nourish the spleen and stomach, and ginseng and pine nuts are used to nourish the heart. The heart yang warms the spleen and earth, which in turn helps the spleen to transport and transform. Therefore, Astragalus, Schisandra chinensis, Chinese yam, chicken's gizzard lining, Poria cocos, ginseng, and pine nuts are used as adjuvants.

[0041] Osteoarthritis of the knee joint due to liver and kidney deficiency and phlegm and blood stasis syndrome belongs to lower limb arthritis. Millettia reticulata and Achyranthes bidentata are used as guiding drugs to lead the medicine downward.

[0042] The whole prescription is composed of mistletoe, eucommia, dodder seed, scorpion, earthworm, phellodendron, atractylodes, ligusticum chuanxiong, corydalis, angelica, astragalus, schisandra, yam, chicken gizzard lining, poria, ginseng, pine nuts, millettia reticulata and Achyranthes bidentata. It can treat liver and kidney deficiency and phlegm and blood stasis syndrome of knee osteoarthritis by nourishing the liver and kidney, removing wind and phlegm, eliminating stubborn arthritis, clearing away heat and dampness, relieving arthritis and relieving pain, promoting blood circulation and removing blood stasis, relieving arthritis and relieving pain, nourishing the lungs, spleen and stomach, and nourishing the heart.

[0043] The experiment of the effect of the present invention on rat granuloma caused by button showed that compared with the model group, the granuloma of the rats in the aspirin group was significantly reduced. Compared with the model group, the granuloma of the medium and high dose groups of the granules prepared in Example 1 of the present invention was significantly reduced, and the effect of the high dose group was close to that of the positive drug group.

[0044] The experiment on the effect of xylene on the ear swelling of mice showed that the swelling of mice in the aspirin group was significantly reduced compared with the model group. The swelling of the medium and high dose groups of the granules prepared in Example 1 of the present invention was significantly reduced compared with the model group, and the effect of the high dose group was close to that of the positive drug group.

[0045] The experiment of the present invention on the number of writhing of mice induced by acetic acid showed that the number of writhing of mice in the aspirin group was significantly reduced compared with the model group. The number of writhing of mice in the low, medium and high dose groups of the granules prepared in Example 1 of the present invention was significantly reduced compared with the model group, and the high dose group had a better effect than the positive drug group.

[0046] The pharmacodynamic study experiment on the rat knee osteoarthritis model of the present invention showed that the bone density of the model group was significantly decreased compared with the blank control group, and there was a significant difference between the two, indicating that the modeling was successful. The bone density of the low, medium and high dose groups of the granules prepared in Example 1 of the present invention was significantly increased compared with the model group, and there was a significant difference between the two.

[0047] The HSS knee score in the clinical research experiment showed that after 8 weeks of treatment, the HSS knee score of the control group was 83.67±7.81, and the HSS knee score of the present invention group was 95.39±10.62. The granules prepared in Example 1 of the present invention were better than the control group in treating liver and kidney deficiency and phlegm and blood stasis syndrome in knee osteoarthritis, indicating that the present invention is reasonably compatible and has significant efficacy. The clinical effective rate showed that the control group had 14 cases of marked effect, 17 cases of effective, 9 cases of ineffectiveness, and a clinical effective rate of 77.5%. The granules prepared in Example 1 of the present invention were 21 cases of marked effect, 16 cases of effective, 3 cases of ineffectiveness, and a clinical effective rate of 92.5%. The granules prepared in Example 1 of the present invention were better than the control group in treating liver and kidney deficiency and phlegm and blood stasis syndrome in knee osteoarthritis, indicating that the present invention is reasonably compatible and has significant efficacy. DETAILED DESCRIPTION

[0048] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, 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 appended claims of the application equally.

[0049] Embodiment 1: Take 250g of parasitic lonicera, 200g of Eucommia bark, 200g of Cuscuta chinensis, 150g of scorpion, 100g of earthworm, 250g of Phellodendron chinense, 200g of Atractylodes macrocephala, 200g of Ligusticum chuanxiong, 200g of Corydalis yanhusuo, 250g of Angelica sinensis, 200g of Astragalus, 200g of Schisandra chinensis, 350g of Chinese yam, 150g of chicken gizzard lining, 200g of Poria, 200g of Ginseng, 200g of Platycladus orientalis, 150g of Millettia spatholobi, and 200g of Achyranthes bidentata, and the preparation method comprises the following steps:

