Traditional Chinese medicine compound composition for treating primary membranous nephropathy as well as preparation method and application of traditional Chinese medicine compound composition

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating primary membranous nephropathy and a preparation method thereof. The traditional Chinese medicine compound composition comprises raw astragalus membranaceus, codonopsis pilosula nnannf, rhizoma atractylodis, rhizoma atractylodis macrocephalae, old caulis perllae, schizonepeta, radix platycodonis, fructus forsythiae, radix pseudostellariae, eclipta alba, radix trichosanthis, radix salviae miltiorrhizae, radix actinidiae chinensis, radix curcumae, ligusticum wallichii, fried angelica sinensis, polygonum cuspidatum, pyrrosia lingua, cortex eucommiae, rhizoma smilacis glabrae and rhizoma dioscoreae nipponicae. According to the pathogenesis characteristics of the primary membranous nephropathy, the formula is screened according to the traditional Chinese medicine theory and clinical experience, the formula is obtained through screening by adopting the core principle of tonifying the spleen and kidney, removing poison and nourishing yin and promoting blood circulation to remove meridian obstruction, the whole formula has the multiple effects of tonifying the spleen and kidney, removing poison and nourishing yin, promoting blood circulation to remove blood stasis and the like, and meanwhile, the principles of tonifying the spleen and the kidney, tonifying the spleen and the kidney and treating slowly through mild tonifying are emphasized. Clinical practice shows that the prescription can significantly reduce 24-hour urine protein, increase serum albumin, improve lipid metabolism disorder and edema symptoms, improve the PMN pathological process from multiple dimensions of inflammation inhibition, oxidative stress relief, fibrosis intervention and the like, and is good in clinical safety.

Description

TECHNICAL FIELD

[0001] The application relates to a traditional Chinese medicine compound composition, in particular to a traditional Chinese medicine compound composition for treating primary membranous nephropathy and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. BACKGROUND

[0002] Membranous nephropathy is a pathological diagnosis name, and the diagnosis mainly relies on kidney biopsy. Its pathological feature is immune complex deposition under the epithelial cells of the glomerular basement membrane with diffuse thickening of the basement membrane. From the perspective of the cause of the disease, membranous nephropathy can be divided into two clear clinical types, namely primary membranous nephropathy and secondary membranous nephropathy.

[0003] Primary membranous nephropathy (PMN) is the main subtype of membranous nephropathy (MN), and its etiology and pathogenesis have not been fully elucidated. Modern medical research generally believes that the pathogenesis of PMN mainly involves abnormal activation of the immune system, and the core mechanism is mainly the combination of specific antigens on the surface of podocytes and circulating autoantibodies to form immune complexes. In the whole pathophysiological process, these circulating immune complexes tend to be selectively deposited in a specific area of the glomerular basement membrane, that is, the subepithelial area. It is this deposition process that triggers the classical complement activation pathway, leading to the formation of the membrane attack complex. The membrane attack complex can change the permeability of the podocyte membrane, induce the influx of calcium ions and the reconstruction of the cytoskeleton, and ultimately lead to the down-regulation of the expression of key molecules of podocytes. At the same time, anaphylatoxins such as C5a produced during the complement activation process can induce podocytes to produce pro-inflammatory cytokines, further exacerbating the damage and shedding of podocytes. This process is considered to be the core link of the pathophysiology of PMN and the important basis for its clinical manifestations such as proteinuria and nephrotic syndrome. In terms of immune mechanisms, studies have revealed that a variety of podocyte target antigens are closely related to the pathogenesis of PMN, including PLA2R and THSD7A, which play a key role in the pathological process of PMN. These antigens not only directly damage podocytes after binding with autoantibodies, but also further exacerbate glomerular damage through the activation of the complement system (such as C5b-9 membrane attack complex). In addition, abnormal activation of the complement system is also considered to be one of the key factors for the progression of PMN. In addition to the immune mechanism, the onset of PMN is also closely related to genetic factors and environmental pollution. Genetic studies have shown that certain genetic polymorphisms (such as HLA-DQA1 and PLA2R1 genes) may increase the susceptibility of individuals to PMN. At the same time, environmental factors such as air pollution, heavy metal exposure and certain drugs are also believed to induce or aggravate PMN.

[0004] From the pathological features, PMN mainly manifested as diffuse thickening of glomerular basement membrane (GBM). Through transmission electron microscopy (TEM) observation, it can be found that there is a characteristic high electron density substance aggregation phenomenon on the outside of the glomerular basement membrane. Combined with the results of immunohistochemical analysis, it can be seen that immunoglobulin G (IgG) and complement component C3 show a typical intermittent fluorescent distribution pattern in the glomerular capillary wall. Clinical phenotype analysis of primary membranous nephropathy shows that nearly 80% of cases meet the diagnostic criteria of nephrotic syndrome (NS). From the pathophysiological features, this group of patients generally have the following typical clinical manifestations: (1) significant proteinuria with 24-hour urine protein quantification exceeding 3.5g; (2) hypoproteinemia with serum albumin level less than 30g / L; (3) edema signs caused by fluid accumulation in the peripheral interstitial space and increased lipid content in the blood, etc.

[0005] Based on evidence-based medical guidelines, the current first-line treatment for PMN mainly uses the combined use of glucocorticoids and immunosuppressive agents, but long-term use may cause abnormal glucose metabolism, increased risk of infection, bone marrow suppression, and other adverse reactions. In recent years, the application value of traditional Chinese medicine in the treatment of PMN has become increasingly prominent, and it has unique advantages in improving clinical symptoms and protecting renal function through multi-target and multi-pathway integrated regulation. A large number of clinical trials have confirmed that compared with traditional Western medicine, the combination of traditional Chinese and Western medicine treatment shows significant comprehensive advantages: (1) significantly improves disease remission rate; (2) effectively controls proteinuria levels; (3) reduces the risk of disease recurrence. In addition, the combination of traditional Chinese and Western medicine treatment has unique advantages in improving patient prognosis and can significantly alleviate adverse reactions caused by glucocorticoid and immunosuppressive therapy. PMN is a pathological diagnosis name in modern medicine, and there is no direct corresponding disease name in traditional Chinese medicine theory. From the perspective of traditional Chinese medicine syndrome differentiation and treatment system, the clinical manifestations of primary membranous nephropathy (PMN) mainly belong to the following disease categories: (1) edema disease characterized by facial and extremity edema; (2) urinary turbidity disease manifested by turbid urine and increased foam; (3) kidney wind disease mainly with soreness of waist and knees, aversion to cold and cold limbs; (4) deficiency disease characterized by fatigue, pale and weak complexion, etc. SUMMARY

