Anti-inflammatory and analgesic patch containing traditional Chinese medicines and preparation method thereof

Abstract

The invention provides an anti-inflammatory analgesic patch containing traditional Chinese medicines, the preparation is composed of a backing layer, a medicine storage layer and a protective layer, the medicine storage layer contains 5-60% of traditional Chinese medicine extract, 10-70% of a pressure-sensitive adhesive, 0-50% of a tackifier, 0-50% of a plasticizer, 0-5% of an antioxidant, 0-5% of an anti-aging agent, 0-20% of a transdermal enhancer and the like. The traditional Chinese medicine anti-inflammatory and analgesic patch provided by the invention is safe, effective, good in compliance, non-irritant, good in adhesion, convenient to use and remarkable in curative effect.

Description

Technical Field

[0001] The invention relates to a patch, in particular to an anti-inflammatory and analgesic patch containing traditional Chinese medicine. Background Art

[0002] Aconitum is the dried root of Aconitum kusnezoffii of the Ranunculaceae family. It tastes pungent and bitter, and enters the heart, liver, and kidney meridians. It has the effects of killing stickiness, drying yellow water, and relieving pain. It is one of the commonly used medicinal materials of the Mongolian people. The chemical components of Aconitum kusnezoffii are mainly alkaloid compounds, which can be divided into diester alkaloids and monoester alkaloids according to their structure. Among them, diester alkaloids have pharmacological effects such as analgesia, anti-inflammatory and cardiotonic. Terminalia chebula is the dried mature fruit of Terminalia chebula of the Combretaceae family. It tastes bitter and sour, and enters the lung and large intestine meridians. It has the effects of antibacterial, anti-inflammatory, digestive and detoxification, and is known as the king of Mongolian medicine. Mongolian doctors believe that the role of Terminalia chebula in Mongolian medicine is equivalent to that of Chinese medicine licorice. Terminalia chebula is not only commonly used in processing, but also commonly seen in many classic Mongolian medicine prescriptions, which shows its wide application and great effect. The 19th century "Mongolian Medicine Canon" pointed out that "Termia chebula must be used in prescriptions containing Aconitum kusnezoffii." According to statistics, 100% of the prescriptions containing Aconitum recorded in the Mongolian Medical Prescriptions contain Terminalia chebula. Piper longum L. is a perennial herbaceous climbing vine of the Piper family. Its dried nearly mature or mature fruit ears are used as medicine. Piper longum tastes spicy and warm, and is non-toxic. Its main function is analgesia. It is often used to treat abdominal pain caused by stomach cold, diarrhea, angina pectoris caused by coronary heart disease, vomiting acid water and other diseases.

[0003] Terminalia chebula, aconite and Piper longum are traditional Chinese medicines used for anti-inflammatory and analgesic purposes, and are mainly taken orally, applied externally or in traditional plasters. When taken orally, the onset of action is slow, especially when used for inflammatory and painful diseases of human joints and surrounding tissues such as arthritis, the pain cannot be relieved quickly. In addition, there are first-pass liver effect and gastrointestinal inactivation. External application and traditional plaster administration have the defects of inconvenient medication, difficult cleaning and large toxic and side effects. Therefore, it is urgent to improve the duration of action, safety and convenience of medication through appropriate pharmaceutics. Patches, as transdermal drug delivery preparations, can act directly on the painful area, have quick effect, are convenient and comfortable to apply, easy to remove and clean, have few toxic and side effects, and avoid the adverse reactions of gastrointestinal administration, which can meet the needs well.

[0004] Patches refer to thin, flexible preparations made of raw materials and suitable materials for application on the skin, which can produce systemic or local effects. Compared with ordinary drug preparations, patches, as a new type of transdermal drug delivery system, have good compliance; avoid the first-pass effect of the liver and gastrointestinal inactivation, thereby improving the therapeutic effect; prolong the drug action time, reduce the number of medications, and are easy to administer and stop; control the constant and persistent entry of drugs into the human circulation, give full play to the efficacy, and reduce the many advantages of adverse drug reactions. Compared with traditional plasters, patches have the advantages of being able to be repeatedly removed and pasted, and having less skin irritation and allergies. Therefore, in the current market where the administration of traditional Chinese medicine is single and has serious side effects, an anti-inflammatory and analgesic patch containing traditional Chinese medicine has become a dosage form of traditional Chinese medicine that people hope to achieve. Summary of the invention

[0005] The purpose of the present invention is to provide a safe, effective, compliant, non-irritating, and non-sticky anti-inflammatory and analgesic patch containing traditional Chinese medicine. The anti-inflammatory and analgesic patch containing traditional Chinese medicine is composed of a backing layer, a drug reservoir layer, and a protective layer, wherein the drug reservoir layer is composed of a traditional Chinese medicine extract of Terminalia chebula, Aconitum kusnezoffii, and Piper longum, a pressure-sensitive adhesive, a tackifier, a plasticizer, an antioxidant, an anti-aging agent, a transdermal accelerator, and the like.

