External plaster for treating arthritis and preparation method thereof

Abstract

The invention relates to an external plaster for treating arthritis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The invention provides a traditional Chinese medicine composition for treating arthritis. The traditional Chinese medicine composition comprises the following components: radix aconiti preparata, radix aconiti kusnezoffii preparata, frankincense, myrrh, garden balsam stem, lycopodium clavatum, borneol and camphor. According to the traditional Chinese medicine composition, monarch drugs are prepared from radix aconiti preparata and prepared kusnezoff monkshood roots, ministerial drugs are prepared from frankincense and myrrh, adjuvant drugs are prepared from garden balsam stems and lycopodium clavatum, conductant drugs are prepared from borneol and camphor, and the traditional Chinese medicine composition follows the rules of monarch, minister, assistant and conductant drugs, is scientific in formula and good in transdermal absorption and has the multiple effects of promoting blood circulation to remove blood stasis, relieving swelling and pain, dispelling wind and eliminating dampness and warming and activating meridians. The traditional Chinese medicine composition has a remarkable effect on knee osteoarthritis, is small in irritation, and has an effect equivalent to that of a needle-knife therapy.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a topical plaster for treating arthritis and its preparation method. Background Technology

[0002] Arthritis is a common chronic joint disease, mainly characterized by redness, swelling, heat, pain, and impaired function of the joints. Current treatments often involve oral nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics, which, while effective to some extent, can easily lead to adverse reactions such as gastrointestinal, liver, and kidney damage with long-term use. External plasters, as an important dosage form of traditional Chinese medicine, have advantages such as high local drug concentration, direct action, and fewer side effects.

[0003] However, some existing arthritis plasters have the following shortcomings: 1) poor transdermal absorption, making it difficult for the medicine to penetrate deep into the lesion; 2) limited active ingredients, focusing mainly on pain relief or blood circulation improvement, and insufficient comprehensive treatment of the root cause of inflammation; 3) high allergy rate and poor application comfort. Therefore, developing a traditional Chinese medicine external plaster with good transdermal properties, comprehensive efficacy, and safe and comfortable use is of great practical significance. Summary of the Invention

[0004] The purpose of this invention is to provide a topical plaster for treating arthritis and its preparation method, so as to solve the problems of poor efficacy, single drug effect and poor comfort of existing arthritis plasters.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating arthritis, comprising the following components in parts by weight: Prepared Aconitum carmichaelii 15-25 parts, prepared Aconitum kusnezoffii 15-25 parts, frankincense 10-20 parts, myrrh 10-20 parts, Clematis chinensis 15-25 parts, Lycopodium clavatum 15-25 parts, borneol 3-7 parts, and camphor 3-7 parts.

[0006] Preferably, the components include the following parts by mass: Prepared Aconitum carmichaelii 20 parts, prepared Aconitum kusnezoffii 20 parts, frankincense 15 parts, myrrh 15 parts, Clematis chinensis 20 parts, Lycopodium clavatum 20 parts, borneol 5 parts and camphor 5 parts.

[0007] This invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of plasters for treating arthritis.

[0008] This invention provides a plaster for treating arthritis, comprising a traditional Chinese medicine composition, a saponifying agent, a backing layer, and an anti-adhesive film; The traditional Chinese medicine composition is the aforementioned traditional Chinese medicine composition; The saponifying agent is red lead; The backing layer is one of non-woven fabric, cotton fabric and paper; The anti-sticking liner is one of the following: silicone paper, plastic film, aluminum foil-polyethylene composite film, and rigid gauze.

[0009] This invention provides a method for preparing the plaster, comprising the following steps: (1) Mix and pulverize processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Clematis armandii and Lycopodium clavatum to obtain a mixture. Mix the mixture with an ethanol solution and extract by hot reflux 1 to 3 times. Combine the extracts, filter with a filter cloth to obtain a filtrate, recover the ethanol under reduced pressure, and concentrate to obtain an extract with a relative density of 1.25 to 1.30. (2) Mix frankincense and myrrh and grind them to obtain mixed powder. Mix the mixed powder with sesame oil and extract for 25-35 minutes. Filter to remove the residue and refine the oil for 5-10 minutes. Cool to obtain medicinal oil. (3) Mix the medicinal oil with the saponifying agent to obtain the plaster base; (4) Mix and pulverize borneol and camphor to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster matrix obtained in step (3) to obtain a plaster. (5) Apply the plaster to the backing layer, cover it with an anti-sticking film, cut and package it to obtain the plaster.

