Preparation method and application of composition cataplasm containing effective components of sunflower discs

Abstract

The invention relates to the technical field of preparation of external dressings, in particular to a preparation method and application of composition cataplasm containing effective components of sunflower discs. The cataplasm is prepared from the following raw material medicines: sunflower disc, rhizoma smilacis glabrae, cortex phellodendri, chicory, rhizoma atractylodis, radix puerariae, chrysanthemum, calcined oyster shell, dandelion, vinegar frankincense, lycopodium clavatum, folium mori, radix achyranthis bidentatae, leech, liquorice, artificial musk and borneol according to a monarch, minister and assistant prescription principle. The preparation method comprises the following steps: carrying out electron beam sterilization, crushing, wall breaking, extraction, enzymolysis, ultrafiltration and constant-temperature heating concentration on raw material medicines to prepare extract clear paste, uniformly mixing the extract clear paste with a cataplasm matrix, and coating a backing material with the mixture to prepare a cataplasm finished product. The prepared cataplasm is high in content of effective components, can achieve the purpose of treating gout symptoms through external application, is directly applied to affected parts, and is good in medicine absorption effect, low in toxic and side effects and convenient to use.

Description

Technical Field

[0001] The invention relates to the technical field of external dressing preparation, and specifically to a preparation method and application of a composite cataplasm containing effective ingredients of sunflower discs. Background Art

[0002] Gout is a metabolic disease caused by hyperuricemia, and its main manifestations include inflammation of joints and soft tissues, tophi deposition, chronic arthritis and joint damage caused by the deposition of urate crystals in the joints and surrounding soft tissues. Some patients with severe gout also have symptoms of capillary thrombosis in the affected area, which affects the blood circulation and treatment effect of the affected area. If it develops further or if effective intervention measures are not taken, it can also affect the kidneys, causing chronic interstitial nephritis and the formation of urate stones in the kidneys, posing a threat to the patient's health. Existing drugs for the treatment of gout mainly include chemical synthetic drugs and traditional Chinese medicine preparations. However, clinical studies have found that many gout patients will experience abnormal pain in the affected area and repeated attacks when using uric acid-lowering drugs during the attack period. Therefore, at this time, the clinic often stops lowering uric acid first. , instead of using anti-inflammatory analgesics to treat pain and then lowering uric acid, it is effective in relieving the pain and swelling caused by gout attacks, but the drug cannot be stopped immediately after gout is relieved to prevent gout from recurring; glucocorticoids cannot relieve gout attacks, and such drugs need to be used correctly under the guidance of a doctor, and cannot be used privately, especially for these chemical drugs. Long-term use may bring a series of toxic and side effects, such as liver and kidney damage, gastrointestinal reactions, etc., which seriously affect the patient's quality of life and long-term health. On the other hand, there are some Chinese medicine preparations for the treatment of gout and symptom intervention, but there is no effective preparation that can directly administer to the affected part, and take into account the advantages of anti-inflammatory, analgesic, thrombolytic, and low toxic and side effects. At the same time, traditional prescriptions also have problems such as inconvenience in use. For example, many traditional Chinese medicine decoctions require patients to decoct for a long time, and the dosage is large, which is not convenient to carry and store; in addition, some Chinese medicine preparations may have problems such as incomplete extraction and impurity residues during the preparation process, which affects the safety and effectiveness of the drugs.

[0003] The use of a composition containing the active ingredients of sunflower discs for the preparation of oral drugs for the treatment of gout symptoms has been seen in relevant literature. However, the large dosage, poor taste, indirect administration to the affected area and indirect absorption will seriously affect the efficacy of the drug. In particular, gout is a stubborn disease and long-term use will also cause certain damage to the patient's gastrointestinal tract, liver and kidneys. Therefore, the research and development of a composition containing the active ingredients of sunflower discs that can be directly administered transdermally, is safe, effective and easy to use, and its cataplasm for the treatment of gout, especially in combination with other drugs for symptom intervention and treatment, has important market demand and practical application value.

[0004] A large number of studies have also shown that in actual production, most common agricultural and sideline products such as sunflower discs are used to extract their effective substances. Because most of them are dry products with different degrees of maturity, we have concluded through multiple comparative experimental analyses that the content of effective substances and the content of Aspergillus flavus in dry sunflower discs are obviously different from those in yellowed sunflower discs. In addition, traditional technologies such as high-temperature sterilization, high-temperature drying of raw materials, and high-temperature steaming and concentration are generally used in the preparation process. There are disadvantages such as high-temperature denaturation and loss of effective substances, low extraction efficiency, high Aspergillus flavus content, and large differences in the content of extracts from batches. The solution proposed in the present invention aims to solve the above technical problems. Summary of the invention

[0005] In order to solve the problems existing in the prior art, the purpose of the present invention is to provide a preparation method and application of a composition patch containing the active ingredients of sunflower discs, and discloses the whole process from the entire formulation to the selection of raw materials to the preparation of a composition patch containing the active ingredients of sunflower discs. The patch prepared by this method not only has a high content of active ingredients and good efficacy, but also the patch is direct to administer, easy to use, and has low toxic and side effects.

[0006] To achieve the above object, the present invention provides the following technical solutions.

[0007] A composite cataplasm containing the active ingredient of sunflower disc, wherein the raw materials of the cataplasm are sunflower disc, smilax glabra, phellodendron, chicory, atractylodes, kudzu root, chrysanthemum, calcined oyster, dandelion, vinegar frankincense, lycopodiella cuneata, mulberry leaf, cyathula, leech, liquorice, artificial musk and borneol; The bio-enzymatic hydrolysis materials are: glucosidase EG2, polygalacturonase PE, and sutylase PR3; The raw materials of the papulabure matrix are: gelatin, kaolin, sodium polyacrylate, polyvinyl alcohol, sodium carboxymethyl cellulose, glycerol, phosphorous acid, and potassium aluminum sulfate.

[0008] Preferably, the raw materials of the cataplasm are the following raw materials in parts by weight: 70-90 parts of sunflower disc, 40-60 parts of smilax glabra, 40-60 parts of phellodendron, 40-60 parts of chicory, 30-50 parts of atractylodes, 30-50 parts of kudzu root, 20-40 parts of chrysanthemum, 20-40 parts of calcined oyster, 20-40 parts of dandelion, 20-40 parts of vinegar frankincense, 20-40 parts of lycopodii, 20-40 parts of mulberry leaf, 20-40 parts of Achyranthes bidentata, 20-40 parts of leech, 10-20 parts of licorice, 3-5 parts of artificial musk, and 3-5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.1-0.2 parts of glucosidase EG2, 0.1-0.2 parts of polygalacturonase PE, and 0.05-0.15 parts of sutylase PR3; The raw materials of the papulabure matrix are: 5-15 parts of gelatin, 10-20 parts of kaolin, 10-20 parts of sodium polyacrylate, 10-20 parts of polyvinyl alcohol, 5-10 parts of sodium carboxymethyl cellulose, 15-25 parts of glycerol, 1-3 parts of phosphorous acid, and 1-3 parts of potassium aluminum sulfate.

