Traditional Chinese medicine composition for easing pain, plaster as well as preparation method and application of plaster

Abstract

The invention discloses a traditional Chinese medicine composition for easing pain, a plaster and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition for easing pain is prepared from the following components by weight: 10-35% of semen strychni; 5-20% of radix cyathulae; 5-20% of frankincense; 5-20% of bombyx batryticatus; 5-20% of scorpion; 5-20% of ground beetles; 5-20% of ephedra stem; 5-20% of myrrh; 5-20% of rhizoma atractylodis; 5-20% of dragon's blood; 5-20% of cinnamon; 5-20% of dahurian angelica root; 5-20% of notopterygium root; and 5-20% of licorice root. The invention also relates to a plaster of the traditional Chinese medicine composition for analgesia as well as a preparation method and application of the plaster. The traditional Chinese medicine composition for easing pain is suitable for treating shoulder, neck, waist and leg pain, rheumatic arthralgia, exercise and traumatic injury pain, pain and swelling caused by skeletal fluorosis, intractable facial paralysis caused by facial paralysis, trigeminal neuralgia and the like; the traditional Chinese medicine composition has the effects of relieving swelling and pain, promoting blood circulation to remove blood stasis, dispelling cold evil and warming and dredging meridians and collaterals, and has the advantages of quick response, long drug effect maintenance time, mild drug effect and small irritation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for pain relief, a plaster and a preparation method and application thereof. Background Art

[0002] Shoulder, neck, waist and leg pain is a common and frequently occurring disease, which is classified as arthralgia by traditional Chinese medicine. Pain is the main clinical symptom of this type of disease, causing physical and mental suffering and inconvenience in life for patients. In 2018, the World Health Organization listed chronic pain as an independent disease. Long-term and recurrent chronic pain can damage nerve tissue, thus seriously affecting the quality of life of patients. The survey results on the self-medication habits of chronic pain patients show that more than 60% of chronic pain patients manage pain through self-diagnosis and treatment. Topical medications are the first choice for early chronic pain treatment, and patches or plasters are widely used because of their significant advantages.

[0003] Currently, there are plaster preparations on the market for treating shoulder, neck, waist and leg pain, which have certain effects of promoting blood circulation and removing blood stasis, warming and unblocking meridians, and reducing swelling and relieving pain. However, existing plasters (such as musk analgesic plasters) mostly rely on volatile ingredients, have problems such as short duration of efficacy and high irritation to the skin. In addition, the traditional formulation has a rough extraction process, and the extraction rate of some active ingredients is insufficient, resulting in unstable efficacy.

[0004] Therefore, it is of great significance to develop long-acting and mild Chinese medicine compositions and plasters for analgesia. Summary of the invention

[0005] The invention aims to provide a traditional Chinese medicine composition for analgesia, a plaster and a preparation method and application thereof; the traditional Chinese medicine composition for analgesia is suitable for treating shoulder, neck, waist and leg pain, rheumatic joint pain, sports and traumatic injury pain, pain and swelling caused by fluorosis, refractory facial paralysis caused by facial nerve paralysis and trigeminal neuralgia, etc., has the effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, evacuating cold pathogens, warming and unblocking meridians, and has a fast onset time, a long drug effect maintenance time, and mild stimulation with little stimulation.

[0006] The technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine composition for analgesia, comprising the following components by weight:

[0008] Nux vomica 10~35%; Cyathula officinalis 5~20%; Frankincense 5~20%; Bombyx batryticatus 5~20%; Scorpio 5~20%; Eupolyphaga sinensis 5~20%; Ephedra 5~20%; Myrrh 5~20%; Atractylodes lancea 5~20%; Sanguisorba officinalis 5~20%; Cinnamon bark 5~20%; Angelica dahurica 5~20%; Notopterygium incisum 5~20%; Licorice 5~20%.

[0009] Preferably, the addition ratio of Strychnos nux vomica, Scorpio sinensis, Eupolyphaga sinensis and Licorice is 1-7:1:1:1.

[0010] More preferably, the addition ratio of Strychnos nux vomica, Scorpio sinensis, Eupolyphaga sinicus, and Licorice is 1.5-4.5:1:1:1; most preferably, the addition ratio of Strychnos nux vomica, Scorpio sinensis, Eupolyphaga sinicus, and Licorice is 3.2:1:1:1. Mixing toxic medicinal materials such as Strychnos nux vomica, Scorpio sinensis, Eupolyphaga sinicus, and Licorice in the above ratio can enhance the analgesic effect and reduce the toxicity, reduce the irritation, and improve the analgesic effect. Strychnos nux vomica can be raw Strychnos nux vomica or processed Strychnos nux vomica, preferably processed Strychnos nux vomica.

[0011] Preferably, it is made from the following components by weight:

[0012] Nux vomica 10~26%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpio 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 5~7%; Cinnamon bark 5~7%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%;

[0013] or,

[0014] Nux vomica 10~15%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpio 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 10~15%; Cinnamon bark 5~7%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%;

[0015] or,

[0016] Nux vomica 10~15%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpion 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 5~7%; Cinnamon bark 10~15%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%.

[0017] Properly increasing the proportion of cinnamon bark and / or dragon's blood in this formula can further enhance the blood stasis-removing effect, is suitable for the treatment of traumatic injuries, and has a better effect on ecchymosis and bruises caused by traumatic injuries.

[0018] Preferably, the composition further comprises 1-5% of Chuanwu and 1-5% of Kusnezoffii by weight. Adding Chuanwu and Kusnezoffii to the analgesic Chinese medicine composition can further enhance the analgesic effect and better focus on the treatment of pain.

[0019] The method for preparing the analgesic Chinese medicine composition as described in any one of the above items comprises the following steps:

[0020] The raw material of Strychnos nux vomica is crushed into particles, refluxed and extracted with 50-70% ethanol as solvent, filtered, and concentrated to an extract A with a density of 1.30-1.35 at 80°C;

[0021] Crush the raw materials of other components except Strychnos nux vomica, use 85-95% ethanol as solvent, reflux extract, filter and concentrate to extract B of 1.15-1.20 at 60°C;

[0022] The extract A and the extract B are combined to obtain the desired analgesic Chinese medicine composition.

[0023] Preferably, the raw material of Strychnos nux vomica is crushed into particles with a particle size of 2 to 5 mm, and 4 times the weight of 60% ethanol is used as a solvent. After soaking overnight, reflux extraction is performed at 60 to 80° C. for 2 to 3 times, each time for 1.5 to 2.5 hours, and the extracts are combined, filtered, and concentrated under reduced pressure to obtain the extract A;

[0024] and / or,

[0025] The raw materials of other components except Strychnos nux vomica were crushed, and refluxed and extracted 2 to 4 times with 4 times the weight of 90% ethanol as solvent, each time for 1.5 to 2.5 hours, and the extracts were combined, filtered and concentrated to obtain the extract B.

[0026] Experiments have found that controlling the particle size of the crushed strychnine to 2-5 mm has the best extraction effect. It can avoid the problem of low extraction rate when directly extracting the whole seeds, and also avoid the problem of difficulty in filtering the extract, making it easier to filter and reflux extraction operations. The average extraction rate of strychnine can reach more than 90%.

[0027] In the preparation method of the analgesic Chinese medicine composition, ethanol solution is used as a solvent to extract the above components. Although the paste yield is slightly lower than that of the water extraction process, the ethanol solution extraction can better take into account the extraction of water-soluble and fat-soluble active ingredients in the medicinal materials. The extract extracted by ethanol solution has a better analgesic effect than the extract extracted by water, and there is no significant difference in anti-inflammatory effect. In the preparation method, 50-70% ethanol is used as the solvent for extracting Strychnos nux vomica, and 60% ethanol is used as the optimal solvent; 85-95% ethanol is used as the solvent for extracting other mixed components, and 90% ethanol is used as the optimal solvent, which can obtain a relatively higher paste yield and better analgesic and anti-inflammatory effects.

