Application of traditional Chinese medicine composition in preparation of medicine for treating or preventing idiopathic inflammatory myopathy

Abstract

The invention provides application of a traditional Chinese medicine composition in preparation of a medicine for treating or preventing idiopathic inflammatory myopathy. The traditional Chinese medicine composition comprises the following components in parts by weight: 1-100 parts of mangnolia officinalis, 1-100 parts of scorched betel nut, 1-100 parts of roasted amomum tsao-ko, 1-100 parts of ephedra, 1-100 parts of semen armeniacae amarae, 1-100 parts of notopterygium root, 1-100 parts of ginger, 1-100 parts of pogostemon cablin, 1-100 parts of eupatorium, 1-100 parts of rhizoma atractylodis, 1-160 parts of poria cocos, 1-120 parts of bighead atractylodes rhizome, 1-100 parts of gypsum, 1-100 parts of scorched hawthorn fruit, 1-100 parts of scorched medicated leaven, 1-100 parts of scorched malt, 1-100 parts of earthworm, 1-100 parts of cynanchum paniculatum, 1-100 parts The traditional Chinese medicine composition can improve the disease symptoms of idiopathic myopathy model rats, reduce the levels of creatine kinase, lactic dehydrogenase and glutamic oxalacetic transaminase in serum of the rats, has a certain regulation effect on the time limit and amplitude of guinea pig electromyogram, can also reduce the activity of creatine phosphokinase, lactic dehydrogenase and glutamic oxalacetic transaminase of the rats, and can improve the curative effect of the rats. The traditional Chinese medicine composition is proved to have a treatment effect on idiopathic inflammatory myopathy.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to the use of a traditional Chinese medicine composition in the preparation of a drug for treating or preventing idiopathic inflammatory myopathy. Background Art

[0002] Idiopathic inflammatory myopathies (IIM) are a group of systemic autoimmune diseases characterized by chronic muscle inflammation leading to progressive muscle atrophy. Clinically, the main manifestations are symmetrical proximal muscle weakness, myalgia, and elevated serum muscle enzymes in the limbs. In addition to muscles, multiple organ systems such as the skin and lungs can also be affected, mainly including polymyositis (PM) and dermatomyositis (DM). The incidence of PM / DM in my country is not very clear. The incidence reported abroad is (0.6-1) / 10,000, with more women than men. The exact cause is still unclear, and it may be related to genetic and environmental factors. Polymyositis often presents with subacute onset, with symmetrical proximal muscle weakness in the limbs within weeks or months, and about 50% of patients may also have myalgia or muscle tenderness. As the course of the disease prolongs, manifestations of involvement outside the skeletal muscle may appear, such as involvement of the lungs, digestive tract, heart, and kidneys. In addition to the same muscle and visceral involvement as DM, PM also has characteristic skin involvement. Due to the unknown etiology and pathological mechanism, the clinical treatment of PM / DM is still mainly based on hormones and immunosuppressants, which lack specificity and cause a large number of drug toxicity and side effects in clinical practice. For example, long-term use of hormone drugs can inhibit the body's response to inflammation, thereby reducing the body's ability to resist infection; it can redistribute fat, and patients may have body changes such as full moon face, buffalo hump, trunk obesity, thin limbs and centripetal obesity; hormones can also decalcify bones and cause osteoporosis. At present, there is no unified name for idiopathic inflammatory myopathy in traditional Chinese medicine, because its muscle and joint pain belongs to the category of "arthralgia" in traditional Chinese medicine, and because its disease site is mainly in the muscles, it is currently collectively referred to as muscle arthralgia. The State Administration of Traditional Chinese Medicine also clearly stipulates in the advantageous diseases of key specialties of traditional Chinese medicine that IIM mainly refers to traditional Chinese medicine muscle arthralgia. It is believed that the main pathogenesis is insufficient constitution, disorder of the generation and restraint of yin and yang, qi and blood and the five elements, which leads to internal accumulation of evil toxins or a combination of internal and external evils, which block the skin and internal organs and damage the internal organs, thus forming a syndrome of evil-blockage and deficiency. Summary of the invention

