Gout patch set and preparation method thereof

Abstract

The present application relates to a kind of gout paste set and preparation method thereof, the gout paste includes: paste A and paste B;Paste A is for the umbilical paste of gout remission period;Paste B is used for the paste of the painful joint of attack period;The drug efficacy component of paste A is made of the first traditional Chinese medicine composition comprising the following components: atractylodes, huangjiu, willow bark, yiyiren, wulingzhi, cansha, baizhu, gancao, tougucao, sandalwood, chishao, chuanqiong, dog spine, fuling, zhuling, dilon, chenpi, huoxiang, wangbuliuxing and suhe xiang;The drug efficacy component of paste B is made of the second traditional Chinese medicine composition comprising the following components: jinyinhua, huangbai, yanhuosuo, wulingzhi, cansha, zihuoding, da xueteng, luoshiteng, jixieteng, tougucao, tuobie worm, oyster, laohu, mody, turmeric, danneling, tianzhu huang and ice. The present application effectively reduces the level of patient's blood uric acid, C-reactive protein and cell sedimentation rate and TCM syndrome score, drug safety is high, and recurrence rate is low.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a gout patch kit and a preparation method thereof. Background Art

[0002] Gout is a chronic metabolic inflammatory disease caused by purine metabolism disorders, excessive uric acid production, or poor uric acid excretion, leading to elevated serum uric acid levels. The gout disease progression consists of five stages: hyperuricemia, acute gouty arthritis, inter-gout phase, chronic gouty arthritis, and gouty nephropathy. Clinical treatment of gout requires prompt intervention during the first three stages to prevent progression to chronic gouty arthritis and gouty nephropathy, which can lead to joint deformities and disability, or even damage to organs such as the kidneys and cardiovascular system.

[0003] Traditional Chinese Medicine (TCM) believes that gout is caused by spleen and stomach dysfunction, leading to internal accumulation of dampness and heat, a common manifestation of damp-heat syndrome in the middle burner. Dampness tends to flow downward, causing it to stagnate and accumulate in the joints of the limbs, blocking local meridians and obstructing the flow of Qi and blood, leading to an acute onset of symptoms. Symptoms include red, swollen, hot, and painful joints, a red tongue, and a greasy, yellow coating. Dampness, a yin pathogen, is prone to nocturnal attacks, resulting in nighttime pain that can resemble a tiger bite. The spleen governs transportation and transformation, while the stomach governs reception. The small intestine digests and transports the essence of food and water to the spleen, nourishing the internal organs. Splenic deficiency and dysfunction lead to internal accumulation of dampness and heat, which is the root cause of gout.

[0004] Currently, relevant guidelines and expert consensus both domestically and internationally agree that nonsteroidal anti-inflammatory drugs, colchicine, and glucocorticoids should be promptly used during an acute gout attack to rapidly control inflammation. For patients in the remission phase of GA (when acute symptoms subside and the condition stabilizes), the key to treatment lies in controlling serum uric acid concentration, inhibiting urate crystal deposition, and promoting crystal dissolution. Uric acid-lowering therapy for gout patients primarily involves using drugs such as febuxostat or allopurinol to inhibit uric acid production or benzbromarone to promote uric acid excretion. While these medications often achieve rapid efficacy, they are often accompanied by significant side effects and contraindications, such as significant gastrointestinal reactions, including bloody gastrointestinal reactions in severe cases, and liver and kidney damage from long-term use. These significant side effects often deter patients from using these medications.

[0005] The umbilical part is the last closed part of the abdominal wall of the human body, and is an organ that communicates with the inside and outside of the body since birth. The stratum corneum epidermidis under the navel is the thinnest, and has poor barrier function. Moreover, the skin under the navel is directly connected with fascia and peritoneum, and has no adipose tissue distribution, so it has good permeability, which is conducive to the penetration of drugs and the acceptance of external stimulation. Modern medical research has also shown that trans-umbilical administration can directly penetrate the skin, diffuse to the rich venous network under the navel, enter the abdominal deep veins through capillaries, or branch into the abdominal related arteries, and finally enter the systemic circulation. Compared with oral administration, the advantages of umbilical administration include: ① high absorption efficiency: the stratum corneum of the umbilical skin is thin, the barrier function is weak, and there is no subcutaneous adipose tissue, which makes it easy for drugs to diffuse and absorb into the blood through the skin, sometimes achieving similar or even better absorption effect than oral administration. ② Reduce the burden on liver and kidney, and have fewer side effects: oral drugs need to pass through the first pass effect of the liver, which may lead to a decrease in the active ingredients of the drugs. Trans-umbilical administration bypasses this process, directly absorbs into the blood, and reduces the metabolic burden on the liver and kidney and potential side effects. ③ Simple and safe: trans-umbilical administration is simple to operate, easy for patients to self-manage, and is particularly suitable for groups who are unwilling or unable to take oral drugs (such as elderly patients with difficulty swallowing). ④ Continuous effect: after the drug is absorbed through the umbilical part, it can continuously act on the whole body, sometimes providing more persistent and better therapeutic effect than oral administration. ⑤ Avoiding gastrointestinal irritation. Gout treatment mainly focuses on invigorating the spleen and stomach, clearing heat and removing dampness, so trans-umbilical administration provides a non-invasive alternative administration route with sustainable effect.

[0006] However, there are few gout drugs for umbilical therapy at present. For example, patent publication CN105193975A discloses a gout drug for umbilical therapy, which contains, by weight, 4-8 parts of Sargentodoxa, 2-6 parts of Fennel, 2-9 parts of Honeysuckle, 1-5 parts of Earthworm, 1-6 parts of Gentiana, 1-7 parts of Angelica, 1-8 parts of Milkvetch Root, 1-10 parts of Cantharis, 1-8 parts of Eucommia, and 1-5 parts of Fried Mylabris. Each umbilical therapy package contains 1-4 mg of colchicine. This scheme combines Chinese and western medicines, is used externally, and provides drugs continuously for 24 hours without interruption. It has the advantages of tonifying the body and expelling pathogenic factors, and treating both the symptoms and the root cause. The drug is obtained by drying and crushing the medicinal materials to 60 mesh, then weighing 18 grams of the powder per package, and adding 5 tablets / 0.5 mg / tablet of colchicine per package. The colchicine tablets are crushed and mixed with the Chinese medicinal powder, then packaged (cotton cloth sewn round package), sealed, and used as umbilical therapy packages. During use, the umbilical therapy package is placed at the navel and fixed with a waistband. The colchicine in the drug has serious side effects, especially when used in high doses or for a long time, or combined with sedative and hypnotic drugs, antibiotics, or lipid-lowering drugs, which can further increase the risk of poisoning. Moreover, Gentiana in the drug is also a recognized highly toxic medicinal material, and its safety needs to be discussed. The drug package is obtained by directly drying and crushing the medicinal powder, without extraction, so the concentration of the effective components is low and the effect is slow. In addition, the current drug design does not distinguish between different stages of gout or only targets a specific stage of gout, and the therapeutic effect of the drug is poor. Moreover, the drug needs to be fixed with a waistband, which is very inconvenient.

[0007] In summary, the current market for external use of drugs, mostly to treat gout acute phase, symptoms subside without corresponding measures, so the disease is repeated, prolonged and difficult to cure, treat the symptoms and not the root cause. The study of acute local treatment, ease of overall treatment, embodies the local and overall, acute and remission of both the symptoms and the root cause. Navel administration of the drug, local administration to treat the symptoms, and the drug compatibility each has its emphasis, for the administration site, using different drugs and transdermal agents, from the perspective of external treatment, embodies the overall view and dialectical view of gout. SUMMARY

[0008] (1) the technical problems to be solved

[0009] In view of the above-mentioned shortcomings, deficiencies of the prior art, the present application provides a kind of gout paste set and preparation method thereof, using pure Chinese medicine preparation, without using toxic medicinal materials, also without colchicine, its safety is higher, drug is designed for gout onset period and gout remission period, can achieve "acute treat its symptoms, slow treat its root cause", treat the symptoms and the root cause, thereby significantly reduce gout attack symptoms, increase the interval of attack, reduce the effect of attack frequency; Use medicinal material concentrated extract and powder to make paste, the concentration of medicinal ingredients is high, release is fast, rapid effect, solve the safety of existing navel therapy medicine bag, slow effect, only for a specific stage of disease and use the technical problems such as inconvenience.