[0028] A Chinese medicine composition plaster for analgesia, comprising a backing layer, a drug-carrying paste layer and a protective layer arranged in sequence;

[0029] The drug-carrying paste layer comprises a drug composition and a matrix material;

[0030] The pharmaceutical composition is the traditional Chinese medicine composition for analgesia described in any one of the above items, or is the traditional Chinese medicine composition for analgesia prepared by any one of the preparation methods described in the above items.

[0031] Preferably, the matrix material comprises sodium polyacrylate, polyacrylic acid, aluminum glycolate, disodium edetate, tartaric acid, sodium carboxymethylcellulose, polyvinyl alcohol, gelatin, kaolin, D-sorbitol, urea, methylparaben, propylparaben, glycerin, propylene glycol and purified water;

[0032] The matrix material uses sodium polyacrylate, polyacrylic acid, sodium carboxymethyl cellulose, polyvinyl alcohol and gelatin to form a composite thickening skeleton system. The three thickening agent components (sodium carboxymethyl cellulose, polyvinyl alcohol and gelatin) synergistically promote the adhesion of the prepared drug-loaded paste layer, which is more than 30% higher than the adhesion when using a single thickening agent, making the structure of the drug-loaded paste layer more stable, with strong adhesion to the effective ingredients of the drug composition, and excellent sustained-release ability, which can well achieve long-term and gentle drug delivery.

[0033] or,

[0034] The matrix material comprises polysorbate 80, L-tartaric acid, peppermint oil, sodium carboxymethylcellulose, glycerin, crotamiton, talc, aluminum glycolate, partially neutralized sodium polyacrylate, acrylic acid grafted starch, methyl ester / 2-ethylhexyl acrylate copolymer emulsion, disodium edetate, titanium dioxide, methylparaben and purified water;

[0035] The matrix material uses partially neutralized sodium polyacrylate, sodium carboxymethyl cellulose, acrylic acid grafted starch and methyl ester / 2-ethylhexyl acrylate copolymer emulsion to form a composite thickening skeleton system. The three thickening agent components (partially neutralized sodium polyacrylate, acrylic acid grafted starch and methyl ester / 2-ethylhexyl acrylate copolymer emulsion) synergistically promote the adhesion of the prepared drug-loaded paste layer, which is more than 30% higher than the adhesion of a single thickening agent, making the structure of the drug-loaded paste layer more stable, having strong adhesion to the effective ingredients of the drug composition, having good sustained-release ability, and being able to well achieve long-term and mild drug delivery.

[0036] or,

[0037] The matrix material includes styrene-isoprene-styrene block copolymer, terpene resin, liquid paraffin, butylated hydroxytoluene, kaolin, propylene glycol, and methyl paraben;

[0038] or,

[0039] The matrix material includes levomenthol, methylpyrrolidone, propylene glycol fatty acid ester, citric acid, isoprene styrene copolymer, polyisobutylene, rosin glycerol ester, mercaptobenzimidazole, butylated hydroxytoluene, and liquid paraffin;

[0040] The matrix material combination forms a temperature-sensitive matrix, which can soften and release drugs at 32-36°C (close to human skin temperature) after being loaded with the drug composition, and remain solid at room temperature, thereby avoiding drug release migration.

[0041] or,

[0042] The matrix material comprises acrylate pressure-sensitive adhesive, isopropyl myristate, propylene glycol and butylated hydroxytoluene.

[0043] Preferably, the drug-carrying paste layer is made of the following components in parts by weight:

[0044] The pharmaceutical composition comprises 5-25%, sodium polyacrylate 3-8%, polyacrylic acid solution of 20% concentration 8-15%, aluminum glycolate 0.1-0.5%, disodium edetate 0.05-0.15%, tartaric acid 1-3%, sodium carboxymethylcellulose 3-8%, polyvinyl alcohol 0.2-1%, gelatin 0.5-2%, kaolin 1-3%, D-sorbitol 15-30%, urea 2-5%, methylparaben 0.05-2%, propylparaben 0.05-0.2%, glycerol 15-25%, propylene glycol 3-8% and purified water 15-30%;

[0045] or,

[0046] 3-8% of the pharmaceutical composition, 0.2-0.6% of polysorbate 80, 0.5-2% of L-tartaric acid, 0.2-1% of peppermint oil, 0.2-1% of carboxymethyl cellulose sodium, 20-40% of glycerol, 1-3% of crotamiton, 5-15% of talc, 0.01-0.05% of aluminum glycolate, 3-10% of partially neutralized sodium polyacrylate, 3-10% of acrylic acid grafted starch, 3-9% of methyl ester / 2-ethylhexyl acrylate copolymer emulsion, 0.005-0.01% of disodium edetate, 0.1-0.5% of titanium dioxide, 0.05-0.15% of methylparaben and 25-50% of purified water;

[0047] or,

[0048] 3-8% of the pharmaceutical composition, 25-40% of styrene-isoprene-styrene block copolymer, 10-20% of terpene resin, 15-25% of liquid paraffin, 3-8% of butylated hydroxytoluene, 5-15% of kaolin, 2-7% of propylene glycol, and 3-7% of methyl paraben;

[0049] or,

[0050] The pharmaceutical composition 5-15%, levomenthol 1-1.5%, methylpyrrolidone 3-5%, propylene glycol fatty acid ester 1.5-2%, citric acid 0.2-0.5%, isoprene styrene copolymer 25-35%, polyisobutylene 1-3%, rosin glycerol ester 15-25%, mercaptobenzimidazole 0.15-0.3%, butylated hydroxytoluene 0.15-0.3%, liquid paraffin 25-40%;

[0051] or,

[0052] The pharmaceutical composition comprises 3-8%, 80-90% of acrylate pressure-sensitive adhesive, 2-5% of isopropyl myristate, 2-5% of propylene glycol, and 1-4% of butylated hydroxytoluene.

[0053] Preferably, the drug-carrying paste layer is made of the following components in parts by weight:

[0054] The pharmaceutical composition 5%, sodium polyacrylate 5%, polyacrylic acid solution with a concentration of 20% 10%, aluminum glycolate 0.23%, disodium edetate 0.1%, tartaric acid 1.5%, sodium carboxymethylcellulose 5%, polyvinyl alcohol 0.42%, gelatin 1.05%, kaolin 1.5%, D-sorbitol 20%, urea 3%, methylparaben 0.1%, propylparaben 0.05%, glycerol 18%, propylene glycol 5% and purified water 24.05%;

[0055] or,

[0056] The pharmaceutical composition 5%, polysorbate 80 0.4%, L-tartaric acid 1.2%, peppermint oil 0.5%, sodium carboxymethylcellulose 0.5%, glycerin 30%, crotamiton 2%, talc 9%, aluminum glycolate 0.03%, partially neutralized sodium polyacrylate 5.5%, acrylic acid grafted starch 4.5%, methyl ester / 2-ethylhexyl acrylate copolymer emulsion 4.5%, disodium edetate 0.008%, titanium dioxide 0.25%, methylparaben 0.1% and purified water 34.012%;

[0057] or,

[0058] The pharmaceutical composition 5%, styrene-isoprene-styrene block copolymer 35%, terpene resin 15%, liquid paraffin 20%, butylated hydroxytoluene 5%, kaolin 10%, propylene glycol 5%, methyl paraben 5%;

[0059] or,

[0060] The pharmaceutical composition 9.17%, levomenthol 1.38%, methylpyrrolidone 3.67%, propylene glycol fatty acid ester 1.83%, citric acid 0.37%, isoprene styrene copolymer 32.79%, polyisobutylene 1.83%, rosin glycerol ester 18.35%, mercaptobenzimidazole 0.23%, butyl hydroxytoluene 0.23%, liquid paraffin 30.15%;

[0061] or,

[0062] The pharmaceutical composition comprises 5%, acrylate pressure-sensitive adhesive 85%, isopropyl myristate 3%, propylene glycol 5%, and butylated hydroxytoluene 2%.