[0006] Purpose of the invention: The purpose of the present invention is to address the deficiencies of the prior art. According to clinical experiments, PMN is classified into the categories of "edema" and "turbid urine" in traditional Chinese medicine. Its etiology and pathogenesis mainly involve spleen and kidney deficiency, invasion of toxic pathogens and obstruction of kidney meridians. Among them, spleen and kidney deficiency is considered to be the fundamental pathogenesis of PMN, invasion of toxic pathogens is the key factor in the occurrence of the disease, and obstruction of kidney meridians is the core part of PMN pathology. In the occurrence and development of PMN, kidney meridian deficiency, kidney meridian obstruction and kidney meridian damage all play an important role. Therefore, the present invention proposes the core principle of "tonifying the spleen and kidney, removing toxic pathogens and nourishing yin, activating blood circulation and unblocking meridians", and creates the Chinese medicine compound composition of the present invention - membrane kidney edema prescription. Another object of the present invention is to provide a preparation method and application of the Chinese medicine compound composition.

[0007] Technical solution: In order to achieve the above objectives, the technical solution adopted by the present invention is:

[0008] A traditional Chinese medicine compound composition for treating primary membranous nephropathy is prepared from the following raw materials in parts by weight:

[0009] 30-90 parts of raw Astragalus, 15-45 parts of Radix Codonopsis pilosulae, 15-45 parts of Rhizoma Atractylodis Macrocephalae, 15-45 parts of Rhizoma Atractylodis Macrocephalae, 12-36 parts of Rhizoma Schizonepetae, 6-18 parts of Radix Platycodonis, 15-45 parts of Rhizoma Polygoni Multiflori, 15-45 parts of Radix Pseudostellariae, 15-45 parts of Rhizoma Ecliptae, 20-60 parts of Radix Trichosanthis, 15-45 parts of Radix Salviae Miltiorrhizae, 20-60 parts of Radix Pyriferae, 15-45 parts of Radix Curcumae Radix, 15-45 parts of Rhizoma Chuanxiong, 15-45 parts of stir-fried Radix Angelicae Sinensis, 20-60 parts of Rhizoma Polygoni Cuspidati, 20-60 parts of Rhizoma Pyriferae, 20-60 parts of Eucommia ulmoides, 30-90 parts of Rhizoma Smilacis Glabrae, and 40-120 parts of Rhizoma Dioscoreae.

[0010] As a preferred embodiment, the Chinese medicinal compound composition for treating primary membranous nephropathy is prepared from the following raw materials in parts by weight:

[0011] 30-60 parts of raw Astragalus, 15-30 parts of Radix Codonopsis pilosulae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 12-24 parts of Rhizoma Schizonepetae, 6-12 parts of Radix Platycodonis, 15-30 parts of Rhizoma Polygoni Multiflori, 15-30 parts of Radix Pseudostellariae, 15-30 parts of Radix Ecliptae, 20-40 parts of Radix Trichosanthis, 15-30 parts of Radix Salviae Miltiorrhizae, 20-40 parts of Radix Pyriferae, 15-45 parts of Radix Curcumae, 15-30 parts of Rhizoma Chuanxiong, 15-30 parts of stir-fried Radix Angelicae Sinensis, 20-40 parts of Polygonum cuspidatum, 20-40 parts of Pyrrosiae serratae, 20-40 parts of Eucommia ulmoides, 30-60 parts of Smilax glabrae, and 40-80 parts of Rhizoma Dioscoreae.

[0012] As a preferred embodiment, the Chinese medicinal compound composition for treating primary membranous nephropathy is prepared from the following raw materials in parts by weight:

[0013] Radix Astragali 30 parts, Radix Codonopsis 15 parts, Radix Atractylodis 15 parts, Rhizoma Atractylodis Macrocephalae 15 parts, old Su Geng 12 parts, Schizonepeta 15 parts, Yujing 6 parts, Forsythia 15 parts, Radix Pseudostellariae 15 parts, Herba Hyperici 15 parts, Radix Bupleuri 20 parts, Radix Salviae Miltiorrhizae 15 parts, Radix Amuricae 20 parts, Radix Curcumae 15 parts, Rhizoma Chuanxiong 15 parts, Stir-baked Radix Angelicae Sinensis 15 parts, Rhizoma Polygoni 20 parts, Radix Pyrrosiae 20 parts, Radix Eucommiae 20 parts, Smilax 30 parts, Radix Dioscoreae 40 parts, Radix Lonicerae 10 parts, and light Fufang 6-12 parts.

[0014] As a preferred solution, the traditional Chinese medicine compound composition for treating primary membranous nephropathy is prepared from the following raw materials in parts by weight:

[0015] Radix Astragali 30 parts, Radix Codonopsis 15 parts, Radix Atractylodis 15 parts, Rhizoma Atractylodis Macrocephalae 15 parts, old Su Geng 12 parts, Schizonepeta 15 parts, Yujing 6 parts, Forsythia 15 parts, Radix Pseudostellariae 15 parts, Herba Hyperici 15 parts, Radix Bupleuri 20 parts, Radix Salviae Miltiorrhizae 15 parts, Radix Amuricae 20 parts, Radix Curcumae 15 parts, Rhizoma Chuanxiong 15 parts, Stir-baked Radix Angelicae Sinensis 15 parts, Rhizoma Polygoni 20 parts, Radix Pyrrosiae 20 parts, Radix Eucommiae 20 parts, Smilax 30 parts, Radix Dioscoreae 40 parts, Radix Lonicerae 10 parts, and light Fufang 6-12 parts.

[0016] The preparation method of the traditional Chinese medicine compound composition for treating primary membranous nephropathy described in the present application comprises the following steps:

[0017] The raw materials of traditional Chinese medicine are taken in parts by weight, soaked in water first, then decocted for 1 to 4 times, each time for 20 minutes to 180 minutes, filtered, the filtrates are combined, and the filtrate is concentrated under reduced pressure to obtain an extract; or a pharmaceutically acceptable carrier is added to prepare a traditional Chinese medicine preparation.

[0018] As a preferred solution, the preparation method of the traditional Chinese medicine compound composition for treating primary membranous nephropathy described above comprises the following steps:

[0019] The raw materials of traditional Chinese medicine are taken in parts by weight, soaked in water first, all the medicines are soaked in cold water for 30 minutes to make the medicinal materials fully absorb water and soften; the water added in the first decoction is appropriate to immerse the medicinal materials by 2-3 cm, and after boiling with a large fire, a small fire is used to maintain a state of slight boiling for 30 minutes, and the medicinal liquid is filtered; the water added in the second decoction is 2 / 3 of the first one, and the decoction time is 20 minutes; the two decoctions are combined and concentrated to the appropriate volume; or a pharmaceutically acceptable carrier is added to prepare granules, tablets, capsules, pills, oral liquids or mixtures, etc.

