A Sanjiu patch and its preparation method and application

By using Sanjiu patch made of a variety of Chinese medicinal materials, combined with traditional preparation methods and acupoint patch treatment methods, the problems of poor treatment effect of gout arthritis and side effects of Western medicine treatment were solved, and significant therapeutic effects and safety were achieved.

CN116763882BActive Publication Date: 2025-03-11KUNMING HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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Patent Information

Application Number
CN202310137072.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-02-17
Publication Date
2025-03-11
Estimated Expiration
2043-02-17

AI Technical Summary

Technical Problem

The prior art is difficult to effectively treat gouty arthritis, and Western medical treatment has side effects and prone to recurrence of the disease.

Method used

A kind of sanjiu paste is made of Chinese medicinal materials such as white aconite, Weilingxian, Xu Changqing, asarum, ponybomb, shanci mushroom, mulberry white bark, borneol, azalkonium, realgar and sapod. The plaster is prepared through traditional preparation methods and treated by acupuncture.

Benefits of technology

Sanjiupae has the effects of warming yang and unblocking meridians and relieving pain, strengthening the spleen and reducing turbidity, removing cold and removing dampness, strengthening the body and eliminating evil, and removing blood stasis and relieving pain. It significantly improves the symptoms of gouty arthritis, and the clinical overall clinical efficiency is as high as 97.22%.

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Abstract

The invention discloses a Sanjiu patch and its preparation method and application. The Sanjiu patch is made of the following raw materials: 10-20 parts of white aconite, 10-20 parts of clematis, 20-30 parts of cynanchum, 10-15 parts of asarum, 9-15 parts of puffball, 5-10 parts of tribulus ternata, 20-30 parts of mulberry bark, 1.5-2.5 parts of borneol, 1.5-2.5 parts of azone, 1-1.5 parts of realgar, 1-1.5 parts of mylabris, 210 parts of yellow ochre, and 500 parts of sesame oil. The Sanjiu patch prepared by the present invention has the effects of warming yang, unblocking collaterals and relieving pain, strengthening the spleen and lowering turbidity, removing cold and removing dampness, strengthening the body and removing evil, dredging meridians and unblocking collaterals, removing blood stasis and relieving pain, and regulating qi and blood. It can be used to treat pain syndromes caused by phlegm turbidity obstruction and cold coagulation and blood stasis, and is also suitable for the prevention and treatment of respiratory system, digestive system, obstetrics and gynecology diseases, orthopedic diseases, rheumatism immune system, pediatric system diseases, and the conditioning of the sub-health state of the body. According to clinical observation, the Sanjiu patch prepared by the present invention has a therapeutic efficacy of up to 97.22% for gouty arthritis.
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Description

Technical Field

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

[0002] Acupoint patch treatment involves multiple systemic diseases, among which the respiratory system has the highest frequency, such as asthma, chronic bronchitis, allergic rhinitis, chronic obstructive pulmonary emphysema, recurrent respiratory tract infections, pneumonia, etc. In addition, it also includes osteoarthritis of the knee, rheumatoid arthritis, frozen shoulder, ankylosing spondylitis and other bone and joint diseases, chronic pelvic inflammatory disease, dysmenorrhea and other gynecological diseases, psoriasis, frostbite and other skin diseases, chronic cor pulmonale, coronary heart disease, diabetic nephropathy and other medical diseases, colds, sub-health conditions, etc.

[0003] Sanjiu patch is a plaster made from a variety of Chinese medicinal materials with pungent, warm and cold-dispelling effects. It is a traditional treatment method of traditional Chinese medicine. According to the theories of "correspondence between heaven and man", "replenishing deficiency", "warming cold" and "external treatment of internal diseases", acupoint plastering is performed during the coldest days of the year when the human body's yang is weakest, yin is strongest and it is easy to get sick. Through the transdermal absorption of the medicinal properties of the pungent, warm and cold-dispelling Chinese medicinal materials by the human body, it can not only dispel wind and cold, warm and nourish the lungs and kidneys, dredge meridians, balance yin and yang, relieve cough and asthma, harmonize internal organs, strengthen muscles and body, improve physical fitness and enhance immunity, but also strengthen and consolidate the efficacy of Sanfu patch in summer, achieve the purpose of preventing and curing diseases, and regulate the body's immune status through meridian conduction.

[0004] With the rapid development of my country's economy, changes in people's living habits and dietary structure, the incidence of acute gouty arthritis has shown an increasing trend year by year, and the age of patients is getting younger and younger. Hyperuricemia is the basis of the disease. High uric acid can further cause the deposition of urate crystals in the synovium, bursa and cartilage of joints, stimulate the activation of synovial endothelial cells and the adhesion and exudation of mononuclear macrophages, phagocytosis of urate crystals, induce immune response and release of inflammatory factors, leading to inflammatory reactions such as redness, swelling, heat and pain in the joints. In severe cases, it can lead to the rupture or infection of gout nodules. Western medicine has great side effects in the treatment of this disease, and the disease is prone to recurrence. Gout can be classified as a disease of "arthralgia, pain arthralgia, and lijiefeng" in traditional Chinese medicine, which mostly refers to wandering limb joint pain. Kidney governs bones, and winter is the season for kidney. Gouty arthritis is closely related to kidney. It is generally believed that the pathogenesis lies in the body's insufficient endowment, spleen and kidney deficiency, and qi and blood deficiency, which cause joints to be invaded by wind, cold, and dampness, causing joint redness, swelling, pain, and difficulty in flexion and extension; or because of spleen dysfunction, phlegm stagnates in the joints; or dampness excretion is reduced, and then stagnates in the meridians. At present, there are many traditional Chinese medicine treatments for gouty arthritis, but the effect is not obvious.

[0005] The invention aims to provide a Sanjiu plaster for gouty arthritis and pain syndrome caused by cold coagulation and blood stasis. Summary of the invention

[0006] The first purpose of the present invention is to provide a Sanjiu patch, and a further purpose is to provide a preparation method and application of the Sanjiu patch.

[0007] The first object of the present invention is achieved in this way. A Sanjiu patch is made of the following raw materials in parts by weight: 10-20 parts of white aconite, 10-20 parts of clematis, 20-30 parts of cynanchum, 10-15 parts of asarum, 9-15 parts of puffball, 5-10 parts of trillium, 20-30 parts of mulberry bark, 1.5-2.5 parts of borneol, 1.5-2.5 parts of azone (penetration enhancer), 1-1.5 parts of realgar, 1-1.5 parts of blister beetle, 210 parts of yellow lead, and 500 parts of sesame oil.