[0063] The preparation method of the above-mentioned analgesic Chinese medicine composition plaster comprises the following steps:

[0064] S11, mixing glycerol, sodium polyacrylate, sodium carboxymethyl cellulose and aluminum glycolate by vacuum stirring to obtain a mixture A1;

[0065] S12, stirring and mixing propylene glycol, the pharmaceutical composition, methylparaben and propylparaben to obtain a mixture B1;

[0066] S13, adding the mixture B1 into the mixture A1, stirring and mixing, to obtain a mixture C1;

[0067] S14, respectively stirring and mixing purified water, gelatin, polyvinyl alcohol, D-sorbitol, urea, tartaric acid, disodium edetate and kaolin; stirring and mixing purified water and a 20% polyacrylic acid solution; adding the mixed mixture to the mixture C1, stirring and mixing in vacuum to obtain a first drug-loaded paste;

[0068] S15, coating the first drug-carrying paste on the backing layer and covering it with a protective layer to prepare a Chinese medicine composition plaster for analgesia;

[0069] or,

[0070] S21, mixing glycerol, partially neutralized sodium polyacrylate, sodium carboxymethyl cellulose and aluminum glycolate by vacuum stirring to obtain a mixture A2;

[0071] S22, stirring and mixing the pharmaceutical composition, polysorbate 80, peppermint oil, crotamiton and methylparaben to obtain a mixture B2;

[0072] S23, adding the mixture B2 into the mixture A2, stirring and mixing, to obtain a mixture C2;

[0073] S24, mixing L-tartaric acid, talc, acrylic acid grafted starch, methyl ester / 2-ethylhexyl acrylate copolymer emulsion, disodium edetate, titanium dioxide and purified water, adding the mixture to the mixture C2, and mixing under vacuum to obtain a second drug-loaded ointment;

[0074] S25, coating the second drug-carrying paste on the backing layer and covering it with a protective layer to prepare a Chinese medicine composition plaster for analgesia;

[0075] or,

[0076] S31, taking styrene-isoprene-styrene block copolymer, terpene resin, liquid paraffin, butylated hydroxytoluene, kaolin, propylene glycol and methyl paraben, heating to 150° C. to melt and stirring to mix, to obtain a mixture A3;

[0077] S32, taking the drug composition, heating it to 40-50° C., melting it and stirring it to mix it evenly; after melting and mixing it evenly, adding it to the mixture A3, stirring and mixing it evenly, to obtain a third drug-loaded paste;

[0078] S33, coating the third drug-carrying paste on the backing layer, allowing it to stand and cool to form, and covering it with a protective layer after forming, to obtain a Chinese medicine composition plaster for analgesia;

[0079] or,

[0080] S41, taking methyl pyrrolidone, propylene glycol fatty acid ester, citric acid, isoprene styrene copolymer, polyisobutylene, rosin glycerol ester and liquid paraffin, heating to 150° C. to melt and stirring to mix, to obtain a mixture A4;

[0081] S42, taking the drug composition, heating it to 40-50° C., melting it and stirring it to mix it evenly; after melting and mixing it evenly, adding it to the mixture A4, and adding levomenthol, mercaptobenzimidazole and butylhydroxytoluene, stirring and mixing it evenly, to obtain a fourth drug-loaded ointment;

[0082] S43, coating the fourth drug-carrying paste on the backing layer, allowing it to stand and cool to form, and covering it with a protective layer after forming, to obtain a Chinese medicine composition plaster for analgesia;

[0083] or,

[0084] S51, dissolving the pharmaceutical composition and butylated hydroxytoluene in propylene glycol and isopropyl myristate, and mixing them uniformly to obtain a mixture A5;

[0085] S52, adding the mixture A5 to the acrylic pressure-sensitive adhesive solution, mixing evenly, to obtain a fifth drug-loaded paste;

[0086] S53, coating the fifth drug-carrying paste on the backing layer, drying, and covering with a protective layer to prepare an analgesic Chinese medicine composition plaster.

[0087] The use of any of the above-mentioned analgesic Chinese medicine compositions in the preparation of drugs for treating shoulder, neck, waist and leg pain, rheumatic joint pain, sports and traumatic injury pain, pain and swelling caused by fluorosis, refractory facial paralysis caused by facial nerve paralysis, and trigeminal neuralgia.

[0088] Compared with the prior art, the present invention has the following beneficial effects:

[0089] 1. The present application adopts Strychnos nux vomica, Cyathula officinalis, Olibanum, Bombyx batryticatus, Scorpio, Eupolyphaga sinensis, Ephedra, Myrrha, Atractylodes macrocephala, Sanguisorba officinalis, Cinnamon bark, Angelica dahurica, Notopterygium wilfordii and Liquorice for compatibility, and scientifically formulates a prescription in combination with traditional Chinese medicine theory to obtain a Chinese medicine composition with the effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, dispersing pathogenic cold, and warming and unblocking meridians, which can expel external pathogenic cold and dampness, warm and unblock meridians for pain relief, and treat both solid and stasis syndromes; wherein, by blending toxic medicinal materials such as Strychnos nux vomica, Scorpio, Eupolyphaga sinensis with Liquorice in a specific ratio, the effects of both enhancing analgesia and reducing toxicity are achieved, and the irritation is small; in addition, the effective ingredients of the various herbs used in the prescription of the Chinese medicine composition are mostly fat-soluble ingredients, have good skin permeability, can be well suitable for external use, and have good efficacy, stability and long duration. The analgesic Chinese medicine composition is suitable for treating shoulder, neck, waist and leg pain, rheumatic joint pain, sports and traumatic injury pain, as well as pain and swelling caused by fluorosis, refractory facial paralysis caused by facial nerve paralysis, trigeminal neuralgia, etc.

[0090] 2. The preparation method of the analgesic Chinese medicine composition of the present application is to crush the strychnine into particles alone, perform ethanol reflux extraction and concentration, and crush the other components together, perform ethanol reflux extraction and concentration, and combine the extract to obtain the extract; the preparation method is simple and can effectively improve the extraction rate of the effective ingredients, especially the average extraction rate of strychnine can reach more than 90%, which is significantly improved compared with the extraction rate of the traditional extraction method (the extraction rate of strychnine is less than 70%); among them, it is found that controlling the particle size of the crushed strychnine to 2~5mm has the best extraction effect, which can avoid the problem of low extraction rate of direct extraction of intact seeds and the problem of difficult filtration of the extract, and facilitate filtration and reflux extraction operations. The average extraction rate of strychnine can reach more than 90%.

[0091] 3. The present application provides various types of analgesic Chinese medicine composition patches (gel patches, hot-melt patches and solvent patches). Through the optimization of matrix materials and sustained-release design, long-term and mild drug administration is achieved, so that the irritation of the patch is low, the effective ingredients are released continuously and stably, and the drug effect lasts for a long time (10 hours or more); at the same time, the present application combines the ethanol extract of the formula medicinal materials with specific transdermal matrix materials (propylene glycol, peppermint oil, levomenthol, isopropyl myristate) to improve the drug penetration and absorption effect, effectively solving the problems of low drug permeability and high irritation of traditional patches (especially rubber patches), and the total clinical effectiveness rate is increased to more than 97%. DETAILED DESCRIPTION

[0092] In the following, only some exemplary embodiments are briefly described. As those skilled in the art will appreciate, the described embodiments may be modified in various ways without departing from the spirit or scope of the present invention. Therefore, the description is considered to be exemplary and non-restrictive in nature.

[0093] The embodiments of the present invention are described in detail below.

[0094] Example 1

[0095] Preparation of Chinese medicine composition (extract).

[0096] Take 403g of Strychnos nux vomica, 126g of Eupolyphaga sinensis, 126g of Cyathula officinalis, 126g of Ephedra sinica, 126g of Frankincense made with vinegar, 126g of Myrrh made with vinegar, 126g of Bombyx batryticatus stir-fried with bran, 126g of Atractylodes macrocephala stir-fried with bran, 126g of Scorpio scorpiorum, 126g of Sanguisorba officinalis, 126g of Cinnamon bark, 126g of Angelica dahurica, 126g of Notopterygium incisum, and 126g of Licorice. The ratio of Strychnos nux vomica, Scorpio scorpiorum, Eupolyphaga sinicus, and Licorice is about 3.2:1:1:1.