[0009] Preferably, the raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disc, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root, 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of licorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

[0010] Preferably, the Phellodendron chinense is wine-processed Phellodendron chinense.

[0011] Preferably, the sunflower discs are yellowed sunflower discs with ripe seeds harvested by puncture and hanging disc method.

[0012] Further preferably, the dosage form of the composition containing the active ingredients of sunflower disc is a cataplasm.

[0013] The present invention also relates to a method for preparing the above-mentioned composition cataplasm, wherein the raw materials are subjected to electron beam sterilization, crushing, wall breaking, extraction, enzymatic hydrolysis, ultrafiltration and constant temperature heating concentration to obtain an extract paste, the extract paste is evenly mixed with the cataplasm matrix, and the paste is coated on a backing material to prepare a finished cataplasm.

[0014] Preferably, in the process of the sunflower disc raw material processing method, the temperature of the sunflower disc raw material for constant temperature heating and drying is 55-60°C.

[0015] Preferably, the temperature during the constant temperature heating and concentration process of the composition extract containing the effective ingredients of sunflower disc to make a clear paste is 60-65°C.

[0016] The present invention also relates to the use of the above-mentioned composition cataplasm containing the effective ingredients of sunflower disc in the preparation of gout symptom medicine.

[0017] The raw material properties of the present invention and the basis for the formulation are as follows: Sunflower disk: It is the disk of the sunflower of the Asteraceae family, rich in alkaloids, flavonoids, small molecule peptides and other effective ingredients. It is sweet and cold in nature; it enters the liver meridian; it clears away heat and soothes the liver, relieves pain and stops bleeding; it is used for headache, dizziness, hypertension, dysmenorrhea, and metrorrhagia.

[0018] Smilax glabra: It is the dried rhizome of Smilax glabra, a plant of the Liliaceae family. It is sweet, light and neutral in nature; it enters the liver and stomach meridians; it detoxifies, removes dampness, and clears the joints; it is used for limb cramps, tendon and bone pain, damp-heat stranguria, leucorrhea, carbuncle, scrofula, and scabies caused by syphilis and mercury poisoning.

[0019] Huangbai: It is the dried bark of the Rutaceae plant Huangpi tree. It is bitter and cold in nature; it enters the kidney and bladder meridians; it clears away heat and dampness, purges fire and removes steam, detoxifies and treats sores; it is used for damp-heat diarrhea, jaundice and red urine, vaginal itching, hot stranguria and painful stranguria, beriberi, bone steaming and fatigue fever, night sweats, spermatorrhea, sores and swelling, eczema and wet sores.

[0020] Chicory: It is the above-ground part or root of the plant chicory of the Asteraceae family. It is slightly bitter and salty in nature, and cool in nature; it enters the spleen, liver, and bladder meridians; it clears the liver and promotes gallbladder function, strengthens the stomach and helps digestion, and promotes diuresis and reduces swelling; it is used for damp-heat jaundice, stomachache, loss of appetite, edema, and oliguria.

[0021] Atractylodes: It is the dried rhizome of Atractylodes macrocephala or Atractylodes macrocephala of the Asteraceae family. It is pungent, bitter, and warm in nature; it enters the spleen, stomach, and liver meridians; it dries dampness and strengthens the spleen, dispels wind and cold, and improves eyesight; it is used for dampness blocking the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic arthralgia, colds, night blindness, and blurred vision.

[0022] Pueraria root: It is the dried root of the leguminous plant Pueraria. It is sweet, pungent and cool in nature. It enters the spleen and stomach meridians. It relieves muscles and reduces fever, promotes the production of body fluids and quenches thirst, clears rashes, raises yang and stops diarrhea, promotes blood circulation and activates collaterals, and clears alcohol poisoning. It is used for exogenous fever and headache, stiff neck and back pain, thirst, thirst, measles that does not clear up, heat dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain and heart pain, and alcohol poisoning.

[0023] Chrysanthemum: It is the dried inflorescence of the chrysanthemum plant of the Asteraceae family. It is sweet, bitter, and slightly cold in nature; it enters the lung and liver meridians; it dispels wind and heat, soothes the liver and improves eyesight, and clears away heat and detoxifies; it is used for wind-heat colds, headaches and dizziness, red and swollen eyes, blurred vision, sores, carbuncles, and swelling.

[0024] Calcined oyster: It is made from the shells of the long oyster, Dalian Bay oyster or Omi oyster of the oyster family. It is salty in nature and slightly cold; it enters the liver, gallbladder and kidney meridians; it calms the mind, subdues yang and replenishes yin, softens and disperses nodules; it is used for palpitations, insomnia, dizziness and tinnitus, scrofula, phlegm nodules, and lumps.

[0025] Dandelion: It is the dried whole herb of dandelion, alkali dandelion or several plants of the same genus in the Asteraceae family. It is bitter, sweet and cold in nature; it enters the liver and stomach meridians; it clears away heat and detoxifies, reduces swelling and resolves knots, and promotes diuresis and relieves stranguria; it is used for carbuncle, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and hot stranguria with astringent pain.

[0026] Frankincense in vinegar: It is made from the resin exuded from the bark of the frankincense tree and other plants of the same genus in the olive family. It is pungent, bitter, and warm in nature and flavor; it enters the heart, liver, and spleen meridians; it can promote blood circulation, relieve pain, reduce swelling, and promote tissue regeneration; it is used for chest pain, heart pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to lumps, rheumatic pain, muscle spasms, injuries from falls, and carbuncles.

[0027] Stretching tendon grass: It is the dried whole herb of Lycopodium, a plant of the Lycopodiaceae family. It is slightly bitter, pungent, and warm in nature; it enters the liver, spleen, and kidney meridians; it dispels wind and dampness, relaxes tendons and activates collaterals; it is used for joint pain and difficulty in flexion and extension.

[0028] Mulberry leaf: It is the dried leaves of the mulberry plant of the Moraceae family. It is sweet, bitter and cold in nature; it enters the lung and liver meridians; it dispels wind-heat, clears the lungs and moistens dryness, clears the liver and improves eyesight; it is used for wind-heat colds, lung heat and dry coughs, dizziness and headaches, and red and blurred eyes.

