A traditional Chinese medicine composition, a patch containing the traditional Chinese medicine composition and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition, a patch containing the traditional Chinese medicine composition and a preparation method of the patch. The traditional Chinese medicine composition contains the following components in parts by weight: eucommia 15-25 parts, papaya 25-35 parts, angelica 15-22 parts, atractylodes 18-25 parts, astragalus 15-25 parts, centipede 1.6-2.4 parts, radix clematidis 15-25 parts, drynaria 18-22 parts, radix glycyrrhizae 10-20 parts and polygonatum 10-20 parts. The patch prepared by optimizing the composition of the traditional Chinese medicine composition and the preparation of the patch has excellent effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition, a patch containing the traditional Chinese medicine composition, and a method for preparing the same. Background Technology

[0002] Lumbar disc herniation is a common and frequently occurring clinical condition. Patients often present with lower back pain, radiating pain or numbness in the lower extremities, and limited mobility, and are characterized by a prolonged course and recurrent episodes. Current treatment methods include analgesic drugs, physical therapy, rehabilitation training, and topical preparations. Among these, traditional Chinese medicine topical patches are widely used as an adjunct treatment for pain-related conditions such as lower back pain and soft tissue injuries due to their convenience, sustained action at the affected area, and reduced adverse reactions associated with oral medications.

[0003] Most existing Chinese medicine patches are based on the principles of promoting blood circulation, removing blood stasis, dispelling wind and dampness, and relieving pain by unblocking the meridians. They are usually prepared by directly mixing coarse powder of multiple Chinese herbs into the paste base, or by decocting multiple herbs together, extracting the extract, and then mixing it with the base. The aforementioned traditional preparation methods still have many shortcomings in practical applications: First, the chemical composition of various medicinal materials varies significantly, including hydrophilic components such as polysaccharides, flavonoids, and glycosides, as well as volatile oils, fat-soluble components, and some moderately polar components. If the entire formula is decocted together or simply pulverized and mixed, it is easy to result in low extraction rates or significant losses of some effective components, leading to unstable pharmacodynamic material basis. Second, the transdermal absorption efficiency of traditional plasters is limited, especially for some components with larger molecular weights or insufficient skin partition coefficients, making it difficult to fully penetrate the stratum corneum and achieve effective concentrations at the lesion site, resulting in slow onset of action, short duration of efficacy, or the need for frequent replacement. Third, the dosage form structure of traditional plasters is relatively simple, often lacking controlled-release structural design and membrane controlled-release regulation methods, leading to uncontrollable drug release curves and easy occurrences of insufficient initial release or significant release attenuation in the later stages. Fourth, common patches may experience leakage, insufficient adhesion, or excessive adhesion during application, leading to skin irritation and allergies, especially when the formula contains volatile components or animal drug powders, which are more likely to affect the comfort and stability of the application.

[0004] In summary, it is necessary to provide a new traditional Chinese medicine composition and its patch to improve the problems of low utilization rate of active ingredients, insufficient transdermal absorption, uncontrollable drug release, and poor product consistency in the existing technology. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition, a patch containing the traditional Chinese medicine composition, and a method for preparing the same. By optimizing the composition of the traditional Chinese medicine composition and the preparation of the patch, the resulting patch has excellent effects.

[0006] To better solve the above-mentioned technical problems, the present invention provides the following technical solution: In a first aspect, a traditional Chinese medicine composition, comprising, by weight, the following components: Eucommia ulmoides 15-25 parts, Chaenomeles speciosa 25-35 parts, Angelica sinensis 15-22 parts, Atractylodes lancea 18-25 parts, Astragalus membranaceus 15-25 parts, Scolopendra subspinipes 1.6-2.4 parts, Corydalis yanhusuo 15-25 parts, Drynaria fortunei 18-22 parts, Glycyrrhiza uralensis 10-20 parts, Polygonatum sibiricum 10-20 parts.

[0007] Secondly, a patch containing a traditional Chinese medicine composition includes a backing layer, a drug active layer, a controlled-release film layer, an adhesive layer, and a release layer; wherein the drug active layer is prepared by using an extract of the traditional Chinese medicine composition as the active ingredient.

[0008] Preferably, the backing layer is selected from either PET backing film or non-woven fabric backing.

[0009] Preferably, the release layer is a silicone oil release film.