[0010] Preferably, the mesh size of the pulverized material in step (1) is 20-40 mesh; the mass ratio of the mixture to the ethanol solution is 1:6-8; and the ethanol solution is a 65-75% ethanol solution.

[0011] Preferably, the extraction temperature of the hot reflux extraction in step (1) is 65~75℃; and the pore size of the filter cloth is 180~220 mesh.

[0012] Preferably, the mesh size of the powder pulverized in step (2) is 180~220 mesh; the mass ratio of the mixed medicinal powder to the sesame oil is 1:3~5; the extraction temperature in step (2) is 65~75℃; and the oil refining temperature is 280~300℃.

[0013] Preferably, the mass ratio of the medicinal oil to the saponifying agent in step (3) is 100:35~40; The particle size of the pulverized material in step (4) is 80~120 mesh.

[0014] Preferably, the content of the plaster on the backing layer in step (5) is 48~52 μg / cm³. 2 .

[0015] The present invention has the following technical effects and advantages: The herbal composition of this invention consists of prepared Aconitum carmichaelii and prepared Aconitum kusnezoffii as the principal ingredients, frankincense and myrrh as the assistant ingredients, Clematis chinensis and Lycopodium clavatum as the adjuvant ingredients, and borneol and camphor as the guiding ingredients. The herbal composition follows the principles of principal, assistant, adjuvant, and guiding ingredients, and is scientifically formulated. It has good transdermal absorption and has multiple effects such as promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and promoting blood circulation. When prepared into a plaster, it has a significant effect on arthritis, especially knee osteoarthritis, and has low irritation. Its effect is comparable to that of acupuncture and knife therapy. Attached Figure Description

[0016] Figure 1 Diagrams illustrating the modeling process for a rabbit model of knee osteoarthritis. Figure 2 X-ray images of the lateral and anterior sides of the knee joints of the model group, needle knife group, and patch group before treatment were taken. Figure 3 X-ray images of the lateral and anterolateral aspects of the knee joints of the model group, needle knife group, and patch group after treatment were taken. Detailed Implementation

[0017] This invention provides a traditional Chinese medicine composition for treating arthritis, comprising the following components in parts by weight: Prepared Aconitum carmichaelii 15-25 parts, prepared Aconitum kusnezoffii 15-25 parts, frankincense 10-20 parts, myrrh 10-20 parts, Clematis chinensis 15-25 parts, Lycopodium clavatum 15-25 parts, borneol 3-7 parts and camphor 3-7 parts; The preferred mass fractions of processed Aconitum carmichaelii, processed Aconitum kusnezoffii, frankincense, myrrh, Clematis chinensis, Lycopodium clavatum, borneol, and camphor are 5 parts each.

[0018] This invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of plasters for treating arthritis.

[0019] This invention provides a plaster for treating arthritis, comprising a traditional Chinese medicine composition, a saponifying agent, a backing layer, and an anti-adhesive film; The traditional Chinese medicine composition is the aforementioned traditional Chinese medicine composition; The saponifying agent is red lead; The backing layer is one of non-woven fabric, cotton fabric and paper; The anti-sticking liner is one of the following: silicone paper, plastic film, aluminum foil-polyethylene composite film, and rigid gauze.

[0020] This invention provides a method for preparing the plaster, comprising the following steps: (1) Mix and pulverize processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Clematis armandii and Lycopodium clavatum to obtain a mixture. Mix the mixture with an ethanol solution and extract by hot reflux 1 to 3 times. Combine the extracts, filter with a filter cloth to obtain a filtrate, recover the ethanol under reduced pressure, and concentrate to obtain an extract with a relative density of 1.25 to 1.30. The reflux extraction is preferably performed twice; the relative density of the extract is preferably 1.27; and the concentration temperature is 60°C. (2) Mix frankincense and myrrh and grind them to obtain mixed powder. Mix the mixed powder with sesame oil and extract for 25-35 minutes. Filter to remove the residue and refine the oil for 5-10 minutes. Cool to obtain medicinal oil. The extraction time is preferably 30 minutes; the oil refining time is preferably 8 minutes. (3) Mix the medicinal oil with the saponifying agent to obtain the plaster base; (4) Pulverize borneol and camphor to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster base obtained in step (3) to obtain a plaster. (5) Apply the plaster to the backing layer, cover it with an anti-sticking film, cut and package it to obtain the plaster.

[0021] In this invention, the mesh size of the pulverized material in step (1) is 20-40 mesh, preferably 30 mesh; the mass ratio of the mixture to the ethanol solution is 1:6-8, preferably 1:7; the ethanol solution is 65-75% ethanol solution, preferably 70% ethanol solution.

