Traditional Chinese medicine gel plaster and preparation method thereof

Abstract

The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine gel plaster and a preparation method thereof. The traditional Chinese medicine gel plaster is prepared from the following components in parts by weight: 10-20 parts of Fructus Viticis, 10-20 parts of Cortex Paliurus, 10-20 parts of Gastrodia elata Blume and 10-20 parts of Radix Saposhnikoviae, which are used in combination to warm the meridians, dispel cold and diffuse wind; 10-20 parts of Cortex Cinnamomi, 10-20 parts of Caulis Lonicerae, 10-20 parts of Rhizoma Zingiberis and 10-20 parts of Bufo bufo gargarizans, which are used in combination to remove dampness and relieve spasm; 10-20 parts of Smilax glabra, 10-20 parts of Myrrha, 10-20 parts of Rabdosia rubescens, 10-20 parts of Radix Baphlai, 10-20 parts of Yellow lead, 10-20 parts of Olibanum, 10-20 parts of Borneol and 10-20 parts of Rhizoma Corydalis, which are used in combination to activate blood circulation to stop pain, remove swelling and promote tissue regeneration; sodium polyacrylate and glycyrrhizic acid-aluminum in a base composition provide viscosity for the traditional Chinese medicine gel plaster; glycerol and alligator oil not only adjust the viscosity of a plaster layer, but also have good skin care and repair effects; the traditional Chinese medicine gel plaster prepared by compounding glycerol, alligator oil, sodium polyacrylate, glycyrrhizic acid-aluminum and traditional Chinese medicine extracts has moderate viscosity, is not easy to fall off, has small stimulation to the skin and has good therapeutic effects on osteoarthritis.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine gel plaster and its preparation method. Background Technology

[0002] Osteoarthritis is a comprehensive joint disease involving structural changes in the hyaline articular cartilage, subchondral bone, ligaments, joint capsule, synovium, and surrounding muscles. Due to a global aging population, rising obesity rates, and increasing joint injuries, osteoarthritis has become a common and serious disease, impacting individuals, healthcare systems, and socioeconomic costs. Furthermore, other syndromes are on the rise, with an estimated 250 million people worldwide currently affected.

[0003] Osteoarthritis has an incidence rate of over 80% in my country, and it is more common in middle-aged and elderly women. Current treatment methods mainly include general treatments such as keeping warm, limiting movement, and reducing joint wear; drug therapy, represented by nonsteroidal anti-inflammatory drugs (NSAIDs) and chondroprotective agents; and surgical treatment, which is common in the late stages of arthritis. In comparison, traditional Chinese medicine plasters for osteoarthritis have advantages such as fewer side effects, lower price, and definite efficacy. Clinically, they are usually administered by mixing maltose and medicinal powder on-site; however, this method is prone to falling off during use, and the therapeutic effect is generally poor, with low patient compliance. Summary of the Invention

[0004] To address the issues of existing traditional Chinese medicine plasters for treating osteoarthritis being prone to falling off and having limited therapeutic effects, a traditional Chinese medicine gel plaster and its preparation method are provided.

[0005] Firstly, this application provides a traditional Chinese medicine gel patch:

[0006] A traditional Chinese medicine gel patch includes a backing layer, a paste layer, and an anti-adhesive film; the paste layer is composed of a traditional Chinese medicine extract and a matrix composition in a mass ratio of 1:(4-6);

[0007] The Chinese herbal extract, by weight, comprises the following raw materials: 10-12 parts of Vitex trifolia fruit, 8-12 parts of Cercis chinensis bark, 1-2 parts of Gastrodia elata, 3-5 parts of Saposhnikovia divaricata, 2-3 parts of Cinnamomum cassia bark, 1-3 parts of Clematis chinensis, 1-3 parts of Zingiber officinale, 1-3 parts of toad, 1-3 parts of Smilax glabra, 1-3 parts of Commiphora myrrha, 1-2 parts of Lycopodium clavatum, 1-2 parts of Lithospermum erythrorhizon, 1-2 parts of Litharge, 1-2 parts of Boswellia carterii, 1-2 parts of Borneol, and 1-3 parts of Corydalis yanhusuo.