[0008] A further object of the present invention is achieved by the preparation method of the Sanjiu patch, which is achieved by the following steps:

[0009] 1) Preparation: Roughly slice or segment Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Tripterygium wilfordii, and Cortex Mori; grind borneol, azone, realgar, and Mylabris into fine powder and pass through a 100-mesh sieve; dry yellow lead, grind it into fine powder, and sieve it through a 100-mesh sieve;

[0010] 2) Refining oil from fried materials: Soak white aconite root, clematis root, cynanchum indica, asarum, puffball, trillium, and mulberry bark in sesame oil for 2-3 days, then transfer them into a pot and fry them into medicinal oil;

[0011] 3) Remove from heat and add the ointment: Remove from heat when the oil temperature reaches above 320℃, add yellow ochre by spreading method when the temperature is not lower than 270℃, evenly sprinkle it in the high-temperature oil, and stir it regularly to make the oil ointment fully and evenly compound. The ointment needs 5~10 minutes. When the oil smoke changes from green to white, stop the fire and stir for 3~5 minutes to obtain a rough plaster;

[0012] 4) Spread the plaster: Cool the crude plaster to remove the fire poison, heat it to remove moisture, and then naturally cool it to 70-80℃, then add borneol; when the temperature drops to about 50℃, add realgar, blister beetle and azone, let it stand, cool and shape it to obtain the finished plaster, apply the finished plaster on cloth or paper to obtain the target Sanjiu patch.

[0013] The application of the Sanjiu patch is in the preparation of medicines for treating gouty arthritis and pain syndromes caused by cold coagulation and blood stasis.

[0014] Another application of the Sanjiu Patch is in the preparation of a drug for preventing and treating respiratory diseases, digestive system diseases, gynecological diseases, orthopedic diseases, rheumatic immune system diseases or pediatric system diseases.

[0015] In the formula, white aconite root, clematis root, radix cynomorii and mulberry bark are all the main medicines.

[0016] The white aconite in the prescription is pungent, hot and toxic. It enters the heart, spleen and kidney meridians. The "Ben Jing" says: It cures wind-cold, cough and evil spirits, warms the middle and treats wounds. It can break up hard masses, accumulations, blood clots, cold-damp paralysis, cramps, knee pain and inability to walk. This product is pungent, warm and dry, with a sharp upward nature. Its effects: restore yang and rescue adverse conditions, benefit yang and replenish fire, warm the middle and dispel cold, and relieve pain.

[0017] Clematis is also known as Lingxian, Heixugong, Tiesaozhu, Qinglongxu, etc. It is warm in nature and pungent in taste. It belongs to the bladder meridian and has the effects of removing rheumatism, unblocking meridians, relieving pain and eliminating bone stagnation. Clematis is a traditional analgesic. It has a pungent and dispersing taste, is impatient and good at moving, can penetrate the five internal organs and twelve meridians, can not only break blood and promote diuresis, unblock meridians and relieve pain, but also can strengthen heart yang, eliminate phlegm and relieve asthma. Wang Kentang, a doctor in the Ming Dynasty, called it "the key analgesic medicine."

[0018] Xu Changqing is pungent and warm. It enters the liver and stomach meridians and flows through the blood. "Compendium of Materia Medica" states: "It is used to treat ghosts and spirits, epidemic diseases caused by poison, evil spirits, and warm malaria. Long-term use will make you strong and light. It is also called Gui Duyou." It has the functions of dispelling wind and relieving pain, detoxifying and reducing swelling, promoting blood circulation and removing blood stasis, and promoting diuresis. Modern pharmacology: The peony phenol contained in this medicine has a wide range of pharmacological effects, including analgesia and sedation, dilation of blood vessels to increase coronary blood flow, slowing down heart rate, softening blood vessels, lowering blood pressure, purifying blood, lowering cholesterol, preventing arteriosclerosis and thrombosis, improving the body's metabolic capacity, enhancing immune function, and anti-inflammatory, antibacterial, anti-tumor, and anti-allergic effects. A large number of literatures show that Xu Changqing has anti-allergic effects and has unique therapeutic effects on diseases such as anaphylactic shock, respiratory allergic reactions, digestive allergic reactions, and skin allergic reactions.

[0019] Mulberry bark, first recorded in the "Compendium of Materia Medica", says: "It is used to treat injuries, fatigue, emaciation, metrorrhagia, pulse cessation, and to replenish deficiency and invigorate qi." The "Famous Doctors' Records" adds that it can "remove water vapor from the lungs, stop spitting blood, thirst, edema, abdominal distension, distension, promote water flow, remove inch white, and can sew up wounds." Mulberry bark mainly contains Diels-Alder type adducts such as mulberry ketone and mulberry bark, and flavonoid derivatives such as total flavonoids of mulberry bark and mulberry bark. Modern pharmacological research results show that mulberry bark has analgesic, anti-inflammatory, antitussive, antiasthmatic, diuretic, hypoglycemic, lipid-lowering, anti-diabetic peripheral neuropathy, liver protection, anti-cancer, anti-aging, kidney function protection, anti-oxidation, anti-tumor, cardioprotection, neuroprotection, and immune activity regulation.

[0020] In terms of prescription and drug compatibility, Aconite, Cynanchum chinense, and Morus alba can all suppress pain. The three are used together. Increasing the dose will have an anesthetic effect. Aconite is toxic, while Cynanchum chinense is non-toxic. Cynanchum chinense is mainly used for rheumatic pain, back pain, and has obvious analgesic effects for heart and stomach pain, dysmenorrhea, and pain caused by falls. Cynanchum chinense injection has a good analgesic effect for rheumatoid arthritis, lumbar muscle strain, stomach pain, abdominal pain, and various cancer pains.

[0021] The ministerial drug is Asarum, which is pungent and warm in nature. It is used for cough, headache, brain movement, cramps of all joints, rheumatism, arthralgia, and dead muscles. Long-term use can improve eyesight, benefit the nine orifices, and make the body light and long-lived (Shennong's Herbal Classic). "Warm the cold in the abdomen and open the stagnation in the chest. Warm the yin meridian and remove the internal cold", which can eliminate rheumatism, arthralgia, and relieve pain. As a meridian-introducing drug, this product is classified according to the description of the Twelve Meridians. The Shaoyin Heart Meridian of the Hand is Coptis chinensis and Asarum. According to the description of the Six Meridians, the Jueyin Meridian uses Asarum, Chuanxiong, and Qingpi. This product is mostly used to treat phlegm, cough, cold, rheumatism, and arthralgia. Modern pharmacological studies have shown that in addition to its pharmacological activities such as analgesia, anti-inflammatory, antitussive, and antiasthmatic based on traditional effects, Asarum also has antiviral, antibacterial, sedative, antioxidant, antidepressant, blood pressure lowering, and cancer cell inhibition effects.

