A Chinese medicine composition for treating gout and preparation method thereof

Abstract

The invention belongs to the technical field of metabolic rheumatism drugs, and particularly relates to a traditional Chinese medicine composition for treating gout and a preparation method thereof. The main components of the composition are, by weight: 20-40 parts of smilax glabra, 20-40 parts of zedoaria, 10-30 parts of atractylodes macrocephala, 10-20 parts of polygonum cuspidatum, 10-20 parts of clematis, 10-20 parts of angelica dahurica, 20-40 parts of parasitic plant, 9-15 parts of plantain seeds, 10-20 parts of ligusticum chuanxiong, 20-30 parts of honeysuckle vine, 20-30 parts of caulis spatholobi, 20-30 parts of trachelospermum jasminoides, 15-25 parts of kadzu vine, 10-30 parts of mulberry branches, 6-12 parts of qin peel, 9-15 parts of tangerine peel, 9-15 parts of earthworms, 1-5 parts of notoginseng powder, and 3-9 parts of roasted liquorice. The composition is composed of Duhuo Jishe Decoction combined with Wuteng Yin plus other medicines such as Smilax glabra, Zedoaria, Polygonum cuspidatum, Clematis chinensis, Plantago seed, Morus alba, Earthworm, Panax notoginseng powder, and roasted liquorice. It can invigorate the spleen to replenish qi, eliminate turbidity and make qi flow. When qi is full, blood can flow, and blood flow can also open the collaterals. The combination of these medicines can strengthen the spleen, eliminate dampness and turbidity, activate blood circulation, remove blood stasis and dredge collaterals, and has remarkable effects on reducing uric acid, improving symptoms such as gout pain, and improving the quality of life of patients.

Description

Technical Field

[0001] The invention belongs to the technical field of metabolic rheumatism drugs, and particularly relates to a traditional Chinese medicine composition for treating gout and a preparation method thereof. Background Art

[0002] Gout is a common metabolic rheumatic disease in clinic. It is caused by purine metabolism disorder and / or reduced uric acid excretion, which leads to increased blood uric acid level, hyperuricemia, and crystal-related arthritis caused by precipitation and deposition of monosodium urate. The typical symptoms during the attack period are redness, swelling, heat, pain and dysfunction of the affected joints. The attack is self-limited and usually resolves within 2 weeks. If not effectively treated, gout can progress to cause structural damage to the joints, loss of function, and eventually disability of the patient, which reduces the patient's quality of life and imposes a heavy burden on the patient's family and social economy. In addition, gout is often accompanied by kidney damage, hyperlipidemia, hypertension, diabetes and other diseases. Therefore, the prevention and treatment of gout has become one of the key research and tackling topics in the world.

[0003] At present, Western medicine is still unclear about the etiology and pathogenesis of gout. Treatment mainly starts from two aspects: controlling inflammatory response and reducing blood uric acid levels. In the acute stage, anti-inflammatory and analgesic treatments such as colchicine, nonsteroidal anti-inflammatory drugs, and glucocorticoids are often used; in the intermittent and chronic stages, allopurinol, febuxostat, benzbromarone, etc. are often used to reduce uric acid. Western medicine has clear targets, but there are different degrees of safety risks. Discontinuation of medication can easily lead to recurrence of the disease, and patient compliance is poor.

[0004] In terms of traditional Chinese medicine, gout has a long history of treatment. Modern doctors have made great achievements in the treatment of gout based on various pathological factors. A large number of studies have also confirmed that traditional Chinese medicine has unique advantages in the treatment of gout. However, the effectiveness of traditional Chinese medicine compound in the treatment of gout still needs to be improved. Summary of the invention

[0005] In view of the current situation that there is still a lack of unified and effective treatment plans for the prevention and treatment of gout by traditional Chinese medicine, the present invention provides a traditional Chinese medicine composition for treating gout and a preparation method thereof. The composition is composed of Duhuo Jishe Decoction combined with Wuteng Yin plus or minus Chinese yam, Zedoaria, Atractylodes macrocephala, Polygonum cuspidatum, Clematidis, Plantago seed, Morus alba, Qinpi, Chenpi, Tuyuan, Panax notoginseng powder and the like, which can invigorate the spleen to replenish qi, eliminate turbidity and make qi flow, and blood can flow when qi is sufficient, and blood flow can also open collaterals. The combination of the medicines can jointly play the functions of invigorating the spleen, eliminating dampness and turbidity, promoting blood circulation, removing blood stasis and unblocking collaterals, and has remarkable effects on reducing uric acid, improving symptoms such as gout pain, and improving the quality of life of patients.

[0006] Gout is classified into the categories of "arthralgia" and "lijie" in traditional Chinese medicine according to its symptoms. The basic pathogenesis is based on deficiency and marked by dampness, turbidity and blood stasis. From the clinical manifestations, gout is often accompanied by redness, swelling, pain, numbness, heaviness, fatigue, abdominal distension, diarrhea, etc. These suggest that spleen deficiency, poor blood circulation, and turbidity and blood stasis blocking the collaterals are the main mechanisms of gout.

[0007] Gout is a disease that "similar to wind in symptoms but not wind in nature". It is actually "the root is weak but the symptoms are strong", and is mostly caused by congenital or acquired factors. Insufficient congenital endowment and insufficient spleen and kidney lead to disordered water transport and transformation, and dampness and turbidity are generated internally and cannot be discharged externally. They combine with blood to form turbidity and blood stasis, stagnate in the meridians, form dampness and turbidity, and turn into heat after a long time. Eating more fatty and sweet food in the acquired environment further damages the spleen and stomach, causing dysfunction of transport and transformation, and the fine substances of water and grain cannot be transported and transformed normally, resulting in dampness and heat, and accumulation of turbidity and blood stasis. Gong Tingxian's "Rejuvenation of All Diseases" said: "All gout and limb pain, pain is caused by fire, and swelling is caused by dampness." Pathological products such as dampness, blood stasis and other pathological products prevent Qi and blood from flowing freely. When evil Qi blocks the middle, it causes lump. Many pathological products flow to the limbs and block the joints. Therefore, the joints cannot be flexed and extended, and the limbs are hot, swollen and painful. It is said that "if Qi does not reach, it will be numb; if blood does not nourish, it will be stiff." Turbidity and blood stasis block the collaterals, Qi and blood are not smooth, and the limbs lose the nourishment of Qi, blood and body fluids, resulting in numbness. "The limbs are the end of all Yang." Dampness and blood stasis block the internal organs and suppress the spleen Qi. The clear Yang Qi cannot be dispersed and reach the limbs, so the limbs feel heavy and tired.

[0008] The inventor combines the traditional Chinese medical theory, from the physiological functions of qi and blood viscera, to the basic pathogenesis of gout, and in the process of clinical practice, finds that the prescriptions and medicines based on the principles of invigorating the spleen, eliminating dampness and purging turbidity, promoting blood circulation, removing blood stasis and unblocking collaterals are used to treat patients with gout that meet the pathogenesis characteristics of spleen deficiency and dampness in traditional Chinese medicine, turbidity and blood stasis blocking collaterals, and are particularly effective in improving limb pain, numbness, heaviness and other symptoms. The invention provides a Chinese medicine composition for the treatment of gout, which is composed of Duhuo Jisheng Decoction combined with Wuling Powder plus and minus, and is combined with drugs such as Tu Fuling, Ze Lan, Bai Zhu, Polygonum cuspidatum, Clematidis, Plantago, Morus alba, Qinpi, Chenpi, Tuyuan, Panax notoginseng powder, etc., which invigorate the spleen to replenish qi, promote turbidity and make qi flow, qi is full and blood flows, blood circulation and collaterals are also unblocked, and all the medicines are used together to play the functions of invigorating the spleen, eliminating dampness and purging turbidity, promoting blood circulation, removing blood stasis and unblocking collaterals, and are effective in reducing uric acid, improving symptoms such as gout pain, and improving the quality of life of patients.