[0003] Traditional Chinese medicine believes that evil toxins and blood stasis are the key factors that cause muscle paralysis. Therefore, it has established blood clearing and detoxification, unblocking meridians and removing numbness as the main treatment methods of traditional Chinese medicine throughout the process, and then the treatment is based on the different stages of the disease and the cold, heat, deficiency and excess of the damaged organs. In the treatment, both the symptoms and the root causes are treated, and wind and toxins are removed, heat and dampness are cleared to treat the symptoms, and blood and muscle are nourished, blood circulation and skin are activated to treat the root causes, so that the inflammation of the damaged muscles is eliminated and the rash on the damaged skin disappears. In addition, traditional Chinese medicine treatment emphasizes syndrome differentiation and treatment. The medicine is used according to each patient and different conditions. The medicinal materials used are all pure natural herbs and minerals, hygienic and environmentally friendly, with few toxic side effects, stable quality, and relatively low price.

[0004] Based on the above advantages of traditional Chinese medicine, in order to solve the technical problems of the treatment of the above idiopathic inflammatory myopathy, the present application provides a Chinese medicine composition for the preparation of a drug for treating or preventing idiopathic inflammatory myopathy, the Chinese medicine composition comprising: 1-100 parts of Magnolia officinalis, 1-100 parts of charred Areca nut, 1-100 parts of stewed Tsaoko fruit, 1-100 parts of Ephedra, 1-100 parts of Bitter Apricot Kernel, 1-100 parts of Notopterygium wilfordii, raw 1-100 parts of ginger, 1-100 parts of patchouli, 1-100 parts of perilla, 1-100 parts of atractylodes, 1-160 parts of tuckahoe, 1-120 parts of atractylodes, 1-100 parts of gypsum, 1-100 parts of charred hawthorn, 1-100 parts of charred six-spirited song, 1-100 parts of charred malt, 1-100 parts of earthworm, 1-100 parts of cynanchum chinense, 1-100 parts of mianma cyperus, and 1-100 parts of scutellaria baicalensis. The application can be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0005] Furthermore, the Chinese medicine composition includes: 10-80 parts of Magnolia officinalis, 10-80 parts of scorched betel nut, 10-80 parts of stewed tsaoko, 10-60 parts of ephedra, 10-60 parts of bitter almond, 10-80 parts of Notopterygium wilfordii, 10-60 parts of ginger, 10-80 parts of patchouli, 10-60 parts of Cyperus rotundus, 10-80 parts of Atractylodes macrocephala, 10-160 parts of Poria cocos, 10-120 parts of Atractylodes macrocephala, 10-80 parts of gypsum, 10-50 parts of scorched hawthorn, 10-80 parts of scorched Liu Shenqu, 10-60 parts of scorched malt, 10-80 parts of earthworms, 10-80 parts of Cynanchum chinense, 10-60 parts of Cynomorium fortunei, and 10-80 parts of Lemongrass seeds.

[0006] Optionally, the Chinese medicine composition includes: 30-50 parts of Magnolia officinalis, 20-30 parts of scorched Areca catechu, 30-50 parts of stewed Tsaoko fruit, 20-30 parts of Ephedra sinica, 20-30 parts of Bitter Apricot, 30-50 parts of Notopterygium wilfordii, 30-50 parts of Ginger, 30-50 parts of Patchouli, 20-30 parts of Cyperus rotundus, 30-50 parts of Atractylodes macrocephala, 120-150 parts of Poria cocos, 80-100 parts of Atractylodes macrocephala, 30-50 parts of Gypsum, 20-30 parts of scorched Crataegus pinnatifida, 30-50 parts of scorched Liu Shenqu, 20-30 parts of scorched malt, 30-50 parts of Pheretima, 30-50 parts of Cynanchum cyrtonema, 20-30 parts of Cyperus rotundus, and 30-50 parts of Lepidium glutamate.