[0029] Achyranthes bidentata: It is the dried root of Achyranthes bidentata, a plant of the Amaranthaceae family. It is bitter, sour, and neutral in nature. It enters the liver and kidney meridians. It can remove blood stasis and dredge menstruation, nourish the liver and kidney, strengthen the tendons and bones, promote diuresis and relieve stranguria, and guide blood downward. It is used for amenorrhea, dysmenorrhea, soreness of the waist and knees, weakness of the tendons and bones, stranguria, edema, headache, dizziness, toothache, mouth sores, hematemesis, and epistaxis.

[0030] Leech: The dried whole body of leech, leech or willow leaf leech of Hirudinidae family. It is salty, bitter, flat, slightly toxic, and enters the liver meridian. It can break blood and dredge meridians, remove blood stasis and eliminate symptoms. It is used for blood stasis, amenorrhea, lumps, hemiplegia caused by stroke, and injuries caused by falls.

[0031] Licorice: It is the dried root and rhizome of the leguminous plants licorice, licorice inflated fruit or licorice glabra. It is sweet and neutral in nature; it enters the heart, lung, spleen and stomach meridians; it nourishes the spleen and replenishes qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines; it is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle, sore and ulcer, and relieves drug toxicity and potency.

[0032] Artificial musk: It is an artificially synthesized musk. It is pungent and warm in nature and flavor; it enters the heart and spleen meridians; it can invigorate the mind, invigorate blood circulation and dredge the menstruation, and relieve swelling and pain; it is used for fever, coma, stroke, phlegm, sudden syncope, coma due to qi stagnation, amenorrhea, masses, dystocia, stillbirth, chest pain, sudden pain in the heart and abdomen, pain from falls, pain and numbness, carbuncle, scrofula, and sore throat.

[0033] Borneol: It is a processed product of the borneol resin of the Dipterocarpaceae plant, or the crystals obtained by distilling and cooling the trunks and branches of the Dipterocarp tree, which are also called "borneol borneol" and "plum slices". The crystals obtained by steam distillation and recrystallization of the stems and leaves of the Asteraceae plant Artemisia selengensis or the branches and leaves of the Lauraceae plant Cinnamomum camphora are called "mechanical borneol". It is pungent, bitter, and slightly cold in nature and flavor; it enters the heart, spleen, and lung meridians; it can open the mind and wake the spirit, clear away heat and relieve pain; it is used for coma and convulsions caused by febrile diseases, convulsions caused by stroke and phlegm, sudden syncope caused by qi stagnation, coma caused by poisoning, chest pain, red eyes, mouth sores, sore throat, and pus in the ear canal.

[0034] The prescription of the present invention is prepared by formulating, experimenting, analyzing and adjusting according to the compatibility principle of monarch, minister and assistant in traditional Chinese medicine combined with modern research theory of traditional Chinese medicine.

[0035] King of medicine: sunflower disc. This case makes full use of the pharmacological properties of sunflower disc’s effective substances, which are rich in alkaloids, flavonoids, small molecule peptides and other effective ingredients; the alkaloids can reduce the production of uric acid by inhibiting the activity of related enzymes in the process of uric acid production. At the same time, it may promote the excretion of uric acid, thereby reducing the concentration of uric acid in the blood. Its flavonoids have antioxidant effects, reduce the damage of oxidative stress to organs such as the kidneys, maintain the normal excretion function of the kidneys, and promote the excretion of uric acid. Small molecule peptides and other ingredients have certain anti-inflammatory effects, which can reduce the inflammatory response during gout attacks and relieve symptoms such as joint pain and swelling. Therefore, they are the king of medicines in this case.

[0036] Assistant drugs: Smilax glabra, Phellodendron amurense, and Chicory. In this case, Smilax glabra is used for detoxification, removal of dampness, and unblocking joints; Phellodendron amurense clears away heat and dampness, purges fire and eliminates steaming, detoxifies and treats sores; Chicory has the effects of diuresis and swelling reduction, so it is the assistant drug.

[0037] Auxiliary drugs: Atractylodes lancea, Pueraria root, chrysanthemum, calcined oyster, dandelion, vinegar frankincense, Herba Lycopodii, mulberry leaf, Achyranthes bidentata, leech. In this case, Atractylodes lancea is used for its special medicinal effect on rheumatic arthralgia; Pueraria root is used to relieve muscles and reduce fever, promote fluid production and quench thirst, and promote blood circulation and activate collaterals; chrysanthemum is used to dissipate wind and clear heat, soothe the liver and improve eyesight, and clear away heat and detoxify; calcined oyster is used to soften and disperse nodules; dandelion is used to clear heat and detoxify, reduce swelling and disperse nodules, and promote diuresis and relieve stranguria; vinegar frankincense is used to promote blood circulation and relieve pain, reduce swelling and promote muscle growth; Herba Lycopodii dispels wind and dampness, relaxes muscles and activates collaterals; mulberry leaf is used to dispel wind and heat, clear the lungs and moisten dryness; Achyranthes bidentata is used to remove blood stasis and promote menstruation, nourish the liver and kidney, strengthen muscles and bones, promote diuresis and relieve stranguria, and guide blood downward; leech is used to break blood and promote menstruation, remove blood stasis and eliminate symptoms. It has a significant effect on the capillary embolism problem caused by gout, which is the most easily overlooked problem, so the above 10 herbs are used as adjuvants.

[0038] Auxiliary drugs: licorice, artificial musk and borneol. Artificial musk has the effects of invigorating the mind, promoting blood circulation and menstruation, reducing swelling and relieving pain; borneol has the effects of invigorating the mind, clearing away heat and relieving pain. The above two flavors are used as auxiliary drugs in this case to facilitate the transdermal absorption of the main drug, the auxiliary drug and the adjuvant drug, and to enhance the effect of the active ingredients.

[0039] The biological enzymatic hydrolysis materials in the formula, glucosidase EG2, polygalacturonase PE, and sutylase PR3, are mainly used for biological enzymatic hydrolysis of the mixed solution of the formula raw materials, aiming to maximize the separation and extraction of effective substances, thereby achieving the reduction of the amount of raw materials while maintaining the same content of effective substances in the composition.

[0040] The selection and proportion of the raw materials of the epitope matrix, gelatin, kaolin, sodium polyacrylate, polyvinyl alcohol, sodium carboxymethyl cellulose, glycerol, phosphorous acid and potassium aluminum sulfate, are mainly selected based on the compatibility with the active ingredients of the composition, the adhesion and viscosity, mutual adhesion and separation, and air permeability of the finished epitope.

