A traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome

Abstract

The present invention relates to the field of drugs for treating kidney disease, in particular to the treatment of idiopathic membranous nephropathy. Specifically provided is a traditional Chinese medicine composition for treating damp-heat syndrome of idiopathic membranous nephropathy. The composition is composed of Simiao Powder, silkworm excrement, talcum powder, forsythia, codonopsis pilosula, atractylodes macrocephala, poria, angelica, millettia reticulata, liquorice and other drugs. The composition mainly has the effects of clearing away heat and dampness, strengthening the spleen and replenishing qi, and supplemented by promoting blood circulation and nourishing blood, and invigorating the kidney and consolidating essence. The combination of the drugs has significant therapeutic effects on reducing the patient's proteinuria level, improving idiopathic membranous nephropathy and damp-heat symptoms caused by the use of hormones, and increasing the complete remission rate of membranous nephropathy.

Description

Technical Field

[0001] The present invention relates to the field of drugs for treating kidney disease, and in particular to a traditional Chinese medicine composition for treating damp-heat syndrome of idiopathic membranous nephropathy. Background Art

[0002] Membranous nephropathy (MN) accounts for approximately 30% of primary nephrotic syndrome cases, with approximately two-thirds of these cases having no apparent secondary cause, termed idiopathic membranous nephropathy (IMN). Clinical manifestations include hypoalbuminemia, edema, and heavy proteinuria, with edema and foamy urine being the most typical manifestation.

[0003] According to statistics, the incidence of idiopathic membranous nephropathy now accounts for 25% of glomerular diseases in my country, ranking second and increasing annually. Clinical prognosis for patients with membranous nephropathy varies. Approximately one-third of patients experience spontaneous remission, one-third experience persistent proteinuria, and one-third of patients experience no significant response to steroids or immunosuppressants, progressing to end-stage renal disease within 10-15 years. Once patients reach end-stage renal disease, renal replacement therapy is often required, severely impacting their quality of life and potentially placing a significant financial burden on their families. Therefore, reducing relapses and delaying progression of membranous nephropathy are the primary goals and priorities for the prevention and treatment of IMN.

[0004] The 2012 KDIGO practice guidelines state that, in addition to basic treatment, the treatment of IMN primarily relies on a combination of steroids and immunosuppressants. Lei Gen et al. analyzed the tongue appearance and syndrome patterns of 103 IMN patients and found that IMN patients often had a thick, greasy tongue coating. Patients who used steroids during treatment often had a mixture of yellow and white coating, while those who did not use steroids had a predominantly white coating, but their tongues were enlarged and had tooth marks. This suggests that steroid use can increase damp-heat symptoms and deplete yin fluid. Furthermore, in clinical practice, the inventors have found that some patients with membranous nephropathy treated with steroids and immunosuppressants achieve only partial remission or even no significant efficacy. In some patients, their condition relapses upon reducing the steroid and immunosuppressant dosage.

[0005] A large number of studies have shown that the addition of traditional Chinese medicine or Chinese patent medicine treatment with hormones or immunosuppressants can effectively improve clinical efficacy and reduce adverse reactions. The current Guidelines for the Clinical Application of Traditional Chinese Medicine in the Treatment of Idiopathic Membranous Nephropathy (2021 Edition) strongly recommends traditional Chinese medicines such as tripterygium wilfordii preparations and sunflower sunflower capsules, but there are potential toxic side effects and unstable efficacy during clinical use. Therefore, how to fill the gap in the existing traditional Chinese medicine treatment of idiopathic membranous nephropathy with damp-heat syndrome has become an urgent problem to be solved in clinical treatment, and it is also the direction of research. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the inventors of the present invention, in combination with the traditional Chinese medical theory, from the physiological functions of the spleen and stomach to the basic pathogenesis of idiopathic membranous nephropathy with damp-heat symptoms, combined with clinical practice, found that when using prescriptions based on the principles of clearing heat and dampness, invigorating the spleen and replenishing qi to treat patients with the pathological characteristics of IMN damp-heat syndrome, the urine protein level is significantly reduced, and the side effects of hormones can be alleviated, and the complete remission rate of membranous nephropathy is improved; on this basis, the inventors provide a traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, which is composed of Simiao Powder in combination with silkworm excrement, talcum powder, forsythia, codonopsis, atractylodes, poria, angelica, millettia reticulata, licorice and other medicines, with clearing heat and dampness, invigorating the spleen and replenishing qi as the main treatment methods, while taking into account blood circulation and nourishing blood, invigorating the kidney and consolidating essence, the combination of various medicines, both attacking and replenishing, has significant therapeutic effects on reducing the patient's proteinuria level, improving idiopathic membranous nephropathy and damp-heat symptoms caused by hormone use, and improving the complete remission rate of membranous nephropathy.

[0007] Traditional Chinese Medicine currently considers the fundamental pathogenesis of idiopathic membranous nephropathy (IMN) damp-heat syndrome to be root deficiency with superficial excess, resulting in accumulation of dampness and heat. Clinically, IMN damp-heat syndrome is often characterized by symptoms such as dry mouth, bitter taste in the mouth, abdominal distension, heaviness, fatigue, edema, yellow and foamy urine, and sticky and uncomfortable bowel movements. These manifestations, with pronounced damp-heat manifestations, suggest that spleen deficiency and endogenous dampness and heat are the primary mechanisms underlying IMN damp-heat syndrome.

[0008] The spleen's primary physiological function is transportation and transformation. First, it transforms food and water into refined substances and transports these substances to the body's various organs and tissues. The production of essence, qi, blood, and body fluids all depends on the spleen's healthy transportation. Second, the spleen transports and transforms water and dampness, absorbing and transferring water, and regulating water metabolism to maintain water balance. If the spleen is deficient and its transportation and distribution are impaired, the formation of dampness and dampness is easy. "All swellings and fullness caused by dampness are attributed to the spleen." Dampness is heavy, turbid, and sticky. The spleen prefers dryness and dislikes dampness. Dampness easily traps the spleen. Water, phlegm, and dampness accumulate in the spleen, impairing its transportation and transformation functions and causing dysfunctional water metabolism. When dampness and dampness accumulate internally, they transform into heat over time, leading to the fusion of dampness and heat. The combination of dampness and heat accumulates in the middle and lower parts of the body, blurring the lines between clear and turbid fluids, and easily leading to proteinuria. The fusion of dampness and heat makes it difficult to distinguish between clear and turbid fluids, allowing the tangible evil to stagnate in the organs, meridians, and tissues. Over time, this stagnation of qi and blood leads to stagnation.