[0006] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the drug reservoir layer contains, by weight percentage of components, 5-60% of traditional Chinese medicine extract, 10-70% of pressure-sensitive adhesive, 0-50% of tackifier, 0-50% of plasticizer, 0-5% of antioxidant, 0-5% of anti-aging agent, 0-20% of transdermal enhancer, etc.

[0007] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the content of the traditional Chinese medicine extract is 5-60%, more preferably 10-40%.

[0008] In the anti-inflammatory and analgesic patch containing traditional Chinese medicine, the content of the pressure-sensitive adhesive material is 10-70%, and more preferably 20-60%.

[0009] In the anti-inflammatory and analgesic patch containing traditional Chinese medicine, the content of the viscosity enhancer is 0-50%, and more preferably 5-45%.

[0010] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the content of the plasticizer is 0-50%, more preferably 5-45%.

[0011] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the content of the antioxidant is 0-5%, more preferably 0.05-3%.

[0012] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the content of the anti-aging agent is 0-5%, more preferably 0.05-3%.

[0013] In the anti-inflammatory and analgesic patch containing traditional Chinese medicine, the content of the transdermal enhancer is 0-20%, and more preferably 0.5-5%.

[0014] The anti-inflammatory and analgesic patch containing Chinese medicine, wherein the pressure-sensitive adhesive material can be selected from rubber-based adhesives, acrylic adhesives, polyisobutylene-based adhesives, and silicone-based adhesives, such as styrene-isoprene-styrene block copolymers, styrene-butadiene-styrene block copolymers, polyisobutylene, chloroprene rubber, polybutadiene, polyisoprene, polysiloxane, acrylic adhesives of crosslinked and uncrosslinked acrylic copolymers, vinyl acetate adhesives, polyacrylate adhesives, ethylene vinyl acetate copolymers, polyurethanes, etc. and mixtures thereof. The pressure-sensitive adhesive material can be one or more of the above-mentioned substances. Preferred styrene-isoprene-styrene block copolymers and polyisobutylene.

[0015] In the anti-inflammatory and analgesic patch containing traditional Chinese medicine, the tackifier is selected from one or more of hydrogenated rosin resin, hydrogenated petroleum resin, hydrogenated terpene resin, polyacrylic acid resin, polybutene, high molecular weight polyisobutylene, and low molecular weight polyisobutylene, preferably hydrogenated rosin resin and hydrogenated terpene resin.

[0016] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the antioxidant is selected from tocopherol and its ester, sesamol of sesame oil, coniferyl benzoate of benzoin, nordihydroguaiac resin and nordihydroguaiaretic acid (NDGA), gallic acid esters (methyl gallate, ethyl gallate, propyl gallate, amyl gallate, butyl gallate, lauryl gallate, etc.), butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA); ascorbic acid and its salts and esters (such as palmitic acid ascorbyl ester), erythrosonic acid (isoascorbic acid) and its salts and esters, monothioglycerol, sodium formaldehyde sulfoxylate, sodium metabisulfite, sodium bisulfite, sodium sulfite, potassium metabisulfite, propionic acid, etc. One or more combinations. Preferred tocopherol, butylated hydroxytoluene (BHT), ascorbic acid. Further preferred tocopherol.

[0017] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the anti-aging agent is selected from heterocyclic antioxidants (sulfur-containing type), such as antioxidant MB, antioxidant MMB, antioxidant MBZ, antioxidant MMBZ, etc. Anti-aging agent MB is preferred.

[0018] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the transdermal penetration enhancer is selected from isopropyl myristate, azone, propylene glycol, menthol, L-menthol, peppermint oil, fatty acid esters, fatty alcohols such as oleic acid, linoleic acid, lauryl alcohol, etc. One or two to three of them can be selected at the same time. Menthol and L-menthol are preferred.

[0019] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the plasticizer is selected from paraffin oil, silicone oil, higher fatty acid, vegetable oil, polybutene, etc. Liquid paraffin is preferred.

[0020] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the backing layer is selected from composite aluminum foil, polyvinyl chloride, polyethylene, polypropylene, polystyrene, polyester, polyethylene terephthalate, polyurethane film, ethylene-vinyl acetate copolymer film, non-woven fabric or knitted fabric, etc. Non-woven fabric or knitted fabric is preferred.