[0050] (1) Grinding of medicinal materials: weigh and grind the following ingredients according to weight: Herba Mori, Eucommia bark, Cuscuta chinensis, Scorpio ternata, Pheretima chinensis, Atractylodes macrocephala, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis, Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Gallus galli, Poria cocos, Ginseng, Semen Platycladi, Caulis Millettiae and Radix Achyranthis Bidentatae into coarse powder;

[0051] (2) Weighing the coarse powder crushed in step (1) by weight, adding water and decocting twice, with the amount of water added each time being 12 times the total weight of the medicinal materials, and the decocting time each time being 1.5 hours, filtering, and concentrating the filtrate by vacuum film to an extract with a relative density of 1.2 at 25° C.;

[0052] (3) adding 5 times the volume of 90% ethanol to the extract obtained in step (2) until the alcohol content of the alcohol precipitation solution is 75%, stirring evenly, standing for 12 hours, and filtering;

[0053] (4) recovering ethanol from the filtrate, concentrating the filtrate in a double-effect concentrator to an extract having a relative density of 1.35 at 70° C., and drying the filtrate to obtain a dry extract;

[0054] (5) Powdering the dry extract obtained in step (4), adding starch, and preparing granules.

[0055] Embodiment 2: Take 200g of parasitic lonicera, 220g of Eucommia bark, 150g of Cuscuta australis, 200g of Scorpio, 80g of Pheretima, 300g of Phellodendron chinense, 150g of Atractylodes macrocephala, 220g of Ligusticum chuanxiong, 150g of Corydalis yanhusuo, 300g of Angelica sinensis, 180g of Astragalus, 250g of Schisandra chinensis, 300g of Dioscorea opposita, 200g of Gallus gallus domestica, 150g of Poria, 220g of Ginseng, 150g of Platycladus orientalis, 200g of Millettia spatholobi, and 150g of Achyranthes bidentata. The preparation method comprises the following steps:

[0056] (1) Grinding of medicinal materials: weigh and grind the following ingredients according to weight: Herba Mori, Eucommia bark, Cuscuta chinensis, Scorpio ternata, Pheretima chinensis, Atractylodes macrocephala, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis, Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Gallus galli, Poria cocos, Ginseng, Semen Platycladi, Caulis Millettiae and Radix Achyranthis Bidentatae into coarse powder;

[0057] (2) Weighing the coarse powder crushed in step (1) by weight, adding water and decocting twice, with the amount of water added each time being 12 times the total weight of the medicinal materials, and the decocting time each time being 1.5 hours, filtering, and concentrating the filtrate by vacuum film to an extract with a relative density of 1.15 at 25° C.;

[0058] (3) adding 5 times the volume of 99% ethanol to the extract obtained in step (2) until the alcohol content of the alcohol precipitation solution is 50%, stirring evenly, standing for 16 hours, and filtering;

[0059] (4) recovering ethanol from the filtrate, concentrating under reduced pressure with a thin film to an extract having a relative density of 1.4 at 50° C., and drying by fluidized bed boiling to obtain a dry extract;

[0060] (5) Powdering the dry extract obtained in step (4), adding dextrin, and preparing capsules.

[0061] Embodiment 3: Take 300g of parasitic lonicera, 180g of Eucommia bark, 250g of Cuscuta australis, 100g of scorpion, 120g of earthworm, 200g of Phellodendron chinense, 250g of Atractylodes macrocephala, 180g of Chuanxiong, 250g of Corydalis yanhusuo, 200g of Angelica sinensis, 220g of Astragalus, 150g of Schisandra chinensis, 400g of Chinese yam, 100g of chicken gizzard lining, 250g of Poria cocos, 180g of ginseng, 250g of Platycladus orientalis, 100g of Millettia spatholobi, and 250g of Achyranthes bidentata, and the preparation method comprises the following steps:

[0062] (1) Grinding of medicinal materials: weigh and grind the following ingredients according to weight: Herba Mori, Eucommia bark, Cuscuta chinensis, Scorpio ternata, Pheretima chinensis, Atractylodes macrocephala, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis, Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Gallus galli, Poria cocos, Ginseng, Semen Platycladi, Caulis Millettiae and Radix Achyranthis Bidentatae into coarse powder;

[0063] (2) Weighing the coarse powder crushed in step (1) by weight, adding water and decocting twice, with the amount of water added each time being 12 times the total weight of the medicinal materials, and the decocting time each time being 1.5 hours, filtering, and concentrating the filtrate by vacuum film to an extract with a relative density of 1.15 to 1.25 at 25° C.;

[0064] (3) adding 5 times the volume of 70% ethanol to the extract obtained in step (2) until the alcohol content of the alcohol precipitation solution is 60%, stirring evenly, standing for 8 hours, and filtering;

[0065] (4) recovering ethanol from the filtrate, concentrating under reduced pressure with a thin film to an extract having a relative density of 1.3 at 80° C., and drying by hot air circulation to obtain a dry extract;

[0066] (5) Powdering the dry extract obtained in step (4), adding microcrystalline cellulose, and preparing tablets.