[0022] Adjuvants include puffball, trillium and borneol.

[0023] Puffball is pungent, mild, and light in nature. It enters the lung meridian and is mainly used to treat malignant sores and horse scabies (Compendium of Materia Medica). It has the functions of clearing the lungs and relieving throat pain, detoxifying and stopping bleeding. It can protect the skin, repair the barrier, and stop bleeding when used externally. Modern pharmacological studies have shown that it includes steroid compounds, proteins and peptides, amino acids, fatty acids and esters, sugars and volatile components. Puffball has pharmacological effects such as anti-tumor, liver protection, hemostasis, cough relief, antioxidant, antibacterial and anti-inflammatory, blood sugar reduction, and cell proliferation promotion.

[0024] In recent years, with the continuous deepening of research on the biological activity of Trillium and its extracts, its pharmacological effects such as anti-tumor, antioxidant, neuroprotective, antibacterial, anti-gout, lipid-lowering and blood sugar-lowering, improving hematopoietic function and enhancing immunity have received widespread attention; in addition, Trillium is often used in compound prescriptions with other Chinese medicines, and has definite efficacy in the treatment of diseases of the respiratory system, digestive system, endocrine and metabolic system, and has broad prospects for clinical application.

[0025] Borneol is pungent, bitter and cool in nature (recorded in *Annotations to the Classic of Materia Medica*). In traditional Chinese medicine, it is often used for its effects of refreshing the mind and opening the orifices, clearing heat and relieving pain, preventing corrosion and promoting granulation. Modern pharmacological studies have shown that borneol has a variety of medicinal effects. It can easily penetrate the blood-brain barrier, promote drug absorption, counteract ischemia and injury in the circulatory system, and has antibacterial, anti-inflammatory and analgesic effects, and can promote wound healing. When used in this formula, it can moderate the warm and dry nature of the formula, and utilize its characteristics of "fragrant and spreading, guiding the meridian upward" and "being weak alone but effective when used as an assistant" to promote the transdermal absorption of the drug effect and enhance the therapeutic effect. Borneol is a natural transdermal penetration enhancer, and it has attracted increasing attention due to its good penetration-enhancing effect, small toxic and side effects and irritation, low price and large supply.

[0026] Azone, as a common matrix for skin penetration, has been widely used clinically. Studies have shown that it has a good penetration-enhancing effect on lipophilic and hydrophilic drugs. Experimental studies have found that after the penetration enhancer takes effect, the resistance of excised skin decreases significantly. The curve of azone shows a stable upward trend, and the curves of borneol plus azone, menthol plus azone are similar to that of azone alone, indicating that the penetration-enhancing effect of azone can be maintained for a long time, but the onset is slow. Azone alone or in combination with menthol and borneol has a good penetration-enhancing effect.

[0027] The adjuvant drugs are realgar and mylabris with the least amount of medicine.

[0028] Realgar is pungent, warm and toxic. It belongs to the liver and large intestine meridians. Its effects include detoxifying, killing insects, drying dampness, eliminating phlegm. It is the essence of pure yang, and it enters the jueyin qi aspect alone, opening the pores and moving the blood vessels, so that the toxic pathogens can be quickly dispersed. The first volume of the 2000 edition of *Pharmacopoeia of the People's Republic of China* records that realgar can detoxify and kill insects, dry dampness and eliminate phlegm, and prevent malaria; it is used for carbuncles, sores, snake and insect bites, abdominal pain due to worm accumulation, epilepsy, and malaria.

[0029] Mylabris, also known as Longwei in *Shennong's Classic of Materia Medica*, Banmao, Banhao, Longhao, Banjun, Tengfa, Yanqing in *Wu Pu's Materia Medica*, Canmao Insect in *Supplementary Records of Materia Medica*, and Longhao (pronounced as ci). *Pharmacopoeia of the People's Republic of China (2015 Edition)* records that mylabris is the dried body of the insect Mylabris phalerata Pallas or Mylabris cichorii Linnaeus of the family Meloidae. It is pungent, hot and highly toxic. It belongs to the liver, stomach and kidney meridians. Its pungency promotes qi and warmth and dredges the channels, and it can enter the blood aspect, and has the effects of promoting blood circulation to remove blood stasis, dissipating stasis and mass, attacking toxins and eroding sores, and has the effect of causing blisters. It is used for mass in the abdomen, amenorrhea, stubborn tinea, scrofula, verruca, carbuncle that does not ulcerate, and malignant sores with necrosis of muscles. Modern pharmacological studies have found that mylabris has anti-tumor, anti-fungal, anti-viral, anti-inflammatory, leukocytosis-promoting and estrogen-like effects.

[0030] In the prescription of the Sanjiu patch of the present invention, Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchii, and Cortex Mori are the main drugs, mainly for treating arthritis diseases with the main function of removing rheumatism and relieving pain, and the drug power is the first in the prescription, which is an indispensable drug in the prescription. Asarum, as a ministerial drug, can effectively reduce the pain threshold of mice in combination with the main drug Radix Aconiti Lateralis, thereby achieving a good analgesic effect. In addition, Asarum is the most pungent and warm in nature, has a strong dispersing power, is good at walking on the head and face, dispels cold and relieves pain, and is also a meridian-guiding drug for Jueyin and Shaoyin. Radix Clematidis is pungent and dispersing, is warm in nature and is smooth, and travels through the twelve meridians, which can both dispel the wind on the surface and transform the dampness inside, promote the meridians and reach the collaterals, and can be promoted and guided. The two drugs are used together, and the exterior and interior are treated together. The two drugs are used together, and the effects of dispelling wind, cold and dampness, dredge the collaterals and relieve pain can be enhanced. Assisted by puffball and Psoralea corylifolia, one is collected and the other is opened, and the wind-heat can be dispersed and released from the fur. In addition, borneol is used as an adjuvant to promote the transdermal absorption of the drug efficacy and enhance the therapeutic effect by utilizing its characteristics of "aromatic movement, leading the meridians upward" and "weak power when acting alone, effective when used as an adjuvant". The adjuvant drugs are realgar and blister beetle with the least dosage. The two drugs are highly toxic and have the power to break blood and remove blood stasis. The power of asarum is used to make the drug power reach the diseased area directly. In summary, this prescription is pungent, warm, dry and hot, like a fire in winter, and has good effects in dispelling cold, removing blood stasis and relieving pain. The combination of various drugs has the effects of promoting blood circulation, unblocking meridians, removing dampness and relieving pain.

