Composition for relieving knee osteoarthritis and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a composition for relieving knee osteoarthritis and a preparation method of an external patch thereof, the composition comprises a Zhuang medicine component and sweet tea liquid, the Zhuang medicine component comprises a main medicine, a male medicine and an auxiliary medicine, and the main medicine comprises dendropanax dentiger, pseudo-ginseng and radix clematidis; the male medicine is prepared from litsea cubeba, tea pepper, cortex cinnamomi and prostrate centipede; the upper medicine comprises polygonum cuspidatum, philippine flemingia root, bark of himalayan coralbean, radix zanthoxyli and fructus liquidambaris. Compared with the prior art, Zhuang medicine components of a main common helper are configured on the basis of KOA Zhuang medicine pathogenesis and Zhuang medicine pathology, and all the medicines are combined for use, so that the purposes of dispelling wind, eliminating dampness, regulating and smoothing a dragon road and a fire road, promoting blood circulation to arrest pain, tonifying deficiency and strengthening muscles and bones are achieved, and the purpose of treating knee osteoarthritis is achieved; meanwhile, animal experiments and clinical experiments verify the efficacy of the external application agent, and the external application agent has the effect of relieving knee osteoarthritis.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a composition for relieving knee osteoarthritis and a preparation method thereof. BACKGROUND

[0002] Knee osteoarthritis (KOA) is a common chronic degenerative joint disease in orthopedics. As the joint with the most movement, the most weight-bearing and the most complex structure in the human body, the knee joint is the joint that degenerates earliest, is damaged most and is most difficult to repair in the human body. According to epidemiological investigations, the probability of KOA in the elderly is extremely high, and research shows that the number of KOA patients over 60 years old is 37.35 million. KOA causes joint pain, stiffness, swelling, and even joint deformation, causing mobility disorders and even disabilities. Persistent pain and mobility disorders seriously affect the patient's life activities.

[0003] The treatment of KOA by Western medicine mainly inhibits the inflammatory response of patients and reduces the pain of patients through ibuprofen, diclofenac and other non-steroidal anti-inflammatory drugs. Although non-steroidal anti-inflammatory drugs can relieve the inflammatory response and pain of patients in the short term, long-term use of non-steroidal anti-inflammatory drugs will make patients drug-dependent. At the same time, non-steroidal anti-inflammatory drugs damage the gastrointestinal tract and poison the liver and kidney. Some patients have complications such as gastrointestinal adverse reactions after taking the drug. Patients with severe KOA are treated by arthroscopic cleaning, osteotomy, unicompartmental replacement or total knee replacement surgery, which is expensive and has a long recovery period, and requires patients to have certain requirements. Patients with contraindications cannot be treated by surgery.

[0004] However, Chinese medicine can effectively relieve the condition and symptoms of KOA patients by reasonably configuring traditional Chinese medicine prescriptions according to the pathogenesis and etiology, and has low toxicity and side effects and is suitable for all patients. Zhuang medicine is a unique traditional medicine of the Zhuang nationality in Guangxi Zhuang Autonomous Region. Zhuang medicine has a long history of development. Zhuang medicine emphasizes main disease and main prescription, that is, formulating a fixed prescription for treating a disease according to the core etiology and pathogenesis. Folk medicine in Zhuang areas often uses external application of Zhuang medicine to treat the disease and achieves good efficacy. Therefore, it is an important task for the medical community to explore safe and effective Zhuang medicine combinations for treating KOA. Zhuang medicine researches and analyzes the etiology and pathology of KOA. SUMMARY

[0005] The purpose of the present application is to provide a composition for relieving knee osteoarthritis, which aims to relieve the pain of KOA patients and reduce or eliminate cold evil and relieve or alleviate symptoms by using Zhuang medicine to treat the etiology and pathogenesis of KOA.

[0006] To achieve the above-mentioned purpose, the present application provides a composition for relieving knee osteoarthritis, which comprises: a Zhuang medicine component and a sweet tea liquid. The tonic component comprises main drugs, common drugs and auxiliary drugs, the main drugs are Fohuo Gui, Sanqi and Weilingxian, the common drugs are Douchijiang, Chadal, Rougui and Pudi Wugong, and the auxiliary drugs are Huzhang, Qianjiba, Haitongpi, Liangmianzhen and Lulutong.

[0007] Preferably, in the above technical solution, the main drugs are Fohuo Gui 20-40 parts, Sanqi 15-35 parts and Weilingxian 15-35 parts by weight; the common drugs are Douchijiang 15-35 parts, Chadal 15-30 parts, Rougui 10-20 parts and Pudi Wugong 10-30 parts; and the auxiliary drugs are Huzhang 15-30 parts, Qianjiba 15-30 parts, Haitongpi 15-30 parts, Liangmianzhen 15-30 parts and Lulutong 10-25 parts.

[0008] Preferably, in the above technical solution, the main drugs are Fohuo Gui 40 parts, Sanqi 30 parts and Weilingxian 30 parts by weight; the common drugs are Douchijiang 30 parts, Chadal 20 parts, Rougui 15 parts and Pudi Wugong 15 parts; and the auxiliary drugs are Huzhang 20 parts, Qianjiba 20 parts, Haitongpi 17.5 parts, Liangmianzhen 17.5 parts and Lulutong 12.5 parts.

[0009] To achieve the above object, the application further provides a preparation method of the external use plaster for relieving knee osteoarthritis, which comprises the following steps: S1, mixing Douchijiang, Fohuo Gui, Chadal, Huzhang, Weilingxian, Qianjiba, Haitongpi, Pudi Wugong, Liangmianzhen, Sanqi, Lulutong and Rougui, and crushing them into particles with a granularity of 100-200 mesh to obtain a tonic component; S2, soaking sweet tea in 90-100 water for 10-15 min to obtain a sweet tea solution, wherein the weight ratio of the sweet tea to the water is 1:10-15; S3, mixing the tonic component and the sweet tea solution uniformly to form a paste, and applying the paste on gauze to obtain the external use plaster.