[0022] In this invention, the extraction temperature of the hot reflux extraction in step (1) is 65~75℃, preferably 70℃; the pore size of the filter cloth is 180~220 mesh, preferably 200 mesh.

[0023] In this invention, the mesh size of the powder pulverized in step (2) is 180~220 mesh, preferably 200 mesh; the mass ratio of the mixed medicinal powder to the sesame oil is 1:3~5, preferably 1:4; the extraction temperature in step (2) is 65~75℃, preferably 70℃; and the oil refining temperature is 280~300℃, preferably 290℃.

[0024] In this invention, the mass ratio of the medicinal oil to the saponifying agent in step (3) is 100:35~40, preferably 100:37; The particle size of the pulverized material in step (4) is 80~120 mesh, preferably 100 mesh.

[0025] In this invention, the content of the plaster on the backing layer in step (5) is 48~52 μg / cm³. 2 Preferably 50 μg / cm 2 .

[0026] In this invention, the principal herb (core treatment) in the traditional Chinese medicine composition is prepared aconite root and prepared aconite tuber, which are extremely pungent and hot in nature, possessing strong effects of dispelling wind and dampness, warming the meridians and relieving pain, and are essential medicines for treating cold-dampness arthralgia; the assistant herbs (supporting enhancement) are frankincense and myrrh, which have the effects of promoting blood circulation and qi circulation, reducing swelling and promoting tissue regeneration, enhancing the analgesic effect of the principal herb, and improving local blood circulation; the adjuvant herbs (synergistic conditioning) are clematis root and lycopodium root, which have the effects of dispelling wind and dampness, relaxing muscles and tendons, guiding the medicine directly to the muscles and bones, and relieving joint contractures; the guiding herbs (guide and enhance efficacy) are borneol and camphor, which have the effects of aromatic dispersion and strong penetrating power, acting as transdermal penetration enhancers to guide the components of the medicine through the skin barrier, while also having a cooling and analgesic effect themselves. The traditional Chinese medicine composition of this invention follows the principles of principal, assistant, adjuvant, and guide herbs, has a scientific formulation, good transdermal absorption, and has multiple effects such as promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and promoting blood circulation. When prepared as a plaster, it has a significant effect on arthritis, especially knee osteoarthritis, and has low irritation, with effects comparable to acupuncture and knife therapy.

[0027] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0028] Example 1

[0029] Traditional Chinese medicine composition for treating arthritis

[0030] Formula: 20g of processed Aconitum carmichaelii, 20g of processed Aconitum kusnezoffii, 15g of frankincense, 15g of myrrh, 20g of Clematis chinensis, 20g of Lycopodium clavatum, 5g of borneol and 5g of camphor.

[0031] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, lead oxide, non-woven fabric, and silicone paper; The preparation method is as follows: (1) Mix 20g of processed Aconitum carmichaelii, 20g of processed Aconitum kusnezoffii, 20g of Clematis armandii and 20g of Lycopodium clavatum and grind them to 30 mesh to obtain a mixture. Mix the mixture with 70% ethanol solution at a mass ratio of 1:7 and extract twice by hot reflux at 70℃. Combine the extracts and filter them with a filter cloth with a pore size of 200 mesh to obtain a filtrate. After recovering the ethanol under reduced pressure, concentrate the extract at 60℃ to obtain an extract with a relative density of 1.27. (2) Mix 15g of frankincense and 15g of myrrh and grind them to 200 mesh to obtain mixed powder. Mix the mixed powder with sesame oil at a mass ratio of 1:4. Extract at 70℃ for 30min. Filter to remove the residue. Refine the oil at 290℃ for 8min. Cool to obtain medicinal oil. (3) Mix the medicinal oil and lead oxide in a mass ratio of 100:37 to obtain the plaster base; (4) Mix 5g of borneol and 5g of camphor and grind them to 100 mesh to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster base obtained in step (3) to obtain a plaster. (5) Apply the plaster at a concentration of 50 μg / cm 2 The content of the agent is applied to non-woven fabric, covered with silicone paper, and then cut and packaged to obtain the plaster.

[0032] Example 2

[0033] Traditional Chinese medicine composition for treating arthritis

[0034] Formula: 18g of processed Aconitum carmichaelii, 22g of processed Aconitum kusnezoffii, 17g of frankincense, 13g of myrrh, 18g of Clematis chinensis, 22g of Lycopodium clavatum, 6g of borneol and 4g of camphor.