[0020] As a preferred solution, the preparation method of the traditional Chinese medicine compound composition for treating primary membranous nephropathy described above comprises the following steps:

[0021] Take each Chinese medicinal raw material by weight, first add 3 to 15 times the amount of water and soak for 30 minutes to allow the medicinal materials to fully absorb water and soften; then boil over high heat, then switch to low heat and maintain a slight boil for 30 minutes, and filter the medicinal liquid; add 2 / 3 of the water used in the first decoction for a second decoction, and boil for 20 minutes; combine the two decoctions and concentrate to an appropriate volume; or add a pharmaceutically acceptable carrier to prepare a Chinese medicinal preparation such as granules, tablets, capsules, pills, oral liquid or mixture.

[0022] The present invention is based on modern medicine's understanding of the pathogenesis of PMN, combined with laboratory test results and clinical manifestations, and uses the holistic concept of traditional Chinese medicine and the idea of ​​syndrome differentiation and treatment to systematically explain the etiology, pathogenesis, treatment principles and methods, and prescriptions of PMN in traditional Chinese medicine. The core pathogenesis of PMN can be summarized as "root deficiency and superficial excess": the main pathogenesis is spleen and kidney deficiency, among which spleen and kidney qi and yang deficiency are the key to the occurrence and development of the disease; the external pathogenesis is closely related to the six exogenous pathogens, especially wind, dampness, and heat, as well as constitutional factors, especially qi deficiency and yang deficiency. With respect to the main pathogenesis, the present invention emphasizes that the spleen and kidney are the core disease sites of PMN, and spleen and kidney qi and yang deficiency lead to abnormal water metabolism and loss of essence and fluid, which are the root causes of the main symptoms of PMN such as proteinuria and edema. In terms of treatment, the present invention first emphasizes tonifying the spleen and kidney, strengthening the body and consolidating the foundation, and especially emphasizes tonifying both the spleen and kidney and treating with balanced tonification and slow treatment. Regarding the objective pathogenesis, the present invention believes that internal and external toxins often combine to cause disease, intertwining and aggravating the condition. Treatment emphasizes detoxification and yin nourishment, and strong prevention of exogenous infections. At the same time, it still emphasizes gentle treatment, not harsh detoxification, and excessive yin nourishment. Furthermore, the present invention believes that internal and external toxins, as well as pathological products produced by PMNs themselves, can accumulate in the kidney meridians. In the occurrence and development of PMNs, kidney meridian deficiency, kidney meridian obstruction, and kidney meridian damage are all important pathological factors. Treatment emphasizes that attention should be paid to the patient's blood stasis as early as possible, and blood circulation methods should be used throughout the treatment process.

[0023] Therefore, the pathogenesis of PMN can be summarized as "spleen and kidney deficiency as the root, and blood stasis and toxins as the symptoms". Spleen deficiency leads to dysfunction of transportation and transformation, and water and dampness stagnate in the body; kidney deficiency leads to weak qi transformation, and the leakage of essence and fine particles; blood stasis and toxins block the kidney meridians, leading to proteinuria, edema and renal damage. Therefore, the present invention proposes the treatment principle of "tonifying the spleen and kidney, removing toxins and nourishing yin, and promoting blood circulation and unblocking meridians" to construct a prescription for membranous kidney edema. The prescription is composed of Chinese medicinal materials such as raw astragalus, Lu Codonopsis pilosula, Atractylodes macrocephala, Atractylodes macrocephala, Old Sophora japonica root, Schizonepeta tenuifolia, Platycodon grandiflorum, Lianchi, Pseudostellaria baicalensis, Eclipta prostrata, Radix Trichosanthis, Purple Salvia miltiorrhiza, Pyrus trichosanthis, Curcuma aromatica, Ligusticum chuanxiong, stir-fried Angelica sinensis, Polygonum cuspidatum, Selaginella scoparia, Eucommia barbata, Smilax glabra, Rhizoma Cynanchum, Cinnamomum cassiae, and Radix Aconiti Lateralis Preparata, covering multiple functions such as tonifying, promoting qi, promoting blood circulation, removing dampness, tonifying yin, and detoxifying.

[0024] In terms of prescription compatibility, the membrane nephrosis prescription established by the application embodies the classic compatibility thought of "monarch, minister and assistant": Huangqi, Dangshen, Baizhu and Cangzhu, etc. supplement the spleen and kidney, and enhance the function of transportation and metabolism and water and liquid metabolism. Jingjie, Yujiegeng, Lianfei enhance the function of preventing external invasion, Taizishen, Hanliancao and Tianhuafen nourish yin and enhance the body's disease resistance. Huzhang, Shiwewe and Tufuling benefit dampness and detoxification; Chuanmou, Danggui and Yujin activate blood and dredge collaterals to improve kidney collateral stasis. Chuan Guizhi and Danfupian warm yang and warm kidney; Duzhong strengthen sinew and bone, and Chuanshandong break blood and resolve mass, and balance of supporting healthy qi and eliminating pathogenic factors, dredge collaterals and guide drugs to the diseased part. In general, the membrane nephrosis prescription established by the application takes "supplementing the spleen and kidney, eliminating toxin and nourishing yin, activating blood and dredging collaterals" as the framework, and achieves the synergistic effect through the combination of various medicinal ingredients, and improves the pathological process of PMN in multiple dimensions such as inflammation inhibition, oxidative stress relief and fibrosis intervention.

[0025] Advantages: Compared with the prior art, the application has the following advantages:

[0026] (1) According to the pathogenic characteristics of primary membranous nephropathy, the prescription is screened according to the theory of traditional Chinese medicine and clinical experience, and the whole prescription has multiple effects such as supplementing the spleen and kidney, eliminating toxin and nourishing yin, activating blood and resolving stasis, and at the same time, emphasizes the principle of supplementing the spleen and kidney, and slow and gentle treatment, eliminating toxin without being too harsh, nourishing yin without being too excessive, and the method of clearing, benefiting and activating blood is applied throughout the treatment. Clinical practice shows that the prescription can significantly reduce 24-hour urine protein, increase serum albumin, improve lipid metabolism disorder and edema symptoms, and improve the pathological process of PMN in multiple dimensions such as inflammation inhibition, oxidative stress relief and fibrosis intervention.

