Preparation method of traditional Chinese medicine transdermal patch for treating rheumatic arthritis

Abstract

The invention relates to a preparation method of a traditional Chinese medicine transdermal patch for treating rheumatic arthritis, which can effectively solve the problems of long-acting effect, stability, good effect and medication for treating rheumatic arthritis in the preparation of a new traditional Chinese medicine transdermal patch, and is prepared from a traditional Chinese medicine compound, a matrix and a penetration enhancer, the traditional Chinese medicine compound and the matrix are prepared from radix angelicae pubescentis, radix saposhnikoviae, radix gentianae macrophyllae, ligusticum wallichii, angelica sinensis, garden balsam stem, radix paeoniae rubra, notopterygium root, hydrogel and glycerol; the penetration enhancer is composed of menthol, borneol, artificial musk and the balance of deionized water, the raw materials are extracted firstly, then nano particles are prepared, a first mixture is prepared, a second mixture is prepared, the pH value is adjusted, coating is conducted, and the traditional Chinese medicine transdermal patch for treating rheumatic arthritis is obtained. The patch is scientific and reasonable in components, convenient to paste, good in effect, capable of stably releasing effective components of the medicine for a long time, high in targeting property, capable of continuously relieving the symptoms of the rheumatic arthritis and ensuring the curative effect, is a great innovation in the aspect of medicines for treating the rheumatic arthritis, and is remarkable in economic and social benefits.

Description

Technical Field

[0001] The present invention relates to medicine, in particular to a method for preparing a Chinese medicine transdermal patch for treating rheumatoid arthritis. Background Art

[0002] Rheumatoid arthritis is a common and frequently occurring disease. It is an autoimmune reactive disease caused by untreated group A Streptococcus (GAS) infection in genetically susceptible hosts. It mainly targets the synovium of the joints and invades the small joints of the hands and feet, most commonly affecting the metacarpophalangeal joints, proximal interphalangeal joints, and metatarsophalangeal joints.

[0003] Rheumatoid arthritis is a migratory, multiple joint disease that mainly affects the knees, ankles, elbows, wrists, shoulders and other large joints. There may be local redness, swelling, heat, pain and tenderness, which may be accompanied by exudation but no suppuration. Joint pain usually subsides within 2 weeks, and there is no residual deformation after the attack, but it often recurs. Symptoms may appear or worsen when the weather turns cold or it is rainy, seriously affecting people's physical health and quality of life. In recent years, research on rheumatoid arthritis has continued to deepen, involving the innovation of its pathogenesis, diagnostic technology and therapeutic drugs. Although there are many drugs for the treatment of rheumatoid arthritis, such as traditional Chinese medicine patches for the treatment of rheumatoid arthritis and "a transdermal patch containing azone" with patent number 201810254988.2, due to problems with the components and preparation methods, their practical application is not satisfactory, mainly reflected in: 1. Traditional Chinese medicine patches for rheumatoid arthritis have low transdermal absorption efficiency, and a large amount of drugs cannot effectively enter the human body to exert their effects, resulting in insufficient drug bioavailability; 2. Traditional Chinese medicine has complex ingredients. Some active ingredients have difficulty penetrating the skin barrier due to their large molecular weight or strong hydrophilicity, thus affecting the therapeutic effect. 3. The penetration enhancers used in existing penetration enhancement technologies, such as some chemically synthesized penetration enhancers, may cause skin irritation or allergic reactions, limiting their clinical application; 4. The release rate of the drug in the patch is difficult to control, and long-term and stable drug release cannot be achieved, making it difficult to continuously relieve the symptoms of rheumatoid arthritis, thus affecting the efficacy of the drug.

[0004] Therefore, developing a new Chinese medicine transdermal patch for treating rheumatoid arthritis is a technical problem that needs to be seriously addressed. Summary of the Invention

[0005] In view of the above situation, in order to overcome the shortcomings of the existing technology, the purpose of the present invention is to provide a method for preparing a Chinese medicine transdermal patch for treating rheumatoid arthritis, which can effectively solve the problem of preparing a new Chinese medicine transdermal patch, ensuring long-term, stable and effective medication for treating rheumatoid arthritis.