[0035] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, lead oxide, non-woven fabric, and plastic film; The preparation method is as follows: (1) Mix 18g of processed Aconitum carmichaelii, 22g of processed Aconitum kusnezoffii, 18g of Clematis armandii and 22g of Lycopodium clavatum and grind them to 30 mesh to obtain a mixture. Mix the mixture with 65% ethanol solution at a mass ratio of 1:8 and extract twice by hot reflux at a temperature of 67℃. Combine the extracts and filter them with a filter cloth with a pore size of 200 mesh to obtain a filtrate. After recovering the ethanol under reduced pressure, concentrate it at 60℃ to obtain an extract with a relative density of 1.28. (2) Mix 17g of frankincense and 13g of myrrh and grind them to 200 mesh to obtain mixed powder. Mix the mixed powder with sesame oil at a mass ratio of 1:5. Extract at 68℃ for 33 minutes, filter to remove the residue, refine the oil at 288℃ for 10 minutes, and cool to obtain medicinal oil. (3) Mix the medicinal oil and lead oxide in a mass ratio of 100:36 to obtain the plaster base; (4) Mix 6g of borneol and 4g of camphor and grind them to 100 mesh to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster base obtained in step (3) to obtain a plaster. (5) Apply the plaster at a concentration of 48 μg / cm 2 The content of the agent is applied to non-woven fabric, covered with silicone paper, and then cut and packaged to obtain the plaster.

[0036] Example 3

[0037] Traditional Chinese medicine composition for treating arthritis

[0038] Formula: 22g of processed Aconitum carmichaelii, 23g of processed Aconitum kusnezoffii, 18g of frankincense, 17g of myrrh, 23g of Clematis chinensis, 18g of Lycopodium clavatum, 6g of borneol and 4g of camphor.

[0039] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, lead oxide, non-woven fabric, and rigid gauze; The preparation method is as follows: (1) Mix 22g of processed Aconitum carmichaelii, 23g of processed Aconitum kusnezoffii, 23g of Clematis armandii and 18g of Lycopodium clavatum and grind them to 30 mesh to obtain a mixture. Mix the mixture with 75% ethanol solution at a mass ratio of 1:6 and extract twice by hot reflux at 72℃. Combine the extracts and filter them with a filter cloth with a pore size of 200 mesh to obtain a filtrate. After recovering the ethanol under reduced pressure, concentrate it at 60℃ to obtain an extract with a relative density of 1.25. (2) Mix 18g of frankincense and 17g of myrrh and grind them to 200 mesh to obtain mixed powder. Mix the mixed powder with sesame oil at a mass ratio of 1:3. Extract at 73℃ for 27min. Filter to remove the residue. Refine the oil at 298℃ for 5min. Cool to obtain medicinal oil. (3) Mix the medicinal oil and lead oxide in a mass ratio of 100:39 to obtain the plaster base; (4) Mix 6g of borneol and 4g of camphor and grind them to 100 mesh to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster base obtained in step (3) to obtain a plaster. (5) Apply the plaster at a concentration of 52 μg / cm 2 The content of the agent is applied to non-woven fabric, covered with silicone paper, and then cut and packaged to obtain the plaster.

[0040] Comparative Example 1

[0041] Traditional Chinese medicine composition for treating arthritis

[0042] The auxiliary herbs, composed of frankincense and myrrh, are replaced with Panax notoginseng and dragon's blood; the specific Chinese medicine formula is as follows: Prepared Aconitum carmichaelii 20g, Prepared Aconitum kusnezoffii 20g, Panax notoginseng 18g, Dragon's Blood 18g, Clematis armandii 20g, Lycopodium clavatum 20g, Borneol 5g, Camphor 5g.

[0043] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, lead oxide, non-woven fabric, and silicone paper; The preparation method uses Panax notoginseng and dragon's blood to refine medicinal oil, and the rest of the method is the same as the preparation method in Example 1, to prepare the plaster.

[0044] Comparative Example 2

[0045] Traditional Chinese medicine composition for treating arthritis

[0046] The adjuvant herbs in the herbal composition are omitted, specifically *Clematis chinensis* and *Lycopodium clavatum*. The specific herbal formula is as follows: Prepared Aconitum carmichaelii 20g, Prepared Aconitum kusnezoffii 20g, Frankincense 15g, Myrrh 15g, Borneol 5g, Camphor 5g.

[0047] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, lead oxide, non-woven fabric, and silicone paper; The preparation method removed Clematis armandii and Clematis chinensis, and the rest of the preparation method was the same as that in Example 1, and the plaster was prepared.