[0009] In summary, the inventor finally found that the treatment of gout should focus on the main links. The inventor believes that strengthening the spleen, removing dampness and turbidity, promoting blood circulation, removing blood stasis and unblocking collaterals are the key. In clinical practice, there are many patients with spleen deficiency, dampness and blood stasis syndrome. Therefore, on the basis of syndrome differentiation and treatment, attention should be paid to promoting dampness and activating blood circulation, while taking into account the spleen and kidney, so that dampness and turbidity can be removed and blood stasis can be resolved without damaging the body. The above is the treatment mechanism proposed by the inventor, and it is applied to the specific treatment process:

[0010] On the basis of the above treatment mechanism, combined with the action mechanism of related drugs, the specific technical solutions provided by the present invention are as follows:

[0011] A Chinese medicine composition for treating gout, the main components of which are calculated by weight:

[0012] 20-40 parts of Smilax glabra, 20-40 parts of Zedoaria, 10-30 parts of Atractylodes macrocephala, 10-20 parts of Polygonum cuspidatum, 10-20 parts of Clematis, 10-20 parts of Angelica dahurica, 20-40 parts of Parasitic loranthus, 9-15 parts of Plantago, 10-20 parts of Ligusticum chuanxiong, 20-30 parts of Caulis lonicerae, 20-30 parts of Caulis Sinomenii, 20-30 parts of Caulis Trachelospermi, 15-25 parts of Caulis Piperis Kadsurae, 10-30 parts of Ramulus mulberry, 6-12 parts of Cortex qinpi, 9-15 parts of Citrus reticulata, 9-15 parts of Earthworm, 1-5 parts of Panax notoginseng powder, and 3-9 parts of roasted Licorice root;

[0013] The best therapeutic effect can be obtained within the above dosage range. Too much or too little drug dosage will lead to changes in the primary and secondary pathogenesis of the prescription.

[0014] Preferably, the main components of the Chinese medicine composition are calculated by weight: 25-35 parts of Smilax glabra, 25-35 parts of Zedoaria, 15-25 parts of Atractylodes macrocephala, 12-18 parts of Polygonum cuspidatum, 12-18 parts of Clematidis, 12-18 parts of Angelica dahurica, 25-35 parts of Viscum album, 10-15 parts of Plantago seed, 12-18 parts of Ligusticum chuanxiong, 20-25 parts of Honeysuckle vine, 20-25 parts of Caulis Sinomenii, 20-25 parts of Trachelospermum jasminoides, 20-25 parts of Caulis Piperis dahurica, 15-25 parts of Morus alba, 7-12 parts of Qinpi, 10-15 parts of Citrus reticulata, 10-15 parts of Earthworm, 2-4 parts of Panax notoginseng powder, and 3-8 parts of roasted Licorice root.

[0015] In the prescription of the present invention, Smilax glabra and Zedoaria are the main ingredients. Smilax glabra is sweet, light and neutral in nature, and can eliminate dampness and reduce turbidity, detoxify and open up joints, and eliminate evil without hurting vital energy. "Ben Cao Zheng Yi" records that "Smilax glabra can eliminate dampness and heat, and can enter the meridians to search and remove the toxins accumulated by dampness and heat"; Zedoaria is pungent, bitter and slightly warm, and enters the liver and spleen meridians, and can soothe the liver and strengthen the spleen, promote diuresis and reduce swelling, and promote blood circulation and remove blood stasis. It can promote diuresis and eliminate dampness to treat the symptoms, and can also benefit the spleen and stomach to tonify the root cause, strengthen the spleen to eliminate dampness, soothe the liver to promote qi, and qi circulation leads to blood circulation, so as to help remove blood stasis and open the meridians; the two medicines are matched as the main ingredients, which can tonify the spleen and eliminate dampness, eliminate blood stasis and open the meridians, and are aimed at the basic pathogenesis of gout caused by spleen deficiency and excessive dampness, and turbid blood stasis blocking the meridians.

[0016] The auxiliary drugs are Atractylodes macrocephala, Polygonum cuspidatum, Clematidis, Angelica dahurica, Plantago seed, mulberry twig, Qinpi and Tangerine peel. Atractylodes macrocephala is sweet, bitter and warm, and can invigorate the spleen and replenish qi, dry dampness and promote diuresis; Polygonum cuspidatum is bitter and cold, can promote bile and reduce jaundice, clear away heat and detoxify, disperse blood stasis and relieve pain; Clematidis is pungent, salty and warm, can dispel rheumatism and dredge meridians; Angelica dahurica is pungent, bitter and slightly warm, can dispel wind and dampness, relieve numbness and relieve pain; Plantago seed is sweet and cold, can clear heat, promote diuresis and relieve stranguria, penetrate dampness and stop diarrhea; mulberry twig is slightly bitter and flat, can dispel rheumatism and benefit the joints; Qinpi is bitter and astringent, cold in nature, can clear heat and dry dampness, astringe and stop dysentery; Tangerine peel is bitter, pungent and warm, can regulate qi and invigorate the spleen, dry dampness and resolve phlegm, and together they help the main drugs to invigorate the spleen and remove dampness, resolve blood stasis and stop numbness.

[0017] With mistletoe, chuanxiong, honeysuckle, Caulis Sinomenii, Caulis Trachelospermi, Caulis Piperis, Tuyuan and Panax notoginseng powder as adjuvants. Mulberry, bitter, sweet and flat, enters the liver and kidney meridians, dispels rheumatism, nourishes the liver and kidney, and strengthens the tendons and bones; Caulis chuanxiong, pungent and warm, has the effects of promoting blood circulation and promoting qi, dispelling wind and relieving pain, and can also be used to control the cold nature of other medicines; honeysuckle is sweet and cold, clears away heat and detoxifies, soothes wind and dredges the meridians, and is mostly used for rheumatic heat arthralgia, red, swollen, hot and painful joints; Caulis Sinomenii, bitter, pungent and flat, dispels rheumatism, dredges the meridians, and promotes urination; Caulis Trachelospermi, bitter and slightly cold, dispels wind and dredges the meridians, cools blood and reduces swelling; Caulis Piperis, pungent, bitter and slightly warm, dispels wind and dampness, dredges the meridians and relieves pain. "Compendium of Materia Medica" says: vine-based medicines are "all vines that can dredge the meridians and enter the meridians", "vines relax tendons and veins, and branches reach the limbs". Chinese medicines based on rattan are good at moving along the meridians. Multiple rattan medicines can be used together to achieve the effect of synergistic enhancement and multiple benefits at one stroke. They can also lead other medicines directly to the affected area and relieve the symptoms of joint redness and swelling. Earthworms are salty, cold, and slightly toxic. They can break blood and remove blood stasis, and fix tendons and bones. Panax notoginseng powder is sweet, slightly bitter, and warm. It can disperse blood stasis and stop bleeding, and relieve swelling and pain. Roasted licorice is used as a messenger. It is sweet and flat. It can nourish the spleen and replenish qi, relieve urgency and stop pain, and is used to harmonize various medicines. The combination of various medicines can play the effects of strengthening the spleen, removing dampness, removing turbidity, and promoting blood circulation, removing blood stasis, and unblocking the meridians.

[0018] The more specific Chinese and Western medicine mechanisms for each medicine are as follows:

[0019] Smilax glabra: sweet, neutral in nature, enters the liver, spleen and stomach meridians, first recorded in "Yunnan Materia Medica", formerly known as Yu Yuliang. "Zhongshan Jing" says: "Smilax glabra can strengthen the spleen and stomach, remove rheumatism, spleen and stomach are healthy, the body's defense system is in good condition, and rheumatism is removed, the tendons and bones are healthy." This product has the functions of detoxification and dehumidification, strengthening the spleen and stomach, and promoting joints. Modern pharmacological studies have shown that Smilax glabra can improve patients' pain tolerance, inhibit T cell function, relieve the onset of inflammatory reactions in patients, and improve the body's circulation function, and has the effect of promoting blood circulation and relieving pain. Smilax glabra has a variety of effective ingredients, among which resveratrol has an inhibitory effect on the activity of xanthine oxidase (XOD), which can enhance the body's antioxidant capacity, reduce the catabolism of purines, and thus inhibit uric acid production; it can also relieve inflammation by activating sirtuin regulator 1 (SIRT1), inhibiting the transcription of NF-κB and AP-1, and downregulating the expression of a variety of inflammation-related factors; total flavonoids can inhibit inflammatory reactions by inhibiting the activation of the NLRP3 inflammasome axis and reducing the expression of downstream inflammatory factors.