[0097] Among them, the strychnine is crushed into mung bean-sized particles with a particle size of 2-5 mm, and reflux extraction is performed using 60% ethanol as a solvent. The ethanol is recovered and concentrated under reduced pressure to a thick paste with a relative density of 1.30-1.35 at 80°C for use.

[0098] The remaining medicinal materials such as the earthworm and Sichuan cyathula were all mixed and crushed, and extracted with 90% ethanol reflux for 3 times, each time for 2 hours. The extracts were combined, filtered, and the filtrate was concentrated to a clear paste with a relative density of 1.15-1.20 at 60°C.

[0099] The above extracts (thick paste and clear paste) are combined to prepare a traditional Chinese medicine composition for analgesia.

[0100] Example 2

[0101] Preparation of Chinese medicine composition (extract).

[0102] Take 186g of Strychnos nux vomica, 84g of Eupolyphaga sinensis, 84g of Cyathula officinalis, 84g of Ephedra sinica, 84g of Frankincense made with vinegar, 84g of Myrrh made with vinegar, 84g of Bombyx batryticatus stir-fried with bran, 84g of Atractylodes macrocephala stir-fried with bran, 84g of Scorpio scorpio, 84g of Sanguisorba officinalis, 84g of Cinnamon bark, 84g of Angelica dahurica, 84g of Notopterygium incisum, and 84g of Licorice. The ratio of Strychnos nux vomica, Scorpio scorpio, Eupolyphaga sinicus, and Licorice is about 2.2:1:1:1.

[0103] The analgesic Chinese medicine composition was prepared in the same manner as in Example 1.

[0104] Example 3

[0105] Preparation of Chinese medicine composition (extract).

[0106] Take 538g of Strychnos nux vomica, 168g of Eupolyphaga sinensis, 168g of Cyathula capitata, 168g of Ephedra sinica, 168g of frankincense made with vinegar, 168g of myrrh made with vinegar, 168g of fried Bombyx batryticatus, 168g of fried Atractylodes lancea, 168g of scorpion, 168g of Sanguisorba officinalis, 168g of cinnamon bark, 168g of Angelica dahurica, 168g of Notopterygium wilfordii, and 168g of licorice.

[0107] The analgesic Chinese medicine composition was prepared in the same manner as in Example 1.

[0108] Example 4

[0109] Preparation of Chinese medicine composition (extract).

[0110] Take 205g of Strychnos nux vomica, 126g of Eupolyphaga sinensis, 126g of Cyathula capitata, 126g of Ephedra sinica, 126g of frankincense made with vinegar, 126g of myrrh made with vinegar, 126g of fried Bombyx batryticatus, 126g of fried Atractylodes lancea, 126g of scorpion, 205g of Sanguisorba officinalis, 126g of cinnamon bark, 126g of Angelica dahurica, 126g of Notopterygium wilfordii, and 126g of licorice.

[0111] The analgesic Chinese medicine composition was prepared in the same manner as in Example 1.

[0112] Example 5

[0113] Preparation of Chinese medicine composition (extract).

[0114] Take 135g of Strychnos nux vomica, 84g of Eupolyphaga sinensis, 84g of Cyathula capitata, 84g of Ephedra sinica, 84g of frankincense made with vinegar, 84g of myrrh made with vinegar, 84g of fried Bombyx batryticatus, 84g of fried Atractylodes lancea, 84g of scorpion, 84g of Sanguisorba officinalis, 135g of cinnamon bark, 84g of Angelica dahurica, 84g of Notopterygium wilfordii, and 84g of licorice.

[0115] The analgesic Chinese medicine composition was prepared in the same manner as in Example 1.

[0116] Example 6

[0117] Preparation of Chinese medicine composition (extract).

[0118] Take 269g of Strychnos nux vomica, 84g of Eupolyphaga sinensis, 84g of Cyathula capitata, 84g of Ephedra sinica, 84g of frankincense made with vinegar, 84g of myrrh made with vinegar, 84g of fried Bombyx batryticatus, 84g of fried Atractylodes lancea, 84g of scorpion, 84g of Sanguisorba officinalis, 84g of cinnamon bark, 84g of Angelica dahurica, 84g of Notopterygium wilfordii, 84g of Licorice, 30g of Aconiti Kusnezoffii, and 30g of Aconitum carmichaelii.

[0119] The analgesic Chinese medicine composition was prepared in the same manner as in Example 1.

[0120] Example 7

[0121] Prepare a Chinese medicine composition plaster (gel plaster).

[0122] (1) Prescription composition of drug-carrying paste layer

[0123] The drug-carrying paste layer is made of the following components by weight:

[0124] Components Weight ratio (w / w) The analgesic Chinese medicine composition prepared in Example 1 5% Sodium polyacrylate (400-600mpa.s) 5% Polyacrylic acid (20% solution) 10 Aluminum Glycol Hydroxide 0.23% Edetate Disodium 0.1% tartaric acid 1.5% Sodium carboxymethylcellulose (90-168mpa.s) 5% Polyvinyl alcohol (75000) 0.42% gelatin 1.05% Kaolin 1.5% D-Sorbitol 20% Urea 3% Methylparaben 0.1% Propylparaben 0.05% glycerin 18% Propylene glycol 5% Purified water 24.05%

[0125] Among them, sodium polyacrylate (400-600mPa.s) and polyacrylic acid (20% solution) mainly play a skeleton supporting role in the drug-loaded paste layer.

[0126] Aluminum glycohydroxy, disodium edetate and tartaric acid mainly play the role of cross-linking and cross-linking regulation in the drug-carrying paste layer; tartaric acid also has the function of pH regulation of the drug-carrying paste layer.

[0127] Sodium carboxymethyl cellulose (90-168mpa.s), polyvinyl alcohol (75000) and gelatin promote each other synergistically, playing a major role in composite thickening in the drug-loaded paste layer. At the same time, they form a composite thickening skeleton system with the skeleton material (sodium polyacrylate (400-600mpa.s) and polyacrylic acid (20% solution)), which greatly enhances the adhesion and structural stability of the drug-loaded paste layer, thereby having a better sustained-release ability of the drug-loaded ingredients.

[0128] Glycerin, propylene glycol and purified water are used as solvents to dissolve different matrix materials respectively, and propylene glycol is used as a transdermal enhancer to promote the skin's absorption of active ingredients.

[0129] (2) Preparation method of analgesic Chinese medicine composition plaster

[0130] According to the prescription composition of the above-mentioned drug-carrying paste layer, the following steps are adopted to prepare:

[0131] S11, weigh glycerol, sodium polyacrylate (400-600 mPa.s), sodium carboxymethyl cellulose (90-168 mPa.s) and aluminum glycolate according to the prescribed amount, and mix them in a blender (ZJ-3 or ZJ-200) by vacuum stirring to obtain a mixture A1.

[0132] S12, weighing the analgesic Chinese medicine composition prepared in Example 1, propylene glycol, methylparaben and propylparaben according to the prescribed amount, stirring and dispersing and mixing them uniformly to obtain a mixture B1.

[0133] S13, adding the mixture B1 into the mixture A1, and continuing to stir and mix evenly to obtain a mixture C1.

[0134] S14, respectively weighing gelatin, polyvinyl alcohol (75000), D-sorbitol, urea, tartaric acid, disodium edetate, kaolin and purified water according to the prescription amount, stirring and dispersing and mixing them; and weighing a polyacrylic acid solution with a concentration of 20% according to the prescription amount, stirring and dispersing and mixing them with purified water; adding the two mixed solutions to the mixture C1, mixing them evenly by vacuum stirring, and obtaining a first drug-loaded ointment.

[0135] S15, evenly coating the first drug-loaded paste on the backing layer, preferably with a coating thickness of 0.5-1 mm, leaving it to form, and covering it with a protective layer after forming to obtain a Chinese medicine composition plaster for analgesia.

