A traditional Chinese medicine composition for treating gout

Abstract

The present invention provides a pharmaceutical composition for treating gout. The composition is composed of multiple Chinese medicinal materials such as goldenseal root and white atractylodes macrocephala. The composition is used to treat gout attacks by clearing and tonifying the spleen and stomach, promoting qi circulation, and activating meridians and strengthening tendons. The composition has significant effects and is suitable for promotion and application.

Description

Technical Field

[0001] The present invention relates to a clinical empirical medicine for treating gout, exploring the treatment of gout from the perspective of "clearing and nourishing the spleen and stomach, promoting qi circulation, and activating collaterals and strengthening tendons", and has achieved significant therapeutic effects in clinical application, belonging to the field of application of traditional Chinese medicine. Background Art

[0002] Gout refers to a group of diseases caused by abnormal purine metabolism, characterized by elevated blood uric acid, recurrent attacks of characteristic acute arthritis, and the deposition of tophi. It primarily affects middle-aged and elderly men with a favorable diet and a small number of postmenopausal women. The primary pathology of gout is the deposition of urate crystals (MSU) in various body tissues, particularly in the joints and kidneys, and the disease has a long course.

[0003] With the continuous improvement of people's living standards, gout has become a globally intractable disease, listed by the World Health Organization (WHO) as one of the top ten intractable diseases of the 21st century. In addition to causing endless pain for patients, gout also increases their financial burden and psychological stress, resulting in a waste of social resources. Therefore, active treatment and preventive measures for gout have received increasing attention from many doctors.

[0004] With the deepening of modern understanding of gout, the exploration of its pathogenesis has become clearer from vague, and the academic classification of gout has been reduced from traditional rheumatic disease to autoinflammatory disease.

[0005] The pathological basis of gout is hyperuricemia (HUA). Hyperuricemia is caused by a disorder in purine metabolism, resulting in overproduction and / or underexcretion of uric acid, leading to plasma urate saturation. When the concentration exceeds 420 µmol / L, it is considered hyperuricemia. HUA may be clinically asymptomatic, known as asymptomatic hyperuricemia. However, approximately 10% of patients develop characteristic acute arthritis, leading to a diagnosis of gout. Clinically, gout is characterized by hyperuricemia, recurrent attacks of characteristic acute arthritis, tophi deposition, kidney damage, and uric acid stone formation.

[0006] The diagnosis of gout requires a comprehensive assessment of the patient's clinical presentation, serum uric acid levels, and imaging studies. Currently, the most widely used criteria are the latest gout diagnostic criteria proposed by the American College of Cardiology (ACR) and the European Union for the Advancement of Health (EULAR) in 2015. These criteria stipulate that a patient with a score ≥ 8 and who has excluded the possibility of secondary gout can be diagnosed. The diagnostic criteria for HUA, on the other hand, involve fasting serum uric acid levels measured on two separate days while on a normal purine diet. Hyperuricemia is defined as a level above 420µmol / L in men and above 360µmol / L in women.

[0007] The basic treatment for gout is drug therapy and surgical treatment. Currently, the treatment drugs for acute gout are clinically effective very quickly, but most of them have certain side effects, among which gastrointestinal damage, liver and kidney damage, and allergic reactions to xanthine oxidase inhibitors are the most common. This requires clinicians to analyze the patient's current situation when using them, carefully consider the patient's tolerance and compliance, and strive for the safest, most effective, and most friendly treatment plan. Because most of the current Western medicine treatments for this disease lack radical measures, the main treatment goals pursued in clinical practice include: quickly and effectively terminating the onset of acute arthritis; preventing the recurrence of acute gouty arthritis; correcting hyperuricemia; preventing the formation of uric acid stones, etc. Therefore, in-depth exploration of potential target genes for the treatment of gout and seeking safer, more effective, widely applicable, and less toxic and side-effect drug treatments have become research hotspots and difficulties that Western medicine urgently needs to solve.

[0008] Traditional Chinese Medicine (TCM) has a wealth of theoretical knowledge and practical experience in understanding gout. Currently, many physicians focus on joint lesions in gout research. However, the joint lesions of gout are not the entirety of gout, but only the tip of the iceberg. Gout research must be considered within the framework of general internal medicine. Physicians should strengthen research beyond joint lesions, starting with traditional TCM theory and focusing on the Yingwei Qi, meridians, spleen and stomach, and dampness. This will promote in-depth research on joint lesions in gout, building on the work of predecessors to achieve a more systematic and complete understanding of gout and take clinical diagnosis and treatment to a higher level.