[0031] The beneficial effects of the present invention are as follows:

[0032] 1. The Sanjiu patch of the present invention uses Rhizoma Cynanchum, Radix Clematis, Radix Cynanchifolia and Cortex Mori as the main medicines, Asarum as the ministerial medicine, Puffball, Psoralea corylifolia and Borneolum as the adjuvants, Realgar and Mylabris as the guiding medicines, selects traditional red lead as the basis of the plaster, uses high-temperature oil refining, mixes with fine medicine, and synthesizes the oil red into a paste, and the matrix can be melted. The Sanjiu patch obtained based on the above medicinal materials and the preparation method of the present invention has the effects of warming yang, dredging collaterals and relieving pain, invigorating the spleen and descending turbidity, dispelling cold and removing dampness, strengthening the body and removing evil, and removing blood stasis and relieving pain. It can be used to treat pain syndromes caused by phlegm turbidity obstruction and cold coagulation and blood stasis, and is also suitable for the respiratory system, digestive system, gynecological and obstetric diseases, orthopedic diseases, rheumatism immune system, pediatric system diseases and regulating the sub-health state of the body, and can play the role of dredging meridians, regulating qi and blood, widening the chest and regulating qi, invigorating the spleen and stomach, invigorating yang, regulating the lung and spleen function of the human body, enhancing the body's immune function, invigorating the body's yang, promoting blood circulation, dispelling cold and removing dampness, and balancing yin and yang.

[0033] 2. The dosage of each drug in the Sanjiu patch prepared by the present invention complies with the provisions of the 2015 edition of the Chinese Pharmacopoeia, and has the advantages of safe application, no toxic side effects, and convenient use, which is convenient for clinical promotion and application.

[0034] 3. Clinical observations have shown that the Sanjiu patch of the present invention has an effective rate of up to 97.22% in the treatment of gout. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The present invention is a flow chart of the preparation of the Sanjiu patch. DETAILED DESCRIPTION

[0036] The present invention is further described below in conjunction with the embodiments, but the present invention is not limited in any way. Any changes or substitutions made based on the teachings of the present invention belong to the protection scope of the present invention.

[0037] The invention discloses a Sanjiu patch, which is prepared from the following raw materials in parts by weight: 10-20 parts of white aconite root, 10-20 parts of clematis root, 20-30 parts of cynanchum chinense, 10-15 parts of asarum, 9-15 parts of puffball, 5-10 parts of trillium, 20-30 parts of mulberry bark, 1.5-2.5 parts of borneol, 1.5-2.5 parts of azone, 1-1.5 parts of realgar, 1-1.5 parts of mylabris, 210 parts of yellow lead and 500 parts of sesame oil.

[0038] The preparation method of the Sanjiu patch is achieved by following the steps:

[0039] 1) Preparation: Roughly slice or segment Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Tripterygium wilfordii, and Cortex Mori; grind borneol, azone, realgar, and Mylabris into fine powder and pass through a 100-mesh sieve; dry yellow lead, grind it into fine powder, and sieve it through a 100-mesh sieve;

[0040] 2) Refining oil from fried materials: Soak white aconite root, clematis root, cynanchum indica, asarum, puffball, trillium, and mulberry bark in sesame oil for 2-3 days, then transfer them into a pot and fry them into medicinal oil;

[0041] 3) Remove from heat and add the ointment: Remove from heat when the oil temperature reaches above 320℃, add yellow ochre by spreading method when the temperature is not lower than 270℃, evenly sprinkle it in the high-temperature oil, and stir it regularly to make the oil ointment fully and evenly compound. The ointment needs 5~10 minutes. When the oil smoke changes from green to white, stop the fire and stir for 3~5 minutes to obtain a rough plaster;

[0042] 4) Spread the plaster: Cool the crude plaster to remove the fire poison, heat it to remove moisture, and then naturally cool it to 70-80℃, then add borneol; when the temperature drops to about 50℃, add realgar, blister beetle and azone, let it stand, cool and shape it to obtain the finished plaster, apply the finished plaster on cloth or paper to obtain the target Sanjiu patch.

[0043] In step 2), the method of frying the drug oil is as follows: fry the drug oil with a slow fire according to the experience of "three times of heating up and three times of heating down" until the drug surface turns brown, and filter the drug residue through a metal sieve lined with copper wire cloth. Continue to heat and simmer with high heat and stir constantly to achieve "water drops into beads".

[0044] The low heat is 80~120℃, and the high heat is 180~190℃.

[0045] In step 4), the method for removing the fire poison is as follows: put the crude plaster in the container into an iron bucket with a large amount of cold water, cool the plaster and solidify it into large pieces, replace the cold water 1 to 2 times a day, soak for 3 to 7 days, and the fire poison can be removed.

[0046] The present invention also provides the use of the Sanjiu patch in preparing medicines for treating gouty arthritis and pain syndromes caused by cold coagulation and blood stasis.

[0047] The present invention further provides the use of the Sanjiu patch in the preparation of a prescription for treating respiratory diseases, digestive system diseases, gynecological diseases, orthopedic diseases, rheumatic immune system diseases or pediatric system diseases.

[0048] Example 1

[0049] A Sanjiu patch is prepared from the following raw materials in parts by weight: 100g of white aconite root, 100g of clematis root, 200g of cynanchum chinense, 100g of asarum, 90g of puffball, 50g of trillium, 200g of mulberry bark, 15g of borneol, 15g of azone, 15g of realgar, 15g of mylabris, 2.1kg of yellow lead, and 5kg of sesame oil.

[0050] The preparation method is as follows:

[0051] (1) Preparation: Cut the coarse materials of Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori into slices or sections. Grind borneol, realgar, and blister beetles into fine powder and pass through a 100-mesh sieve for later use.

[0052] (2) Frying and refining oil: Soak Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori in sesame oil for 2 days, then transfer them to a pot and heat them together. When frying the medicine, use a slow fire (according to the "Beijing Traditional Chinese Medicine Preparation Specifications" (2005), the slow fire is defined as 80-120℃). According to the experience of "three times of heating up and three times of heating down" (three times of frying the medicine oil, concentrating the medicine and increasing the concentration), fry the medicine with a slow fire until the surface of the medicine turns brown, and then filter the medicine residue through a metal sieve lined with copper wire cloth. Continue to heat and refine with high heat and stir constantly to make the medicine oil evenly heated and achieve "water drops into beads", that is, the refined oil is dropped on the water surface, and the oil droplets are spherical or hemispherical.