[0010] Thirdly, a method for preparing a patch containing a traditional Chinese medicine composition includes the following steps: (1) Weigh each raw material according to the measurement ratio; (2) Cut Eucommia ulmoides, Astragalus membranaceus, Polygonatum sibiricum, Drynaria fortunei, and Glycyrrhiza uralensis into sections and grind them into powder. Then mix them with purified water and soak them at room temperature. After that, decoct them and extract them 1-2 times. Filter them, combine the filtrates, concentrate the filtrate and dry it to obtain extract A. Mix Angelica sinensis, Corydalis yanhusuo and ethanol solution and reflux extract them. Concentrate the extract and dry it to obtain extract B. Grind Chaenomeles speciosa and Atractylodes lancea into powder and mix them with ethanol solution. Reflux extract them. Concentrate the extract and dry it to obtain extract C. Crush Scolopendra and sieve it to obtain fine Scolopendra powder. Mix extract A, extract B, extract C and fine Scolopendra powder evenly to obtain active extract of traditional Chinese medicine. (3) The active extract of traditional Chinese medicine is mixed with film-forming material and plasticizer and added to purified water. The mixture is stirred evenly to obtain the active matrix of traditional Chinese medicine. The medical pressure-sensitive adhesive is mixed with the penetration enhancer and stirred to obtain the adhesive material. (4) Coating the surface of the backing layer with a traditional Chinese medicine active matrix and drying it to obtain a traditional Chinese medicine active layer; composite a controlled-release membrane on the surface of the traditional Chinese medicine active layer to obtain a controlled-release membrane layer; coating the surface of the controlled-release membrane with an adhesive layer material, then drying it, finally covering it with a release film layer and pressing it, finally curing it, and cutting it to obtain a patch containing a traditional Chinese medicine composition.

[0011] Preferably, in step (2), when preparing extract A, the amount of purified water used is 8-12 times the weight of the solid; the soaking time is 30-60 min; the decoction extraction temperature is 80-100℃ and the time is 1-2 h.

[0012] Preferably, when preparing extract B, the concentration of the ethanol solution is 50-80% v / v, and the amount of ethanol solution added is 6-12 times the weight of the solid; the reflux extraction conditions are: temperature 70-85℃, extraction time 1.0-2.0h, and extraction times 1-2 times.

[0013] Preferably, when preparing extract C, the concentration of the ethanol solution is 70-95% v / v, and the amount of ethanol solution added is 6-10 times the mass of the solid; the conditions for reflux extraction to prepare extract C are: temperature 75-85℃, time 1-2h, and extraction times 1-2 times.

[0014] Preferably, in step (3), the mass ratio of the active extract of traditional Chinese medicine, the film-forming material and the plasticizer is (10-45):(5-25):(5-20).

[0015] Preferably, the film-forming material is selected from at least one of polyvinyl alcohol, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, and gelatin; and the plasticizer is selected from at least one of propylene glycol, glycerin, and polyethylene glycol.

[0016] Preferably, in step (3), the conditions for preparing the active matrix of traditional Chinese medicine include: stirring at 40-60℃ for 30-90 min, followed by vacuum degassing at -0.06 to -0.09 MPa for 10-30 min to obtain the active matrix of traditional Chinese medicine.

[0017] Preferably, in step (3), the mass ratio of the medical pressure-sensitive adhesive to the penetration enhancer is (90-99.5):(0.5-10).

[0018] Preferably, the medical pressure-sensitive adhesive is selected from at least one of acrylic pressure-sensitive adhesive, silicone pressure-sensitive adhesive, and medical-grade rubber-type pressure-sensitive adhesive; the penetration enhancer is selected from at least one of menthol, borneol, and camphor; and the controlled-release membrane is selected from at least one of ethylene-vinyl acetate copolymer, polyurethane membrane, and cellulose derivative membrane.

[0019] Preferably, in step (3), the conditions for preparing the adhesive material include stirring at room temperature for 30-60 min.

[0020] Preferably, the drying conditions for preparing the active layer of traditional Chinese medicine are: drying at 40-70℃ for 10-40 min; the drying conditions for preparing the adhesive layer are: drying at 30-55℃ for 5-20 min; and the maturation conditions are: placing at 25-40℃ for 12-48 h.