[0010] Preferably, in the above technical solution, in step S1, the tonic component comprises Fohuo Gui 20-40 parts, Sanqi 15-35 parts, Weilingxian 15-35 parts, Douchijiang 15-35 parts, Chadal 15-30 parts, Rougui 10-20 parts, Pudi Wugong 10-30 parts, Huzhang 15-30 parts, Qianjiba 15-30 parts, Haitongpi 15-30 parts, Liangmianzhen 15-30 parts and Lulutong 10-25 parts by weight.

[0011] Preferably, in the above technical solution, in step S3, the step of mixing the Chinese herbal medicine components and the sweet tea liquid uniformly into a paste, applying the paste on gauze, and preparing the external application plaster, the external application plaster has a length x width of 5-20 cm x 5-20 cm, and the paste on the external application plaster has a thickness of 2-3 mm.

[0012] To further improve the medicinal effect of the external application plaster, the application further provides a preparation method of an external application plaster for relieving knee osteoarthritis, which comprises the following steps: S1, mix soybean ginger, fenghe gui, tea hot, giant knotweed, wilson, thousand pound, sea-tortoise shell, flatworm, two-sided needle, sanchi, lalun, and cassia, crush into Chinese herbal medicine powder with a particle size of 40-60 mesh, and put the Chinese herbal medicine powder into an extraction liquid for high-voltage pulse electric field treatment, extraction, centrifugation, and obtain an extraction liquid; S2, place sweet tea in low temperature treatment at-10~-18℃ for 3-5 hours, then boil in pure water and keep warm for 15-30 min, wherein the weight ratio of the sweet tea to water is 1:10-15; S3, mix the extraction liquid and the sweet tea liquid, add sodium carboxymethyl cellulose and starch to adjust into a gelatinous substance, and obtain an external application plaster.

[0013] Preferably, in the above technical solution, in step S1, the extraction liquid is a hexadecyl trimethyl ammonium bromide-ethyl acetate solution.

[0014] Preferably, in the above technical solution, the process parameters of the high-voltage pulse electric field treatment are an electric field intensity of 30-35 kV / cm, a pulse frequency of 90-100 Hz, and a pulse time of 65.6-81.0 μs.

[0015] Preferably, in the above technical solution, when the external application plaster is used, the external application plaster is applied on the knee patellar area, the application thickness is 2-3 mm, and the application part is wrapped with a preservative film.

[0016] The characteristics of the raw materials of the Chinese herbal medicine combination are as follows: Fenghe Gui: fenghe gui is a plant of Artocarpus of Moraceae Artocarpus styracifolius Pierre. dry root. Nature and taste: sweet, warm. Function: regulating the fire path, removing dampness and toxicity, and expelling wind and toxicity. Indications: hair growth (rheumatic pain), lumbar muscle strain, chronic lumbar and leg pain, hemiplegia (hemiplegia), chest pain.

[0017] Sanchi: the strong name is Godienzcaet, which is a plant of Panax of Araliaceae Panax notoginsengThe root and rhizome of Cynanchum stauntoni (Decne.) Choisy. Pungent, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0018] Raglingzsien, the root of Raglingzsien, a plant of Ranunculaceae Clematis chinensis The rhizome and root of Smilax china L. Pungent, salty, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0019] Gosoengngaenz, the whole plant of Gosoengngaenz, a plant of Lycopodiaceae Palhinhaea cernua The whole plant of Asarum sieboldii Miq. Pungent, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0020] Gauginghsaej, the mature fruit of Gauginghsaej, a plant of Lauraceae Litsea cubeba The mature fruit of Evodia rutaecarpa (Lour.) Pers. Pungent, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0021] Cazlat, the nearly mature fruit of Cazlat, a plant of Rutaceae Evodia rutaecarpa The nearly mature fruit of Evodia rutaecarpa (Lour.) Pers. Pungent, bitter, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0022] Gveibiz, the bark of Cinnamomum loureiroi H. L. Pungent, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain. Cinnamomum cassia The bark of Cinnamomum loureiroi H. L. Pungent, warm. Efficacy: Expelling wind-evil, activating blood, stopping bleeding. Indications: Wind-damp arthralgia, numbness of limbs, jaundice, burns, cough, postpartum abdominal pain.

[0023] Goragdingh, sweet, bland, astringent, and neutral in nature. It functions to regulate the Dragon Channel, expel wind and damp toxins, and tonify deficiency and strengthen the bones and tendons. It is indicated for the treatment of gout (lumbago), hemiplegia, impotence, spontaneous sweating, and rheumatic arthralgia.

[0024] Godiengangh, the root and rhizome of Polygonum cuspidatum Sieb. et Zucc. Reynoutria japonica Houtt., of the family Polygonaceae. It is bitter and sour in taste and cold in nature. It functions to clear the Water Channel, expel damp and toxic substances, and relieve pain. It is indicated for the treatment of cough, jaundice, burns, and traumatic injury.

[0025] Godongz, the dried bark or root bark of Erythrina variegate L., of the family Leguminosae. It is bitter and pungent in taste and neutral in nature. It functions to expel wind and damp toxins and regulate the Fire Channel. It is indicated for the treatment of rheumatic arthralgia, joint stiffness, traumatic injury, tinea, and eczema. Erythrina varieate Gocaengloj, the root of Zanthoxylum nitidium (Roxb.) DC., of the family Rutaceae. It is pungent and bitter in taste and neutral in nature. It functions to regulate the Dragon and Fire Channels, expel wind and damp toxins, clear heat and toxic substances, and relieve swelling and pain. It is indicated for the treatment of rheumatic arthralgia, lumbago, scrofula, common cold, toothache, sore throat, burns, hernia, and snakebite.

[0026] Makraeu, the inflorescence of Liquidambar formosana Hance, of the family Hamamelidaceae. It is bitter in taste and neutral in nature. It functions to regulate the Fire Channel, unblock the Water Channel, and expel damp toxins. It is indicated for the treatment of rheumatic arthralgia, edema, postpartum lack of lactation, amenorrhea, and headache.