[0009] Gout is caused by insufficient human constitution, spleen and kidney deficiency, irregular diet, excessive drinking and sex, imbalance of the seven emotions, dampness and turbidity blocking the middle body, heat accumulation and phlegm, turbidity and stickiness, and invasion of wind, cold, dampness and heat, which lead to disharmony of qi and blood, reversal of ascending and descending, dampness and heat flowing into the meridians, and qi and blood blocking the joints, which further develops and evolves. Summary of the Invention

[0010] The formulation concept of the pharmaceutical composition of the present invention emphasizes that dietary factors are the key to the development of gout. It is believed that the basic pathogenesis of this disease is a fatty and sweet diet, which leads to dysfunctional spleen function, stagnation of damp heat, and coagulation of dampness in the joints. It has the pathological characteristics of "originating in the middle burner, flowing to the lower burner, and affecting the lower limbs" and "starting from the spleen and stomach and ending in the liver and kidneys." It is proposed that gout should be named "tongfengbi" and that the syndrome differentiation and treatment should be based on the spleen and stomach theory. The prescriptions and medications selected for the clinical treatment of gout are light, lively, gentle and mellow. Commonly used prescriptions include Simiao San, Xuanbi Tang, Guizhi Shaoyao Zhimu Tang, Duhuo Jisheng Tang, Taohong Siwu Tang, Shuanghe Tang, Sanren Tang, and Leipu Xialing Tang, which are modified according to the symptoms. The treatment is skillful and skillful, and the effects of tea and external washes are used to gradually eliminate gout.

[0011] Currently, many physicians focus on joint pathology in gout research. However, joint pathology in gout is not the entirety of gout, but rather just the tip of the iceberg. Gout research must be considered within the framework of general internal medicine. Physicians should strengthen their research beyond joint pathology, drawing on traditional Chinese medicine theory to explore the relationship between nutrient and defensive qi, meridians, the spleen and stomach, and dampness. This will further enhance research on joint pathology in gout, building on the work of previous researchers to achieve a more systematic and comprehensive understanding of gout and elevate clinical diagnosis and treatment.

[0012] Gout is caused by insufficient human endowment, spleen and kidney deficiency, irregular diet, excessive drinking and sex, imbalance of the seven emotions, dampness and turbidity blocking the middle body, heat accumulation and phlegm, turbidity and stickiness, and invasion of wind, cold, dampness and heat, which lead to disharmony of qi and blood, reversal of ascending and descending, dampness and heat flowing into the meridians, and qi and blood blocking the joints, which further develops and evolves.

[0013] The spleen and stomach, located in the central region, are the source of qi and blood production and the foundation of acquired constitution. The kidneys, located in the lower jiao, are the foundation of innate constitution, responsible for fluid metabolism and containing primordial yin and yang. If a patient consumes alcohol excessively, consumes excessive soups and greasy foods, or overindulges in rich and spicy foods, the heat of the qi can suffocate, causing turbid fluids to flow and overflow. This internal dampness damages the spleen and stomach, impairing digestion and metabolism. Damp heat accumulates, causing phlegm to obstruct the body, and disrupting the ascending and descending of qi, leading to various pathological conditions. Excessive sexual activity, especially when intoxicated, can deplete one's essence and dissipate one's true energy, sapping the vital energy at the gate of life. This hinders the influx of qi, leading to a disharmony between clear and turbid energy, disrupting fluid metabolism, and allowing turbid and toxic phlegm to accumulate in the lower jiao, obstructing the flow of vital energy. This can not only trigger the primary disease but also symptoms such as stranguria, pain, and vomiting.

[0014] Gout is generally more common among the wealthy than among the poor. This is because the wealthy live in excess and overwork, leading to internal weakness, weak tendons, brittle bones, and delicate internal organs. The poor, however, live in meager living arrangements and overwork, leading to internal strength, strong bones, and strong tendons, and robust internal organs. The wealthy often live in spacious mansions, their crypts open to the six pathogens; the poor live in humble alleys and thatched huts, their weeds densely planted, making it difficult for external pathogens to enter. Therefore, gout is a common ailment of the wealthy, and its treatment should combine tonifying the body's internal organs with attacking pathogenic factors. Obese individuals are prone to dampness, while those who indulge in rich food and drink are prone to phlegm. A body with excess phlegm and dampness, at the age of yin qi reaching its zenith, can, if long-term dietary restrictions, such as a fondness for smoking and alcohol, lead to imbalanced internal organ function and a failure of qi to ascend and descend. Deficiency of the spleen and kidneys, coupled with excess phlegm and dampness, weakens the kidneys' ability to regulate water, leading to a thick stomach qi and a weak spleen qi. A weak spleen qi is unable to circulate fluids for the stomach, while a thick stomach qi leads to accumulation of sores and fever. Therefore, the pathological changes of such patients often involve internal retention of water and dampness, damp-heat obstruction, and turbid blood stasis. Although there are excess symptoms on the outside, the inside is deficiency symptoms of spleen and kidney deficiency. Once they are attracted by external evil, they are often trapped in the middle earth, and the dryness and health fail to separate the clear and the turbid, resulting in phlegm, blood heat and blood stasis blocking the meridians and joints, making it difficult to discharge and blood and qi cannot be circulated.