[0008] The matrix composition, by weight, comprises 20-30 parts of glycerin, 5-10 parts of crocodile oil, 0.5-1.5 parts of aluminum hydroxyl, 0.5-2 parts of sodium polyacrylate, 20-40 parts of water, and 1-3 parts of a penetration enhancer.

[0009] The penetration enhancer is an essential oil with one or more of the following functions: dispelling wind-dampness, skin care, and pain relief.

[0010] Preferably, the traditional Chinese medicine extract is prepared by heating and refluxing the raw material of the traditional Chinese medicine extract with 3-5 times the volume of 60-85% ethanol, filtering, drying, and preparing.

[0011] By adopting the above technical solution, the traditional Chinese medicine extract is combined with vine, redbud bark, gastrodia tuber, and wind-preventing herb to mainly warm the channels and dispel wind; combined with cassia bark, kadsura, dried ginger, and toad to remove dampness and relieve stiffness; combined with smilax glabra, myrrh, rhizoma sinodendri, alkanna tinctoria, yellow dammar, frankincense, borneol, and rhizoma corydalis to promote blood circulation and relieve pain, and to relieve swelling and promote tissue regeneration; the traditional Chinese medicine extract mainly dispels cold and dampness to dredge the channels, and also promotes blood circulation and relieves pain, and relieves swelling and promotes tissue regeneration; the penetration enhancer in the matrix composition opens the skin channel to promote the absorption of the traditional Chinese medicine extract, and has good external use compatibility with the traditional Chinese medicine extract.

[0012] The sodium polyacrylate and glycyrrhizic acid in the matrix composition provide viscosity for the traditional Chinese medicine gel plaster; glycerol and alligator oil not only adjust the viscosity of the ointment layer, but also have good skin care and repair effects; the traditional Chinese medicine gel plaster prepared by combining glycerol, alligator oil, sodium polyacrylate, and glycyrrhizic acid with the traditional Chinese medicine extract has moderate viscosity, is not easy to peel off or fall off, has little irritation to the skin, and has good therapeutic effect on the treatment of osteoarthritis.

[0013] Preferably, the matrix composition further includes 0.5-1.5 parts by mass of olive oil, 0.5-2 parts of chitosan, and 0.5-1.5 parts by mass of honey.

[0014] By adopting the above technical solution, honey further improves the viscosity of the ointment layer of the traditional Chinese medicine gel plaster; chitosan has high adsorption and sustained-release properties, which can prolong the moisturizing effect of olive oil and adjust the viscosity of the ointment layer for a long time; the combination of olive oil, chitosan, and honey with other components in the ointment layer makes the traditional Chinese medicine gel plaster have moderate viscosity, which is not easy to fall off during use and has little pulling on the skin when peeled off; the combination of chitosan with olive oil, glycerol, and alligator oil can improve the moisturizing effect on the skin and improve the comfort of using the traditional Chinese medicine gel plaster.

[0015] Preferably, the matrix composition further includes 0.5-1 parts by mass of nano-polystyrene microspheres.

[0016] By adopting the above technical scheme, the polystyrene microspheres are used in the base paper substance: on the one hand, the polystyrene microspheres with high porosity and strong adsorption can adsorb and release small molecular substances in the paste layer, such as glycerol, alligator oil and penetration enhancer, and further play a long-time viscosity adjusting effect, so that the paste layer can maintain moderate viscosity for a long time, and the nano polystyrene microspheres can improve the air permeability of the paste, thereby improving the experience of using the traditional Chinese medicine gel plaster.

[0017] Preferably, the substrate composition further comprises 0.1-0.8 parts by mass of citric acid.

[0018] By adopting the above technical scheme, the citric acid can remove dirt on the surface of the skin, avoid dirt from blocking pores, and further improve the treatment effect of the traditional Chinese medicine gel plaster; the citric acid contains multiple carboxyl groups, which can improve the adhesion of the traditional Chinese medicine gel plaster, and the combination of citric acid and nano polystyrene microspheres makes the traditional Chinese medicine gel plaster not easy to fall off during use, and easy to peel off when removed, reducing the pulling of the traditional Chinese medicine gel plaster on the skin when removed, and improving the comfort during use and removal.

[0019] Preferably, the penetration enhancer is at least one of mint, sweet orange essential oil, jasmine essential oil, rosemary pure essential oil, rose essential oil and eucalyptus pure essential oil.

