Traditional Chinese medicine composition for preventing and treating wind-damp-heat arthralgia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating rheumatic fever arthralgia and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The composition is prepared from the following raw material medicines in parts by weight: 10-30 parts of golden cypress, 5-20 parts of mint, 3-8 parts of coptis chinensis and 5-20 parts of blumea balsamifera. The preparation method comprises the steps of cleaning and selecting, drying, crushing, mixing, sub-packaging and the like, and the traditional Chinese medicine composition has the effects of clearing heat and drying dampness, and activating meridians to stop pain.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for preventing and treating rheumatic fever and its preparation. Preparation method. Background Technology

[0002] Rheumatic and autoimmune diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and gout often manifest as redness, swelling, heat, pain, and morning stiffness in the joints. These conditions fall under the category of "Bi syndrome - damp-heat obstruction" in traditional Chinese medicine. The pathogenesis of this condition is that damp-heat evil obstructs the meridians, leading to poor circulation of qi and blood.

[0003] Modern medicine primarily employs systemic treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and immunosuppressants. While these can control symptoms, long-term oral or injectable administration can easily lead to systemic adverse reactions such as gastrointestinal, liver, and kidney damage, as well as infections, raising significant safety concerns. Traditional Chinese medicine external therapies, such as fumigation and washing, allow medication to directly reach the lesion, avoiding the first-pass effect in the liver and reducing systemic toxicity, offering unique advantages for this type of condition.

[0004] However, existing technologies have some shortcomings. First, most hospital-prepared formulations are complex and contain numerous ingredients, making quality control difficult and batch stability poor. Second, some formulations use toxic herbs such as Aconitum carmichaelii and Strychnos nux-vomica, posing safety risks such as skin allergies and contact dermatitis. Third, most commercially available topical Chinese medicines focus on warming the meridians, dispelling cold, and promoting blood circulation, with a warming and drying nature, which cannot meet the fundamental need of clearing heat for patients with damp-heat obstruction syndrome.

[0005] Therefore, there is an urgent clinical need for a topical preparation with a simplified formulation, clear target indications, high safety, and suitability for industrialization, in order to make up for the shortcomings of existing treatment regimens in terms of efficacy and safety. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the present invention aims to provide a traditional Chinese medicine composition for the prevention and treatment of rheumatic fever that is simple in formulation, has clear target indications, high safety and is suitable for industrialization.

[0007] One of the objectives of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition.

[0008] Another object of the present invention is to provide the use of this traditional Chinese medicine composition in the preparation of a topical medicine for the prevention and treatment of rheumatic fever.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine composition for preventing and treating rheumatic fever, comprising the following raw materials in parts by weight: 10-30 parts of Phellodendron bark, 5-20 parts of peppermint, 3-8 parts of Coptis chinensis, and 5-20 parts of Artemisia argyi.

[0010] Preferably, it is composed of the following raw materials in parts by weight: 15-25 parts of Phellodendron bark, 5-15 parts of peppermint, 3-5 parts of Coptis chinensis, and 5-15 parts of Artemisia argyi.

[0011] More preferably, it is composed of the following raw materials in parts by weight: 20 parts of Phellodendron bark, 10 parts of peppermint, 5 parts of Coptis chinensis, and 10 parts of Artemisia argyi.

[0012] Furthermore, the composition is in the form of a powder. The powder can be packaged into unit packages, each containing 60-90 grams, and stored in an airtight package filled with inert nitrogen.

[0013] A method for preparing the traditional Chinese medicine composition includes the following steps: a) cleaning and selecting Phellodendron bark, peppermint, Coptis chinensis, and Artemisia argyi; b) drying the cleaned medicinal materials to a moisture content ≤10%, preferably at a drying temperature of 40-70℃; c) pulverizing the dried medicinal materials to 80-120 mesh; d) mixing the pulverized medicinal materials evenly according to the specified proportions, preferably using a three-dimensional motion mixer for 15-25 minutes.

[0014] The use of the traditional Chinese medicine composition in the preparation of a topical medicine for the prevention and treatment of rheumatic fever, wherein the rheumatic fever is characterized by redness, swelling, heat and pain in the joints, and the disease includes rheumatoid arthritis, osteoarthritis, ankylosing spondylitis or gouty arthritis.