[0015] Gout presents with diverse clinical manifestations, often with sudden onset of redness, swelling, heat, and pain. The pain is quiet during the day and flares up at night. When it does occur, it penetrates the marrow, causing a sharp, agonizing pain that can lead to unsettled cries and unsettling cries, all manifestations of damp-heat. Long-lasting, recurrent attacks often lead to joint deformities, accumulation of phlegm, and damage to tendons and bones. Once a swelling ruptures, it oozes greasy fluid and persists, forming ulcers. If damp-heat attacks internally, severe symptoms such as constipation and constipation may develop. Therefore, the clinical diagnosis and treatment of gout is often based on a staged approach.

[0016] For chronic gout, the approach should be to address the underlying causes of deficiency of the body's vital essence and excess of pathogenic factors, as well as the complexities of cold and heat. Treating both the symptoms and the root cause simultaneously, the key approach is to strengthen the spleen and eliminate dampness, tonify the kidneys and unblock the meridians, and dispel wind and alleviate pain. The inventors believe that gout often originates from the spleen and kidneys, and that the onset of gout is also related to the spleen and kidneys, so treatment should prioritize their function. In the human body, the generation of dampness and turbidity is most closely linked to the spleen and kidneys. Young patients with initial gout often present with simple spleen deficiency, dampness and heat, and obstructed meridians. Elderly patients with recurrent, persistent gout often experience kidney deficiency, along with dampness stagnation and spleen dysfunction. Therefore, treatment of chronic gout should prioritize regulating the spleen and kidneys. Maintaining smooth spleen and kidney function prevents dampness and dampness from causing harm, embodying the saying, "When vital energy remains within, pathogenic factors cannot enter."

[0017] While local joint swelling and redness are not noticeable in gout patients during remission, they experience soreness and swelling that hinders walking, and pain that interferes with sleep, which worsens on cloudy, rainy, or foggy days. Patients often experience a preference for warmth and aversion to cold, fatigue, poor appetite, abdominal distension, soreness in the waist and knees, or gout stones and nodules on the fingertips, toes, and auricles. A thin, white or slippery tongue and a deep, stringy, and wiry pulse are also common symptoms. Analysis suggests that this is often due to spleen deficiency and excessive dampness, dampness obstructing the middle burner, impaired ascending and descending function, and liver and kidney deficiency. Dampness that originates externally is caused by the rising of earthly qi; dampness that originates internally is caused by the stagnation of spleen yang qi; and prolonged, chronic disease affecting the kidneys is caused by deficiency of vital energy and spleen and kidney insufficiency. Therefore, the inventors modified Yupingfeng Powder with Fangyi Fuling Decoction to develop a prescription for gout during remission that strengthens the spleen and eliminates dampness, tonifies the kidneys and dredges the meridians, and dispels wind and relieves pain.

[0018] This prescription is designed to strengthen Qi and Yin, invigorate the spleen and stomach, regulate Qi flow and eliminate dampness and turbidity, and benefit the liver and kidneys and strengthen the bones and muscles. It combines strengthening and nourishing properties with mild, penetrating properties, avoiding warming, drying, and harsh ingredients. This allows the gentle spring breeze to transform into gentle rain, achieving its desired effect. The inventors noted that for patients with chronic gout characterized by spleen and kidney deficiency and concurrent damp-heat, tonic herbs often require larger doses, such as Atractylodes macrocephala and Gentiana chinensis root, while herbs that promote lifting, dispersing, and opening the body, such as Paeonia lactiflora and Alisma orientalis, often require smaller doses. These crucial points, combined with the inventors' ingenuity and meticulous consideration, represent the key points of their combined use. Targeting the pathological characteristics of acute gout attacks characterized by spleen deficiency and damp-heat, this prescription primarily focuses on clearing the lungs and spleen, dispelling dampness and turbidity, and clearing heat and reducing swelling, supplemented by kidney-tonifying, collateral-draining, and wind-clearing and pain-relieving methods.

[0019] The pharmaceutical composition for treating gout provided by the present invention is prepared from the following raw materials in parts by weight:

[0020] 20-40 parts of gentian root, 5-20 parts of white atractylodes, 5-20 parts of siler, 5-20 parts of fangji

[0021] 10-30 parts of Chinese yam, 5-20 parts of red peony root, 10-30 parts of late silkworm excrement, 10-30 parts of Millettia reticulata.