[0010] (2) technical solutions

[0011] In the first aspect, the present application provides a kind of gout paste set, which comprises: paste A and paste B;Wherein paste A is the navel paste for gout remission period;Paste B is used for paste of painful joint in attack period;

[0012] The medicinal ingredients of paste A are made of first traditional Chinese medicine composition, and the first traditional Chinese medicine composition comprises the following medicinal materials: atractylodes, radix cyathulae, cortex phellodendri, coix seed, five spirit fat, silkworm sand, atractylodes, licorice, kudzu vine, mulberry branch, red peony root, chuanmiao, dog spine, poria cocos, radix ophiopogonis, pericarpium citri reticulatae, agastache, wangbuluixing and suhe xiang;

[0013] The medicinal ingredients of paste B are made of second traditional Chinese medicine composition, and the second traditional Chinese medicine composition comprises the following medicinal materials: honeysuckle, cortex phellodendri, corydalis, five spirit fat, silkworm sand, purple flower dindin, da xueteng, Luo Shiteng, Jixieteng, kudzu vine, eupolyphaga, oyster, frankincense, myrrh, turmeric, chandonghuang and menthol.

[0014] According to the preferred embodiment of the present application, the components in the first traditional Chinese medicine composition are as follows in weight parts:

[0015] Cangzhu 10 parts, Niuxi 10 parts, Huangbai 20 parts, Yiyiren 20 parts, Wulingzhi 8 parts, Canhua 8 parts, Baizhu 10 parts, Gancao 10 parts, Tougucao 10 parts, Sangzhi 10 parts, Chishao 10 parts, Chuanqiong 6 parts, Xuduan 12 parts, Gouji 10 parts, Fuling 10 parts, Zhuling 10 parts, Dilong 6 parts, Chenpi 6 parts, Huoxiang 10 parts, Wangfuzhij 6 parts and Ruhe 0.3 parts.

[0016] According to the preferred embodiment of the present application, the components in the second traditional Chinese medicine composition are as follows in terms of weight parts: Jinyinhua 10 parts, Huangbai 10 parts, Yanhuosuo 6 parts, Wulingzhi 6 parts, Canhua 8 parts, Zihua Diding 20 parts, Daxueteng 12 parts, Luoshiteng 10 parts, Jixieteng 10 parts, Tougucao 15 parts, Tuobichong 6 parts, Muli 20 parts, Rushang 4 parts, Modyang 4 parts, Jianghuang 6 parts, Danshanxing 6 parts, Tianzhu Huang 6 parts and Bingfen 0.3 parts.

[0017] According to the preferred embodiment of the present application, the components in the first traditional Chinese medicine composition are as follows in terms of weight parts:

[0018] Cangzhu 10 parts, Niuxi 10 parts, Huangbai 20 parts, Yiyiren 20 parts, Wulingzhi 8 parts, Canhua 8 parts, Baizhu 10 parts, Gancao 10 parts, Tougucao 10 parts, Sangzhi 10 parts, Chishao 10 parts, Chuanqiong 6 parts, Xuduan 12 parts, Gouji 10 parts, Fuling 10 parts, Zhuling 10 parts, Dilong 6 parts, Chenpi 6 parts, Huoxiang 10 parts, Wangfuzhij 6 parts and Ruhe 0.3 parts.

[0019] According to the preferred embodiment of the present application, the components in the second traditional Chinese medicine composition are as follows in terms of weight parts: Jinyinhua 10 parts, Huangbai 10 parts, Yanhuosuo 6 parts, Wulingzhi 6 parts, Canhua 8 parts, Zihua Diding 20 parts, Daxueteng 12 parts, Luoshiteng 10 parts, Jixieteng 10 parts, Tougucao 15 parts, Tuobichong 6 parts, Muli 20 parts, Rushang 4 parts, Modyang 4 parts, Jianghuang 6 parts, Danshanxing 6 parts, Tianzhu Huang 6 parts and Bingfen 0.3 parts.

[0020] In the second aspect, the present application provides a preparation method of the gout patch set, which comprises the following steps:

[0021] The preparation method of the patch A is as follows:

[0022] Step 1: Atractylodes lancea, Achyranthes bidentata, Phellodendron chinense, Coix seed, Ophiopogon japonicus, Silkworm excrement, Atractylodes macrocephala, Licorice root, Herba scutellariae baicalensis, Morus alba, Paeonia lactiflora, Ligusticum chuanxiong, Dipsacus root, Cibotium bark, Poria cocos, Polyporus umbellatus, Earthworm, Tangerine peel, Patchouli rhizome, and Vaccaria segetalis are divided into two portions according to predetermined dosages, namely, Chinese medicine A1 and Chinese medicine A2; 7-9 times the weight of water is added to Chinese medicine A1 to soak the Chinese medicine, and the mixture is slowly boiled for 35-45 minutes. After filtering, 7-9 times the weight of water is added, and the mixture is slowly boiled for 25-35 minutes. The mixture is filtered again, and the two filtrates are combined. The filtrates are concentrated by rotary evaporation (at 40-60° C.) to a relative density of 1.9-2.2 to obtain Chinese medicine concentrate A;

[0023] Step 2: The Chinese medicine A2 was powdered and passed through an 80-mesh sieve to obtain powder; the storax was ground and mixed with 95% ethanol in a volume ratio of 1:2, and allowed to stand for 20-30h and filtered to obtain storax liquid;

[0024] Step 3: Add the medicinal powder to the Chinese medicine concentrate A and stir evenly. Then, preheat to 60-70°C and stop heating. Add an appropriate amount of propolis and continue stirring until it becomes viscous. Then, add the storax solution and stir quickly to obtain a medicinal paste. Place the medicinal paste in a mold and cool it to form a spherical navel-filling pill with a diameter of 1-1.2 cm. Combine with a breathable and waterproof non-woven fabric with viscose on the inner surface to obtain a patch A.

[0025] The preparation method of patch B is as follows:

[0026] S1. Divide honeysuckle, phellodendron amurense, corydalis yanhusuo, tsutsuga chinensis, silkworm excrement, viola yedoensis, safflower vine, trachelospermum officinale, scutellaria baicalensis, scutellaria baicalensis, scutellaria baicalensis, earthworm, oyster, frankincense, myrrh, turmeric, arisaema cinerea, and dahlia jasminoides into two portions according to predetermined dosages, namely, Chinese medicine B1 and Chinese medicine B2; add 7-9 times the weight of water to Chinese medicine B1 to soak the Chinese medicine, simmer for 35-45 minutes, filter, add 7-9 times the weight of water, simmer for 25-35 minutes, filter again, combine the two filtrates, and concentrate the filtrates by rotary evaporation (at 40-60° C.) to a relative density of 1.9-2.2 to obtain Chinese medicine concentrate B;

[0027] S2, grind the Chinese medicine B2 into powder and pass it through an 80-mesh sieve to obtain medicine powder;

[0028] S3. Add the medicinal powder to the Chinese medicine concentrate B and stir evenly, then preheat to 60-70°C and stop heating, add propolis (add an appropriate amount of propolis and stir continuously until it becomes viscous), and stir continuously until it becomes viscous, then add borneol and stir quickly and evenly to obtain a medicinal paste; put the medicinal paste into a mold and cool it to shape it to obtain a sheet-like medicinal skin with a thickness of 0.2 cm ± 0.05 cm; match it with a breathable and waterproof non-woven fabric with viscose on the inner surface to obtain a patch B; Patch B is used to be applied to painful joints.