[0009] The spleen also has important physiological functions, such as regulating blood and ascending the clear, regulating the body's vital essences, such as qi and blood. A healthy spleen can transport the essence of food and drink to the heart and lungs, nourishing the limbs and bones. If dampness and heat accumulate in the spleen over time, they further damage the spleen, disrupting its proper functioning. Firstly, the spleen fails to regulate blood, causing blood components to escape; secondly, the spleen fails to ascend the clear, causing food and drink to flow downward, leading to proteinuria. Thus, spleen deficiency and dampness and heat interact, acting as a causal force.

[0010] At the same time, the kidney is the innate foundation of the human body and is responsible for storing essence. "The kidney is responsible for hibernation, the basis of storage, and the place where essence is located." Kidney deficiency leads to failure in consolidation and retention, and the lower part of the body is not solid, resulting in excessive loss of essence and fine substances, which can also participate in the formation of proteinuria.

[0011] The root cause of idiopathic membranous nephropathy is spleen deficiency. A spleen deficiency impairs healthy function and the distribution of body fluids is disrupted, which can easily lead to the formation of dampness, which in turn causes edema and sticky, uncomfortable bowel movements. Dampness traps the earth, disrupting the transport and transformation of the middle jiao, disrupting the production and transport of grain essences, and causing poor nourishment of the internal organs and tissues, leading to fatigue, loss of appetite, and other symptoms. If dampness stagnates and persists, it will eventually turn into heat. The combination of dampness and heat depletes body fluids, leading to dryness, bitter taste in the mouth, and scanty, yellow urine. Accumulation of dampness and heat causes the spleen to lose its ability to control and regulate, failing to distinguish between clear and turbid fluids. Excessive excretion of essences can easily lead to proteinuria. A spleen deficiency and the accumulation of dampness and heat can lead to long-term obstruction of the meridians, resulting in a prolonged and unresolved condition in many clinical patients.

[0012] The inventors finally discovered that the treatment of IMN damp-heat syndrome should focus on the main links and main contradictions. Based on this, the inventors believe that clearing away heat and dampness while taking into account the spleen and replenishing qi is the key. In clinical practice, there are many patients with spleen deficiency damp-heat syndrome, so we should pay attention to the relationship between clearing away heat and dampness and strengthening the spleen on the basis of syndrome differentiation and treatment, and take into account both the symptoms and the root causes. When the spleen is sufficient, the spleen's functions of transporting qi, regulating blood, raising the clear and lowering the turbid can be restored. When the qi and blood are sufficient and the water metabolism is normal, it is beneficial for the spleen to control the fine substances, and the protein in the urine can be reduced; at the same time, the dampness and heat are removed, avoiding the spleen deficiency and dampness and heat coagulation that cause the disease to be prolonged and difficult to cure. The above is the treatment mechanism proposed by the inventor. On the basis of the above treatment mechanism, combined with the mechanism of action of relevant drugs, the specific technical solutions provided by the inventor are as follows:

[0013] A traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, characterized in that its main components are, by weight:

[0014] 6-15 parts of Atractylodes lancea, 6-15 parts of Phellodendron chinense, 15-45 parts of Coix seeds, 9-30 parts of Cyathula, 5-15 parts of Silkworm excrement, 10-20 parts of talc, 6-15 parts of Forsythia suspensa, 9-30 parts of Codonopsis pilosula, 6-15 parts of Atractylodes macrocephala, 10-20 parts of Poria, 6-15 parts of Chinese Angelica sinensis, 9-18 parts of Millettia reticulata, and 3-6 parts of Licorice.

[0015] The best therapeutic effect can be achieved within the above dosage range. Excessive or insufficient drug dosage will lead to changes in the primary and secondary pathogenesis of the prescription.

[0016] Furthermore, the main components of the above-mentioned pharmaceutical composition are calculated by weight:

[0017] 10-15 parts of Atractylodes lancea, 8-12 parts of Phellodendron chinense, 25-35 parts of Coix seeds, 15-25 parts of Cyathula, 10-15 parts of Silkworm excrement, 15-20 parts of Talcum powder, 10-15 parts of Forsythia suspensa, 15-30 parts of Codonopsis pilosula, 10-15 parts of Atractylodes macrocephala, 15-20 parts of Poria cocos, 10-15 parts of Chinese angelica, 10-18 parts of Millettia reticulata, and 5-6 parts of Licorice.

[0018] Most preferably, the main components are calculated by weight:

[0019] 12 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 30 parts of Coix seeds, 24 parts of Cyathula, 15 parts of Silkworm excrement, 15 parts of Talcum powder, 12 parts of Fructus Forsythiae, 18 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 15 parts of Poria, 12 parts of Angelica sinensis, 15 parts of Millettia reticulata, and 6 parts of Radix Glycyrrhizae.

[0020] In the above-mentioned pharmaceutical composition, the specific medication mechanism is as follows:

[0021] The above-mentioned prescription is adapted from Simiao Powder, which can be found in the book "Cheng Fang Fang Du" written by Zhang Bingcheng, a physician in the Qing Dynasty. It is composed of four herbs: Atractylodes lancea, Phellodendron chinense, Achyranthes bidentata, and Coix seed. The original prescription is mainly used to treat impotence caused by damp-heat. Most of the improved prescriptions based on it in the existing technology are used to treat redness, swelling, heat and pain in joints throughout the body caused by the flow of damp evil or leucorrhea in women caused by the flow of damp heat.

[0022] The inventors of the present invention creatively started from the pathogenesis of damp-heat syndrome of idiopathic membranous nephropathy, took the functions of clearing away heat, drying dampness and strengthening the spleen of the above basic prescription, and applied it for the first time to the symptoms of non-damp evil influx: the inventors believed that the Atractylodes macrocephala in the prescription is pungent, bitter and warm, and can dry dampness and strengthen the spleen, which can dry dampness to eliminate the symptoms, and strengthen the spleen and strengthen the earth to eliminate the source of damp evil; Phellodendron chinense is bitter and cold, and goes to the lower burner, clearing heat and drying dampness and strengthening yin; Coix seed is sweet and light in taste, cool in nature, and can strengthen the spleen and eliminate dampness; the inventors specially selected Cyathula capitata, because Cyathula capitata enters the liver and kidney meridians, promotes blood circulation and diuresis, nourishes the liver and kidneys, and also leads the power of other medicines to enter the lower burner.