[0006] The technical solution provided by the present invention is a method for preparing a transdermal patch of traditional Chinese medicine for treating rheumatoid arthritis. The transdermal patch is made of a traditional Chinese medicine compound, a matrix and a penetration enhancer. The traditional Chinese medicine compound and the matrix are calculated by weight percentage as follows: A Chinese herbal compound comprises: 11-13% angelica dahurica, 7-9% siler, 5-7% gentiana macrophylla, 6-8% ligusticum chuanxiong, 6-8% angelica sinensis, 6-8% radix scutellariae, 4-6% red peony root, and 2-4% notopterygium wilfordii; a matrix comprises 38-42% aqueous gel and 4-6% glycerol, the total amount of the Chinese herbal compound and the matrix being 100%; the aqueous gel is carbomer; the penetration enhancer comprises, by weight percentage, 2.5-3.5% menthol, 1.5-2.5% borneol, 0.4-0.6% artificial musk, and the balance being deionized water; the amount of the penetration enhancer is 10% of the total amount of the Chinese herbal compound and the matrix. The preparation method is as follows: 1. Extraction of active ingredients of traditional Chinese medicine compound: Wash and grind Angelica dahurica, Radix Saposhnikoviae radix, Radix Gentianae macrophyllae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Herba Polygoni Multiflori, Radix Paeoniae Rubrae, and Radix Notopterygii, pass through a 40-mesh sieve, mix well, and extract the active ingredients by supercritical carbon dioxide extraction (known technology). The extraction conditions are: pressure 25 MPa, temperature 45°C, CO2 flow rate 20 L / h, and extraction time 2 hours to obtain the active ingredient extract of traditional Chinese medicine; 2. Preparation of nanoparticles: Poly(lactic-co-glycolic acid) (PLGA) nanoparticles were used to encapsulate the active ingredients of traditional Chinese medicine. The PLGA was dissolved in dichloromethane and mixed with the extract of the active ingredients of the traditional Chinese medicine. The mixture was then ultrasonically emulsified at a power of 500W for 10 minutes. The solvent was then evaporated and centrifuged. The solvent was evaporated using a rotary evaporator at a speed of 60 rpm and a temperature of 30°C to remove the dichloromethane. Nanoparticles with a particle size of 100-200 nm were prepared. The high specific surface area of these nanoparticles can significantly improve the dispersibility and transdermal ability of the drug. 3. Nanoparticles prepared from the extract of the active ingredient of traditional Chinese medicine, menthol, borneol, and artificial musk were placed in 95% ethanol by volume and ultrasonically dispersed for 30 minutes under the following conditions: power 300 W, frequency 40 kHz, to obtain a first drug-penetration enhancer mixture; 4. Add the aqueous gel and glycerol to deionized water and stir evenly to form a matrix solution. Slowly add the first drug-permeation enhancer mixture to the matrix solution and continue stirring until the mixture is evenly mixed to form a second mixture. 5. The second mixture uses methacrylic acid-ethyl acrylate copolymer (Eudragit L100-55) as a pH-responsive material, with the pH adjusted to 5.5-7.4 to match the acidic microenvironment (pH 5.5-6.0) of rheumatoid arthritis lesions. This ensures rapid drug release in the target area while minimizing exposure to normal tissue. Since the pH of rheumatoid arthritis lesions is 5.5-6.0 (normal tissue pH is approximately 7.4), the material dissolves in the acidic environment, accelerating drug release. 6. The mixed material is coated on a 0.2 mm thick polyethylene-aluminum foil composite backing layer to a thickness of 0.5-1 mm. A scraper is used to control the uniformity with an error of ±0.1 mm. The mixture is dried at 40°C for 2 hours. After drying, it is covered with a controlled release film to control the drug release rate and achieve long-term sustained release. This is to obtain a Chinese medicine transdermal patch for the treatment of rheumatoid arthritis.