[0067] Example 4: Effect of the present invention on button-induced granuloma in rats

[0068] Rats were randomly divided into 5 groups, namely, model group, positive control group, low-, medium- and high-dose groups of granules prepared in Example 1 of the present invention, with 20 rats in each group, half male and half female; 3% sodium pentobarbital solution was injected intraperitoneally for anesthesia, subcutaneous incision was made on the back, and pre-sterilized plastic buttons were inserted and sutured. The first administration was given 2 hours after surgery. The low-, medium- and high-dose groups of granules prepared in Example 1 of the present invention were gavaged with granules prepared in Example 1 of the present invention, which were equivalent to 5g / kg, 15g / kg and 30g / kg of crude drug, respectively, and the administration volume was 0.1ml / 10g. The positive control group was gavaged with aspirin 0.065g / kg, and the administration volume was 0.1ml / 10g. The model group was given an equal volume of distilled water, and the drug and water were given once a day for 14 consecutive days. After 14 days of administration, the animals were killed, the buttons attached to the granuloma were carefully peeled off, and the net weight of the granuloma was weighed. The results are shown in Table 1.

[0069] Table 1 Effect of the present invention on button-induced granuloma in rats

[0070] Group Granuloma net weight / g Model Group 0.214±0.032 Positive drug group <![CDATA[0.146±0.054 ## ]]> Low dose group 0.197±0.038 Medium dose group <![CDATA[0.165±0.041 # ]]> High dose group <![CDATA[0.148±0.062 ## ]]>

[0071] Compared with the model group, # P<0.05 ## P<0.01

[0072] As can be seen from Table 1, compared with the model group, the granulomas of rats in the aspirin group were significantly reduced. Compared with the model group, the granulomas of the medium and high dose groups of the granules prepared in Example 1 of the present invention were significantly reduced, and the effect of the high dose group was close to that of the positive drug group.

[0073] Example 5: Effect of the present invention on xylene-induced ear swelling in mice

[0074] Kunming mice were randomly divided into groups, namely, model group, aspirin group, low, medium and high dose groups of granules prepared in Example 1 of the present invention, 20 mice in each group, half male and half female; the low, medium and high dose groups of granules prepared in Example 1 of the present invention were respectively gavaged with granules prepared in Example 1 of the present invention, which were equivalent to 5g / kg, 15g / kg and 30g / kg of the raw drug amount, respectively, and the administration volume was 0.1ml / 10g. The positive control group was gavaged with 0.065g / kg of aspirin, and the administration volume was 0.1ml / 10g. The model group was given an equal volume of distilled water, and the drug was administered and watered once a day for 7 consecutive days. 1.5h after the last administration, 40ul of xylene was taken with a pipette and evenly applied to the front and back sides of the right ear of the mouse. After 2 hours, the mice were killed by vertebral dislocation, and the two ears were cut along the auricle baseline. The round ear pieces were punched at the same position with a 7mm puncher, weighed, and the swelling degree and swelling inhibition rate were calculated. The calculation formula was: swelling degree = weight of right ear piece - weight of left ear piece; inhibition rate = average swelling degree of model group - average swelling degree of drug-treated group) average swelling degree of model group. The results are shown in Table 2.

[0075] Table 2 Effect of the present invention on xylene-induced ear swelling in mice

[0076] Group Swelling Swelling inhibition rate / % Model Group 0.0131±0.0015 Positive drug group <![CDATA[0.0048±0.0012 ## ]]> 63.36 Low dose group 0.0104±0.0018 20.61 Medium dose group <![CDATA[0.0076±0.0021 # ]]> 41.98 High dose group <![CDATA[0.0051±0.0019 ## ]]> 61.07

[0077] Compared with the model group, # P<0.05 ## P<0.01

[0078] As can be seen from the table, compared with the model group, the swelling of mice in the aspirin group was significantly reduced. Compared with the model group, the swelling of the medium and high dose groups of the granules prepared in Example 1 of the present invention was significantly reduced, and the effect of the high dose group was close to that of the positive drug group.