[0029] The above-mentioned preparation of plaster A alone with atractylodes, radix cyathulae, cortex phellodendri, coix, five spirit, silkworm excrement, atractylodes, licorice, through bone grass, mulberry branch, red peony root, chuanxiong, rhizoma, dog spine, poria cocos, polyporus, earthworm, dried tangerine or dried tangerine peel, agastache, wang bushu, according to the established dose is divided into 2 parts, 1 part is powder after 80 mesh screen drug powder; In the preparation of plaster B, honeysuckle, cortex phellodendri, corydalis, five spirit, silkworm excrement, purple flower, da xueteng, Luo shi teng, chicken arrow, through bone grass, earthworm, oyster, frankincense, myrrh, turmeric, chandan, and the main components of the drug are divided into 2 parts, 1 part is powder after 80 mesh screen drug powder; The other part is extracted by water to obtain concentrated drug solution. The effective components of propolis, saffron, ice and the like are unstable under high temperature decoction, and are not suitable for water decoction extraction; The main effective components of saffron, ice and the like are strong volatile components, which have good permeability, can be directly volatilized and absorbed through the skin after filling into the navel; The propolis is shaped, which is safe and has good adhesion and adsorption. At the same time, the mixed drug powder and concentrated drug solution can keep the navel filling pill in a certain shape and strength (avoiding the rapid liquidization of the pill after absorbing sweat), so that the drug powder can play a therapeutic role, and also play the roles of excipient, dispersant and drug carrier.

[0030] In the above preparation process, the medicine is divided into two parts. One part of medicinal materials is decocted to extract the effective components in the medicinal materials, so that the medicine is dissolved in water, the concentration of the medicine is improved, the human body can be quickly absorbed, and the speed of taking effect is shortened. The other part of medicinal materials is powdered to retain a variety of active ingredients in the medicinal materials, which can strengthen the efficacy and prolong the efficacy period. After the traditional Chinese medicine is powdered, the surface area is increased, the powder particles are dispersed, the effective components are easily dissolved and absorbed by the human body, the bioavailability of the traditional Chinese medicine can be improved, and the drug solution has a slow release effect. The present application adopts trans-umbilical administration, which is external application, but the effective components can directly reach the subumbilical vein layer, enter the blood quickly, and have the effect of internal administration. Therefore, the combination of powdering and extracting drug solution can achieve the best efficacy. The plaster of the present application mixes the concentrated drug solution with the powder (powdering) to make the external use of the powder more severe, especially suitable for the disease in the local part. The type of the medicine of the present application focuses on the combination of the whole and the local part, not only in the treatment concept, but also in the selection and preparation of the preparation, avoiding the rapid and severe of the powder by water decoction, entering the body to seek the holistic treatment, using the powdering powder to combine the local part, and focusing on the local treatment of the disease.

[0031] The drug solution and the powdered medicinal materials are absorbed into the blood, which is good and fast, reduces the adverse nature of the medicine, and is more suitable for the whole. When used alone, the effect is poor. The powder made of powdered medicinal materials is used externally, and the effect is direct and severe. The local use of the powder is more, and the combination of the two has better effect.

[0032] The prepared patch A and patch B need to be stored in cold storage. Propolis is a hard solid below 15 degrees, can be melted into a viscous liquid at 65 degrees, plays a role of adhesion and molding, and can be softened at 36 degrees, consistent with human body temperature. When the patch contacts the human body, the propolis softens to make the filling pill or drug coating better fit the shape of the human joint or the shape of the navel skin, maximize the contact of the drug active ingredients with the skin pores and penetrate into the skin, improve the speed of effect and ensure the drug concentration. As an excipient, propolis itself has the effects of clearing heat and resolving toxins, reducing swelling and relieving pain, which is consistent with the needs of the disease and has no side effects. Modern pharmacological studies have confirmed that the active substances contained in propolis have anti-inflammatory activity and immune regulation activity. In the process of making the ointment, low temperature distillation and concentration are adopted at 40-60℃, and the traditional decoction method is used to stimulate the drug properties. Low temperature distillation and concentration retain the original drug effect without changing, avoid the complexity of the traditional patch ointment production process and the possible lead toxicity, and maximize the retention and concentration of the drug active ingredients.

[0033] In the present application, the gout onset period refers to the appearance of gout joint redness, swelling, heat, pain and other symptoms collectively referred to as gout onset period. The gout remission period refers to the diagnosis of gout but no related symptoms or once had related symptoms, now no obvious symptoms collectively referred to as gout intermittent remission period.

[0034] Since the onset period and the remission period run through the entire course of the disease, the gout patch set of the present application can be actually applicable to each period of gout hyperuricemia period, acute gouty arthritis period, gout intermittent period, chronic gouty arthritis period and gout nephropathy period.

[0035] (Three) beneficial effects

[0036] The present application provides a kind of gout patch set and preparation method thereof, using pure traditional Chinese medicine preparation, without using toxic medicinal materials, without mixing colchicine, its safety is higher, drug is designed for gout onset period and gout remission period, can achieve "acute treat its mark, slow treat its root", treat both the symptoms and the root, thereby significantly reduce gout onset symptoms, increase the interval of attack, reduce the effect of attack frequency;Use medicinal material concentrated extract and medicine powder to make patch, drug active ingredient concentration is high, release is fast, effect is rapid, solve the safety of existing navel therapy medicine bag, slow effect, only for a specific stage of disease and use the technical problems such as inconvenience.

[0037] During gout attack period, patients often have metabolic disorders in their bodies, and MSU accumulates in joints and causes a violent inflammatory reaction, which manifests as redness, swelling, heat, pain, etc.; Now, patients have obvious gout symptoms, and the pain is unbearable. It should be based on treating its symptoms, so acute phase patches are used to apply locally in pain with clearing away heat and toxic substances, cooling blood and relieving pain, which accelerates and relieves symptoms, and alleviates the suffering of gout patients; Therefore, the Chinese medicine composition of patch B of the present invention is mainly grouped with "clearing away heat and toxic substances, cooling blood, reducing swelling and relieving pain" as a therapeutic principle. After gout enters remission, the body has no obvious symptoms, but the cause of the disease has not disappeared. Now, administration through umbilical patching to invigorate the spleen and harmonize the stomach, clear away heat and dispel dampness to treat its root, in line with the traditional Chinese medical theory of "treating both the symptoms and the root causes in an emergency and slowly treating the root causes"; Therefore, the Chinese medicine composition of patch A of the present invention is mainly grouped with "invigorating the spleen and harmonize the stomach, clearing away heat and removing dampness" as a therapeutic principle.

[0038] Clinical single-blind trials have shown that the present invention can effectively reduce patients' blood uric acid, C-reactive protein and cell sedimentation rate levels and Traditional Chinese Medicine (TCM) syndrome scores, and effectively improve patients' TCM symptoms such as joint pain, joint tenderness, joint swelling, poor joint flexion and extension, local joint skin temperature, fever, thirst, irritability, and yellow urine. The total effective rate reached 96.55%, and the drug is highly safe. Before and after treatment, the patient's vital signs, routine examinations of blood, urine, and feces, as well as liver and kidney function, electrocardiogram and other examinations were all normal, and the recurrence rate of patients after treatment was low. DETAILED DESCRIPTION

[0039] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below in conjunction with specific embodiments.

[0040] The present invention provides a gout patch set, comprising: patch A and patch B; patch A is a navel patch for use during the remission period of gout; patch B is a patch for use on painful joints during the attack period;

[0041] The active ingredients of patch A are made from the first traditional Chinese medicine composition, which contains the following medicinal materials: Atractylodes lancea, Achyranthes bidentata, Phellodendron chinense, Coix seed, Ophiopogon japonicus, Silkworm excrement, Atractylodes macrocephala, Licorice root, Herba scutellariae, Morus alba, Paeonia lactiflora, Ligusticum chuanxiong, Dipsacus asper, Cibotium barometz, Poria cocos, Polyporus umbellatus, Earthworm, Tangerine peel, Patchouli, Vaccaria segetalis, and Styrax odorata;

[0042] The active ingredients of patch B are made from the second traditional Chinese medicine composition, which contains the following medicinal materials: honeysuckle, phellodendron, corydalis, aconiti lobata, silkworm feces, viola yedoensis, safflower, trachelospermum officinale, scutellaria baicalensis, scutellaria baicalensis, scutellaria baicalensis, scutellaria baicalensis, earthworm, oyster, frankincense, myrrh, turmeric, arisaema, jasmine and borneol.

