A traditional Chinese medicine composition for treating juvenile gouty arthritis, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating gouty arthritis in teenagers and a preparation method and application thereof. The traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: phoenix clothes 4-8 parts by weight, patchouli 4-8 parts by weight, green millet 10-15 parts by weight, east wind orange 20-25 parts by weight, citron 4-8 parts by weight and cubeb 2-3 parts by weight. Based on the analysis of traditional Chinese medicine theory, the traditional Chinese medicine composition has the basic functions of nourishing yin, resolving turbidity, clearing heat and expelling wind, resolving phlegm and promoting qi. Animal experiments show that the traditional Chinese medicine composition is effective for treating gouty arthritis in teenagers and has no side effects. Therefore, the application provides a new effective technical means for treating gouty arthritis in teenagers, and has a very wide application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to a traditional Chinese medicine composition, a preparation method and application thereof, in particular to a traditional Chinese medicine composition for treating adolescent gouty arthritis, a preparation method and application thereof. The present application belongs to the technical field of medicine. BACKGROUND

[0002] Gouty arthritis is a common joint disease in clinical practice (Liu F, Shen F, Bai Y, et al. Mechanism of Dai Tong Xiao in the treatment of gouty arthritis through the NLRP3 signaling pathway [J]. J Ethnopharmacol, 2024, 319(3): 117313.), which often occurs in large joint parts of the body, especially in joint parts with low blood vessel density, such as knee joint, elbow joint, and toe joint cartilage, articular disc, and joint capsule (Qin DE, Liang W, Yu Y, et al. Modified Simiaowan prevents and treats gouty arthritis via the Nrf2 / NLRP3 inflammasome signaling pathway [J]. J Ethnopharmacol, 2024, 318(1): 116906.). It is generally more obvious in the first metatarsophalangeal joint of the lower extremity, which presents swelling, pain, and other symptoms in the first metatarsophalangeal joint of the lower extremity, and severe deformity.

[0003] At present, gouty arthritis can occur in adolescents, which is clinically referred to as adolescent gouty arthritis. Adolescent gouty arthritis can occur in both males and females, with males being more common, which is related to the fact that adolescents often wear little clothing in cold weather or have irregular diet (Cheng Y, Huang X, Tang Y, et al. Effects of evodiamine on ROS / TXNIP / NLRP3 pathway against gouty arthritis [J]. Naunyn Schmiedebergs Arch Pharmacol, 2024, 397(2): 1015-1023.). It is also related to the fact that adolescent males drink beer and have irregular living habits, which are associated with adolescent gouty arthritis.

[0004] Studies have shown that different related factors, such as gender factors, genetic factors, psychological factors, social factors, dietary factors, habit factors, emergency factors (Qu P, Du S, Wang W, et al. Treatment of gouty arthritis with traditional Chinese medicine decoction Meta-analysis network pharmacology analysis and molecular docking [J]. Medicine Baltimore, 2024, 103(1): e36722.), stress factors, etc. are associated with adolescent gouty arthritis. In fact, gender factors, genetic factors, psychological factors, social factors, dietary factors (Li D, Yue X, Wang A, et al. Relieving urinary tract obstructions may increase the risk of gouty arthritis in patients with hyperuricemia and postrenal obstructions [J]. Medicine Baltimore, 2024, 103(2): e36911.), habit factors, emergency factors, stress factors, etc. often act on the body in combination to cause adolescent gouty arthritis.

[0005] The main clinical manifestations of juvenile gouty arthritis in hospitals include systemic clinical manifestations and local clinical manifestations (Yuan Z, Miao L, Zhang S, et al. The role of acid-sensing ion channels in monosodium urate-induced gouty pain in mice [J]. Pflugers Arch, 2024, 476(1): 101-110.). Among them, the systemic clinical manifestations include changes in blood indicators, such as an increase in the number of white blood cells, especially an increase in the number of neutrophils, and also include an increase in body temperature due to inflammatory mediators (Shao Q, Wang J. The Role of Ultrasound Semi-Quantitative Scoring in the Diagnosis and Assessment of Gout and Hyperuricemia [J]. J Ultrasound Med, 2024, 43(2): 281-291.). The local clinical manifestations mainly include connective tissue lesions and urinary system lesions. The connective tissue lesions include redness and swelling due to the accelerated blood flow in the connective tissue, and the production of a large amount of inflammatory mediators to cause pain and itching. The urinary system lesions include glomerular and tubular structural abnormalities caused by urate deposition, leading to glomerular-tubular imbalance (Tang Y, Du Y, Ye J, et al. Intestine-Targeted Explosive Hydrogel Microsphere Promotes Uric Acid Excretion for Gout Therapy [J]. Adv Mater, 2024, 36(3): e2310492.), and in severe cases, it can also cause renal failure. In order to treat uremia caused by renal failure, kidney replacement therapy is often used, which can seriously affect the life span and quality of life of the body.

[0006] According to traditional Chinese medicine theory, gouty arthritis is more common in adolescents (Wang Zhengyang, Zhao Yusun, Chen Shannai, et al. Influence of Gouty Drink on Patients with Dampness Constitution in Remission Stage of Gouty Arthritis [J]. Rheumatism and Arthritis, 2023, 12(12): 6-10.), and its main pathogenesis is more common, such as adolescents often wear less clothing in cold weather, or adolescents have improper diet and stomach disorders, which can cause excessive loss of yang qi, causing the body to be deficient in yin, and the body's yin deficiency often causes internal heat (Li Huayan, Du Mingrui. Discussion on the Etiology and Pathogenesis of Gout in Synopsis of Golden Chamber and Its Clinical Application of Prescription [J]. Rheumatism and Arthritis, 2023, 12(12): 51-54.), the body's kidney yin, liver yin, heart yin, spleen yin, and lung yin are insufficient, the body's turbidity cannot be discharged in time, and the body's organs are accompanied by heat, dampness, wind, and turbidity accumulation, which can cause the body to develop diseases (Zhang Panke, Wang Fang, Li Dan, et al. Clinical observation on 45 cases of elderly gout treated with Huashi Jiangtu Drink for the treatment of spleen deficiency and dampness [J]. Rheumatism and Arthritis, 2023, 12(12): 11-14+31.), often in areas where the body's blood vessels are not dense, turbidity accumulates, and turbidity accumulates for a long time, causing the body to feel uncomfortable, such as swelling and pain in some joints of the lower extremities, difficulty walking, joint stiffness, and even deformity (Gao Yunqi, Tian Xuemei, Wang Haidong, et al. Based on the theory of meridians, discuss the treatment of refractory gout with needle knife [J]. Rheumatism and Arthritis, 2023, 12(12): 47-50+61.), so the effective treatment of adolescent gouty arthritis in clinical practice needs to nourish yin and remove turbidity.