[0136] Wherein, the backing layer is a stretch fabric or a non-woven fabric, preferably a four-sided stretch non-woven fabric; and the protective layer is preferably a polyethylene terephthalate (PET) film.

[0137] Example 8

[0138] Prepare a Chinese medicine composition plaster (gel plaster).

[0139] This embodiment is basically the same as Embodiment 7, the only difference being that the pharmaceutical composition used is the analgesic Chinese medicine composition prepared in Embodiment 2.

[0140] Example 9

[0141] Prepare a Chinese medicine composition plaster (gel plaster).

[0142] (1) Prescription composition of drug-carrying paste layer

[0143] The drug-carrying paste layer is made of the following components by weight:

[0144] Components Weight ratio (w / w) Example 2: Chinese herbal composition for analgesia 5% Polysorbate 80 0.4% L-Tartaric acid 1.2% peppermint 0.5% Sodium Carboxymethyl Cellulose (2000) 0.5% glycerin 30% Crotamiton 2% talcum powder 9% Aluminum Glycol Hydroxide 0.03% Partially neutralized sodium polyacrylate NP700 5.5% Acrylic acid grafted starch (SANWET IM-300MPS) 4.5% Methyl acrylate / 2-ethylhexyl acrylate copolymer emulsion (NIKASOL TS-620) 4.5% Edetate Disodium 0.008% Titanium Dioxide 0.25% Methylparaben 0.1% Purified water 34.012%

[0145] Among them, the partially neutralized sodium polyacrylate NP700 mainly plays a skeleton supporting role in the drug-loaded paste layer.

[0146] Sodium carboxymethyl cellulose (2000), acrylic acid grafted starch (SANWET IM-300MPS) and methyl ester / 2-ethylhexyl acrylate copolymer emulsion (NIKASOL TS-620) promote each other synergistically, mainly playing a composite thickening role in the drug-loaded paste layer, and at the same time forming a composite thickening skeleton system with the skeleton material (partially neutralized sodium polyacrylate NP700), which greatly improves the adhesion and structural stability of the drug-loaded paste layer, thereby having a better sustained-release ability of the drug-loaded ingredients.

[0147] L-tartaric acid, aluminum glycolate and disodium edetate mainly play the role of cross-linking and cross-linking regulation in the drug-carrying paste layer; L-tartaric acid also has the function of pH regulation of the drug-carrying paste layer.

[0148] Adding peppermint oil as a penetration enhancer can effectively promote the transdermal absorption of active ingredients in the drug-carrying ointment layer.

[0149] (2) Preparation method of analgesic Chinese medicine composition plaster

[0150] According to the prescription composition of the above-mentioned drug-carrying paste layer, the following steps are adopted to prepare:

[0151] S21, weigh glycerol, partially neutralized sodium polyacrylate NP700, sodium carboxymethyl cellulose (2000) and aluminum glycolate according to the prescribed amount, mix them in a blender (ZJ-3 or ZJ-200) by vacuum stirring to obtain a mixture A2.

[0152] S22, weigh the analgesic Chinese medicine composition (i.e., pharmaceutical composition) prepared in Example 2, polysorbate 80, peppermint oil, crotamiton, and methylparaben according to the prescribed amount, and stir and disperse to mix them to obtain a mixture B2.

[0153] S23, adding the mixture B2 into the mixture A2, and continuing to stir and mix evenly to obtain a mixture C2.

[0154] S24, weigh L-tartaric acid, talc, acrylic acid grafted starch (SANWET IM-300MPS), methyl ester / 2-ethylhexyl acrylate copolymer emulsion (NIKASOL TS-620), disodium edetate, titanium dioxide and purified water according to the prescription amount, stir and disperse to mix, add to the above mixture C2 after mixing, continue to stir and mix in vacuum to obtain a second drug-loaded ointment.

[0155] S25, evenly coating the second drug-loaded paste on the backing layer, preferably with a coating thickness of 0.5-1 mm, allowing it to stand for molding, and covering it with a protective layer after molding to obtain a Chinese medicine composition plaster for analgesia.

[0156] Wherein, the backing layer is a stretch fabric or a non-woven fabric, preferably a four-sided stretch non-woven fabric; and the protective layer is preferably a polyethylene terephthalate (PET) film.

[0157] Example 10

[0158] Prepare a Chinese medicine composition plaster (hot-melt plaster).

[0159] (1) Prescription composition of drug-carrying paste layer

[0160] The drug-carrying paste layer is made of the following components by weight:

[0161] Components Weight ratio (w / w) The analgesic Chinese medicine composition prepared in Example 1 5% Styrene-isoprene-styrene block copolymer (SIS D1163P) 35% Terpene resin 15% Liquid paraffin 20% Butylated Hydroxytoluene 5% Kaolin 10% Propylene glycol 5% Methylparaben 5%

[0162] The drug-carrying paste layer uses styrene-isoprene-styrene block copolymer (SIS D1163P) as a hot-melt non-hydrophilic matrix, adds terpene resin as a tackifier, adds liquid paraffin as a softener, adds propylene glycol as a solvent, and the components are cleverly combined to form a temperature-sensitive matrix, so that the drug-carrying paste layer will soften at 32-36°C (close to human skin temperature) and begin to release drugs; under room temperature conditions, the drug-carrying paste remains solid, which can better avoid the release and migration of active drug ingredients, especially avoid the volatilization and release of volatile active ingredients during transportation and storage, and can effectively improve the effectiveness of the patch; at the same time, propylene glycol acts as a transdermal accelerator to promote the transdermal absorption rate of active ingredients.

[0163] (2) Preparation method of analgesic Chinese medicine composition plaster

[0164] According to the prescription composition of the above-mentioned drug-carrying paste layer, the following steps are adopted to prepare:

[0165] S31, weigh styrene-isoprene-styrene block copolymer (SIS D1163P), terpene resin, liquid paraffin, butylated hydroxytoluene, kaolin, propylene glycol and methyl paraben into a container according to the prescription amount, heat to 150° C. to melt them and stir to mix them, to obtain a mixture A3.

[0166] S32, weigh the analgesic Chinese medicine composition (i.e., pharmaceutical composition) prepared in Example 1 according to the prescribed amount, heat it to 40-50° C. in a container, stir it to melt and mix it; after melting and mixing, add it to the above mixture A3, stir and mix it, to obtain a third drug-loaded ointment.

[0167] S33, evenly coating the third drug-loaded paste on the backing layer, preferably with a coating thickness of 0.5-1 mm, leaving it to cool and form, and covering it with a protective layer after forming to obtain a Chinese medicine composition plaster for analgesia.

[0168] Wherein, the backing layer is a stretch fabric or a non-woven fabric, preferably a stretch fabric; and the protective layer is preferably a polyethylene terephthalate (PET) film.

[0169] Embodiment 11

[0170] Prepare a Chinese medicine composition plaster (hot-melt plaster).

[0171] This embodiment is basically the same as Embodiment 10, the only difference being that the prescription composition of the drug-carrying paste layer is different.

[0172] The drug-carrying paste layer of this embodiment is made of the following components by weight:

[0173] Components Weight ratio (w / w) The analgesic Chinese medicine composition prepared in Example 1 9% Styrene-isoprene-styrene block copolymer (SIS D1163P) 35% Terpene resin 15% Liquid paraffin 18% Butylated Hydroxytoluene 5% Kaolin 8% Propylene glycol 5% Methylparaben 5%

[0174] Example 12

[0175] Prepare a Chinese medicine composition plaster (hot-melt plaster).