[0023] At the same time, the inventors determined that the basic formula above was strong in clearing heat and dampness, but weak in strengthening the spleen and replenishing qi. From the perspective of the underlying mechanism, spleen deficiency is the primary cause. A healthy spleen can transform dampness, and when dampness is eliminated, heat cannot arise. Therefore, the inventors decided to use Codonopsis pilosula to nourish the spleen, Atractylodes macrocephala to strengthen the spleen and replenish qi, and Poria cocos to strengthen the spleen with a sweet and mild flavor.

[0024] Because dampness and heat tend to cling together and are difficult to separate, making them difficult to dispel, the inventors believe that the treatment process should focus on separating dampness and heat, allowing each to find its own path. Once dampness is removed, heat cannot remain alone; heat is easy to clear, but dampness is difficult to remove. Therefore, the inventors creatively added Forsythia suspensa to the above-mentioned prescription, leveraging its agglomeration-dispersing properties to dissipate the dampness and heat that cling together; talcum powder clears heat and dampness, allowing heat to dissipate and dampness to be easily removed; silkworm excrement dissipates dampness, harmonizes the stomach, and returns to the middle jiao, raising the clear and lowering the turbid; Poria cocos promotes diuresis and eliminates dampness, and combined with coix seed, it promotes downward movement; these herbs work together to achieve the desired effect of separating dampness and heat.

[0025] The inventors also comprehensively utilized Millettia reticulata and Angelica sinensis to nourish blood and invigorate blood circulation, relax meridians and activate collaterals, regulate the liver to strengthen the spleen, and use licorice to harmonize various medicines, and finally obtained the above-mentioned final technical solution.

[0026] The more specific Chinese and Western medicinal mechanisms for each of the herbs in the above formula are as follows:

[0027] Atractylodes lancea: Pungent, bitter, and warm, it enters the spleen, stomach, and liver meridians. It expels dampness and strengthens the spleen, dispels wind and cold, and improves eyesight. The Compendium of Materia Medica states: "It treats dampness, phlegm, and fluid retention... as well as downward flow of spleen dampness, turbid leukorrhea, and loose bowel movements." A decoction of Atractylodes lancea has hypoglycemic effects and also has sodium and potassium excretion properties. Modern pharmacological research shows that Atractylodes lancea can inhibit the release of central corticotropin-releasing factor, stimulate the vagus nerve, promote the release of the gastrointestinal hormones gastrin and motilin, inhibit the release of vasoactive intestinal peptide and 5-HT receptors, and increase the number of interstitial cells of Cajal in gastrointestinal tissue, promoting gastric emptying and gastrointestinal motility.

[0028] Phellodendron amurense: Bitter and cold, it enters the kidney and bladder meridians. It clears heat and dampness, purges fire and eliminates steam, detoxifies and treats sores. Phellodendron amurense and the berberine it contains have significant anti-inflammatory and anti-proliferative, anti-ulcer, and choleretic effects. Additionally, Phellodendron amurense has antiarrhythmic, antihypertensive, sedative, hypoglycemic, hypolipidemic, anticancer, liver and kidney cell protection, heart failure prevention, endothelial damage amelioration, and neuroprotective properties.

[0029] Coix seed: Sweet, mild, and cooling, it enters the spleen, stomach, and lung meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, eliminates numbness, drains pus, and detoxifies and resolves stagnation. Coix seed decoction has a significant inhibitory effect on cancer cells. Its fatty oil can lower serum calcium and blood sugar levels and has antipyretic, sedative, analgesic, and immune-regulating effects. Pharmacological studies have shown that when hypercholesterolemic rats were gavaged with coix seed extract, the polyphenols in coix seed lowered blood cholesterol levels and oxidative stress markers, inhibited peroxide production, and protected cardiovascular health. Studies have identified angiotensin-converting enzyme as the primary antihypertensive target of coix seed oligopeptides.

[0030] Sichuan Cyathula: Sweet, slightly bitter, and neutral in flavor, it enters the liver and kidney meridians, dispels blood stasis, promotes menstruation, unclogs joints, and promotes diuresis and urination. Total saponins from this herb can lower blood pressure and improve neurological symptoms after stroke in rats. Polysaccharides from this herb can enhance immunity, inhibit tumor metastasis, increase white blood cell counts, and protect the liver. Modern pharmacological studies have shown that Sichuan Cyathula has antiplatelet aggregation, improves microcirculation, and promotes protein synthesis.

[0031] Silkworm excrement: Sweet, pungent, and warm, it enters the liver, spleen, and stomach meridians, dispelling wind and dampness while harmonizing the stomach and eliminating dampness. Silkworm excrement decoctions have anti-inflammatory properties, and the chlorophyll derivatives they contain inhibit liver cancer cells in vitro. Silkworm excrement extracts inhibit α-glucosidase activity, improving abnormal glucose and lipid metabolism in diabetic animals and potentially beneficial in the prevention and treatment of chronic complications of diabetes.

[0032] Talc: Sweet, light, and cold, it enters the bladder, lung, and stomach meridians. It promotes diuresis, relieves stranguria, and clears heat and relieves summer heat. It can also be used externally to dispel dampness and heal sores. Talc has diuretic, adsorbent, and astringent properties, and can protect the intestinal lining when taken internally.

[0033] Forsythia suspensa: Bitter and slightly cold, it enters the lung, heart, and small intestine meridians. It clears heat and detoxifies, reduces swelling, resolves stagnation, and dispels wind-heat. A decoction of Forsythia suspensa has broad-spectrum antibacterial properties, and the oleanolic acid it contains has mild diuretic and cardiotonic effects. Compounds in Forsythia suspensa that have been shown to exert anti-inflammatory effects include forsythoside A, forsythiaside, arctiin, and its aglycones. Modern experiments have demonstrated that Forsythoside A activates regulatory T cells in mice with systemic endotoxemia, thereby achieving immune regulation.