[0041] The whole prescription has the effects of eliminating dampness and turbidity, promoting blood circulation and removing blood stasis, relieving swelling and relieving pain, and dissolving thrombus and opening the orifices. Because it is directly administered to the affected part in vitro, the dosage of the monarch drug and the ministerial drug in the prescription is increased compared with the traditional oral administration, so that the efficacy can be guaranteed. The prescription of the present invention is used for hyperuricemia, gout, acute arthritis and other diseases, and specifically refers to the theory of Chinese medicine that joint redness, swelling, pain, flexion and extension difficulties, joint deformation and the like belong to damp-heat arthralgia syndrome, and also combines the achievements of modern Chinese medicine and pharmacology, especially adopting the cataplasm dosage form, which opens up a new way for the clinical medication of gout.

[0042] 1. The present invention is based on the records of Chinese medicine for the treatment of gout and the theoretical research on gout symptoms in modern Chinese medicine. On the basis of exploring traditional prescriptions, it overcomes the problem that oral medicines have certain toxic and side effects, and changes the administration method of the composition based on the principle of compatibility of monarch, minister, assistant and envoy, so that the effective ingredients of the composition can act on the affected part conveniently and directly. Through a large number of animal experiments and clinical case comparison, analysis and adjustment, it takes into account treatment, prevention and maintenance, and is easy to be accepted clinically.

[0043] 2. Focus on the formulation and selection of raw materials, strictly control the raw material quality control link, effectively ensure and improve the content of effective substances in the formula of the main medicine sunflower plate, and ensure the content of effective substances in the formula and the quality of the finished product.

[0044] 3. Direct administration of the drug to the affected area using a papule reduces damage to the user's liver and kidney functions. At the same time, the addition of a transdermal agent increases the affected area's absorption of effective substances such as alkaloids, flavonoids, and protein small molecule peptides.

[0045] 4. Strictly follow the preparation process of electron beam sterilization, crushing, wall breaking, extraction, enzymatic hydrolysis, ultrafiltration and constant temperature heating to concentrate the raw materials into a composite extract paste containing the effective ingredients of sunflower discs. In particular, the electron beam sterilization, wall breaking and enzymatic hydrolysis technology are adopted to effectively improve the separation and extraction of effective substances in sunflower discs and effective ingredients of other raw materials, improve the utilization rate of raw materials and reduce production costs.

[0046] 5. Constant temperature concentration technology is used throughout the process to control the processing temperature of raw materials and semi-finished products below 65°C, which prevents the high-temperature denaturation of effective substances to the greatest extent and ensures the quality and use effect of the finished products. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1This is a schematic diagram of the detection results of the active ingredients and aflatoxin content in Example 1 of the present invention and Comparative Example 1; Figure 2 Schematic diagram of the detection results of the effective ingredient content in Example 1 of the present invention and Comparative Example 2; Figure 3 Schematic diagram of the detection results of the effective ingredient content in Example 1 of the present invention and Comparative Example 3; Figure 4 This is a schematic diagram comparing the results of the animal pharmacology rat toe swelling experiment in the present invention; Figure 5 The H&E staining images of the kidney and liver of the rats in the blank control group (left kidney, right liver, Figures 5 to 8 same); Figure 6 This is the H&E staining image of the kidney and liver of rats in the Example 1 group of the present invention; Figure 7 H&E staining of kidney and liver of rats in the Shangshi Zhitong ointment group; Figure 8 This is the H&E staining image of the kidney and liver of rats in the sunflower disc small molecule peptide oral dosage group. DETAILED DESCRIPTION

[0048] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Example 1

[0049] A composition cataplasm containing the active ingredient of sunflower disk, wherein the raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disk, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root, 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of liquorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

[0050] The Phellodendron chinense described in this embodiment is the Phellodendron chinense processed with wine, which can reduce the bitter and cold nature of Phellodendron chinense and enhance the effect of clearing dampness and heat and benefiting joints.

[0051] The sunflower discs described in this embodiment are yellowed sunflower discs whose seeds are ripe and harvested by puncturing and hanging discs, and the harvesting method includes the following steps: S510: Select sunflower discs with seeds that are already mature and whose sunflower discs are not completely dried and yellowed, have a moisture content of 50% to 70%, are not moldy, and have a complete appearance, and remove the flower buds connected to the seeds on the discs to block the photosynthesis of the seeds, accelerate the drying of the seeds, and facilitate threshing. At this time, the seeds are already mature and do not affect the yield and quality of the sunflower seeds; S520: Under the premise of not destroying the cavity of the connecting part between the soft stem and the sunflower disk, cutting off the connecting soft stem on the back side of the sunflower disk along the connecting part with the upright main stem; S530: Cut off the upper part of the upright main stem at an angle of 45° to the ground, and pierce and hang the sunflower discs cut in the above step according to the conventional agricultural production method, but in this step, the seeds must be facing upwards to accelerate the drying process of the seeds, facilitate rapid threshing, and prevent the effective substances in the sunflower disc from continuing to transfer to the seeds; S540: After the sunflower disks are naturally air-dried for 7 to 10 days, they are harvested and completely threshed, including the empty and barren grains without seeds in the center of the sunflower disks; S550: The obtained completely seedless sunflower discs are heated and dried for 8 to 10 minutes at a temperature below 55 to 60°C for a second time, and then the dry products with a moisture content of 5% to 10% are selected and collected in batches and sorted. After cooling to natural temperature, they are placed in a ventilated and rainproof raw material warehouse for storage for later use.

[0052] Furthermore, the preparation method of the composition cataplasm containing the active ingredient of sunflower disc comprises the following steps: S710: cutting off excess stems from the sunflower disk, adding the sunflower disk into a crusher with a screen fineness of 15 mesh, and crushing the sunflower disk at a speed of 1000 r / min for 10 minutes to obtain crushed sunflower disk material; S720: adding raw Chinese medicinal materials including Rhizoma Smilacis Glabrae, Cortex Phellodendri, Chicory, Rhizoma Atractylodis Macrocephalae, Radix Puerariae, Flos Chrysanthemi, Concha Ostreae, Herba Taraxaci, Folium Vinegaris, Herba Lycopodii, Folium Mori, Radix Achyranthis Bidentatae and Radix Glycyrrhizae into a pulverizer having a screen fineness of 15 mesh, and crushing at a speed of 1000 r / min for 10 min to obtain raw Chinese medicinal material crushed materials; S730: After the sunflower disc and the raw Chinese medicinal material crushed material are subjected to electron beam sterilization for 6 minutes, a rotary wall breaking machine with a rotation speed of 10000r / min is used for mechanical wall breaking to obtain sunflower disc and raw Chinese medicinal material wall-broken powder with a fineness of not less than 1000 mesh; in this step, if Chinese medicinal material pieces are used, the step of electron beam sterilization of the raw medicinal pieces can be omitted; S740: mixing the sunflower disc and raw Chinese medicinal material broken wall powder with purified water at 43-46° C. in a mass ratio of 11:9, and then stirring at a speed of 350 r / min for 15 min to obtain a mixed solution of sunflower disc, raw Chinese medicinal material broken wall powder and purified water; Adding glucosidase EG2, polygalacturonase PE1 and sutylase PR3 enzyme preparations to the mixed solution in sequence, performing enzymolysis for 1.75 hours at a pH of 6.0 and a temperature of 43 to 46° C., and obtaining a mixed solution of sunflower discs after enzymolysis and raw material Chinese medicinal material wall-broken powder and purified water; leaving the mixed solution to stand for 24 hours, taking out the supernatant and storing it separately, filtering the lower turbid liquid and precipitate with a plate and frame filter press, and mixing the obtained filtrate with the aforementioned clear liquid to obtain an extract of a composition containing the active ingredients of sunflower discs after enzymolysis; S750: The extract is ultrafiltered through an ultrafilter with a membrane pore size of 75 kDa to obtain a purer ultrafiltration extract of the composition containing the active ingredients of sunflower disc after enzymatic hydrolysis.