[0021] Preferably, when composite controlled-release membranes are used, a roller press is employed for composite processing, including aligning the controlled-release membrane with the formed active layer of traditional Chinese medicine during feeding; heating the composite area to 30-60℃ by heating the composite rollers, controlling the composite pressure to 0.2-0.6MPa, and the linear speed to 0.5-3.0m / min; maintaining the tension of the controlled-release membrane at 2-15N and the tension of the active drug layer at 5-25N during the composite process.

[0022] Preferably, the release film lamination includes: pre-treating the release film at 25-40℃ for 2-12 hours; laying the semi-finished product coated with the adhesive layer flat, and gradually laminating the release film from one end, so that the release film contacts the adhesive layer; pressing with a rubber roller to remove air; lamination conditions: 0.05-0.3MPa, 20-35℃, 1-5min.

[0023] Preferably, the thickness of the backing layer is 10-150 μm, more preferably 20-80 μm, and even more preferably 25-50 μm; the thickness of the controlled-release membrane layer is 5-100 μm, and even more preferably 15-60 μm; the thickness of the drug-active layer is 300-2000 μm, and even more preferably 600-1300 μm; the thickness of the adhesion layer is 30-200 μm, and even more preferably 50-120 μm; and the thickness of the release layer is 25-200 μm, more preferably 50-150 μm, and even more preferably 75-125 μm.

[0024] Compared with the prior art, the present invention has at least the following advantages: 1. The traditional Chinese medicine composition of the present invention includes Eucommia ulmoides, Chaenomeles speciosa, Angelica sinensis, Atractylodes lancea, Astragalus membranaceus, Scolopendra subspinipes, Corydalis yanhusuo, Drynaria fortunei, Glycyrrhiza uralensis, and Polygonatum sibiricum. By optimizing the dosage of each component, the traditional Chinese medicine composition is prepared to meet the comprehensive requirements of tonifying the kidney and strengthening bones, promoting blood circulation and unblocking collaterals, and regulating qi and relieving pain. It is suitable for external treatment or adjuvant treatment of symptoms such as low back and leg pain caused by lumbar disc-related diseases. It is beneficial to improve local microcirculation and promote the repair of soft tissues and supporting structures while relieving pain, thereby improving the overall therapeutic effect and sustainability.

[0025] 2. The patch of the present invention adopts a structure of backing layer, drug active layer, controlled release film layer, adhesive layer and release layer, which can achieve controlled release of drug during the application process; by optimizing the thickness and type of controlled release film layer, the initial release and later maintenance of drug active ingredients can be effectively balanced, so that the patch can maintain stable release for a longer period of time, which helps to reduce the frequency of patch replacement.

[0026] 3. This invention employs different extraction and enrichment methods for different medicinal materials. Extract A is prepared from medicinal materials primarily containing hydrophilic components, extract B from medicinal materials primarily containing moderately polar components, and extract C from medicinal materials primarily containing volatile or fat-soluble components. Centipede is then prepared into a fine powder and combined with each extract to obtain an active extract of the traditional Chinese medicine. The above-mentioned segmented extraction and compounding methods can significantly improve the problems of insufficient extraction of effective components and significant loss of heat-sensitive components caused by traditional extraction methods, thereby increasing the utilization rate of effective components and making it suitable for large-scale production.

[0027] 4. This invention adds a certain amount of penetration enhancer to the adhesive layer, which can improve the transdermal penetration ability of active ingredients and increase the local effective concentration while ensuring the safety and adhesion stability of the patch. This improves the problems of insufficient transdermal absorption, slow onset of action and short duration of action of traditional Chinese medicine patches.

[0028] 5. In addition, by controlling the thickness of each layer in the patch and optimizing the patch preparation process, the present invention effectively balances the drug loading, adhesion and application comfort of the patch, reduces the risk of leakage, detachment, edge lifting or skin irritation, and improves the stability of product use. Detailed Implementation

[0029] To further illustrate the technical means and effects of the present invention in achieving the intended purpose, the following detailed description of the specific implementation methods, structures, features and effects of the present invention, in conjunction with preferred embodiments, is provided below.

[0030] The performance parameters and sources of some raw materials in this invention embodiment are as follows: Polyvinyl alcohol (PVA, Shanghai Maclean Biochemical Technology Co., Ltd., batch number C14782532); Hydroxypropyl methylcellulose: 15000 cps (pharmaceutical excipient, Huzhou Zhanwang Pharmaceutical); Medical-grade acrylic pressure-sensitive adhesive: DURO-TAK180-129A, Shanghai Hongchong New Material Technology Co., Ltd.; EVA controlled-release membrane: 3M China Co., Ltd.; Silicone oil release film: Jiangsu Sidike New Material Technology Co., Ltd.