[0034] Codonopsis: Sweet and neutral, it enters the spleen and lung meridians, strengthening the spleen and lungs, nourishing blood and promoting fluid production. Codonopsis polysaccharides can increase peripheral blood hemoglobin, promote compensatory hematopoietic function of the spleen, and enhance immune function. Codonopsis has anti-aging, anti-hypoxia, anti-radiation, blood sugar lowering, lipid regulation, and anti-myocardial ischemia effects.

[0035] Atractylodes macrocephala: Bitter, sweet, and warm, it enters the spleen and stomach meridians, invigorating the spleen and replenishing qi, dispelling dampness and promoting diuresis, stopping sweating, and stabilizing pregnancy. Modern pharmacological studies have shown that Atractylodes lactone I enhances salivary amylase activity, promotes nutrient absorption, and regulates gastrointestinal function. Atractylodes macrocephala decoction has a pronounced and long-lasting diuretic effect. Atractylodes macrocephala polysaccharides and volatile oil can enhance cellular immunity. Atractylodes macrocephala extracts can be used as immunostimulatory adjuvants or adjuvant boosters, increasing serum-specific IgG responses and intestinal mucosal immunity. Atractylodes macrocephala extracts exert anti-inflammatory effects by regulating macrophage activity through NF-κB and its dependent mechanisms.

[0036] Poria cocos: Sweet, mild, and neutral, it enters the heart, lung, spleen, and kidney meridians, promoting diuresis and dispelling dampness, strengthening the spleen, and calming the mind. Pharmacological studies have shown that Poria cocos decoction has a diuretic effect. Poria cocos polysaccharide has immune-enhancing properties. Animal experiments have shown that Poria cocos' diuretic effect is related to the fact that pachylin is an aldosterone receptor antagonist, which improves myocardial motility and promotes water metabolism. Crude carboxymethyl pachylin can regulate the expression of tumor-immune-related proteins and significantly prolong the survival of mice with intestinal cancer by up to 24.59%. It can also significantly inhibit cyclophosphamide-induced immune and hematopoietic dysfunction, alleviating cyclophosphamide's adverse reactions.

[0037] Angelica sinensis: Sweet, pungent, and warm, it enters the liver, heart, and spleen meridians, nourishing and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. Pharmacological studies have shown that angelica extract can significantly promote hemoglobin and red blood cell production in mice, and that angelica and its sodium ferulate have significant antithrombotic effects. Angelica sinensis has been shown to enhance immunity, inhibit the proliferation of granulation tissue in the late stages of inflammation, and resist lipid peroxidation, as well as have anti-tumor, antibacterial, and anti-radiation effects. Researchers at home and abroad have found that angelica's anti-inflammatory effects are primarily achieved by inhibiting the release of inflammatory mediators such as interleukin-6 (IL-6), nitric oxide (NO), tumor necrosis factor-α (TNF-α), IL-1β, and prostaglandin E2 (PGE2), blocking the expression of genes and proteins involved in inflammatory signaling pathways such as NF-κB and MAPK, and maintaining the host immune cells' high sensitivity to external stimuli, thereby exerting its anti-inflammatory effects.

[0038] Millettia spatholobi: Bitter, sweet, and warm, it enters the liver and kidney meridians, promoting blood circulation and replenishing blood, regulating menstruation and relieving pain, and relaxing tendons and activating joints. Pharmacological actions indicate that the total flavonoids and catechins in Millettia spatholobi have certain hematopoietic functions. Millettia spatholobi decoctions can lower cholesterol in animals and combat atherosclerotic lesions. Millettia spatholobi extracts have significant anti-inflammatory and antiviral effects, and have a bidirectional regulatory effect on the immune system. Compound Millettia spatholobi can promote blood circulation and remove blood stasis, lowering blood coagulation factor levels, and is effective in treating deep vein thrombosis in the lower extremities.

[0039] Licorice: Sweet and neutral, it enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, clears heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various herbs. Licorice has antidiuretic, lipid-lowering, hepatoprotective, and adrenocortical hormone-like effects. Licorice treatment with Tripterygium wilfordii reduced serum levels of AST, ALT, CRE, and UREA in rats, as well as the cytokines IL-1β, IL-6, and TNF-α, indicating that licorice can mitigate Tripterygium wilfordii-induced liver damage.

[0040] The inventors also provide a method for preparing the above-mentioned Chinese medicine composition, the specific steps are as follows:

[0041] First, weigh out each Chinese medicine according to the ratio of raw materials, wrap and decoct with talcum powder and silkworm sand, then add water together with other medicines until the surface of the medicine is covered by 2-3 fingers, soak for one hour, boil over high heat, then simmer over low heat for 20-30 minutes, filter out the juice and set aside, add water to the residue again until the surface of the residue is covered by 2-3 fingers, boil over high heat, then simmer over low heat for 20 minutes, filter out the juice and combine it with the previous juice.

[0042] The main reason for decocting talcum powder and silkworm excrement in the above preparation method is:

[0043] Talc powder has small particles and a light texture. Although it is small in size, it has a large total area. The particles are highly hydrophobic and have a large surface tension. If they are not wrapped during decoction, they will float on the liquid surface and be difficult to sink to the bottom of the pot. Insufficient decoction will reduce the dissolution of the effective ingredients in the compound; it will easily overflow the frying pan when boiling, and it will be difficult to filter the juice after decoction, so it needs to be wrapped during decoction.

[0044] Silkworm excrement contains a large amount of mucus components, with a large expansion coefficient and high viscosity. It easily absorbs water and expands during the decoction process, releases water into the soup, and easily settles to the bottom, causing sticking in the pot. At the same time, the mucus components will also reduce the fluidity of the medicinal solution, reduce the diffusion power, and affect the dissolution and diffusion of other ingredients in the compound. Therefore, silkworm excrement is chosen to be wrapped and decocted to avoid sticking in the pot and reduce the dissolution of other Chinese medicinal ingredients in the compound.

[0045] The drug obtained by using the above-mentioned formula and preparation method has a very significant clinical effect. The inventor has proved through a large number of experiments that compared with Huangkui Capsules, a Chinese patent medicine strongly recommended in the current clinical application guide for the treatment of idiopathic membranous nephropathy (2021 edition), it not only has a more obvious effect on reducing urine protein, but also has a fast onset and stable efficacy. It has a significant effect in improving idiopathic membranous nephropathy and damp-heat symptoms caused by the use of hormones, and increasing the complete remission rate of membranous nephropathy. Therefore, the technical solution of the present invention has obvious advantages from theory to clinical effect.