[0053] S760: The purified, enzymatically hydrolyzed composition extract containing the sunflower disk active ingredients is heated at a constant temperature of 60-65° C. and concentrated to a relative density of 1.20-1.30, and then artificial musk powder and borneol powder are added and heated for 5 minutes to obtain a finished product-grade composition extract containing the sunflower disk active ingredients. The finished product is placed in a refrigerator at a temperature of 2-8° C. for standby use; S770: Evenly mix the composition paste containing the active ingredients of sunflower disc with the cataplasm matrix, and apply it on the backing material to prepare a cataplasm finished product; specifically comprising the following steps: S771: adding gelatin to 35 to 65 parts by weight of purified water, adding the mixture into a speed-adjustable blending mixer, and stirring and swelling the mixture at a speed of 200 to 400 r / min; S772: Add kaolin, sodium polyacrylate, polyvinyl alcohol, and sodium carboxymethyl cellulose in sequence, and stir evenly at a speed of 100 to 200 r / min; S773: Add glycerol, stir evenly at a speed of 100 to 200 r / min, slowly add phosphorous acid and potassium aluminum sulfate, adjust the degree of cross-linking, and form a cataplasm matrix; S774: Add 10 to 30 parts by weight of a composition extract containing the active ingredients of sunflower disc to the cataplasm base, add the mixture to a low-temperature speed-adjustable mixer, and stir the mixture at a speed of 100 to 200 r / min for 8 to 10 minutes to obtain a cataplasm base material of a composition extract containing the active ingredients of sunflower disc; S775: Apply the cataplasm base material of the extract of the composition containing the active ingredients of sunflower disc on the backing cloth using a coating machine, and cover it with a single-sided waxed paper protective film to obtain a cataplasm semi-finished product of the composition containing the active ingredients of sunflower disc; S776: Cut and punch air holes in the semi-finished product of the composition cataplasm containing the active ingredients of sunflower disc, put it into a light-proof paper bag covered with an aluminum foil layer and seal it to obtain a finished product of the composition cataplasm containing the active ingredients of sunflower disc.

[0054]

[0055] Comparative Example 1 This comparative example provides the test results of the content of alkaloids, flavonoids, protein small molecule peptides, mineral active ingredients and aflatoxin in the extract of the composite paste prepared from dried sunflower discs, a common agricultural and sideline product, in the process of preparing a composite paste containing the active ingredients of sunflower discs (see Figure 1 ).

[0056] A composition cataplasm containing the active ingredient of sunflower disk, wherein the raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disk, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root, 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of liquorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

[0057] The Phellodendron amurense described in this comparative example is the Phellodendron amurense processed with wine, which can reduce the bitter and cold nature of Phellodendron amurense and enhance the effect of clearing dampness and heat and benefiting the joints.

[0058] The sunflower disks described in this comparative example are common agricultural and sideline products, and the harvesting method thereof comprises the following steps: S510: Selecting common agricultural and sideline products of dried sunflower discs, visually sorting out intact, undamaged, and non-rotten sunflower discs for use; S520: removing the remaining seeds on the sunflower disk, including the empty seeds and barren seeds without seeds in the center of the sunflower disk; S550: collecting the sunflower discs completely free of seeds for later use; The preparation method of the composition cataplasm containing the effective ingredients of sunflower disc is the same as that in Example 1.

[0059]

[0060] Comparative Example 2: This comparative example provides the comparative test results of the content of alkaloids, flavonoids, protein small molecule peptides and mineral active ingredients in the composition extract containing the active ingredients of sunflower discs under the premise of conventional 70-80°C constant temperature drying in the drying process of the sunflower disc raw material in the present invention (see Figure 2 ).

[0061] A composition cataplasm containing the active ingredient of sunflower disk, wherein the raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disk, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root, 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of liquorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

[0062] The Phellodendron amurense described in this comparative example is the Phellodendron amurense processed with wine, which can reduce the bitter and cold nature of Phellodendron amurense and enhance the effect of clearing dampness and heat and benefiting the joints.

[0063] The sunflower discs described in this comparative example are yellowed sunflower discs whose seeds are ripe and harvested by puncturing and hanging discs, and the harvesting method comprises the following steps: S510: Select sunflower discs with seeds that are already mature and whose sunflower discs are not completely dried and yellowed, have a moisture content of 50% to 70%, are not moldy, and have a complete appearance, and remove the flower buds connected to the seeds on the discs to block the photosynthesis of the seeds, accelerate the drying of the seeds, and facilitate threshing. At this time, the seeds are already mature and do not affect the yield and quality of the seeds; S520: Under the premise of not destroying the cavity of the connecting part between the soft stem and the sunflower disk, cutting off the connecting soft stem on the back side of the sunflower disk along the connecting part with the upright main stem; S530: Cut off the upper part of the upright main stem at an angle of 45° to the ground, and pierce and hang the sunflower discs cut in the above step according to the conventional agricultural production method, but in this step, the seeds must be facing upwards to accelerate the drying process of the seeds, facilitate rapid threshing, and prevent the effective substances in the sunflower disc from continuing to transfer to the seeds; S540: After the sunflower disks are naturally air-dried for 7 to 10 days, they are harvested and completely threshed, including the empty and barren grains without seeds in the center of the sunflower disks; S550: After the obtained completely seed-free sunflower discs are heated and dried at a constant temperature of 70-80° C. for 3-5 hours, dry products with a moisture content of 5%-10% are selected and collected in batches and cooled to natural temperature for later use; The preparation method of the composition cataplasm containing the effective ingredients of sunflower disc is the same as that in Example 1.