[0015] Based on long-term clinical observation of rheumatic fever (i.e., damp-heat obstruction syndrome) prevalent in Guizhou and other regions, the inventors discovered that its core pathogenesis lies in the obstruction of meridians by damp-heat pathogens, leading to poor circulation of qi and blood. Traditional external preparations for warming the meridians and dispelling cold are insufficient to meet the fundamental need for clearing heat and drying dampness. To solve this technical problem, this invention draws on the wisdom of ethnic medicine and the essence of classic prescriptions, using the Guizhou Miao herb *Artemisia argyi* as the principal ingredient, leveraging its effects of promoting blood circulation, unblocking meridians, and guiding the medicine directly to the affected area. Simultaneously, it integrates the core heat-clearing and dampness-drying properties of the "Huanglian Jiedu Tang" from *Zhouhou Beiji Fang*, selecting the *Coptis chinensis*-*Phellodendron chinense* herb pair, and adding peppermint for its pungent and cooling properties to promote surface penetration. Through the synergistic combination of these four herbs, the invention achieves a concise formulation and clearly defined target syndrome.

[0016] Modern pharmacological studies have further confirmed the scientific validity of this formula: the main active ingredients of Artemisia annua can alleviate inflammatory responses by inhibiting the non-classical NF-κB signaling pathway. [1] The combination of Phellodendron bark and Coptis chinensis can synergistically regulate the NF-κB pathway and significantly reduce the levels of key inflammatory factors such as TNF-α and IL-6. [2] Menthol in peppermint is not only an effective anti-inflammatory and analgesic component, but also a highly efficient transdermal absorption enhancer. By regulating the concentration of calcium ions in keratinocytes and downregulating the level of tight junction proteins, it significantly enhances the transdermal penetration of drug components. [3,4,5]This indicates that the formulation of this invention not only conforms to traditional Chinese medicine theory, but its efficacy in relieving joint redness, swelling, heat, and pain also has a clear modern pharmacological basis.

[0017] Compared with the prior art, the present invention has the following significant advantages: 1) The formulation of this invention is simple and its target is clearly defined. The formulation of this invention is based on the traditional Chinese medicine principle of "clearing heat and drying dampness, unblocking the channels and relieving pain" for damp-heat obstruction syndrome. In the formula, *Artemisia argyi* is the chief herb, guiding the medicine directly to the affected area; *Coptis chinensis* and *Phellodendron chinense* are the assistant herbs, clearing heat and drying dampness; and *Mentha haplocalyx* is the adjuvant herb, with its pungent and cooling properties, acting as a penetration enhancer. The combination of these four herbs achieves the effects of clearing heat and drying dampness, unblocking the channels and relieving pain, specifically targeting symptoms of redness, swelling, heat, and pain in the joints.

[0018] 2) This invention has high safety. This formula eliminates toxic medicinal materials such as Aconitum carmichaelii and Strychnos nux-vomica; all components are either food-grade or commonly used Chinese medicinal herbs with high safety profiles. Experiments show that only a very small number of patients experience mild, self-relieving skin irritation, and no systemic toxic side effects have been observed, demonstrating good safety.

[0019] 3) The components of this invention exhibit synergistic effects. Pharmacodynamic experiments have demonstrated that the powder of this invention can significantly inhibit paw swelling in rats, reduce the arthritis index, and lower the levels of inflammatory factors (IL-1β, IL-6, TNF-α) in synovial tissue, with effects close to or superior to the positive control drug. Comparative studies have confirmed that replacing or altering any ingredient or its proportion leads to a significant decrease in efficacy, indicating that the formulation of this invention is a synergistic organic whole.

[0020] 4) The quality of this invention is controllable and suitable for industrialization. The prescription contains few ingredients, the raw materials are readily available, and the preparation process is simple. By controlling the particle size, mixing method, and packaging conditions, the uniformity and stability of product quality are effectively guaranteed, making it very suitable for large-scale industrial production and application. Detailed Implementation

[0021] The following examples are intended to further illustrate the invention, but not to limit its scope in any way. Unless otherwise specified, the methods described in this invention employ conventional experimental techniques in the art, and the reagents and materials used are commercially available.

[0022] Example 1 Weigh out 15 parts of Phellodendron bark, 5 parts of peppermint, 3 parts of Coptis chinensis, and 5 parts of Artemisia argyi. After cleaning the above-mentioned medicinal materials, dry them at 40℃ until the moisture content is ≤10%, pulverize them separately to 80 mesh, and mix them in a three-dimensional motion mixer for 15 minutes according to the proportion. Then, divide them into 60g units, sterilize them by gamma irradiation with an irradiation dose ≤5 kGy, fill them with nitrogen, seal them, and store them for later use.