[0007] The components of the present invention are scientific and reasonable, and are made into a Chinese medicine transdermal patch for treating rheumatoid arthritis through a specific preparation method. The patch is easy to use and has good effects. It releases the active ingredients of the drug in a long-term and stable manner, has strong targeting, continuously relieves the symptoms of rheumatoid arthritis, and ensures therapeutic effects. It is a major innovation in the treatment of rheumatoid arthritis and has significant economic and social benefits. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a process flow chart of the present invention; Figure 2 Schematic diagram of the pharmacological action mechanism of the present invention; Figure 3 HPLC analysis chart of the Chinese herbal penetration enhancer of the present invention (menthol: TRPM8 cation channel agonist, enhancing transmembrane transport; borneol: P-glycoprotein inhibitor, reducing drug efflux; artificial musk: nanostructured carrier, achieving sustained release); Figure 4 This is a comparison chart of the transdermal absorption effect of the present invention; Figure 5 Graph showing in vitro release characteristics of the transdermal patch of the present invention. DETAILED DESCRIPTION

[0009] The specific implementation methods of the present invention are described in detail below with reference to examples and specific situations. Example

[0010] A method for preparing a Chinese medicine transdermal patch for treating rheumatoid arthritis. The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix, and a penetration enhancer. The Chinese medicine compound and the matrix are expressed in weight percentages as follows: The Chinese herbal compound comprises: 12% of Angelica dahurica, 8% of Saposhnikovia divaricata, 6% of Gentiana macrophylla, 7% of Ligusticum chuanxiong, 7% of Angelica sinensis, 7% of Radix scutellariae, 5% of Radix Paeoniae Rubra and 3% of Notopterygium wilfordii; the matrix comprises 40% of aqueous gel and 5% of glycerol; the penetration enhancer comprises 3% of menthol, 2% of borneol, 0.5% of artificial musk and 94.5% of deionized water in weight percentage; the amount of the penetration enhancer is 10% of the total amount of the Chinese herbal compound and the matrix; the preparation method is as follows (see Figure 1 ): 1. Extraction of active ingredients of traditional Chinese medicine compound: Wash and grind Angelica dahurica, Radix Saposhnikoviae radix, Radix Gentianae macrophyllae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Herba Polygoni Multiflori, Radix Paeoniae Rubrae, and Radix Notopterygii, pass through a 40-mesh sieve, mix well, and extract the active ingredients by supercritical carbon dioxide extraction. The extraction conditions are: pressure 25 MPa, temperature 45°C, CO2 flow rate 20 L / h, and extraction time 2 hours to obtain the active ingredient extract of traditional Chinese medicine; 2. Preparation of nanoparticles: Poly(lactic-co-glycolic acid) (PLGA) nanoparticles were used to encapsulate the active ingredients of traditional Chinese medicine. The PLGA was dissolved in dichloromethane and mixed with the extract of the active ingredients of the traditional Chinese medicine. The mixture was then ultrasonically emulsified at a power of 500W for 10 minutes. The solvent was then evaporated and centrifuged. The solvent was evaporated using a rotary evaporator at a speed of 60 rpm and a temperature of 30°C to remove the dichloromethane. Nanoparticles with a particle size of 100-200 nm were prepared. The high specific surface area of these nanoparticles can significantly improve the dispersibility and transdermal ability of the drug. 3. Nanoparticles prepared from the extract of the active ingredient of traditional Chinese medicine, menthol, borneol, and artificial musk were placed in 95% ethanol by volume and ultrasonically dispersed for 30 minutes under the following conditions: power 300 W, frequency 40 kHz, to obtain a first drug-penetration enhancer mixture; 4. Add the aqueous gel and glycerol to deionized water and stir evenly to form a matrix solution. Slowly add the first drug-permeation enhancer mixture to the matrix solution and continue stirring until the mixture is evenly mixed to form a second mixture. 5. The second mixture uses methacrylic acid-ethyl acrylate copolymer (Eudragit L100-55) as a pH-responsive material, with the pH adjusted to 5.5-7.4 to match the acidic microenvironment (pH 5.5-6.0) of rheumatoid arthritis lesions. This ensures rapid drug release in the target area while minimizing exposure to normal tissue. Since the pH of rheumatoid arthritis lesions is 5.5-6.0 (normal tissue pH is approximately 7.4), the material dissolves in the acidic environment, accelerating drug release. 6. The mixed material is coated on a 0.2 mm thick polyethylene-aluminum foil composite backing layer to a thickness of 0.5-1 mm. A scraper is used to control the uniformity with an error of ±0.1 mm. The mixture is dried at 40°C for 2 hours. After drying, it is covered with a controlled release film to control the drug release rate and achieve long-term sustained release. This is to obtain a Chinese medicine transdermal patch for the treatment of rheumatoid arthritis. Example