[0007] The theory of traditional Chinese medicine believes that the liver wood stores blood, the heart fire governs blood, the spleen earth governs blood, the lung gold assists the kidney water, the five elements are related to each other, and are born and restrained by each other. Long-term improper diet or indulgence in young people can cause spleen and stomach disorder, deficiency of yin (Shao Qin. Strengthening the application of ultrasound in the management of gout and hyperuricemia disease [J]. Rheumatism and Arthritis, 2023, 12 (12): 55-61.), sometimes like strong wine, smoking, stimulating the body heat to resist cold stimulation or air conditioning wind toxin stimulation, accompanied by less clothing and often being invaded by wind toxin (Zhuang Lihua, Guo Qingxin, Rao Huachun. Synovial fluid and blood uric acid in the diagnosis of gouty arthritis [J]. Rheumatism and Arthritis, 2023, 12 (11): 22-27.), accompanied by heat toxin invading the body of different joint parts, the body of different joint parts, especially the blood vessels of the joint parts, appear qi and blood not smooth (Nie Jia, Luo Linru, Ma Xi, etc. The understanding and discussion of TCM pathogenesis of gout [J]. Rheumatism and Arthritis, 2023, 12 (04): 52-55.), blood vessels are not smooth, dampness gathers, phlegm toxin invades the blood vessels of the joint parts of the body, the blood vessels of the body are not usually caused by liver qi disorder (Yang Qi, Zhu Yucheng, Cheng Lili, etc. Based on intestinal flora, discuss the mechanism of TCM treatment of hyperuricemia and gout [J]. Rheumatism and Arthritis, 2023, 12 (11): 40-43+80.), the spleen qi runs poorly, the body water and fine metabolism is out of order, often accompanied by phlegm toxin, dampness, heat toxin and other further aggravate the body damage, the first metatarsophalangeal joint of the lower limbs of the body appears obvious swelling, swelling, itching pain (Du Shiyu, Hao Chenhui, Guan Xin, etc. Professor Tang Xiaohu's clinical experience in treating hyperuricemia [J]. Rheumatism and Arthritis, 2023, 12 (10): 35-38.), in severe cases, it can also cause part of the body joint deformity, which will bring inconvenience to the body walking, movement, etc. (Yang Jinghua, Zhu Changhao, Wang Yao Guang. Research progress of treating gout from 'deficiency, evil and stasis' [J]. Rheumatism and Arthritis, 2023, 12 (04): 71-74.), affect the normal life of the body (Gong Zhongjie, Yu Jia, Lu Yun, etc. Research on adverse event signal mining of polyethylene glycol recombinant uricase injection based on FAERS database [J]. Rheumatism and Arthritis, 2023, 12 (09): 17-21+30.), so the effective treatment of adolescent gouty arthritis in clinic still needs to clear heat, expel wind, resolve phlegm and promote qi.

[0008] Through comprehensive analysis, it is shown that the treatment of adolescent gouty arthritis needs to nourish yin and turbidity, clear heat and expel wind, resolve phlegm and promote qi, so the invention selects traditional Chinese medicine with the functions of nourishing yin and turbidity, clearing heat and expel wind, resolving phlegm and promoting qi to carry out experimental research on treating adolescent gouty arthritis, which is beneficial to improve the clinical manifestations. SUMMARY

[0009] The purpose of the present application is to provide a traditional Chinese medicine composition for treating adolescent gouty arthritis and its preparation method and application.

[0010] In order to achieve the above-mentioned purpose, the present application adopts the following technical means:

[0011] The application discloses a traditional Chinese medicine composition for treating gouty arthritis in teenagers, which is composed of phoenix clothes, patchouli, indigofera, east wind orange, citron, and cubeb.

[0012] The traditional Chinese medicine composition for treating gouty arthritis in teenagers has the basic effects of nourishing yin and resolving turbidity, clearing heat and dispelling wind, and resolving phlegm and promoting qi. The phoenix clothes, also known as chicken egg white skin, egg membrane, and phoenix retreat, are produced in various places in China, have neutral nature and bland taste, belong to the meridian system of the lung meridian, the stomach meridian and the spleen meridian, and have the basic effects of nourishing yin and dissipating nebula, closing wounds and setting bones, and tonifying deficiency and clearing the lung; the patchouli, also known as large-leafed mint, earthy sage, and haixia sage, belongs to the labiatae plant, is produced in Hainan, Guangxi and Guangdong, has slightly warm nature and pungent taste, belongs to the meridian system of the lung meridian, the spleen meridian and the stomach meridian, and has the basic effects of resolving turbidity and relieving the exterior, relieving summer-heat and stopping vomiting, and stimulating appetite and aroma; the indigofera, also known as dog tail, grass cassia and wild cockcomb flower, belongs to the amaranthaceae plant, is produced in most areas of China, has slightly cold nature and bitter taste, belongs to the meridian system of the liver meridian, and has the basic effects of clearing heat and removing nebula; the east wind orange, also known as mountain citrus, east wind orange, false pepper, dog bone and wu citrus, belongs to the rutaceae plant, is produced in Guangxi, Hainan and Guangdong, has slightly warm nature and bitter and pungent taste, belongs to the meridian system of the spleen meridian, the stomach meridian and the lung meridian, and has the basic effects of dispelling wind and relieving pain, relieving cough and relieving the exterior, and regulating qi and resolving phlegm; the citron, also known as citrus, citron, citron and hook-shaped dry, belongs to the rutaceae plant, is produced in Sichuan, Anhui and Jiangsu, has warm nature and bitter, pungent and acrid taste, belongs to the meridian system of the lung meridian, the spleen meridian and the liver meridian, and has the basic effects of resolving phlegm and soothing the liver, and regulating qi; and the cubeb, also known as mountain cinnamomum, cubeb, smelly camphor and chenggacocha, belongs to the lauraceae plant, is produced in Yunnan, Zhejiang and Jiangsu, has warm nature and pungent taste, belongs to the meridian system of the bladder meridian, the kidney meridian, the stomach meridian and the spleen meridian, and has the basic effects of regulating qi and dispelling cold, and relieving pain and warming the center.