[0176] (1) Prescription composition of drug-carrying paste layer

[0177] The drug-carrying paste layer is made of the following components by weight:

[0178] Components Weight ratio (w / w) The analgesic Chinese medicine composition prepared in Example 1 9.17% Levomenthol 1.38% Methylpyrrolidone 3.67% Propylene glycol fatty acid esters 1.83% Citric acid 0.37% Isoprene styrene copolymer 32.79% Polyisobutylene 1.83% Glycerol ester of rosin 18.35% Mercaptobenzimidazole 0.23% Butylated Hydroxytoluene 0.23% Liquid paraffin 30.15%

[0179] The drug-carrying paste layer uses isoprene styrene copolymer as a hot-melt matrix, adds polyisobutylene and rosin glycerol ester as tackifiers, uses liquid paraffin as a solvent and softener, and adds mercaptobenzimidazole as an anti-aging agent. The components are cleverly combined to form a temperature-sensitive matrix, so that the drug-carrying paste layer can soften at 32-36°C (close to human skin temperature) and begin to release drugs; at room temperature, the drug-carrying paste remains solid, which can better avoid the release and migration of active ingredients of drugs, especially the volatilization and release of volatile active ingredients during transportation and storage, which can effectively improve the effectiveness of the patch. Levomenthol is added as a penetration enhancer to promote transdermal absorption of active ingredients.

[0180] (2) Preparation method of analgesic Chinese medicine composition plaster

[0181] According to the prescription composition of the above-mentioned drug-carrying paste layer, the following steps are adopted to prepare:

[0182] S41, weigh methyl pyrrolidone, propylene glycol fatty acid ester, citric acid, isoprene styrene copolymer, polyisobutylene, rosin glycerol ester and liquid paraffin into a container according to the prescribed amount, heat to about 150° C. to melt them and stir to mix them, to obtain a mixture A4.

[0183] S42, weigh the analgesic Chinese medicine composition (i.e., pharmaceutical composition) prepared in Example 1 according to the prescription amount, heat it to 40-50° C. in a container, stir it to melt and mix it; after melting and mixing, add it to the above mixture A4, stir and mix it, to obtain a fourth drug-loaded ointment.

[0184] S43, evenly coating the fourth drug-loaded ointment on the backing layer, leaving it to cool and form, and covering it with a protective layer after forming, to obtain a Chinese medicine composition plaster for analgesia.

[0185] Embodiment 13

[0186] A Chinese medicine composition plaster (solvent-based plaster) is prepared.

[0187] (1) Prescription composition of drug-carrying paste layer

[0188] The drug-carrying paste layer is made of the following components by weight:

[0189] Components Weight ratio (w / w) The analgesic Chinese medicine composition prepared in Example 1 5% Acrylic pressure sensitive adhesive (DURO-TAK 129A) 85% Isopropyl myristate 3% Propylene glycol 5% Butylated Hydroxytoluene 2%

[0190] The drug-carrying paste layer uses acrylic pressure-sensitive adhesive (DURO-TAK 129A) as a matrix, and isopropyl myristate and propylene glycol are added synergistically as transdermal enhancers to obtain a drug-carrying paste layer of a solvent-based patch. The patch has a high transdermal absorption rate, stable and reliable drug efficacy, and simple components and manufacturing processes.

[0191] (2) Preparation method of analgesic Chinese medicine composition plaster

[0192] According to the prescription composition of the above-mentioned drug-carrying paste layer, the following steps are adopted to prepare:

[0193] S51, weigh the analgesic Chinese medicine composition (i.e., pharmaceutical composition) prepared in Example 1 according to the prescribed amount, dissolve butylated hydroxytoluene in propylene glycol and isopropyl myristate, and mix well to obtain a mixture A5.

[0194] S52, weighing an acrylate pressure-sensitive adhesive solution, adding the mixture A5 to the acrylate pressure-sensitive adhesive solution, and mixing well to obtain a fifth drug-loaded paste.

[0195] S53, coating the fifth drug-carrying paste on the backing layer, and after drying, covering it with a protective layer to obtain an analgesic Chinese medicine composition plaster.

[0196] Verification Example 1 Pharmacodynamics Test

[0197] Experimental groups:

[0198] Grouping Chinese medicine composition plaster for pain relief Blank control group No plaster First gel patch group Prepared from Example 7 Second gel patch group Prepared from Example 8 The third gel patch group Prepared from Example 9 The first hot melt patch set Prepared from Example 10 Second hot melt patch group Prepared from Example 11 The third hot-melt patch group Prepared from Example 12 Solvent-based patch kit Prepared from Example 13

[0199] Dosage regimen and evaluation:

[0200] 80 male Kunming rats were randomly divided into 8 groups, with 10 rats in each group. The hair of the same part of the abdomen was shaved with an electric shaver 24 hours before the experiment, about 4 cm 2, leaving the skin bare. The test group attached the above patches to the hair removal area, with an area of ​​1cm×1cm, and administered once a day, 6 hours each time, for 3 consecutive days. After the last administration, the patches were removed, and each rat was intraperitoneally injected with a fresh 0.6% acetic acid solution 0.2ml / 10g, and the number of rat twists within 20min was counted and the pain inhibition rate was calculated.

[0201] Inhibition rate = (average number of twisting times in blank control group - average number of twisting times in experimental group) / average number of twisting times in blank control group * 100%.

[0202] Test results and conclusions

[0203] The test results are shown in Table 1.

[0204] Table 1 shows the test results of rat twisting times and pain inhibition rate

[0205] Group Number of twists (X±SD) Pain suppression rate (%) Blank control group 16.0±0.23 N / A First gel patch group (Example 7) 4.6±0.08 71.25 Second gel patch group (Example 8) 6.3±0.11 60.63 The third gel patch group (Example 9) 6.5±0.21 59.38 The first hot-melt patch group (Example 10) 4.8±0.14 70.00 Second hot-melt patch set (Example 11) 4.4±0.32 72.25 The third hot-melt patch group (Example 12) 4.5±0.06 71.88 Solvent-based patch group (Example 13) 4.7±0.13 70.63

[0206] According to the results shown in Table 1, compared with the blank control group, each drug administration group can significantly reduce the number of twisting caused by acetic acid, indicating that each experimental group has a good analgesic effect. The first gel patch group (patch of Example 7, adding 5% of the Chinese medicine composition of Example 1) is compared with the second gel patch group (patch of Example 8, adding 5% of the Chinese medicine composition of Example 2), indicating that the prescription of Example 1 has a better analgesic effect than the prescription of Example 2. The second gel patch group (patch of Example 8, adding 5% of the Chinese medicine composition of Example 2) is compared with the third gel patch group (patch of Example 9, adding 5% of the Chinese medicine composition of Example 2), indicating that there is no significant difference between the patches made of the two gel-type matrix materials, and their pharmaceutical compositions can both exert good analgesic effects. The comparison between the first hot-melt patch group (the patch of Example 10, with 5% of the Chinese medicine composition of Example 1 added) and the second hot-melt patch group (the patch of Example 11, with 9% of the Chinese medicine composition of Example 1 added) showed that both 5% and 9% of the Chinese medicine composition added to the patch had good analgesic effects, wherein the analgesic effect was improved to a certain extent when the amount of the Chinese medicine composition added was increased from 5% to 9%, but the difference was not obvious. The comparison between the second hot-melt patch group (the patch of Example 11, with 9% of the Chinese medicine composition of Example 1 added) and the third hot-melt patch group (the patch of Example 12, with 9.17% of the Chinese medicine composition of Example 1 added) showed that there was no significant difference between the patches made of the two hot-melt matrix materials, and their drug compositions could both exert good analgesic effects. Comparison between the first gel patch group (the patch of Example 7, with 5% of the Chinese medicine composition of Example 1 added), the first hot-melt patch group (the patch of Example 10, with 5% of the Chinese medicine composition of Example 1 added), and the solvent patch group (the patch of Example 13, with 5% of the Chinese medicine composition of Example 1 added) showed that there was no significant difference in the patches made of the three matrix materials, and their drug compositions could all exert good analgesic effects.

[0207] Verification Example 2 Pharmacology and pharmacodynamics test

[0208] Experimental drugs: analgesic Chinese herbal composition patch (using gel patch); excipient control patch (not containing analgesic Chinese herbal composition).

[0209] Dosage (g of Chinese herbal composition for analgesia / kg of body weight): 0.075g / kg; 0.15g / kg; 0.3g / kg.