[0007] Specifically, the Chinese medicine composition can also be: 50 parts of Magnolia officinalis, 30 parts of scorched betel nut, 30 parts of simmered tsaoko, 20 parts of ephedra, 30 parts of bitter almond, 50 parts of Notopterygium wilfordii, 50 parts of ginger, 50 parts of patchouli, 30 parts of Cyperus rotundus, 50 parts of Atractylodes macrocephala, 150 parts of Poria cocos, 100 parts of Atractylodes macrocephala, 50 parts of gypsum, 30 parts of scorched hawthorn, 30 parts of scorched Liu Shenqu, 30 parts of scorched malt, 50 parts of earthworm, 50 parts of Cynomorium wilfordii, 30 parts of Cynomorium fortunei, and 50 parts of Lemongrass seeds.

[0008] The above-mentioned composition can be directly ground into powder by raw materials, or can be an extract or other forms prepared by any conventional means.

[0009] Specifically, the aforementioned drugs for treating idiopathic inflammatory myopathy include oral dosage forms, injection dosage forms or external dosage forms.

[0010] After weighing the raw materials in proportion according to the dosage form of the drug, pharmaceutically acceptable excipients such as fillers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, bases, etc. are added during the preparation, and the drug is prepared according to conventional production methods in the pharmaceutical field to prepare conventional dosage forms acceptable to pharmacy, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0011] The present application also provides a method for preparing any of the aforementioned Chinese medicine compositions, the preparation method comprising: weighing Magnolia officinalis, scorched areca nut, stewed tsaoko, ephedra, bitter almond, Notopterygium wilfordii, ginger, patchouli, Cymbidium orchioides, Atractylodes lancea, Poria cocos, Atractylodes macrocephala, gypsum, scorched hawthorn, scorched Liushenqu, scorched malt, earthworm, Cynanchum chinense, Cynomorium fortunei, and Semen Lepidium chinense respectively according to the formula, extracting twice with water, adding 6 times the amount of water for the first time and extracting for 1.5 hours, adding 4 times the amount of water for the second time and extracting for 1.0 hour, combining the extracts, filtering, concentrating the filtrate to a relative density of 1.10 to 1.15, centrifuging and filtering, vacuum drying the filtrate, spray drying and pulverizing to obtain the product.

[0012] Furthermore, the preparation method of the above-mentioned Chinese medicine composition granules comprises the following steps:

[0013] According to the formula, 50 parts of Magnolia officinalis, 30 parts of charred Areca nut, 30 parts of stewed Tsaoko fruit, 20 parts of Ephedra, 30 parts of Bitter Apricot, 50 parts of Notopterygium, 50 parts of Ginger, 50 parts of Patchouli, 30 parts of Perilla frutescens, 50 parts of Atractylodes, 150 parts of Poria, 100 parts of Atractylodes, 50 parts of Gypsum, 30 parts of charred Crataegus, 30 parts of charred Liu Shenqu, 30 parts of charred Malt, 50 parts of Pheretima, 50 parts of Cynanchum wilfordii, 30 parts of Cynomorium fortunei, and 50 parts of Semen Lepidii were respectively weighed, and water was added for reflux extraction twice, 6 times of water was added for the first time, and the extraction was performed for 1.5 hours, and 4 times of water was added for the second time, and the extraction was performed for 1.0 hour. The extracts were combined, filtered, and the filtrate was concentrated to a relative density of 1.10-1.15, centrifuged and filtered, and the filtrate was vacuum dried and spray dried to obtain an intermediate composition, and sucralose and dextrin were added, mixed, and granules were obtained.