[0013] In the traditional Chinese medicine composition for treating gouty arthritis in teenagers, the phoenix clothes and the patchouli, as the monarch drugs, mainly have the basic effect of nourishing yin and resolving turbidity; the indigofera and the east wind orange, as the ministerial drugs, mainly have the basic effect of clearing heat and dispelling wind; the citron, as the auxiliary drug, mainly has the basic effect of resolving phlegm; and the cubeb, as the guide drug, mainly has the basic effect of regulating qi. Therefore, the traditional Chinese medicine composition composed of the phoenix clothes, the patchouli, the indigofera, the east wind orange, the citron and the cubeb can be selected to carry out systematic research on gouty arthritis in teenagers.

[0014] Preferably, the Chinese medicine composition for treating adolescent gouty arthritis of the present application is composed of the following raw medicinal materials in parts by weight: Phoenix Garment 4-8 parts by weight, Patchouli 4-8 parts by weight, Green Millet Seed 10-15 parts by weight, East Wind Orange 20-25 parts by weight, Citron 4-8 parts by weight, and Cubeb 2-3 parts by weight.

[0015] More preferably, the Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: Phoenix Garment 6 parts by weight, Patchouli 6 parts by weight, Green Millet Seed 12 parts by weight, East Wind Orange 22.5 parts by weight, Citron 6 parts by weight, and Cubeb 2.25 parts by weight.

[0016] Further, the present application also proposes the use of the Chinese medicine composition in the preparation of a medicine for treating adolescent gouty arthritis.

[0017] Preferably, the medicine is water decoction, powder, paste, granules, capsules or tablets.

[0018] Further, the present application also proposes a method for preparing the Chinese medicine composition into water decoction, comprising the following steps:

[0019] (1) weighing each raw medicinal material according to the weight parts;

[0020] (2) putting the raw medicinal materials in step (1) into a round-bottom flask and soaking them with purified water for 3-4 hours, and then decocting them at 100℃ for 2-3 hours;

[0021] (3) filtering the medicinal liquid obtained after decoction in step (2) through 2 layers of gauze, 6 layers of gauze, 8 layers of gauze, 12 layers of gauze and 18 layers of gauze in sequence to obtain the first filtrate of the Chinese medicine composition;

[0022] (4) putting the medicinal residue after filtration in step (3) into a round-bottom flask and soaking them with purified water for 3-4 hours, and then decocting them at 100℃ for 2-2.5 hours;

[0023] (5) repeating step (3) to obtain the second filtrate of the Chinese medicine composition;

[0024] (6) thoroughly mixing the first filtrate and the second filtrate to obtain the water decoction of the Chinese medicine composition.

[0025] Further, the present application also proposes a method for preparing the Chinese medicine composition into paste, which is based on the method for preparing the water decoction and further comprises baking the obtained water decoction using a drying oven to obtain the dry paste of the Chinese medicine composition.

[0026] Further, the application further provides a method for preparing the powder of the traditional Chinese medicine composition, and has the characteristics that, based on the preparation method of the traditional Chinese medicine composition, the dry paste of the traditional Chinese medicine composition is further crushed and ground, and then filtered through 10-mesh, 20-mesh, 40-mesh, 80-mesh and 100-mesh sieves in sequence to obtain the dry powder of the traditional Chinese medicine composition.

[0027] Compared with the prior art, the application has the beneficial effects that:

[0028] The application discloses a novel traditional Chinese medicine composition for treating adolescent gouty arthritis and a preparation method thereof. The traditional Chinese medicine composition comprises Fenghuangyi, Guanghuoxiang, Qingxiezi, Dongfengju, Xiangli, and Bocingqie. Based on the theory of traditional Chinese medicine, the traditional Chinese medicine composition has the basic functions of nourishing yin, clearing heat and removing wind, and resolving phlegm and promoting qi. Based on animal experiment analysis, the high dose (14.24 g / kg) and the medium dose (7.12 g / kg) of the traditional Chinese medicine composition can improve the joint swelling degree level of the toe region of the white male Kunming mouse outbred group (albino mouse) adolescent gouty arthritis model mouse, the arthritis inflammation index level of the region, and the inflammation medium content level of the region, and simultaneously reduce the NOD-like receptor heat protein domain related protein 3 expression level of the white male Kunming mouse outbred group (albino mouse) adolescent gouty arthritis model mouse (toe region), while the high dose (14.24 g / kg) and the medium dose (7.12 g / kg) of the traditional Chinese medicine composition have no influence on the main organ index of the white male Kunming mouse outbred group (albino mouse) adolescent gouty arthritis model mouse and the weight of the mouse, which indicates that the traditional Chinese medicine composition composed of Fenghuangyi, Guanghuoxiang, Qingxiezi, Dongfengju, Xiangli and Bocingqie is effective in treating adolescent gouty arthritis and has no side effects. Therefore, the application provides a new effective technical means for treating adolescent gouty arthritis, and has a very wide application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 Influence of the traditional Chinese medicine composition on the joint swelling degree of the model mouse (toe region);

[0030] Note: the horizontal coordinate is the group, and the vertical coordinate is the joint swelling degree (mL);

[0031] Figure 2 Influence of the traditional Chinese medicine composition on the arthritis inflammation index of the model mouse (toe region);

[0032] Note: the horizontal coordinate is the group, and the vertical coordinate is the arthritis inflammation index (value);

[0033] Figure 3 Influence of the traditional Chinese medicine composition on the interleukin-1 beta of the model mouse (toe region);