[0210] (1) Analgesia test: The effects of acetic acid on the writhing reaction of mice, the tail-flick reaction of rats in a waterbath, and the tail-flick reaction of mice in a waterbath were tested.

[0211] (2) Anti-inflammatory test: The effect of croton oil on mouse ear swelling, carrageenan on rat foot swelling and cotton ball granuloma were tested.

[0212] (3) Observation of the effect of promoting blood circulation and removing blood stasis: Blood rheology test was conducted to observe the effect on rat hematocrit and whole blood viscosity under high shear rate and low shear rate.

[0213] (4) Autologous hematoma absorption test: observe the absorption of autologous hematoma in mice.

[0214] Test results:

[0215] The acetic acid writhing test in mice showed that the inhibition rates of the patch of the present invention on animal writhing were 72.4%, 56.9% and 41.7%, respectively, showing a strong analgesic effect; the tail-flick test showed that the patch took effect quickly and showed obvious analgesic effect 0.5 hours after taking the drug. The analgesic test proved that the gel patch of the present invention can very significantly increase the pain threshold of pain caused by chemical stimulation, photothermal stimulation, and warm stimulation.

[0216] Anti-inflammatory tests show that the plaster of the present invention has a very significant anti-inflammatory effect on three acute and chronic experimental inflammation models, and has a fast onset time and a long duration of drug efficacy.

[0217] The blood rheology test shows that the gel plaster of the present invention also has a certain effect of promoting blood circulation and removing blood stasis, indicating that the drug has the effect of relaxing muscles and promoting blood circulation, promoting blood circulation and relieving pain by promoting blood circulation and removing blood stasis, which is beneficial to the recovery of damaged tissues. The hematoma absorption test shows that the drug can promote the absorption of its own hematoma and accelerate the repair of damaged tissues, indicating that the external use of the plaster also has the effect of treating traumatic injuries and eliminating blood stasis and swelling.

[0218] Test conclusion:

[0219] The gel patch of the present invention can treat pain caused by various soft tissue injuries or chronic strains by promoting absorption of damaged tissue hematoma, anti-inflammatory and analgesic effects, and certain blood circulation and blood stasis removal effects. The test results are consistent with the functions and indications of the Chinese medicine composition.

[0220] Verification Example 3: Comparative Efficacy Test

[0221] The gel patch prepared in Example 7 of the present invention was studied and compared with the commercially available Voltaren cream (diclofenac diethylamide). The results showed that the onset time of the patch of the present invention was shortened by about 50% (the onset time of Voltaren cream was about 40 minutes, and the onset time of the patch of the present invention was about 20 minutes); the analgesic duration of the patch of the present invention was prolonged, the analgesic duration of Voltaren cream was about 4 hours, and the analgesic duration of the patch of the present invention was about 10 hours.

[0222] The gel patch prepared in Example 7 of the present invention was compared with a patch prepared using conventional rubber patch technology, and the transdermal absorption rate was studied using the Franz diffusion cell method. The results showed that the cumulative permeation amount of the patch of the present invention was about 2 times higher than that of the patch prepared using conventional rubber patch technology.

Claims

1. A Chinese medicine composition for analgesia, characterized in that: Made from the following components by weight: Nux vomica 10~35%; Cyathula officinalis 5~20%; Frankincense 5~20%; Bombyx batryticatus 5~20%; Scorpio 5~20%; Eupolyphaga sinensis 5~20%; Ephedra 5~20%; Myrrh 5~20%; Atractylodes lancea 5~20%; Sanguisorba officinalis 5~20%; Cinnamon bark 5~20%; Angelica dahurica 5~20%; Notopterygium incisum 5~20%; Licorice 5~20%.

2. The analgesic Chinese medicine composition according to claim 1, characterized in that: The adding ratio of Strychnos nux vomica, Scorpio sinensis, Eupolyphaga sinensis and Licorice is 1-7:1:1:

1.

3. The analgesic Chinese medicine composition according to claim 1 or 2, characterized in that: Made from the following components by weight: Nux vomica 10~26%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpio 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 5~7%; Cinnamon bark 5~7%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%; or, Nux vomica 10~15%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpio 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 10~15%; Cinnamon bark 5~7%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%; or, Nux vomica 10~15%; Cyathula officinalis 5~7%; Frankincense 5~7%; Bombyx batryticatus 5~7%; Scorpion 5~7%; Eupolyphaga sinensis 5~7%; Ephedra 5~7%; Myrrh 5~7%; Atractylodes lancea 5~7%; Sanguisorba officinalis 5~7%; Cinnamon bark 10~15%; Angelica dahurica 5~7%; Notopterygium incisum 5~7%; Licorice 5~7%.

4. The analgesic Chinese medicine composition according to claim 1 or 2, characterized in that: It also includes 1-5% of Chuanwu and 1-5% of Kusnezoffii by weight.

5. The method for preparing the analgesic Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: The raw material of Strychnos nux vomica is crushed into particles, refluxed and extracted with 50-70% ethanol as solvent, filtered, and concentrated to an extract A with a density of 1.30-1.35 at 80°C; Crush the raw materials of other components except Strychnos nux vomica, use 85-95% ethanol as solvent, reflux extract, filter and concentrate to extract B of 1.15-1.20 at 60°C; The extract A and the extract B are combined to obtain the desired analgesic Chinese medicine composition.

6. The method for preparing the analgesic Chinese medicine composition according to claim 5, characterized in that: The raw material of Strychnos nux vomica was crushed into particles with a particle size of 2-5 mm, and 4 times the weight of 60% ethanol was used as a solvent. After soaking overnight, the mixture was refluxed and extracted at 60-80° C. for 2-3 times, each time for 1.5-2.5 hours, and the extracts were combined, filtered, and concentrated under reduced pressure to obtain the extract A; and / or, The raw materials of other components except Strychnos nux vomica were crushed, and refluxed and extracted 2 to 4 times with 4 times the weight of 90% ethanol as solvent, each time for 1.5 to 2.5 hours, and the extracts were combined, filtered and concentrated to obtain the extract B.

7. A Chinese medicine composition plaster for analgesia, characterized in that: It includes a backing layer, a drug-carrying paste layer and a protective layer which are arranged in sequence; The drug-carrying paste layer comprises a drug composition and a matrix material; The pharmaceutical composition is the analgesic Chinese medicine composition according to any one of claims 1 to 4, or is the analgesic Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 6.

8. The analgesic Chinese medicine composition plaster according to claim 7, characterized in that: The matrix material comprises sodium polyacrylate, polyacrylic acid, aluminum glycolate, disodium edetate, tartaric acid, sodium carboxymethylcellulose, polyvinyl alcohol, gelatin, kaolin, D-sorbitol, urea, methylparaben, propylparaben, glycerin, propylene glycol and purified water; or, The matrix material comprises polysorbate 80, L-tartaric acid, peppermint oil, sodium carboxymethylcellulose, glycerin, crotamiton, talc, aluminum glycolate, partially neutralized sodium polyacrylate, acrylic acid grafted starch, methyl ester / 2-ethylhexyl acrylate copolymer emulsion, disodium edetate, titanium dioxide, methylparaben and purified water; or, The matrix material includes styrene-isoprene-styrene block copolymer, terpene resin, liquid paraffin, butylated hydroxytoluene, kaolin, propylene glycol, and methyl paraben; or, The matrix material includes levomenthol, methylpyrrolidone, propylene glycol fatty acid ester, citric acid, isoprene styrene copolymer, polyisobutylene, rosin glycerol ester, mercaptobenzimidazole, butylated hydroxytoluene, and liquid paraffin; or, The matrix material comprises acrylate pressure-sensitive adhesive, isopropyl myristate, propylene glycol and butylated hydroxytoluene.