[0023] Instructions for use: Take one unit of the powder prepared by the above method, mix it with 900ml of 38℃ warm water, stir well, and after the temperature drops to a level that the skin can tolerate, use it for fumigation and washing of the affected area. Each fumigation and washing session lasts 25 minutes, once a day, for 14 days as one course of treatment.

[0024] Example 2 Weigh out 20 parts of Phellodendron bark, 10 parts of peppermint, 5 parts of Coptis chinensis, and 10 parts of Artemisia argyi. After cleaning the above-mentioned medicinal materials, dry them at 60℃ until the moisture content is ≤10%, pulverize them separately to 100 mesh, and mix them in a three-dimensional motion mixer for 20 minutes according to the proportion. Then, divide them into 80g units, sterilize them by gamma irradiation with an irradiation dose ≤5 kGy, fill them with nitrogen, seal them, and store them for later use.

[0025] Instructions for use: Take one unit of the powder prepared by the above method, mix it with 1000 ml of 40℃ warm water, stir well, and after the temperature drops to a level that the skin can tolerate, apply it to the affected area for fumigation and washing. Each fumigation and washing session lasts for 30 minutes, twice a day, for 14 days as one course of treatment.

[0026] Example 3 Weigh out 25 parts of Phellodendron bark, 15 parts of peppermint, 5 parts of Coptis chinensis, and 15 parts of Artemisia argyi. After cleaning the above-mentioned medicinal materials, dry them at 70℃ until the moisture content is ≤10%, pulverize them separately to 120 mesh, and mix them in a three-dimensional motion mixer for 25 minutes according to the proportion. Then, divide them into 90g units, sterilize them by gamma irradiation with an irradiation dose ≤5 kGy, fill them with nitrogen, seal them, and store them for later use.

[0027] Instructions for use: Take one unit of the powder prepared by the above method, mix it with 1100 ml of 42 ℃ warm water, stir well, and after the temperature drops to a level that the skin can tolerate, use it for fumigation and washing of the affected area. Each fumigation and washing session lasts 35 minutes, twice a day, for 14 days as one course of treatment.

[0028] Comparative Example 1: 30 parts of Phellodendron bark, 20 parts of peppermint, 8 parts of Coptis chinensis, and 20 parts of Artemisia argyi were weighed. The preparation method was the same as in Example 2. Comparative Example 2: 20 parts of Scutellaria baicalensis, 10 parts of peppermint, 5 parts of Coptis chinensis, and 10 parts of Artemisia argyi were weighed. The preparation method was the same as in Example 2.

[0029] Comparative Example 3: 20 parts of Phellodendron bark, 10 parts of Forsythia fruit, 5 parts of Coptis root, and 10 parts of Artemisia argyi were weighed. The preparation method was the same as in Example 2.

[0030] Comparative Example 4 Weigh out 20 parts of Phellodendron bark, 10 parts of peppermint, 5 parts of Coptis chinensis, and 10 parts of borneol. The preparation method is the same as in Example 2.

[0031] Experimental Example 1 1) Experimental materials Experimental animals: Healthy male SD rats, weighing 180-200 g, clean grade, purchased from Beijing Jikang Medical Technology Co., Ltd.

[0032] Test drug: The present invention group includes the powders prepared in Examples 1, 2, and 3.

[0033] Comparative examples: Powders prepared by comparative examples 1, 2, 3, and 4.

[0034] Positive control drug: Diclofenac sodium plaster.

[0035] Reagents and instruments: Freund's complete adjuvant was purchased from Xinbosheng Biotechnology; paw volume measuring instrument was purchased from Beijing Zhishu Duobao Biotechnology Co., Ltd.; electronic balance.

[0036] 2) Experimental methods Modeling and Grouping Except for the blank control group, the remaining rats were injected subcutaneously into the right hind paw metatarsal region with 0.1 mL of Freund's complete adjuvant to induce inflammation and establish an AA model. On the 7th day after modeling, the rats were randomly divided into 9 groups of 10 each, according to their body weight and the degree of primary paw swelling.

[0037] Blank control group: No model was created; the patient was given warm water fumigation.

[0038] Model control group: treated with warm water fumigation.

[0039] Positive control group: Diclofenac sodium patches were administered. The patches were cut to a size corresponding to the swollen area of ​​the rat's paw, applied tightly, and changed daily.

[0040] Example 1 group: The powder of Example 1 of the present invention was used for fumigation and washing.

[0041] Example 2 group: The powder of Example 2 of the present invention was used for fumigation and washing.