[0046] In summary, the present invention is based on Simiao Powder, combines traditional Chinese medicine theory and the symptoms of patients with idiopathic membranous nephropathy with damp-heat syndrome, and according to the theory of disease-syndrome combination, obtains a traditional Chinese medicine composition specifically for treating idiopathic membranous nephropathy with damp-heat syndrome, which mainly focuses on clearing away heat and dampness, strengthening the spleen and replenishing qi, and supplemented by promoting blood circulation and nourishing blood, and invigorating the kidney and consolidating essence. The combination of these medicines has a significant effect on the damp-heat syndrome of idiopathic membranous nephropathy.

[0047] Specific implementation

[0048] The present invention is not limited to the following embodiments. The following embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and improvements may be made to the present invention without departing from the spirit and scope of the present invention. These changes and improvements all fall within the scope of the present invention as claimed.

[0049] Example 1

[0050] A traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, comprising the following components by weight:

[0051] 12 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 30 parts of Coix seeds, 24 parts of Cyathula root, 15 parts of Silkworm excrement, 15 parts of Talcum powder, 12 parts of Forsythia suspensa, 18 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 12 parts of Chinese Angelica sinensis, 15 parts of Millettia reticulata, and 6 parts of Licorice root;

[0052] The preparation method is as follows:

[0053] Wrap talcum powder and silkworm excrement with gauze respectively, then mix them evenly with the raw materials, add 1000ml of cold water, and soak for 1 hour;

[0054] The mixed raw materials were boiled over high heat, simmered over low heat for 30 minutes, and filtered through gauze to obtain the filtrate and the medicinal residue (including the decocted talcum powder and silkworm excrement);

[0055] (3) mixing the medicinal residue obtained in step (2) with 500 ml of hot water and decocting the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, decocting the mixture over low heat for 20 minutes, and filtering the mixture again with gauze to obtain the filtrate and the medicinal residue;

[0056] The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a medicinal solution for treating damp-heat syndrome of membranous nephropathy.

[0057] Example 2

[0058] A traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, comprising the following components by weight:

[0059] 6 parts of Atractylodes lancea, 6 parts of Phellodendron chinense, 15 parts of Coix seeds, 9 parts of Cyathula, 5 parts of Silkworm excrement, 10 parts of Talcum powder, 6 parts of Forsythia suspensa, 9 parts of Codonopsis pilosula, 6 parts of Atractylodes macrocephala, 10 parts of Poria, 6 parts of Angelica sinensis, 9 parts of Millettia reticulata, and 3 parts of Licorice root;

[0060] The preparation method is as follows:

[0061] (1) Wrap talcum powder and silkworm excrement with gauze respectively, then mix them evenly with the raw materials, add 600 ml of cold water, and soak for 1 hour;

[0062] (2) Boil the mixed raw materials over high heat, simmer for 30 minutes over low heat, and filter through gauze to obtain the filtrate and the residue (including the decocted talcum powder and silkworm excrement);

[0063] (3) mixing the medicinal residue obtained in step (2) with 400 ml of hot water and decocting the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, decocting the mixture over low heat for 20 minutes, and filtering the mixture again with gauze to obtain the filtrate and the medicinal residue;

[0064] The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a medicinal solution for treating damp-heat syndrome of membranous nephropathy.

[0065] Example 3

[0066] A traditional Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, comprising the following components by weight:

[0067] 15 parts of Atractylodes lancea, 12 parts of Phellodendron chinense, 30 parts of Coix seeds, 24 parts of Cyathula root, 15 parts of Silkworm excrement, 20 parts of Talcum powder, 15 parts of Forsythia suspensa, 30 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 12 parts of Chinese Angelica sinensis, 15 parts of Millettia reticulata, and 6 parts of Licorice root;

[0068] The preparation method is as follows:

[0069] Wrap talcum powder and silkworm excrement with gauze respectively, then mix them evenly with the raw materials, add 1400ml of cold water, and soak for 1 hour;

[0070] The mixed raw materials were boiled over high heat, simmered over low heat for 30 minutes, and filtered through gauze to obtain the filtrate and the medicinal residue (including the decocted talcum powder and silkworm excrement);

[0071] The medicinal residue obtained in step (2) was mixed with 600 ml of hot water and decocted. The hot water was purified water at a temperature of 80° C. The mixture was boiled over high heat, simmered over low heat for 20 minutes, and then filtered again with gauze to obtain a filtrate and medicinal residue.

[0072] The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a medicinal solution for treating damp-heat syndrome of membranous nephropathy.

[0073] Experimental example

[0074] 1. Clinical data

[0075] 1.1 Source of research subjects and sample size:

[0076] A total of 30 patients were included in this study, all of whom were outpatients and inpatients in the Nephrology Department of Shandong Provincial Hospital of Traditional Chinese Medicine from June 2020 to December 2021.

[0077] 1.2 Diagnostic criteria

[0078] 1.2.1 Western medicine diagnostic criteria

[0079] This study was mainly based on the KDIGO "Clinical Practice Guidelines for Glomerulonephritis" (2012 edition) and the 2017 "KDIGO Kidney Disease Debate Conference Expert Consensus" and combined with the requirements of this clinical trial.

[0080] Renal biopsy confirmed membranous nephropathy, excluding secondary causes.

[0081] ② Serum PLA2R antibodies are positive, excluding secondary factors.

[0082] 1.2.2 TCM syndrome diagnostic criteria

[0083] Refer to the Idiopathic Membranous Nephropathy Damp-Heat Syndrome Diagnostic Scale (see Appendix 1) and combine the scores of each item:

[0084] Appendix 1 Diagnostic Scale for Damp-Heat Syndrome in Idiopathic Membranous Nephropathy

[0085] 1. Do you have a dry mouth?

[0086] ①Not at all②Yes, but mild③Yes, but moderate④Relatively severe⑤Very severe

[0087] 2. Do you have a bitter taste in your mouth?

[0088] ①Not at all②Yes, but mild③Yes, but moderate④Relatively severe⑤Very severe

[0089] 3. Have you recently experienced reduced urine volume or darker yellow urine?