[0027] (2) The traditional Chinese medicine compound composition for treating primary membranous nephropathy provided by the application can be prepared into various dosage forms with a pharmaceutical carrier, and is convenient to take clinically, and experimental results show that the composition provided by the application has reliable curative effect and is safe to use, and has no toxic and side effects after long-term use. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 Comparison of 24-UTP (mg / 24h) before and after treatment;

[0029] Figure 2 Comparison of serum albumin (g / L) before and after treatment. DETAILED DESCRIPTION

[0030] The application can be better understood according to the following examples. However, those skilled in the art will readily understand that the specific material proportions, process conditions and their results described in the examples are only used to illustrate the application, and should not and will not limit the application described in detail in the claims.

[0031] Example 1

[0032] 1. A Chinese medicinal compound composition for treating primary membranous nephropathy, which is prepared from the following raw materials in parts by weight:

[0033] 30g of raw Astragalus, 15g of Radix Codonopsis pilosulae, 15g of Atractylodes macrocephalae, 15g of Atractylodes macrocephalae, 12g of old Sophora flavescens, 15g of Schizonepeta tenuifolia, 6g of Platycodon grandiflorum, 15g of Lianchi root, 15g of Pseudostellariae pseudoginseng, 15g of Eclipta prostrata, 20g of Radix Trichosanthis, 15g of Salvia miltiorrhizae, 20g of Pyrus trichosanthis root, 15g of Curcuma aromatica, 15g of Ligusticum chuanxiong, 15g of stir-fried Angelica sinensis, 20g of Polygonum cuspidatum, 20g of Pyrola, 20g of Eucommia barbata, 30g of Smilax glabra, and 40g of Rhizoma Cynoglossi.

[0034] 2. The preparation process provided by the present invention comprises the following steps:

[0035] Take the above Chinese medicinal materials according to their weight, first add 8 times the amount of water and soak for 30 minutes to allow the medicinal materials to fully absorb water and soften; then boil over high heat, then switch to low heat and maintain a slight boiling state for 30 minutes, and filter the medicinal liquid; add 6 times the amount of water for a second decoction, and boil for 20 minutes; combine the two decoctions, concentrate to an appropriate volume, package, and sterilize with circulating steam for 30 minutes to obtain the mixture.

[0036] Example 2

[0037] 1. A Chinese medicinal compound composition for treating primary membranous nephropathy, which is prepared from the following raw materials in parts by weight:

[0038] 30g of raw Astragalus, 15g of Radix Codonopsis pilosulae, 15g of Atractylodes macrocephalae, 15g of Rhizoma Atractylodis Macrocephalae, 12g of Rhizoma Sophorae flavescentis, 15g of Schizonepeta tenuifolia, 6g of Platycodon grandiflorum, 15g of Rhizoma Cyperi, 15g of Radix Pseudostellariae, 15g of Herba Ecliptae, 20g of Radix Trichosanthis, 15g of Radix Salviae Miltiorrhizae, 20g of Rhizoma Cyperi, 15g of Curcuma aromatica, 15g of Rhizoma Chuanxiong, 15g of stir-fried Radix Angelicae Sinensis, 20g of Polygonum cuspidatum, 20g of Pyrrosiae serratae, 20g of Eucommia barbata, 30g of Smilax glabrae, 40g of Rhizoma Cyperi, 10g of Cinnamomum cassiae, and 6g of Radix Aconiti Lateralis Preparata.

[0039] 2. A method for preparing a Chinese medicine compound composition for treating primary membranous nephropathy, comprising the following steps:

[0040] Take the above Chinese medicinal materials by weight, first add 10 times the amount of water and soak for 30 minutes to allow the medicinal materials to fully absorb water and soften; then boil over high heat, then reduce heat and maintain a slight boil for 30 minutes, and filter the medicinal liquid; add 8 times the amount of water for a second decoction, and boil for 20 minutes; combine the two decoctions, concentrate to obtain a concentrated solution, add an appropriate amount of dextrin, granulate with 85% ethanol, dry, and shape the particles to obtain granules.

[0041] Example 3

[0042] 1. A Chinese medicinal compound composition for treating primary membranous nephropathy, which is prepared from the following raw materials in parts by weight:

[0043] 60g of raw Astragalus, 30g of Radix Codonopsis pilosulae, 30g of Atractylodes macrocephalae, 30g of Atractylodes macrocephalae, 24g of old Sophora flavescens, 30g of Schizonepeta tenuifolia, 12g of Platycodon grandiflorum, 30g of Lianchi, 30g of Pseudostellariae pseudoginseng, 30g of Eclipta prostrata, 40g of Radix Trichosanthis, 30g of Salvia miltiorrhiza, 40g of Pyrus trichinellia root, 30g of Curcuma aromatica, 30g of Ligusticum chuanxiong, 30g of stir-fried Angelica sinensis, 40g of Polygonum cuspidatum, 40g of Selaginella dahurica, 40g of Eucommia ulmoides, 60g of Smilax glabra, 80g of Rhizoma Cynoglossi, 20g of Cinnamomum cassia twig, and 12g of Radix Aconiti Lateralis Preparata.

[0044] 2. A method for preparing a Chinese medicine compound composition for treating primary membranous nephropathy, comprising the following steps:

[0045] Take the above Chinese medicinal raw materials by weight, first add 12 times the amount of water and soak for 30 minutes to allow the medicinal materials to fully absorb water and soften; then boil over high heat, then switch to low heat and maintain a slight boiling state for 60 minutes, and filter the medicinal liquid; add 10 times the amount of water for a second decoction, and boil for 30 minutes; combine the two decoctions, concentrate to obtain a concentrated solution, vacuum dry, crush, and encapsulate to obtain capsules.

[0046] Example 4 Clinical efficacy test

[0047] 1. General Information Sources

[0048] Patients who visited the outpatient clinic and ward of the Nephrology Department of the Affiliated Hospital of Nanjing University of Chinese Medicine from January 2015 to June 2024 and were diagnosed with primary membranous nephropathy by renal puncture biopsy were included as research subjects.

[0049] 2. Research Plan

[0050] 2.1 Diagnostic criteria

[0051] 2.1.1 Western medicine diagnostic criteria

[0052] The main references are the following authoritative documents: Minutes of a Special Discussion on Diagnosis, Treatment and Efficacy Standards of Kidney Disease in 2003 and Nephrology (2020 Fourth Edition) edited by Professor Wang Haiyan

[47] . The diagnosis is based on the following: (1) Pathological examination of renal tissue biopsy: diffuse thickening of the glomerular basement membrane and spike formation can be seen under light microscopy; electron microscopy shows subepithelial electron-dense material deposition; immunofluorescence shows granular deposition of IgG and C3 along the capillary wall. (2) Pathological staging: Meet the diagnostic criteria for membranous nephropathy stage I or II. Secondary factors are excluded: autoimmune diseases such as systemic lupus erythematosus; infectious diseases such as hepatitis B virus; solid tumors or hematological malignancies; drug-related factors such as nonsteroidal anti-inflammatory drugs.