[0043] The first traditional Chinese medicine composition for preparing patch A is mainly composed according to the therapeutic principle of "invigorating the spleen and stomach, clearing heat and removing dampness", and the second traditional Chinese medicine composition for preparing patch B is mainly composed according to the therapeutic principle of "clearing heat and removing toxicity, cooling blood and relieving swelling and pain".

[0044] The first traditional Chinese medicine composition mainly plays the effects of invigorating the spleen, clearing heat and removing dampness, and removing blood stasis in the muscles in the remission period. The following is the effect description of each component.

[0045] The first traditional Chinese medicine composition takes atractylodes rhizome, radix cyathulae, phellodendri cortex and coix seed as the monarch drug, invigorates the spleen, clears heat and removes dampness, wherein atractylodes rhizome invigorates the spleen and dries dampness, and helps to improve the condition of spleen deficiency and dampness. Radix cyathulae tonifies the liver and kidney, and strengthens the bones and joints, and can be used to relieve joint pain. Phellodendri cortex clears heat and dries dampness, purges fire and removes toxicity, and is suitable for gout patients with internal damp-heat. Coix seed invigorates the spleen, removes dampness, clears heat and removes pus, and is beneficial to reduce uric acid and reduce dampness. The four ingredients are used as the monarch drug, which is a wonderful formula for treating dampness and arthralgia.

[0046] The first traditional Chinese medicine composition takes poria cocos, polyporus, pericarpium citri reticulatae, agastache, atractylodes and silkworm excrement as the ministerial drug, which assists the monarch drug to clear damp-heat, regulate qi and relieve pain. Poria cocos and polyporus are used in a 1:1 combination to enhance the effect of poria cocos in invigorating the spleen, removing water and dampness, which is in line with the pathogenesis of gout. Both poria cocos and polyporus have the effect of removing water and dampness, which helps to remove excess water and uric acid in the body. Silkworm excrement clears heat and removes dampness, dispels wind and stops itching, which helps to eliminate symptoms of damp-heat. Atractylodes invigorates the spleen, benefits qi, dries dampness and removes water, which strengthens the function of the spleen and stomach and promotes the metabolism of uric acid. Pericarpium citri reticulatae regulates qi and invigorates the spleen, dries dampness and reduces phlegm, which helps to improve the digestive function. Agastache removes dampness and is suitable for dampness and stagnation of the spleen and stomach.

[0047] The first traditional Chinese medicine composition takes five kinds of animal fat, earthworm, herba veronicastrae, ramulus mori, radix paeoniae rubra, ligusticum wallichii, rhizoma discontinu, and dog spine as the auxiliary drug, which regulates qi and blood to remove blood stasis and relieve pain. Five kinds of animal fat: promotes blood circulation and relieves pain, which is suitable for pain caused by blood stasis. Earthworm (dried earthworm): clears heat and calms wind, dredges collaterals and removes uric acid, and relieves joint redness, heat and pain. Herba veronicastrae: dispels wind and removes dampness, promotes blood circulation, removes blood stasis, detoxifies and relieves pain. Ramulus mori: dispels wind and dampness, benefits joints, and is used for treating arthralgia. Radix paeoniae rubra: promotes blood circulation and removes blood stasis, and relieves pain, which helps to relieve arthritic inflammation. Ligusticum wallichii: promotes blood circulation and regulates qi, dispels wind and relieves pain, which is widely used for various pain symptoms. Rhizoma discontinu: tonifies the liver and kidney, and strengthens the bones and joints, which is beneficial to the recovery of joint function in the later stage of gout. Dog spine: tonifies the liver and kidney, and strengthens the waist and knees, which is used for treating soreness and weakness of the waist and legs caused by kidney deficiency.

[0048] The first traditional Chinese medicine composition uses licorice, cowslip, and styrax as the base medicine to harmonize the various medicines and enhance the effect of promoting qi and penetration. Licorice: harmonizes the various medicines and reduces the stimulation of the body by the medicine. Cowslip: promotes blood circulation, removes swelling and pain, and promotes blood circulation. Styrax: can aromatically open the skin orifices to help open the skin orifices and promote the penetration of the medicine. To be suitable for umbilical external treatment, high-purity alcohol is used to extract styrax, which has the nature of aromatically opening the skin orifices and the nature of alcohol running away. The pores of the skin orifices are opened, and the nature of the plaster is helped to enter the body. The whole prescription is mainly based on invigorating the spleen and removing dampness, and also has the effect of promoting blood circulation and removing blood stasis. Spleen deficiency and dampness, dampness, make qi stagnation and blood stasis, and attack. Therefore, the relief period is treated from invigorating the spleen and removing dampness to treat the root, which is in line with the treatment idea of "treating the symptoms of the disease" to remove the pathogenic factors of the whole body.

[0049] The second traditional Chinese medicine composition mainly plays the effects of clearing heat and resolving toxins, dredging collaterals and relieving pain, and removing dampness and swelling during the attack period. The following is the effect of each component.

[0050] The second traditional Chinese medicine composition uses honeysuckle and yellow bark as the monarch to clear heat and resolve toxins, cool blood and remove swelling. Among them, honeysuckle: has the effects of clearing heat and resolving toxins, cooling blood and removing swelling, and reducing fever and swelling caused by inflammation. Yellow bark: clears heat and removes dampness, purges fire and resolves toxins, and improves the symptoms of damp heat in the acute stage of gout, which helps to relieve joint redness, swelling, and pain.

[0051] The second traditional Chinese medicine composition uses corydalis, five spirit fat, silkworm ash, and purple flower ground ivy as the minister, which helps the monarch to clear heat and resolve toxins, and promotes blood circulation to remove blood stasis and relieve pain. Among them, corydalis: promotes blood circulation and relieves pain, especially good at relieving pain caused by qi stagnation and blood stasis, and is the main medicine for pain relief, especially suitable for joint pain caused by gout. Five spirit fat: promotes blood circulation and relieves pain, removes blood stasis, and is often used to treat blood stasis pain, including joint pain caused by gout. Silkworm ash: clears heat and removes dampness, dispels wind and relieves itching, and has a certain effect on damp heat type gout. Purple flower ground ivy: clears heat and resolves toxins, cools blood and removes swelling, and helps to reduce local inflammatory reactions during gout attacks.

[0052] The second traditional Chinese medicine composition takes Sargentgloryvine stem, Loxogenin, Canthium dicocum, Herba Lysimachiae, Eupolyphaga, Ostrea, Olibanum, Myrrha, and Curcuma as auxiliary medicines, and has the effects of activating blood, dredging collaterals, reducing swelling, softening and resolving masses, and removing blood stasis and relieving pain. Among them, Sargentgloryvine stem (red vine): activating blood and dredging collaterals, reducing swelling and relieving pain, which has an auxiliary treatment effect on joint swelling and pain caused by gout. Loxogenin: dispelling wind and dredging collaterals, and cooling blood and reducing swelling, which helps to relieve the symptoms of gouty arthritis. Canthium dicocum: promoting qi and relieving pain, which can be used for auxiliary treatment of joint pain caused by damp-heat and toxic evil. Herba Lysimachiae: dispelling wind and dampness, relaxing muscles and activating blood, removing blood stasis and reducing swelling, and detoxifying and relieving pain. Eupolyphaga: breaking blood and removing blood stasis, which is suitable for red, swollen, and hot pain of gout. Ostrea: softening and resolving masses, and tonifying yang and nourishing yin, which helps to regulate the internal environment of dampness and heat, and indirectly relieve the symptoms of gout. Olibanum and Myrrha: good medicines for activating blood and relieving pain, which can promote blood circulation and relieve joint pain and swelling caused by gout. Curcuma: activating blood and removing blood stasis, and relieving inflammation and pain, and the effective component curcumin has good anti-inflammatory effect, which is beneficial to gout.