[0014] Advantageous Effects of the Invention

[0015] The Chinese medicine composition of the present application can significantly improve the symptoms of model rats, improve the levels of creatine kinase (CK), lactate dehydrogenase (LDH), and aspartate aminotransferase (AST) in rat serum, and at the same time has a certain regulatory effect on the duration and amplitude of the electromyogram of the model guinea pig, and can also reduce the activity of creatine phosphokinase (CPK), lactate dehydrogenase (LDH) and aspartate aminotransferase (AST), indicating that the Chinese medicine composition has a certain therapeutic effect on idiopathic inflammatory myopathy. DETAILED DESCRIPTION

[0016] The present application aims to provide an application of a Chinese medicine composition in the preparation of a drug for treating or preventing idiopathic myopathy. In order to enable those skilled in the art to more clearly understand the technical solution of the present application, the technical solution of the present application will be described in detail below in conjunction with specific examples. If the specific conditions are not specified in the following experiments, they are all carried out according to conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, whose manufacturers are not specified, are all conventional products that can be purchased commercially. The experimental methods without specifying the detailed conditions are carried out in accordance with conventional test methods or in accordance with the operating instructions recommended by the supplier.

[0017] It should be noted that the following detailed description is illustrative and is intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those generally understood by those of ordinary skill in the art to which the present application belongs. The following examples are only intended to further illustrate the technical solution of the present application, rather than to limit the scope of protection of the present application.

[0018] Example 1: Preparation of composition granules

[0019] According to the formula, the following raw materials were weighed respectively: 50 parts of Magnolia officinalis, 30 parts of scorched areca nut, 30 parts of stewed tsaoko fruit, 20 parts of ephedra, 30 parts of bitter almond, 50 parts of Notopterygium wilfordii, 50 parts of ginger, 50 parts of patchouli, 30 parts of eupatorium, 50 parts of atractylodes, 150 parts of Poria, 100 parts of Atractylodes macrocephala, 50 parts of gypsum, 30 parts of scorched hawthorn, 30 parts of scorched six Shenqu, 30 parts of scorched malt, 50 parts of earthworm, 50 parts of Cynanchum chinense, 30 parts of Cynomorium mongolicum, and 50 parts of Lemongrass seeds. Add water to the above-weighed medicinal materials and reflux extract twice. For the first time, add 6 times of water and extract for 1.5 hours. For the second time, add 4 times of water and extract for 1.0 hour. Combine the extracts, filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, vacuum dry the filtrate, spray dry and pulverize to obtain an intermediate, add sucralose and dextrin, mix well, and obtain granules.

[0020] Experimental Example 1: Therapeutic effect on polymyositis model rats

[0021] First, muscle homogenate was prepared as an antigen. Healthy New Zealand rabbits were anesthetized with Beitsu Mianxin (Changsha Beit Biotechnology Research Institute, specification: 2mL:0.2g, batch number: 20210102), the skin was disinfected, skeletal muscle tissue was taken, and nerves, blood vessels, fascia, and adipose tissue were removed on an ice table. The treated tissue was then cut into pieces and soaked in ice saline for 30 minutes, followed by homogenization. The homogenized liquid was filtered and crushed, and observed under a microscope (Olympus, CKX31SF). After confirming that there were no intact cells, the supernatant was taken after centrifugation at 4°C and 3500r / min using a centrifuge (eppendorf, 5804R) for 10 minutes. The protein content in the supernatant after centrifugation was determined using the BCA protein concentration assay kit (Biyuntian Biotechnology Research Institute, product number: P0012S), and the result was 13.1mg / mL. The supernatant was divided into multiple standard containers and placed in a -80°C refrigerator for storage.

[0022] Then, the SD rat polymyositis animal model was established: 36 SPF-grade SD male rats weighing 180-200g were adaptively fed for 7 days, and 6 were randomly selected as the blank group using the random number table method, and were fed with normal feed and drinking water. The remaining 30 rats were modeled by subcutaneous injection of complete Freund's adjuvant (sigma, product number: F5881) mixed with antigen 1:1 (volume ratio) at multiple points on the back. The rats were injected once a week with an injection dose of 0.4mL each time for 4 consecutive weeks. In the 4th week, the rats showed reduced activity, muscle atrophy, forelimb flexion, hindlimb weakness and difficulty in eating upright, indicating that the model was successfully established.