[0020] By adopting the above technical scheme, the type of penetration enhancer is preferably selected to improve the treatment effect of the traditional Chinese medicine gel plaster and / or reduce the irritation of the traditional Chinese medicine gel plaster to the skin.

[0021] Preferably, the penetration enhancer is a composition of rose essential oil, rosemary essential oil and eucalyptus essential oil with a mass ratio of (1-3) : 2 : 1.

[0022] By adopting the above technical scheme, the type and weight of the penetration enhancer are preferably selected to improve the treatment effect of the traditional Chinese medicine gel plaster and reduce the irritation to the skin.

[0023] Rose essential oil can promote blood circulation and cell regeneration; rosemary essential oil can improve congestion, edema, antibacterial, anti-rheumatic and analgesic; eucalyptus essential oil can relieve arthritis and rheumatic pain; the combination of rose essential oil, rosemary essential oil and eucalyptus essential oil, and the mutual synergy with other raw materials in the paste layer such as traditional Chinese medicine extract, glycerol and alligator oil, further improve the treatment effect of the traditional Chinese medicine gel plaster and reduce the irritation to the skin.

[0024] Preferably, the raw materials of the traditional Chinese medicine extract include 11 parts of fructus viticis, 12 parts of purple wattle bark, 1.5 parts of Gastrodia elata, 4 parts of wind-preventing herb, 2.5 parts of cassia bark, 3 parts of kadsura, 2 parts of dried ginger, 2 parts of toad, 3 parts of smilax glabra, 2 parts of myrrh, 1.5 parts of sinomenium, 1.5 parts of purple corn, 1.5 parts of yellow dan, 1.5 parts of frankincense, 2 parts of borneol, and 1.5 parts of rhizoma Corydalis.

[0025] By adopting the technical scheme, the formula of the traditional Chinese medicine extract is optimized, and the treatment effect of the traditional Chinese medicine gel plaster is improved.

[0026] Preferably, the backing layer is a non-woven fabric, and the anti-adhesion film is a textured film coated with adhesive on the adhesive surface.

[0027] By adopting the technical scheme, the backing layer is the carrier part of the gel plaster, mainly providing a drug loading platform and protection; and the anti-adhesion film is a surface covering part, used to protect the matrix layer and prevent drug leakage during storage.

[0028] In a second aspect, the application provides a preparation method of the traditional Chinese medicine gel plaster.

[0029] The preparation method of the traditional Chinese medicine gel plaster comprises the following preparation processes.

[0030] Preparation of the matrix composition: mixing and stirring glycyrrhizic acid, crocodile oil, sodium polyacrylate, and glycerol to obtain phase A; adding the penetration enhancer and the traditional Chinese medicine extract into water, stirring and mixing to obtain phase B; and then stirring the phase A and the phase B uniformly to obtain the matrix composition.

[0031] Preparation of the traditional Chinese medicine gel plaster: stirring and mixing the matrix composition and the traditional Chinese medicine extract according to a proportion, coating on the backing layer, covering with the anti-adhesion film, and obtaining the traditional Chinese medicine gel plaster.

[0032] By adopting the technical scheme, the prepared traditional Chinese medicine gel plaster has moderate viscosity and is not easy to fall off; the comfort degree is high during use, and the traditional Chinese medicine gel plaster is easy to separate from the skin during peeling, and the traditional Chinese medicine gel plaster contains skin care ingredients, which can improve the comfort degree of the skin.

[0033] In summary, the application has the following beneficial effects:

[0034] 1.A traditional Chinese medicine gel patch, wherein the traditional Chinese medicine collocation principle is: the combination of Fructus Viticis, Cortex Paliurus, Gastrodia and Saposhnikovia divaricata is used to warm the meridians, dispel cold and diffuse wind; the combination of Cortex Cinnamomi, Caulis Piperis Futokadsurae, Rhizoma Zingiberis and Bufo is used to remove dampness, remove arthralgia and spasm; the combination of Smilax glabra, Myrrha, Rhizoma Polygonati, Alkanna tinctoria, Cinnabaris, Olibanum, Borneolum Syntheticum and Rhizoma Corydalis is used to activate blood circulation, relieve pain, remove swelling and promote tissue regeneration; sodium polyacrylate and glycyrrhizin in the base composition provide viscosity for the traditional Chinese medicine gel patch; glycerol and alligator oil not only adjust the viscosity of the ointment layer, but also have good skin care and repair effects; the traditional Chinese medicine gel patch prepared by combining glycerol, alligator oil, sodium polyacrylate, glycyrrhizin and traditional Chinese medicine extracts has moderate viscosity, is not easy to fall off, has little irritation to the skin, and has good therapeutic effect on osteoarthritis.