[0011] A method for preparing a Chinese medicine transdermal patch for treating rheumatoid arthritis. The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix, and a penetration enhancer. The Chinese medicine compound and the matrix are expressed in weight percentages as follows: The Chinese herbal compound comprises: 13% of Angelica dahurica, 9% of Saposhnikovia divaricata, 7% of Gentiana macrophylla, 8% of Ligusticum chuanxiong, 8% of Angelica sinensis, 7% of Herba scutellariae baicalensis, 4% of Paeonia lactiflora and 2% of Notopterygium wilfordii; the matrix comprises 38% of aqueous gel and 4% of glycerol; the penetration enhancer comprises, by weight percentage, 2.5% of menthol, 2.5% of borneol, 0.4% of artificial musk and 94.6% of deionized water. Example

[0012] A method for preparing a Chinese medicine transdermal patch for treating rheumatoid arthritis. The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix, and a penetration enhancer. The Chinese medicine compound and the matrix are expressed in weight percentages as follows: The Chinese herbal compound comprises: 11% of Angelica dahurica, 7% of Saposhnikovia divaricata, 5% of Gentiana macrophylla, 6% of Ligusticum chuanxiong, 7% of Angelica sinensis, 6% of Herba schizonepetae, 6% of Paeonia lactiflora and 4% of Notopterygium wilfordii; the matrix comprises 42% of aqueous gel and 6% of glycerol; the penetration enhancer comprises, by weight percentage, 3.5% of menthol, 1.5% of borneol, 0.6% of artificial musk and 94.4% of deionized water.

[0013] According to the composition given in the above embodiment, any amount of Chinese medicine can be prepared as needed. The examples given are only used to illustrate the specific implementation methods of the present invention, and are not used to limit the scope of protection of the present invention. The technical core protected by the present invention is the Chinese medicine composition, which can be prepared in any amount according to actual needs.

[0014] In the above-mentioned drug combinations, wherein: Duhuo: slightly warm in nature, pungent and bitter in taste, enters the kidney meridian and bladder meridian, dispels wind and dampness, relieves numbness and relieves pain.

[0015] Saposhnikovia divaricata: warm in nature, pungent and bitter in taste, enters the bladder meridian, liver meridian and kidney meridian, dispels wind, removes dampness, detoxifies and relieves pain.

[0016] Gentiana macrophylla: It is neutral in nature, bitter and spicy in taste, and enters the stomach meridian, liver meridian, and gallbladder meridian. It can dispel rheumatism, reduce fever, relax muscles and relieve pain.

[0017] Chuanxiong: warm in nature, pungent in taste, enters the liver meridian, gallbladder meridian, and pericardium meridian, promotes blood circulation and qi, dispels wind and relieves pain.

[0018] Angelica: warm in nature, sweet and spicy in taste, enters the liver meridian, heart meridian, and spleen meridian, replenishes blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements.

[0019] Radix Polygoni Multiflori: warm in nature, pungent in taste, enters the kidney meridian and liver meridian, dispels wind and dampness, relaxes muscles and activates blood circulation, disperses blood stasis and reduces swelling, detoxifies and relieves pain.

[0020] Red Peony Root: slightly cold in nature, bitter in taste, enters the Liver and Spleen Meridians, clears heat and cools blood, disperses blood stasis and relieves pain.

[0021] Qianghuo: warm in nature, pungent and bitter in taste, enters the bladder meridian and kidney meridian, relieves exterior symptoms, dispels cold, dispels wind and dampness, and relieves pain.

[0022] Aqueous gel (carbomer): It is composed of a solid phase (i.e., matrix - carbomer) and a liquid phase (water) as a dispersion medium. Based on its hydrogel properties, this product can adhere to the surface of the cornea and store liquid. The structure of the gel will be destroyed by the salt in the tears, releasing the water in it.

[0023] Glycerin: also known as propylene glycol, a humectant in pharmaceutical formulations, is a colorless, odorless, sweet-tasting viscous liquid. Due to its three hydroxyl groups, glycerin is miscible with water and is hygroscopic.

[0024] Menthol: also called menthol, is used as a stimulant in medicine, acting on the skin or mucous membranes, and has a cooling and antipruritic effect.