[0031] Example 1 A method for preparing a patch containing a traditional Chinese medicine composition includes the following steps: (1) Weigh the following raw materials by weight: 20 parts of Eucommia ulmoides, 30 parts of Chaenomeles speciosa, 18 parts of Angelica sinensis, 22 parts of Atractylodes lancea, 20 parts of Astragalus membranaceus, 2 parts of Scolopendra subspinipes, 20 parts of Corydalis yanhusuo, 20 parts of Drynaria fortunei, 15 parts of Glycyrrhiza uralensis, and 15 parts of Polygonatum sibiricum. (2) Wash Eucommia ulmoides, Astragalus membranaceus, Polygonatum sibiricum, Drynaria fortunei and raw Glycyrrhiza uralensis, cut them into sections and crush them to 20 mesh; add 10 times the weight of purified water and soak for 45 min, then decoct and extract (extraction temperature 95℃, extraction time 1.5 h, extraction times 2), combine the extracts, filter through a 200 mesh filter cloth, concentrate under reduced pressure at 60℃ to a relative density of 1.20, and then spray dry to obtain extract A; (3) After crushing Angelica sinensis and Corydalis yanhusuo to 20 mesh, add 70% v / v ethanol solution, the amount of ethanol is 8 times the weight of the medicinal materials; reflux extract at 80℃ for 1.5h, extract twice, combine the extracts, filter and concentrate under reduced pressure to paste, and then dry under vacuum to obtain extract B; (4) Pulverize papaya and Atractylodes lancea to 20 mesh and add 90% v / v ethanol solution. The amount of ethanol used is 8 times the weight of the medicinal materials. Reflux extract at 80℃ for 1.5h. Extract once. Filter the extract, concentrate under reduced pressure and dry to obtain extract C. (5) After drying the centipede, crush it and pass it through a 200-mesh sieve to obtain centipede powder; (6) Mix the above extracts A, B, C and centipede powder evenly to obtain the active extract of traditional Chinese medicine; add the above active extract of traditional Chinese medicine, polyvinyl alcohol, hydroxypropyl methylcellulose, propylene glycol and glycerin in a mass ratio of 30:12:8:10:5 to purified water, stir at 50°C for 60 min to fully dissolve and form a uniform solution; then degas under vacuum at -0.08 MPa for 20 min to obtain the active matrix of traditional Chinese medicine; mix medical acrylic pressure-sensitive adhesive with menthol and borneol in a mass ratio of 95:3:2, stir at room temperature for 45 min to obtain the adhesive material; (7) Select a 40μm thick nonwoven fabric as the backing layer; uniformly coat the surface of the backing layer with a traditional Chinese medicine active matrix, the wet film thickness is 1000μm, and dry at 60℃ for 30min to form a traditional Chinese medicine active layer; roll-press the EVA controlled-release film (30μm thick) with the traditional Chinese medicine active layer (temperature 50℃, pressure 0.4 MPa, linear speed 1.5 m / min); coat the surface of the controlled-release film with an adhesive material, the thickness is 80μm, and dry at 40℃ for 10min; finally, cover the surface of the adhesive layer with a silicone oil release film and press (pressing pressure: 0.15MPa, pressing temperature: 30℃, time: 3min), and cure the obtained patch at 35℃ for 24h; cut it into 10cm×14cm specifications to obtain the patch.