[0053] (3) Remove from heat and add the ointment: Before removing from heat and adding the ointment, first dry the ointment, grind it into powder and sieve it through a 100-mesh sieve, weigh the weight accurately, remove from heat when the oil temperature reaches above 320°C, add the ointment by spreading at a temperature not lower than 270°C, evenly sprinkle it in the high-temperature oil, and stir it regularly to make the ointment fully and evenly compounded. It takes 5 to 10 minutes to add the ointment. When the oil smoke changes from green to white, do a test of age (use a spoon to take a small amount of ointment and put it into cold water and knead it repeatedly. If it is not sticky, there are threads when you pull it, and it breaks when you pull it again, there is no oil on your hands, and the back of the paper cannot absorb oil when you stick it on it, then it is suitable for age; if it is sticky, too sticky, and the threads are too long and not easy to break, then it is too tender; if it is difficult to knead, too hard, and breaks when you pull it, then it is too old), then stop the fire and stir for 3 to 5 minutes to remove the smoke.

[0054] (4) Eliminate fire poison: Place the crude plaster in a container into an iron bucket with a large amount of cold water to cool the crude plaster and solidify it into large pieces. Replace the cold water twice a day and soak for 3 days. The fire poison can be eliminated.

[0055] (5) Spread the plaster: After the plaster removes the fire poison, put it in a pot and heat it over a low fire to dissolve it and remove all the water. When the temperature drops to 75°C, add borneol powder; when the temperature drops to about 50°C, add realgar and blister beetle powder, and then add azone. Let it stand and solidify, cut it into several 1.2kg small pieces, place the finished plaster in the center of the plaster cloth and spread it into a round plaster. Apply 0.6g each time and seal it for 3 days.

[0056] Example 2

[0057] A Sanjiu patch is prepared from the following raw materials in parts by weight: 150g of white aconite root, 150g of clematis root, 250g of cynanchum chinense, 130g of asarum, 100g of puffball, 90g of trillium, 250g of mulberry bark, 20g of borneol, 20g of azone, 15g of realgar, 15g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0058] The preparation method is as follows:

[0059] (1) Preparation: Cut the coarse materials of Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori into slices or sections. Grind borneol, realgar, and blister beetles into fine powder and pass through a 100-mesh sieve for later use.

[0060] (2) Frying and refining oil: Soak Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori in sesame oil for 3 days, then transfer them to a pot and heat them together. When frying the medicine, use a slow fire (according to the "Beijing Traditional Chinese Medicine Preparation Specifications" (2005), the slow fire is defined as 80-120℃). According to the experience of "three times of heating up and three times of heating down" (three times as the degree of frying the medicine oil, concentrating the medicine and increasing the concentration), fry the medicine with a slow fire until the surface of the medicine turns brown, and then filter the medicine residue through a metal sieve lined with copper wire cloth. Continue to heat and refine with high heat and stir constantly to make the medicine oil evenly heated and achieve "water drops into beads", that is, the refined oil is dropped on the water surface, and the oil droplets are spherical or hemispherical.

[0061] (3) Remove from heat and add the ointment: Before removing from heat and adding the ointment, first dry the ointment, grind it into powder and sieve it through a 100-mesh sieve, weigh the weight accurately, remove from heat when the oil temperature reaches above 320°C, add the ointment by spreading at a temperature not lower than 270°C, evenly sprinkle it in the high-temperature oil, and stir it regularly to make the ointment fully and evenly compounded. It takes 5 to 10 minutes to add the ointment. When the oil smoke changes from green to white, do a test of age (use a spoon to take a small amount of ointment and put it into cold water and knead it repeatedly. If it is not sticky, there are threads when you pull it, and it breaks when you pull it again, there is no oil on your hands, and the back of the paper cannot absorb oil when you stick it on it, then it is suitable for age; if it is sticky, too sticky, and the threads are too long and not easy to break, then it is too tender; if it is difficult to knead, too hard, and breaks when you pull it, then it is too old), then stop the fire and stir for 3 to 5 minutes to remove the smoke.

[0062] (4) Eliminate fire poison: Place the crude plaster in a container into an iron bucket with a large amount of cold water to cool the crude plaster and solidify it into large pieces. Replace the cold water once a day and soak for 5 days. The fire poison can be eliminated.

[0063] (5) Spread the plaster: After the plaster removes the fire poison, put it in a pot and heat it over a low fire to dissolve it and remove all the water. When the temperature drops to 70℃, add borneol powder; when the temperature drops to 50℃, add realgar and blister beetle powder, and then add azone. Let it stand and solidify, cut it into several 1.5kg small pieces, place the finished plaster in the center of the plaster cloth and spread it into a round plaster. Apply 0.6g each time and seal it for 3 days.

[0064] Example 3

[0065] A Sanjiu patch is prepared from the following raw materials in parts by weight: 200g of white aconite root, 200g of clematis root, 300g of cyperus rotundus, 150g of asarum, 120g of puffball, 100g of trillium, 300g of mulberry bark, 25g of borneol, 25g of azone, 15g of realgar, 15g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0066] The preparation method is as follows:

[0067] (1) Preparation: Cut the coarse materials of Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori into slices or sections. Grind borneol, realgar, and blister beetles into fine powder and pass through a 100-mesh sieve for later use.

[0068] (2) Frying and refining oil: Soak Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Trillium, and Cortex Mori in sesame oil for 2 days, then transfer them to a pot and heat them together. When frying the medicine, use a slow fire (according to the "Beijing Traditional Chinese Medicine Preparation Specifications" (2005), the slow fire is defined as 80-120℃). According to the experience of "three times of heating up and three times of heating down" (three times of frying the medicine oil, concentrating the medicine and increasing the concentration), fry the medicine with a slow fire until the surface of the medicine turns brown, and then filter the medicine residue through a metal sieve lined with copper wire cloth. Continue to heat and refine with high heat and stir constantly to make the medicine oil evenly heated and achieve "water drops into beads", that is, the refined oil is dropped on the water surface, and the oil droplets are spherical or hemispherical.

[0069] (3) Remove from heat and add the ointment: Before removing from heat and adding the ointment, first dry the ointment, then grind it into powder and sieve it through a 100-mesh sieve, weigh the weight accurately, and remove from heat when the oil temperature reaches above 320°C. When the temperature is not lower than 270°C, add the ointment by spreading, evenly sprinkle it in the high-temperature oil, and stir it regularly to make the ointment fully and evenly compounded. It takes 5 to 10 minutes to add the ointment. When the oil smoke changes from green to white, do a test of age (use a spoon to take a small amount of ointment and put it into cold water to knead it repeatedly. If it is not sticky, there are threads when you pull it, and it breaks when you pull it again, there is no oil on your hands, and the back of the paper cannot absorb oil when you stick it on it, then it is suitable for age; if it is sticky, too sticky, and the threads are too long and not easy to break, then it is too tender; if it is difficult to knead, too hard, and breaks when you pull it, then it is too old). Then stop the heat and stir for 3 minutes to remove the smoke.