[0020] Ze Lan: Spicy, bitter, slightly warm, enters the liver and spleen meridians. "Rihuazi Zhujia Bencao" says: "Ze Lan opens the nine orifices, benefits the joints, nourishes blood and qi, breaks up old blood, and eliminates symptoms and masses..." The main effects are promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncle, and also has the effect of promoting diuresis and reducing swelling, promoting diuresis and eliminating dampness to eliminate turbidity, breaking up blood and nourishing blood to dredge the meridians, and has excellent effects on the symptoms of dampness, turbidity and blood stasis. Ze Lan's active ingredient, isozelanflavin, can effectively inhibit the overexpression of renal connective tissue growth factor (CTGF) and nuclear factor κB (NF-κB), and promote the expression of cell growth factor and vascular endothelial growth factor, thereby playing a role in protecting the kidney, protecting the kidney, and anti-inflammatory.

[0021] Atractylodes: sweet, bitter, warm in nature, enters the spleen and stomach meridians, has the functions of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. "Changsha Yaojie" records that Atractylodes "tonifies the middle and dries dampness, quenches thirst and produces body fluid, is most beneficial to the spleen essence, and greatly nourishes the stomach qi..." Studies have confirmed that the atractylodes lactone in Atractylodes has anti-inflammatory and antioxidant effects.

[0022] Polygonum cuspidatum: bitter, cold, enters the liver, gallbladder, and lung meridians, has the effects of promoting bile and relieving jaundice, clearing away heat and detoxifying, dispersing blood stasis and relieving pain, relieving cough and reducing phlegm, and is often used as a drug treatment for acute gout attacks, and is effective in relieving pain symptoms. Modern research has confirmed that resveratrol, the active ingredient in Polygonum cuspidatum, promotes uric acid excretion and protects the kidneys by regulating renal organic ion receptors, and can also improve toe swelling; Rhein can reduce the deposition of crystals in gouty arthritis joints and has a certain degree of improvement on arthritis; Polygonum cuspidatum extract can also reduce blood uric acid levels and inhibit xanthine oxidase activity, thereby inhibiting oxidation and inflammatory reactions, and improving the pathological changes of gouty arthritis.

[0023] Clematis: pungent, salty, warm, belongs to the bladder meridian, good at removing rheumatism and unblocking meridians. Treats stubborn arthritis, gout, cold pain in the waist and knees, accumulation of lumps and masses, etc. "Pharmaceutical Chemistry" states: "Clematis is fierce and quick, good at moving but not staying, and unblocks the twelve meridians. It mainly treats wind, dampness, phlegm, and stagnation in the meridians, causing gout, joint pain, or swelling, or numbness." The Tang Dynasty's "Haishang Jiyan Fang" also states: "Clematis, removes all winds and unblocks the twelve meridians." Clematis alcohol extract can significantly reduce serum urea nitrogen, urine albumin, urine albumin excretion rate, renal hypertrophy index, and significantly reduce the thickening and expansion of glomerular basement membrane and renal tubules. It can play an anti-inflammatory and analgesic role by inhibiting inflammatory factors, inhibiting signal pathways, and immunosuppression; Clematis total saponins can inhibit foot swelling and play an anti-inflammatory activity.

[0024] Duhuo: pungent, bitter, slightly warm, enters the kidney and bladder meridians. Duhuo is pungent, dispersing, bitter and dry, slightly warm and can clear the body. It mainly disperses the internal wind and cold dampness and clears the joints to relieve pain. It has the effects of dispelling wind and dampness, relieving numbness and relieving pain. Duhuo alcohol extract can improve the swelling of joints and inflammatory damage, inhibit the release of inflammatory factors such as TNF-α, IL-1β, IL-6, and has obvious anti-inflammatory, detumescent and analgesic effects.

[0025] Plantago: sweet, cold, enters the liver, kidney, lung, small intestine meridians. "Shennong's Herbal Classic" states that this product "relieves pain, promotes urination, and removes dampness and arthritis". It mainly contains phenylethanoid glycosides, flavonoids, cyclopentane and polysaccharides, which have the effects of clearing heat, promoting diuresis, and removing dampness and relieving stranguria. Modern pharmacological studies have found that chemical components in plantago, such as verbascoside, have an inhibitory effect on XOD, can increase the excretion of uric acid by promoting the excretion of urine, significantly reduce the patient's blood uric acid (UA) level, and inhibit the secretion of inflammatory factors. It has a certain therapeutic effect on gout, and is safe for use in anti-gout.

[0026] Mulberry branch: slightly bitter, neutral, belongs to the liver meridian, can dispel rheumatism and benefit joints. Mulberry branch extract can significantly reduce serum uric acid levels and increase uric acid excretion within 24 hours; and mulberry branch extract with resveratrol as the main ingredient can significantly downregulate a variety of inflammatory mediators and has a good anti-inflammatory effect.

[0027] Qinpi: bitter, astringent, cold, enters the liver, gallbladder, and large intestine meridians, can clear away heat and dampness, astringe and stop diarrhea, stop leukorrhea, and improve eyesight. Studies have confirmed that Qinpi coumarin has analgesic effects on acute gouty arthritis, can inhibit joint swelling, reduce the amount of joint cavity effusion, reduce joint capsule tissue, synovial tissue congestion, edema, degeneration and necrosis, and lymphocyte and neutrophil infiltration and other pathological changes, and can also reduce blood uric acid.

[0028] Tangerine peel: bitter, pungent, warm, enters the lung and spleen meridians, has the functions of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It was first recorded in "Shennong's Herbal Classic", and "Compendium of Materia Medica" said: "It regulates the middle and fast diaphragm, guides stagnation and eliminates phlegm, promotes diuresis and breaks symptoms, promotes the five internal organs, and cures all diseases, all of which are due to its function of regulating qi and drying dampness." Modern research has confirmed that Sichuan tangerine peel can relieve acute kidney injury and relieve pain through antioxidant, anti-inflammatory, anti-apoptotic and other effects.

[0029] Mulberry parasite: bitter, sweet, neutral, enters the liver and kidney meridians, has the effects of removing rheumatism, nourishing the liver and kidney, and strengthening the bones and muscles. The "Rihuazi Bencao" says that this product "helps the bones and muscles, and benefits the blood vessels", and can treat both the symptoms and the root causes when treating gout. Studies have shown that the extract of Mulberry parasite significantly promotes the vitality of human primary osteoarticular chondrocytes acted by IL-1β and reduces the apoptosis rate; its active ingredient quercetin can reduce the inflammatory hyperplasia of the ankle synovium and bone / cartilage destruction, and inhibit the inflammatory response.

[0030] Chuanxiong: pungent, warm, enters the liver, gallbladder, and pericardium meridians. It is a blood Qi medicine that can promote blood circulation and Qi, remove blood stasis, and has the effect of dispelling wind and relieving pain. "Rihuazi Bencao" says: Chuanxiong "treats all wind, all Qi, all strain, and all blood. It replenishes the five labors, strengthens the tendons and bones, regulates all meridians, breaks up the blood, nourishes the heart blood, and grows flesh." Chuanxiong can both promote blood circulation and activate blood circulation, and promote blood circulation with Qi. When blood reaches the end of the limbs, numbness, coolness, and pain stop. Chuanxiong decoction has the effect of inhibiting the central nervous system, so it can have analgesic effect. Modern pharmacological research has found that Chuanxiong contains ligustrazine, alkaloids, phenolic substances, visfatin and other ingredients, which have the effects of dilating microvessels, anti-platelet aggregation, improving microcirculation, anti-inflammatory analgesia and neuroprotection.

[0031] Honeysuckle: Sweet in taste, cold in nature, enters the lung and stomach meridians. Its sweet and cold nature can clear away heat and detoxify, and can also promote blood circulation, relieve pain, and act on symptoms such as redness, swelling, heat, pain, and difficulty in flexion and extension of joints. Modern pharmacological studies have found that the active ingredients in honeysuckle have anti-inflammatory and antipyretic effects, and the luteolin in honeysuckle inhibits platelet aggregation, prevents thrombosis, and increases blood flow.