[0053] The second traditional Chinese medicine composition takes Arisaema cum Bile, Rhizoma Gastrodiae, and Borneolum Syntheticum as medicines, and has the effects of considering phlegm and dampness and opening the orifices. Arisaema cum Bile and Rhizoma Gastrodiae: these two medicines are mainly aimed at phlegm and dampness or hot phlegm symptoms, and traditional Chinese medicine believes that swelling is closely related to phlegm evil. Therefore, Arisaema cum Bile and Rhizoma Gastrodiae are added in the second traditional Chinese medicine composition,

[0054] It is mainly aimed at red, swollen, and hot pain in the acute stage, and improves the physical condition of gout patients. Borneolum Syntheticum: clearing heat and relieving pain, opening the orifices and refreshing the mind, which directly relieves the pain when used externally, at the same time, it opens the skin and helps the penetration and absorption of the medicine.

[0055] The gout patch set of the application comprises patch A and patch B. Patch A uses styrax as an orifice-opening agent, and through its volatile action, it can open the orifices, slowly penetrate, and is suitable for the remission period and the relatively closed space after filling the navel. Patch B uses borneolum syntheticum as an orifice-opening agent, and is suitable for local red, swollen, and hot pain in the acute stage of gout. Borneolum syntheticum has strong volatility, and has the effects of opening the orifices and clearing heat and relieving pain, and is especially suitable for the acute stage. Gout patients often have alternating “remission period” and “acute stage”. The treatment effect of patch A on the “remission period” promotes the treatment effect of patch B on the “acute stage”, and the treatment effect of patch B on the “acute stage” also promotes the treatment effect of patch A on the “remission period”. The two are complementary to each other, and the gout patch set of the application provides a reasonable and coherent solution.

[0056] The following is a preferred embodiment of the application.

[0057] Example 1

[0058] The present embodiment provides a gout patch set, which comprises: patch A and patch B; wherein patch A is an umbilical patch for the remission period of gout; patch B is a patch for painful joints in the attack period;

[0059] The pharmacodynamic component of the patch A is made of a first traditional Chinese medicine composition, which comprises the following medicinal materials: 10 parts of atractylodes, 10 parts of radix cyathulae, 20 parts of phellodendri cortex, 20 parts of coicis semen, 8 parts of five-ingredient balm, 8 parts of silkworm excrement, 10 parts of atractylodes, 10 parts of licorice, 10 parts of kadsura longipes, 10 parts of morus, 10 parts of red peony root, 6 parts of ligusticum, 12 parts of rhizoma discontinu, 10 parts of gynostemma, 10 parts of poria cocos, 10 parts of polyporus, 6 parts of earthworm, 6 parts of dried tangerine or orange peel, 10 parts of agastache, 6 parts of herba epimedii, and 0.3 parts of styrax.

[0060] The pharmacodynamic component of the patch B is made of a second traditional Chinese medicine composition, which comprises the following medicinal materials: 10 parts of honeysuckle, 10 parts of phellodendri cortex, 6 parts of rhizoma corydalis, 6 parts of five-ingredient balm, 8 parts of silkworm excrement, 20 parts of viola, 12 parts of caulis sargentodoxae, 10 parts of loxocalyx, 10 parts of paederus, 15 parts of kadsura longipes, 6 parts of hardy shrimp, 20 parts of oyster, 4 parts of frankincense, 4 parts of myrrh, 6 parts of curcuma, 6 parts of aconite, 6 parts of radix curculignis, and 0.3 parts of borneol.

[0061] The preparation method of the above gout patch set comprises:

[0062] The preparation method of the patch A is as follows:

[0063] Step 1: Atractylodes, radix cyathulae, phellodendri cortex, coicis semen, five-ingredient balm, silkworm excrement, atractylodes, licorice, kadsura longipes, morus, red peony root, ligusticum, rhizoma discontinu, gynostemma, poria cocos, polyporus, earthworm, dried tangerine or orange peel, agastache, and herba epimedii are weighed according to the specified dosage and divided into two parts with a mass ratio of 4:6, which are traditional Chinese medicine A1 (40%) and traditional Chinese medicine A2 (60%) respectively. Traditional Chinese medicine A1 is soaked in 8 times the weight of water, and boiled on a low fire for 40 minutes. After filtration, 8 times the weight of water is added, and boiled on a low fire for 30 minutes. The filtrate is collected again, and the filtrate of the two times is combined. The filtrate is rotary evaporated and concentrated to a relative density of 1.95 (50℃) to obtain traditional Chinese medicine concentrated solution A.

[0064] Step 2: Traditional Chinese medicine A2 is powdered and passed through an 80-mesh sieve to obtain a medicinal powder. Styrax is ground and mixed with 95% ethanol at a volume ratio of 1:2. After standing for 24 hours, the styrax liquid is filtered.

[0065] Step 3: The medicinal powder is added to the traditional Chinese medicine concentrated solution A and stirred uniformly. Then, the temperature is raised to 65℃ and the heating is stopped. An appropriate amount of propolis is added and continuously stirred until the state is viscous. Then, the styrax liquid is added and stirred uniformly to obtain a medicinal paste. The medicinal paste is placed in a mold and cooled to obtain spherical umbilical filling pills with a diameter of 1-1.2 cm. The patch A is obtained by combining the umbilical filling pills with a breathable and waterproof non-woven fabric with adhesive on the inner surface.

[0066] The preparation method of the patch B is as follows:

[0067] S1, Honeysuckle, Huangbai, Corydalis, Wulingzhi, silkworm sand, purple flower, Daxueteng, Luoshteng, Jixiuteng, Tougucao, Eupolyphaga, Ostrea, Frankincense, Myrrh, Curcuma, Chilanansheng, and Radix Bupleuri were weighed according to the specified dose and divided into two parts with a ratio of 5:5, which were Chinese medicine B1 and Chinese medicine B2 respectively. Add 8 times the weight of water to soak the Chinese medicine, and boil for 40 minutes on low heat. After filtration, add 9 times the mass of water and boil for 30 minutes on low heat. Filter again, combine the two filtrates, and rotary evaporate the filtrate to a relative density of 1.97 (50℃) to obtain Chinese medicine concentrate B;

[0068] S2, powder the Chinese medicine B2 through an 80-mesh sieve to obtain a medicine powder;

[0069] S3, add the medicine powder to the Chinese medicine concentrate B and stir evenly. Then preheat to 60℃ and stop heating. Add an appropriate amount of propolis and continuously stir until it reaches a viscous state. Then add ice and stir quickly and evenly to obtain a medicine paste. Place the medicine paste in a mold and cool and shape it to obtain a sheet-shaped coating with a thickness of 0.2 cm ± 0.05 cm. Cooperate with a breathable and waterproof non-woven fabric with adhesive on the inner surface to obtain patch B.

[0070] Patch B is used to be applied to the painful joint area.

[0071] Clinical trial

[0072] This study has obtained the ethical approval of the Medical Ethics Committee of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, with the ethics number: JZFYLL202405240069.

[0073] (I) Research methods

[0074] 1. General information

[0075] 96 patients with acute gouty arthritis treated in the outpatient and inpatient departments of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from April 2023 to September 2023 were selected as the research objects. According to the random number table method, the patients were divided into three groups, with 32 cases in each group. One case in the control group voluntarily withdrew, one case had poor compliance, and a total of two cases dropped out, with 30 cases completing the test. Two cases in the test group were lost to follow-up, one case had poor compliance, and a total of three cases dropped out, with 29 cases completing the test. One case in the comparison group was lost to follow-up, one case voluntarily withdrew, and one case had poor compliance, for a total of three cases dropped out, with 29 cases completing the test.

[0076] 2. Diagnostic criteria

[0077] Western medicine refers to the 2015 ACR / EULAR gout classification standard; Chinese medicine refers to the gout diagnosis basis and damp-heat accumulation syndrome classification standard in the "Diagnosis and Treatment Criteria for Chinese Medicine Syndromes" published by the State Administration of Traditional Chinese Medicine in 1994.