[0042] Example 3 group: The powder of Example 3 of the present invention was used for fumigation and washing.

[0043] Comparative Example 1: The patient was given fumigation with the powder from Comparative Example 1.

[0044] Comparative Example 2: The patient was given fumigation with the powder from Comparative Example 2.

[0045] Comparative Example 3: The patient was given fumigation with the powder from Comparative Example 3.

[0046] Comparative Example 4: The patient was given fumigation with the powder from Comparative Example 4.

[0047] 3) Dosing regimen Fumigation and administration: Dissolve each powder sample in warm water at 40℃ according to the usage instructions to prepare a 1 g / mL suspension. Fix the rats and immerse their swollen right hind limb in the solution, with the liquid level above the ankle joint, for 30 minutes each time, once a day for 21 consecutive days.

[0048] Patch administration: The positive control group applied the patch once a day to ensure full contact between the drug and the skin.

[0049] 4) Detection indicators Paw swelling: The volume of the right hind paw of rats was measured using a paw volume analyzer before modeling and on days 7 and 21 after drug administration. Swelling (mL) = Post-inflammatory paw volume - Pre-inflammatory paw volume.

[0050] Arthritis Index (AI): The joints of the limbs of each rat were scored at the same time point.

[0051] Scoring criteria: 0 points, no redness or swelling; 1 point, redness and swelling of the little toe joint; 2 points, swelling of the toe joints and metatarsals; 3 points, swelling of the paws below the ankle joint; 4 points, swelling of all paws, including the ankle joint. The cumulative score for all four limbs is the arthritis index for each rat.

[0052] 0) Statistical processing Experimental data are expressed as mean ± standard deviation (x ± s). One-way ANOVA was performed using SPSS 22.0 software, and the minimum significance test was used for comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0053] 1) Experimental Results The results of the foot swelling test are shown in Table 1 below.

[0054] Table 1. Comparison of changes in paw swelling in different groups of rats (mL)

[0055] Note: Compared with the model control group, *P<0.05, **P<0.01.

[0056] As shown in the table, compared with the model control group, all treatment groups showed a certain inhibitory effect from day 7. With the extension of the treatment time, the inhibitory effect of the Example 2 group was the most significant and stable. On day 21 of treatment, its swelling degree was close to the level of the positive control group and significantly better than that of the comparative groups 1-4.

[0057] Comparative Example 1 showed acceptable results in the early stages, but the effect stalled on day 21, with significantly higher swelling than in Example 2. This indicates that beyond the preferred range of the invention, long-term efficacy is poor, and there may be risks of tolerance or side effects. The inhibitory effects of Comparative Examples 2-4 were significantly weaker than those of Example 2, with Comparative Example 2 showing the worst effect, indicating a synergistic effect between the components of the invention, enhancing efficacy.

[0058] The results of the Arthritis Index (AI) experiment are shown in Table 2 below.

[0059] Table 2 Comparison of Arthritis Index (AI) among Rats in Different Groups

[0060] Note: Compared with the model control group, *P<0.05, **P<0.01.

[0061] As shown in the table, Example 2 group performed best in reducing the systemic arthritis index. Throughout the experimental period, its AI value was significantly lower than that of the model control group and Comparative Examples 1-4, demonstrating its optimal therapeutic effect. The AI ​​values ​​of Comparative Examples 2-4 groups were higher than those of Example 2 group, indicating that replacing any one of the drugs would lead to a decrease in the overall efficacy, and that the formulation of this invention is a synergistic organic whole.

[0062] Experimental Example 2 1) Experimental materials Sample: Rats after Experiment 1. After the last administration, the rats were fasted but allowed free access to water for 12 hours.

[0063] Reagents: ELISA kit was purchased from Guangzhou Orida Biotechnology Co., Ltd.; RIPA tissue lysis buffer was purchased from Shanghai Xinyu Biotechnology Co., Ltd.; BCA protein concentration assay kit was purchased from Shanghai Lianmai Bioengineering Co., Ltd.

[0064] Instruments: Microplate reader; high-speed refrigerated centrifuge; tissue homogenizer.

[0065] 2) Experimental methods Synovial tissue collection: The rat was quickly dissected, and the synovial tissue of the right hind limb ankle joint was collected. The tissue was rinsed with pre-cooled physiological saline, dried with filter paper, weighed accurately, and stored in a -80°C refrigerator.