[0032] Caulis Sinomenii: bitter, pungent, neutral in nature, enters the liver and spleen meridians, dispels rheumatism, dredges meridians, and promotes urination. It is used for rheumatic pain, joint swelling, paralysis and itching. Sinomenine is the most abundant compound in Caulis Sinomenii, which has analgesic and anti-inflammatory effects. Clinical use has found that sinomenine can effectively relieve joint inflammation and inhibit osteoclast damage to bone. In addition, Caulis Sinomenii also contains chemical components such as triterpenes, volatile oils, phenanthroquinone anthraquinone and phenols, which have pharmacological effects such as anti-inflammatory, analgesic, anti-inflammatory, and immunosuppressive.

[0033] Trachelospermum erythrorhizome: bitter and slightly cold, it enters the heart, liver and kidney meridians, dispels wind, dredges the meridians, cools blood and reduces swelling. It is recorded in "Compendium of Materia Medica": "Trachelospermum erythrorhizome has a mild smell, and its functions are to treat wind-heat carbuncle and swelling of tendons, bones and joints, and to whiten and resist aging." Trachelospermum erythrorhizome mainly consists of luteolin, stigmasterol, ibogaine and oleasterol, which can reduce cartilage degeneration and play an anti-inflammatory role by controlling and reducing the appearance of multiple inflammatory mediators and basic matrix degradation.

[0034] Kadzus pulsatilla: pungent, bitter, slightly warm, and enters the liver meridian. This product was first seen in the Ming Dynasty's "Ren Zhai Zhi Zhi Fu Yi Fang Lun". It has the functions of dispelling wind and dampness, unblocking meridians and relieving pain. It is mainly used to treat wind-cold dampness arthralgia, limb pain, tendon spasm, and flexion and extension difficulties. Modern pharmacological studies have confirmed that Kadzus pulsatilla can reduce serum uric acid levels and reduce plantar swelling; Kadzus pulsatilla n-butanol extract can reduce the expression of NF-κB, IκB and IκK in synovial tissue and the content of TNF-α, IL-6, and IL-8 in serum and synovial tissue, thereby achieving analgesic and anti-inflammatory effects.

[0035] Earthworm: salty, cold, slightly toxic, enters the liver meridian. This product is salty and cold and enters the blood, and is good at moving around. It can break up blood and remove blood stasis, eliminate stagnation and promote menstruation. Modern pharmacological research shows that earthworm extract and water-extracted alcohol precipitation have the effects of anti-thrombosis and thrombus dissolution respectively; the extract can inhibit platelet aggregation and adhesion rate, and reduce the number of aggregations.

[0036] Panax notoginseng powder: sweet, slightly bitter, warm in nature, enters the liver and stomach meridians, has the effects of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain. This product has a two-way regulatory effect of "stopping bleeding without leaving stasis, and promoting blood circulation without hurting new blood", which can restore capillary permeability, increase venous tension, improve local microcirculation, promote the decrease of plasma-lymphatic barrier permeability, and relieve swelling.

[0037] Roasted Licorice: sweet, neutral, 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 urgency and relieves pain, and harmonizes various medicines. Modern research shows that licorice contains a variety of chemical components, such as glycyrrhizic acid, glycyrrhetinic acid, glycyrrhizic acid polysaccharide, etc., which have anti-inflammatory and anti-allergic effects and can improve the body's immune function.

[0038] Furthermore, the inventors have rationally optimized the above-mentioned drug components and finally obtained the following technical solution: The main components of the drug are calculated by weight:

[0039] 30 parts of Smilax glabra, 30 parts of Herba Eupatorii, 20 parts of Atractylodes macrocephala, 15 parts of Polygonum cuspidatum, 15 parts of Radix Clematidis, 15 parts of Radix Angelicae Pubescentis, 30 parts of Herba Taxillae Sinensis, 12 parts of Semen Plantaginis, 15 parts of Rhizoma Chuanxiong, 20 parts of Caulis Loniceraes, 20 parts of Caulis Sinomenii, 20 parts of Caulis Trachelospermi, 20 parts of Caulis Piperis Kadsuriae, 20 parts of Ramulus Mori, 9 parts of Cortex Qinpi, 12 parts of Pericarpium Citri Reticulatae, 12 parts of Tuyuan, 3 parts of Notoginseng Powder, 6 parts of Radix Glycyrrhizae Preparata.

[0040] Based on the above drug composition, the inventor further provides the following preparation and administration methods:

[0041] Firstly weigh out various Chinese medicines, among which Panax notoginseng powder will be taken later. Except for Panax notoginseng powder, add water to the remaining medicines until the surface of the medicine is covered by 3-5 cm. Soak for 1.5-2 hours. Boil over high heat, then simmer for 40-50 minutes. Filter out the medicine juice for later use. Add water to the residue again until the surface of the residue is covered by 1-2 cm. Boil over high heat, then simmer for 20-30 minutes. Filter out the medicine juice and combine it with the above-mentioned medicine juice to obtain the Chinese medicine decoction. Add Panax notoginseng powder when taking it.

[0042] Preferably, the Plantain Seed is decocted in a wrapped bag. The Plantain Seed is wrapped in a cloth bag and then decocted with other medicines. This is because the Plantain Seed contains mucus and is very sticky. If it is not "wrapped and decocted", it will easily become gelatinized, which will not only stick to the bottom of the pot, but also make the medicine liquid turbid and difficult to take.

[0043] Dosage: 1 dose per day, divided into morning and evening, taken warm 1-2 hours after meals.

[0044] The medicine obtained by the prescription and preparation method of the present invention is applied to clinical practice, and the curative effect is very significant. The inventor has proved through a large number of experiments that compared with the currently commonly used gout treatment medicine etoricoxib tablets, the pharmaceutical composition of the present invention has a significant curative effect, has significant advantages in reducing uric acid levels, improving clinical symptoms such as pain, and improving the quality of life of patients, and has a low recurrence rate. Therefore, the technical scheme of the present invention has obvious advantages from theory to clinical effect. In actual conditions, the prescription of the present invention can be selected for use in conjunction with Western medicine (such as etoricoxib tablets).

[0045] In summary, the present invention is based on Duhuo Jishe Decoction combined with Wuteng Yin, combined with traditional Chinese medicine theory, and based on the theory of disease-symptom combination, a Chinese medicine composition specifically for the treatment of gout is obtained, which can strengthen the spleen to replenish qi, eliminate turbidity and make qi flow, and when qi is full, blood can flow, and when blood flows, the collaterals are also unblocked. The combination of various medicines can play the role of strengthening the spleen, eliminating dampness and turbidity, promoting blood circulation, removing blood stasis and dredging collaterals, and has remarkable effects on reducing uric acid, improving symptoms such as gout pain, and improving the quality of life of patients. DETAILED DESCRIPTION

[0046] The present invention is not limited by the following embodiments. The following embodiments and descriptions are only for illustrating the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may be subject to various changes and improvements, and these changes and improvements all fall within the scope of the present invention to be protected.

[0047] In the following prescription, the plantain seeds are wrapped and decocted. The plantain seeds are wrapped in a cloth bag and then decocted with other medicines.

[0048] Example 1

[0049] A Chinese medicine composition for treating gout, prepared from the following medicines:

[0050] Smilax glabra 30g, Eupatorium fortunei 30g, Atractylodes macrocephala 20g, Polygonum cuspidatum 15g, Clematidis 15g, Angelica dahurica 15g, Viscum album 30g, Plantago seed 12g, Ligusticum chuanxiong 15g, Honeysuckle 20g, Caulis Sinomenii 20g, Trachelospermum officinale 20g, Caulis Piperis 20g, Morus alba 20g, Qinpi 9g, Tangerine peel 12g, Earthworm 12g, Panax notoginseng powder 3g, and roasted Licorice root 6g.