[0023] Rats were administrated according to different groups: After the model was successfully established in the fourth week, the modeled rats were randomly divided into the model group, the high, medium and low dose groups of the Chinese medicine composition granules and the positive drug methylprednisolone tablet group, with 6 rats in each group. The clinical use of the positive drug methylprednisolone tablets (specification: 4mg*30 tablets, manufacturer: Pfizer Italia Srl. Product batch number: GG7099) for adults is oral administration, once a day, and the dosage is 4mg once. According to the adult body weight of 60kg, the daily dosage for adults is 4mg×1 / 60kg=0.067mg / kg. Therefore, according to the pharmacopoeia, the equivalent dosage of each dose group of rats is 0.067mg / kg×60kg×0.018 / 0.2kg=0.362mg / kg. The drug was administered orally at a dosage of 10mL / kg for 4 consecutive weeks. The blank group and the model group were also gavaged with normal saline at a dosage of 10mL / kg once a day for 4 consecutive weeks. At the end of the fourth week, blood samples were collected from the abdominal aorta of the rats under anesthesia, and all rats in each group were killed after the collection.

[0024] Observation indicators:

[0025] 1) Rats’ general status score measurement: After the last drug intervention, the rats were scored according to the LennonLA scoring standard. 0 points: muscle strength is roughly normal. 1 point: weakness when biting, chewing or shouting. 2 points: difficulty walking, head drooping, especially obvious when resting. 3 points: weakness shouting, difficulty breathing, obvious muscle atrophy, and dying. (Those with moderate symptoms were scored as 0.5, 1.5, and 2.5 points) SPSS20.0 was used to perform statistics on the results: the scoring data were described by quartiles (M(Q1, Q3)), and the KW non-parametric test was performed. P<0.05 indicated that the data were statistically significant.

[0026] 2) Serum muscle enzyme determination: The creatine kinase (CK) kit (Jianglai Biotechnology Co., Ltd., product number: JL13903, specification: 96T), LDH lactate dehydrogenase kit (Nanjing Jiancheng Bioengineering Institute, product number: A020-2-2, specification: 96T) and AST aspartate aminotransferase kit (Nanjing Jiancheng Bioengineering Institute, product number: C010-2-1, specification: 96T) were used to detect the levels of creatine kinase (CK), lactate dehydrogenase (LDH) and aspartate aminotransferase (AST) in serum, and the values ​​were read using an ELISA reader (Molecular Devices).

[0027] Then, GraphPad prism 7 statistical software was used for data processing, and all data were expressed as mean ± standard deviation (X ± SD). One-way ANOVA test combined with Dunnett's multiple comparison test method was selected for data statistical analysis, and P < 0.05 indicated that the data were statistically significant.

[0028] The scoring results showed that after modeling, the symptom scores of the model group and each drug-administered group were higher than those of the blank group, and the scores increased significantly (P<0.01), indicating that the modeling was successful. After 4 weeks of administration, the scores of the high-dose group of Chinese medicine combination granules and the positive drug methylprednisolone tablet group were significantly improved compared with the model group (P<0.05). See Table 1.

[0029] Table 1 Comparison of scores of rats in each group after the last administration ( n=6)

[0030]

[0031] Note: Compared with the blank control group, ## P<0.01; compared with the model group, * P<0.05.

[0032] Comparison of CK, LDH and AST in each group of rats after the last administration showed that compared with the blank group, the levels of CK (P<0.001), LDH (P<0.05) and AST (P<0.001) in the serum of the model group rats were increased, while the medium and high dose groups of the Chinese medicine composition granules could significantly reduce the CK content (P<0.01); each dose group of the Chinese medicine composition granules could significantly reduce the activity of LDH (P<0.001 or P<0.01); each dose group of the Chinese medicine composition granules could significantly reduce the activity of AST (P<0.001); the results are shown in Table 2.