[0078] 3. Inclusion Criteria

[0079] Patients with acute gout who meet the diagnostic criteria of Western medicine and whose acute attack time is within 24 hours; patients who meet the disease differentiation and syndrome differentiation of damp-heat accumulation type gout in TCM; aged 18-70 years old and without serious underlying diseases, who are tolerant to the drugs and treatment methods designed in this study; who voluntarily participate in this clinical study and sign the informed consent form.

[0080] 4. Exclusion Criteria

[0081] Patients who do not take other gout treatment drugs at the same time during the onset of the disease; patients with skin lesions around the affected joints; patients with allergic constitution or allergy to the drugs in this study; patients with serious primary diseases of the heart, liver, kidney, and hematopoietic system; patients with a history of gastric ulcer, duodenal bulb ulcer, and gastric bleeding; patients with mental illness and psychological abnormalities who do not cooperate with treatment; patients with other rheumatic diseases whose joint symptoms cannot be ruled out as being caused by other diseases; patients with gouty nephropathy and renal insufficiency; patients with joint deformity in the later stage of the disease and loss of labor capacity; pregnant, lactating women, or women with recent childbearing requirements; patients who are participating in other clinical drug trials.

[0082] 5. Disqualification Criteria

[0083] Patients who do not meet the criteria but are mistakenly included; patients whose statistical or evaluation data is missing, incorrect, or incomplete, affecting the efficacy evaluation; patients who develop other diseases affecting treatment during the trial period; patients who require other treatment interventions during the trial period; patients whose symptoms worsen due to their own reasons during the trial period, resulting in changes in the treatment period and the inability to maintain consistency with other patients; patients who develop serious adverse reactions during the trial period; patients who develop serious other concurrent diseases or disease progression during the trial period, which may result in dangerous events.

[0084] 6. Dropout Criteria

[0085] Patients with poor compliance who do not strictly follow the doctor's orders, affecting the efficacy evaluation; patients who develop serious adverse events during treatment and are not suitable for further participation in the study; patients who voluntarily withdraw from the treatment process, are lost to follow-up, or do not complete the entire treatment period.

[0086] 7. Intervention Measures

[0087] Conventional life guidance: limit smoking, abstain from alcohol; reduce the intake of high-purine and fructose-rich beverages; increase the intake of fresh vegetables; maintain regular work and rest; prevent intense exercise or sudden cooling; drink adequate water (more than 2000 mL of water per day); during the acute attack period, pay attention to protecting the affected joints and lying in bed more.

[0088] Because gout has the characteristics of repeated acute attacks and self-dissipation after the attack, the patients meeting the standard are treated with the acute phase (using patch B) within 24 hours of the acute attack in this study, and the treatment time is 7 days. After the inflammation in the acute phase is relieved, the remission phase (using patch A) is treated, and the combination of treating the symptoms and the root cause and the combination of the whole and the local are combined, and the test cycle is 30 days. At the same time, in order to ensure the rigor and scientificity of this test, a single-blind method is used in the design of the test scheme.

[0089] The control group (Ctrol group): The placebo ointment is made with starch as the main raw material (the appearance and color are consistent with the test group), which is applied externally on the local part in the acute phase for 1-7 days, and is applied externally on the umbilical part in the remission phase for 8-30 days, 1 patch / each time, 1 time / day, and the patching time is 8 hours per day.

[0090] The test group: In the acute phase for 1-7 days, the patch B of Example 1 is used to apply externally on the local part, and in the remission phase for 8-30 days, the patch A of Example 1 is used to apply externally on the umbilical part, 1 patch / each time, 1 time / day, and the patching time is 8 hours per day.

[0091] The comparison group: In the acute phase and the remission phase for 30 days, the patch B of Example 1 is used to apply externally on the local part, 1 patch / each time, 1 time / day, and the patching time is 8 hours per day.

[0092] The three groups are all taken as 30 days as 1 course of treatment, and the treatment is 1 course, on the basis of conventional life guidance, in the acute phase for 1-7 days, the two groups of patients are all given oral etoricoxib tablets (produced by Hangzhou Merck Sharp & Dohme Pharmaceutical Co., Ltd., national drug standard code: J20180059), 120 mg / each time, 1 time / day; if the patient's gout acutely attacks again within 8-30 days, the doctor should intervene in time, and guide the drug use according to the situation, the treatment time of this study is extended, and the drug use days of the acute phase and the remission phase of the two groups are consistent.

[0093] 8. Observation index

[0094] (1) Patient pain score: The visual analog scale method (VAS) supervised by the Pain Society of the Chinese Medical Association is used, the total score is 0-10, the higher the score, the higher the degree of pain 0: no pain, no any pain feeling; 1-3: mild pain, does not affect work and life; 4-6: moderate pain, affects work, does not affect life; 7-9: severe pain, affects work and life; 10: severe pain, unbearable. The researchers evaluate the patient's pain score once before treatment and after the end of the treatment cycle.

[0095] (2) TCM syndrome score: According to the "Diagnosis and Treatment Criteria for Traditional Chinese Medicine" (1994 edition), "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" (2002 edition): five main symptoms of joint pain, joint tenderness, joint swelling, joint flexion and extension, and local skin temperature are assigned different scores according to no, mild, moderate, and severe, from low to high, 0, 2, 4, 6 points. Four secondary symptoms of fever, thirst, restlessness, and yellow urine are evaluated as 0, 1, 2, and 3 points according to no, mild, moderate, and severe. The tongue and pulse are recorded as true, and are not included in the scoring.

[0096] (3) Laboratory tests: Fasting blood tests were performed at 8 am before treatment and at the end of the treatment period, including blood uric acid (UA), serum C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR).

[0097] (4) Recurrence: The researchers followed up with patients who had clinical control, significant effect, and effectiveness after treatment for 6 months, and recorded the recurrence of patients within 6 months.

[0098] 9. Safety indicators:

[0099] (1) General physical examination items (body temperature, heart rate, blood pressure, pulse, etc.);

[0100] (2) Electrocardiogram; blood, urine, and stool routine; liver and kidney function, etc.

[0101] (3) Observe possible adverse reactions, including local and systemic reactions such as allergic or non-allergic dermatitis, general rash, allergic reactions, and systemic reactions. Analyze the causes of adverse reactions, make accurate judgments in a timely manner, and record the treatment process and results accurately.

[0102] 10. Efficacy determination criteria

[0103] Refer to the "Diagnosis and Treatment Criteria for Traditional Chinese Medicine" (1994 edition), "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" (2002 edition) to determine the efficacy determination criteria, as follows:

[0104] Clinical control: clinical symptoms and signs disappear or basically disappear, joint function returns to normal, laboratory-related indicators are normal, and syndrome score reduction is ≥90%;

[0105] Significant effect: clinical symptoms and signs are significantly improved, joint function is basically restored to normal, laboratory-related indicators are basically normal, and syndrome score reduction is 70%≤<90%;

[0106] Effective: clinical symptoms and signs are improved, joint function and laboratory-related indicators are improved, and syndrome score reduction is 30%≤<70%;

[0107] Ineffective: There is no significant improvement in clinical symptoms and signs, or they may even worsen, joint function has not returned to normal, there is no significant change in laboratory-related indicators, and the syndrome score decreases by <30%.

[0108] Calculation formula (nimodipine method): TCM syndrome score reduction rate = (total score before treatment - total score after treatment) / total score before treatment × 100%

[0109] Total effective rate = (number of clinically controlled patients + markedly effective patients + effective patients) / total number of patients × 100%. Follow-up information after 3 months of treatment was included as a reference in relevant efficacy indicators.

[0110] 11. Statistical analysis

[0111] SPSS 26.0 software was used to analyze the data, and the measurement data were expressed as mean ± standard deviation ( ±s), and if the data satisfy the normal distribution and the variance is equal, the paired sample T test is used for the comparison within each group; the one-way analysis of variance is used for the comparison between each group; if it does not meet the requirements, the rank sum test is used. For count data, the frequency or percentage (%) is used, and the inter-group comparison is used. 2 For ranked data, the rank-sum test was used for comparisons between groups. P < 0.05 indicated statistically significant differences.