[0064]

[0065] Comparative Example 3: This comparative example provides the results of the comparative test of the effective substance content in the composition extract containing the active ingredients of sunflower discs and the present invention (see Figure 3 ), A composition cataplasm containing the active ingredient of sunflower disk, wherein the raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disk, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root, 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of liquorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

[0066] The Phellodendron amurense described in this comparative example is the Phellodendron amurense processed with wine, which can reduce the bitter and cold nature of Phellodendron amurense and enhance the effect of clearing dampness and heat and benefiting the joints.

[0067] The sunflower discs described in this comparative example are yellowed sunflower discs with ripe seeds harvested by the puncture and hanging method, and the harvesting method is the same as that in Example 1.

[0068] The preparation method of the composite cataplasm containing the active ingredient of sunflower disk comprises the following steps: S710: cutting off excess stems from the sunflower disk, adding the sunflower disk into a crusher with a screen fineness of 15 mesh, and crushing the sunflower disk at a speed of 1000 r / min for 10 minutes to obtain crushed sunflower disk material; S720: adding raw Chinese medicinal materials including Rhizoma Smilacis Glabrae, Cortex Phellodendri, Chicory, Rhizoma Atractylodis Macrocephalae, Radix Puerariae, Flos Chrysanthemi, Concha Ostreae, Herba Taraxaci, Folium Vinegaris, Herba Lycopodii, Folium Mori, Radix Achyranthis Bidentatae and Radix Glycyrrhizae into a pulverizer having a screen fineness of 15 mesh, and crushing at a speed of 1000 r / min for 10 min to obtain raw Chinese medicinal material crushed materials; S730: After the sunflower disc and the raw Chinese medicinal material crushed material are subjected to electron beam sterilization for 6 minutes, a rotary wall breaking machine with a rotation speed of 10000 r / min is used to mechanically break the wall to obtain sunflower disc and raw Chinese medicinal material wall-broken powder with a fineness of not less than 1000 mesh; S740: The sunflower disc and raw material Chinese medicinal material broken wall powder are mixed with purified water at 43-46° C. in a mass ratio of 11:9, and then stirred at a speed of 350 r / min for 15 min to obtain a mixed solution of sunflower disc, raw material Chinese medicinal material broken wall powder and purified water; glucosidase EG2, polygalacturonase PE1 and sutylase PR3 enzyme preparations are added to the mixed solution in sequence, and enzymolysis is performed for 1.75 h at pH 6.0 and a temperature of 43-46° C. to obtain a mixed solution of sunflower disc, raw material Chinese medicinal material broken wall powder and purified water after enzymolysis; the mixed solution is allowed to stand for 24 h, the supernatant is taken out and stored separately, the lower layer of turbid liquid and precipitate are filtered using a plate and frame filter press, and the obtained filtrate is mixed with the aforementioned clear liquid to obtain an enzymolyzed composition extract containing the effective ingredients of sunflower disc; S750: ultrafiltration of the extract through an ultrafilter with a membrane pore size of 75 kDa to obtain a purer ultrafiltration extract of the composition containing the active ingredients of sunflower disc after enzymatic hydrolysis; S760: The purified, enzymatically hydrolyzed composition extract containing the sunflower disk active ingredients is heated and concentrated under conventional 70-80° C. constant temperature concentration conditions to a relative density of 1.20-1.30, at which point artificial musk powder and borneol powder are added, and the heating is continued for 5 minutes to obtain a finished product-grade composition extract containing the sunflower disk active ingredients. The extract is placed in a refrigerator at a temperature of 2-8° C. for standby use; S770: Evenly mix the composition paste containing the effective ingredients of sunflower disc with the base of the papulum agent, and apply it on the backing material to form a finished papulum agent. The specific steps are the same as those in Example 1.

[0069]

[0070] Combining the contents of active substances in the sunflower disc of the main medicine in Table 2, Table 3 and Table 4, the following conclusions are drawn: 1. The effective components such as alkaloids, flavonoids, protein small molecule peptides, etc. in the extract prepared from the dried sunflower discs of common agricultural and sideline products are significantly lower than those in the yellowed sunflower discs selected by the method of the present invention, and the mineral content does not change much, while the content of aflatoxin is higher than that in the preferred yellowed sunflower discs of the present invention, indicating that the sunflower disc selection and storage method described in Example 1 of the present invention is obviously effective; 2. In the process of drying the selected sunflower disks, the sunflower disk raw materials were heated and dried at a constant temperature of 70-80°C, and the alkaloids, flavonoids, protein small molecule peptides and mineral active ingredients in the prepared extract were significantly lower than those in the method of the present invention, indicating that the sunflower disk drying method of Example 1 of the present invention has obvious technical effects; 3. During the process of heating and concentrating the composition extract at a constant temperature of 70-80°C, the indicators of alkaloids, flavonoids, protein small molecule peptides and mineral effective ingredients in the prepared extract clear paste, except for minerals, were significantly lower than those of the method described in the present invention. Therefore, it was concluded that the method of heating and concentrating the sunflower disc extract into a clear paste described in Example 1 of the present invention is a technical solution with significant effects.

[0071] In order to verify the efficacy of the composition of the present invention, our technical department conducted pharmacological research and experiments. The research methods and test results adopted are as follows: 1. The following rat animal experiment was used to verify the effect of the present invention on the uric acid level and toe swelling of the hyperuricemia animal model.

[0072] 2. Experimental animals: 50 male Wista rats, weighing 200-220 g, purchased from Liaoning Changsheng Biotechnology Co., Ltd.

[0073] 3. Experimental reagents: (1) Chloral hydrate anesthetic and sodium urate solution reagents were purchased from Nanjing Jiancheng Biological Co., Ltd.; (2) Sunflower disk small molecule peptide oral preparation was purchased from Jilin Pharmaceutical Group South Square Pharmaceutical Building. The dosage form is powder and produced by Nanjing Tongrentang Pharmaceutical Group; (3) The pain-relieving plaster was purchased from the South Square Pharmaceutical Building of Jilin Pharmaceutical Group. The dosage form is a papule and it was produced by Henan Lingrui Group. (4) The finished product of the cataplasm containing the composition of the sunflower disk active ingredients obtained in Example 1 of the present invention.