[0048] Comparative Example 3

[0049] Traditional Chinese medicine composition for treating arthritis

[0050] Formula: 20g of processed Aconitum carmichaelii, 20g of processed Aconitum kusnezoffii, 15g of frankincense, 15g of myrrh, 20g of Clematis chinensis, 20g of Lycopodium clavatum, 5g of borneol, and 5g of camphor.

[0051] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, non-woven fabric, and silicone paper; The preparation method is as follows: (1) Mix 20g of processed Aconitum carmichaelii, 20g of processed Aconitum kusnezoffii, 15g of frankincense, 15g of myrrh, 10g of Clematis armandii and 20g of Lycopodium clavatum and grind them to 100 mesh to obtain a mixture. Mix the mixture with 75% ethanol solution at a mass ratio of 1:10 and extract twice by hot reflux at 70℃. Combine the extracts and filter them with a filter cloth with a pore size of 200 mesh to obtain a filtrate. After recovering the ethanol under reduced pressure, concentrate the extract at 60℃ to obtain an extract with a relative density of 1.25. (2) Mix 5g of borneol and 5g of camphor and grind them to 100 mesh to obtain a mixture. Mix the mixture with the extract obtained in step (1) to obtain a plaster. (3) Apply the plaster at a concentration of 50 μg / cm 2 The content of the agent is applied to non-woven fabric, covered with silicone paper, and then cut and packaged to obtain the plaster.

[0052] Comparative Example 4

[0053] Traditional Chinese medicine composition for treating arthritis

[0054] Formula: 20g of processed Aconitum carmichaelii, 20g of processed Aconitum kusnezoffii, 27g of frankincense, 23g of myrrh, 14g of Clematis chinensis, 13g of Lycopodium clavatum, 10g of borneol, and 10g of camphor.

[0055] A plaster for treating arthritis includes the above-mentioned traditional Chinese medicine composition, non-woven fabric, and silicone paper; The preparation method is the same as in Example 1, and the plaster is prepared.

[0056] Test case

[0057] Animal experiments were conducted using New Zealand rabbits, with five groups: a blank group, a model group, a needle knife group, and patch groups 1-5. The patches used in Example 1 and Comparative Examples 1-4 were applied to each group. After animal modeling, the animals were divided into groups and treated with corresponding methods. Throughout the experiment, photos were taken and adverse conditions were observed. The animals were sacrificed 4 weeks after treatment, and samples were collected for testing. This provides zoological research data for the safety evaluation and application of related products.

[0058] 1. Experimental Materials

[0059] 1.1 Laboratory Animals

[0060] 32 male New Zealand rabbits, 6 months old, weighing 2.5-3.0 kg, purchased from Beijing Yongxin Kangtai Technology Development Co., Ltd.

[0061] 1.2 Experimental Consumables

[0062] Medical pressure-sensitive adhesive tape, foam double-sided tape, resin bandage (150×1800mm), polymer fixation bandage.

[0063] 2. Experimental Methods

[0064] 2.1 Adaptation to feeding

[0065] Male New Zealand rabbits were acclimatized and subjected to arthritis modeling after 3 days.

[0066] 2.2 Establishment of a rabbit model of knee osteoarthritis

[0067] The left hind limb was fixed and immobilized in an extended position. The modeling process was as follows: Figure 1 As shown, the details are as follows: An assistant secured the New Zealand rabbit to the experimental table in a supine position (fixing the forelimbs and left hindlimb), keeping the left hindlimb extended. Medical pressure-sensitive tape (2cm wide) was wrapped around the left hindlimb (covering the groin to the knee joint). Foam double-sided tape was then wrapped around the left hindlimb sequentially (covering the area of ​​the pressure-sensitive tape). A resin bandage (150×1800mm) was wrapped around the foam tape area once. A polymer fixation bandage was wrapped tightly against the resin bandage once. Foam double-sided tape was wrapped around the rabbit's ankle once. The resin bandage was wrapped around the ankle to the knee once and secured with pressure-sensitive tape. A polymer fixation bandage was then wrapped around the resin bandage from the knee to the ankle. A self-adhesive sports bandage was wrapped around the polymer fixation bandage (from the groin to the ankle) and reinforced with pressure-sensitive tape. The rabbit's left hindlimb was immobilized in an extended position for 4 weeks. During this period, the rabbit was followed up daily to observe for any dislodgement of the fixation device and for any swelling in the foot. If dislodgement or swelling was found, the fixation device was reinforced and repaired again.