[0070] (4) Eliminate fire poison: Place the crude plaster in a container into an iron bucket with a large amount of cold water to cool the crude plaster and solidify it into large pieces. Replace the cold water twice a day and soak for 7 days to eliminate fire poison.

[0071] (5) Spread the plaster: After the plaster removes the fire poison, put it in a pot and heat it over a low fire to dissolve it and remove all the water. When the temperature drops to 80℃, add borneol powder; when the temperature drops to about 50℃, add realgar and blister beetle powder, and then add azone. Let it stand and solidify, cut it into several 1.0kg small pieces, place the finished plaster in the center of the plaster cloth and spread it into a round plaster. Apply 0.6g each time and seal it for 4 days.

[0072] Example 4

[0073] A Sanjiu patch is prepared from the following raw materials in parts by weight: 200g of white aconite root, 250g of clematis root, 300g of cynanchum chinense, 100g of asarum, 90g of puffball, 80g of trillium, 250g of mulberry bark, 20g of borneol, 15g of azone, 10g of realgar, 12g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0074] The preparation method is the same as that in Example 1.

[0075] Example 5

[0076] A Sanjiu patch is prepared from the following raw materials in parts by weight: 120g of white aconite root, 180g of clematis root, 220g of cyperus rotundus, 140g of asarum, 140g of puffball, 70g of trillium, 270g of mulberry bark, 18g of borneol, 18g of azone, 12g of realgar, 14g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0077] Example 6

[0078] A Sanjiu patch is prepared from the following raw materials in parts by weight: 180g of white aconite root, 120g of clematis root, 270g of cyperus rotundus, 110g of asarum, 140g of puffball, 50g of trillium, 270g of mulberry bark, 20g of borneol, 15g of azone, 12g of realgar, 13g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0079] Example 7

[0080] A Sanjiu patch is prepared from the following raw materials in parts by weight: 200g of white aconite root, 200g of clematis root, 300g of cyperus rotundus, 150g of asarum, 120g of puffball, 100g of trillium, 300g of mulberry bark, 20g of borneol, 20g of azone, 15g of realgar, 15g of mylabris, 2.1kg of yellow lead and 5kg of sesame oil.

[0081] Case 1 Renal colic

[0082] Patient Zhao, male, 28 years old. Visited the hospital on November 13, 2018. The patient had pain in the back and waist, pulling the lower abdomen. When the pain was severe, it could radiate to the perineum and inner thigh. He had weak urination, intermittent urination, and urination dripped down. He had soreness in the waist and knees, fatigue, and repeated symptoms. He came to the hospital after being referred to the surgical department for diagnosis and treatment (details unknown). Examination: percussion pain in the kidney area, pale tongue, thin white fur, and tight pulse. Chinese medicine diagnosis: low back pain (kidney qi deficiency syndrome), Western medicine diagnosis: renal colic.

[0083] The 39-day period of the 39-day period of each year is used to apply the 39-day period prepared in Example 3. The first, middle and last fu are applied once, and the fu can be strengthened once before and after the fu. Each fu is applied 3 to 6 times, and there is a 10-day interval between each fu. 3 years is a course of treatment. Main acupoints are selected: Jingmen (bilateral), Shenshu (bilateral), Bladdershu (bilateral), Sanyinjiao (bilateral), the intersection of the line between the anterior superior iliac spine and the outer edge of the rectus abdominis muscle (middle ureter tenderness point, bilateral), and acupoints: Guanyuan and Mingmen. After 1 year of application, the pain is relieved compared with before, and the frequency of attacks is reduced. After 3 years of continuous application, the patient's back pain and dysuria symptoms are basically eliminated, and the fatigue is significantly improved, and the spirit is restored.

[0084] Case 2: Osteoarthritis of the knee

[0085] Patient Li, female, 62 years old. Visited the doctor on October 28, 2019. Chief complaint: bilateral knee pain for 2 years, aggravated with difficulty in movement for 1 week. The patient developed bilateral knee pain 2 years ago after accidentally feeling the cold and dampness. The pain was mainly cold pain, aggravated by cold, and relieved by warmth. The pain was related to weather changes, and the symptoms recurred without systematic diagnosis and treatment. One week ago, the pain in the bilateral knees worsened after feeling the cold again, with a heavy feeling, accompanied by difficulty in movement, good appetite and sleep, and regular bowel movements. Examination: Both knees were slightly swollen, without obvious joint deformity, obvious local tenderness in the patellar bottom and joint space of both knees, and snapping could be heard during joint flexion and extension. The tongue was pale, the tongue coating was white and greasy, and the pulse was tight. Chinese medicine diagnosis: knee arthritis (cold and dampness stagnation syndrome), Western medicine diagnosis: knee osteoarthritis.

[0086] The 39-day period of the 39-day period of each year is used to apply the 39-day period prepared in Example 4. The first, middle and last fu are applied once each, and the fu can also be strengthened once before and after the fu. Each fu is applied 3 to 6 times, and there is a 10-day interval between each fu. 3 years is a course of treatment. The main acupoints are selected: Liangqiu (bilateral), Dubi (bilateral), Xuehai (bilateral), Heding (bilateral), Taixi (bilateral), and the acupoints are Yinlingquan (bilateral), Sanyinjiao (bilateral). After 1 year of application, the symptoms of pain in both knee joints have improved. After 3 years of continuous application, the symptoms of pain in both knee joints of the patient have been significantly improved, the activities are basically flexible, and the pain in both knee joints has not increased in cold weather and weather changes.

[0087] Case 3 Allergic rhinitis

[0088] Patient Li, male, 38 years old. Visited the doctor on April 26, 2019. Main complaint: nasal congestion, nasal itching, and clear runny nose for 3 months. The patient had nasal congestion, nasal itching, and clear runny nose in the morning without obvious cause 3 months ago, accompanied by sneezing, fatigue, shortness of breath, laziness, normal appetite and sleep, normal urination, and loose stools. Examination: sallow complexion, pale and fat tongue with teeth marks on the edges, thin white fur, and weak pulse. Chinese medicine diagnosis: allergic rhinitis (spleen deficiency syndrome), Western medicine diagnosis: allergic rhinitis.

[0089] The 39-day treatment of the 1 ...