[0090] ①Not at all②Yes, but mild③Yes, but moderate④Relatively severe⑤Very severe

[0091] 4. Have you recently had difficulty defecating, a sticky and uncomfortable feeling, or the feeling of wanting to defecate again after defecation?

[0092] ①Not at all②Yes, but mild③Yes, but moderate④Relatively severe⑤Very severe

[0093] 5. Do you have a feeling of abdominal bloating?

[0094] ①Not at all②Yes, but mild③Yes, but moderate④Relatively severe⑤Very severe

[0095] The following content is to be filled in by the doctor: (Please tick “√”)

[0096] 6. Slippery and rapid pulse ① No ② Yes

[0097] 7. Red tongue ① No ② Yes

[0098] 8. Yellow and greasy tongue coating ① No ② Yes

[0099] Syndrome differentiation results:

[0100] Damp-heat syndrome: □Yes □No

[0101] Investigator's Signature:

[0102] Survey Date:

[0103] Based on the inventor's preliminary clinical comprehensive investigation and research, the comprehensive weight coefficients of various symptoms related to the damp-heat syndrome of idiopathic membranous nephropathy were determined by combining statistical methods such as the Delphi method and factor analysis as follows: (See Table 1)

[0104] Table 1 Comprehensive weight coefficient of each symptom

[0105]

[0106]

[0107] Among them, the internal heat items include: dry mouth, bitter taste in the mouth, short and dark urine; the dampness and turbidity items include: uncomfortable bowel movements, abdominal distension; the tongue and pulse items include: slippery and rapid pulse, red tongue, and yellow and greasy tongue coating.

[0108] The inventors determined that the diagnostic threshold for damp-heat syndrome of idiopathic membranous nephropathy is 171.5 based on the receiver operating characteristic curve obtained from the preliminary comprehensive clinical investigation and the optimal cut-off point theory.

[0109] (1) Damp-heat syndrome: Y represents the symptom score of damp-heat syndrome in idiopathic membranous nephropathy:

[0110] Y=9 dry mouth + 16 bitter taste in the mouth + 14 short dark urine + 13 uncomfortable bowel movements + 3 abdominal distension + 17 slippery and rapid pulse + 9 red tongue + 19 yellow and greasy tongue coating.

[0111] The quantification of the above symptom items is based on a scale of 1 to 5, representing: "not present at all" as 1 point, "mild" as 2 points, "general" as 3 points, "relatively serious" as 4 points, and "very serious" as 5 points. The quantification of tongue and pulse items is binary: "present" as 3 points, and "absent" as 1 point.

[0112] Syndrome determination: The patient must have at least one internal heat indicator (dry mouth, bitter taste in the mouth, short dark urine) and one dampness and turbidity indicator (uncomfortable bowel movements, abdominal distension). If the sum of the scores of these indicators is ≥171.5, the patient is diagnosed with damp-heat syndrome.

[0113] (2) Diagnostic criteria for the classification of damp-heat syndrome of membranous nephropathy into mild, moderate and severe types: syndrome score ∈ [171.5, 207.125) is mild syndrome of Yin deficiency and Yang hyperactivity; syndrome score ∈ [207.125, 257.875) is moderate; syndrome score ∈ [257.875, +∞) is severe.

[0114] 1.3 Implementation Standards

[0115] 1.3.1 Inclusion criteria

[0116] (1) Aged 18-80 years; (2) Meet the Western medical diagnostic criteria for idiopathic membranous nephropathy; (3) Meet the TCM syndrome diagnostic criteria; (4) Have good compliance, normal comprehension ability, and be able to fill out the questionnaire truthfully and objectively; (5) Obtain informed consent.

[0117] 1.3.2 Exclusion criteria

[0118] (1) Patients with other types of glomerular diseases;

[0119] (2) Those who are currently using Chinese medicine to treat other diseases;

[0120] (3) Those who suffer from mental illness or mental disorder and are unable to understand and cooperate with the investigation; or those who have other major systemic diseases such as heart, brain, liver and hematopoietic system;

[0121] (4) Pregnant or lactating women;

[0122] (5) End-stage renal disease at onset, i.e., eGFR < 15 ml / min / 1.73 m 2 ; or those who have received renal replacement therapy;

[0123] (6) Those who are currently undergoing or have undergone other medical trials in the past four months.

[0124] 1.3.3 Falling off and rejection standards:

[0125] (1) The subject voluntarily withdraws from the study;

[0126] (2) The researcher decides to withdraw the patient from the study, such as if the patient is diagnosed with other diseases during the study and requires special drug treatment;

[0127] (3) The subject violates the requirements of the research protocol;

[0128] (4) The subjects were lost to follow-up.

[0129] 2. Research Methods

[0130] 2.1 Research Design

[0131] The 30 patients were randomly divided into an experimental group and a control group using a random number table, with 15 patients in each group. The treatment course lasted 8 weeks. Changes in the TCM syndrome quantitative scores of the Idiopathic Membranous Nephropathy Damp-Heat Syndrome Diagnostic Scale and clinical efficacy observation indicators were observed in both groups before and after treatment. After the treatment course, all data were statistically analyzed using SPSS 21.0 statistical software to compare the differences between the experimental group and the control group before and after treatment, and between the two groups.

[0132] 2.2 Treatment methods

[0133] Control group: Huangkui Capsules (Jiangsu Suzhong Pharmaceutical Group Co., Ltd., approval number: National Medicine Standard Z19990040), taken orally, 5 capsules at a time, 3 times a day.

[0134] Experimental group: 400 ml of the medicinal solution was obtained by decocting using the process and dosage of Example 1, and taken warm twice a day, morning and evening, 200 ml each time.

[0135] 2.3 Treatment course

[0136] The observation period for both the experimental group and the control group was 8 weeks.

[0137] 2.4 Clinical observation indicators and efficacy evaluation criteria

[0138] 2.4.1 Observation indicators

[0139] (1) Quantitative scoring of TCM syndromes in the diagnostic scale for idiopathic membranous nephropathy (damp-heat syndrome).

[0140] (2) Clinical efficacy observation indicators: ① Biochemical indicators: albumin, total cholesterol, triglycerides, creatinine, urea nitrogen, uric acid; ② Urinary protein excretion: urine protein, 24-hour urine protein quantification, urine protein / urine creatinine ratio.