[0022] 5-20 parts of Rhizoma Alismatis, 5-20 parts of Radix Dichroae, 10-30 parts of Cibotium barometz, and 10-30 parts of Radix Clematidis.

[0023] Preferably, the composition of the present invention is prepared from the following raw materials in parts by weight:

[0024] 20 parts of gentian root, 20 parts of white atractylodes, 5 parts of siler, 20 parts of stephania tetrandra

[0025] 10 parts of Smilax glabra, 20 parts of red peony root, 10 parts of late silkworm excrement, 30 parts of Millettia reticulata

[0026] 5 parts of Rhizoma Alismatis, 20 parts of Radix Dichroae, 10 parts of Cibotium barometz, and 30 parts of Radix Clematidis.

[0027] Preferably, the composition of the present invention can also be prepared from the following raw materials in parts by weight:

[0028] 30 parts of genus chinensis, 12 parts of atractylodes macrocephala, 9 parts of siler, 10 parts of fangji

[0029] 20 parts of Chinese yam, 10 parts of red peony root, 15 parts of late silkworm excrement, 15 parts of Millettia reticulata

[0030] 9 parts of Rhizoma Alismatis, 12 parts of Radix Dichroae, 15 parts of Cibotium barometz, and 15 parts of Radix Clematidis.

[0031] Preferably, the composition of the present invention can also be prepared from the following raw materials in parts by weight:

[0032] 35 parts of genus chinensis, 10 parts of atractylodes macrocephala, 10 parts of siler, 20 parts of fangji

[0033] 30 parts of Chinese yam, 5 parts of red peony root, 20 parts of late silkworm excrement, 20 parts of Millettia reticulata

[0034] 15 parts of Rhizoma Alismatis, 10 parts of Radix Dichroae, 20 parts of Cibotium barometz, and 20 parts of Radix Clematidis.

[0035] In the composition of the present invention, the Atractylodes macrocephala is stir-fried Atractylodes macrocephala, and the Radix Dichroae is Radix Dichroae serratae.

[0036] The composition of the present invention can be prepared into a preparation dosage form of capsules, tablets, pills, powders, sprays or ointments.

[0037] The gout treated by the composition of the present invention is gout of spleen deficiency and dampness, dampness obstruction in the middle jiao, and liver and kidney deficiency type.

[0038] The gout treated by the composition of the present invention is preferably in the remission stage of gout.

[0039] The invention also discloses application of the composition in preparing diuretic drugs.

[0040] In the formula, the root of golden brook is neutral in nature, pungent and bitter in taste, enters the lung and spleen meridians, clears the lungs and benefits the spleen, promotes blood circulation and dredges the meridians, and is the main medicine; the stir-fried white atractylodes is warm in nature, sweet and bitter in taste, enters the spleen and stomach meridians, invigorates qi and strengthens the spleen, dries dampness and promotes diuresis; the windproof is slightly warm in nature, pungent and sweet in taste, dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain and spasms; the powdered stephania is cold in nature, pungent and bitter in taste, dispels wind and relieves pain, promotes diuresis and reduces swelling; the wild smilax is neutral in nature, sweet and light in taste, detoxifies and removes dampness, and dredges the joints; the late silkworm sand is warm in nature and sweet in taste, enters the spleen, stomach and liver meridians, harmonizes the stomach, dries dampness and resolves turbidity; the coix seed is neutral in nature and bitter in taste, enters the stomach and kidney meridians, promotes dampness and removes The herbal formulas are: Radix Atractylodes, Radix Stephaniae, Radix Smilacis Glabrae, and Radix Trichosanthis. They are used to invigorate the spleen and dispel dampness; Radix Alisma is cold in nature, sweet and light in taste, and can dissipate water and dampness, dispel turbidity, purge heat, dissipate turbidity and reduce lipids. Together with Radix Saposhnikoviae, they can invigorate the spleen and dissolve dampness, dispel wind and relieve pain, and serve as assistant herbs. Red Peony Root is slightly cold in nature, bitter in taste, clears heat and cools blood, disperses blood stasis and relieves pain; Cibotium barbata nourishes the liver and kidneys, strengthens the waist and knees; Clematidis has a new dispersing and warming effect, is strong and good at moving, and can circulate the twelve meridians, dispelling rheumatism and activating blood circulation to relieve pain. The above herbs are adjuvant herbs. Millettia reticulata activates blood circulation to relieve pain, dredges meridians, and guides the herbs into the meridians, and serves as guiding herbs. The combination of these herbs aims to strengthen Qi and Yin and invigorate the spleen and stomach, regulate Qi and eliminate dampness and turbidity, benefit the liver and kidneys, and strengthen the tendons and bones. It combines strengthening the body with mild and penetrating herbs, and avoids warm, dry, and harsh herbs. All symptoms of the disease will disappear.