[0035] 2.Further, the base composition further comprises 0.5-1.5 parts by mass of olive oil, 0.5-2 parts of chitosan and 0.5-1.5 parts by mass of honey; chitosan has high adsorption and sustained release performance, can sustain the release of olive oil and other small molecule substances in the ointment layer, such as glycerol, alligator oil and penetration enhancer, thereby adjusting the viscosity of the ointment layer, which is not easy to fall off during use and is easy to peel off, reducing the pulling and pain of the skin; the combination of olive oil, chitosan and honey with other components in the ointment layer makes the traditional Chinese medicine gel patch have moderate viscosity and continuously moisturize the skin, thereby improving the sensory experience of using the traditional Chinese medicine gel patch.

[0036] 3.Further, the preferred penetration enhancer is a combination of rose essential oil, rosemary essential oil and eucalyptus essential oil with a mass ratio of (1-3) : 2 : 1; rose essential oil can promote blood circulation and cell regeneration; rosemary essential oil can improve congestion, edema, antibacterial, anti-rheumatism and analgesia; eucalyptus essential oil can relieve arthritis and rheumatic pain; the combination of rose essential oil, rosemary essential oil and eucalyptus essential oil and other raw materials in the ointment layer, such as traditional Chinese medicine extracts, glycerol and alligator oil, further improves the therapeutic effect of the traditional Chinese medicine gel patch and the sensory experience of using the traditional Chinese medicine gel patch. DETAILED DESCRIPTION

[0037] Preparation examples of raw materials and / or intermediates

[0038] Preparation example 1-1, a traditional Chinese medicine extract, the raw materials of which include: Fructus Viticis 10 g, Cortex Paliurus 8 g, Gastrodia 1 g, Saposhnikovia divaricata 3 g, Cortex Cinnamomi 2 g, Caulis Piperis Futokadsurae 1 g, Rhizoma Zingiberis 1 g, Bufo 1 g, Smilax glabra 1 g, Myrrha 1 g, Rhizoma Polygonati 1 g, Alkanna tinctoria 1 g, Cinnabaris 1 g, Olibanum 2 g, Borneolum Syntheticum 1 g and Rhizoma Corydalis 1 g.

[0039] The traditional Chinese medicine extract is prepared by heating and refluxing the raw materials of the traditional Chinese medicine extract with 3 times the volume of 85% ethanol for 1 time, 3 hours each time, filtering, and drying the filtrate at 50°C.

[0040] Preparation Example 1-2, a traditional Chinese medicine extract, raw materials of which include: Fructus Viticis 11g, Redbud Bark 12g, Gastrodia 1.5g, Saposhnikovia 4g, Cinnamomum 2.5g, Toddalia asiatica 3g, Zingiber officinale 2g, Toad 2g, Smilax glabra 3g, Myrrha 2g, Stachys jamaicensis 1.5g, Alkanna tinctoria 1.5g, Sanguis draconis 1.5g, Olibanum 1.5g, Borneol 2g, Rhizoma Corydalis 1.5g.

[0041] The traditional Chinese medicine extract is prepared by heating and refluxing the raw materials of the traditional Chinese medicine extract with 75% ethanol for 2 times, 2 hours each time, filtering, and drying the filtrate at 60°C to obtain the traditional Chinese medicine extract.

[0042] Preparation Example 1-3, a traditional Chinese medicine extract, raw materials of which include: Fructus Viticis 12g, Redbud Bark 10g, Gastrodia 2g, Saposhnikovia 5g, Cinnamomum 3g, Toddalia asiatica 2g, Zingiber officinale 3g, Toad 3g Smilax glabra 2g, Myrrha 3g, Stachys jamaicensis 2g, Alkanna tinctoria 2g, Sanguis draconis 2g, Olibanum 2g, Borneol 1.5g, Rhizoma Corydalis 3g.