[0034] Note: The horizontal coordinate is group; the vertical coordinate is the specific value of interleukin-1β (pg / mL) content;

[0035] Figure 4 The effect of the traditional Chinese medicine composition on tumor necrosis factor-α of model mice (paw);

[0036] Note: The horizontal coordinate is group; the vertical coordinate is the specific value of tumor necrosis factor-α (pg / mL) content;

[0037] Figure 5 The effect of the traditional Chinese medicine composition on NOD-like receptor heat protein domain related protein 3 protein of model mice (paw);

[0038] Note: The horizontal coordinate is group; the vertical coordinate is the average optical density value of NOD-like receptor heat protein domain related protein 3 protein;

[0039] Figure 6 The effect of the traditional Chinese medicine composition on NOD-like receptor heat protein domain related protein 3 gene of model mice (paw);

[0040] Note: The horizontal coordinate is group; the vertical coordinate is the specific value of NOD-like receptor heat protein domain related protein 3 gene (average optical density value);

[0041] Figure 7 The effect of the traditional Chinese medicine composition on heart index of model mice and lung index of model mice;

[0042] Note: The horizontal coordinate is group; the vertical coordinate is heart index (mg / g) and lung index (mg / g);

[0043] Figure 8 The effect of the traditional Chinese medicine composition on kidney index of model mice and liver index of model mice;

[0044] Note: The horizontal coordinate is group; the vertical coordinate is kidney index (mg / g) and liver index (mg / g);

[0045] Figure 9 The effect of the traditional Chinese medicine composition on body weight of model mice;

[0046] Note: The horizontal coordinate is group; the vertical coordinate is the body weight value (g) at 0 day, 7 days and 15 days. DETAILED DESCRIPTION

[0047] The advantages and features of the present application will become more apparent with the following description in conjunction with the accompanying drawings. The embodiments are only exemplary and do not constitute any limitation on the scope of the present application. Those skilled in the art should understand that the details and forms of the technical solutions of the present application can be modified or replaced without departing from the spirit and scope of the present application, and such modifications and replacements fall within the protection scope of the present application.

[0048] Example 1 Preparation of a traditional Chinese medicine composition for treating juvenile gouty arthritis

[0049] The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: Fenghuangyi 6 parts by weight, Guanghuoxiang 6 parts by weight, Qingxianzi 12 parts by weight, Dongfengju 22.5 parts by weight, Xiangru 6 parts by weight, and Bozhengqiao 2.25 parts by weight.

[0050] Example 2 Preparation of a traditional Chinese medicine composition for treating juvenile gouty arthritis

[0051] The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: Fenghuangyi 5 parts by weight, Guanghuoxiang 7 parts by weight, Qingxianzi 11 parts by weight, Dongfengju 24 parts by weight, Xiangru 4 parts by weight, and Bozhengqiao 3 parts by weight.

[0052] Example 3 Preparation of a traditional Chinese medicine composition for treating juvenile gouty arthritis

[0053] The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: Fenghuangyi 8 parts by weight, Guanghuoxiang 4 parts by weight, Qingxianzi 15 parts by weight, Dongfengju 20 parts by weight, Xiangru 8 parts by weight, and Bozhengqiao 2 parts by weight.

[0054] Example 4 Preparation of a water decoction for treating juvenile gouty arthritis

[0055] Including the following steps:

[0056] (1) Weigh each raw medicinal material according to the following weight:

[0057] The conventional use dosage of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangru 6g, and Bozhengqiao 2.25g is 54.75g per serving. Six portions of the traditional Chinese medicine composition composed of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangru 6g, and Bozhengqiao 2.25g need to be weighed, totaling 328.5g.

[0058] (2) Put the 328.5g of the traditional Chinese medicine composition composed of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangru 6g, and Bozhengqiao 2.25g in a round-bottom flask and decoct at 100℃ for 2.2 hours;

[0059] (3) The medicinal liquid obtained after decocting in step (2) is filtered through 2 layers of gauze, 6 layers of gauze, 8 layers of gauze, 12 layers of gauze, and 18 layers of gauze in sequence, to obtain the first filtrate of the traditional Chinese medicine composition;

[0060] (4) The medicinal residue after filtering in step (3) is put into a round-bottom flask and soaked in purified water for 3.2 hours, and then decocted at 100°C for 2.2 hours;

[0061] (5) Step (3) is repeated to obtain the second filtrate of the traditional Chinese medicine composition;

[0062] (6) The first filtrate and the second filtrate are thoroughly mixed to obtain the water decoction of the traditional Chinese medicine composition.

[0063] Example 5 Preparation of a plaster for treating juvenile gouty arthritis

[0064] On the basis of the water decoction obtained in Example 4, the obtained water decoction is baked using a drying oven to obtain dry plaster 85.96 g.

[0065] Example 6 Preparation of a powder for treating juvenile gouty arthritis

[0066] On the basis of the dry plaster obtained in Example 5, the obtained dry plaster of the traditional Chinese medicine composition is crushed, ground, and filtered through 10-mesh, 20-mesh, 40-mesh, 80-mesh, and 100-mesh sieves in sequence to obtain dry powder 82.23 g of the traditional Chinese medicine composition. The powder is packaged at 10 g per bag and stored in a -80°C refrigerator. When needed, it can be dissolved at room temperature.

[0067] Example 7 Animal experiment

[0068] 1 Required materials

[0069] 1.1 Animal materials

[0070] 63 white, male, outbred Kunming mice (albino mice), 2 months old (production license SCXK (black) 2013-004), produced at the Experimental Animal Center of Heilongjiang University of Chinese Medicine, and the mice were of clean grade and weighed (18 ± 2) g. The white, male, outbred Kunming mice (albino mice) were raised by conventional methods, given a normal humidity environment, normal lighting, etc. The white, male, outbred Kunming mice (albino mice) were raised in single cages, and the raising place was the Experimental Animal Center of Heilongjiang University of Chinese Medicine. The raising personnel was Professor Li Baolong of the Experimental Animal Center of Heilongjiang University of Chinese Medicine, and the living conditions of the white, male, outbred Kunming mice (albino mice) were observed at any time.

[0071] 1.2 Pharmaceutical materials

[0072] The powder was prepared according to Example 6.