[0090] Case 4 Dysmenorrhea

[0091] Patient Zhang, female, 27 years old. Visited the doctor on March 25, 2019. Main complaint: dysmenorrhea for 2 years, aggravated for half a year. The patient had dysmenorrhea since menarche at the age of 14. She usually likes to eat cold drinks. Every time her menstruation comes, her lower abdomen is swollen and painful and refuses to be pressed. She likes warmth and fears cold. The menstrual cycle is 28-35 days, and the menstruation lasts for 4-5 days. The amount is small and the color is light and dark, there are blood clots, and the menstruation is not smooth. In the past six months, due to the high pressure of work, the symptoms have also worsened. The lower abdomen is very painful during menstruation and refuses to be pressed. She likes warmth and fears cold, has little appetite, and has loose stools. When the pain is severe, she is afraid of cold limbs and cannot work. Gynecological color ultrasound examinations have been performed and no abnormalities are found. The tongue is pale and dark, the tongue coating is white and slippery, and the pulse is deep and thin. Chinese medicine diagnosis: abdominal pain during menstruation (spleen and stomach deficiency and cold with blood stasis), Western medicine diagnosis: primary dysmenorrhea.

[0092] The 39-day treatment of the 1 ...

[0093] Case 5: Sub-healthy Yang deficiency constitution

[0094] Patient Zhao, female, 49 years old. Visited the hospital on October 12, 2018. The patient usually had palpitations, chest tightness, cold limbs, chills, insomnia and dreaminess. She needed to take 1-2 tablets of Estazolam tablets every day to fall asleep. She was tired, weak, short of breath, lazy to speak, restless, cold pain in the abdomen, backache, poor appetite, and normal bowel movements. Examination: pale tongue with teeth marks on the edges, thin white fur, and weak pulse.

[0095] The Sanjiu patch prepared in Example 3 is applied on the Sanjiu days of each year. The first, middle and last days of the year are applied once, and the pre- and post-days of the year can also be strengthened once, 3 to 6 times per day, 10 days between each day, and 3 years as a course of treatment. Acupoints: Zhiyang, Zhishi, Feishu (bilateral), Dazhui, Xinshu (bilateral), Shenshu (bilateral), Pishu (bilateral), Zusanli (bilateral). After 1 year of application, the patient's symptoms of palpitation and chest tightness improved, and sleep improved. After 3 years of continuous application, the patient's symptoms of palpitation and chest tightness improved significantly, diet improved, spirit recovered, and no longer needed to take estazolam tablets to fall asleep.

[0096] The clinical efficacy test results of the Sanjiu patch of the present invention are introduced below.

[0097] Case information

[0098] 1.1 Case selection

[0099] The 180 selected patients were all treated in the Acupuncture Department of Kunming Traditional Chinese Medicine Hospital and met the diagnostic criteria for gouty arthritis. The general data of the selected cases, such as gender, age, course of disease and pain site, showed no statistically significant difference after statistical processing (P>0.05). The 180 patients who met the inclusion criteria were randomly divided into 5 groups, 4 of which were treatment groups and 1 was a control group, with 36 people in each group.

[0100] Diagnostic criteria

[0101] Western medicine diagnostic criteria: in line with the relevant diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout in China (2019)": elevated or normal blood uric acid; suspected gout patients with peripheral joint swelling, pain or tenderness; urate crystals found in the joint fluid, bursa or tophi; ultrasound examination of patients with joint swelling has a double-track sign.

[0102] TCM diagnostic criteria: Refer to the syndrome differentiation criteria of phlegm-turbidity obstruction type in the TCM Disease Diagnosis and Treatment Criteria: joint swelling, even diffuse swelling around joints, local numbness and pain, or "scrotal" nodules, dry skin, dark skin color. Dark purple tongue, or ecchymosis, thin yellow fur, thin and astringent or deep and stringy pulse.

[0103] Inclusion criteria

[0104] (1) Volunteer to be the subject and sign the informed consent form; (2) Meet the diagnostic criteria of gouty arthritis in both Chinese and Western medicine; (3) Have a disease course of more than half a year and less than 15 years; (4) Aged between 30 and 65 years old, regardless of gender. (5) Patients without organic dysfunction.

[0105] Treatment

[0106] ①Control group: acupuncture treatment only, referring to the national TCM industry higher education "Fourteenth Five-Year Plan" planning textbook "Acupuncture Therapy" (New Century Fifth Edition).

[0107] Main acupoint: local Ashi point; auxiliary acupoint: Gongsun Xuehai

[0108] The metatarsophalangeal joint is paired with Bafeng and Neiting; the ankle joint is paired with Shenmai and Kunlun; the interphalangeal joint is paired with Baxie and Sifeng; the wrist joint is paired with Yangchi and Wangu; the knee joint is paired with Xiyan and Yanglingquan.

[0109] Operation: Refer to the acupuncture depth and direction in the "Fourteenth Five-Year Plan" national planning textbook for general higher education "Acupuncture" (Fifth Edition, New Century) edited by Liang Fanrong and Wang Hua and the "Fourteenth Five-Year Plan" national planning textbook for general higher education "Meridian Acupoints", and perform acupuncture operations according to the acupuncture depth of different patients.

[0110] ② Treatment group 1: on the basis of the control group, the Sanjiu patch prepared in Example 1 was additionally applied.

[0111] ③ Treatment group 2: on the basis of the control group, the Sanjiu patch prepared in Example 2 was additionally applied.

[0112] ④ Treatment group 3: on the basis of the control group, the Sanjiu patch prepared in Example 3 was additionally applied.

[0113] ⑤ Treatment group 4: on the basis of the control group, the Sanjiu patch prepared in Example 4 was additionally applied.

[0114] Treatment course: The patient's acupuncture operation follows one acupuncture every other day, 10 times as a course of treatment, a total of one course of acupuncture. Sanjiu patch follows the first two days of each nine-day continuous application for 2 days, 2 times a day, the acupoints are mainly selected for the patch, mainly the painful area, 8 acupoints are selected for patching each time, and the patch can be applied 1 hour after the end of acupuncture, each patch lasts 3 to 4 hours, a total of 12 times. Evaluate the efficacy after the treatment.

[0115] Efficacy evaluation criteria

[0116] Cured: Joint movement becomes normal, and symptoms such as heat, pain, and swelling in the affected joint disappear;

[0117] Markedly effective: Joint movements are basically normal, and symptoms such as heat, pain, and swelling in the affected joints disappear;

[0118] Effective: The joint movement is slightly restricted, and the symptoms such as heat, pain, and swelling in the affected joints basically disappear;

[0119] Ineffective: There was no significant improvement in joint function, and no significant relief of symptoms such as heat, pain, and swelling in the affected joints.

[0120] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0121] Clinical Results

[0122] 4.1 Treatment Group 1

[0123] The comparison of patient age and disease course between treatment group 1 and control group is shown in Table 1-2, and the clinical observation results of treatment group 1 are shown in Table 3.

[0124] Table 1 Comparison of the age composition of patients in treatment group 1 and control group (unit: years)

[0125]

[0126] Note: The age composition of the two groups was compared by two independent sample t-test, t=0.557, P=0.36>0.05, with no statistically significant difference.