[0141] The above symptoms and indicators were checked and recorded once before and after treatment.

[0142] (3) Record adverse drug reactions during treatment.

[0143] 2.4.2 Criteria for determining efficacy

[0144] (1) The criteria for judging the efficacy of syndromes are based on the changes in the score of the idiopathic membranous nephropathy (damp-heat syndrome) diagnostic scale:

[0145] TCM syndrome efficacy evaluation criteria:

[0146] Clinically cured means that the clinical symptoms and signs disappear or basically disappear, and the symptom score is reduced by >95%.

[0147] The clinical symptoms and signs of markedly effective TCM patients were significantly improved, and the syndrome scores were reduced by >70%.

[0148] The clinical symptoms and signs of effective TCM treatment were improved, and the syndrome scores were reduced by ≥30%.

[0149] Ineffective TCM had no significant improvement in clinical symptoms and signs, or even worsened, and the symptom score decreased by less than 30%.

[0150] Note: The calculation formula (nimodipine method) is: [(score before treatment - score after treatment) / score before treatment] × 100%.

[0151] (2) Disease efficacy evaluation criteria:

[0152] Clinically controlled urine routine examination shows negative protein, or the 24-hour urine protein quantity is normal; renal function is normal.

[0153] Significantly effective routine urine protein test results in a 2+ reduction, or a 24-hour urine protein reduction of ≥40%; renal function is normal or basically normal (difference from normal values ​​not exceeding 15%).

[0154] A valid urine routine examination shows a decrease of 1 “+” in protein, or a decrease of <40% in 24-hour urine protein; renal function is normal or improved.

[0155] Ineffective clinical manifestations and the above laboratory tests have no improvement or worsening.

[0156] Note: Total effectiveness = clinical control + marked effect + effectiveness.

[0157] 2.4.3 Safety evaluation standards:

[0158] Level 1: Safe, no adverse reactions.

[0159] Level 2: Relatively safe, with mild adverse reactions, and no treatment is required and the medication can be continued.

[0160] Level 3: There are safety issues, but the adverse reactions are not serious and the medication can continue after treatment.

[0161] Level 4: There are serious safety issues and the drug cannot be continued after treatment.

[0162] 2.5 Statistical methods

[0163] All data in this study were analyzed using SPSS 21.0. All statistical tests were two-sided, with P < 0.05 considered statistically significant, and P < 0.01 considered statistically significant. All data were expressed as mean ± standard deviation (X ± S). Intergroup comparisons before and after treatment were performed with the independent sample t-test, while intragroup comparisons before and after treatment were performed with the paired sample t-test. Non-hierarchical categorical data were analyzed with the chi-square test, and hierarchical data were analyzed with the rank sum test.

[0164] 3. Research Results

[0165] 3.1 General Information

[0166] All patients were from the outpatient and inpatient departments of the Department of Nephrology and Urology of Shandong Provincial Hospital of Traditional Chinese Medicine from June 2020 to December 2021, totaling 30 cases, with 15 cases in the experimental group and 15 cases in the control group. No cases dropped out during the treatment in both groups. All 30 cases were patients with idiopathic membranous nephropathy. Among them, the youngest patient in the experimental group (15 cases) was 29 years old and the oldest was 71 years old, with an average age of 48.93±11.310 years old; the youngest patient in the control group (15 cases) was 21 years old and the oldest was 74 years old, with an average age of 56.47±13.840 years old. After statistical analysis and comparison, there was no difference in age between the two groups (see Tables 2 and 3 for details).

[0167] Table 2 Comparison of gender between the two groups of patients

[0168]

[0169] Table 3 Comparison of age distribution between the two groups

[0170]

[0171] The gender of the two groups was compared using Fisher's exact test, and the age was compared using the independent sample t-test. The results showed that there was no statistically significant difference (P>0.05), indicating that the gender and age of the two groups were comparable.

[0172] 3.2 Comparison of laboratory indicators

[0173] 3.2.1 Comparison of renal function between the two groups before and after treatment (Scr, BUN, UA)

[0174] Before treatment, there was no statistically significant difference in Scr, BUN, and UA between the two groups (P>0.05). After treatment, the two groups showed a decrease in Scr and BUN in the experimental group (P>0.05), but there was no statistically significant difference between the experimental group and the control group (P>0.05). See Tables 4 and 5 for details.

[0175] Table 4 Comparison of renal function between the two groups before treatment (Scr, BUN, UA)

[0176]

[0177] Note: Before treatment, the P values ​​of Scr, BUN and UA between the two groups were 0.615, 0.056 and 0.492 respectively.

[0178] Table 5 Comparison of renal function between the two groups after treatment (Scr, BUN, UA)

[0179]

[0180] 3.2.2 Comparison of Alb levels between the two groups before and after treatment

[0181] Before treatment, there was no significant difference in Alb between the two groups, indicating comparability (P>0.05). Before and after treatment, Alb increased in both the experimental and control groups (P<0.05). After treatment, there was a statistically significant difference between the experimental and control groups (P<0.05); see Tables 6 and 7 for details.

[0182] Table 6 Alb in the two groups before treatment

[0183]

[0184] Table 7 Alb in the two groups after treatment

[0185]

[0186] 3.2.3 Comparison of urine protein levels between the two groups before and after treatment

[0187] Before treatment, there was no significant difference in the 24-hour urine protein quantification between the two groups of patients, and they were comparable (P>0.05). Before and after treatment, the two groups of patients showed that the 24-hour urine protein quantification decreased in both the experimental and control groups (P<0.05). After treatment, there was a statistically significant difference between the experimental group and the control group (P<0.05). See Tables 8 and 9 for details.

[0188] Table 8 Quantification of 24-hour urine protein in the two groups before treatment

[0189]

[0190] Table 9 Quantification of 24-hour urine protein in the two groups before and after treatment

[0191]

[0192] 3.3 Comparison of scale scores between the two groups before and after treatment

[0193] Before treatment, there was no significant difference in the scale scores of the two groups of patients, and they were comparable (P>0.05). Compared with the two groups of patients before and after treatment, the scale scores of the experimental group and the control group decreased (P<0.05). After treatment, there was a statistically significant difference between the experimental group and the control group (P<0.05); see Tables 10 and 11 for details.