[0112] (2) Research results

[0113] 1. Statistical analysis of general data

[0114] (1) Comparison of gender among the three groups of patients

[0115] There were 88 patients in total, 79 of whom were male and 9 were female. There were 30 patients in the control group, of whom 26 were male, accounting for 86.67%, and 4 were female, accounting for 13.33%. There were 29 patients in the experimental group, of whom 27 were male, accounting for 93.10%, and 2 were female, accounting for 6.90%. There were 29 patients in the comparative group, of whom 26 were male, accounting for 89.66%, and 3 were female, accounting for 10.34%. 2 Check and get X 2 =0.666, P=0.717>0.05, indicating that there was no statistically significant difference in gender among the three groups of patients, indicating that the gender data of the three groups were comparable. See Table 1.

[0116] Table 1: Comparison of gender ratios among the three groups of patients .

[0117] (2) Comparison of age among the three groups of patients

[0118] The age of the three groups of patients was compared. The maximum age of the control group was 68 years old, the minimum age was 22 years old, and the average age was 45.73±9.83 years old; the maximum age of the test group was 66 years old, the minimum age was 22 years old, and the average age was 46.21±10.14 years old; the maximum age of the comparison group was 65 years old, the minimum age was 23 years old, and the average age was 46.69±9.92 years old. By single factor variance analysis, F=0.068, P=0.934>0.05, indicating that the difference between the ages of the three groups of patients has no statistical significance, indicating that the age data of the three groups is comparable. See Table 2.

[0119] Table 2: Comparison of the ages of the three groups of patients .

[0120] (3) Comparison of the course of the three groups of patients

[0121] The course of the three groups of patients was compared. The longest course of the control group was 10 years, the shortest course was 1 year, and the average course was 6.10±2.54 years; the longest course of the test group was 10 years, the shortest course was 2 years, and the average course was 6.31±2.75 years; the longest course of the comparison group was 9 years, the shortest course was 1 year, and the average course was 6.17±2.83 years. By multiple independent sample rank sum test, H c =0.215, P=0.898>0.05, indicating that the difference between the courses of the three groups of patients has no statistical significance, indicating that the course data of the three groups is comparable. See Table 3.

[0122] Table 3: Comparison of the courses of the three groups of patients .

[0123] (4) Comparison of the BMI of the three groups of patients

[0124] The BMI of the three groups of patients was compared. The average BMI of the control group was 25.27±2.85 kg / m 2 ; the average BMI of the test group was 25.55±2.41 kg / m 2 ; the average BMI of the comparison group was 26.03±2.56 kg / m 2 . By multiple independent sample rank sum test, H c =1.248, P=0.536>0.05, indicating that the difference between the BMIs of the three groups of patients has no statistical significance, indicating that the BMI data of the three groups is comparable. See Table 4.

[0125] Table 4: Comparison of the body mass index (BMI) of the three groups of patients .

[0126] 2, Comparison of VAS (Visual Analog Scale) scores of three groups of patients

[0127] Comparison of intragroup data: after treatment, the VAS scores of the three groups decreased, and the two related sample rank sum test showed that the control group Z=-4.571, P<0.001, the test group Z=-4.718, P<0.001; the two paired sample T test showed that the comparison group t=13.508, P<0.001, indicating that the difference in VAS scores between the three groups of patients before and after treatment was statistically significant, suggesting that the three interventions were effective. Comparison of intergroup data: the multiple independent sample rank sum test showed that the difference in VAS scores of the three groups of patients before treatment was not statistically significant (H c =0.522, P=0.77>0.05), indicating that the VAS score data of the three groups before treatment was comparable; the difference in VAS scores of the three groups of patients after treatment was statistically significant (H c =17.867, P<0.001), suggesting that the test group was more effective than the control group and the comparison group in relieving pain. See Table 5.

[0128] Table 5: Comparison of VAS scores of three groups of patients before and after treatment (points) .

[0129] 3, Comparison of serum uric acid (UA) levels of three groups of patients

[0130] Comparison of intragroup data: after treatment, the UA (Uric Acid) levels of the three groups decreased, and the two related sample rank sum test showed that the control group Z=-4.556, P<0.001; the test group Z=-4.681, P<0.001; the comparison group Z=-4.703, P<0.001, indicating that the difference in UA levels between the three groups of patients before and after treatment was statistically significant, suggesting that the three interventions were effective. Comparison of intergroup data: the multiple independent sample rank sum test showed that the difference in UA levels of the three groups of patients before treatment was not statistically significant (H c =0.526, P=0.769>0.05), indicating that the UA data of the three groups before treatment was comparable; the one-way ANOVA analysis showed that the difference in UA levels of the three groups of patients after treatment was statistically significant (F=43.887, P<0.001), and the LSD test suggested that the test group was more effective than the control group and the comparison group in reducing UA. See Table 6.

[0131] Table 6: Comparison of serum uric acid (UA) of three groups of patients before and after treatment (μmol / L) .

[0132] 4. Comparison of serum C-reactive protein (CRP) levels of three groups of patients

[0133] The data within the group were compared: after treatment, the CRP levels of the three groups were decreased, and the two related sample rank sum test showed that the control group Z=-3.965, P<0.001; the test group Z=-4.705, P<0.001; and the comparison group Z=-4.601, P<0.001, indicating that the difference in CRP levels between the three groups of patients before and after treatment was statistically significant, suggesting that the three interventions were effective. Comparison of data between groups: by multiple independent sample rank sum test, it was found that the difference in CRP levels of the three groups of patients before treatment was not statistically significant (H c =0.876, P=0.645>0.05), indicating that the CRP data of the three groups before treatment was comparable; the difference in CRP levels of the three groups of patients after treatment was statistically significant (H c =34.026, P<0.001), suggesting that the test group was more effective than the control group and the comparison group in reducing CRP. See Table 7.

[0134] Table 7: Comparison of serum C-reactive protein (CRP) of three groups of patients before and after treatment (mg / L) .

[0135] 5. Comparison of erythrocyte sedimentation rate (ESR) levels of three groups of patients

[0136] The data within the group were compared: after treatment, the ESR levels of the three groups were decreased, and the two related sample rank sum test showed that the control group Z=-4.671, P<0.001; the test group Z=-4.705, P<0.001; and the comparison group Z=-4.706, P<0.001, indicating that the difference in ESR levels between the three groups of patients before and after treatment was statistically significant, suggesting that the three interventions were effective. Comparison of data between groups: by multiple independent sample rank sum test, it was found that the difference in ESR levels of the three groups of patients before treatment was not statistically significant (H c =2.049, P=0.359>0.05), indicating that the ESR data of the three groups before treatment was comparable; the difference in ESR levels of the three groups of patients after treatment was statistically significant (H c =38.320, P<0.001), suggesting that the test group was more effective than the control group and the comparison group in reducing ESR. See Table 8.

[0137] Table 8: Comparison of cell sedimentation rate (ESR) of three groups of patients before and after treatment (mm / h) .

[0138] 6, Comparison of TCM syndrome scores in three groups of patients

[0139] The data in the group were compared: after treatment, the TCM syndrome scores of the three groups decreased, and the two correlation sample rank sum test showed that the control group Z=-4.787, P<0.001; the test group Z=-4.706, P<0.001; and the comparison group Z=-4.705, P<0.001, indicating that the differences in TCM syndrome scores between the three groups before and after treatment were statistically significant, suggesting that the three interventions were effective. Comparison of data between groups: by multiple independent sample rank sum test, it was found that the TCM syndrome scores of the three groups before treatment had no statistically significant difference (H c =2.311, P=0.315>0.05), indicating that the TCM syndrome score data of the three groups before treatment were comparable; the TCM syndrome scores of the three groups after treatment had statistically significant difference (H c =21.976, P<0.001), suggesting that the test group was more effective than the control group and the comparison group in improving joint pain, joint tenderness, joint swelling, joint flexion and extension, joint local skin temperature, fever, thirst, restlessness, and other TCM symptoms. See Table 9.