[0053] 2.1.2 TCM Syndrome Standards

[0054] Refer to the Chinese Internal Medicine (9th edition) and "Guidelines for Clinical Research of New Drugs of Chinese Medicine" to be prepared, in line with the TCM spleen-kidney deficiency, blood stasis and water-dampness syndrome 1 main syndrome and 1-2 syndromes can be diagnosed.

[0055] (1) Spleen-kidney deficiency

[0056] Main symptoms: soreness and weakness of the waist and knees, fatigue, edema, poor appetite or abdominal distension.

[0057] Syndrome: loose stools, frequent urination, night urination, pale tongue, teeth marks, white and thin, thin pulse.

[0058] (2) Blood stasis

[0059] Main symptoms: dark complexion, fixed or stabbing pain in the waist.

[0060] Syndrome: purple tongue, blood spots, thin and tight pulse.

[0061] (3) Water-dampness

[0062] Main symptoms: facial or limb edema.

[0063] Syndrome: tongue, white and greasy, thin pulse.

[0064] 2.2 Inclusion criteria

[0065] (1) In line with the diagnostic criteria of primary membranous nephropathy;

[0066] (2) In line with the TCM spleen-kidney deficiency, blood stasis and water-dampness syndrome;

[0067] (3) Age 18-85 years, gender unrestricted;

[0068] (4) 24h-UTP≤3.5g / d and ALB≥30g / L; GFR≥60ml / (min·1.73㎡); Follow-up time more than 6 months.

[0069] 2.3 Exclusion criteria

[0070] (1) Combined with serious other systemic diseases (serious infection, mental abnormalities, gastrointestinal bleeding, cardiovascular and cerebrovascular diseases);

[0071] (2) Pregnant or lactating women;

[0072] (3) Receive hormone and immunosuppressive therapy;

[0073] (4) Incomplete medical records, unable to evaluate the efficacy.

[0074] 2.4 Design

[0075] 2.4.1 Grouping

[0076] All patients in this study were from the outpatient or ward of the Department of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine. All patients were treated with the combination of traditional Chinese and Western medicine treatment plan, including Western medicine basic treatment and traditional Chinese medicine composition. Patients treated with membrane renal edema prescription were used as the observation group, and patients not treated with the prescription were used as the control group.

[0077] 2.4.2 Treatment regimen

[0078] 2.4.2.1 Combination of traditional Chinese and Western medicine treatment regimen

[0079] Western medicine basic treatment includes: (1) Diet management: adhere to the diet guidelines of low salt, low fat, and high quality protein. (2) Control blood pressure and proteinuria: use ACEI / ARB to reduce blood pressure and protein. (3) Lipid-lowering: statins for hypercholesterolemia and fibrates for hypertriglyceridemia. (4) Diuresis and edema reduction: according to the edema condition, use loop diuretics, thiazide diuretics or potassium-sparing diuretics, etc. (5) Improve hypercoagulable state: give aspirin enteric-coated tablets if necessary.

[0080] 2.4.2.2 Membrane renal edema prescription treatment regimen

[0081] The decoction prepared according to the traditional Chinese medicine raw material composition and preparation method of Example 2 of the present application is combined and concentrated to an appropriate volume, and taken 3 times after breakfast, lunch and dinner.

[0082] 2.4.2.3 Observation time

[0083] Regularly take medicine according to doctor's advice for 6 months.

[0084] 2.4.3 Observation index

[0085] 2.4.3.1 General information

[0086] The gender, age, pathological stage, history of hypertension, history of diabetes, etc. of the selected patients were observed.

[0087] 2.4.3.2 Efficacy index Main index: 24h-UTP, Alb; secondary index: TC, TG, Scr; safety index: Hb, ALT, AST, K+.

[0088] 2.5 Comprehensive efficacy evaluation standard

[0089] Refer to the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine" to develop Table 1 Clinical Comprehensive Efficacy Standard.

[0090] Table 1 Clinical Comprehensive Efficacy Evaluation Standard

[0091] Efficacy Description Clinical control 24-hour urinary protein excretion normal, normal renal function Marked efficacy 24-hour urinary protein excretion reduced by >40%, normal renal function Efficacy 24-hour urinary protein excretion reduced by <40%, normal renal function No efficacy Worsening or no improvement in clinical presentation and laboratory tests as described above

[0092] 2.6 Statistical method

[0093] SPSS 26.0 software was used for data analysis. First, the collected data were matched by propensity score nearest neighbor matching method 1:1. The matched data were tested for normality. For measurement data conforming to normal distribution, parametric test method was used: independent sample t test was used for group comparison, and paired sample t test was used for intra-group comparison, and the data were expressed as mean ± standard deviation. For non-normal distribution measurement data, non-parametric test method was used: Mann-Whitney U test was used for group comparison, and Wilcoxon signed rank test was used for intra-group comparison. Chi-square test was used for analysis of count data. Mann-Whitney U test was used for rank data. All statistical analyses were considered statistically significant at P<0.05.

[0094] 3. Results

[0095] 3.1 Case screening

[0096] A total of 208 PMN patients who met the PMN pathological diagnosis criteria were included in this study. Ten patients aged less than 18 years or more than 85 years were excluded, five patients with severe complications (severe infection, mental abnormalities, gastrointestinal bleeding, cardiovascular and cerebrovascular diseases) were excluded, 24 patients with 24h-UTP>3.5g / d or ALB<30g / L were excluded, 15 patients receiving hormone or immunosuppressive therapy were excluded, 4 patients with GFR<60ml / (min·1.73㎡) were excluded, and 5 patients with incomplete medical records were excluded. Finally, a total of 145 cases remained. Among the 145 patients, 87 patients were included in the observation group and 58 patients were included in the control group.