[0027] Sweet tea, the leaf of Rubus suavissimus S. K. Lee L. T. Lu, of the family Rosaceae. It is sweet in taste and neutral in nature. It functions to detoxify and tonify deficiency and harmonize all medicines. Pharmacological studies have shown that sweet tea has anti-allergic, anti-inflammatory, antioxidant, and anti-tumor effects.

[0028] Rubus chingii var. suavissimus The pathogenesis of osteoarthritis of the knee joint in Zang medicine is that toxic, cold, and damp evils invade the knee joint, causing obstruction and stagnation of the Dragon Channel, which leads to obstruction of the flow of qi and blood and the appearance of swelling of the knee joint. The swelling triggers the Fire Channel, causing pain. The continuous obstruction and stagnation of the Dragon Channel leads to the deficiency of the bones and tendons of the knee joint, causing swelling, stiffness, and necrosis of the knee joint, which triggers the Fire Channel and causes persistent pain.

[0029] The pathogenesis of osteoarthritis of the knee joint in Zang medicine is that toxic, cold, and damp evils invade the knee joint, causing obstruction and stagnation of the Dragon Channel, which leads to obstruction of the flow of qi and blood and the appearance of swelling of the knee joint. The swelling triggers the Fire Channel, causing pain. The continuous obstruction and stagnation of the Dragon Channel leads to the deficiency of the bones and tendons of the knee joint, causing swelling, stiffness, and necrosis of the knee joint, which triggers the Fire Channel and causes persistent pain. ​

[0030] Zhuang Medicine Pathology of Knee Osteoarthritis: Based on the Zhuang Medicine theory of "main, general, helping, and leading" compatibility, this prescription selects Zhuang herbs with relatively warm properties and flavors as its components based on their properties and efficacy. Combining the pathogenesis of knee osteoarthritis and the characteristics of Zhuang medicine, the components are divided into four categories: principal herbs, general herbs, helping herbs, and leading herbs. Principal herbs are primarily used to treat congestion and stasis in the "Dragon Pathway" (Dragon Path), addressing the symptoms. General herbs are primarily used to treat deficiency-cold syndromes, addressing the root cause. Helping herbs assist the principal herbs in producing their therapeutic effects or are used to treat concurrent symptoms. Leading herbs, also known as guiding herbs, are used to guide the herbs in the prescription to the affected area or to harmonize the medicinal flavors. The formula is as follows: maple lotus and cinnamon can regulate the fire path, remove dampness and toxins, and dispel wind toxins; Panax notoginseng can regulate the dragon path and fire path, replenish blood, stop bleeding, disperse blood stasis and relieve pain; Clematis can dispel wind and toxins and unblock the dragon path. The three herbs have strong medicinal effects and are the main herbs. They can dispel wind and dampness, regulate the dragon path, promote blood circulation and relieve pain; centipede, fermented black beans, ginger, tea pepper and cinnamon are all hot in nature and are public herbs. They can dispel cold toxins, remove wind toxins, remove dampness and toxins, and unblock the dragon path and fire path to relieve pain; Tripterygium wilfordii, Polygonum cuspidatum, Zanthoxylum bungeanum, Pittosporum tobira bark and Rhizoma Smilacis Glabrae are auxiliary herbs. In addition to increasing the efficacy of the main herbs, Tripterygium wilfordii can replenish deficiency and strengthen tendons and bones, and Polygonum cuspidatum is slightly cold in nature and can restrain the dryness and heat of the herbs in the formula; sweet tea is a supporting herb that can harmonize the above herbs and eliminate toxic and side effects such as skin allergies that may be caused by the herbs. The Zhuang medicine composition of the present invention is used in combination to dispel wind, dampness and cold, regulate dragon and fire pathways, promote blood circulation and relieve pain, and strengthen muscles and bones, thereby achieving the purpose of treating knee osteoarthritis.

[0031] The Zhuang medicine prescription is a proven prescription, and its efficacy needs to be verified through clinical practice. This prescription has been clinically verified. The Zhuang medicine patch prepared from the Zhuang medicine composition of the present invention can significantly improve the symptoms of joint pain, swelling, flexion and extension difficulties in patients with knee osteoarthritis, and the therapeutic effect is definite.

[0032] Compared with the prior art, the beneficial effects of the method of the present invention are as follows: (1) This prescription is based on the principle of “the master helps the doctor” in Zhuang medicine theory. It takes into account the etiology and the pharmacological properties of the drugs. It selects herbs with hot, neutral or slightly cold properties to avoid aggravating the cold poison with cold herbs. Although they are effective in treating carbuncle, they aggravate the cold evil and lead to recurrence of the disease. (2) Optimize the preparation of the topical patch, promote the precipitation of the main ingredients of the Chinese medicinal materials in the topical patch and preserve them on the topical patch. The main ingredients penetrate into the prepatellar area of ​​the affected knee through the skin of the prepatellar area, thereby improving the efficacy and effectively relieving knee joint abscess and pain. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present application are described clearly and completely. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application. Embodiment 1

[0034] A composition for relieving knee osteoarthritis, the heavy medicine combination ingredients are as follows: the main medicine is Fenghegui 40 parts, Sanqi 30 parts, Weilingxian 30 parts; the public medicine is Douchijiang 30 parts, Chala 20 parts, Rougui 15 parts, Pudiwugong 15 parts; the auxiliary medicine is Huazhe 20 parts, Qianjiba 20 parts, Haitongpi 17.5 parts, Liangmianzhen 17.5 parts, Lulutong 12.5 parts, and the heavy medicine combination ingredients are weighed as follows: Fenghegui 80g, Sanqi 60g, Weilingxian 60g, Douchijiang 60g, Chala 40g, Rougui 30g, Pudiwugong 30g, Huazhe 40g, Qianjiba 40g, Haitongpi 35g, Liangmianzhen 35g, Lulutong 25g and sweet tea 30g.