[0074] Modeling and drug administration methods (1) After 5 days of laboratory adaptation, 50 rats were randomly divided into 5 groups: blank control group, model control group, Example 1 group, sunflower disk small molecule peptide oral group and injury and pain relief plaster group, with 10 rats in each group; (2) First, the circumferential dimensions of the toe joints of the rats in each group were measured and recorded according to the group and number. The rats in each group were fixed in a supine position and anesthetized with intraperitoneal injection of chloral hydrate at a dose of 3.5 mL / kg. For the rats in the other groups except the blank control group, a sterile syringe was inserted into the joint cavity along the posterior side of the right toe joint of the hind limb and the medial side of the Achilles tendon at a 30-40° angle, and 0.25 mL of sodium urate solution (25 μg / mL) was slowly injected, with the bulging of the contralateral joint capsule as the injection standard, to form an acute gout model; 0.25 mL of normal saline was injected into the joint cavity of the rats in the blank control group; (3) For the Shangshi Zhitong Plaster group and the Example 1 group of the present invention, the drug-administered part of the rat's toe was covered with skin, and the above two patches were used to fully surround and wrap the toe, and the patches were changed every 12 hours; during this period, the skin was replenished irregularly according to the actual situation, and at the same time, 25 mL / kg of medical purified water at a temperature of 35°C to 46°C was used for enema feeding once a day, and the enema feeding was continued for 8 days; (4) For the sunflower disk small molecule peptide oral dosage group, 2.5 g / kg of sunflower disk small molecule peptide oral dosage was fully mixed with 25 mL / kg of medical purified water at a temperature of 35°C to 46°C, and then the rats were fed enema once every 12 hours for 8 consecutive days; (5) For the blank control group and the model control group, 25 mL / kg of medical purified water at a temperature of 35°C to 46°C was used for enema feeding once a day for 8 consecutive days; (6) The toe joint perimeter dimensions of each group were measured on the 2nd, 4th, 6th and 8th day of modeling, and the degree of joint swelling was calculated. Swelling degree = (toe joint perimeter dimensions after inflammation - toe joint perimeter dimensions before inflammation) / toe joint perimeter dimensions before inflammation × 100%. The test results of rat toe swelling degree are shown in Table 5.

[0075] (7) 2 hours after the last administration on the 8th day, blood was collected from the abdominal aorta of the rats. After standing at room temperature for 3 minutes, the blood was centrifuged at 3000 r / min for 20 minutes. The serum was collected and stored at -20°C for later use. The serum uric acid level was detected by an automatic biochemical analyzer. The test results of blood uric acid are shown in Table 6. Experimental Results By comparing the inhibitory effect of Example 1 of the present invention on joint swelling in gout model rats with other groups and the test results of blood uric acid content, it was found that the test data of Example 1 of the present invention in inhibiting the swelling of the toes of rats caused by sodium urate and the blood uric acid level were significantly better than those of other groups, proving that Example 1 of the present invention has obvious technical effects.

[0076] (8) One rat was randomly selected from each group, and its kidney and liver tissues were taken for H&E staining. The morphological changes were as follows: Figure 5-Figure 8 As shown, the blank control group ( Figure 5 ), the hepatocytes were clear, the hepatocyte cords were clear, the hepatocyte cytoplasm was plump, and the plumpness of the renal tubular epithelial cytoplasm was poor, but basically within the visible normal range; Example 1 of the present invention ( Figure 6 ), the hepatocytes were clear, the hepatocyte cords were clear, occasional punctate necrosis was observed, the cytoplasm of the renal tubular epithelium was poorly plump, and occasional eosinophilic changes and epithelial cell cavitation were observed; the Shangshi Zhitong Ointment Group ( Figure 7 ), the hepatocytes were clear, the hepatocyte cords were clear, the hepatocyte cytoplasm was plump, and occasionally there were punctate necrosis foci. The renal tubular epithelial cells were cavitated, and occasionally there were slight eosinophilic changes in the renal tubular epithelial cells; the sunflower disc small molecule peptide oral group ( Figure 8 ), the hepatocytes are clear, the hepatocyte cords are not clear, the hepatocytes are atrophic, and punctate necrosis and eosinophilic changes of the hepatocytes are obvious; the eosinophilic changes of the renal tubular epithelial cells are obvious, and the renal tubular epithelial cells are cavitated and partially damaged; Experimental Results Through the analysis of the liver and kidney staining indexes of rats, it can be clearly observed that the chromosome number and morphological indexes of the group using Example 1 of the present invention are significantly better than those of other comparison groups, especially the sunflower disk small molecule peptide oral dosage group.

[0077] Clinical medical experiments Case 1 Patient Zhang, male, 64 years old, gout for 7 years, repeated many times, blood uric acid value reached 735umol / L, blood creatinine 136umol / L. Taking sunflower disc small molecule peptide oral agent three times a day, 15g each time, after taking for three weeks, blood uric acid value decreased and stabilized at 390umol / L. But dizziness, restlessness and insomnia, occasional fever symptoms, considering that the patient has gout for many years, blood creatinine level is high, uric acid in the blood accumulates and metabolizes for a long time, causes serious burden to the kidney, and renal function is impaired. Use the cataplasm of the present invention instead, change the plaster once a day, after one month of use, serum uric acid level is stabilized at 400umol / L, blood creatinine drops to 95umol / L, and is still in continuous use.

[0078] Case 2 Patient Li, male, 39 years old, was found to have a high blood uric acid value during a physical examination on June 10, 2020. The hospital detected that the blood uric acid level reached 480umol / L and the blood creatinine level was 120umol / L. Taking sunflower disc small molecule peptide oral agent three times a day, 15g each time, after taking it for two weeks, the blood uric acid level dropped to 350umol / L, and the blood creatinine level was 110umol / L. There are often symptoms such as lack of energy and fatigue, soreness of waist and knees, and edema in the morning, but due to the patient's long-term irregular work and rest diet, the patient's kidney deficiency constitution is considered. Take the cataplasm of the present invention instead, change the medicine once a day, and after using it for months, the blood uric acid level is stabilized at 320umol / L, the blood creatinine level is stabilized at 80umol / L, and the blood creatinine level is reduced. The patient's fatigue phenomenon is alleviated, and there is no recurrence after discontinuation of use for half a year.

[0079] Case 3 Patient Liu, male, 51 years old, suffered from hyperuricemia for 3 years, and developed gout symptoms in October 2023, with a blood uric acid value of 546umol / L and a blood creatinine of 134umol / L. Taking sunflower disc small molecule peptide oral agent, three times a day, 15g each time, after taking it for half a month, the blood uric acid value dropped to 385umol / L, blood creatinine 138umol / L, accompanied by long-term weakness in the waist and knees, dizziness and tinnitus symptoms. Considering that the patient has had high blood uric acid for more than ten years, it has caused damage to the kidneys. Use the cataplasm of the present invention instead, change the medicine once a day, and after one month of use, the blood uric acid value is stabilized at 310umol / L, the blood creatinine level is stabilized at 78umol / L, the waist and knees are weak, and the symptoms of dizziness and tinnitus disappear, indicating that the drug effect is good, and there is no recurrence after three months of discontinuation.