[0021] The anti-inflammatory and analgesic patch containing traditional Chinese medicine, wherein the protective layer is selected from polyethylene terephthalate (PET), polypropylene (PP), and anti-sticking paper, preferably polyethylene terephthalate (PET) treated with fluorine or silicon.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] The anti-inflammatory and analgesic patch of traditional Chinese medicine provided by the present invention is safe, effective, has good compliance, is non-irritating, has good adhesion, and can be used to relieve the symptoms and signs of osteoarthritis, relieve the symptoms and signs of rheumatoid arthritis in adults, treat acute pain in adults, etc.

[0024] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention, it can be implemented in accordance with the contents of the specification. In order to make the above and other purposes, features and advantages of the present invention more obvious and easy to understand, the following specifically cites a preferred embodiment and describes it in detail with the accompanying drawings as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a table of the preparation method of this embodiment;

[0026] Figure 2 This is a table of the preparation method of this embodiment;

[0027] Figure 3 This is a table of the preparation method of this embodiment;

[0028] Figure 4 This is a table of the preparation method of this embodiment;

[0029] Figure 5 This is a table of the preparation method of this embodiment;

[0030] Figure 6 This is a table of the preparation method of this embodiment;

[0031] Figure 7 This is a table of the preparation method of this embodiment;

[0032] Figure 8The adhesion test results of the Chinese medicine anti-inflammatory and analgesic patches of Examples 1-4 and Comparative Examples 1-3 are shown;

[0033] Fig. 9 The swelling degree of the paw of the mouse with primary arthritis lesions in this example;

[0034] Fig.10 This is an investigation of the number of body twisting and pain inhibition rate of mice in this example. DETAILED DESCRIPTION

[0035] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, under the premise of no conflict, the various embodiments or technical features described below can be arbitrarily combined to form a new embodiment.

[0036] It should be noted that when a component is referred to as being "fixed to" another component, it may be directly on the other component or there may also be a component centered. When a component is considered to be "connected to" another component, it may be directly connected to the other component or there may also be a component centered. When a component is considered to be "set on" another component, it may be directly set on the other component or there may also be a component centered. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0038] Embodiment 1:

[0039] See also Figures 1 to 10 ,

[0040] Preparation method

[0041] 25 g SIS, 10 g hydrogenated rosin resin, 40.5 g liquid paraffin, 0.25 g butylated hydroxytoluene, and 0.25 g 2-mercaptobenzimidazole were heated and mixed, and then 20 g Chinese herbal extract and 4 g L-menthol were added, and heated and mixed to obtain a uniform paste;

[0042] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0043] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0044] Embodiment 2:

[0045] Preparation method

[0046] 36 g SIS, 30.25 g liquid paraffin, 0.25 g butylated hydroxytoluene, and 0.5 g 2-mercaptobenzimidazole were heated and mixed, and then 30 g Chinese herbal extract and 3 g L-menthol were added, and heated and mixed to obtain a uniform paste;

[0047] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0048] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0049] Embodiment three:

[0050] Preparation method

[0051] 20 g SIS, 20.7 g liquid paraffin, 15 g hydrogenated terpene resin, and 0.3 g butylated hydroxytoluene were heated and mixed, and then 40 g Chinese herbal extract and 4 g L-menthol were added, and heated and mixed to obtain a uniform paste;

[0052] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0053] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0054] Embodiment 4:

[0055] Preparation method

[0056] 20 g SIS, 31.5 g liquid paraffin, 10 g hydrogenated rosin resin, 5 g polyisobutylene, 0.3 g butylated hydroxytoluene, and 0.2 g 2-mercaptobenzimidazole were heated and mixed, and then 30 g Chinese herbal extract and 3 g L-menthol were added, and heated and mixed to obtain a uniform paste;

[0057] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0058] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0059] Comparative Example 1

[0060] Preparation method

[0061] Heat and mix 15 g SIS and 19 g liquid paraffin, then add 65 g Chinese herbal extract and 1 g L-menthol, heat and mix to obtain a uniform paste;

[0062] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0063] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0064] Comparative Example 2

[0065] Preparation method

[0066] Heat and mix 10g SIS, 25g hydrogenated rosin resin, 40g liquid paraffin, and 0.5g butylated hydroxytoluene, then add 20g Chinese herbal extract and 4.5g peppermint oil, heat and mix to obtain a uniform paste;

[0067] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0068] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0069] Comparative Example 3

[0070] Preparation method

[0071] Heat and mix 28g SIS, 15g hydrogenated rosin resin, 50g liquid paraffin, and 0.5g butylated hydroxytoluene, then add 5g Chinese herbal extract and 1.5g peppermint oil, heat and mix to obtain a uniform paste;

[0072] The above paste is applied on the anti-sticking surface of the protective layer, with a coating area of ​​about 0.7m2 to obtain a drug storage layer;

[0073] The backing layer is covered on the medicine reservoir layer, and then cut into appropriate sizes to obtain the anti-inflammatory and analgesic patch of traditional Chinese medicine.