[0035] A preparation method of an external use plaster for relieving knee osteoarthritis, the preparation method is as follows: S1, the medicinal materials are weighed according to the above weight, and the weighed Fenghegui, Sanqi, Weilingxian, Douchijiang, Chala, Rougui, Pudiwugong, Huazhe, Qianjiba, Haitongpi, Liangmianzhen and Lulutong are crushed by a traditional Chinese medicine crusher, and the heavy medicine powder with a particle size of 120 mesh is screened; S2, the sweet tea 30g is soaked in 98℃ pure water 350mL for 15min to obtain a sweet tea liquid, which is cooled to 45℃ at room temperature; S3, the heavy medicine powder is mixed with the sweet tea liquid to form a paste, the paste is applied on 10cm*15cm gauze with a thickness of 2-3mm to obtain the external use plaster, which is stored in a sterile self-sealing bag at room temperature. Embodiment 2

[0036] A composition for relieving knee osteoarthritis, the heavy medicine combination ingredients are as follows: the main medicine is Fenghegui 40 parts, Sanqi 30 parts, Weilingxian 30 parts; the public medicine is Douchijiang 30 parts, Chala 20 parts, Rougui 15 parts, Pudiwugong 15 parts; the auxiliary medicine is Huazhe 20 parts, Qianjiba 20 parts, Haitongpi 17.5 parts, Liangmianzhen 17.5 parts, Lulutong 12.5 parts, and the heavy medicine combination ingredients are weighed as follows: Fenghegui 80g, Sanqi 60g, Weilingxian 60g, Douchijiang 60g, Chala 40g, Rougui 30g, Pudiwugong 30g, Huazhe 40g, Qianjiba 40g, Haitongpi 35g, Liangmianzhen 35g, Lulutong 25g and sweet tea 30g.

[0037] A preparation method of an external application plaster for relieving knee osteoarthritis, the preparation method being as follows: S1, the medicinal materials are weighed according to the above weights, the weighed Fohogui, Sanqi, Weilingxian, Douchijiang, Chalai, Rougui, Pudiwugong, Hujang, Qianjiba, Haitongpi, Liangmianzhen and Lulutong are crushed by a traditional Chinese medicine crusher, the traditional Chinese medicine powder with a particle size of 60 meshes is screened, the traditional Chinese medicine powder is placed in a cetyltrimethylammonium bromide-ethyl acetate solution, high-voltage pulse electric field treatment is performed, the electric field strength is 35 kV / cm, the pulse frequency is 90 Hz, the pulse time is 81.0 μs, it is placed at a temperature of 50°C for extraction for 2 hours, and the supernatant is obtained by centrifugation as the extraction liquid; S2, the sweet tea is placed in low temperature for 3 hours, then boiled in 350 mL pure water and kept for 15 min, and the sweet tea liquid is obtained, and cooled to 45°C at room temperature; S3, the extraction liquid and the sweet tea liquid are mixed and concentrated to 1 / 3 of the original volume, sodium carboxymethyl cellulose and starch are added to form a gel-like substance, and the external application plaster is obtained. Example 3

[0038] A composition for relieving knee osteoarthritis, the traditional Chinese medicine components are Fohogui 20-40 parts, Sanqi 15-35 parts, Weilingxian 15-35 parts, the public medicine is Douchijiang 15-35 parts, Chalai 15-30 parts, Rougui 10-20 parts, Pudiwugong 10-30 parts, the auxiliary medicine is Hujang 15-30 parts, Qianjiba 15-30 parts, Haitongpi 15-30 parts, Liangmianzhen 15-30 parts, and Lulutong 10-25 parts.

[0039] A preparation method of an external application plaster for relieving knee osteoarthritis, the preparation method being as follows: S1, the medicinal materials are weighed according to the above weights, the weighed Fohogui, Sanqi, Weilingxian, Douchijiang, Chalai, Rougui, Pudiwugong, Hujang, Qianjiba, Haitongpi, Liangmianzhen and Lulutong are crushed by a traditional Chinese medicine crusher, the traditional Chinese medicine powder with a particle size of 60 meshes is screened, the traditional Chinese medicine powder is placed in a cetyltrimethylammonium bromide-ethyl acetate solution, high-voltage pulse electric field treatment is performed, the electric field strength is 35 kV / cm, the pulse frequency is 90 Hz, the pulse time is 81.0 μs, it is placed at a temperature of 50°C for extraction for 2 hours, and the supernatant is obtained by centrifugation as the extraction liquid; S2, the sweet tea is placed in low temperature for 3-5 hours, then boiled in pure water and kept for 15-30 min, the weight ratio of the sweet tea to water is 1:10-15, the sweet tea liquid is obtained, and cooled to 45°C at room temperature; S3, the leaching liquor and sweet tea liquid mixed concentration to the original volume of 1 / 3, add sodium carboxymethyl cellulose and starch into gel-like material, get external use paste.

[0040] Comparative Example 1 A composition for relieving knee osteoarthritis, the Chinese herbal medicine combination ingredients by mass fraction of the main drug is Fenghegui 40 parts, Sanqi 30 parts, Weilingxian 30 parts; the public drug is Douchijiang 30 parts, Wumiaoceng 20 parts, Yimucao 15 parts, Pugedi Wugong 15 parts; the auxiliary drug is Huozhang 20 parts, Qianjiba 20 parts, Gaolong 17.5 parts, Liangmianzhen 17.5 parts, Fangji 12.5 parts, the Chinese herbal medicine combination ingredients are weighed as follows: Fenghegui 80g, Sanqi 60g, Weilingxian 60g, Douchijiang 60g, Wumiaoceng 40g, Yimucao 30g, Pugedi Wugong 30g, Huozhang 40g, Qianjiba 40g, Gaolong 35g, Liangmianzhen 35g, Fangji 25g and sweet tea 30g.