[0025] Borneol: cold in nature, pungent and bitter in taste, enters the heart meridian, spleen meridian and lung meridian, opens the orifices and refreshes the mind, clears heat and relieves pain.

[0026] Artificial musk: warm in nature, pungent in taste, enters the heart meridian and spleen meridian, opens the orifices and refreshes the mind, promotes blood circulation and menstruation, reduces swelling and relieves pain.

[0027] According to the principles of traditional Chinese medicine, the above-mentioned Chinese medicinal components are classified into the main and secondary roles, the monarch, the minister, the assistant and the envoy, and are functionally related and mutually compatible to exert their effects. In the prescription, Duhuo is the monarch, which is pungent, dispersing, bitter and dry, warming in nature, and good at relieving rheumatic pain in the lower body, especially pain in the waist, knees and joints. It is an important medicine for treating rheumatic pain. With Fangfeng and Qianghuo as the ministers, Fangfeng is a "wind-removing and moistening agent" that dispels cold without drying out, removes dampness from the surface, and helps Duhuo dispel the evil in the skin surface meridians. Qianghuo has a strong smell and is good at treating pain in the shoulders, back and limbs. When used with Duhuo, it can treat both upper and lower parts of the body and expand the scope of expelling evil. Gentiana macrophylla, amphibians, Chuanxiong, Chinese angelica, and red peony root are used as adjuvant drugs. Gentiana macrophylla clears away heat and relaxes tendons and muscles, while amphibians specializes in rheumatism between tendons and bones. The two penetrate deeply into the meridians to relieve stubborn pain. Chuanxiong promotes qi and blood circulation, Chinese angelica replenishes blood and moistens dryness, while red peony root cools blood and disperses blood stasis. The three harmonize the blood and prevent rheumatism from causing blood stasis over a long period of time, and prevent warm and dry drugs from damaging yin and blood, embodying the idea of "treating wind by treating blood first" and achieving a synergistic effect. To guide the drugs: Chuanxiong "goes up to the head and down to the blood sea", and amphibians "penetrates the tendons and bones". The two lead the drugs to the diseased area and enhance targeting.

[0028] The combination of various drugs has the functions of dispelling wind and dampness, promoting blood circulation and unblocking meridians, and taking into account nourishing blood and nourishing, and is effectively combined with the matrix and penetration enhancer. It is effective in treating rheumatoid arthritis for external use, has good efficacy, high efficiency, no toxic side effects, and a short cycle. It has achieved very good beneficial technical effects through experiments. The relevant test materials are as follows (taking Example 1 as an example): 1. Animal Experiments Sixty SD rats of similar weight were randomly divided into three groups, with 20 rats in each group. A rat rheumatoid arthritis model was established by injection of Freund's complete adjuvant.

[0029] Control group: administered with a Chinese herbal compound patch without a penetration enhancer (the formulation was the same as in Example 1, with the penetration enhancer removed).

[0030] Experimental group 1: The Chinese herbal compound muscle-soothing and bone-penetrating patch prepared in Example 1 was administered.

[0031] Experimental group 2: XX brand rheumatism patch (patent number CN202080016834.5 (patent name: a transdermal patch containing azone-containing chemical penetration enhancer)).

[0032] The rats were administered the drug daily for 14 consecutive days, with joint swelling and pain responses (measured by pressure pain threshold) observed daily. Following the experiment, joint tissue was obtained for pathological examination, and serum levels of inflammatory factors, such as tumor necrosis factor α (TNF-α) and interleukin 1β (IL-1β), were measured.

[0033] Related pharmacological mechanisms and penetration enhancer HPLC analysis are shown in Figure 2 、 3 The transdermal absorption effect is compared with the in vitro release characteristic curve of the transdermal patch of the present invention. Figure 4 、 5 .

[0034] 2. Experimental Results Joint swelling degree: The joint swelling degree of rats in experimental group 1 was significantly lower than that in the control group and experimental group 2. On the 7th and 14th days after administration, the joint swelling rates of experimental group 1 were 15% and 8%, respectively, those of the control group were 25% and 15%, and those of experimental group 2 were 22% and 12%.

[0035] Pain response: The pressure pain threshold of rats in experimental group 1 was significantly higher than that in the control group and experimental group 2, indicating that the patch in experimental group 1 was more effective in relieving pain.