[0074] The adhesion, anti-inflammatory and analgesic effects and skin irritation of Examples 1-4 and Comparative Examples 1-3 were investigated.

[0075] 1. Adhesion test of Examples 1-4 and Comparative Examples 1-3

[0076] Initial adhesion: According to the first method of general chapter 0952 of Part 4 of the 2020 edition of the Chinese Pharmacopoeia (determination of initial adhesion), the test sample (together with packaging materials) is placed at 18-25°C and relative humidity of 40%-70% for more than 2 hours. Then take 3 pieces of the test sample, remove the cover liner at room temperature, and place them on an inclined plane at an angle of 30° to the horizontal plane, with the paste side facing up. The upper 1 cm and the part below 6 cm of the test sample are covered with polyester film, leaving 5 cm of paste surface in the center. Steel balls of different numbers are taken to roll freely from the top of the test sample, and the maximum number of the steel ball that can stay is recorded.

[0077] Adhesion: Test according to the second method (determination of adhesion) of Part IV General Rules 0952 of the 2020 edition of the Chinese Pharmacopoeia. Before the test, place the test sample (together with the packaging material) at 18-25°C and relative humidity of 40%-70% for more than 2 hours. Scrub the test plate and loading plate with a wiping material dipped in anhydrous ethanol, and wipe them carefully with a clean dust-free cloth. Repeat this cleaning for more than 3 times until the surface of the test plate and loading plate is clean after visual inspection. Take 1 test sample, cut it into 7cm×7cm size, and stick the test sample parallel to the longitudinal direction of the plate on the middle of the adjacent test plate and loading plate, respectively. Roll the test sample back and forth three times with a pressure roller. After the product is pasted on the board, place it at room temperature for 20 minutes, fix it to the test stand, and record the time when the test sample falls off.

[0078] Depend on Figure 8 It can be seen that the Chinese medicine anti-inflammatory and analgesic patches prepared in Examples 1-4 of the present invention have good adhesion performance, and Example 4 is particularly outstanding.

[0079] 2. Investigation of the anti-inflammatory effects of Examples 1-4 and Comparative Examples 1-3

[0080] 35 mice were randomly divided into 7 groups and given the anti-inflammatory and analgesic patches containing Chinese medicine prepared in Examples 1-4 and Comparative Examples 1-3, with a dosing area of ​​35 cm2 applied to the backs of model mice (with all hair removed) for 24 hours a day for 2 consecutive weeks, and the swelling degree of the paws of the mice was measured (swelling degree of the paws = volume of the left hind paw after inflammation - volume of the right hind paw without inflammation).

[0081] Mouse inflammation model: Inflammation was induced by subcutaneous injection of 0.10 mL of Freund's complete adjuvant into the plantar of the left hind paw.

[0082] Fig. 9 . Plantar swelling of primary arthritis lesions in mice

[0083] Depend on Fig. 9It can be seen that the anti-inflammatory effect of the Chinese medicine anti-inflammatory and analgesic patches prepared in Examples 1-4 of the present invention is significant, and the patch is firmly applied during the application process, not easy to fall off, and can ensure continuous drug administration, among which Example 4 has the best effect. However, the application effect of Comparative Examples 1-3 is not good, and different degrees of edge warping and even falling off occur during the application process, which seriously affects the drug administration effect, and the anti-inflammatory effect is also much less than that of Examples 1-4.

[0084] 3. Analgesic effect study of Examples 1-4 and Comparative Examples 1-3

[0085] 35 mice were randomly divided into 7 groups and given the anti-inflammatory and analgesic patches containing Chinese medicine prepared in Examples 1-4 and Comparative Examples 1-3, with a dosing area of ​​35 cm2, respectively, on the backs of model mice (with all hair removed) for 24 hours a day for 2 consecutive weeks, and the number of times the mice twisted was measured.

[0086] Two hours after administration, mice were intraperitoneally injected with 0.6% acetic acid, with an injection volume of 0.2 mL / mouse.