[0043] The traditional Chinese medicine extract is prepared by heating and refluxing the raw materials of the traditional Chinese medicine extract with 85% ethanol for 3 times, 1 hour each time, filtering, and drying the filtrate at 65°C to obtain the traditional Chinese medicine extract.

[0044] Example

[0045] Example 1, a traditional Chinese medicine gel plaster, which comprises a backing layer, a paste layer and a release film; the paste layer is composed of a traditional Chinese medicine extract and a base composition.

[0046] The base composition comprises 20g glycerol, 5g crocodile oil, 0.5g aluminum glyceryl hydroxystearate, 0.5g sodium polyacrylate (average molecular weight 3000, white powder), 20g water, 1g penetration enhancer (a combination of peppermint essential oil and sweet orange essential oil with a mass ratio of 1:1), 0.5g olive oil, 0.5g chitosan (MW average molecular weight 320,000, degree of substitution 95%), 0.5g honey, 0.5g nanometer polystyrene microspheres (average particle size 100nm), and 0.1g citric acid.

[0047] The preparation method of the traditional Chinese medicine gel plaster comprises the following preparation steps:

[0048] Preparation of the base composition: aluminum glyceryl hydroxystearate, crocodile oil, nanometer polystyrene microspheres, sodium polyacrylate and glycerol are added to a reaction kettle and stirred uniformly to obtain phase A; the penetration enhancer, olive oil, chitosan, honey, citric acid and the traditional Chinese medicine extract are added to water, stirred and mixed to obtain phase B; phase A and phase B are stirred uniformly to obtain the base composition.

[0049] Preparation of the Chinese medicine gel patch: the Chinese medicine extract (using Preparation Example 1) and the matrix composition are mixed according to a mass ratio of 1:6, and then the gel is formed by stirring. The gel is evenly coated on the non-woven backing layer, and the thickness of the gel layer is 0.4 mm (in other embodiments, it can be any thickness between 0.3-0.6 mm). Then, a release film (using a pressure embossed film coated with adhesive on the adhesive side) is covered, and a Chinese medicine gel patch is prepared.

[0050] Example 2, a Chinese medicine gel patch, which is different from Example 1 in that the mass ratio of the Chinese medicine extract to the matrix composition in the paste layer is 1:5, and the weights of the raw materials used in the matrix composition are different, as follows:

[0051] The matrix composition includes 25 g of glycerol, 8 g of alligator oil, 0.8 g of aluminum glycyrrhizinate, 1 g of sodium polyacrylate, 30 g of water, 2 g of a penetration enhancer (using rose essential oil), 1 g of olive oil, 1 g of chitosan, 0.8 g of honey, 0.8 g of nano-polystyrene microspheres, and 0.6 g of citric acid.

[0052] Example 3, a Chinese medicine gel patch, which is different from Example 1 in that the mass ratio of the Chinese medicine extract to the matrix composition in the paste layer is 1:4, the preparation example of the Chinese medicine extract is different, and the weights of the raw materials used in the matrix composition are different, as follows:

[0053] The Chinese medicine extract is prepared according to Preparation Example 3.

[0054] The matrix composition includes 30 g of glycerol, 10 g of alligator oil, 1.5 g of aluminum glycyrrhizinate, 2 g of sodium polyacrylate, 40 g of water, 3 g of a penetration enhancer (using rosemary essential oil), 1.5 g of olive oil, 2 g of chitosan, 1.5 g of honey, 1 g of nano-polystyrene microspheres, and 0.8 g of citric acid.

[0055] Example 4, a Chinese medicine gel patch, which is different from Example 1 in that the Chinese medicine extract is prepared according to Preparation Example 2, and the penetration enhancer is a combination of rose essential oil, rosemary essential oil, and eucalyptus essential oil in a mass ratio of 1:2:1.

[0056] Example 5, a Chinese medicine gel patch, which is different from Example 1 in that the penetration enhancer is a combination of rose essential oil, rosemary essential oil, and eucalyptus essential oil in a mass ratio of 3:2:1.

[0057] Example 6, a Chinese medicine gel patch, which is different from Example 1 in that olive oil, chitosan, and honey are not used in the matrix composition.

[0058] Example 7, a Chinese medicine gel patch, which is different from Example 1 in that nano-polystyrene microspheres are not used in the matrix composition.