[0051] The preparation method is as follows:

[0052] (1) First, weigh out all the Chinese medicinal materials according to the ratio of the raw materials, except for Panax notoginseng powder, mix them evenly, and add 1200 ml of cold water to soak the plantago seeds in a cloth bag for 1.5 hours;

[0053] (2) Boil the mixed raw materials over high heat, simmer over low heat for 45 minutes, and filter through gauze to obtain the filtrate and residue;

[0054] (3) mixing the residue obtained in step (2) with 550 ml of hot water and boiling the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, boiling the mixture over low heat for 25 minutes, and filtering the mixture again with gauze to obtain a filtrate and the residue;

[0055] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed, and Panax notoginseng powder is added when taking the mixture to obtain a Chinese medicine decoction for treating gout.

[0056] Example 2

[0057] A Chinese medicine composition for treating gout, prepared from the following medicines:

[0058] Smilax glabra 30g, Zedoaria 25g, Atractylodes macrocephala 15g, Polygonum cuspidatum 12g, Clematidis 12g, Angelica dahurica 12g, Viscum album 20g, Plantago seed 9g, Ligusticum chuanxiong 12g, Honeysuckle 20g, Caulis Sinomenii 20g, Trachelospermum officinale 20g, Caulis Piperis 15g, Morus alba 15g, Qinpi 6g, Tangerine peel 9g, Earthworm 9g, Panax notoginseng powder 3g, and roasted Licorice root 3g.

[0059] The preparation method is as follows:

[0060] (1) Weigh out all the Chinese medicinal materials according to the ratio of raw materials, except for Panax notoginseng powder, mix them evenly, and add 900 ml of cold water to soak the plantago seeds in a cloth bag for 1.5 hours;

[0061] (2) Boil the mixed raw materials over high heat, simmer over low heat for 40 minutes, and filter through gauze to obtain the filtrate and residue;

[0062] (3) mixing the residue obtained in step (2) with 400 ml of hot water and boiling the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, boiling the mixture over low heat for 20 minutes, and filtering the mixture again with gauze to obtain a filtrate and the residue;

[0063] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed, and Panax notoginseng powder is added when taking the mixture to obtain a Chinese medicine decoction for treating gout.

[0064] Example 3

[0065] A Chinese medicine composition for treating gout, prepared from the following medicines:

[0066] 40g of Smilax glabra, 40g of Zedoaria, 25g of Atractylodes macrocephala, 20g of Polygonum cuspidatum, 20g of Clematidis, 20g of Angelica dahurica, 40g of Viscum album, 15g of Plantago seed, 20g of Ligusticum chuanxiong, 30g of Honeysuckle vine, 30g of Caulis Sinomenii, 30g of Trachelospermum jasminoides, 25g of Caulis Piperis dahurica, 30g of Morus alba, 9g of Qinpi, 15g of Citrus reticulata, 15g of Earthworm, 5g of Panax notoginseng powder, and 9g of roasted Licorice root.

[0067] The preparation method is as follows:

[0068] (1) Weigh out all the Chinese medicinal materials according to the ratio of raw materials, except for Panax notoginseng powder, mix them evenly, and add 1500 ml of cold water to soak the plantago seeds in a cloth bag for 1.5 hours;

[0069] (2) Boil the mixed raw materials over high heat, simmer over low heat for 50 minutes, and filter through gauze to obtain the filtrate and residue;

[0070] (3) mixing the residue obtained in step (2) with 600 ml of hot water and boiling the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, boiling the mixture over low heat for 30 minutes, and filtering the mixture again with gauze to obtain a filtrate and the residue;

[0071] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed, and Panax notoginseng powder is added when taking the mixture to obtain a Chinese medicine decoction for treating gout.

[0072] Example 4

[0073] A Chinese medicine composition for treating gout, prepared from the following medicines:

[0074] Smilax glabra 35g, Zedoaria 35g, Atractylodes macrocephala 25g, Polygonum cuspidatum 18g, Clematidis 18g, Angelica dahurica 18g, Viscum album 35g, Plantago seed 15g, Ligusticum chuanxiong 18g, Honeysuckle 25g, Caulis Sinomenii 25g, Trachelospermum jasminoides 25g, Caulis dahuricae 25g, Caulis Piperis 25g, Morus alba 25g, Cortex qinpi 12g, Citrus reticulatae 15g, Earthworm 15g, Panax notoginseng powder 4g, and roasted liquorice root 8g.

[0075] The preparation method is as follows:

[0076] (1) Weigh out all the Chinese medicinal materials according to the ratio of raw materials, except for Panax notoginseng powder, mix them evenly, and add 1300 ml of cold water to soak the plantago seeds in a cloth bag for 1.5 hours;

[0077] (2) Boil the mixed raw materials over high heat, simmer over low heat for 50 minutes, and filter through gauze to obtain the filtrate and residue;

[0078] (3) mixing the residue obtained in step (2) with 600 ml of hot water and boiling the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, boiling the mixture over low heat for 30 minutes, and filtering the mixture again with gauze to obtain a filtrate and the residue;

[0079] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed, and Panax notoginseng powder is added when taking the mixture to obtain a Chinese medicine decoction for treating gout.

[0080] Experimental example

[0081] 1. Clinical data

[0082] 1.1 Source of research subjects and sample size:

[0083] Study subjects: Outpatients and inpatients of the Department of Endocrinology of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from June 2019 to December 2022. 50 patients who met the case criteria were selected and divided into a treatment group and a control group according to the random number table method, with 25 cases in each group. The relevant data results before treatment, 7 days of treatment, and 14 days of treatment were recorded, and the observation treatment time was 14 days.

[0084] 1.2 Diagnostic criteria:

[0085] 1.2.1 Western medicine diagnostic criteria:

[0086] The diagnostic criteria for gout established by the American College of Rheumatology (ACR) in 1977 are as follows:

[0087] (1) There are specific urate crystals in the joint fluid.

[0088] (2) Use chemical methods or polarized light microscopy to confirm that tophi contain sodium urate crystals.

[0089] (3) Six of the following 12 items (clinical, laboratory, and X-ray manifestations) are present: ① Acute arthritis attack > 1 time. ② Inflammatory manifestations reach a peak within 1 day. ③ Attack of monarthritis. ④ Visible redness of the joint. ⑤ Pain or swelling of the first metatarsophalangeal joint. ⑥ Unilateral involvement of the first metatarsophalangeal joint. ⑦ Unilateral involvement of the tarsal joint. ⑧ Suspected tophi. ⑨ Hyperuricemia. ⑩ Asymmetric intra-articular swelling (confirmed by X-ray). Subcortical cysts without bone erosion (confirmed by X-ray). Negative microbial culture of joint fluid during the arthritis attack. The diagnosis can be confirmed if any of the above items (1)(2)(3) are met.

[0090] 1.2.2 TCM diagnostic criteria

[0091] ① Most of the cases occur in a single toe joint, with sudden redness, swelling and pain, which gradually becomes more severe like a tiger bite, with symptoms such as mild during the day and severe at night, and repeated attacks, which may be accompanied by fever, headache, etc.

[0092] ② More common in middle-aged and elderly men, who may have a family history of gout. It is often caused by fatigue, overeating, excessive intake of high-purine foods, drinking, and exogenous colds.

[0093] ③ Initially, the disease may occur in a single joint, most commonly the first metatarsophalangeal joint. Then the ankle, heel, fingers and other small joints may become red, swollen, hot and painful, and even the joint cavity may leak fluid. After repeated attacks, "lumps" (tophus) may appear around the joints, the auricle, the helix, and the toes and phalanges.

[0094] ④ Increased uric acid in blood and urine. The total white blood cell count may increase during the attack.

[0095] ⑤ If necessary, perform renal B-ultrasound detection, urine routine, renal function tests, etc. to understand the status of post-gouty renal lesions. X-ray examination: It can show irregular perforated circular defects in the bone adjacent to the joint at the edge of the cartilage.

[0096] 1.2.3 Diagnostic criteria for TCM syndromes The diagnostic criteria for spleen deficiency, dampness and blood stasis syndromes are determined by referring to the TCM industry standard of the People's Republic of China, "Diagnosis and Efficacy Criteria for TCM Diseases and Syndromes" (ZY / T001.1-94), and "Practical TCM Rheumatology", as follows:

[0097] Main symptoms: redness, swelling and tingling in the joints of the limbs, or no obvious pain, local swelling, deformation, numbness, and difficulty in flexion and extension. Secondary symptoms: fatigue, dizziness, headache, skin and nails, thirst but no desire to drink, decreased appetite, abdominal distension,

[0098] Loose stools.