[0066] Detection of inflammatory factors in synovial tissue: An appropriate amount of synovial tissue was taken and added to pre-cooled PBS at a weight (g):volume (mL) ratio of 1:9. The tissue was then mechanically homogenized under ice-water bath conditions. The prepared 10% homogenate was centrifuged at 5000 rpm and 4℃ for 10 minutes, and the supernatant was collected. The total protein concentration in the supernatant was determined using the BCA method to correct for subsequent cytokine content. Following the ELISA kit instructions strictly, the tissue homogenate supernatant was used to detect IL-1β, IL-6, and TNF-α. The final results are expressed as picograms per milligram of protein (pg / mg prot).

[0067] 2) Statistical Analysis: Experimental data are expressed as mean ± standard deviation (x ± s). One-way ANOVA was performed using SPSS 22.0 software. The minimum significance test was used for comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0068] 3) Experimental Results The experimental results are shown in Table 3 below.

[0069] Table 3 Comparison of inflammatory factor levels in synovial tissue of rats in different groups

[0070] Note: Compared with the model control group, *P<0.05, **P<0.01 As shown in the table, the anti-inflammatory effect in local tissues was better in Example 2 group, with IL-1β, IL-6, and TNF-α levels lower than those in the positive control group and all comparative groups. This indicates that the powder of the present invention, administered through fumigation and washing, can efficiently accumulate at the lesion site and exert a local anti-inflammatory effect. All comparative groups showed inferior effects in synovial tissue compared to the Example 2 group. In particular, the decrease in inflammatory factor levels in synovial tissue in Comparative Group 2 and the Comparative Group was very small, showing only minor improvement compared to the model control group. This indicates that Phellodendron bark is the core drug for clearing damp-heat pathogens from the joints, while the blood-activating and meridian-clearing effects of Artemisia annua, which guides the drug directly to the lesion, are crucial for the distribution and efficacy of the drug in local tissues. The absence or substitution of either of these ingredients will lead to a loss of local therapeutic effect.

[0071] Experimental Example 3 1) General Information Based on the case data of Wu Zhengshi Dechangxiang Clinic from 2018 to 2022, a total of 200 patients with joint pain due to damp-heat obstruction were included.

[0072] 2) Diagnostic criteria: Western medicine diagnostic criteria: Refer to the diagnostic criteria for osteoarthritis or rheumatoid arthritis established by the American College of Rheumatology (ACR).

[0073] Traditional Chinese Medicine (TCM) diagnostic criteria: Refer to the "Damp-Heat Obstruction Syndrome" criteria in the "Guiding Principles for Clinical Research of New Chinese Herbal Drugs". Primary symptoms: Redness, swelling, burning pain in the joints; Secondary symptoms: Thirst without desire to drink, fever, yellow urine. Tongue and pulse: Red tongue with a yellow, greasy coating; slippery and rapid pulse.

[0074] 3) Inclusion criteria: Meets the diagnostic criteria of both traditional Chinese and Western medicine; Age 18-75; No other medications for treating arthritis were taken within one week prior to enrollment; Participants voluntarily participate in this study and sign an informed consent form.

[0075] 4) Exclusion criteria: Patients with severe heart, liver, kidney, or hematopoietic system diseases; pregnant or lactating women; patients with local skin damage or infection around joints; and patients allergic to any component of this product.

[0076] 5) Grouping and Treatment Methods: 200 eligible subjects were randomly divided into 3 groups. The invention group consisted of 100 subjects, who received the treatment described in the embodiment of this invention.

[0077] 2. Preparation of the fumigation and washing powder. Usage: Take one 80g packet, dissolve it in 1000 mL of 40℃ warm water, and fumigate and wash the affected area for 30 minutes each time, once daily, for 14 consecutive days. The control group (n=50) received the powder prepared in control example 2, using the same method as the present invention group. The positive control group (n=50) received commercially available diclofenac diethylamine emulsion, applied evenly to the affected area three times daily for 14 consecutive days. There were no statistically significant differences in baseline data such as age, gender, disease duration, and pre-treatment VAS scores among the three groups, making them comparable.

[0078] 6) Observation indicators Visual Analogue Scale (VAS): Before treatment and on day 14 of treatment, the same physician, unaware of the patient's grouping, guides the patient to mark their pain level on the same VAS card. VAS card: A 10cm long straight line, with 0 indicating "no pain" and 10 indicating "severe pain," and the score is recorded.

[0079] Morning stiffness duration: Record the duration (in minutes) of joint stiffness felt by the patient each morning after waking up.

[0080] Safety evaluation: Blood and urine routine tests and liver and kidney function tests were performed before and after treatment; all treatment-related adverse reactions (such as skin allergies, irritation, etc.) were closely observed and recorded.