[0041] The Latin names and processing methods of the active ingredients of the compositions of the present invention are from the Chinese Materia Medica Dictionary (first edition, July 1977, Shanghai Science and Technology Press) and the Chinese Pharmacopoeia (2005 edition, Chemical Industry Press). The pharmaceutical compositions of the present invention can be formulated into any conventional pharmaceutically acceptable dosage form, such as capsules, tablets, pills, powders, soft capsules, or ointments, using conventional preparation techniques, for example, those described in Fan Biting's Pharmaceutics of Traditional Chinese Medicine (first edition, December 1997, Shanghai Science Press).

[0042] In the application of the present invention, the pharmaceutical composition is one of capsules, tablets, pills, powders, soft capsules or ointment preparations. In order to realize the above dosage forms, pharmaceutically acceptable excipients need to be added when preparing these dosage forms, such as: fillers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, bases, etc. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agents include: polyvinyl pyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch slurry, polyvinyl pyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: sodium saccharin, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; flavorings include: sweeteners and various flavors; preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroethidine acetate, eucalyptus oil, etc.; matrices include: PEG6000, PEG4000, insect wax, etc. In order to enable the above dosage forms to realize Chinese medicine pharmacy, other pharmaceutically acceptable excipients need to be added when preparing these dosage forms (the excipients recorded for each dosage form in Fan Biting's "Chinese Medicine Pharmacy", Shanghai Science Press, 1st edition, December 1997).

[0043] To demonstrate the efficacy of the composition of the present invention in treating gout, the following clinical trials were conducted using the preparation prepared according to Example 1, which is the inventor's core formula. The inventor has decades of clinical experience in medication and has developed numerous modified formulas for treating gout. The present invention is the most widely used, has the largest audience, and has the best effect.

[0044] Gout is a difficult-to-cure, recurrent metabolic rheumatic disease whose biochemical basis is hyperuricemia. Recurrent attacks of gouty arthritis are its primary clinical feature. In later stages, tophi, gouty nephropathy, uric acid urinary stones, joint dysfunction, and even deformities often develop, leading to the development of chronic gouty arthritis. Many physicians throughout history, such as Yu Tuan, Zhang Jiebin, and You Yi, have attributed the concept of gout to the description of "bi syndrome" in the Yellow Emperor's Classic of Internal Medicine. The text's descriptions of "thief wind" and "Nineteen Pathogenesis" also contribute to our understanding of the nature of gout. For example, "When evil wind and pathogenic qi enter the body, it causes illness... These are all caused by dampness, which is hidden in the blood vessels and between the flesh, and stays there for a long time without leaving. If something falls, the bad blood will not leave. Suddenly, the patient becomes unhappy and angry, eats inappropriately, and experiences cold or heat at irregular times, and the Teng meridians are blocked and not unblocked." This points out that gout involves the blood, and is related to the exposure to dampness, improper diet, and Teng meridian blockage. This suggests that we should remove dampness and activate blood circulation, regulate diet, and open up the Teng meridians to treat gout. In the "Nineteen Articles on Pathogenesis," "All swellings and fullness caused by dampness are related to the spleen," "All pains, itches, and sores are related to the heart," and "All diseases with swelling, pain, soreness, and shock are related to the fire," etc. This suggests that gout is related to internal injuries to the spleen and the infiltration of dampness. In the treatment of swelling and pain, attention should be paid to the use of methods to clear away heart fire and stabilize the heart qi. Traditional Chinese medicine has a relatively deep understanding of gout. Traditional Chinese medicine and Western medicine have different treatment methods for gout. This study used the pharmaceutical composition of the present invention for treatment, and the report is as follows:

[0045] 1 Materials and Methods

[0046] 1.1 General Information

[0047] Sixty patients with chronic gouty arthritis admitted to Hebei Yiling Hospital from January to December 2018 were selected. (1) Inclusion criteria: ① All were adults; ② All had normal liver and kidney function; ③ All met the diagnostic criteria for chronic gouty arthritis. (2) Exclusion criteria: ① History of mental illness; ② Cardiovascular and cerebrovascular disease; ③ Allergy to the medication used. Based on the treatment method, the patients were divided into a control group of 30 and an experimental group of 30. All patients gave informed consent, and the study was approved by the ethics committee.