[0099] Tongue and pulse: The tongue is dull or has ecchymosis, the tongue coating is white or yellow greasy, the pulse is deep and thin or stringy and slippery.

[0100] The diagnosis of spleen deficiency, dampness excess and blood stasis can be made based on the main symptoms and any 3 secondary symptoms + tongue and pulse.

[0101] 1.3 Case selection criteria

[0102] 1.3.1 Inclusion criteria:

[0103] (1) Those who meet the diagnostic criteria for gout and TCM syndromes;

[0104] (2) Complete clinical data, including at least general condition, medical history, clinical symptoms, and prescribed medications;

[0105] (3) The main clinical symptom is gout. If other diseases are present, these other diseases should be in a relatively stable state;

[0106] (4) 18 ≤ ≤ 65 years old, regardless of gender;

[0107] (5) Have normal language communication and thinking abilities;

[0108] (6) Informed consent and voluntary participation in the study.

[0109] 1.3.2 Exclusion criteria

[0110] (1) Those who meet the diagnostic criteria for dual syndromes;

[0111] (2) Pregnant or lactating women;

[0112] (3) Patients who cannot take medication regularly due to various reasons, cannot judge the efficacy, or have missing medical records;

[0113] (4) Patients with other osteoarthritis diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other severe osteoarthritis;

[0114] (5) Patients with contraindications to NSAIDs such as those with severe cardiovascular, liver, kidney and hematopoietic system diseases;

[0115] (6) Patients with mental illness;

[0116] (7) Patients with secondary gout.

[0117] 1.3.3 Shedding Standard

[0118] (1) Those who have serious adverse events or complications and are not suitable for further treatment;

[0119] (2) The subjects had poor compliance, using less than 80% of the prescribed amount or more than 120% of the prescribed amount;

[0120] (3) those who voluntarily withdrew from treatment or were lost to follow-up;

[0121] (4) Those who have not completed the entire course of treatment, which affects the judgment of efficacy or safety;

[0122] (5) The data are incomplete, which affects the judgment of effectiveness and safety.

[0123] 1.3.4 Treatment of dropout cases

[0124] (1) When a subject drops out, the researcher should contact the subject as much as possible to ask for the reason and complete the assessment items as much as possible;

[0125] (2) All dropped out cases were required for the statistics of the full analysis set, and there was no need to replace the dropped out patients.

[0126] 1.3.5 Elimination (termination) criteria

[0127] (1) Serious adverse reactions or adverse events such as allergies occurred during the observation period, making it difficult to continue treatment;

[0128] (2) If the condition worsens during the course of the disease, the patient will be treated as an ineffective case;

[0129] (3) Serious deviations occurred during the implementation of the clinical trial protocol;

[0130] (4) The subject requests to withdraw from the clinical trial.

[0131] 2. Research Methods

[0132] 2.1 Study Design:

[0133] Fifty eligible gout patients were selected, and the patients were numbered using SPSS25.0 statistical software. They were randomly divided into a control group and a treatment group with 25 cases in a 1:1 ratio. The experimental group and the control group were treated with different methods for 14 days, and the clinical effects before and after treatment were observed. The basic information of the patients was collected, including: demographic characteristics including gender and age. Medical history characteristics: time of first onset, first site, first symptom, course of disease, past history, drinking history, smoking history, family history, previous treatment (excluding whether it is secondary gout), etc.

[0134] 2.2 Treatment methods

[0135] 2.2.1 Basic treatment: ① No smoking, no drinking; ② No food with high purine content (such as seafood, mutton, etc.); ③ Exercise regularly, avoid strenuous exercise or sudden cold; ④ Reduce the amount of fructose-rich drinks; ⑤ Drink more than 2000ml of water per day; ⑥ Control weight; ⑦ Eat more fresh vegetables; ⑧ Eat and rest regularly. 2.2.2 Group treatment:

[0136] (1) Control group:

[0137] The patient was given basic treatment and oral administration of 120 mg of the nonsteroidal anti-inflammatory drug etoricoxib tablets (trade name Ankangxin, 5 tablets / box, 60 mg each tablet, national medicine standard number H2018027, Via Complutense 14028805 Alcala De Henares Madrid, Spain) once a day.

[0138] (2) Experimental group:

[0139] The patient was given basic treatment and the pharmaceutical composition of Example 1 was taken (the prescription and process of Example 1 were used to decoct 200 ml of the medicinal solution, which was taken warm twice a day, morning and evening, 100 ml each time).

[0140] The observation period for both the control group and the experimental group was 14 days, followed by regular follow-up to understand the improvement of patients' subjective symptoms and laboratory tests before and after treatment, and to record their adverse reactions and recurrences.

[0141] 2.3 Observation indicators

[0142] The VAS scores of joint pain, joint tenderness, joint swelling, skin color of affected joints, joint skin temperature, degree of joint function limitation, joint pain relief time, fever degree, thirst degree, uric acid, erythrocyte sedimentation rate, and CRP of the two groups of patients before and after treatment.

[0143] 1) Joint pain VAS score:

[0144] 0 points: No pain

[0145] 0-3 points: Mild pain, which basically does not affect the patient's work and life

[0146] 4-6 points: The patient has pain that affects sleep and has a slight impact on life, but can still be tolerated

[0147] 7-10 points: The patient has gradually stronger pain, which is unbearable and affects appetite and sleep.

[0148] 2) Joint tenderness index:

[0149] 0 points: no tenderness

[0150] 1 degree (1 point): Slight pain when pressing hard

[0151] 2 degrees (2 points): Pain is felt with slight pressure

[0152] 3rd degree (3 points): obvious tenderness, cannot be touched

[0153] 3) Joint swelling index:

[0154] 0 points: no swelling

[0155] 1st degree (1 point): Slight swelling, the joint texture becomes shallow, the swelling does not exceed the nearby bone prominence, and the bony mark of the joint is

[0156] Zhi Mingxian

[0157] Grade 2 (2 points): Moderate swelling, the swelling is level with the nearby bone prominence, and the skin texture disappears

[0158] Grade 3 (3 points): Severe swelling, tight skin, swelling above nearby bony prominences or diffuse swelling

[0159] 4) Skin color index of affected joints:

[0160] 0 points: Normal skin color

[0161] 1 degree (1 point): pale skin, slightly red

[0162] 2 degrees (2 points): The skin is red and the color is obvious

[0163] 3 degrees (3 points): Bright red skin, shiny skin

[0164] 5) Skin temperature index:

[0165] 0 points: Normal skin temperature

[0166] 1 degree (1 point): No noticeable heat

[0167] 2 degrees (2 points): Slightly hot to the touch

[0168] 3 degrees (3 points): obviously hot to the touch

[0169] 6) Joint Mobility Index:

[0170] 0 points: No restriction on movement

[0171] 1 degree (1 point): Mild limitation, but can still engage in normal activities

[0172] 2 degrees (2 points): Obvious limitation, unable to engage in normal activities, can take care of oneself

[0173] Grade 3 (3 points): Severe limitation, can only lie in bed or sit or lie down

[0174] 7) Pain relief time: record the time when the patient feels that the pain is significantly relieved (in hours)

[0175] 8) Fever index:

[0176] 0 points: <37.0℃

[0177] 1 degree (1 minute): 37.0-37.9℃

[0178] 2 degrees (2 minutes): 38.0-38.9℃

[0179] 3 degrees (3 minutes): 39.0-39.9℃

[0180] 9) Thirst score:

[0181] 0 points: No thirst

[0182] 1 degree (1 point): Mild thirst

[0183] 2 degrees (2 points): Thirst, relieved by drinking

[0184] 3 degrees (3 points): Severe thirst, which is not significantly relieved by drinking

[0185] 10) Laboratory indicators: UA, ESR, and CRP at different time points during treatment.

[0186] Note: Tongue and pulse are important diagnostic bases for syndromes and are not included in the scoring.

[0187] 2.4 Criteria for determining disease efficacy

[0188] Refer to the "Guidelines for Clinical Research of New Chinese Medicines" formulated in 2002:

[0189] Markedly effective: The overall improvement rate of major symptoms and signs is ≥70%. Uric acid, erythrocyte sedimentation rate, and CRP are normal or significantly improved or close to normal.