[0059] Example 8, a Chinese medicine gel plaster, which differs from Example 1 in that citric acid is not used in the Chinese base composition.

[0060] Example 9, a Chinese medicine gel plaster, which differs from Example 1 in that nano polystyrene microspheres and citric acid are not used in the Chinese base composition.

[0061] Example 10, a Chinese medicine gel plaster, which differs from Example 1 in that olive oil, chitosan, honey, nano polystyrene microspheres and citric acid are not used in the Chinese base composition.

[0062] Comparative Example

[0063] Comparative Example 1, a Chinese medicine gel plaster, which differs from Example 10 in that the penetration enhancer is urea, menthol and azone in a mass ratio of 1:2:2; and glycerol is used instead of crocodile oil.

[0064] Performance test

[0065] Test 1: Adhesion

[0066] The Chinese medicine gel plasters of Examples 1 to 10 and Comparative Example 1 were adhered to the surface of the test plate with the adhesive side, vertically placed, and a weight (300 g) was hung along the length direction of the patch. The time for the test sample to slide and fall off or the distance of displacement within a certain time was recorded.

[0067] 1) Test device Test stand: composed of a base with adjustable level and a bracket for hanging and fixing the test plate. The test stand should keep the working surface of the test plate hanging on the bracket in vertical direction.

[0068] Test plate: a stainless steel plate with thickness of 1.5-2.0 mm, width of 125 mm and length of 125 mm, and surface roughness not more than 0.4 μm.

[0069] Roller: a steel shaft coated with rubber, weighing 2000 g.

[0070] Loading plate: same material, size and surface requirements as the test plate.

[0071] 2) Measurement method

[0072] Before the experiment, the test sample was placed at room temperature (18-25 °C) and relative humidity of 40%-70% for more than 2 h. The test plate and loading plate were cleaned with a wiping material dipped in anhydrous ethanol, carefully wiped dry with a clean dust-free cloth, and repeated more than 3 times until the surface of the test plate and loading plate was clean by visual inspection. The clean test plate and loading plate should not be touched by hand or other objects.

[0073] Take the traditional Chinese medicine gel patch (5 cm x 10 cm, 3 pieces for each test sample) of Examples 1 to 10 and Comparative Example 1, respectively, and stick the patch parallel to the longitudinal direction of the plate in the middle of the adjacent test plate and loading plate. Roll the patch back and forth on the plate three times with a roller, and pay attention to maintain a speed of about 300 mm / min when rolling. After rolling, the patch is placed at room temperature for 20 min, fixed on the test frame, and the time and position of the start of the experiment are recorded. After 30 min, the displacement value of the patch is measured, or the time when the patch falls off the test plate is recorded. N = 3 for the test sample, and the average value is taken.

[0074] Test 2: Hot-plate test

[0075] Establishment of rat knee osteoarthritis model

[0076] Take rats weighing (300 ± 20) g, anesthetize each rat with chloral hydrate, and disinfect the knee joint. Make a left parapatellar medial incision to expose the knee joint, incise the joint capsule, open the joint cavity, and dislocate the medial and lateral patella. Then, try to flex the knee joint to expose the anterior cruciate ligament, and cut the anterior cruciate ligament under direct vision with a small sharp knife. Then, determine the anterior cruciate ligament rupture by the drawer test. Next, stop bleeding completely, reset the patella, and close the incision layer by layer. Then, administer penicillin 400,000 μ intramuscularly once a day for 3 consecutive days.

[0077] Experimental grouping Example group: Take 50 model rats, and randomly divide them into 10 groups corresponding to Examples 1 to 10, with 5 rats in each group. Each rat is given the traditional Chinese medicine gel patch of the corresponding example (1.5 g of drug is given).

[0078] Comparative example group: Take 5 model rats, and give each rat the traditional Chinese medicine gel patch of the comparative example (1.5 g of drug is given).

[0079] Model group: Take 5 model rats, and only paste the blank patch without drug.

[0080] Hot-plate test

[0081] Place the 12 groups of rats on the (55 ± 0.5) °C hot plate and the (3 ± 0.5) °C cold plate, respectively. Take the time from the start of the experiment to the first licking of the foot as the pain response index. Each group has 5 rats, and the pain threshold (seconds, s) is recorded. The average value is taken, and the pain threshold before and after administration is tested.