[0036] Pathological section observation: The pathological changes such as inflammatory cell infiltration and synovial hyperplasia in the joint tissue of rats in experimental group 1 were significantly alleviated, which was better than that in the control group and experimental group 2.

[0037] Serum inflammatory factor levels: The levels of tumor necrosis factor α (TNF-α) and interleukin 1β (IL-1β) in the serum of experimental group 1 were significantly lower than those in the control group and experimental group 2, indicating that the anti-inflammatory effect of the patch in experimental group 1 was more prominent.

[0038] 3. Conclusion Experimental results show that the patch of the present invention with the addition of a Chinese medicine compound penetration enhancer has a more significant therapeutic effect in treating rheumatoid arthritis than a patch of a simple Chinese medicine composition and a traditional Chinese medicine patch. Compared with the existing technology, it has the following outstanding beneficial technical effects: 1. Improved transdermal efficiency: Verified by the SD rat model experiment, the transdermal rate of this patch is more than 40% higher than that of traditional Chinese medicine patches. "The transdermal rate of experimental group 1 is 252 mg / cm²·h, which is significantly higher than the transdermal rate of commercially available products (180 mg / cm²·h) (data source: "Chinese Journal of Pharmacy" 2023, Vol. 21, Issue 5)", which can enable more effective ingredients of traditional Chinese medicine to enter the human body and take effect.

[0039] 2. Reduced skin irritation: The product uses a natural herbal compound penetration enhancer, avoiding the use of chemical penetration enhancers, reducing the risk of skin irritation and allergies. A clinical trial (sample size N=200, approved by the Ethics Committee of Kaifeng Xiangfu District Traditional Chinese Medicine Hospital, batch number: 2023-ETH-001) showed an allergy rate of only 1.0% (2 cases / 200 cases), significantly lower than the 3%-5% of commercially available products (data source: "Safety Assessment Report on Traditional Chinese Medicine Transdermal Patch" (2023), jointly completed by Kaifeng Xiangfu District Traditional Chinese Medicine Hospital and Henan University of Traditional Chinese Medicine). 3. Achieve precise controlled release: Through the synergistic effect of the controlled-release membrane layer (pore size 50-100nm) and the acid-base responsive material (pH 5.5-7.4 sensitive), the 24-hour cumulative release rate of the drug in the lesion area (pH 5.5-6.0) reaches 92.3±2.1%, while the normal tissue area (pH 7.4) releases only 28.5±3.4% (n=6).

[0040] 4. Enhanced therapeutic effect: Nanoparticle encapsulation technology and pH-responsive targeted release mechanism enable drugs to act more accurately on the lesion site, improving the targetedness and effectiveness of treatment.

[0041] While conducting experiments on Example 1, the same experiments were also conducted on other examples, and the same or similar structures were obtained in all of them, which will not be described in detail here.

[0042] It should be noted that the above are only embodiments, which are used to illustrate the specific implementation of the present invention, rather than to limit the scope of protection of the present invention. Any technical solutions that are essentially the same as those of the present application and are made by using equivalent replacement means shall fall within the scope of protection of the present invention.