[0073] 1.3 Reagent materials

[0074] The modeling reagent was sodium urate (Sigma, USA) which was used conventionally, and the detection index enzyme-linked immunoreagent kit of tumor necrosis factor-α, interleukin-1β, etc. was purchased from Nanjing Jiancheng Biological Engineering Institute. The control drug allopurinol (Wuhan Dong Kangyuan Technology Co., Ltd.) and NOD-like receptor pyrin domain-associated protein 3 and β-action primers were purchased from SCB Company, USA. Other related experimental reagents were all domestic analytical pure and provided by Professor Zhou Zhongguang of Heilongjiang University of Chinese Medicine, Associate Professor Zhang Yingbo of Qiqihaer Medical College and Professor Li Baolong of Heilongjiang University of Chinese Medicine.

[0075] 1.4 Required instruments

[0076] The experimental pipette was produced by DLAB Company (model G0071211). The experimental universal pulverizer was produced by Lin Da Machinery Co., Ltd. (model TT30-FW-100). The experimental-20℃ refrigerator was produced by Xinfeng Company (model BCD-208WK3CT). The experimental enzyme label instrument was produced by Shanghai Rikang Company (model WG-D0506). The experimental-80℃ refrigerator was produced by Snowsea Company (model BCD-58S128E). The experimental centrifuge was produced by Yancheng Anxin Experimental Instrument Co., Ltd. (model AXTD4). The experimental super-clean workbench was produced by Su Xin Environmental Technology Co., Ltd. (model YJ). The experimental electronic balance was produced by Sartorius Company (model PLZOZ-S).

[0077] 2 Required experimental methods

[0078] 2.1 Required animal grouping

[0079] 63 white, male, outbred Kunming mice (albino mice), 2 months old (production license SCXK (black) 2013-004), were randomly grouped, including a control treatment group, a virtual operation group, a control positive group, a modeling demonstration group, a multiple dose group of a traditional Chinese medicine composition, a moderate dose group of a traditional Chinese medicine composition and a low dose group of a traditional Chinese medicine composition. Each group had 9 mice. The multiple dose group of the traditional Chinese medicine composition was the multiple dose group, the moderate dose group of the traditional Chinese medicine composition was the moderate dose group, and the low dose group of the traditional Chinese medicine composition was the low dose group. The white, male, outbred Kunming mice (albino mice) in each group, 63 in number and 2 months old (production license SCXK (black) 2013-004), were raised in single cages.

[0080] 2.2 Required animal modeling

[0081] The white male Kunming mouse outbred group (albino mice) mice 63, 2 months old (production license SCXK (black) 2013-004) were acclimated to the surrounding environment for one week, and the white male Kunming mouse outbred group (albino mice) mice 63, 2 months old (production license SCXK (black) 2013-004) were observed at any time. The 2.5% sodium urate solution was used to model the white male Kunming mouse outbred group (albino mice) mice in each group. The reference for modeling (Yang Liu, Xiong Xiaohua, Wang Xizhi. Discussion on the treatment of Shengyang Huatou Decoction for hyperuricemia based on the theory of ascending clear and descending turbid [J]. Rheumatism and Arthritis, 2023, 12 (02): 53-56+65.; Ma Yanyun, Bai Guizhen. Clinical efficacy of electroacupuncture combined with external application of traditional Chinese medicine in the treatment of elderly patients with acute gout and its influence on serum inflammatory factors [J]. Rheumatism and Arthritis, 2023, 12 (08): 14-17+53.; Tsujimoto K, Jo T, Nagira D, et al. The lysosomal Ragulator complex activates NLRP3 inflammasome in vivo via HDAC6 [J]. EMBO J, 2023, 42 (1): e111389.) The white male Kunming mouse outbred group (albino mice) mice were selected for modeling, including the first modeling of white male Kunming mouse outbred group (albino mice) mice and the second modeling of white male Kunming mouse outbred group (albino mice) mice, with a 7-day interval between the two. The process of modeling white male Kunming mouse outbred group (albino mice) mice was the same each time. For the control positive group, the modeling demonstration group, the traditional Chinese medicine composition multiple dose group, the traditional Chinese medicine composition moderate amount group, and the traditional Chinese medicine composition small dose group, the white male Kunming mouse outbred group (albino mice) mice were operated on using a clean bench, and the 2.5% sodium urate solution was prepared in a sterile environment for storage and use in white male Kunming mouse outbred group (albino mice) mice. In the right lower limb of the white male Kunming mouse outbred group (albino mice) juvenile gouty arthritis model mice, the white male Kunming mouse outbred group (albino mice) foot bottom and white male Kunming mouse outbred group (albino mice) foot back were selected for injection of appropriate liquids, including 0.05 mL of 2.5% sodium urate solution. The virtual surgery group and its control treatment group injected a certain volume of 0.05 mL of normal saline into the right foot bottom and foot back of the white male Kunming mouse outbred group (albino mice). After the first modeling of white male Kunming mouse outbred group (albino mice) mice and the second modeling of white male Kunming mouse outbred group (albino mice) mice, the basic state of the white male Kunming mouse outbred group (albino mice) mice in each group was observed.

[0082] 2.3 Experimental dose conversion

[0083] The traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g is analyzed, and the dosage conversion is arranged for the administration. The body surface area ratio of mice and human body is generally 0.0026:1, and the administration dosage of the traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g is calculated according to this. The conventional dosage of the traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g for each 54.75g is 54.75g x 0.0026 x 50 / kg = 7.12g / kg. The conventional administration dosage of allopurinol for each 54.75g is 0.03g / kg.

[0084] 2.4 Administration of each group of animals

[0085] Four hours after the end of the second modeling, the administration of white male Kunming inbred mice (albino mice) is started. The control treatment group, the virtual operation group, and the modeling demonstration group are all given normal saline (0.3mL) by gavage for 15 days, and the control positive group is given allopurinol (0.03g / kg) by gavage for 15 days. The multiple dose group of white male Kunming inbred mice (albino mice) is given 2 times the dosage of 7.12g / kg for the traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g for each 54.75g. The moderate dose group of white male Kunming inbred mice (albino mice) is given 7.12g / kg for the traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g for each 54.75g. The low dose group of white male Kunming inbred mice (albino mice) is given half the dosage of 7.12g / kg for the traditional Chinese medicine composition consisting of Fenghuangyi 6g, Guanghuoxiang 6g, Qingxianzi 12g, Dongfengju 22.5g, Xiangli 6g, and Bocengqia 2.25g for each 54.75g for 15 days. The white male Kunming inbred mice (albino mice) in each group are observed at any time after administration.