[0068] 2.3 Experimental Methods

[0069] 2.3.1 Animal Grouping

[0070] After immobilizing the rabbits (28 in total) for 4 weeks, the lower limb fixation bandages were removed. After 3 days of free eating and activity, the behavior was evaluated according to the Lequesne MG scoring method. Based on the behavioral score results, all the model animals were evenly distributed into model group, needle knife group, patch group 1-5, with 4 rabbits in each group. There was no difference in Lequesne MG scores among the groups. The control group consisted of 4 healthy rabbits.

[0071] The Lequesne MG scoring criteria are as follows: ① Painful stimulation: Fix the mouse and stimulate the affected limb (No response 0 points, affected limb contraction 1 point, affected limb contraction + mild systemic reaction 2 points, erratic movement and struggling 3 points) ② Gait: Observe the walking status of mice (0 points for no limping, 1 point for mild limping, 2 points for obvious limping, and 3 points for the affected limb not participating in walking) ③Joint range of motion; measuring the range of motion of the affected joints in mice. (0 points for angles above 90°, 1 point for angles between 45° and 90°, 2 points for angles between 15° and 45°, and 3 points for angles less than 15°) ④ Joint swelling (No swelling: 0 points; mild swelling: 1 point; severe swelling: 2 points).

[0072] Two evaluators conducted independent evaluations, and the average value was used for statistical analysis.

[0073] 2.3.2 Treatment Plan

[0074] Blank group: Data is collected twice a week without any intervention for two weeks; Model group: Data is collected twice a week without any processing, and intervention is carried out for two weeks; Needle knife group: Needle knife treatment was performed. After routine skin preparation of the rabbit's left hind limb, the needle knife insertion point was precisely marked and disinfected. The needle knife was then inserted. Treatment was given twice a week for a total of two weeks. Specific needle knife procedures at each insertion point are as follows: ① Insertion points of the vastus medialis and lateralis tendons: Release the continuation points of the vastus medialis and lateralis tendons respectively. Insert the needle knife parallel to the tendon and perpendicular to the skin cut surface, making two cuts each time and applying pressure. ② Insertion points of the rectus femoris tendon: Release the upper edge of the scapula, i.e., the rectus femoris tendon. The needle knife insertion angle and direction are the same as above. ③ Insertion points of the biceps femoris tendon: Release the transition point of the biceps femoris tendon. The needle knife insertion angle and direction are the same as above. ④ Insertion points of the pes anserine bursa: Release the conjoined tendon of the sartorius, gracilis, and semitendinosus muscles, i.e., the pes anserine bursa. The needle knife insertion angle and direction are the same as above. ⑤ Insertion points of tenderness and nodules: The operator explores around the rabbit's knee joint. If the rabbit's hind limb trembles or tries to avoid touching a certain point, it is a tender point and is marked. At the same time, the cord nodules are also marked. The needle knife insertion angle and direction are the same as above.

[0075] Patch groups 1-5: Apply the patches obtained in Example 1 and Comparative Examples 1-4 twice a week for two weeks.

[0076] 2.4 Behavioral observation and scoring results

[0077] The Lequesne MG scoring method in section 2.3 was used to evaluate the behavior of animals in the model group, acupuncture knife group, and patch group 1-5 before and after treatment. The results are shown in Table 1.

[0078] Table 1. Behavioral scores of different treatment groups

[0079] As shown in Table 1, the behavioral scores of the acupuncture knife group and patch groups 1-5 were significantly lower than those of the model group after treatment, indicating that acupuncture knife therapy and patch application methods have therapeutic effects on the rabbit model of knee osteoarthritis. The scores of the acupuncture knife group and patch group 1 after treatment were not significantly different, indicating that the patch for treating arthritis in this application has a good therapeutic effect, comparable to that of acupuncture knife therapy. Comparing the scores of patch groups 1-5 after treatment, the score of patch group 1 was significantly lower than that of patch groups 2-5, indicating that the traditional Chinese medicine composition in this application has a synergistic effect and, combined with the preparation method, has a significant therapeutic effect on arthritis. Therefore, subsequent studies will only measure the indicators of the blank group, model group, acupuncture knife group, and patch group 1.

[0080] 2.5 X-ray imaging was performed on live rabbits from different treatment groups.

[0081] Two weeks after modeling and treatment intervention, X-ray images were taken of the lateral and anterior aspects of the knee joints in the model group, the needle knife group, and the patch group (patch group 1). The results are as follows: Figure 2 and 3 As shown, Figure 2 X-ray images of the lateral and anterior aspects of the knee joints in the model group, needle knife group, and patch group before treatment were taken. Figure 3 X-ray images of the lateral and anterolateral aspects of the knee joints of the model group, needle knife group, and patch group after treatment were taken.