[0032] Example 2 A method for preparing a patch containing a traditional Chinese medicine composition includes the following steps: (1) Weigh the following raw materials by weight: 18 parts Eucommia ulmoides, 28 parts Chaenomeles speciosa, 20 parts Angelica sinensis, 20 parts Atractylodes lancea, 18 parts Astragalus membranaceus, 2 parts Scolopendra subspinipes, 18 parts Corydalis yanhusuo, 19 parts Drynaria fortunei, 12 parts Glycyrrhiza uralensis, and 15 parts Polygonatum sibiricum. (2) Wash Eucommia ulmoides, Astragalus membranaceus, Polygonatum sibiricum, Drynaria fortunei and raw Glycyrrhiza uralensis, cut them into sections and crush them to 20 mesh; add 9 times the weight of purified water and soak for 45 min, then decoct and extract (extraction temperature 90℃, extraction time 1.5 h, extraction times 2), combine the extracts, filter through a 200 mesh filter cloth, concentrate under reduced pressure at 60℃ to a relative density of 1.20, and then spray dry to obtain extract A; (3) After crushing Angelica sinensis and Corydalis yanhusuo to 20 mesh, add 60% v / v ethanol solution, the amount of ethanol is 8 times the weight of the medicinal materials; reflux extract at 80℃ for 1.5h, extract twice, combine the extracts, filter and concentrate under reduced pressure to paste, and then dry under vacuum to obtain extract B. (4) Pulverize papaya and Atractylodes lancea to 20 mesh and add 85% v / v ethanol solution. The amount of ethanol used is 8 times the weight of the medicinal materials. Reflux extract at 80℃ for 1 h. Extract once in total. Filter the extract, concentrate under reduced pressure and dry to obtain extract C. (5) After drying the centipede, crush it and pass it through a 200-mesh sieve to obtain centipede powder; (6) Mix the above extracts A, B, C and centipede powder evenly to obtain the active extract of traditional Chinese medicine; add the above active extract of traditional Chinese medicine, polyvinyl alcohol, hydroxypropyl methylcellulose, propylene glycol and glycerin in a mass ratio of 30:12:8:10:5 to purified water, stir at 50°C for 60 min to fully dissolve and form a uniform solution; then degas under vacuum at -0.08 MPa for 20 min to obtain the active matrix of traditional Chinese medicine; mix medical acrylic pressure-sensitive adhesive with menthol and borneol in a mass ratio of 95:3:2, stir at room temperature for 45 min to obtain the adhesive material; (7) Select a 40μm thick nonwoven fabric as the backing layer; uniformly coat the surface of the backing layer with a traditional Chinese medicine active matrix, the wet film thickness is 1000μm, and dry at 60℃ for 30min to form a traditional Chinese medicine active layer; roll-press the EVA controlled-release film (30μm thick) with the traditional Chinese medicine active layer (temperature 50℃, pressure 0.4 MPa, linear speed 1.5 m / min); coat the surface of the controlled-release film with an adhesive material, the thickness is 80μm, and dry at 40℃ for 10min; finally, cover the surface of the adhesive layer with a silicone oil release film and press (pressing pressure: 0.15MPa, pressing temperature: 30℃, time: 3min), and cure the obtained patch at 35℃ for 24h; cut it into 10cm×14cm specifications to obtain the patch.

[0033] Example 3 A method for preparing a patch containing a traditional Chinese medicine composition includes the following steps: (1) Weigh the following raw materials by weight: 20 parts Eucommia ulmoides, 30 parts Chaenomeles speciosa, 20 parts Angelica sinensis, 20 parts Atractylodes lancea, 20 parts Astragalus membranaceus, 2 parts Scolopendra subspinipes, 20 parts Corydalis yanhusuo, 20 parts Drynaria fortunei, 15 parts Glycyrrhiza uralensis, and 15 parts Polygonatum sibiricum. (2) Wash Eucommia ulmoides, Astragalus membranaceus, Polygonatum sibiricum, Drynaria fortunei and raw Glycyrrhiza uralensis, cut them into sections and crush them to 20 mesh; add 10 times the weight of purified water and soak for 45 min, then decoct and extract (extraction temperature 95℃, extraction time 1.5 h, extraction times 2), combine the extracts, filter through a 200 mesh filter cloth, concentrate under reduced pressure at 60℃ to a relative density of 1.20, and then spray dry to obtain extract A; (3) After crushing Angelica sinensis and Corydalis yanhusuo to 20 mesh, add 70% v / v ethanol solution, the amount of ethanol is 8 times the weight of the medicinal materials; reflux extract at 80℃ for 1.5h, extract twice, combine the extracts, filter and concentrate under reduced pressure to paste, and then dry under vacuum to obtain extract B; (4) Pulverize papaya and Atractylodes lancea to 20 mesh and add 90% v / v ethanol solution. The amount of ethanol used is 8 times the weight of the medicinal materials. Reflux extract at 80℃ for 1.5h. Extract once. Filter the extract, concentrate under reduced pressure and dry to obtain extract C. (5) After drying the centipede, crush it and pass it through a 200-mesh sieve to obtain centipede powder; (6) Mix the above extracts A, B, C and centipede powder evenly to obtain the active extract of traditional Chinese medicine; add the above active extract of traditional Chinese medicine, polyvinyl alcohol, hydroxypropyl methylcellulose, propylene glycol and glycerin in a mass ratio of 30:12:8:10:5 to purified water, stir at 50°C for 60 min to fully dissolve and form a uniform solution; then degas under vacuum at -0.08 MPa for 20 min to obtain the active matrix of traditional Chinese medicine; mix medical acrylic pressure-sensitive adhesive with menthol and borneol in a mass ratio of 95:3:2, stir at room temperature for 45 min to obtain the adhesive material; (7) Select a 40μm thick nonwoven fabric as the backing layer; uniformly coat the surface of the backing layer with a traditional Chinese medicine active matrix, the wet film thickness is 1200μm, and dry at 60℃ for 30min to form a traditional Chinese medicine active layer; roll-press the EVA controlled-release film (30μm thick) with the traditional Chinese medicine active layer (temperature 50℃, pressure 0.4 MPa, linear speed 1.5 m / min); coat the surface of the controlled-release film with an adhesive material, the thickness is 80μm, and dry at 40℃ for 10min; finally, cover the surface of the adhesive layer with a silicone oil release film and press (pressing pressure: 0.15MPa, pressing temperature: 30℃, time: 3min), and mature the obtained patch at 35℃ for 24h; cut it into 10cm×14cm specifications to obtain the patch.