[0079] Example 6: Effect of the present invention on the number of writhing times induced by acetic acid in mice

[0080] Kunming mice were randomly divided into groups, namely, model group, aspirin group, low-dose, medium-dose and high-dose groups of granules prepared in Example 1 of the present invention, 15 mice in each group, half male and half female; the low-dose, medium-dose and high-dose groups of granules prepared in Example 1 of the present invention were respectively gavaged with granules prepared in Example 1 of the present invention, which were equivalent to 5g / kg, 15g / kg and 30g / kg of the raw drug amount, respectively, and the administration volume was 0.1ml / 10g. The positive control group was gavaged with aspirin 0.065g / kg, and the administration volume was 0.1ml / 10g. The model group was given an equal volume of distilled water, and the drug and water were given once a day for 7 consecutive days. After the last administration, the mice were intraperitoneally injected with 0.6% glacial acetic acid 0.1Ml / 10g, and the number of twists of the mice within 0.5h was recorded. The results are shown in Table 3.

[0081] Table 3 Effect of the present invention on the number of writhing times of mice induced by glacial acetic acid

[0082]

[0083]

[0084] Compared with the model group, # P<0.05 ## P<0.01

[0085] As can be seen from Table 3, compared with the model group, the writhing times of mice in the aspirin group were significantly reduced. Compared with the model group, the writhing times of mice in the low, medium and high dose groups of the granules prepared in Example 1 of the present invention were significantly reduced, and the high dose group had a better effect than the positive drug group.

[0086] Example 7: Pharmacodynamic study of the present invention on rat knee osteoarthritis model

[0087] Preparation of rat knee osteoarthritis model: 30 SD rats were divided into blank control group, model control group and drug administration group, with 10 rats in each group. The rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (0.3ml / 100g). After anesthesia, they were fixed on the operating table in supine position. The hair in the surgical area and the surrounding area was shaved with a blade, washed with wet gauze, and disinfected with iodine tincture. The rats were draped in a conventional manner, and the knee joints of the rats were slightly flexed. A microsyringe was inserted into the joint cavity from the lower medial side of the patella and injected with 50μl of iodoacetate. The knee joints of the rats in the blank control group were injected with an equal amount of sterile saline. After injection, the rats were placed in a standard animal cage for free movement and feeding.

[0088] The drug administration started on the second day after modeling. Treatment group: The dosage of rats administered by gavage was based on the daily clinical dosage of humans, and was converted into the equivalent clinical dosage of humans by the human-rat body surface area ratio. The granules prepared in Example 1 of the present invention were prepared into a concentration of 1g crude drug / ml, and administered by gavage at a dose of 2ml / kg. The blank control group and the model control group were administered by gavage at the same dose of 0.9% saline, and the gavage was continued for 28 days. The bone density of the rat knee joint was tested, and the results are shown in Table 4.

[0089] Table 4 Effect of the present invention on bone density in rat knee osteoarthritis model

[0090] Group <![CDATA[Bone density (g / cm 2 )]]> Blank control group 0.296±0.131 Model Group <![CDATA[0.212±0.131 ## ]]> The present invention group <![CDATA[0.286±0.165 ** ]]>

[0091] Compared with the blank control group, # P<0.05 ## P<0.01, compared with the model group * P<0.05, ** P<0.01

[0092] As shown in Table 4, compared with the blank control group, the model group had a significantly decreased bone density, and there was a significant difference between the two groups, indicating that the modeling was successful. Compared with the model group, the granules prepared in Example 1 of the present invention had a significantly increased bone density, and there was a significant difference between the two groups.

[0093] Example 8: Clinical study

[0094] General information: 80 patients participated in the trial in our hospital, aged 50-81 years old; 40 cases were in the treatment group, including 22 cases on one knee and 18 cases on both knees, 19 males and 21 females, with an average age of 61.56 years old; 40 cases were in the control group, including 19 cases on one knee and 21 cases on both knees, 22 males and 18 females, with an average age of 60.98. The gender and age balance of the two groups of patients were tested, and there was no significant difference, so the two groups were comparable.

[0095] Western medicine diagnostic criteria: pain under the ilium, repeated swelling of the joints, mild or moderate limitation of joint movement. X-rays show: small bone spurs proliferate on the upper and lower edges of the ilium, bone spurs proliferate on the joint edges and intercondylar ridges, and narrow joint space.