[0033] Table 2 Comparison of CK, LDH and AST in rats of each group after the last administration ( n=6)

[0034]

[0035] Note: Compared with the blank control group, # P<0.05, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0036] Experimental Example 2 Effect on Experimental Immune Myositis Guinea Pig Model

[0037] First, prepare muscle homogenate as an antigen: use Beitsu Mianxin (Changsha Beit Biotechnology Research Institute, specification: 2mL: 0.2g, batch number: 20210102) to anesthetize and kill healthy New Zealand rabbits, disinfect the skin, take skeletal muscle tissue, and remove its nerves, blood vessels, fascia, and fat tissue on an ice table. Weigh the pure skeletal muscle, add an appropriate amount of autoclaved PBS (pH7.2) buffer (Biyuntian Biotechnology Research Institute, product number: C0221A) at a weight-to-volume ratio of 20% of the skeletal muscle, homogenize with a homogenizer, and then cover with four layers of gauze and filter in a 4°C refrigerator. The next day, the filtrate was collected and the muscle cells were broken, and then homogenized three times with a homogenizer. After filtration, the detergent Triton X-100 (Biyotime Biotechnology Research Institute, product number: ST797-100 mL) was added at a volume of 100:1, and stirred evenly with a magnetic stirrer. After centrifugation at 3500 r / min at 4°C for 10 min, the supernatant was taken and the protein concentration was quantified (20 mg / mL) using a BCA protein concentration assay kit (Biyotime Biotechnology Research Institute, product number: P0012S), and the supernatant was stored in a -80°C refrigerator after aliquoting.

[0038] Then, an experimental immune myositis guinea pig model was established: after 36 Hartley male guinea pigs weighing 220-250g were adaptively fed for 7 days, 6 were randomly selected as the blank group using the random number table method, and the remaining 30 were used for modeling. The guinea pigs were subcutaneously injected once a week into the back, with each injection dose of 0.2mL muscle homogenate + 0.1mL complete Freund's adjuvant (Sigma, product number: F5881). The injection was continued for 8 weeks. The guinea pigs showed severe reduction in diet, weight loss, mental depression, laziness, loose and rough hair, and dullness, etc., which was considered a successful modeling.

[0039] Eight weeks after the immunization, the guinea pigs were randomly divided into a model group, a high-, medium-, and low-dose group of Chinese medicine composition granules, and a positive drug group, with 6 animals in each group. According to the positive drug prednisone tablets (Zhejiang Xianjun Pharmaceutical Co., Ltd., specification: 5mg*100 tablets / box, product batch number: LA22243), the clinical dosage for adults is 5-10 mg (1-2 tablets) per oral administration, and 10-60 mg (2-12 tablets) per day. According to the adult body weight of 60 kg, the daily dosage for adults is 60 mg / 60 kg = 1 mg / kg. Therefore, the equivalent dosage for guinea pigs is 1 mg / kg × 60 kg × 0.031 / 0.4 kg = 4.65 mg / kg. The guinea pig feeding volume is 10 mL / kg per time according to the animal body weight, once a day, for a total of 7 days. The blank group and the model group were also gavaged with normal saline once a day at a dosage of 10 mL / kg for a total of 7 days. During the experiment, care should be taken to give guinea pigs an appropriate amount of fresh vegetables every day to avoid vitamin C deficiency.

[0040] Detection indicators

[0041] 1) Electromyography (EMG) detection: After the last immunization, the guinea pigs in each group were fixed on a wooden board and electromyography (EMG) was performed using an electromyograph (Viking Quest XP Nicole Biomedical Inc. Madison Wisconsin 53711). The recording electrode was a 20 mm long, 0.45 mm diameter concentric needle electrode. The EMG of the hind limb calf muscle and the proximal lateral muscle of the forelimb was detected, and the changes in the duration and amplitude during light contraction were recorded. The room temperature was 15-20°C.