[0190] Effective: Overall improvement rate of main symptoms and signs ≥30%. Uric acid, erythrocyte sedimentation rate, and CRP have improved or not improved. Ineffective: Overall improvement rate of main symptoms and signs ≤30%. Uric acid, erythrocyte sedimentation rate, and CRP have not improved.

[0191] Note: The main symptoms and signs refer to the clinical symptoms observed by joint pain and all TCM syndrome scores. The overall improvement rate refers to the percentage of improvement of joint VAS scores, TCM syndrome scores and other indexes, that is, the average value of [(pre-treatment value - post-treatment value) / pre-treatment value × 100%) after adding them together.

[0192] 2.5 Disease recurrence rate

[0193] Eight weeks after the end of treatment, patients were followed up for disease recurrence and the clinical recurrence rate was recorded.

[0194] 2.6 Safety evaluation

[0195] Before and after treatment, routine blood and urine tests, liver function, and kidney function were tested, and the patient's subjective symptoms, such as headache, dizziness, nausea, vomiting, irregular menstruation, etc., were observed, and other adverse reactions during the treatment were recorded at any time.

[0196] 2.7 Statistical analysis

[0197] SPSS 27.0 statistical software was used for statistical analysis. The t test was used for normal distribution, and the rank sum test was used for non-normal distribution. The joint pain scores and clinical biochemical indicators of the two groups during the treatment were statistically analyzed by multiple measurement analysis of variance and multivariate analysis of variance; the rank sum test was used for the ranked data; the chi-square test was used for the count data 2 If P < 0.05, the difference is statistically significant; if P < 0.01, the difference is statistically significant; if P > 0.05, the difference is not statistically significant.

[0198] 3 Results and analysis

[0199] 3.1 General Information

[0200] A total of 50 gout patients who met the observation criteria were included in this clinical study, including 25 in the experimental group (24 males and 1 female), and 25 in the control group (23 males and 2 females).

[0201] Table 1 Distribution of general information of the two groups

[0202]

[0203] The chi-square test with continuity correction showed that there was no statistical difference in gender between the two groups (P>0.05); the age of the two groups conformed to the normal distribution and variance homogeneity, and there was no significant difference after t-test, P>0.05.

[0204] 3.2 Comparison of pain VAS scores between the two groups before and after treatment

[0205] Table 2 Pain VAS scores of the two groups before and after treatment

[0206]

[0207] The test results of the VAS score of joint pain in the two groups of patients before treatment showed that P=0.173>0.05, with no significant difference. The test results of the data before and after treatment in the experimental group showed that P<0.01, with significant difference; the test results of the data before and after treatment in the control group showed that P<0.01, with statistical difference; the test results of the data after treatment in the two groups showed that P<0.01, with significant statistical difference.

[0208] 3.3 Comparison of inflammatory indicators between the two groups before and after treatment

[0209] Table 3 Comparison of inflammatory indicators between the two groups before and after treatment

[0210]

[0211] The CRP data test results of the two groups of patients before treatment showed that P = 0.308 > 0.05, with no significant difference. The CRP data test results of the experimental group before and after treatment showed that P < 0.01, with statistical difference; the CRP data test results of the control group before and after treatment showed that P < 0.01, with statistical difference; the test results of the two groups after treatment showed that P < 0.01, with significant difference. The ESR data test results of the two groups before treatment showed that P = 0.845 > 0.05, with no significant difference. The ESR data test results of the experimental group before and after treatment showed that P < 0.01, with significant difference; the ESR data test results of the control group before and after treatment showed that P = 0.06 > 0.05, with no statistical significance; the data test results of the two groups after treatment showed that P = 0.932 > 0.05, with no significant difference.

[0212] 3.4 Comparison of serum uric acid levels between the two groups before and after treatment

[0213] Table 4 Comparison of serum uric acid between the two groups before and after treatment (μmol / L)

[0214]

[0215] The test results of blood uric acid data before treatment in the two groups showed that P=0.244>0.05, with no significant difference. The test results of blood uric acid data before and after treatment in the experimental group showed that P<0.01, with significant statistical difference; the test results of blood uric acid data before and after treatment in the control group showed that P<0.01, with statistical difference; the test results of data after treatment in the two groups showed that P<0.01, with significant difference.

[0216] 3.5 Comparison of TCM syndrome scores between the two groups before and after treatment

[0217] Table 5 Comparison of TCM syndrome scores between the two groups before and after treatment

[0218]

[0219] After treatment, the joint single item scores (joint tenderness, joint swelling, skin color, skin temperature, and range of motion) in the TCM syndrome sub-items of the two groups of patients were significantly improved, and there were differences in the comparison of each single item between the experimental group and the control group before and after treatment (P < 0.01). The degree of fever (P = 0.245) and thirst (P = 0.687) in the control group after treatment did not change significantly compared with before treatment, and the difference was not statistically significant (P> 0.05); the degree of fever and thirst in the experimental group after treatment were significantly reduced compared with before, with statistical significance (P < 0.01). The above results show that both groups can reduce joint tenderness, joint swelling, skin color, skin temperature, and range of motion symptoms, and the experimental group can also effectively improve the symptoms of fever and thirst in patients.

[0220] 3.6 Clinical efficacy of the two groups

[0221] Table 6 Clinical symptoms and efficacy

[0222]

[0223] After 14 days of treatment, the total effective rate of the experimental group was 96%, and the total effective rate of the control group was 76%. The experimental group was compared with the control group, and the one-way sequential contingency table data were tested using non-parametric test, Z=-2.017, P=0.044<0.05, and the difference was statistically significant.

[0224] 3.7 Clinical recurrence rate in the two groups

[0225] Table 7 Comparison of clinical recurrence rate

[0226]

[0227] Eight weeks after the end of treatment, 2 patients in the experimental group relapsed, with a relapse rate of 8%, and 7 patients in the control group relapsed, with a relapse rate of 28%. The difference between the experimental group and the control group was statistically significant (P<0.01). (See Table 7)

[0228] 3.7 Drug Safety Evaluation

[0229] Before and after treatment, the vital signs, urine routine, liver and kidney functions of patients in the experimental group and the control group were normal.

[0230] The specific details of adverse reactions are as follows: During the treatment process of this study, there were no adverse reactions in the treatment group; 5 patients in the control group developed abdominal distension and poor appetite, which the patients could tolerate and relieve on their own, and no special treatment was given. The total adverse reactions accounted for about 16%.

[0231] Specific cases

[0232] Case 1

[0233] Patient Cao, male, 46 years old. Chief complaint: right knee swelling and pain for 5 days. Current medical history: The patient reported that he went to a local hospital for treatment due to pain in both knees 8 years ago. The blood uric acid showed 536μmol / L and was diagnosed with gout. The patient had swelling and pain in the right knee 5 days ago without obvious cause, accompanied by redness, swelling and pain in the first metatarsal on the right side. The symptoms worsened at night. He took diclofenac sodium by himself, which was generally effective, with poor appetite and sleep, yellow urine, and regular stool. Red tongue with thick and greasy yellow fur, and stringy pulse. Past history: 8 years of gout history, 2 years of hypertension history, and 10 years of fatty liver history. Physical examination: The patient's right knee was red and swollen, the local skin was hot, the joint movement was mildly stiff, and the floating patella test was (-). Laboratory tests: blood uric acid 542μmol / L, CRP: 23.2mg / L, ESR: 60mm / 60min. (Visited at the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine on August 30, 2019). Syndrome differentiation: gout-damp-heat accumulation syndrome. Prescription: 30g of Smilax glabra, 30g of Zedoariae, 20g of Atractylodes macrocephala, 15g of Polygonum cuspidatum, 15g of Clematidis, 15g of Angelica dahurica, 30g of Parasitic loranthus, 12g of Plantago, 15g of Ligusticum chuanxiong, 20g of Caulis lonicerae, 20g of Caulis cyrtonemae, 20g of Caulis trachelospermi, 20g of Caulis kauri, 20g of Morus alba, 9g of Cortex qinpi, 12g of Citrus reticulatae, 12g of Earth Yuan, 3g of Radix Notoginseng powder, 6g of Radix Glycyrrhizae Preparata, according to the Chinese medicine decoction obtained by the preparation method of Example 1, 1 dose of 200ml per day, warmed twice in the morning and evening, and washed into Radix Notoginseng powder when taking, 100ml each time, 7 pairs. In addition, drink plenty of water every day, have a light diet, avoid high-purine diet, pay attention to rest and keep warm.