[0086] 2.5 Detection of joint swelling degree

[0087] The white male Kunming mice outbred group (albino mice) in each group is marked, especially the (toe) of the white male Kunming mice outbred group (albino mice) in each group. After 4h of the last administration of the white male Kunming mice outbred group (albino mice) in each group, the white male Kunming mice outbred group (albino mice) in each group is conventionally grabbed, the white male Kunming mice outbred group (albino mice) in each group is anesthetized, and the fixed part of the white male Kunming mice outbred group (albino mice) in each group is cut, which is the (toe) of the white male Kunming mice outbred group (albino mice) in each group, including the white male Kunming mice outbred group (albino mice) in each group from the knee bending mark, which is cut and placed in a graduated cylinder containing pre-cooled physiological saline to measure the volume change of the (toe) of the white male Kunming mice outbred group (albino mice), and the volume scale of the (toe) of the white male Kunming mice outbred group (albino mice) is accurately recorded. The calculation formula is: the joint swelling degree (mL) of the white male Kunming mice outbred group (albino mice) from the knee bending mark = the joint volume scale value (mL) of the white male Kunming mice outbred group (albino mice) after the experiment from the knee bending mark - the joint volume scale value (mL) of the white male Kunming mice outbred group (albino mice) before the experiment from the knee bending mark. The joint swelling degree of the white male Kunming mice outbred group (albino mice) is evaluated in this way.

[0088] 2.6 Detection of arthritis inflammation index

[0089] After 4h of the last administration, each group of white male Kunming mice outbred (albino mice) was conventionally grabbed, each group of white male Kunming mice outbred (albino mice) was anesthetized, and the arthritic inflammation index of each group of white male Kunming mice outbred (albino mice) was evaluated. The arthritic inflammation index evaluation method of each group of white male Kunming mice outbred (albino mice) was divided into 5 levels. Grade 4, 7-8 points, mainly manifested as swelling of each group of white male Kunming mice outbred (albino mice) (toe), the swelling was very obvious, the bone markers of each group of white male Kunming mice outbred (albino mice) could not be seen, each group of white male Kunming mice outbred (albino mice) was often accompanied by limited conventional activity, and each group of white male Kunming mice outbred (albino mice) even appeared joint deformity. Grade 3, 5-6 points, manifested as obvious swelling of each group of white male Kunming mice outbred (albino mice), each group of white male Kunming mice outbred (albino mice) could not see the bone markers, and each group of white male Kunming mice outbred (albino mice) appeared local manifestations such as redness, heat, pain, etc. Grade 2, 3-4 points, each group of white male Kunming mice outbred (albino mice) (toe) appeared obvious swelling, each group of white male Kunming mice outbred (albino mice) could not see the bone markers, and each group of white male Kunming mice outbred (albino mice) appeared red, hot, and painful joints. Grade 1, 1-2 points, manifested as local swelling of each group of white male Kunming mice outbred (albino mice) (toe), each group of white male Kunming mice outbred (albino mice) could see the bone markers, and each group of white male Kunming mice outbred (albino mice) appeared red and hot joints. Grade 0, 0 points, manifested as no swelling of each group of white male Kunming mice outbred (albino mice).

[0090] 2.7 Detection of inflammatory mediators

[0091] 4h after the last administration, the white male Kunming mice outbred group (albino mice) of each group were routinely grabbed, anesthetized, and sampled (foot toe part). The skin was removed, and routine processing was performed, including tissue fixation, tissue embedding, tissue sectioning, tissue deparaffinization, tissue dehydration, tissue repair, tissue sealing, primary antibody treatment (4°C overnight), tissue washing, secondary antibody incubation, tissue washing, hematoxylin restain, observation under an optical microscope, storage of relevant images, calculation of the average optical density (MOD) of NOD-like receptor heat protein domain-related protein 3 protein in the tissues of the white male Kunming mice outbred group (albino mice) (foot toe part) using routine picture analysis software, and data analysis.

[0092] 2.8 Detection of NOD-like receptor heat protein domain-related protein 3 protein expression

[0093] 4h after the last administration, the white male Kunming mice outbred group (albino mice) of each group were routinely grabbed, anesthetized, and sampled (foot toe part). The skin was removed, and routine processing was performed, including tissue fixation, tissue embedding, tissue sectioning, tissue deparaffinization, tissue dehydration, tissue repair, tissue sealing, primary antibody treatment (4°C overnight), tissue washing, secondary antibody incubation, tissue washing, hematoxylin restain, observation under an optical microscope, storage of relevant images, calculation of the average optical density (MOD) of NOD-like receptor heat protein domain-related protein 3 protein in the tissues of the white male Kunming mice outbred group (albino mice) (foot toe part) using routine picture analysis software, and data analysis.

[0094] 2.9 Detection of NOD-like receptor heat protein domain-related protein 3 gene expression

[0095] After the last administration of each group of white male Kunming mice outbred (albino mice) ended 4h, each group of white male Kunming mice outbred (albino mice) was routinely grabbed, each group of white male Kunming mice outbred (albino mice) was anesthetized, each group of white male Kunming mice outbred (albino mice) was sampled (foot toe), the skin was removed, the white male Kunming mice outbred (albino mice) (foot toe) RNA was extracted, and the white male Kunming mice outbred (albino mice) (foot toe) cDNA was reversely transcribed. The specific primers of NOD-like receptor pyrin domain-associated protein 3 gene were designed. NOD-like receptor pyrin domain-associated protein 3 upstream and downstream primers (Forward: 5'-CGC TCG GGC TTA AGC CGA CGC GCG TAC-3'; Reverse: 3'-AGG CGA CAT TGC AAT GTC CGT TGA GCC-5'); β-action upstream and downstream primers (Forward: 5'-AGC GCG GTC ATC CGA CTG GTC-3'; Reverse: 3'-CCG GTC TAG CGC GCA TGC ACT-5'). For the white male Kunming mice outbred (albino mice) (foot toe) experiment, special SYBR Green I fluorescent material was needed to determine NOD-like receptor pyrin domain-associated protein 3. The reaction parameters were set for NOD-like receptor pyrin domain-associated protein 3, including 50℃ for 2.2min, 95℃ for 10.3min, 95℃ for 16s, 60℃ for 1.2min, 42 cycles, analysis and calculation of the expression level of NOD-like receptor pyrin domain-associated protein 3 gene in joint tissue of white male Kunming mice outbred (albino mice) (foot toe), to evaluate the gene expression level of white male Kunming mice outbred (albino mice) (foot toe).