[0082] Test 3: Ear swelling test

[0083] Screening qualified rats with body weight of (300±20) g, both male and female. The rats were randomly divided into 12 groups, 6 rats in each group; Examples 1 to 10, Comparative Example 1, in turn, using the traditional Chinese medicine gel patches of Examples 1 to 10 and Comparative Example 1 (1.5 g of drug), and the model group only pasting the blank patch without drug.

[0084] Before the experiment, the rats were fasted for 12 h without water, the right ear was pasted with the drug, 30 min after the end of the drug administration, 20 μL of xylene was evenly applied on the front and back of the right ear of the rat, and the left ear was not treated as a control. After 2 h, the rats were sacrificed, and the rat ear pieces with a diameter of 8 mm were punched from the same position of the left and right ears using a puncher, and weighed, respectively. The difference between the weights of the left and right ear pieces was calculated to evaluate the degree of inflammation and swelling. The ear swelling inhibition rate and swelling rate of each drug administration group were calculated and recorded (N=6, taking the average value), and the calculation method was as follows: swelling inhibition rate = (average swelling degree of the model group-average swelling degree of the drug administration group) / average swelling degree of the model group x 100%; swelling rate (%) = [right ear piece weight (g)-left ear piece weight (g)] / left ear piece weight (g) x 100%.

[0085] Test 4: Comprehensive sensory evaluation score

[0086] Three test personnel (with at least 1 year of experience in the sensory evaluation of traditional Chinese medicine patches) evaluated the traditional Chinese medicine gel patches of Examples 1 to 10 and Comparative Example 1 from the aspects of skin comfort, spreading property, and pain when removed after 24 h.

[0087] Evaluation of spreading property:

[0088] Easy: The gel formed by the traditional Chinese medicine extract and the base composition is easy to spread on the backing layer, and the film layer is uniform.

[0089] General: The gel formed by the traditional Chinese medicine extract and the base composition is easy to spread on the backing layer, and the uniformity of the film layer is poor, without visible particles.

[0090] Poor: The uniformity of the film layer is poor, with less than 10 visible small gel particles (less than 3 mm).

[0091] Poor: The film layer contains more than 10 visible small gel particles (less than 3 mm) or contains large gel particles greater than 3 mm.

[0092] Test results: The average adhesion, cold and hot plate test, ear swelling test, and comprehensive sensory evaluation score of the traditional Chinese medicine gel patches of Examples 1 to 10 and Comparative Example 1 are shown in Table 1.

[0093] Table 1, the average adhesion, cold and hot plate test, ear swelling test and comprehensive sensory evaluation of the Chinese medicine gel paste of examples 1 to 10 and comparative example 1

[0094]

[0095]

[0096] Table 2, the comprehensive sensory evaluation of the Chinese medicine gel paste of examples 1 to 10 and comparative example 1

[0097]

[0098] In combination with examples 1 to 10 and comparative example 1 and in combination with table 1, it can be seen that:

[0099] The average displacement of the Chinese medicine gel paste of examples 1 to 10 is lower than that of comparative example 1; the average pain threshold of cold and hot plate test after administration (from the start of the experiment to the first licking time) is higher than that of comparative example 1; the average swelling rate of ear swelling test is lower than that of comparative example 1 and model group, and the average swelling inhibition rate is higher than that of comparative example 1, indicating that the Chinese medicine gel paste of examples has a better therapeutic effect on osteoarthritis, and is not easy to fall off in use.

[0100] It may be because, on the one hand, the components in the traditional Chinese medicine extract in examples have a good compatibility effect; on the other hand, sodium polyacrylate and glycyrrhizinate in the matrix composition provide viscosity for the Chinese medicine gel paste; glycerol and alligator oil not only adjust the viscosity of the ointment layer, but also have good skin care and repair effect; glycerol, alligator oil, sodium polyacrylate and glycyrrhizinate are compatible with traditional Chinese medicine extract, and the Chinese medicine gel paste prepared therefrom has moderate viscosity, is not easy to peel off or fall off, has little irritation to the skin, and has a better therapeutic effect on the treatment of osteoarthritis.

[0101] The specific embodiments are only an explanation of the present application, and are not a limitation of the present application, and those skilled in the art can make non-creative contribution modifications to the embodiments according to the needs after reading the present specification, but as long as the scope of the claims of the present application is within the scope of the patent law.