[0048] 1.2 Methods

[0049] 1.2.1 Treatment of the control group

[0050] All patients quit smoking and drinking, followed a regular low-purine diet, drank more than 2000 ml of water daily, and walked more than 5000 meters slowly daily. Patients with hypertension were given a low-salt diet, those with dyslipidemia were given a low-fat diet, and those with diabetes and impaired glucose tolerance were given a diabetic diet. If the urine pH was <6.0, sodium bicarbonate tablets (Guangzhou Kanghe Pharmaceutical Co., Ltd., national medicine standard number H44021960, 0.5 g / tablet) were given, 3 times a day, 1 g / time; allopurinol tablets (Guangzhou Kanghe Pharmaceutical Co., Ltd., national medicine standard number H44021695, 0.1 g / tablet) were given, 2 to 3 times a day, 0.1 g / time (depending on the uric acid level, to ensure that the blood uric acid level was >200 μmol / L).

[0051] 1.2.2 Treatment of the experimental group

[0052] While maintaining a controlled diet and exercising, the composition of Example 1 was used for treatment. The basic ingredients were: genus chinensis, stir-fried atractylodes macrocephala, saposhnikovia root, stephania tetrandra, smilax glabra, red peony root, late silkworm feces (package), millettia reticulata, oriental dwarf rhizome, radix schizonepetae, cibotrya japonica, and clematis root. The drugs were provided by the hospital. 800ml of water was used to boil 400ml of the above drugs. One dose (200ml each) was taken daily, morning and evening after meals.

[0053] 1.3 Observation indicators and judgment criteria

[0054] (1) Compare the blood uric acid, erythrocyte sedimentation rate, and CRP levels of the two groups of patients before and after treatment. (2) Observe and compare the clinical efficacy of the two groups of patients. The efficacy evaluation criteria are as follows: cured: after treatment, the patient has normal laboratory indicators and joint function, and is completely asymptomatic; markedly effective: after treatment, the patient has basically normal main laboratory indicators and joint function, and has no major symptoms; effective: after treatment, the patient has better main laboratory indicators and joint function, and basically has no major symptoms; ineffective: after treatment, the patient's main laboratory indicators, joint function, and main symptoms have no significant changes. (3) Observe and compare the time it takes for joint pain to disappear and the occurrence of adverse gastrointestinal reactions in the two groups of patients.

[0055] 1.4 Statistical analysis

[0056] SPSS 21.0 software was used to perform statistical analysis on the data. ), t-test was used for comparison between groups, and paired t-test was used for comparison within groups; count data were expressed as rate (%), and chi-square test was used for comparison, with P < 0.05 considered statistically significant.

[0057] 2 Results

[0058] 2.1 Comparison of general information between the two groups

[0059] The experimental group included 27 males (90.0%) and 3 females (10.0%), aged 34 to 66 years (mean, 50.3±8.4) years, with a disease duration of 3 days to 16 years (mean, 9.1±2.4) years. The control group included 25 males (70.0%) and 5 females (16.7%), aged 35 to 67 years (mean, 51.4±8.7) years, with a disease duration of 3 days to 16 years (mean, 9.6±1.5) years. There were no statistically significant differences in the general information between the two groups (P>0.05).

[0060] 2.2 Comparison of serum uric acid, erythrocyte sedimentation rate, and CRP levels between the two groups before and after treatment

[0061] After treatment, the blood uric acid, erythrocyte sedimentation rate, and CRP levels in the two groups were lower than those before treatment, and the experimental group was significantly lower than the control group, with statistically significant differences (P<0.05), see Table 1.

[0062] 2.3 Comparison of clinical efficacy between the two groups of patients

[0063] The total effective rate of the experimental group was 93.3% (28 / 30), which was significantly higher than that of the conventional Western medicine treatment group (70.0% (21 / 30), and the difference was statistically significant (x 2 =14.450, P<0.05), see Table 2.

[0064] 2.4 Comparison of joint pain disappearance time and gastrointestinal adverse reactions between the two groups

[0065] The time it took for joint pain to disappear in the experimental group was significantly shorter than that in the control group, and the difference was statistically significant (P<0.05). The incidence of adverse gastrointestinal reactions in the experimental group was 3.3%, which was not significantly different from 6.7% in the control group (P>0.05), as shown in Table 3.

[0066]

[0067]

[0068]

[0069] 3 Discussion

[0070] At present, Western medicine has not yet elucidated the specific pathogenesis of gout, nor does it have effective methods or medications for preventing and curing the disease. Chronic gouty arthritis is generally treated with drugs such as allopurinol that inhibit uric acid production. However, due to the disadvantage of long-term use, which can damage liver and kidney function, many people cannot adhere to the treatment. Chronic gouty arthritis patients often experience recurrent joint pain and often need to use non-steroidal anti-inflammatory drugs or even hormonal painkillers. Although these drugs can achieve certain results, they can cause severe gastrointestinal reactions and damage the patient's liver and kidney function. At the same time, these drugs cannot effectively control the recurrence of the patient's condition. The long-term benefits of traditional Chinese medicine treatment are significantly better than those of Western medicine.