[0097] 3.2 Propensity score nearest neighbor matching results

[0098] A total of 145 PMN patients who met the inclusion and exclusion criteria were collected in this study, including 87 patients in the observation group and 58 patients in the control group. To reduce confounding bias, the age, sex, PMN pathological type, history of diabetes, history of hypertension, and baseline laboratory indicators of the 145 patients were introduced into the SPSS 26.0 software as covariates for propensity score nearest neighbor matching method 1:1 matching, and 39 patients in the observation group and 39 patients in the control group were obtained after matching. After normality test of the matched samples, the baseline data of the observation group and the control group were statistically analyzed, and the results showed that there was no statistically significant difference in age, sex, PMN pathological type, history of diabetes, history of hypertension, 24h-UTP, Alb, TC, TG, and Scr between the two groups after matching, and they were comparable. (See Table 2)

[0099] Table 2 Baseline characteristics of observation group and control group before and after matching

[0100]

[0101] Note: Comparison between groups, t test, rank test: a: P>0.05, b: P<0.05

[0102] 3.3 Comparison of efficacy

[0103] 3.3.1 Comparison of main efficacy indicators

[0104] 3.3.1.1 Comparison of 24-hour urinary protein excretion before and after treatment

[0105] Baseline data analysis showed that there was no significant difference in the 24h-UTP levels of patients in the two groups before treatment (P>0.05), indicating that the two groups were comparable. After 6 months of treatment, the 24h-UTP of patients in the two groups was significantly decreased (P<0.001), indicating that both treatment regimens could effectively reduce proteinuria. Further comparison between groups found that the 24h-UTP of the observation group decreased significantly more than that of the control group (P<0.01), indicating that the treatment regimen of the observation group had better clinical efficacy in reducing urinary protein excretion. The specific results are shown in Table 3, Figure 1 .

[0106] Table 3 Comparison of 24-UTP (mg / 24h) before and after treatment

[0107]

[0108] Note: ★Paired t test: P<0.001 within the observation group and the control group before and after treatment; After treatment, the comparison between groups conforms to the normal distribution but not to the homogeneity of variance, so the Mann-Whitney U test is used to calculate the P value between groups after treatment, and the result shows P<0.01.

[0109] 3.3.1.2 Comparison of serum albumin before and after treatment

[0110] Baseline characteristic analysis showed that there was no significant difference in the Alb levels of patients in the two groups before treatment (P>0.05), indicating that the two groups were comparable. After 6 months of treatment, the Alb levels of patients in the two groups were significantly increased (P<0.001), showing that both treatment regimens could effectively increase the serum albumin level. Further comparison between groups showed that the Alb of the observation group increased more than that of the control group (P<0.05), which had statistical significance, indicating that the treatment regimen of the observation group had more significant clinical efficacy in increasing serum albumin. The specific results are shown in Table 4, Figure 2 Efficacy Description Clinical control 24-hour urinary protein excretion normal, normal renal function Marked efficacy 24-hour urinary protein excretion reduced by >40%, normal renal function Efficacy 24-hour urinary protein excretion reduced by <40%, normal renal function No efficacy Worsening or no improvement in clinical presentation and laboratory tests as described above Figure 1 Figure 2 Efficacy Description Clinical control .

[0111] Table 4 Comparison of serum albumin (g / L) before and after treatment

[0112]

[0113] Note: By paired t-test: the P value of observation group and control group before treatment compared with after treatment within group were all <0.001; the comparison between groups after treatment was in accordance with normal distribution but not in accordance with variance homogeneity, therefore Mann-Whitney U test was used to calculate the P value between groups after treatment, the results showed P<0.05.

[0114] 3.3.2 Comparison of comprehensive efficacy

[0115] The efficacy evaluation after 6 months of treatment showed that the clinical efficacy distribution of the observation group was: 0 cases of clinical control, 26 cases of marked effect, 8 cases of effectiveness, and 5 cases of invalid; the efficacy distribution of the control group was: 0 cases of clinical control, 16 cases of marked effect, 9 cases of effectiveness, and 14 cases of invalid. The cases of clinical control, marked effect and effectiveness were all included in the effective treatment category. Statistical analysis results showed that the total effective rate of the observation group was 87.18%, which was significantly higher than 64.10% of the control group. By Mann-Whitney U rank test, the difference in comprehensive efficacy between the two groups had statistical significance (P<0.05), indicating that the treatment regimen of the observation group was superior to the control group in controlling proteinuria and improving treatment effect. See Table 5 for details.

[0116] Table 5 Comparison of total effective rate

[0117]

[0118] 3.3.3 Comparison of secondary efficacy indicators

[0119] Baseline data analysis showed that there was no significant difference in the levels of TC and TG between the two groups before treatment (P>0.05), indicating that the two groups were comparable. After 6 months of treatment, the levels of TC, TG and Scr in the two groups were significantly lower than those before treatment (P<0.001), suggesting that both treatment regimens could effectively improve lipid metabolism and renal function. Further comparison between groups found that the observation group performed better in improving lipid metabolism abnormalities: the decrease in TC and TG was significantly greater than that in the control group (P<0.05). See Table 6 for specific results.

[0120] Table 6 Comparison of TC, TG and Scr before and after treatment Mean±SD / M (P25, P75)

[0121]

[0122] Note: By paired t-test: the P value of observation group and control group before treatment compared with after treatment within group were all <0.001; the comparison between groups after treatment was in accordance with normal distribution but not in accordance with variance homogeneity, therefore Mann-Whitney U test was used to calculate the P value between groups after treatment, the results showed P<0.05.

[0123] 3.3.4 Safety indicators

[0124] During the treatment, the K+, ALT and AST of the patients in both groups were normal, and no adverse reactions occurred.

[0125] 4. Summary of curative effect

[0126] 4.1 Comprehensive evaluation of curative effect

[0127] Decreasing 24-hour urinary protein quantification

[0128] Proteinuria, as one of the core clinical manifestations of primary membranous nephropathy (PMN), is not only an important indicator for evaluating disease activity, but also a prognostic risk factor independent of renal function. The level and duration of urinary protein are closely related to the renal outcome, so effective control of proteinuria is the key goal of PMN treatment. The present study found that after 6 months of standardized treatment, the 24-hour urinary protein quantification of the patients in both groups was significantly reduced compared with the baseline level (P<0.001), and the decrease in the observation group was significantly better than that in the control group (P<0.01). This result suggests that the Membrane Kidney Edema Prescription established in the present application has a significant effect in reducing urinary protein excretion, and its mechanism of action may involve the regulation of T lymphocyte subsets to play an immune regulatory role, improve the permeability of the glomerular filtration membrane, and inhibit podocyte damage and basement membrane thickening. From the perspective of traditional Chinese medicine theory, the formation of proteinuria is mainly due to deficiency of both the spleen and the kidney. Deficiency of the spleen weakens the ascending function of the spleen, and deficiency of the kidney leads to the failure of containment, resulting in the excretion of subtle substances and the formation of proteinuria. The Membrane Kidney Edema Prescription has the effect of tonifying Qi and invigorating the spleen, which can enhance the ascending function of the spleen; improve the transportation function of the spleen by drying dampness and invigorating the spleen; and warm and tonify the kidney Yang to enhance the containment ability of the kidney. The combined use of various drugs can invigorate the spleen and tonify the kidney, ascend and contain, thereby reducing the excretion of subtle substances and reducing the level of urinary protein. In addition, the Membrane Kidney Edema Prescription may further protect the glomerular filtration barrier and delay the progression of PMN through multiple mechanisms such as regulating immune system function, reducing inflammatory response and antioxidant stress.