[0234] 2019.9.6 Second visit: The patient's pain was significantly relieved after taking the medicine for more than 1 day. The swelling and pain of the right knee has been reduced, and the pain in the first metatarsal on the right side has been significantly relieved compared with before. There is still mild swelling, the skin temperature is slightly higher, the skin color has darkened, the sleep has improved, the appetite is good, the urine color is slightly yellow, the stool is regular, the tongue is red and the coating is yellow and greasy, and the pulse is stringy. Recheck the blood uric acid: 491mmol / L, CRP: 15.4mg / L, ESR: 52mm / 60min. The above prescription was continued for 7 doses.

[0235] 2019.9.13 Third visit: No redness, swelling, heat or pain in local joints, no restriction of movement, and daily activities can be carried out. Appetite and sleep are good, bowel movements are normal, tongue is red with yellow-white fur, and pulse is weak and stringy. Re-examination of blood uric acid: 480mmol / L, CRP: 8.2mg / L, ESR: 31mm / 60min. The above prescription was continued for 7 doses. Two weeks later, the patient's symptoms disappeared and laboratory indicators returned to normal.

[0236] Case 2

[0237] Patient Wang, male, 28 years old. Chief complaint: swelling and pain in the first metatarsophalangeal joint of the right foot for 1 day. Current medical history: The patient had excessive seafood consumption and drinking 2 days ago, and the first metatarsophalangeal joint of the right foot was swollen and painful in the early morning yesterday. A few hours later, the local skin was red and hot, the joint was swollen, and the pain was severe and unbearable, but no diagnosis and treatment was given. Current symptoms: The first metatarsophalangeal joint of the right foot is obviously swollen, the skin color is bright red and shiny, the skin temperature is high, and the self-reported pain is severe and unbearable, which worsens at night. The pain makes it difficult to sleep all night, the tenderness is obvious, and it cannot be touched, and the movement is limited. No fever, usually less water intake, dry mouth, can be relieved after drinking water. Accompanied by abdominal distension, occasional choking and hiccups, poor appetite, no nausea, acid reflux. Yellow urine, loose stools, 3 rows a day, red tongue, enlarged tongue, slippery pulse. Previously healthy, denied family history of genetic diseases, denied allergies. Blood uric acid: 551mmol / L, CRP: 23.1mg / L, ESR: 61mm / 60min. The rest (-). (2020.10.2 visited the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine). Syndrome differentiation: gout-damp heat accumulation syndrome. 30g of Smilax glabra, 30g of Ze Lan, 20g of Atractylodes macrocephala, 15g of Polygonum cuspidatum, 15g of Clematidis, 15g of Angelica dahurica, 30g of Viscum album, 12g of Plantago, 15g of Ligusticum chuanxiong, 20g of Honeysuckle vine, 20g of Caulis Sinomenii, 20g of Trachelospermum officinale, 20g of Caulis Piperis chinensis, 20g of Caulis Piperis marissima, 20g of Morus alba, 9g of Qinpi, 12g of Chenpi, 12g of Tuyuan, 3g of Panax notoginseng powder, 6g of roasted licorice, according to the Chinese medicine decoction obtained by the preparation method of Example 1, 1 dose of 200ml per day, warm twice in the morning and evening, and add Panax notoginseng powder when taking it, 100ml each time, 5 pairs. Also advise you to drink plenty of water every day, eat a light diet, avoid high-purine foods, and pay attention to rest and keep warm.

[0238] 2020.10.7 Second visit: The patient's pain was significantly relieved after taking the medicine for 2 days. The swelling of the first metatarsophalangeal joint of the right foot is now significantly relieved compared with before, but there is still mild swelling, slightly higher skin temperature, slight pain, mild pressure pain, darker skin color, and cannot stand for a long time. Abdominal distension is slightly relieved, appetite is still good, slightly thirsty, slightly yellow urine, loose stools, 2 times a day. The tongue is red with thin yellow fur, the tongue is fat, and the pulse is slippery and rapid. Recheck blood uric acid: 500mmol / L, CRP: 16.6mg / L, ESR: 49mm / 60min. Continue to take 7 packs of the above.

[0239] 2020.10.14 Third visit: No redness, swelling, heat or pain in local joints, no restriction of movement, daily activities can be carried out. No abdominal distension, occasional belching after meals. Good appetite and sleep, occasional loose stools, once a day. Red tongue with white coating, enlarged tongue, deep and rapid pulse. Rechecked blood uric acid: 478mmol / L, CRP: 8.4mg / L, ESR: 40mm / 60min. Continue to take 7 sets of the above. Follow-up two weeks later showed that the patient's symptoms disappeared and laboratory indicators returned to normal.

[0240] It can be seen that the Chinese medicine composition obtained by the present invention for treating gout has a total effective rate of 96%, a relapse rate of 8%, and a significant therapeutic effect. The Chinese medicine composition for treating gout provided by the present invention strengthens the spleen to replenish qi, eliminates turbidity and promotes qi circulation, qi is full and blood is circulated, and blood circulation is also unblocked. The combination of various medicines can play the functions of strengthening the spleen, eliminating dampness and turbidity, promoting blood circulation, removing blood stasis and unblocking collaterals, and has remarkable effects on reducing uric acid, improving symptoms such as gout pain, and improving the quality of life of patients.

Claims

1. A Chinese medicine composition for treating gout, characterized in that: The components are calculated by weight: 25-35 parts of Smilax glabra, 25-35 parts of Zedoaria, 15-25 parts of Atractylodes macrocephala, 12-18 parts of Polygonum cuspidatum, 12-18 parts of Clematidis, 12-18 parts of Angelica dahurica, 25-35 parts of Viscum album, 10-15 parts of Plantago seed, 12-18 parts of Ligusticum chuanxiong, 20-25 parts of Honeysuckle vine, 20-25 parts of Caulis Sinomenii, 20-25 parts of Trachelospermum jasminoides, 20-25 parts of Caulis Piperis, 15-25 parts of Morus alba, 7-12 parts of Cortex qinpi, 10-15 parts of Citrus reticulata, 10-15 parts of Earthworm, 2-4 parts of Panax notoginseng powder and 3-8 parts of roasted Licorice root.

2. A Chinese medicine composition for treating gout according to claim 1, characterized in that: The components are calculated by weight: 30 parts of Smilax glabra, 30 parts of Zedoaria, 20 parts of Atractylodes macrocephala, 15 parts of Polygonum cuspidatum, 15 parts of Clematidis, 15 parts of Angelica dahurica, 30 parts of Viscum album, 12 parts of Plantago, 15 parts of Ligusticum chuanxiong, 20 parts of Honeysuckle Caulis, 20 parts of Caulis Sinomenii, 20 parts of Trachelospermum jasminoides, 20 parts of Caulis Piperis, 20 parts of Morus alba, 9 parts of Cortex qinpi, 12 parts of Citrus reticulata, 12 parts of Earthworm, 3 parts of Panax notoginseng powder, and 6 parts of roasted Licorice root.

3. A method for preparing a Chinese medicine composition for treating gout according to claim 1 or 2, characterized in that: The specific steps are as follows: first weigh each Chinese medicine, except for Panax notoginseng powder, add water to the remaining medicine until the surface of the medicine is 3-5 cm above the medicine surface, soak for 1.5-2 hours, boil over high heat, then simmer for 40-50 minutes, filter out the medicine juice for later use; add water to the residue again, until the surface of the residue is 1-2 cm above the medicine residue, boil over high heat, then simmer for 20-30 minutes, filter out the medicine juice and combine it with the above-mentioned medicine juice to obtain the Chinese medicine decoction, and add Panax notoginseng powder when taking it.

4. A method for preparing a Chinese medicine composition for treating gout according to claim 3, characterized in that: The plantain seeds are wrapped and fried.

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