[0042] 2) Serum muscle enzyme spectrum detection: At the end of the experiment, blood samples were collected from the abdominal aorta of all guinea pigs, and the levels of creatine phosphokinase (CPK), lactate dehydrogenase (LDH) and aspartate aminotransferase (AST) were detected using a fully automatic biochemical analyzer (BK-600, Shandong Bo Ke Biological).

[0043] GraphPadprism 7 statistical software was used to process the data, and all data are presented as mean ± standard deviation. One-way ANOVA combined with Dunnett's multiple comparison test was used for statistical analysis of the data, and P < 0.05 indicated that the data were statistically significant.

[0044] Experimental Results

[0045] The comparison results of the duration and amplitude of the electromyogram of guinea pigs in each group showed that the duration and amplitude of the electromyogram of guinea pigs in the model group were significantly lower than those in the blank group (P<0.001). The duration of the electromyogram of guinea pigs in the medium and high dose groups of the Chinese medicine composition granules were significantly improved compared with the model group (P<0.001, P<0.01). The duration and amplitude of the electromyogram of guinea pigs in the medium and high dose groups of the Chinese medicine composition granules were significantly improved compared with the model group (P<0.01, P<0.001). See Table 3.

[0046] Table 3 Comparison of electromyography duration and amplitude of guinea pigs in each group ( n=6)

[0047]

[0048] Note: Compared with the blank control group, ### P<0.001; compared with the model group, ** P<0.01, *** P<0.001.

[0049] The comparison results of CPK, LDH and AST in guinea pigs of each group after the last administration showed that compared with the blank group, the CPK, LDH and AST in the serum of guinea pigs in the model group were increased (P<0.001), while the medium and high dose groups of the Chinese medicine composition granules could significantly reduce the activity of CPK (P<0.01); the high dose group of the Chinese medicine composition granules could significantly reduce the activity of LDH (P<0.01); each dose group of the Chinese medicine composition granules could significantly reduce the activity of AST (P<0.05, P<0.01); the results are shown in Table 4.

[0050] Table 4 Comparison of CPK, LDH and AST in guinea pigs in each group after the last administration ( n=6)

[0051]

[0052] Note: Compared with the blank control group, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0053] The composition proposed in the present application can significantly improve the symptom scores of model animals and the changes in the myoenzyme spectrum in the serum, and improve the changes in the duration and amplitude of the electromyogram.

[0054] The above embodiments of the present application are merely examples to clearly illustrate the present application, and are not intended to limit the embodiments of the present application. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present application should be included in the protection scope of the claims of the present application.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for treating or preventing idiopathic inflammatory myopathy, characterized in that: The Chinese medicine composition comprises: 1-100 parts of Magnolia officinalis, 1-100 parts of charred Areca catechu, 1-100 parts of stewed Tsaoko fruit, 1-100 parts of Ephedra, 1-100 parts of bitter almond, 1-100 parts of Notopterygium wilfordii, 1-100 parts of ginger, 1-100 parts of Patchouli, 1-100 parts of Cyperus rotundus, 1-100 parts of Atractylodes macrocephala, 1-160 parts of Poria cocos, 1-120 parts of Atractylodes macrocephala, 1-100 parts of Gypsum, 1-100 parts of charred Crataegus pinnatifida, 1-100 parts of charred Liu Shenqu, 1-100 parts of charred malt, 1-100 parts of Pheretima, 1-100 parts of Cynanchum cyrtonema, 1-100 parts of Lepidium chinense.

2. The use according to claim 1, characterized in that: The Chinese medicine composition comprises: 10-80 parts of Magnolia officinalis, 10-80 parts of scorched Areca catechu, 10-80 parts of stewed Tsaoko fruit, 10-60 parts of Ephedra sinica, 10-60 parts of Bitter Apricot, 10-80 parts of Notopterygium wilfordii, 10-60 parts of Ginger, 10-80 parts of Patchouli, 10-60 parts of Cyperus rotundus, 10-80 parts of Atractylodes macrocephala, 10-160 parts of Poria cocos, 10-120 parts of Atractylodes macrocephala, 10-80 parts of Gypsum, 10-50 parts of scorched Crataegus pinnatifida, 10-80 parts of scorched Liu Shenqu, 10-60 parts of scorched malt, 10-80 parts of Pheretima, 10-80 parts of Cynanchum cyrtonema, 10-60 parts of Lepidium chinense, and 10-80 parts of Semen Lepidii.