[0041] A preparation method of external use paste for relieving knee osteoarthritis, the preparation method is as follows: S1, the above-mentioned weight is weighed respectively, the weighed Fenghegui, Sanqi, Weilingxian, Huozhang, Qianjiba, Gaolong, Liangmianzhen, Fangji and Wumiaoceng are crushed by a Chinese herbal medicine crusher, and the Chinese herbal medicine powder with a particle size of 120 mesh is screened; S2, sweet tea 30g is soaked in 98℃ pure water 350mL for 15min to obtain sweet tea liquid, which is cooled to 45℃ at room temperature; S3, the Chinese herbal medicine powder is mixed with the sweet tea liquid to form a paste, the paste is applied on 10cm×15cm gauze with a thickness of 2-3mm to obtain the external use paste. It is stored in a sterile self-sealing bag at room temperature.

[0042] Comparative Example 2 A composition for relieving knee osteoarthritis, the Chinese herbal medicine combination ingredients by mass fraction of the main drug is Fenghegui 40 parts, Sanqi 30 parts, Weilingxian 30 parts; the public drug is Douchijiang 30 parts, Wumiaoceng 20 parts, Yimucao 15 parts, Pugedi Wugong 15 parts; the auxiliary drug is Huozhang 20 parts, Qianjiba 20 parts, Gaolong 17.5 parts, Liangmianzhen 17.5 parts, Fangji 12.5 parts, the Chinese herbal medicine combination ingredients are weighed as follows: Fenghegui 80g, Sanqi 60g, Weilingxian 60g, Douchijiang 60g, Wumiaoceng 40g, Yimucao 30g, Pugedi Wugong 30g, Huozhang 40g, Qianjiba 40g, Gaolong 35g, Liangmianzhen 35g, Fangji 25g and sweet tea 30g.

[0043] A preparation method of external use paste for relieving knee osteoarthritis, the preparation method is as follows: S1, the medicinal materials were weighed according to the above weight, the weighed acorus gramineus, panax notoginseng, radix clematidis, sojae, kadsura japonica, motherwort, eurycnema gloriosae, giant knotweed, radix tinosporae, radix mori, radix sargentodoxae, radix stephaniae tetrandrae and radix acanthopanacis were crushed by a traditional Chinese medicine crusher, and the traditional Chinese medicine powder with a particle size of 120 mesh was screened; S2, 30g of sweet tea was placed in 98℃ pure water 350mL for 15min to obtain sweet tea liquid, and cooled to 45℃ at room temperature; S3, the traditional Chinese medicine powder and sweet tea liquid were mixed into a paste, the paste was applied on 10cm*15cm gauze with a thickness of 2-3mm, and an external application plaster was obtained. It was stored in a sterile self-sealing bag at room temperature.

[0044] Comparative example 3 A composition for relieving knee osteoarthritis, the traditional Chinese medicine combination components were as follows: the main medicine was herba epimedii 40 parts, panax notoginseng 30 parts, radix clematidis 30 parts; the public medicine was sojae 30 parts, alocasia macrorrhiza 20 parts, cinnamomum cassia 15 parts, eurycnema gloriosae 15 parts; the auxiliary medicine was giant knotweed 20 parts, radix tinosporae 20 parts, radium sargentodoxae 17.5 parts, radix sargentodoxae 17.5 parts, acanthopanax 12.5 parts, the weights of the traditional Chinese medicine combination components were as follows: herba epimedii 80g, panax notoginseng 60g, radix clematidis 60g, sojae 60g, alocasia macrorrhiza 40g, cinnamomum cassia 30g, eurycnema gloriosae 30g, giant knotweed 40g, radix tinosporae 40g, radium sargentodoxae 35g, radix sargentodoxae 35g, acanthopanax 25g and sweet tea 30g.

[0045] A preparation method of an external application plaster for relieving knee osteoarthritis, the preparation method was as follows: S1, the medicinal materials were weighed according to the above weight, the weighed herba epimedii, panax notoginseng, radix clematidis, sojae, alocasia macrorrhiza, cinnamomum cassia, eurycnema gloriosae, giant knotweed, radix tinosporae, radium sargentodoxae, radix sargentodoxae and acanthopanax were crushed by a traditional Chinese medicine crusher, the traditional Chinese medicine powder with a particle size of 60 mesh was screened, the traditional Chinese medicine powder was placed in a cetyltrimethylammonium bromide-ethyl acetate solution, and high-voltage pulse electric field treatment was performed, the electric field strength was 35kV / cm, the pulse frequency was 90Hz, the pulse time was 81.0μs, it was placed at a temperature of 50℃ for 2 hours of extraction, and the supernatant was obtained by centrifugation as an extraction liquid; S2, 30g of sweet tea was placed in -18℃ for 3 hours of low temperature treatment, then boiled in 350mL of pure water and kept for 15min to obtain sweet tea liquid, which was cooled to 45℃ at room temperature; S3, the extraction liquid and sweet tea liquid were mixed and concentrated to 1 / 3 of the original volume, carboxymethyl cellulose sodium and starch were added to form a gel-like substance, and an external application plaster was obtained.

[0046] Comparative example 4 A composition for relieving knee osteoarthritis, the composition of the present application comprises the following components by weight: Fenghegui 40 parts, Sanqi 30 parts, Weilingxian 30 parts; Douchijiang 30 parts, Wumeiteng 20 parts, Rougui 15 parts, Pudiwugong 15 parts; Huozhang 20 parts, Qianjiba 20 parts, Haitongpi 17.5 parts, Liangmianzhen 17.5 parts, Wujiaopi 12.5 parts. The components are weighed as follows: Fenghegui 80g, Sanqi 60g, Weilingxian 60g, Douchijiang 60g, Wumeiteng 40g, Rougui 30g, Pudiwugong 30g, Huozhang 40g, Qianjiba 40g, Haitongpi 35g, Liangmianzhen 35g, Wujiaopi 25g.