[0096] TCM diagnostic criteria: Based on the "Guidelines for Clinical Research of New Chinese Medicines for the Treatment of Osteoarthritis" in the "Guidelines for Clinical Research of New Chinese Medicines" (Trial Version 2002): Knee osteoarthritis is most commonly caused by liver and kidney deficiency and phlegm and blood stasis syndrome. The main symptoms are joint pain, swelling and hypertrophy, weakness and lack of strength. Secondary symptoms are hypertrophy of joints, limited movement, red tongue, or fat and pale tongue, thin or thin and greasy fur, and slippery or stringy pulse.

[0097] Treatment method: The treatment group was given the granules prepared in Example 1 of the present invention, with a daily dosage of; 25g of parasitic lonicera, 20g of Eucommia ulmoides, 20g of Cuscuta chinensis, 15g of scorpion, 10g of earthworm, 25g of Phellodendron chinense, 20g of Atractylodes macrocephala, 20g of Chuanxiong, 20g of Corydalis yanhusuo, 25g of Angelica sinensis, 20g of Astragalus membranaceus, 20g of Schisandra chinensis, 35g of Chinese yam, 15g of chicken gizzard lining, 20g of Poria cocos, 20g of ginseng, 20g of Platycladus orientalis, 15g of Millettia spatholobi, and 20g of Achyranthes bidentata, divided into two doses. The course of treatment was 8 weeks. No other similar drugs were used during the treatment period. The control group was given bone spur capsules (National Medicine Standard Z20050686, Yangzhou Zhonghui Pharmaceutical Co., Ltd.), each containing 0.36g, 3 capsules at a time, 3 times a day, and the course of treatment was 8 weeks. No other similar drugs were used during the treatment period.

[0098] Basic treatment: Instruct the patient to perform isometric training of the quadriceps. Isometric training of the quadriceps uses the straight leg raising method and progressive load training. First, perform simple straight leg raising. When the patient feels that the muscle strength has increased, increase the training load by adding sandbags (or rice bags) to the calves and gradually increase the load. Rest for half a minute after each exercise, and switch to the other lower limb after 8-10 minutes. This is a set, 3-4 sets per day. The patient should protect the affected knee with a knee brace during daily activities.

[0099] HSS Knee Score: Knee Function Score is a widely used scoring system for evaluating the functional status of the knee joint. It is usually used to evaluate the recovery after knee surgery, the severity of diseases such as arthritis, and the overall function of the knee joint. It was proposed in 1976 by the Hospital for Special Surgery (HSS), the top orthopedic hospital in the United States, to evaluate the function of the knee before and after surgery. The HSS score includes pain, function, range of motion, muscle strength, deformity, and stability. The total score is 100 points. The higher the score, the better the knee function. The specific contents of the HSS score include: 1. Pain (30 points): evaluate the pain level of the knee joint. 2. Function (22 points): evaluate the daily activity ability of the knee joint. 3. Mobility (18 points): evaluate the range of motion of the knee joint. 4. Muscle strength (10 points): evaluate the strength of the muscles around the knee joint. 5. Deformity (10 points): evaluate the degree of deformity of the knee joint. 6. Stability (10 points): evaluate the stability of the knee joint. The results are shown in Table 5.

[0100] Table 5 HSS knee joint scores before treatment, 2 weeks, 4 weeks and 8 weeks in the two groups

[0101] Group Before treatment 2 weeks 4 weeks 8 weeks Control group 68.65±7.98 76.54±9.12 81.38±7.23 83.67±7.81 The present invention group 69.09±8.32 83.09±7.48 <![CDATA[88.18±9.43 * ]]> <![CDATA[95.39±10.62 ** ]]>

[0102] Compared with the control group * P<0.05, ** P<0.01

[0103] As shown in Table 5, after 8 weeks of treatment, the HSS knee joint score of the control group was 83.67±7.81, and the HSS knee joint score of the group of the present invention was 95.39±10.62. The granules prepared in Example 1 of the present invention were better than those of the control group in the treatment of liver and kidney deficiency and phlegm and blood stasis syndrome in knee osteoarthritis, indicating that the present invention has reasonable compatibility and significant therapeutic effect.

[0104] Efficacy judgment criteria: Significant effect: knee joint pain is significantly reduced or disappeared, and swelling is significantly reduced or completely reduced. Effective: knee joint pain is reduced before treatment, and swelling is reduced compared with before. Ineffective: no change or aggravation before and after treatment. The results are shown in Table 6.