[0034] Comparative Example 1 The difference between this example and Example 1 is that all the medicinal materials were mixed together with purified water and boiled for extraction. The boiling conditions were the same as those for extract A, and the other conditions were the same as those in Example 1.

[0035] Comparative Example 2 The difference between this example and Example 1 is that the controlled-release membrane layer is not included, while the other conditions are the same as in Example 1.

[0036] Comparative Example 3 The difference between this example and Example 1 is that no penetration enhancer is added when preparing the adhesive layer material; all other conditions are the same as in Example 1. Comparative Example 4 The difference between this example and Example 1 is that all the medicinal materials are pulverized to 100 mesh, without extraction, and directly mixed with purified water and coated onto the backing layer. Other operations are the same as in Example 1.

[0037] The performance of the patches prepared in the above embodiments and comparative examples was tested, and the test methods and results are as follows: Animal pharmacodynamic experiments: 1. Experimental materials: Test drug: The patches prepared in the examples and comparative examples, with a size of 10cm×14cm / patch; Experimental animals: SPF-grade KM mice, weighing 18-22g, half male and half female; SD rats, weighing 180-220g, male; animals were housed in a standard environment (temperature 22-25℃, relative humidity 50%-60%), with free access to food and water, and were acclimatized for 1 week before the experiment; 2. Experimental methods: (1) Xylene-induced ear swelling experiment in mice: One hundred and forty KM mice were randomly divided into 14 groups (n=10): blank control group, aspirin positive control group (0.2 g / kg by gavage), Example 1-3 groups, and Comparative Example 1-4 groups. The drug administration groups were treated with the drug on the abdomen after hair removal 24 h before the experiment (the patch area was 2 cm × 2 cm), while the blank control group was treated with a blank patch without the drug. One h after the last drug administration, 0.02 mL of xylene was evenly applied to both sides of the right auricle of the mice, and the left ear was used as a control. After 30 min of inflammation, the mice were euthanized by cervical dislocation, and both ears were cut off along the auricle baseline. Ear pieces were removed from the same position using an 8 mm diameter punch, and accurately weighed. The difference in weight between the left and right ear pieces was used as the degree of swelling, and the swelling inhibition rate was calculated.

[0038] Swelling inhibition rate (%) = (swelling degree in blank group - swelling degree in drug-treated group) / swelling degree in blank group × 100%.

[0039] (2) Hot plate analgesia test: Female mice were pre-selected (screening criteria: pain threshold between 5-30 s on a 55℃ hot plate). 140 qualified mice were randomly divided into 14 groups (n=10): a blank control group, an aspirin positive control group (0.2 g / kg by gavage), Example 1-3 groups, and Comparative Example 1-4 groups. The normal pain threshold (time to lick hind paw) was measured in each group. The treatment group received an abdominal patch, while the blank control group received a blank patch. The pain threshold was measured at 1, 2, 4, 6, and 8 h after administration. If there was no response within 60 s, it was counted as 60 s. The percentage increase in pain threshold was calculated. Pain threshold increase rate (%) = (pain threshold after administration - pain threshold before administration) / pain threshold before administration × 100%.