[0047] A preparation method of an external use plaster for relieving knee osteoarthritis, the preparation method comprises the following steps: S1, the medicinal materials are weighed according to the above weight, and the weighed Fenghegui, Sanqi, Weilingxian, Douchijiang, Wumeiteng, Rougui, Pudiwugong, Huozhang, Qianjiba, Haitongpi, Liangmianzhen and Wujiaopi are crushed by a traditional Chinese medicine crusher, and the granulometry of the obtained traditional Chinese medicine powder is 120 mesh; S2, the traditional Chinese medicine powder is mixed with water to form a paste, the paste is applied on 10cm×15cm gauze, the thickness of the paste is 2-3mm, and an external use plaster is obtained. The external use plaster is stored in a sterile self-sealing bag at room temperature.

[0048] I. Animal experiment (1) Experimental animals and feed Experimental animals: SD rats, SPF level, both male and female, body weight 180-220g, Guangxi Medical University Experimental Animal Center of Guangxi Zhuang Autonomous Region, certificate number: Gui2022-0001.

[0049] Feed: mouse maintenance feed, Beijing Kaocuo Li Hesed Feed Co., Ltd.

[0050] (2) KOA rat model establishment and experiment The rats are bred in an environment with humidity of 98% and temperature of 8-12℃, and the rats are placed in 4℃ ice water with height higher than knee joint of hind limbs for 3 hours every day. After continuous breeding for 10 weeks under the breeding conditions, the knee joint immobilization model is used, specifically, the right hind limb of the rat is stretched to the straight position of the knee joint, medical cotton fat pad is taken between the right ankle and hip joint of the rat, and the right knee joint of the rat is uniformly fixed with 5-6 layers of plaster bandage. The right knee joint of the rat is fixed in the straight position of 180° for 2 weeks. After 2 weeks of immobilization, the following two symptoms are observed: ① obvious swelling of the right hind limb knee joint, or the circumference of the right hind limb is greater than 1.65 cm; ② right hind limb stiffness; ③ right hind limb suspension during exercise. The successfully prepared KOA rat model is randomly divided into 7 groups, one group is a model group without any drug, and the other 6 groups are respectively prepared by the external application patches of Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4. The external application patches are applied externally once a day, each time for 6 hours of continuous application, and continuously applied for 14 days. Another group is a blank group, which is a normal rat without modeling. The rats in this group are not administered with any drug.

[0051] Table 1 Swelling of the knee joint of rats before and after treatment n Joint circumference before administration (cm) Joint circumference after administration (cm) Swelling degree blank group 15 1.45±0.24 1.46±0.31 0.01 model group 15 2.36±0.37 2.56 ± 0.43 ** ]] 0.20 Example 1 15 2.41±0.67 1.62 ± 0.66 ∆∆ ]] -0.79 Example 2 15 2.36±0.54 1.51 ± 0.54 ∆ ]] -0.85 Comparative Example 1 15 2.40±0.71 1.78 ± 0.83 ∆ ]] -0.62 Comparative Example 2 15 2.38±0.42 1.72 ± 0.65 ∆ ]] -0.66 Comparative Example 3 15 2.37±0.52 1.63 ± 0.49 ∆ ]] -0.74 Comparative Example 4 15 2.37±0.23 1.68 ± 0.72 ∆∆ ]] -0.69 Compared with the normal control group, **p<0.01; compared with the model group, Δp<0.05, ΔΔp<0.01 As can be seen from Table 1, the circumference of the right hind limb knee joint of the model group, Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 before administration is obviously larger than that of the rats in the blank group, indicating that the KOA rats have obvious swelling of the knee joint. After administration, the circumference of the right hind limb knee joint of Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 is obviously reduced compared with that of the rats in the model group, indicating that the external application patches have curative effect on relieving the swelling of the knee joint of KOA rats. The swelling degrees of the rats externally applied with the external application patches of Example 1, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 are different, indicating that the traditional Chinese medicine components of the external application patches have significant influence on the subsidence of the swelling of the knee joint.

[0052] Table 2 Influence of administration of each group on hemorheology index of KOA rats n C-reactive protein (μg / L) erythrocyte sedimentation rate (mm / h) blank group 15 237.43±53.87 15.78±1.36 model group 15 314.79 ± 87.46 ** ]] 18.69 ± 3.03 * ]] Example 1 15 257.31±74.51 16.31 ± 1.17 ∆ ]]> Example 2 15 249.04 ± 65.25 ∆ ]] 16.07 ± 1.23 ∆∆ ]] Comparative Example 1 15 292.82 ± 63.58 ∆ ]] 17.36 ± 0.96 ∆ ]] Comparative Example 2 15 273.69±86.36 16.98 ± 2.39 ∆ ]] Comparative Example 3 15 264.74 ± 93.64 ∆ ]] 16.54±2.02 Comparative Example 4 15 281.17 ± 48.72 ∆∆ ]] 17.46±1.41 Compared with the normal control group, *p<0.05; **p<0.01; compared with the model group, Δp<0.05, ΔΔp<0.01 From Table 2, it can be seen that in the animal experiment, the C-reactive protein level of the model group was significantly higher than that of the blank group, and the C-reactive protein and erythrocyte sedimentation rate of the application groups of Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4 were significantly lower than those of the model group, indicating that applying the application to the diseased knee joint had a significant remission effect on the knee joint inflammation of KOA rats.

[0053] (3) KOA rat recurrence After treatment, the KOA rats in Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4 were labeled and raised in an environment with a humidity of 98% and a temperature of 8-12°C. The rats were placed in 4°C ice water that was higher than the knee joint of the hind limb for 3 hours every day. Under this environmental condition, the KOA rats were continuously raised for 15 days. If one of the following symptoms appeared, it was determined that the KOA rat had a recurrence: ① The right hind limb knee joint was obviously swollen, or the circumference of the right hind limb was greater than 1.80 cm; ② The right hind limb appeared stiff; ③ The right hind limb was suspended during exercise. The recurrence of the knee joint of the KOA rats in each group is shown in Table 3.