[0129] Increasing serum albumin

[0130] From the theory of Zang-fu organs in TCM, the spleen is the foundation of acquired constitution, which is responsible for the transportation and transformation of water and food essence and has the function of ascending clear and descending turbid. When the spleen is in good condition, water and food essence can be transported and distributed normally to nourish the whole body. When the spleen is weak, the transportation and transformation of water and food essence is impaired, leading to the deficiency of Qi and blood, the failure of clear and turbid to ascend and descend, and the decline of albumin level and malnutrition. In this study, after 6 months of standardized treatment, the serum albumin levels of the two groups of patients were significantly higher than those at baseline (P<0.001), and the increase in the observation group was significantly better than that in the control group (P<0.05). This result suggests that the Membranous Nephropathy Edema Decoction has a significant effect on improving the nutritional status of PMN patients. From the analysis of TCM pathogenesis, before treatment, patients had weak spleen and stomach, which led to the failure of water and food essence to be transported and distributed normally, resulting in the decline of albumin level and malnutrition. With the progress of treatment, the Membranous Nephropathy Edema Decoction can make essence and substance be transported and distributed normally to nourish the whole body through the function of invigorating the spleen and replenishing Qi, thereby improving the albumin level and nutritional status of patients. From the perspective of modern medicine, with the decrease of 24-UTP and the improvement of protein metabolism, the serum albumin level is steadily increased. In summary, the Membranous Nephropathy Edema Decoction can significantly improve the serum albumin level of PMN patients and improve their nutritional status by improving the function of the spleen and stomach and reducing proteinuria.

[0131] Improving lipid metabolism disorder

[0132] Primary membranous nephropathy patients often have lipid metabolism disorder, mainly manifested as a significant increase in TC and TG levels, which is closely related to the decline in Alb. The decline in Alb level leads to a decrease in plasma colloid osmotic pressure, which in turn activates the synthesis of liver lipoprotein and inhibits the activity of lipoprotein lipase, ultimately leading to hyperlipidemia and hypercoagulable state. Therefore, correcting lipid metabolism disorder and improving hypercoagulable state are important goals of PMN treatment. In this study, after 6 months of standardized treatment, the TC and TG levels of the two groups of patients were significantly lower than those at baseline (P<0.001), and the decrease in the observation group was significantly better than that in the control group (P<0.05). This result suggests that the Membranous Nephropathy Edema Decoction has a significant effect on regulating lipid metabolism, and its mechanism may be related to the improvement of albumin level, the restoration of plasma colloid osmotic pressure, the regulation of lipoprotein metabolism-related enzyme activity, and the improvement of liver lipid metabolism function. From the perspective of TCM theory, hyperlipidemia can be attributed to the "blood stasis" category, and its pathogenesis is mainly related to the stagnation of Qi and blood and the obstruction of phlegm and turbidity. The drugs such as Danshen, Danggui, and Chuanqiong in the Membranous Nephropathy Edema Decoction have the functions of promoting blood circulation and removing blood stasis, dredging collaterals and resolving turbidity, which are in line with this treatment principle and can improve the circulation of Qi and blood, promote the dispersion of phlegm and turbidity, and thus regulate lipid metabolism disorder. In addition, Huangqi and Duzhong in the Membranous Nephropathy Edema Decoction have the functions of tonifying Qi and spleen and warming and tonifying kidney Yang, which can enhance the metabolic function of the body; Cangshu and Chao Baizhu can improve the function of the spleen and stomach through drying dampness and invigorating the spleen, thereby promoting the normal metabolism of lipids and effectively improving the lipid metabolism disorder state of PMN patients.

[0133] Decreasing edema

[0134] The study found that after 6 months of standardized treatment, the edema symptoms of patients in both groups were relieved, especially after the treatment of the film kidney edema prescription of the application, Chuan Gui Zhi and Dan Fu Pian can warm Yang and relieve damp-heat, and canogia root can remove damp-heat, which can significantly reduce the edema symptoms of PMN patients and achieve obvious curative effect.

[0135] Safety analysis

[0136] After 6 months of treatment, the levels of serum creatinine, serum potassium, glutathione transaminase and glutathione transaminase in patients in both groups did not show obvious abnormalities, and no adverse events occurred. This result shows that the film kidney edema prescription has high safety in the treatment of primary membranous nephropathy. The film kidney edema prescription can not only effectively relieve the clinical symptoms of PMN through multiple mechanisms such as regulating the immune system, improving renal hemodynamics and protecting renal function, but also avoid the common adverse reactions in traditional treatment (such as liver and kidney function damage and electrolyte disturbance). This reflects that the film kidney edema prescription shows good safety and clinical application prospect in the treatment of PMN.

[0137] The film kidney edema prescription provided by the application can reduce the 24-hour urine protein quantification of PMN patients, increase serum albumin, improve lipid metabolism disorder and edema, and delay the occurrence and development of the disease; and has good safety.

[0138] The above embodiments only serve to illustrate the technical concept and characteristics of the application, and the purpose is to enable those skilled in the art to understand the content of the application and implement it, and cannot limit the protection scope of the application, and any equivalent changes or modifications made according to the spirit and essence of the application should be covered within the protection scope of the application.

Claims

1. A Chinese medicinal compound composition for treating primary membranous nephropathy, characterized in that: It is made from the following raw materials in parts by weight: 30-90 parts of raw Astragalus, 15-45 parts of Radix Codonopsis pilosulae, 15-45 parts of Rhizoma Atractylodis Macrocephalae, 15-45 parts of Rhizoma Atractylodis Macrocephalae, 12-36 parts of Rhizoma Schizonepetae, 6-18 parts of Radix Platycodonis, 15-45 parts of Rhizoma Polygoni Multiflori, 15-45 parts of Radix Pseudostellariae, 15-45 parts of Rhizoma Ecliptae, 20-60 parts of Radix Trichosanthis, 15-45 parts of Radix Salviae Miltiorrhizae, 20-60 parts of Radix Pyriferae, 15-45 parts of Radix Curcumae Radix, 15-45 parts of Rhizoma Chuanxiong, 15-45 parts of stir-fried Radix Angelicae Sinensis, 20-60 parts of Rhizoma Polygoni Cuspidati, 20-60 parts of Rhizoma Pyriferae, 20-60 parts of Eucommia ulmoides, 30-90 parts of Rhizoma Smilacis Glabrae, and 40-120 parts of Rhizoma Dioscoreae.