[0096] 2.10 Detection of organ index

[0097] After the last administration of each group of white male Kunming mice outbred (albino mice) ended 4h, each group of white male Kunming mice outbred (albino mice) was killed by cervical dislocation, and each group of white male Kunming mice outbred (albino mice) was sampled. The main organs of heart, liver, lung, and kidney were evaluated for the organ index level of heart, liver, lung, and kidney. The calculation formula was: the organ index (mg / g) of the main organs of heart, liver, lung, and kidney of each group of white male Kunming mice outbred (albino mice) = organ weight (mg) of the main organs of heart, liver, lung, and kidney of each group of white male Kunming mice outbred (albino mice) / body weight (g) of each group of white male Kunming mice outbred (albino mice).

[0098] 2.11 Detection of mouse body weight

[0099] The body weight of each group of white male Kunming mouse outbred population (albino mice) was detected by electronic balance at different time points including 0 days, 7 days, and 15 days during the administration of each group of white male Kunming mouse outbred population (albino mice), the body weight data changes of each group of white male Kunming mouse outbred population (albino mice) were counted, and the side effect level of the traditional Chinese medicine composition on each group of white male Kunming mouse outbred population (albino mice) was evaluated.

[0100] 2.12 Statistical analysis

[0101] SPSS19.0 software was used to analyze the experimental data of each group of white male Kunming mouse outbred population (albino mice), and the experimental data of each group of white male Kunming mouse outbred population (albino mice) was represented by , and single factor analysis of variance was used for comparison between multiple groups of white male Kunming mouse outbred population (albino mice).

[0102] 3 Experimental results

[0103] 3.1 Effect of traditional Chinese medicine composition on joint swelling degree of model mice (toe)

[0104] The results showed that compared with the control treatment group of white male Kunming mouse outbred population (albino mice), the joint swelling degree of the model mice (toe) in the modeling demonstration group was significantly increased (P<0.05), while the joint swelling degree of the model mice (toe) in the virtual operation group changed not obviously (P>0.05); compared with the modeling demonstration group of white male Kunming mouse outbred population (albino mice), the joint swelling degree of the model mice (toe) in the control positive group, multiple dose group, and moderate amount group was significantly reduced (P<0.05), while the joint swelling degree of the model mice (toe) in the low dose group changed not obviously (P>0.05). See Table 1, Figure 1 .

[0105] Table 1 Effect of traditional Chinese medicine composition on joint swelling degree of model mice (toe)

[0106]

[0107] Note: compared with the control treatment group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0108] 3.2 Effect of traditional Chinese medicine composition on arthritis inflammation index of model mice (toe)

[0109] The results showed that compared with the control group, the arthritic inflammation index of the model mice in the modeling demonstration group was significantly increased (P<0.05), and the arthritic inflammation index of the model mice in the virtual operation group was not significantly changed (P>0.05); compared with the modeling demonstration group, the arthritic inflammation index of the model mice in the control positive group, the multiple dose group and the moderate dose group was significantly decreased (P<0.05), and the arthritic inflammation index of the model mice in the low dose group was not significantly changed (P>0.05). See Table 2, Figure 2 .

[0110] Table 2 Effect of the traditional Chinese medicine composition on the arthritic inflammation index of the model mice (toe)

[0111]

[0112] Note: compared with the control group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0113] 3.3 Effect of the traditional Chinese medicine composition on the interleukin-1β of the model mice (toe)

[0114] The results showed that compared with the control group, the interleukin-1β of the model mice in the modeling demonstration group was significantly increased (P<0.05), and the interleukin-1β of the model mice in the virtual operation group was not significantly changed (P>0.05); compared with the modeling demonstration group, the interleukin-1β of the model mice in the control positive group, the multiple dose group and the moderate dose group was significantly decreased (P<0.05), and the interleukin-1β of the model mice in the low dose group was not significantly changed (P>0.05). See Table 3, Figure 3 .

[0115] Table 3 Effect of the traditional Chinese medicine composition on the interleukin-1β of the model mice (toe)

[0116]

[0117] Note: compared with the control group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0118] 3.4 The effect of traditional Chinese medicine composition on tumor necrosis factor-α of model mice (toe)

[0119] The results showed that compared with the control treatment group of white male Kunming mice outbred (albino mice), the tumor necrosis factor-α of model mice (toe) of the modeling demonstration group increased significantly (P<0.05), and the tumor necrosis factor-α of model mice (toe) of the virtual operation group changed not obviously (P>0.05); compared with the modeling demonstration group of white male Kunming mice outbred (albino mice), the tumor necrosis factor-α of model mice (toe) of the control positive group, the multiple dose group and the moderate amount group decreased significantly (P<0.05), and the tumor necrosis factor-α of model mice (toe) of the low dose group changed not obviously (P>0.05). See Table 4, Figure 4 .