[0082] according to Figure 2 and Figure 3Before treatment, X-ray images of the lateral and anteroposterior aspects of the knee joints in the model group, needle knife group, and patch group (patch group 1) showed that all rabbit joints were swollen, with numerous osteophytes on the articular surface, narrowed joint space, and hardened, rough, and uneven cartilage surface. No significant differences were observed, indicating successful modeling. After treatment, the model group still exhibited joint swelling, numerous osteophytes on the articular surface, and hardened, rough, and uneven cartilage surface. The patch group (patch group 1) showed mild joint swelling, a small amount of osteophytes, and mild hardening on the articular surface. The needle knife group had a basically normal joint appearance, with occasional superficial wear and hardening of the cartilage surface. Compared with before treatment, both the needle knife group and the patch group (patch group 1) showed widened joint space, significantly reduced joint effusion, and smoother cartilage surface, but the needle knife group showed better results than the patch group. This indicates that both needle knife therapy and external patch intervention can effectively improve the cartilage pathology of the rabbit model of knee osteoarthritis, with needle knife therapy being more effective, followed by patch therapy.

[0083] 2.6 Determination of serum TNF-α, IL-1β, and IL-6 levels in animals of different treatment groups

[0084] TNF-α, IL-1β, and IL-6, as important pro-inflammatory cytokines, play indispensable roles in inflammatory responses. Through synergy and interaction, they jointly regulate the body's immune response and inflammatory response to cope with various external stimuli and damage. However, excessive inflammatory responses can also cause harm to the body; therefore, it is necessary to rationally regulate the levels of these cytokines in clinical treatment. The pro-inflammatory cytokines TNF-α, IL-1β, and IL-6 play a crucial role in inflammatory responses.

[0085] After two weeks of intervention, venous blood was collected from the marginal ear vein of rabbits. After the blood was allowed to stand, serum was separated, and the levels of TNF-α, IL-1β, and IL-6 in the serum of animals in the model group, needle knife group, and patch group (patch group 1) were detected. The results are shown in Table 2.

[0086] Table 2. Serum levels of TNF-α, IL-1β, and IL-6 in animals from different treatment groups.

[0087] As shown in Table 2, the levels of TNF-α, IL-1β, and IL-6 in the serum of animals treated with acupuncture and knife therapy and patch therapy (patch group 1) were significantly lower than those in the model group and similar to those in the blank group. This indicates that acupuncture and knife therapy and external patch therapy can effectively improve the levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the blood of rabbit models of knee osteoarthritis.

[0088] 2.7 Determination of the contents of TK, CGRP, 5-HT, SP, BK, and NPY in the knee joint effusion of animals in different treatment groups

[0089] TK (Tyrosine Kinase): A core molecule in cell signaling. Elevated levels indicate active inflammation or tissue repair in the knee joint, commonly seen in synovitis, cartilage damage, and other conditions. CGRP (Calcitonin Gene-Related Peptide): A potent neuropeptide that primarily mediates pain signal transmission and vasodilation. Increased levels are positively correlated with knee pain severity, especially in inflammatory or neurogenic pain. 5-HT (Serotonin): Also known as serotonin, it has both inflammation-regulating and pain-modulating functions. Abnormally elevated levels may exacerbate joint inflammation and amplify pain perception. SP (Substance P): A classic pain-inducing neuropeptide that directly induces pain and promotes the release of inflammatory mediators. Higher levels generally indicate more severe joint pain and more active inflammation. BK (Brain Kinase): A potent inflammatory mediator that can induce pain, increase vascular permeability, and promote inflammatory cell infiltration. Elevated levels indicate acute or chronic joint inflammation, often accompanied by increased effusion and swelling. NPY (Neuropeptide Y): A neuropeptide involved in vascular regulation and inflammation control. Changes in its levels may be related to abnormal local blood circulation in joints and persistent inflammation.

[0090] Two weeks after modeling and treatment intervention, knee joint effusion was aspirated, and the contents of TK, CGRP, 5-HT, SP, BK, and NPY in the knee joint effusion of the model group, needle knife group, and patch group (patch group 1) were detected. The results are shown in Tables 3-8.