3. The use according to claim 2, characterized in that: The Chinese medicine composition comprises: 30-50 parts of Magnolia officinalis, 20-30 parts of scorched Areca catechu, 30-50 parts of stewed Tsaoko fruit, 20-30 parts of Ephedra sinica, 20-30 parts of Bitter Apricot, 30-50 parts of Notopterygium wilfordii, 30-50 parts of Ginger, 30-50 parts of Patchouli, 20-30 parts of Cyperus rotundus, 30-50 parts of Atractylodes macrocephala, 120-150 parts of Poria cocos, 80-100 parts of Atractylodes macrocephala, 30-50 parts of Gypsum, 20-30 parts of scorched Crataegus pinnatifida, 30-50 parts of scorched Liu Shenqu, 20-30 parts of scorched malt, 30-50 parts of Pheretima, 30-50 parts of Cynanchum cyrtonema, 20-30 parts of Cynomorium wilfordii, and 30-50 parts of Lepidium chinense.

4. The use according to any one of claims 1 to 3, characterized in that: The dosage form of the idiopathic inflammatory myopathy drug includes an oral dosage form, an injection dosage form or an external administration preparation.

5. The use according to claim 4, characterized in that: The dosage forms of the idiopathic inflammatory myopathy drug include decoction, granules, capsules, tablets, oral liquid, pills, tincture, syrup, gel, spray and injection.

6. The use according to any one of claims 1 to 3, characterized in that: The preparation method of the traditional Chinese medicine composition comprises: weighing Magnolia officinalis, charred Areca nut, stewed tsaoko, ephedra, bitter almond, Notopterygium wilfordii, ginger, patchouli, Perilla frutescens, Atractylodes lancea, Poria cocos, Atractylodes macrocephala, gypsum, charred hawthorn, charred Liushenqu, charred malt, earthworm, Cynanchum chinense, Cynomorium fortunei, and Semen tiliaceum according to the formula, adding water for reflux extraction twice, combining the extracts, filtering, concentrating the filtrate, filtering, drying, and crushing to obtain the composition.

7. The use according to claim 6, characterized in that: The preparation method of the traditional Chinese medicine composition comprises: adding 6 times of water in the first reflux extraction and extracting for 1.5 hours, adding 4 times of water in the second reflux extraction and extracting for 1.0 hour; combining the two extracts and filtering them, concentrating them to a relative density of 1.10-1.15, centrifugally filtering, vacuum drying the filtrate, spray drying and crushing to obtain the composition.

8. The use according to any one of claims 1 to 3, characterized in that: The preparation method of the Chinese medicine composition granules comprises: according to the formula, respectively weighing Magnolia officinalis, charred Areca nut, stewed tsaoko, ephedra, bitter almond, Notopterygium wilfordii, ginger, patchouli, Perilla frutescens, Atractylodes lancea, Poria cocos, Atractylodes macrocephala, gypsum, charred hawthorn, charred Liushenqu, charred malt, earthworm, Cynanchum chinense, Cynomorium mianmai, and Semen tiliaceum, adding water and refluxing to extract twice, adding 6 times of water for the first time and extracting for 1.5 hours, adding 4 times of water for the second time and extracting for 1.0 hour, combining the extracts, filtering, concentrating the filtrate to a relative density of 1.10-1.15, centrifuging, vacuum drying the filtrate, spray drying and pulverizing to obtain an intermediate composition, adding sucralose and dextrin, mixing evenly, and obtaining granules.

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