2. A Chinese medicinal compound composition for treating primary membranous nephropathy according to claim 1, characterized in that: It is made from the following raw materials in parts by weight: 30-60 parts of raw Astragalus, 15-30 parts of Radix Codonopsis pilosulae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 12-24 parts of Rhizoma Schizonepetae, 6-12 parts of Radix Platycodonis, 15-30 parts of Rhizoma Polygoni Multiflori, 15-30 parts of Radix Pseudostellariae, 15-30 parts of Radix Ecliptae, 20-40 parts of Radix Trichosanthis, 15-30 parts of Radix Salviae Miltiorrhizae, 20-40 parts of Radix Pyriferae, 15-45 parts of Radix Curcumae, 15-30 parts of Rhizoma Chuanxiong, 15-30 parts of stir-fried Radix Angelicae Sinensis, 20-40 parts of Polygonum cuspidatum, 20-40 parts of Pyrrosiae serratae, 20-40 parts of Eucommia ulmoides, 30-60 parts of Smilax glabrae, and 40-80 parts of Rhizoma Dioscoreae.

3. A Chinese medicinal compound composition for treating primary membranous nephropathy according to claim 2, characterized in that: It is made from the following raw materials in parts by weight: 30 parts of raw astragalus, 15 parts of Radix Codonopsis pilosulae, 15 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of old Sophora flavescens, 15 parts of Herba Schizonepetae, 6 parts of Platycodon grandiflorum, 15 parts of Rhizoma Polygoni Multiflori, 15 parts of Radix Pseudostellariae, 15 parts of Herba Ecliptae, 20 parts of Radix Trichosanthis, 15 parts of Radix Salviae Miltiorrhizae, 20 parts of Radix Pyriferae, 15 parts of Radix Curcumae Radix, 15 parts of Rhizoma Chuanxiong, 15 parts of stir-fried Radix Angelicae Sinensis, 20 parts of Polygonum cuspidatum, 20 parts of Pyrrosiae serratae, 20 parts of Eucommia barbatae, 30 parts of Smilax glabrae, and 40 parts of Rhizoma Dioscoreae.

4. A Chinese medicinal compound composition for treating primary membranous nephropathy, characterized in that: It is made from the following raw materials in parts by weight: 30-60 parts of raw Astragalus, 15-30 parts of Radix Codonopsis pilosulae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 12-24 parts of Rhizoma Sophorae Fructus, 15-30 parts of Herba Schizonepetae, 6-12 parts of Radix Platycodonis, 15-30 parts of Rhizoma Polygoni Multiflori, 15-30 parts of Radix Pseudostellariae, 15-30 parts of Herba Ecliptae, 20-40 parts of Radix Trichosanthis, 15-30 parts of Radix Salviae Miltiorrhizae, 20-40 parts of Radix Pyriferae, 15-45 parts of Radix Curcumae, 15-30 parts of Rhizoma Chuanxiong, 15-30 parts of stir-fried Radix Angelicae Sinensis, 20-40 parts of Polygonum cuspidatum, 20-40 parts of Pyrrosiae serratae, 20-40 parts of Eucommia ulmoides, 30-60 parts of Smilax glabrae, 40-80 parts of Rhizoma Cynoglossi, 10-20 parts of Rhizoma Cinnamomi, and 6-12 parts of Radix Aconiti Lateralis Preparata.

5. A Chinese medicinal compound composition for treating primary membranous nephropathy according to claim 4, characterized in that: It is made from the following raw materials in parts by weight: 30 parts of raw astragalus, 15 parts of Radix Codonopsis pilosulae, 15 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of old stems of Sophora flavescens, 15 parts of Herba Schizonepetae, 6 parts of Platycodon grandiflorum, 15 parts of Rhizoma Coptidis, 15 parts of Radix Pseudostellariae, 15 parts of Herba Ecliptae, 20 parts of Radix Trichosanthis, 15 parts of Radix Salviae Miltiorrhizae, 20 parts of Radix Pyriferae, 15 parts of Radix Curcumae Radix, 15 parts of Rhizoma Chuanxiong, 15 parts of stir-fried Radix Angelicae Sinensis, 20 parts of Polygonum cuspidatum, 20 parts of Pyrrosiae pyrifera, 20 parts of Eucommia barbata, 30 parts of Rhizoma Smilacis Glabrae, 40 parts of Rhizoma Dioscoreae, 10 parts of Radix Cassiae, and 6 parts of Radix Aconiti Lateralis Preparata.

6. The method for preparing the Chinese medicinal compound composition for treating primary membranous nephropathy according to any one of claims 1 to 5, characterized in that: The following steps are involved: Take each Chinese medicinal raw material according to weight, soak it in water first, then decoct it for 1 to 4 times, each time for 20 to 180 minutes, filter it, combine the filtrates, and concentrate the filtrates under reduced pressure to obtain an extract; or add a pharmaceutically acceptable carrier to prepare a Chinese medicinal preparation.

7. The method for preparing the Chinese medicinal compound composition for treating primary membranous nephropathy according to claim 6, characterized in that: The following steps are involved: Take each Chinese medicinal raw material by weight, soak it in water first, and soak all the medicines in cold water for 30 minutes to allow the medicines to fully absorb water and soften; add water in an amount sufficient to immerse the medicines by 2-3 cm for the first decoction, boil over high heat, then switch to low heat and maintain a slight boil for 30 minutes, and filter the medicinal liquid; add water in an amount of 2 / 3 of the first decoction amount for the second decoction, and boil for 20 minutes; combine the two decoctions and concentrate them to an appropriate volume; or add a pharmaceutically acceptable carrier to prepare a Chinese medicine preparation.

8. The method for preparing the Chinese medicinal compound composition for treating primary membranous nephropathy according to claim 6 or 7, characterized in that: The Chinese medicine preparations include granules, tablets, capsules, pills, oral liquids or mixtures.

9. Use of the Chinese herbal compound composition according to any one of claims 1 to 4 in the preparation of medicaments for preventing and treating membranous nephropathy.

10. Use of the traditional Chinese medicine compound composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating primary membranous nephropathy.

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