[0194] Table 10 Scale scores of the two groups before and after treatment

[0195]

[0196] Table 11 Scale scores of the two groups before and after treatment

[0197]

[0198] 3.4 Comparison of TCM syndrome efficacy before and after treatment between the two groups

[0199] Table 12 Comparison of TCM syndrome efficacy between the two groups before and after treatment

[0200]

[0201] After statistical analysis, the two groups were compared before and after treatment. The effective rate of TCM symptoms in the experimental group reached 60.00%, while that in the control group was 13.33%. The experimental group was better than the control group, and the corresponding significance of Fisher's exact test was P=0.021<0.05 (see Table 12).

[0202] 3.5 Comparison of disease efficacy between the two groups before and after treatment

[0203] Table 13 Comparison of disease efficacy between the two groups before and after treatment

[0204]

[0205] After statistical analysis, the two groups were compared before and after treatment. The total effective rate of the experimental group was 93.33%, and the total effective rate of the control group was 53.33%. The experimental group was significantly better than the control group. The significance of Fisher's exact test was P = 0.035 < 0.05 (see Table 13).

[0206] 3.6 Safety Evaluation

[0207] During the study, neither group of patients experienced any drug-related discomfort symptoms or adverse reactions, so the safety of both drugs was good, with a safety rating of Level 1.

[0208] Specific clinical cases

[0209] 1. Zhang, a 38-year-old male, presented to the outpatient clinic of Shandong Provincial Hospital of Traditional Chinese Medicine in July 2021 with "bilateral lower extremity edema for over three months." His symptoms included bilateral lower extremity edema, fatigue, abdominal distension, no vomiting, back pain, normal appetite, good sleep, foamy urine, sticky bowel movements once daily, and discomfort during bowel movements. His tongue was dark red with a greasy yellow coating and a slippery and rapid pulse. Auxiliary examinations revealed albumin levels of 31.2 g / L, creatinine levels of 76 μmol / L, urine protein levels of 3+, and a 24-hour urine protein count of 10.52 g.

[0210] The drug obtained in Example 1 was administered daily, 400 ml of the drug, taken twice daily, morning and evening, warm, 200 ml each time. After 8 weeks of treatment, the patient's albumin level was 38.2 g / l, creatinine was 62 μmol / l, urine protein was 1+, and 24-hour urine protein was 2.59 g. The TCM symptom score before treatment was 209 points, and the TCM symptom score after 8 weeks of treatment was 141 points.

[0211] 2. Mr. Tang, a 44-year-old male, visited our outpatient clinic in July 2021 due to "recurrent bilateral lower limb edema for more than two years." His symptoms included mild lower limb edema, fatigue, back pain, good appetite and sleep, and loose, unformed stools once a day. His tongue was dark red with a greasy yellow coating and a slippery pulse. Auxiliary examinations revealed albumin levels of 38.7 g / l, creatinine levels of 58 μmol / l, urea levels of 5.59 mmol / l, total cholesterol levels of 7.39 mmol / l, triglycerides of 2.62 mmol / l, urine protein levels of 1+, and a 24-hour urine protein level of 1.98 g.

[0212] The drug obtained in Example 1 was administered daily, 400 ml of the drug, taken twice daily, morning and evening, 200 ml each time. After 8 weeks of treatment, the patient's albumin level was 40.2 g / l, creatinine level was 53 umol / l, urea level was 4.59 mmol / l, total cholesterol level was 6.58 mmol / l, triglyceride level was 1.97 mmol / l, urine protein level was 1-, and 24-hour urine protein level was 0.22 g. The TCM symptom score before treatment was 208 points, and the TCM symptom score after 8 weeks of treatment was 186 points.

[0213] In Case 1, the patient's symptom score decreased by 68 points, resulting in an effective TCM syndrome-based efficacy assessment; urine protein decreased by 2+, resulting in a markedly effective efficacy assessment. In Case 2, although the patient's symptom score did not decrease sufficiently, urine protein essentially became negative, and the 24-hour urine protein count decreased by ≥40%, resulting in a markedly effective efficacy assessment. Reducing proteinuria is the primary treatment goal in membranous nephropathy, and clinical manifestations gradually improve with the resolution of proteinuria. Despite differences in symptom scores, both cases achieved marked efficacy.

[0214] Based on the above clinical trial results, it can be seen that the traditional Chinese medicine composition obtained by the present invention is specifically used to treat idiopathic membranous nephropathy with damp-heat syndrome. It mainly clears away heat and dampness, strengthens the spleen and replenishes qi. The combination of various medicines has significant therapeutic effects in reducing patients' proteinuria levels, improving idiopathic membranous nephropathy and damp-heat symptoms caused by the use of hormones, and increasing the complete remission rate of membranous nephropathy.

Claims

1. A Chinese medicine composition for treating idiopathic membranous nephropathy with damp-heat syndrome, characterized in that: The components are calculated by weight as follows: 10-15 parts of atractylodes, 8-12 parts of phellodendron, 25-35 parts of coix seeds, 15-25 parts of cyathula, 10-15 parts of silkworm excrement, 15-20 parts of talc, 10-15 parts of forsythia, 15-30 parts of codonopsis, 10-15 parts of atractylodes, 15-20 parts of poria, 10-15 parts of angelica, 10-18 parts of millettia reticulata, and 5-6 parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: Its components are calculated by weight: 12 parts of Atractylodes lancea, 9 parts of Phellodendron chinense, 30 parts of Coix seeds, 24 parts of Cyathula, 15 parts of Silkworm excrement, 15 parts of Talcum powder, 12 parts of Fructus Forsythiae, 18 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 15 parts of Poria, 12 parts of Angelica sinensis, 15 parts of Millettia reticulata, and 6 parts of Radix Glycyrrhizae.

3. The method for preparing the Chinese medicine composition for treating damp-heat syndrome of idiopathic membranous nephropathy according to claim 1, characterized in that: The specific steps are as follows: First, weigh out each Chinese herbal medicine according to the ratio of raw materials, decoct them with talcum powder and silkworm excrement, then add water together with other herbs until the herbs are covered by 2-3 fingers, soak for one hour, boil over high heat, then simmer over low heat for 20-30 minutes, filter the juice and set aside; Add water to the residue again until it covers the surface of the residue by 2-3 fingers, bring to a boil over high heat, then simmer over low heat for 20 minutes, filter out the juice and combine it with the previous juice.

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