[0105] Table 6 Comparison of therapeutic effects of the present invention on treating knee osteoarthritis

[0106] Group Significant effect efficient invalid Effectiveness (%) Control group 14 17 9 77.5 The present invention group 21 16 3 92.5

[0107] As shown in Table 6, the control group had 14 markedly effective cases, 17 effective cases, 9 ineffective cases, and an effective rate of 77.5%. The granules prepared in Example 1 of the present invention had 21 markedly effective cases, 16 effective cases, and 3 ineffective cases, and an effective rate of 92.5%. The granules prepared in Example 1 of the present invention were better than those of the control group in the treatment of liver and kidney deficiency and phlegm and blood stasis syndrome in knee osteoarthritis, indicating that the present invention has a reasonable compatibility and significant therapeutic effect.

[0108] Although 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 the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating knee osteoarthritis, characterized in that: The invention is prepared by extracting 19 kinds of Chinese medicinal pieces in the following weight proportions, and the weight proportions of each Chinese medicinal piece are as follows: 20-30 parts of mistletoe, 18-22 parts of eucommia bark, 15-25 parts of dodder seeds, 10-20 parts of scorpion, 8-12 parts of earthworm, 20-30 parts of phellodendron, 15-25 parts of atractylodes, 18-22 parts of ligusticum chuanxiong, 15-25 parts of corydalis, 20-30 parts of angelica, 18-22 parts of astragalus, 15-25 parts of schisandra, 30-40 parts of yam, 10-20 parts of chicken's gizzard lining, 15-25 parts of poria, 18-22 parts of ginseng, 15-25 parts of cypress seeds, 10-20 parts of millettia reticulata, and 15-25 parts of achyranthes bidentata.

2. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The product is prepared by extracting 19 Chinese medicinal pieces in the following weight proportions, and the weight proportions of each Chinese medicinal piece are as follows: 25 parts of mistletoe, 20 parts of eucommia, 20 parts of dodder seeds, 15 parts of scorpion, 10 parts of earthworms, 25 parts of phellodendron, 20 parts of atractylodes, 20 parts of ligusticum chuanxiong, 20 parts of corydalis, 25 parts of angelica, 20 parts of astragalus, 20 parts of schisandra, 35 parts of yam, 15 parts of chicken gizzard lining, 20 parts of poria, 20 parts of ginseng, 20 parts of pine nuts, 15 parts of millettia reticulata, and 20 parts of achyranthes bidentata.

3. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The preparation method comprises the following steps: (1) Grinding of medicinal materials: weigh and grind the following ingredients according to weight: Herba Mori, Eucommia bark, Cuscuta chinensis, Scorpio ternata, Pheretima chinensis, Atractylodes macrocephala, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis, Radix Astragali, Fructus Schisandrae Chinensis, Rhizoma Dioscoreae, Gallus galli, Poria cocos, Ginseng, Semen Platycladi, Caulis Millettiae and Radix Achyranthis Bidentatae into coarse powder; (2) Weighing the coarse powder crushed in step (1) by weight, adding water and decocting twice, with the amount of water added each time being 12 times the total weight of the medicinal materials, and the decocting time each time being 1.5 hours, filtering, and concentrating the filtrate to an extract with a relative density of 1.15 to 1.25 at 25° C.; (3) adding 5 times the volume of 70%-99% ethanol to the extract obtained in step (2) until the alcohol content of the alcohol precipitation solution is 50-80%, stirring evenly, standing for 8-16 hours, and filtering; (4) recovering ethanol from the filtrate, concentrating it to an extract having a relative density of 1.3 to 1.4 at 50 to 80° C., and drying it to obtain a dry extract; (5) Powdering the dry extract obtained in step (4), adding auxiliary materials, and preparing into one of capsules, pills, tablets or granules.

4. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The concentration method in step (2) of the preparation method is selected from one of reduced pressure film concentration, direct heating open concentration, single-effect concentrator concentration or double-effect concentrator concentration.

5. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The concentration method in step (4) of the preparation method is selected from one of reduced pressure film concentration, direct heating open concentration, single-effect concentrator concentration or double-effect concentrator concentration.

6. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The drying method in step (4) of the preparation method is selected from one of hot air circulation drying, vacuum drying, fluidized bed boiling drying, spray drying or microwave drying.

7. The Chinese medicine composition for treating knee osteoarthritis according to claim 1, characterized in that: The knee osteoarthritis belongs to the syndrome of liver and kidney deficiency and phlegm and blood stasis.

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