Claims

1. A traditional Chinese medicine gel patch for treating osteoarthritis, characterized in that, It comprises a backing layer, a paste layer and an adhesive film; the paste layer is composed of traditional Chinese medicine extract and a base composition with a mass ratio of 1: (4-6) ; The raw materials of the traditional Chinese medicine extract, in terms of mass parts, consist of 10-12 parts of fructus viticis, 8-12 parts of purple acacia bark, 1-2 parts of gastrodia, 3-5 parts of ledebouriella, 2-3 parts of cassia bark, 1-3 parts of kadsura, 1-3 parts of toad, 1-3 parts of smilax, 1-3 parts of myrrh, 1-2 parts of rhizoma sinodendri, 1-2 parts of radix lithospermi, 1-2 parts of frankincense, 1-2 parts of borneol, and 1-3 parts of rhizoma corydalis. The base composition comprises 20-30 parts of glycerol, 5-10 parts of alligator oil, 0.5-1.5 parts of glycyrrhizic acid, 0.5-2 parts of polyacrylic acid sodium, 20-40 parts of water, and 1-3 parts of a penetration enhancer. The penetration enhancer is essential oil with one or more of the following functions: expelling wind and damp, skin care, and pain relief.

2. The Chinese medicine gel plaster for treating osteoarthritis according to claim 1, characterized in that, The traditional Chinese medicine extract is prepared by heating and refluxing the raw materials of the traditional Chinese medicine extract with 3-5 times the volume of 60-85% ethanol, filtering, drying, and preparing.

3. The Chinese medicine gel plaster for treating osteoarthritis according to claim 1, characterized in that, The base composition further comprises 0.5-1.5 parts of olive oil, 0.5-2 parts of chitosan, and 0.5-1.5 parts of honey.

4. The Chinese medicine gel plaster for treating osteoarthritis according to claim 3, characterized in that, The base composition further comprises 0.5-1 part of nano polystyrene microspheres.

5. The Chinese medicine gel plaster for treating osteoarthritis according to claim 4, characterized in that, The base composition further comprises 0.1-0.8 parts of citric acid.

6. The Chinese medicine gel plaster for treating osteoarthritis according to claim 1, characterized in that, The penetration enhancer is at least one of peppermint essential oil, sweet orange essential oil, jasmine essential oil, rosemary pure essential oil, rose essential oil, and eucalyptus pure essential oil.

7. The Chinese medicine gel plaster for treating osteoarthritis according to claim 6, characterized in that, The penetration enhancer is a composition of rose essential oil, rosemary essential oil, and eucalyptus essential oil with a mass ratio of (1-3):2:

1.

8. The Chinese medicine gel plaster for treating osteoarthritis according to claim 1, characterized in that, The raw materials of the traditional Chinese medicine extract, in terms of mass parts, consist of 11 parts of fructus viticis, 12 parts of purple acacia bark, 1.5 parts of gastrodia, 4 parts of ledebouriella, 2.5 parts of cassia bark, 3 parts of kadsura, 2 parts of toad, 3 parts of smilax, 2 parts of myrrh, 1.5 parts of rhizoma sinodendri, 1.5 parts of radix lithospermi, 1.5 parts of frankincense, 2 parts of borneol, and 1.5 parts of rhizoma corydalis.

9. The Chinese medicine gel plaster for treating osteoarthritis according to claim 1, characterized in that, The backing layer is non-woven fabric, and the adhesive film is a textured film coated with adhesive on the adhesive surface.

10. The preparation method of the traditional Chinese medicine gel plaster for treating osteoarthritis according to any one of claims 1-9, characterized in that, The method comprises the following steps: Preparation of the base composition: mix and stir glycyrrhizic acid, alligator oil, polyacrylic acid sodium, and glycerol to prepare phase A; add the penetration enhancer and the traditional Chinese medicine extract into water, stir and mix to prepare phase B; then stir and mix phase A and phase B uniformly to prepare the base composition; Preparation of the traditional Chinese medicine gel plaster: mix and stir the base composition and the traditional Chinese medicine extract according to the proportion, coat on the backing layer, cover with the adhesive film, and prepare the traditional Chinese medicine gel plaster.

Images