[0054] Table 3 Recurrence of the knee joint of KOA rats group number of experiments (only) number of relapses (only) relapse rate (%) Example 1 15 4 26.67 Example 2 15 3 20.00 Comparative Example 1 15 13 86.67 Comparative Example 2 15 10 66.67 Comparative Example 3 15 5 33.33 Comparative Example 4 15 6 40.00 From Table 3, it can be seen that the number of KOA rat recurrences in Comparative Example 1 and Comparative Example 2 was the largest, and the recurrence of the mice in Example 1, Example 2, Comparative Example 1, and Comparative Example 4 was less.

[0055] The circumference of the right hind limb knee joint of the KOA rats was measured and recorded. The right hind limb knee joint of the KOA rats in each group was externally applied with the external patching agent once a day, and each application lasted for 6 hours. The application was continuously performed for 14 days, and the circumference of the knee joint after the application was detected again.

[0056] Table 4 Circumference and swelling degree of the knee joint before and after the application group n joint circumference (cm) joint circumference after administration (cm) swelling degree Example 1 4 2.07±0.92 1.47±0.66 -0.6 Example 2 3 1.94±0.81 1.46±0.81 -0.48 Comparative Example 1 13 2.28 ± 0.96 ** ]] 1.67±0.73 -0.61 Comparative Example 2 10 2.32 ± 1.19 * ]] 1.66±0.98 -0.66 Comparative Example 3 5 2.09 ± 1.03 * ]] 1.48±0.56 -0.61 Comparative Example 4 6 2.16±0.87 1.48±0.62 -0.68 Compared with the Example 1 group, *p<0.05; **p<0.01.

[0057] From Table 5, it can be seen that the degree of carbuncle of the knee joint of the KOA rats in Example 1, Example 2, and Comparative Example 3 was lighter than that in Comparative Example 1, Comparative Example 2, and Comparative Example 4 as a whole, and the carbuncle of each group was significantly subsided after the application.

[0058] Table 5 Effect of the application of each group on the hemorheology index of the KOA rats group n C-reactive protein (μg / L) erythrocyte sedimentation rate (mm / h) Example 1 4 245.35±58.63 16.11±1.10 Example 2 3 242.26 ± 78.42 ** ]] 16.03 ± 1.06 * ]] Comparative Example 1 13 266.42 ± 92.06 * ]] 17.13 ± 1.13 * ]] Comparative Example 2 10 263.36 ± 106.11 * ]] 17.38 ± 1.25 ** ]] Comparative Example 3 5 244.22 ± 89.45 ** ]] 16.48±1.05 Comparative Example 4 6 248.87 ± 74.87 * ]] 16.33 ± 0.94 ** ]] Compared with the Example 1 group, *p<0.05; **p<0.01.

[0059] As can be seen from Table 5, the C-reactive protein level and the erythrocyte sedimentation rate level of the KOA rats in Example 1, Example 2, Comparative Example 3 and Comparative Example 4 after the application of the medicine are similar, and the C-reactive protein level and the erythrocyte sedimentation rate level of Comparative Example 1 and Comparative Example 2 are higher than that of Example 1, which indicates that the examples have better effects on relieving inflammation than Comparative Example 1 and Comparative Example 2.

[0060] II. Clinical Experiment: Application of the External Application Plaster in Clinic (1) Application method: the external application plaster prepared according to the preparation method of Example 1 or Example 2 is applied externally on the knee patellar region of the patient, once a day, and the plaster is applied for 6 hours a day, and one treatment course is 7 days. The curative effect after the external application of the external application plaster for one month is shown in Table 6 and Table 7.

[0061] The patients are scored by visual analogue scale (VAS) and Womac index before and after one month of treatment, and the swelling degree of the knee joint of the patients is measured.

[0062] The swelling degree of the knee joint is measured by measuring the circumference of the knee joint at 2 cm above the patella of the affected side and the healthy side using a flexible ruler.

[0063] The VAS scoring method is as follows: a ruler with a scale of 0 cm-10 cm is used, one end is 0, representing no pain, and the other end is 10, representing severe pain, and the middle scale represents different degrees of pain. When measuring, the patient is asked to mark the pain degree on the scale and record it. The Womac index scoring scale consists of 3 items, i.e. pain, stiffness and joint function, a total of 24 questions. The total score is 0-96, and the higher the score, the worse the knee function.

[0064] Table 6: Basic information of patients and evaluation of swelling degree of knee joint name age gender time of first diagnosis knee joint swelling degree evaluation knee joint swelling degree evaluation before treatment after treatment (1 month) Jiang 65 female 2024.10.09 moderate mild Chen 55 female 2024.10.09 moderate mild Li 68 female 2024.10.19 moderate mild Liang 77 male 2024.10.23 severe mild Jiang 74 female 2024.11.13 moderate mild Xuan 83 female 2025.01.04 moderate mild Wei 73 female 2025.02.26 severe mild Yang 72 female 2025.03.05 moderate mild Table 7: VAS evaluation and Womac index of patients before and after treatment name VAS VAS Womac index Womac index before treatment after treatment (1 month) before treatment after treatment (1 month) Jiang 6 1 40 15 Chen 6 1 42 18 Li 6 1 38 11 Liang 8 2 50 10 Jiang 6 1 39 12 Xuan 7 2 42 15 Wei 8 2 49 26 Yang 6 1 44 25 Effect of the treatment of patients with knee osteoarthritis: Case 1: Xu, male, 58 years old, a resident of Heping District, Tianjin City, with knee pain and swelling for 2 years, diagnosed as knee osteoarthritis in hospital, and treated with the external application plaster for 2 courses, and the symptoms of knee pain and swelling were significantly improved.

[0065] Case 2: Wei, female, 51 years old, a resident of Du'an County, with knee pain for 5 years and difficulty in flexion and extension of the knee for 2 months, diagnosed as knee osteoarthritis in hospital, and treated with the external application plaster for 3 courses, and the symptoms of knee pain and difficulty in flexion and extension were significantly improved.

[0066] Case 3: Huang, female, 62 years old, a person from Wuming County, knee pain with joint cold for 1 year, diagnosed with knee osteoarthritis in hospital, and the knee pain and joint cold symptoms were significantly improved after using the paste for 1 course of treatment.