[0071] Zhu Danxi was the first physician to coin the term "gout." He believed gout to be the same as the "white tiger limb disease" (Baihu Lijie). He elaborated on the symptoms, pathogenesis, and treatment of gout in works such as "Gezhi Yu Lun," "Danxi Shoujing," "Danxi Xinfa," and "Danxi Zhaixuan." For example, "Gezhi Yu Lun·Tongfeng Lun" states: "Gout is generally caused by blood being heated to the point of boiling. Subsequently, the patient may experience wading in cold water, standing in damp places, using a fan to cool themselves, or lying in the wind. The coldness of the body attacks the hot blood, causing it to become turbid and astringent, resulting in pain. The pain is more severe at night, and it circulates in the yin meridians." He believed the pathogenesis is the accumulation of external wind, cold, and dampness on top of blood heat, leading to the obstruction of the meridians by dampness and turbidity. "Danxi Xinfa·Tongfeng" summarizes the pathogenesis of gout attacks as "phlegm-dampness, wind-heat, rheumatism, and blood deficiency." In the process of treating gout, Zhu Danxi creatively combined several methods, including drying dampness and resolving phlegm, harmonizing the middle and regulating qi, and activating blood circulation and unblocking the meridians, by flexibly decomposing and integrating them. He formulated prescriptions such as the Shangzhongxia Tongfeng Fang (General Gout Formula) and Qianxing San (Sneak Powder), striving to accurately grasp the pathogenesis of gout. He incorporated the concept of "damp-heat theory," which states that "damp-heat causes eight out of ten cases of gout," into the entire process of gout treatment. This is reflected in the extensive discussion of Bi syndrome in the Yellow Emperor's Internal Classic, particularly in the Suwen Bi Lun (Discussion on Bi) and the Lingshu Zhou Bi Lun (Discussion on Bi). The main pathogenesis of Bi syndrome, as discussed in the following sections, is that "the three Qis of wind, cold, and dampness coexist and combine to form Bi," and that "wind, cold, and dampness invade the external organs and the flesh," are often emphasized by physicians. They believe that Bi syndrome is primarily related to the invasion of external pathogens into the five organs (tendons, veins, flesh, skin, and bones).

[0072] The inventor agrees with Zhu Danxi's understanding of gout, emphasizing that dietary factors are the key to the occurrence of gout. Mr. Lu believes that the basic pathogenesis of this disease is a fatty and sweet diet, impaired spleen function, stagnation of damp heat, and coagulation of dampness in the joints. It has the pathological characteristics of "originating from the middle burner, flowing to the lower burner, affecting the lower limbs", and "starting from the spleen and stomach, and ending in the liver and kidneys". He proposed that gout should be named "tongfengbi" and based on the spleen and stomach theory for syndrome differentiation and treatment. In the clinical treatment of gout, Mr. Lu selected prescriptions and medicines that are light, lively, gentle and mellow. He often used Simiao Powder, Xuanbi Decoction, Guizhi Shaoyao Zhimu Decoction, Duhuo Jishe Decoction, Taohong Siwu Decoction, Shuanghe Decoction, Sanren Decoction, Leipu Xiajian Decoction, etc. to adapt to the symptoms, and used his skills and wisdom, and used tea and external washes to slowly and gradually grind away the gout stones.

[0073] The medication used in this study's experimental group is primarily designed to bolster qi and yin, strengthen the spleen and stomach, and benefit the liver and kidneys, strengthening the tendons and bones. It avoids warming, drying, and harsh ingredients, allowing the gentle spring breeze to slowly transform into rain, ultimately achieving its desired effect. It uses genus bronchis and stir-fried white atractylodes to tonify qi and yin and nourish the spleen and stomach. When using tonic and strengthening herbs, larger doses are often required. Saposhnikovia divaricata and Stephania tetrandra are used to dispel wind and dampness; Late cane sand (packaged), Smilax glabra, Alisma orientalis, and Codonopsis pilosula are used to dissipate dampness and turbidity; Millettia reticulata and Paeonia lactiflora nourish and activate blood circulation; and Cibotium barometz and Clematis root dredge the meridians, collectively achieving the effects of lifting, dispersing, and opening.