[0127] Table 2 Comparison of disease course (unit: year) between treatment group 1 and control group

[0128]

[0129] Note: The age composition of the two groups was compared by two independent sample t-tests, t=1.7, P=0.113>0.05, and there was no statistically significant difference, so they were comparable.

[0130] Table 3 Comparison of the therapeutic efficacy between treatment group 1 and control group (unit: case)

[0131]

[0132] Note: According to the chi-square test, X 2 =6.470, P=0.039<0.05, statistically significant.

[0133] 4.2 Treatment Group 2

[0134] The comparison of patient age and disease course between treatment group 2 and control group is shown in Tables 4-5, and the clinical observation results of treatment group 2 are shown in Table 6.

[0135] Table 4 Comparison of the age composition of patients in treatment group 2 and control group (unit: years)

[0136]

[0137] Note: The age composition of the two groups was compared by two independent sample t-test, t=0.653, P=0.879>0.05, and there was no statistically significant difference, so they were comparable.

[0138] Table 5 Comparison of disease course (unit: year) between treatment group 2 and control group

[0139]

[0140] Note: The age composition of the two groups was compared by two independent sample t-tests, t=0.52, P=0.9132>0.05, and there was no statistically significant difference, so they were comparable.

[0141] Table 6 Comparison of the therapeutic efficacy between treatment group 2 and control group (unit: case)

[0142]

[0143] Note: The total effective rate of the two groups was compared by chi-square test. 2 =7.477, P=0.024<0.05, statistically significant.

[0144] 4.3 Treatment Group 3

[0145] The comparison of patient age and disease course between treatment group 3 and control group is shown in Table 1-2, and the clinical observation results of treatment group 3 are shown in Table 9.

[0146] Table 7 Comparison of the age composition of patients in treatment group 3 and control group (unit: years)

[0147]

[0148] Note: The age composition of the two groups was compared by two independent sample t-test, t=0.618, P=0.538>0.05, and there was no statistically significant difference, so they were comparable.

[0149] Table 8 Comparison of disease course (unit: year) between treatment group 3 and control group

[0150]

[0151] Note: The age composition of the two groups was compared by two independent sample t-tests, t=0.156, P=0.876>0.05, with no statistically significant difference, and they were comparable.

[0152] Table 9 Comparison of post-treatment efficacy between treatment group 3 and control group (unit: case)

[0153]

[0154] Note: The total effective rate of the two groups was compared by chi-square test. 2 =14.99, P=0.001<0.05, statistically significant.

[0155] 4.4 Treatment Group 4

[0156] The comparison of patient age and disease course between treatment group 4 and control group is shown in Tables 10-11, and the clinical observation results of treatment group 4 are shown in Table 12.

[0157] Table 10 Comparison of the age composition of patients in treatment group 4 and control group (unit: years)

[0158]

[0159] Note: The age composition of the two groups was compared by two independent sample t-test, t=0.296, P=0.582>0.05, with no statistically significant difference and being comparable.

[0160] Table 11 Comparison of disease course (unit: year) between treatment group 4 and control group

[0161]

[0162] Note: The age composition of the two groups was compared by two independent sample t-test, t=0.685, P=0.932>0.05, and there was no statistically significant difference, so they were comparable.

[0163] Table 12 Comparison of post-treatment efficacy between treatment group 4 and control group (unit: case)

[0164]

[0165] Note: The total effective rate of the two groups was compared by chi-square test. 2 =11.92, P=0.003<0.05, statistically significant.

[0166] The above results show that the Sanjiu patch of the present invention has a better therapeutic effect on gouty arthritis, especially Example 3 has the highest total effective rate, which is as high as 97.22%, higher than other example groups and significantly higher than the control group.

Claims

1. A Sanjiu patch, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-20 parts of white aconite root, 10-20 parts of clematis root, 20-30 parts of cynanchum chinense, 10-15 parts of asarum, 9-15 parts of puffball, 5-10 parts of trillium, 20-30 parts of mulberry bark, 1.5-2.5 parts of borneol, 1.5-2.5 parts of azone, 1-1.5 parts of realgar, 1-1.5 parts of mylabris, 210 parts of yellow lead and 500 parts of sesame oil.

2. The method for preparing the Sanjiu patch according to claim 1, characterized in that: To do this, follow these steps: 1) Preparation: Roughly slice or segment Radix Aconiti Lateralis, Radix Clematis, Radix Cynanchum, Asarum, Puffball, Tripterygium wilfordii, and Cortex Mori; grind borneol, azone, realgar, and Mylabris into fine powder and pass through a 100-mesh sieve; dry yellow lead, grind it into fine powder, and sieve it through a 100-mesh sieve; 2) Refining oil from fried materials: Soak white aconite root, clematis root, cynanchum indica, asarum, puffball, trillium, and mulberry bark in sesame oil for 2-3 days, then transfer them into a pot and fry them into medicinal oil; 3) Remove from heat and add the ochre: Remove from heat when the oil temperature reaches above 320℃, add yellow ochre by spreading method when the temperature is not lower than 270℃, sprinkle evenly in the high temperature oil, and stir regularly to make the oil ochre fully and evenly combined; It takes 5 to 10 minutes to make the pill. When the oil smoke changes from green to white, stop the fire and stir for 3-5 minutes to obtain a crude plaster; 4) Spread the plaster: Cool the crude plaster to remove the fire poison, heat it to remove moisture, and then naturally cool it to 70-80℃, then add borneol; when the temperature drops to about 50℃, add realgar, blister beetle and azone, let it stand, cool and shape it to obtain the finished plaster, apply the finished plaster on cloth or paper to obtain the target Sanjiu patch.

3. The preparation method according to claim 2, characterized in that: In step 2), the method of frying the explosive oil is as follows: fry the oil with a slow fire according to the experience of "three times of heating up and three times of heating down" until the surface of the drug turns brown, and filter the drug residue through a metal sieve lined with copper wire cloth; Continue to heat over high heat and stir constantly to achieve the state of "water drops forming beads".

4. The preparation method according to claim 3, characterized in that: The low heat is 80~120℃, and the high heat is 180~190℃.

5. The preparation method according to claim 2, characterized in that: In step 4), the method for removing the fire poison is as follows: put the crude plaster in the container into an iron bucket with a large amount of cold water, cool the plaster and solidify it into large pieces, replace the cold water 1 to 2 times a day, soak for 3 to 7 days, and the fire poison can be removed.

6. Use of the Sanjiu patch according to claim 1 in the preparation of a drug for treating gouty arthritis.

7. Use of the Sanjiu patch according to claim 1 in preparing medicines for treating pain caused by cold coagulation and blood stasis.

Citation Information

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