[0091] Table 3. TK content in knee joint effusion of animals in different treatment groups

[0092] Table 4. CGRP content in knee joint effusion of animals in different treatment groups

[0093] Table 5. Content of 5-HT in knee joint effusion of animals in different treatment groups

[0094] Table 6. SP content in knee joint effusion of animals in different treatment groups

[0095] Table 7. BK content in knee joint effusion of animals in different treatment groups

[0096] Table 8. NPY content in knee joint effusion of animals in different treatment groups

[0097] As shown in Tables 3-8, the levels of TK, CGRP, 5-HT, SP, BK, and NPY in the knee joint effusion of the animals treated with acupuncture and knife therapy and the patch group (patch group 1) were significantly lower than those in the model group and similar to those in the blank group. This indicates that acupuncture and knife therapy and external patch intervention can effectively improve the levels of TK, CGRP, 5-HT, SP, BK, and NPY in the knee joint effusion of the rabbit model of knee osteoarthritis.

[0098] As can be seen from the above embodiments, the present invention provides a topical plaster for treating arthritis and its preparation method. The principal ingredients of the traditional Chinese medicine composition of the present invention are processed Aconitum carmichaelii and processed Aconitum kusnezoffii, the assistant ingredients are frankincense and myrrh, the adjuvant ingredients are Clematis chinensis and Lycopodium clavatum, and the guiding ingredients are borneol and camphor. The composition follows the principles of principal, assistant, adjuvant, and guiding herbs, is scientifically formulated, has good transdermal absorption, and possesses multiple effects such as promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, dispelling wind and dampness, and warming the meridians and promoting blood circulation. When prepared as a plaster, it has a significant effect on arthritis, especially knee osteoarthritis, with low irritation and effects comparable to acupuncture and knife therapy.

[0099] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating arthritis, characterized in that, The components include the following parts by mass: Prepared Aconitum carmichaelii 15-25 parts, prepared Aconitum kusnezoffii 15-25 parts, frankincense 10-20 parts, myrrh 10-20 parts, Clematis chinensis 15-25 parts, Lycopodium clavatum 15-25 parts, borneol 3-7 parts, and camphor 3-7 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The components include the following parts by mass: Prepared Aconitum carmichaelii 20 parts, prepared Aconitum kusnezoffii 20 parts, frankincense 15 parts, myrrh 15 parts, Clematis armandii 20 parts, Lycopodium clavatum 20 parts, borneol 5 parts and camphor 5 parts.

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

4. A plaster for treating arthritis, characterized in that, Includes traditional Chinese medicine composition, saponifying agent, backing layer and anti-sticking film; The traditional Chinese medicine composition is the traditional Chinese medicine composition according to claim 1 or 2; The saponifying agent is red lead; The backing layer is one of non-woven fabric, cotton fabric and paper; The anti-sticking liner is one of the following: silicone paper, plastic film, aluminum foil-polyethylene composite film, and rigid gauze.

5. The method for preparing the plaster according to claim 4, characterized in that, Includes the following steps: (1) Mix and pulverize processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Clematis armandii and Lycopodium clavatum to obtain a mixture. Mix the mixture with an ethanol solution and extract by hot reflux 1 to 3 times. Combine the extracts, filter with a filter cloth to obtain a filtrate, recover the ethanol under reduced pressure, and concentrate to obtain an extract with a relative density of 1.25 to 1.

30. (2) Mix frankincense and myrrh and grind them to obtain mixed powder. Mix the mixed powder with sesame oil and extract for 25-35 minutes. Filter to remove the residue and refine the oil for 5-10 minutes. Cool to obtain medicinal oil. (3) Mix the medicinal oil with the saponifying agent to obtain the plaster base; (4) Mix and pulverize borneol and camphor to obtain a mixture. Mix the mixture, the extract obtained in step (1), and the plaster matrix obtained in step (3) to obtain a plaster. (5) Apply the plaster to the backing layer, cover it with an anti-sticking film, and cut and package it to obtain the plaster.

6. The preparation method according to claim 5, characterized in that, The pulverization in step (1) is 20-40 mesh; the mass ratio of the mixture to the ethanol solution is 1:6-8; and the ethanol solution is a 65-75% ethanol solution.

7. The preparation method according to claim 5, characterized in that, The extraction temperature of the hot reflux extraction in step (1) is 65~75℃; the pore size of the filter cloth is 180~220 mesh.

8. The preparation method according to claim 5, characterized in that, The pulverization in step (2) is 180~220 mesh; the mass ratio of the mixed medicinal powder to sesame oil is 1:3~5; the extraction temperature in step (2) is 65~75℃; and the oil refining temperature is 280~300℃.

9. The preparation method according to claim 5, characterized in that, The mass ratio of the medicinal oil to the saponifying agent in step (3) is 100:35~40; The particle size of the pulverized material in step (4) is 80~120 mesh.

10. The preparation method according to claim 5, characterized in that, The content of the plaster on the backing layer in step (5) is 48~52 μg / cm³. 2 .

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