[0087] Fig.10 .Study on the number of writhing times and pain inhibition rate in mice

[0088] Depend on Fig.10 It can be seen that the analgesic effect of the Chinese medicine anti-inflammatory and analgesic patches prepared in Examples 1-4 of the present invention is significant, and the best effect is obtained in Example 4. However, the analgesic effect of Comparative Examples 1-3 is much less than that of Examples 1-4.

[0089] 4. Skin irritation study of Example 4

[0090] Twenty-four SD rats, half male and half female, weighing about 200-220 g, were divided into three groups, and the abdominal skin was shaved with a shaver. The first group of rats applied a 3 cm × 3 cm anti-inflammatory and analgesic patch containing Chinese medicine prepared in Example 4 to the depilatory area, which was removed after 24 hours, the second group applied a control blank patch to the depilatory area, which was removed after 24 hours, and the third group was removed after continuous administration for 14 days, and the stimulation of the depilatory area was observed at the time of removal, 24 hours after removal, 48 hours after removal, and 72 hours after removal.

[0091] The results showed that the skin in the hair removal areas of the three groups of rats did not show allergic symptoms such as erythema and edema, indicating that the patch is non-irritating to the skin and has good safety.

[0092] In summary, the anti-inflammatory and analgesic patch containing traditional Chinese medicine provided by the present invention has good compliance, good adhesion, no irritation, good anti-inflammatory and analgesic effects, and is easy to use.

[0093] Working principle:

[0094] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. An anti-inflammatory and analgesic patch containing traditional Chinese medicine, the preparation consists of a backing layer, a drug reservoir layer and a protective layer, wherein the drug reservoir layer contains 5-60% of traditional Chinese medicine extract, 10-70% of pressure-sensitive adhesive, 0-50% of tackifier, 0-50% of plasticizer, 0-5% of antioxidant, 0-5% of anti-aging agent, 0-20% of transdermal enhancer, etc.

2. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The Chinese medicinal extract is the extract of Terminalia chebula, Aconitum kusnezoffii and Herba Astragali.

3. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The pressure-sensitive adhesive material can be selected from rubber adhesives, acrylic adhesives, polyisobutylene adhesives, silicone adhesives, such as styrene-isoprene-styrene block copolymers (SIS), styrene-butadiene-styrene block copolymers, polyisobutylene, chloroprene rubber, polybutadiene, polyisoprene, polysiloxane, acrylic adhesives of cross-linked and uncross-linked acrylic copolymers, vinyl acetate adhesives, polyacrylate adhesives, ethylene vinyl acetate copolymers, polyurethanes, etc. and mixtures thereof. The pressure-sensitive adhesive material can be one or more of the above substances.

4. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The tackifier is selected from one or more of hydrogenated rosin resin, hydrogenated petroleum resin, hydrogenated terpene resin, polyacrylic resin, polybutene, high molecular weight polyisobutylene and low molecular weight polyisobutylene.

5. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The plasticizer is selected from paraffin oil, silicone oil, higher fatty acid, vegetable oil, polybutene and the like.

6. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The antioxidant is selected from one or more combinations of tocopherol and its esters, sesamol of sesame oil, coniferyl benzoate of benzoin, nordihydroguaiac resin and nordihydroguaiaretic acid (NDGA), gallic acid esters (methyl gallate, ethyl gallate, propyl gallate, amyl gallate, butyl gallate, lauryl gallate, etc.), butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA); ascorbic acid and its salts and esters (such as palmitic acid ascorbyl ester), erythrosonic acid (isoascorbic acid) and its salts and esters, monothioglycerol, sodium formaldehyde sulfoxylate, sodium metabisulfite, sodium bisulfite, sodium sulfite, potassium metabisulfite, propionic acid, etc.

7. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The antioxidant is selected from heterocyclic antioxidants (sulfur-containing type), such as antioxidant MB, antioxidant MMB, antioxidant MBZ, antioxidant MMBZ, etc.

8. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The transdermal enhancer is selected from isopropyl myristate, azone, propylene glycol, menthol, L-menthol, peppermint oil, fatty acid esters, fatty alcohols such as oleic acid, linoleic acid, lauryl alcohol, etc. One or two to three of them can be selected at the same time.

9. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The backing layer is selected from composite aluminum foil, polyvinyl chloride, polyethylene, polypropylene, polystyrene, polyester, polyethylene terephthalate, ethylene-vinyl acetate copolymer film, non-woven fabric or knitted fabric.

10. The anti-inflammatory and analgesic patch containing traditional Chinese medicine according to claim 1, characterized in that: The protective layer is selected from polyethylene terephthalate (PET), polypropylene (PP), release paper and the like.

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