[0080] Case 4 Patient Zhan, male, 41 years old, suffered from hyperuricemia for 2 years. In October 2022, he developed gout symptoms, with a blood uric acid value of 456umol / L and a blood creatinine of 144umol / L. He took chemical drugs three times a day for half a month, and his blood uric acid value dropped to 365umol / L and blood creatinine to 128umol / L. He used the cataplasm of the present invention and changed the dressing once a day. After one month of use, his blood uric acid value stabilized at 300umol / L, and his blood creatinine level stabilized at 75umol / L. His back and knees were sore, and his symptoms of dizziness and tinnitus disappeared, indicating that the drug was effective. There was no recurrence after three months of discontinuation.

[0081] Case 5 Patient Sun, male, 50 years old, suffered from hyperuricemia for 4 years. In August 2023, he developed gout symptoms, with a blood uric acid value of 626umol / L and a blood creatinine of 144umol / L. After taking chemical drugs for half a month, the blood uric acid value dropped to 455umol / L and the blood creatinine was 128umol / L. He switched to the cataplasm of the present invention and changed the medicine once a day. After one month of use, the blood uric acid value stabilized at 340umol / L and the blood creatinine level stabilized at 88umol / L. The soreness of the waist and knees indicated that the drug effect was good. There was no recurrence after three months of discontinuation.

[0082] The embodiments of the present invention are given for the purpose of illustration and description, and are not intended to be exhaustive or to limit the invention to the disclosed forms. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiments are selected and described in order to better illustrate the principles and practical applications of the present invention and to enable those of ordinary skill in the art to understand the present invention and thereby design various embodiments with various modifications suitable for specific uses.

Claims

1. A composition cataplasm containing the active ingredients of sunflower disk, It is characterized in that The raw materials of the cataplasm are: sunflower disc, smilax glabra, phellodendron, chicory, atractylodes, kudzu root, chrysanthemum, calcined oyster, dandelion, vinegar frankincense, lycopodiella, mulberry leaf, cyathula, leech, liquorice, artificial musk and borneol; The bio-enzymatic hydrolysis materials are: glucosidase EG2, polygalacturonase PE, and sutylase PR3; The raw materials of the papulabure matrix are: gelatin, kaolin, sodium polyacrylate, polyvinyl alcohol, sodium carboxymethyl cellulose, glycerol, phosphorous acid, and potassium aluminum sulfate.

2. The composition cataplasm containing the active ingredient of sunflower disc according to claim 1, It is characterized in that The raw materials of the cataplasm are the following raw materials in parts by weight: 70-90 parts of sunflower disc, 40-60 parts of smilax glabra, 40-60 parts of phellodendron, 40-60 parts of chicory, 30-50 parts of atractylodes, 30-50 parts of kudzu root, 20-40 parts of chrysanthemum, 20-40 parts of calcined oyster, 20-40 parts of dandelion, 20-40 parts of vinegar frankincense, 20-40 parts of lycopodii, 20-40 parts of mulberry leaf, 20-40 parts of cyathula, 20-40 parts of leech, 10-20 parts of liquorice, 3-5 parts of artificial musk, and 3-5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.1-0.2 parts of glucosidase EG2, 0.1-0.2 parts of polygalacturonase PE, and 0.05-0.15 parts of sutylase PR3; The raw materials of the papulabure matrix are: 5-15 parts of gelatin, 10-20 parts of kaolin, 10-20 parts of sodium polyacrylate, 10-20 parts of polyvinyl alcohol, 5-10 parts of sodium carboxymethyl cellulose, 15-25 parts of glycerol, 1-3 parts of phosphorous acid, and 1-3 parts of potassium aluminum sulfate.

3. The composition cataplasm containing the active ingredient of sunflower disc according to claim 1, It is characterized in that The raw materials of the cataplasm are the following raw materials in parts by weight: 90 parts of sunflower disc, 60 parts of smilax glabra, 60 parts of phellodendron, 60 parts of chicory, 50 parts of atractylodes, 50 parts of kudzu root; 40 parts of chrysanthemum, 40 parts of calcined oyster, 40 parts of dandelion, 40 parts of vinegar frankincense, 40 parts of lycopodii, 40 parts of mulberry leaf, 40 parts of Achyranthes bidentata, 40 parts of leech, 20 parts of liquorice, 5 parts of artificial musk, and 5 parts of borneol; The biological enzymatic hydrolysis materials are: 0.2 parts of glucosidase EG2, 0.2 parts of polygalacturonase PE, and 0.15 parts of sutylase PR3; The raw materials of the papulum matrix are: 15 parts of gelatin, 20 parts of kaolin, 20 parts of sodium polyacrylate, 20 parts of polyvinyl alcohol, 10 parts of sodium carboxymethyl cellulose, 25 parts of glycerol, 3 parts of phosphorous acid, and 3 parts of potassium aluminum sulfate.

4. A composition cataplasm containing the active ingredient of sunflower disc according to any one of claims 1 to 3, Features: The Phellodendron amurense is wine-processed Phellodendron amurense.

5. A composition cataplasm containing the active ingredient of sunflower disc according to any one of claims 1 to 3, Features: The sunflower disc is a yellowed sunflower disc with ripe seeds that is harvested by puncturing and hanging.

6. A composition cataplasm containing the active ingredient of sunflower disc according to any one of claims 1 to 3, Features: The dosage form of the composition containing the active ingredient of sunflower disc is a cataplasm.

7. A method for preparing a composition cataplasm containing the active ingredient of sunflower disc according to any one of claims 1 to 6, Features: The raw materials are sterilized by electron beam, crushed, broken, extracted, enzymatically hydrolyzed, ultrafiltered and concentrated by constant temperature heating to obtain an extract paste, which is then evenly mixed with a cataplasm matrix and applied onto a backing material to prepare a cataplasm finished product.

8. The composition cataplasm containing the active ingredient of sunflower disc according to claim 5, Features: In the process of the sunflower disk raw material processing method, the temperature of the sunflower disk raw material for constant temperature heating and drying is 55-60°C.

9. The method for preparing the composition cataplasm containing the active ingredient of sunflower disk according to claim 7, Features: The temperature during the constant temperature heating and concentration process of the composite extract containing the effective components of the sunflower disc to make a paste is 60-65°C.

10. Use of the composition cataplasm containing the active ingredients of sunflower disc according to any one of claims 1 to 6 in the preparation of gout symptom medicines.

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