Claims

1. A method for preparing a transdermal patch of traditional Chinese medicine for treating rheumatoid arthritis, characterized in that: The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix and a penetration enhancer. The Chinese medicine compound and the matrix are calculated by weight percentage: The Chinese herbal compound comprises: 12% of Angelica dahurica, 8% of Saposhnikovia divaricata, 6% of Gentiana macrophylla, 7% of Ligusticum chuanxiong, 7% of Angelica sinensis, 7% of Radix scutellariae, 5% of Paeonia lactiflora and 3% of Notopterygium wilfordii; the matrix comprises: 40% of aqueous gel and 5% of glycerin; the penetration enhancer comprises, by weight percentage, 3% of menthol, 2% of borneol, 0.5% of artificial musk and 94.5% of deionized water; the amount of the penetration enhancer is 10% of the total amount of the Chinese herbal compound and the matrix. The preparation method is as follows: (1) Extraction of active ingredients of Chinese herbal compound: Wash and crush Angelica dahurica, Radix Saposhnikoviae, Radix Gentianae, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Herba Polygoni Multiflori, Radix Paeoniae Rubra and Radix Notopterygii, pass through a 40-mesh sieve, mix evenly, and extract the active ingredients by supercritical carbon dioxide extraction. The extraction conditions are: pressure 25 MPa, temperature 45°C, CO2 flow rate 20 L / h, and time 2 hours to obtain the active ingredient extract of Chinese herbal compound; (2) Preparation of nanoparticles: Polylactic acid-glycolic acid copolymer nanoparticles are used to encapsulate the active ingredients of traditional Chinese medicine. The polylactic acid-glycolic acid copolymer is dissolved in dichloromethane and mixed with the extract of the active ingredients of traditional Chinese medicine. The mixture is subjected to ultrasonic emulsification treatment at a power of 500W for 10 minutes, and then the solvent is evaporated and centrifuged. The solvent is evaporated using a rotary evaporator at a speed of 60rpm and a temperature of 30℃ to remove dichloromethane, thereby preparing nanoparticles with a particle size of 100~200 nm. The high specific surface area characteristics of these nanoparticles can significantly improve the dispersibility and transdermal ability of the drug. (3) Place the nanoparticles made from the extract of the active ingredient of traditional Chinese medicine, menthol, borneol, and artificial musk in ethanol with a volume concentration of 95%, and ultrasonically disperse them for 30 minutes. The ultrasonic dispersion conditions are: power 300W, frequency 40kHz, to obtain the first drug-penetration enhancer mixture; (4) Add the aqueous gel and glycerol to deionized water and stir evenly to form a matrix solution. Slowly add the first drug-permeation enhancer mixture to the matrix solution and continue stirring until the mixture is evenly mixed to form a second mixture. (5) The second mixture uses methacrylic acid-ethyl acrylate copolymer as a pH-responsive material, and the pH value is adjusted to the range of 5.5-7.4 to match the acidic microenvironment of the rheumatoid arthritis lesion site, which can ensure the rapid release of the drug in the target area while reducing the risk of exposure to normal tissues. Since the pH value of the rheumatoid arthritis lesion site is 5.5-6.0, the material dissolves in the acidic environment, thereby accelerating the release of the drug; (6) The mixed material is coated on a polyethylene-aluminum foil composite backing layer with a thickness of 0.2 mm. The material coating thickness is 0.5-1 mm. A scraper is used to control the uniformity with an error of ±0.1 mm. The mixed material is dried at 40°C for 2 hours. After drying, it is covered with a controlled release film to control the drug release rate and achieve long-term sustained release. The Chinese medicine transdermal patch for treating rheumatoid arthritis is thus obtained.

2. The method for preparing the transdermal Chinese medicine patch for treating rheumatoid arthritis according to claim 1, wherein: The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix and a penetration enhancer. The Chinese medicine compound and the matrix are calculated by weight percentage: The Chinese herbal compound comprises: 13% of Angelica dahurica, 9% of Saposhnikovia divaricata, 7% of Gentiana macrophylla, 8% of Ligusticum chuanxiong, 8% of Angelica sinensis, 7% of Herba scutellariae baicalensis, 4% of Paeonia lactiflora and 2% of Notopterygium wilfordii; the matrix comprises 38% of aqueous gel and 4% of glycerol; the penetration enhancer comprises, by weight percentage, 2.5% of menthol, 2.5% of borneol, 0.4% of artificial musk and 94.6% of deionized water.

3. The method for preparing the transdermal patch of traditional Chinese medicine for treating rheumatoid arthritis according to claim 1, wherein: The Chinese medicine transdermal patch is made of a Chinese medicine compound, a matrix and a penetration enhancer. The Chinese medicine compound and the matrix are calculated by weight percentage: The Chinese herbal compound comprises: 11% of Angelica dahurica, 7% of Saposhnikovia divaricata, 5% of Gentiana macrophylla, 6% of Ligusticum chuanxiong, 7% of Angelica sinensis, 6% of Herba schizonepetae, 6% of Paeonia lactiflora and 4% of Notopterygium wilfordii; the matrix comprises 42% of aqueous gel and 6% of glycerol; the penetration enhancer comprises, by weight percentage, 3.5% of menthol, 1.5% of borneol, 0.6% of artificial musk and 94.4% of deionized water.

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