[0081] 7) Statistical processing Data analysis was performed using SPSS 22.0 software. Quantitative data were expressed as mean ± standard deviation (x ± s). Paired t-tests were used for comparisons within a group before and after treatment, one-way ANOVA was used for comparisons among multiple groups, and the least significant difference method was used for pairwise comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0082] 8) Results The scoring comparison results are shown in Table 4.

[0083] Table 4 Comparison of VAS scores and morning stiffness duration before and after treatment in each group of patients.

[0084] Note: Compared with the present invention group, *P<0.05, **P<0.01.

[0085] As shown in the table, the VAS scores of all three groups of patients decreased significantly after treatment compared to before treatment. The VAS score of the invention group decreased the most, with an average decrease of 3.7 points, and its efficacy was comparable to that of the positive control group.

[0086] The VAS score improvement in the comparative group was lower than that in the invention group, with an average decrease of only 1.9 points. This indicates that the combined formulations of the invention have a synergistic effect.

[0087] Consistent with the VAS score trend, the invention group showed the best effect in shortening morning stiffness time, comparable to the positive control group and significantly better than the comparative group. This indicates that the invention not only relieves pain but also effectively improves joint function.

[0088] During treatment, two patients in the invention group experienced mild local skin redness and itching, which disappeared spontaneously after the fumigation time was shortened to 20 minutes and did not affect subsequent treatment. One patient in the positive control group reported a mild burning sensation at the application site. No clinically significant abnormalities were observed in blood and urine routine tests, or in liver and kidney function indicators in any group before and after treatment. The results indicate that the powder of this invention has good safety, with few and mild adverse reactions.

[0089] The above description of the embodiments is only for understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from the principles of the invention, and these improvements and modifications will also fall within the protection scope of the claims of the present invention.

[0090] [1] Fan Dongsheng, Li Ling, Wang Keke, et al. Research progress on chemical constituents and pharmacological activities of Artemisia annua [J]. China Pharmacy, 2022, 33(10):1274-1280. [2] He Xianfang, Wang Wanlin, Wang Hongying, et al. Aina oil alleviates LPS-induced macrophage inflammatory response by influencing arachidonic acid metabolism through NF-κB nonclassical signaling [J]. Journal of Sun Yat-sen University (Medical Sciences), 2024, 45(02):216-225. [3] Han, Sirui. Research progress on the application of Phellodendron bark and Coptis chinensis in radiation-induced skin injury protection [J]. Practical Electrocardiography and Clinical Diagnosis and Treatment, 2025, 34(02):291-295. [4] Wang Fei, Wu Xiaoyu, Chen Shuting, et al. Research progress in the pharmacology of menthol [J]. Anhui Agricultural Science Bulletin, 2025, 31(16):82-88. [5] Liu Wenbin, Huang Zhao, Wang Hui. Menthol promotes permeation by regulating the concentration of calcium ions in keratinocytes [J]. Chinese Journal of Pharmacology, 2023, 39(01):23-28.

Claims

1. A traditional Chinese medicine composition for preventing and treating rheumatic fever, characterized in that, It is composed of the following raw materials in parts by weight: 10-30 parts of Phellodendron bark, 5-20 parts of peppermint, 3-8 parts of Coptis chinensis, and 5-20 parts of Artemisia argyi.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: 15-25 parts of Phellodendron bark, 5-15 parts of peppermint, 3-5 parts of Coptis chinensis, and 5-15 parts of Artemisia argyi.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: 20 parts of Phellodendron bark, 10 parts of peppermint, 5 parts of Coptis chinensis, and 10 parts of Artemisia argyi.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The composition is in the form of a powder.

5. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: a) Clean and select Phellodendron bark, peppermint, Coptis chinensis, and Artemisia argyi separately; b) Dry the cleaned medicinal materials to a moisture content of ≤10%; c) Grind the dried medicinal materials to 80-120 mesh; d) Mix the ground medicinal materials evenly according to the proportions described in any one of claims 1-3 to obtain the final product.

6. The method according to claim 5, characterized in that, The drying temperature in step b) is 40-70℃; in step d), a three-dimensional motion mixer is used to mix for 15-25 minutes.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of an external medicine for the prevention and treatment of rheumatic fever.

8. The use according to claim 7, characterized in that, The rheumatic fever is characterized by redness, swelling, heat and pain in the joints. The diseases include rheumatoid arthritis, osteoarthritis, or gouty arthritis.

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