[0120] Table 4 The effect of traditional Chinese medicine composition on tumor necrosis factor-α of model mice (toe)

[0121]

[0122]

[0123] Note: compared with the control treatment group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0124] 3.5 The effect of traditional Chinese medicine composition on NOD-like receptor heat protein domain related protein 3 protein of model mice (toe)

[0125] The results showed that compared with the control treatment group, the NOD-like receptor heat protein domain related protein 3 protein of model mice (toe) of the modeling demonstration group increased significantly (P<0.05), and the NOD-like receptor heat protein domain related protein 3 protein of model mice (toe) of the virtual operation group changed not obviously (P>0.05); compared with the modeling demonstration group of white male Kunming mice outbred (albino mice), the NOD-like receptor heat protein domain related protein 3 protein of model mice (toe) of the control positive group, the multiple dose group and the moderate amount group decreased significantly (P<0.05), and the NOD-like receptor heat protein domain related protein 3 protein of model mice (toe) of the low dose group changed not obviously (P>0.05). See Table 5, Figure 5 .

[0126] Table 5 The effect of traditional Chinese medicine composition on NOD-like receptor heat protein domain related protein 3 protein of model mice (toe)

[0127]

[0128] Note: Compared with the control treatment group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0129] 3.6 Effect of the traditional Chinese medicine composition on the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe)

[0130] The results show that, compared with the control treatment group, the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe) in the modeling demonstration group is significantly increased (P<0.05), and the change of the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe) in the virtual operation group is not obvious (P>0.05); compared with the modeling demonstration group, the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe) in the control positive group, the multiple dose group, and the moderate amount group is significantly reduced (P<0.05), and the change of the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe) in the small dose group is not obvious (P>0.05). See Table 6, Figure 6 .

[0131] Table 6 Effect of the traditional Chinese medicine composition on the NOD-like receptor heat protein domain related protein 3 gene of the model mouse (toe)

[0132]

[0133] Note: Compared with the control treatment group: @ P>0.05, @@ P<0.05; compared with the modeling demonstration group: & P<0.05, && P>0.05

[0134] 3.7 Effect of the traditional Chinese medicine composition on the heart index of the model mouse and the lung index of the model mouse

[0135] The results show that, compared with the control treatment group, the change of the heart index and the lung index of the mice in the modeling demonstration group and the virtual operation group is not obvious (P>0.05); compared with the modeling demonstration group, the change of the heart index and the lung index of the mice in the control positive group, the multiple dose group, the moderate amount group, and the small dose group is not obvious (P>0.05). See Table 7, Figure 7 .

[0136] Table 7 Effect of the traditional Chinese medicine composition on the heart index of the model mouse and the lung index of the model mouse n=9

[0137]

[0138]

[0139] Note: Compared with the control treatment group: @ P>0.05; Compared with the modeling demonstration group: & P>0.05

[0140] 3.8 Effect of the Chinese medicine composition on the kidney index of the model mice and the liver index of the model mice

[0141] The results show that compared with the control treatment group, the kidney index and the liver index of the mice in the modeling demonstration group and the virtual operation group do not change significantly (P>0.05); compared with the modeling demonstration group, the kidney index and the liver index of the mice in the control positive group, the multiple dose group, the moderate dose group, and the small dose group do not change significantly (P>0.05). See Table 8, Figure 8 .

[0142] Table 8 Effect of the Chinese medicine composition on the kidney index of the model mice and the liver index of the model mice n=9

[0143]

[0144] Note: Compared with the control treatment group: @ P>0.05; Compared with the modeling demonstration group: & P>0.05

[0145] 3.9 Effect of the Chinese medicine composition on the body weight of the model mice

[0146] The results show that compared with the body weight of the mice in the control treatment group at 0 days, 7 days, and 15 days, the body weight of the mice in the modeling demonstration group at 0 days, 7 days, and 15 days does not change significantly (P>0.05), and the body weight of the mice in the virtual operation group at 0 days, 7 days, and 15 days does not change significantly (P>0.05); compared with the body weight of the mice in the modeling demonstration group at 0 days, 7 days, and 15 days, the body weight of the mice in the control positive group, the multiple dose group, the moderate dose group, and the small dose group at 0 days, 7 days, and 15 days does not change significantly (P>0.05). See Table 9, Figure 9 .

[0147] Table 9 Effect of the Chinese medicine composition on the body weight of the model mice n=9

[0148]

[0149]

[0150] Note: Compared with the control treatment group: @ P>0.05; Compared with the modeling demonstration group:& P＞0.05。

Claims

1. A traditional Chinese medicine composition for treating gouty arthritis in adolescents, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 4-8 parts of phoenix skin, 4-8 parts of patchouli, 10-15 parts of celosia seed, 20-25 parts of tangerine peel, 4-8 parts of citron, and 2-3 parts of cubeb.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 6 parts of phoenix skin, 6 parts of patchouli, 12 parts of celosia seed, 22.5 parts of tangerine peel, 6 parts of citron, and 2.25 parts of cubeb.

3. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating gouty arthritis in adolescents.

4. The application as described in claim 3, characterized in that, The medicine is a decoction, powder, paste, granule, capsule or tablet.

5. A method for preparing a decoction from the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh each raw material according to the weight proportions described in claim 1 or 2; (2) Place the raw material described in step (1) into a round-bottom flask and soak it in pure water for 3-4 hours. Then, decoct it at 100°C for 2-3 hours. (3) The decoction obtained after step (2) is filtered through 2 layers of gauze, 6 layers of gauze, 8 layers of gauze, 12 layers of gauze and 18 layers of gauze in sequence to obtain the first filtrate of the Chinese medicine composition. (4) Place the drug residue filtered in step (3) into a round-bottom flask and soak it in pure water for 3-4 hours, then decoct it at 100°C for 2-2.5 hours. (5) Repeat step (3) to obtain the second filtrate of the Chinese herbal medicine composition; (6) The first filtrate and the second filtrate are thoroughly mixed to obtain the decoction of the traditional Chinese medicine composition according to claim 1 or 2.

6. A method for preparing a paste from the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Based on the method described in claim 5, the method further includes baking the decoction obtained in a drying oven to obtain a dry extract of the traditional Chinese medicine composition.

7. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2 into a powder, characterized in that, Based on the method described in claim 6, the method further includes pulverizing and grinding the obtained dry extract of the traditional Chinese medicine composition, and filtering it sequentially through a 10-mesh sieve, a 20-mesh sieve, a 40-mesh sieve, an 80-mesh sieve, and a 100-mesh sieve to obtain the dry powder of the traditional Chinese medicine composition.

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