[0074] In summary, the medication used in the experimental group of this study has significant clinical efficacy in the treatment of stable gout and is worthy of clinical promotion and application. DETAILED DESCRIPTION

[0075] Example 1:

[0076] 30g of goldenrod root, 12g of white atractylodes, 9g of stir-fried saposhnikovia root, 10g of Stephania tetrandra.

[0077] 20g of Chinese yam, 10g of red peony root, 15g of late silkworm excrement, and 15g of Millettia reticulata.

[0078] Alisma orientalis 9g, Herba Cyperi 12g, Cibotium barometz 15g, Clemati 15g

[0079] Take 800ml of water to boil the above medicines into 400ml. Take one dose per day, 200ml each time, once in the morning and once in the evening after meals.

[0080] Example 2:

[0081] Golden Sparrow Root 20g, Atractylodes Macrocephala 20g, Saposhnikovia Divaricata 5g, Stephania Tetrandra 20g, Smilax glabra 10g, Paeonia lactiflora 20g

[0082] Late silkworm excrement 10g, Millettia reticulata 30g, Alisma orientalis 5g, Dioscorea 20g, Cibotium barometz 10g, Clemati 30g

[0083] Take 800ml of water to boil the above medicines into 400ml. Take one dose per day, 200ml each time, once in the morning and once in the evening after meals.

[0084] Example 3:

[0085] 35g of ginseng root, 10g of white atractylodes, 10g of siler, 20g of stephania tetrandra

[0086] 30g of Chinese yam, 5g of red peony root, 20g of late silkworm excrement, 20g of Millettia reticulata.

[0087] Alisma orientalis 15g, Radix Dipterocarpa 10g, Cibotium barometz 20g, Clematidis 20g

[0088] Take 800ml of water to boil the above medicines into 400ml. Take one dose per day, 200ml each time, once in the morning and once in the evening after meals.

[0089] Example 4:

[0090] Goldenrod root 28g, Atractylodes macrocephala 15g, Saposhnikovia divaricata 8g, Stephania tetrandra 15g

[0091] Smilax glabra 15g, red peony root 8g, late silkworm excrement 16g, Millettia reticulata 18g

[0092] Alisma orientalis 8g, Radix Dichroae 10g, Cibotium barometz 20g, Clematidis 20g

[0093] Take 800ml of water to boil the above medicines into 400ml. Take one dose per day, 200ml each time, once in the morning and once in the evening after meals.

Claims

1. A pharmaceutical composition for treating chronic gouty arthritis, characterized in that The composition is prepared from the following raw materials in parts by weight: 20-40 parts of goldenrod root, 5-20 parts of stir-fried white atractylodes, 5-20 parts of siler, 5-20 parts of fangji 10-30 parts of Chinese yam, 5-20 parts of red peony root, 10-30 parts of late silkworm excrement, 10-30 parts of Millettia reticulata. 5-20 parts of Rhizoma Alismatis, 5-20 parts of Rhizoma Cynomorii, 10-30 parts of Rhizoma Cibotii, and 10-30 parts of Rhizoma Clematidis.

2. The composition of claim 1, wherein The composition is prepared from the following raw materials in parts by weight: 20 parts of goldenrod root, 20 parts of stir-fried white atractylodes, 5 parts of siler, 20 parts of stephania tetrandra 10 parts of Smilax glabra, 20 parts of red peony root, 10 parts of late silkworm excrement, 30 parts of Millettia reticulata 5 parts of Rhizoma Alismatis, 20 parts of Rhizoma Dioscoreae, 10 parts of Rhizoma Cibotii, and 30 parts of Radix Clematidis.

3. The composition of claim 1, wherein The composition is prepared from the following raw materials in parts by weight: 30 parts of goldenrod root, 12 parts of stir-fried white atractylodes, 9 parts of siler, 10 parts of fangji 20 parts of Chinese yam, 10 parts of red peony root, 15 parts of late silkworm excrement, 15 parts of Millettia reticulata 9 parts of Rhizoma Alismatis, 12 parts of Rhizoma Dioscoreae, 15 parts of Rhizoma Cibotii, and 15 parts of Radix Clematidis.

4. The composition of claim 1, wherein The composition is prepared from the following raw materials in parts by weight: 35 parts of goldenrod root, 10 parts of stir-fried white atractylodes, 10 parts of siler, 20 parts of fangji 30 parts of Chinese yam, 5 parts of red peony root, 20 parts of late silkworm excrement, 20 parts of Millettia reticulata 15 parts of Rhizoma Alismatis, 10 parts of Rhizoma Dioscoreae, 20 parts of Rhizoma Cibotii, and 20 parts of Radix Clematidis.

5. The composition according to any one of claims 1 to 4, characterized in that The composition can be prepared into a preparation dosage form of capsules, tablets, pills, powders, sprays or ointments.

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