[0140] Table 9: Comparison of TCM syndrome scores of three groups of patients before and after treatment (points) .

[0141] 7, Comparison of curative effects of three groups of patients

[0142] After the completion of the treatment course, 30 cases in the control group, of which 5 cases were markedly effective, 14 cases were effective, 11 cases were ineffective, and the total effective rate was 63.33%; 29 cases in the test group, of which 9 cases were clinically controlled, 11 cases were markedly effective, 8 cases were effective, and 1 case was ineffective, and the total effective rate was 96.55%; 29 cases in the comparison group, of which 3 cases were clinically controlled, 8 cases were markedly effective, 14 cases were effective, and 4 cases were ineffective, and the total effective rate was 86.21%. The total effective rates of the three groups were analyzed by multiple independent sample rank sum test, and H c =22.4, P<0.001, indicating that the differences in total effective rates of the three groups were statistically significant, suggesting that the total effective rate of the test group was higher than that of the control group and the comparison group. See Table 10.

[0143] Table 10: Comparison of curative effects of three groups of patients after treatment (cases) .

[0144] Note: Total effective rate (%) = (clinical control + marked effect + effective) / number of patients × 100%.

[0145] 8. Safety Assessment

[0146] (1) Drug safety assessment

[0147] Before, during and after treatment, the three groups of patients underwent routine examinations of vital signs, blood, urine, and feces, as well as liver and kidney function, electrocardiogram, etc. to evaluate the safety of the drug. No normal results before treatment and abnormal results after treatment were found, indicating that the drug is safe.

[0148] (2) Comparison of adverse reactions among the three groups of patients

[0149] In terms of adverse reactions, one patient in the experimental group experienced itching and rash during treatment. After timely symptomatic treatment, the discomfort symptoms disappeared and the treatment was not interrupted during the study. 2 The incidence of adverse reactions in the three groups of patients was analyzed and X 2 =2.058, P=0.357>0.05, indicating that there was no statistically significant difference in the incidence of adverse reactions among the three groups of patients. See Table 11.

[0150] Table 11: Comparison of the incidence of adverse reactions in the two groups of patients (cases) .

[0151] 9. Comparison of recurrence rates among the three groups of patients

[0152] The patients in the three groups who were effective after treatment were followed up for 3 months, and the recurrence rate within 3 months was counted. During the follow-up period, 9 patients in the control group, 2 patients in the experimental group, and 5 patients in the comparison group relapsed. 2 The recurrence rate of the three groups of patients was analyzed and X 2 =10.706, P=0.005<0.05, indicating that the differences in recurrence rates among the three groups were statistically significant, suggesting that the experimental group can effectively reduce the recurrence rate of gout patients compared with the control group and the comparison group. See Table 12.

[0153] Table 12: Comparison of recurrence rates among three groups of patients (cases) .

[0154] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, and are not intended to limit the present application; although the present application has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions recorded in the above embodiments can be modified, or some or all of the technical features can be replaced by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A gout patch set, characterized in that: It includes: patches A and patch B; patch A is an umbilical patch used for gout remission; Patch B is a patch for painful joints during attacks; The medicinal ingredients of patch A are prepared from the first Chinese medicine composition, which is composed of the following medicinal materials in parts by weight: Ingredients: 10 parts of Atractylodes lancea, 10 parts of Achyranthes bidentata, 20 parts of Phellodendron chinense, 20 parts of Coix seed, 8 parts of Ophiopogon japonicus, 8 parts of silkworm excrement, 10 parts of Atractylodes macrocephala, 10 parts of Glycyrrhiza uralensis, 10 parts of Herba Polygoni Multiflori, 10 parts of Morus alba, 10 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 12 parts of Dipsacus asper, 10 parts of Cibotium barometz, 10 parts of Poria cocos, 10 parts of Polyporus umbellatus, 6 parts of Earthworm, 6 parts of Tangerine peel, 10 parts of Patchouli, 6 parts of Vaccaria segetalis, and 0.3 parts of Styrax odoratus. The medicinal ingredients of patch B are prepared from the second Chinese medicine composition, which is composed of the following medicinal materials in parts by weight: Ingredients: 10 parts of honeysuckle, 10 parts of phellodendron, 6 parts of corydalis, 6 parts of cinnamomum camphora, 8 parts of silkworm excrement, 20 parts of viola yedoensis, 12 parts of sanguisorba officinalis, 10 parts of trachelospermum officinale, 10 parts of scutellaria baicalensis, 15 parts of scutellaria baicalensis, 6 parts of earthworm, 20 parts of oyster, 4 parts of frankincense, 4 parts of myrrh, 6 parts of turmeric, 6 parts of arisaema, 6 parts of jasmine and 0.3 parts of borneol.

2. The preparation method of the gout patch set according to claim 1, characterized in that: The preparation method of patch A is as follows: Step 1: Atractylodes lancea, Achyranthes bidentata, Phellodendron chinense, Coix seed, Ophiopogon japonicus, Silkworm excrement, Atractylodes macrocephala, Licorice root, Herba scutellariae baicalensis, Morus alba, Paeonia lactiflora, Rhizoma Chuanxiong, Dipsacus asper, Cibotium barometz, Poria cocos, Polyporus umbellatus, Earthworm, Tangerine peel, Patchouli, and Vaccaria segetalis are divided into two parts according to the established dosage, namely Chinese medicine A1 and Chinese medicine A2; Chinese medicine A1 is soaked in 7-9 times the weight of water, boiled over low heat for 35-45 minutes, filtered, and then 7-9 times the weight of water is added, boiled over low heat for 25-35 minutes, filtered again, and the two filtrates are combined. The filtrates are concentrated by rotary evaporation to a relative density of 1.9-2.2 to obtain Chinese medicine concentrate A; Step 2: The Chinese medicine A2 was powdered and passed through an 80-mesh sieve to obtain powder; the storax was ground and mixed with 95% ethanol in a volume ratio of 1:2, and allowed to stand for 20-30h and filtered to obtain storax liquid; Step 3: Add the medicinal powder to the Chinese medicine concentrate A and stir evenly. Then, preheat to 60-70°C and stop heating. Add propolis and continue stirring until it becomes viscous. Then, add the storax solution and stir quickly to obtain a medicinal paste. Place the medicinal paste in a mold and cool it to form a spherical navel-filling pill with a diameter of 1-1.2 cm. Combine with a breathable and waterproof non-woven fabric with viscose on the inner surface to obtain a patch A. The preparation method of patch B is as follows: S1, honeysuckle, phellodendron, corydalis, pentastragalus, silkworm excrement, viola yedoensis, safflower caulis, trachelospermum officinale, scutellaria baicalensis, scutellaria baicalensis, scutellaria baicalensis, earthworm, oyster, frankincense, myrrh, turmeric, arisaema, and dahliae are divided into two parts according to the established dosage, namely Chinese medicine B1 and Chinese medicine B2; add 7-9 times the weight of water to Chinese medicine B1 to soak the Chinese medicine, boil it over low heat for 35-45 minutes, filter it, add 7-9 times the weight of water, boil it over low heat for 25-35 minutes, filter it again, combine the two filtrates, and concentrate the filtrate by rotary evaporation to a relative density of 1.9-2.2 to obtain Chinese medicine concentrate B; S2, grind the Chinese medicine B2 into powder and pass it through an 80-mesh sieve to obtain medicine powder; S3. Add the powder to the Chinese medicine concentrate B and stir evenly. Then, preheat to 60-70°C and stop heating. Add propolis and stir continuously until it becomes viscous. Then add borneol and stir quickly to obtain a paste. Place the paste in a mold and cool it to form a sheet-like coating with a thickness of 0.2 cm ± 0.05 cm. Patch B is obtained by combining a breathable and waterproof non-woven fabric with viscose on the inner surface.