[0040] The test results are shown in Table 1.

[0041] Table 1 ; As can be seen from the test results in Table 1, compared with the blank control group and the aspirin group, the patch containing the traditional Chinese medicine composition prepared in this embodiment of the invention showed a high inhibition rate (51.61%-56.23%) in the xylene-induced mouse ear swelling model, and maintained a high pain threshold elevation rate from 1 to 8 hours in the hot plate analgesia test, especially maintaining a high level of 48.2%-52.7% in the 6-8 hour stage, showing good analgesic persistence.

[0042] Compared to the examples, Comparative Example 1, which used a uniform water decoction for extraction of all medicinal materials, showed a swelling inhibition rate of only 32.98% and a 4-hour pain threshold increase rate of 42.3%, significantly lower than the 56.23% and 75.6% of Example 1. This indicates that using differentiated solvent systems and extraction methods for different medicinal materials is more conducive to enriching suitable active ingredients and reducing the extraction of ineffective or interfering components, thereby improving the anti-inflammatory and analgesic effects of the patch.

[0043] Without the controlled-release membrane layer, the swelling inhibition rate of the patch in Comparative Example 2 decreased to 28.84%, and the analgesic maintenance capacity also decreased (32.8% at 8 hours), significantly lower than that in Examples 1-3 (48.2%-52.7% at 8 hours). This demonstrates that the controlled-release membrane layer helps achieve sustained drug release and stability of transdermal delivery, thereby improving analgesic performance and anti-inflammatory effects in the mid-to-late stages.

[0044] Comparative Example 3, without adding a penetration enhancer to the adhesive layer material, showed a reduced swelling inhibition rate of 21.48% and significantly weakened analgesia (26.8% at 4 hours and 15.3% at 8 hours). In contrast, the patch of the Example 2, with the addition of menthol and borneol to the adhesive system, effectively improved transdermal absorption and efficacy.

[0045] The traditional Chinese medicine composition in Comparative Example 4, which was directly pulverized and coated without extraction, showed a swelling inhibition rate of only 14.77% and a low pain threshold improvement rate (only 11.5% after 4 hours). This indicates that the present invention obtains a relatively enriched and controllable active extract of traditional Chinese medicine through extraction, concentration, and drying, and forms a uniform drug carrier layer with the film-forming matrix, which can effectively improve the anti-inflammatory and analgesic effects of the patch.

[0046] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, Based on parts by weight, it includes the following components: Eucommia ulmoides 15-25 parts, Chaenomeles speciosa 25-35 parts, Angelica sinensis 15-22 parts, Atractylodes lancea 18-25 parts, Astragalus membranaceus 15-25 parts, Scolopendra subspinipes 1.6-2.4 parts, Corydalis yanhusuo 15-25 parts, Drynaria fortunei 18-22 parts, Glycyrrhiza uralensis 10-20 parts, Polygonatum sibiricum 10-20 parts.

2. A patch containing a traditional Chinese medicine composition, characterized in that, It includes a backing layer, a drug active layer, a controlled-release membrane layer, an adhesive layer, and a release layer; the drug active layer is prepared by using an extract of the traditional Chinese medicine composition according to claim 1 as the active ingredient.

3. A patch containing a traditional Chinese medicine composition according to claim 2, characterized in that, The backing layer is selected from PET backing film and non-woven fabric backing; and / or the release layer is silicone oil release film.

4. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 3, characterized in that, Includes the following steps: (1) Weigh each raw material according to the measurement ratio; (2) Cut Eucommia ulmoides, Astragalus membranaceus, Polygonatum sibiricum, Drynaria fortunei, and Glycyrrhiza uralensis into sections and grind them into powder. Then mix them with purified water and soak them at room temperature. After that, decoct them and extract them 1-2 times. Filter them, combine the filtrates, concentrate the filtrate and dry it to obtain extract A. Mix Angelica sinensis, Corydalis yanhusuo and ethanol solution and reflux extract them. Concentrate the extract and dry it to obtain extract B. Grind Chaenomeles speciosa and Atractylodes lancea into powder and mix them with ethanol solution. Reflux extract them. Concentrate the extract and dry it to obtain extract C. Crush Scolopendra and sieve it to obtain fine Scolopendra powder. Mix extract A, extract B, extract C and fine Scolopendra powder evenly to obtain active extract of traditional Chinese medicine. (3) The active extract of traditional Chinese medicine is mixed with film-forming materials and plasticizer and added to purified water. The mixture is stirred evenly to obtain the active matrix of traditional Chinese medicine. The medical pressure-sensitive adhesive and the penetration enhancer are mixed and stirred to obtain the adhesive material; (4) Coating the surface of the backing layer with a traditional Chinese medicine active matrix and drying it to obtain a traditional Chinese medicine active layer; composite a controlled-release membrane on the surface of the traditional Chinese medicine active layer to obtain a controlled-release membrane layer; coating the surface of the controlled-release membrane with an adhesive layer material, then drying it, finally covering it with a release film layer and pressing it, finally curing it, and cutting it to obtain a patch containing a traditional Chinese medicine composition.

5. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, In step (2), when preparing extract A, the amount of purified water used is 8-12 times the weight of the solid; the soaking time is 30-60 min; the decoction extraction temperature is 80-100℃ and the time is 1-2 h. When preparing extract B, the concentration of the ethanol solution is 50-80% v / v, and the amount of ethanol solution added is 6-12 times the weight of the solid; the reflux extraction conditions are: temperature 70-85℃, extraction time 1.0-2.0h, and extraction times 1-2 times. When preparing extract C, the concentration of the ethanol solution is 70-95% v / v, and the amount of ethanol solution added is 6-10 times the mass of the solid. The conditions for reflux extraction to prepare extract C are: temperature 75-85℃, time 1-2h, and extraction times 1-2 times.

6. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, In step (3), the mass ratio of the active extract of traditional Chinese medicine, film-forming material and plasticizer is (10-45):(5-25):(5-20).

7. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, The film-forming material is selected from at least one of polyvinyl alcohol, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, polyvinylpyrrolidone, and gelatin; And / or the plasticizer is selected from at least one of propylene glycol, glycerin, and polyethylene glycol; And / or the medical pressure-sensitive adhesive is selected from at least one of acrylic pressure-sensitive adhesive, silicone pressure-sensitive adhesive, and medical-grade rubber-type pressure-sensitive adhesive; And / or the penetration enhancer is selected from at least one of menthol, borneol, and camphor. And / or the controlled-release membrane is selected from at least one of ethylene-vinyl acetate copolymer, polyurethane membrane, and cellulose derivative membrane.

8. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, In step (3), the conditions for preparing the active matrix of traditional Chinese medicine include: stirring at 40-60℃ for 30-90 min, followed by vacuum degassing at -0.06 to -0.09 MPa for 10-30 min to obtain the active matrix of traditional Chinese medicine; And / or the mass ratio of the medical pressure-sensitive adhesive to the penetration enhancer is (90-99.5):(0.5-10); And / or the conditions for preparing the adhesive material include: stirring at room temperature for 30-60 min.

9. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, In step (4), the drying conditions for preparing the active layer of traditional Chinese medicine are: drying at 40-70℃ for 10-40 min; the drying conditions for preparing the adhesion layer are: drying at 30-55℃ for 5-20 min; the ripening conditions are: placing at 25-40℃ for 12-48 h. When using a controlled-release membrane and / or composite material, a roller laminating machine is employed for lamination, including: aligning the controlled-release membrane with the formed active medicinal layer during feeding; heating the lamination area to 30-60℃ using heated lamination rollers, controlling the lamination pressure at 0.2-0.6MPa, and the linear speed at 0.5-3.0m / min; maintaining the controlled-release membrane tension at 2-15 N and the active medicinal layer tension at 5-25 N during the lamination process. The release film lamination process includes: pre-treating the release film at 25-40℃ for 2-12 hours; laying the semi-finished product coated with the adhesive layer flat, gradually laminating the release film from one end, ensuring contact between the release film and the adhesive layer; pressing with a rubber roller to remove air; lamination conditions: 0.05-0.3MPa, 20-35℃, 1-5min.

10. The method for preparing a patch containing a traditional Chinese medicine composition according to claim 4, characterized in that, The thickness of the backing layer is 10-150 μm, the thickness of the controlled-release membrane layer is 5-100 μm, the thickness of the drug active layer is 300-2000 μm, the thickness of the adhesion layer is 30-200 μm, and the thickness of the release layer is 25-200 μm.