[0067] Case 4: Wu, female, 55 years old, a person from Tiandong County, knee pain with knee flexion and extension for 2 years, diagnosed with knee osteoarthritis in hospital, and the knee pain and joint cold symptoms were significantly improved after using the paste for 2 courses of treatment.

[0068] Case 5: Li, male, 43 years old, a person from Xixiangtang District of Nanning City, knee pain with swelling for 3 months, diagnosed with knee osteoarthritis in hospital, and the knee pain and swelling symptoms were significantly improved after using the paste for 1 course of treatment.

[0069] The present application can be implemented in various different ways and is not limited to the described embodiments, and it will be understood by those skilled in the art that the present application can be implemented by other specific ways without changing the technical idea or essential characteristics of the present application. Therefore, it should be understood that the above-described embodiments are exemplary and are not intended to limit the present application.

Claims

1. A composition for relieving knee osteoarthritis, characterized in that: include: Zhuang medicine components and sweet tea liquid; The Zhuang medicine components include main medicine, common medicine and auxiliary medicine. The main medicine is laurel, Panax notoginseng and Clematis chinensis; the common medicine is fermented black beans, ginger, galangal, cinnamon bark and centipede; the auxiliary medicine is knotweed, clematis cuspidatum, pittosporum tobira bark, two-sided needle and rhizoma smilacis ulmoides.

2. The composition for alleviating knee osteoarthritis according to claim 1, wherein In parts by weight, the main medicine is 20-40 parts of Osmanthus fragrans, 15-35 parts of Panax notoginseng, and 15-35 parts of Clematis chinensis; the common medicine is 15-35 parts of fermented black beans and ginger, 15-30 parts of chili pepper, 10-20 parts of cinnamon bark, and 10-30 parts of centipede; the auxiliary medicine is 15-30 parts of Polygonum cuspidatum, 15-30 parts of Tripterygium wilfordii, 15-30 parts of Pittosporum tobira bark, 15-30 parts of Zanthoxylum bungeanum, and 10-25 parts of Scolopendra subspinipes.

3. The composition for alleviating knee osteoarthritis according to claim 2, wherein: In parts by weight, the main medicine is 40 parts of maple laurel, 30 parts of Panax notoginseng, and 30 parts of Clematis; the public medicine is 30 parts of fermented black beans and ginger, 20 parts of tea, 15 parts of cinnamon, and 15 parts of centipede; the auxiliary medicine is 20 parts of polygonum cuspidatum, 20 parts of smilax china, 17.5 parts of pittosporum tobira bark, 17.5 parts of lianmianzhen, and 12.5 parts of fennel.

4. A method for preparing an external patch for relieving knee osteoarthritis, characterized in that: The preparation method comprises: S1, mixing fermented black ginger, maple laurel, tea pepper, knotweed, clematis root, kelp, pittosporum bark, centipede, two-sided needle, notoginseng, fennel, and cinnamon bark, and grinding to a particle size of 100-200 mesh to obtain a Zhuang medicine component; S2, soaking the sweet tea in 90-100 ml of water for 10-15 minutes to obtain a sweet tea liquid, wherein the weight ratio of the sweet tea to water is 1:10-15; S3, uniformly mixing the Zhuang medicine component and the sweet tea liquid to form a paste, and applying the paste on gauze to prepare an external patch.

5. The method for preparing the external patch for relieving knee osteoarthritis according to claim 4, wherein: In step S1, the Zhuang medicine components are calculated by weight as follows: 20-40 parts of maple laurel, 15-35 parts of Panax notoginseng, 15-35 parts of clematis, 15-35 parts of fermented black beans and ginger, 15-30 parts of galangal, 10-20 parts of cinnamon, 10-30 parts of centipede, 15-30 parts of knotweed, 15-30 parts of scutellaria, 15-30 parts of scutellaria baicalensis, 15-30 parts of pittosporum tobira bark, 15-30 parts of two-sided needle and 10-25 parts of rhizoma smilacis gracile.

6. The method for preparing the external patch for relieving knee osteoarthritis according to claim 4, wherein: In step S3, the Zhuang medicine component and the sweet tea liquid are evenly mixed to form a paste, and the paste is applied to gauze to prepare an external patch. The external patch has a length × width of 5-20 cm × 5-20 cm, and a thickness of the paste on the external patch is 2-3 mm.

7. A method for preparing an external patch for relieving knee osteoarthritis, characterized in that: The preparation method comprises: S1, mixing fermented black ginger, maple laurel, tea pepper, knotweed, clematis root, clematis root, pittosporum bark, centipede, two-sided needle, notoginseng, fennel, and cinnamon bark, grinding into a medicinal powder with a particle size of 40-60 mesh, placing the medicinal powder in an extraction solution, subjecting it to a high-voltage pulse electric field treatment, extraction, and centrifugation to obtain an extract; S2, treating the sweet tea at a low temperature of -10 to -18°C for 3 to 5 hours, then boiling the sweet tea in purified water and keeping the water warm for 15 to 30 minutes, wherein the weight ratio of the sweet tea to water is 1:10 to 15; S3, mixing and concentrating the extract and the sweet tea solution, adding sodium carboxymethyl cellulose and starch to form a gel-like substance to obtain an external patch.

8. The method for preparing the external patch for relieving knee osteoarthritis according to claim 7, wherein: In step S1, the extract is a hexadecyltrimethylammonium bromide-ethyl acetate solution.

9. The method for preparing the external patch for relieving knee osteoarthritis according to claim 7, wherein: The process parameters of the high-voltage pulse electric field treatment are: electric field intensity of 30-35 kV / cm, pulse frequency of 90-100 Hz, and pulse time of 65.6-81.0 μs.

10. The method for preparing the external patch for relieving knee osteoarthritis according to claim 7, wherein: When the external patch is used, the external patch is applied to the prepatellar area of ​​the affected knee with a coating thickness of 2-3 mm, and the coated area is wrapped with plastic wrap.