9. The analgesic Chinese medicine composition plaster according to claim 7 or 8, characterized in that: The drug-carrying paste layer is made of the following components by weight: The pharmaceutical composition comprises 5-25%, sodium polyacrylate 3-8%, polyacrylic acid solution of 20% concentration 8-15%, aluminum glycolate 0.1-0.5%, disodium edetate 0.05-0.15%, tartaric acid 1-3%, sodium carboxymethylcellulose 3-8%, polyvinyl alcohol 0.2-1%, gelatin 0.5-2%, kaolin 1-3%, D-sorbitol 15-30%, urea 2-5%, methylparaben 0.05-2%, propylparaben 0.05-0.2%, glycerol 15-25%, propylene glycol 3-8% and purified water 15-30%; or, 3-8% of the pharmaceutical composition, 0.2-0.6% of polysorbate 80, 0.5-2% of L-tartaric acid, 0.2-1% of peppermint oil, 0.2-1% of carboxymethyl cellulose sodium, 20-40% of glycerol, 1-3% of crotamiton, 5-15% of talc, 0.01-0.05% of aluminum glycolate, 3-10% of partially neutralized sodium polyacrylate, 3-10% of acrylic acid grafted starch, 3-9% of methyl ester / 2-ethylhexyl acrylate copolymer emulsion, 0.005-0.01% of disodium edetate, 0.1-0.5% of titanium dioxide, 0.05-0.15% of methylparaben and 25-50% of purified water; or, 3-8% of the pharmaceutical composition, 25-40% of styrene-isoprene-styrene block copolymer, 10-20% of terpene resin, 15-25% of liquid paraffin, 3-8% of butylated hydroxytoluene, 5-15% of kaolin, 2-7% of propylene glycol, and 3-7% of methyl paraben; or, The pharmaceutical composition 5-15%, levomenthol 1-1.5%, methylpyrrolidone 3-5%, propylene glycol fatty acid ester 1.5-2%, citric acid 0.2-0.5%, isoprene styrene copolymer 25-35%, polyisobutylene 1-3%, rosin glycerol ester 15-25%, mercaptobenzimidazole 0.15-0.3%, butylated hydroxytoluene 0.15-0.3%, liquid paraffin 25-40%; or, The pharmaceutical composition comprises 3-8%, 80-90% of acrylate pressure-sensitive adhesive, 2-5% of isopropyl myristate, 2-5% of propylene glycol, and 1-4% of butylated hydroxytoluene.

10. The analgesic Chinese medicine composition plaster according to claim 9, characterized in that: The drug-carrying paste layer is made of the following components by weight: The pharmaceutical composition 5%, sodium polyacrylate 5%, polyacrylic acid solution with a concentration of 20% 10%, aluminum glycolate 0.23%, disodium edetate 0.1%, tartaric acid 1.5%, sodium carboxymethylcellulose 5%, polyvinyl alcohol 0.42%, gelatin 1.05%, kaolin 1.5%, D-sorbitol 20%, urea 3%, methylparaben 0.1%, propylparaben 0.05%, glycerol 18%, propylene glycol 5% and purified water 24.05%; or, The pharmaceutical composition 5%, polysorbate 80 0.4%, L-tartaric acid 1.2%, peppermint oil 0.5%, sodium carboxymethylcellulose 0.5%, glycerin 30%, crotamiton 2%, talc 9%, aluminum glycolate 0.03%, partially neutralized sodium polyacrylate 5.5%, acrylic acid grafted starch 4.5%, methyl ester / 2-ethylhexyl acrylate copolymer emulsion 4.5%, disodium edetate 0.008%, titanium dioxide 0.25%, methylparaben 0.1% and purified water 34.012%; or, The pharmaceutical composition 5%, styrene-isoprene-styrene block copolymer 35%, terpene resin 15%, liquid paraffin 20%, butylated hydroxytoluene 5%, kaolin 10%, propylene glycol 5%, methyl paraben 5%; or, The pharmaceutical composition 9.17%, levomenthol 1.38%, methylpyrrolidone 3.67%, propylene glycol fatty acid ester 1.83%, citric acid 0.37%, isoprene styrene copolymer 32.79%, polyisobutylene 1.83%, rosin glycerol ester 18.35%, mercaptobenzimidazole 0.23%, butyl hydroxytoluene 0.23%, liquid paraffin 30.15%; or, The pharmaceutical composition comprises 5%, acrylate pressure-sensitive adhesive 85%, isopropyl myristate 3%, propylene glycol 5%, and butylated hydroxytoluene 2%.

11. The method for preparing the analgesic Chinese medicine composition plaster according to any one of claims 8 to 10, characterized in that: The following steps are involved: S11, mixing glycerol, sodium polyacrylate, sodium carboxymethyl cellulose and aluminum glycolate by vacuum stirring to obtain a mixture A1; S12, stirring and mixing propylene glycol, the pharmaceutical composition, methylparaben and propylparaben to obtain a mixture B1; S13, adding the mixture B1 into the mixture A1, stirring and mixing, to obtain a mixture C1; S14, respectively stirring and mixing purified water, gelatin, polyvinyl alcohol, D-sorbitol, urea, tartaric acid, disodium edetate and kaolin; stirring and mixing purified water and a 20% polyacrylic acid solution; adding the mixed mixture to the mixture C1, stirring and mixing in vacuum to obtain a first drug-loaded paste; S15, coating the first drug-carrying paste on the backing layer and covering it with a protective layer to prepare a Chinese medicine composition plaster for analgesia; or, S21, mixing glycerol, partially neutralized sodium polyacrylate, sodium carboxymethyl cellulose and aluminum glycolate by vacuum stirring to obtain a mixture A2; S22, stirring and mixing the pharmaceutical composition, polysorbate 80, peppermint oil, crotamiton and methylparaben to obtain a mixture B2; S23, adding the mixture B2 into the mixture A2, stirring and mixing, to obtain a mixture C2; S24, mixing L-tartaric acid, talc, acrylic acid grafted starch, methyl ester / 2-ethylhexyl acrylate copolymer emulsion, disodium edetate, titanium dioxide and purified water, adding the mixture to the mixture C2, and mixing under vacuum to obtain a second drug-loaded ointment; S25, coating the second drug-carrying paste on the backing layer and covering it with a protective layer to prepare a Chinese medicine composition plaster for analgesia; or, S31, taking styrene-isoprene-styrene block copolymer, terpene resin, liquid paraffin, butylated hydroxytoluene, kaolin, propylene glycol and methyl paraben, heating to 150° C. to melt and stirring to mix, to obtain a mixture A3; S32, taking the drug composition, heating it to 40-50° C., melting it and stirring it to mix it evenly; after melting and mixing it evenly, adding it to the mixture A3, stirring and mixing it evenly, to obtain a third drug-loaded paste; S33, coating the third drug-carrying paste on the backing layer, allowing it to stand and cool to form, and covering it with a protective layer after forming, to obtain a Chinese medicine composition plaster for analgesia; or, S41, taking methyl pyrrolidone, propylene glycol fatty acid ester, citric acid, isoprene styrene copolymer, polyisobutylene, rosin glycerol ester and liquid paraffin, heating to 150° C. to melt and stirring to mix, to obtain a mixture A4; S42, taking the drug composition, heating it to 40-50° C., melting it and stirring it to mix it evenly; after melting and mixing it evenly, adding it to the mixture A4, and adding levomenthol, mercaptobenzimidazole and butylhydroxytoluene, stirring and mixing it evenly, to obtain a fourth drug-loaded ointment; S43, coating the fourth drug-carrying paste on the backing layer, allowing it to stand and cool to form, and covering it with a protective layer after forming, to obtain a Chinese medicine composition plaster for analgesia; or, S51, dissolving the pharmaceutical composition and butylated hydroxytoluene in propylene glycol and isopropyl myristate, and mixing them uniformly to obtain a mixture A5; S52, adding the mixture A5 to the acrylic pressure-sensitive adhesive solution, mixing evenly, to obtain a fifth drug-loaded paste; S53, coating the fifth drug-carrying paste on the backing layer, drying, and covering with a protective layer to prepare an analgesic Chinese medicine composition plaster.

12. Use of the analgesic Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating shoulder, neck, waist and leg pain, rheumatic joint pain, sports and traumatic pain, pain and swelling caused by fluorosis, refractory facial paralysis caused by facial nerve paralysis, and trigeminal neuralgia.