A traditional Chinese medicine compound for reducing urinary protein, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine compound for reducing urinary protein, a traditional Chinese medicine preparation and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compounds. The technical problem that the existing western medicine can reduce the urinary protein level of a patient to a certain extent, has a relatively high risk of adverse reactions, and has poor long-term curative effect and obvious symptom recurrence after drug withdrawal is solved. According to weight parts, the traditional Chinese medicine compound is composed of the following raw medicinal materials: Radix Rehmanniae Preparata 10-30 parts, Rhizoma Dioscoreae 10-30 parts, Fructus Corni 10-30 parts, Radix Hedysari 10-20 parts, Fructus Schisandrae 5-15 parts, Semen Luffae 5-15 parts, Corn Silk 10-30 parts, Rhizoma Alismatis 10-30 parts, Radix Astragali 10-30 parts, Fructus Rosae Laevigatae 10-30 parts, Semen Euryales 10-30 parts, Semen Astragali Complanati 5-15 parts, Radix Salviae Miltiorrhizae 5-30 parts, Rhizoma Rhei 3-10 parts and Rhizoma Coptidis 3-5 parts. The various components are compatible, complement each other, increase the effect of reducing urinary albumin and protecting the kidney, and are reasonably combined to achieve the effect of coordination and synergism.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine compound technology, specifically relating to a traditional Chinese medicine compound for reducing proteinuria, a traditional Chinese medicine preparation and its preparation method. Background Technology

[0002] Currently, diabetic nephropathy is one of the major microvascular complications of diabetes, characterized primarily by proteinuria. As the disease progresses, the amount of protein in the urine gradually increases, eventually leading to massive proteinuria, which is a major cause of end-stage renal disease. Timely diagnosis and effective management of diabetic nephropathy to slow disease progression remain significant clinical challenges. Although the emergence of drugs such as sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists, novel nonsteroidal mineralocorticoid receptor antagonists, and endothelin antagonists has brought new hope to the management of diabetic nephropathy, these Western medical treatments can only produce partial efficacy for the treatment of diabetic nephropathy. Most treatments still focus on symptomatic relief, such as controlling blood sugar, blood pressure, and blood lipids, and improving microcirculation.

[0003] However, the current treatment method using Western medicine still has the following problems: although Western medicine can reduce the level of protein in the urine to a certain extent, the long-term efficacy is not good, and the patient's symptoms recur significantly after stopping the medication. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine compound for reducing proteinuria, a traditional Chinese medicine preparation thereof, and a method for preparing the same.

[0005] The kidneys are the "foundation of storage," responsible for preserving essential nutrients. When kidney yin is deficient, this function fails, leading to symptoms such as seminal emission, night sweats, frequent urination, and metrorrhagia, all of which result in the leakage of essential nutrients. Albumin is one such "essential substance." Rehmannia glutinosa (Shu Di Huang) is slightly warm in nature and sweet in taste, entering the liver and kidney meridians. As the principal herb, it specifically nourishes kidney yin and is known as a "great tonic for true water." By nourishing kidney yin, it restores the kidneys' ability to retain nutrients, thereby reducing the loss of essential nutrients. When used in combination with other herbs, it strengthens the kidneys and consolidates the foundation, addressing the root cause of deficiency by enhancing storage, while clearing damp-heat and resolving blood stasis to treat the symptoms. The formula consists of yam, cornus officinalis, achyranthes bidentata, schisandra chinensis, dodder seed, corn silk, alisma plantago-aquatica, astragalus membranaceus, stir-fried rosehip kernel, euryale ferox, and astragalus complanatus, all serving as assistant herbs. Rehmannia glutinosa, combined with yam and cornus officinalis, nourishes kidney yin, replenishes essence, and tonifies all three yin channels, restoring the kidney's function of storing essence. Achyranthes bidentata guides the medicine downwards, directing blood (fire) downwards, restoring the body's vital energy, and reducing premature ejaculation. Schisandra chinensis astringes sweat and consolidates essence, euryale ferox consolidates the kidneys and astringes essence, and rosehip reduces urination and stops enuresis; these three herbs together form a "barrier of astringency," reducing the loss of essence (protein). Dodder seed and astragalus complanatus are warm but not drying, tonifying kidney yang to aid qi transformation, working synergistically with Rehmannia glutinosa to "seek yang within yin." Corn silk, alisma plantago-aquatica, and astragalus membranaceus together tonify qi and promote water metabolism, eliminating edema, clearing the upper and lowering the lower, reducing proteinuria, treating both qi and water, and regulating the ascending and descending of qi. Salvia miltiorrhiza, rhubarb processed with wine, and Coptis chinensis processed with wine are used as adjuvant herbs. Salvia miltiorrhiza is slightly cold and clears heat from the blood, while rhubarb processed with wine is bitter and cold and drains heat from blood stasis. This dual approach clears heat from blood stasis. Salvia miltiorrhiza invigorates blood without harming the body's vital energy, while rhubarb has a strong effect in breaking up blood stasis. The wine processing moderates its intensity. Salvia miltiorrhiza unblocks blood vessels, while rhubarb processed with wine unblocks the intestines and bowels, draining blood stasis and turbidity through both the intestines and blood vessels. The combination of these two herbs combines cooling and dispersing properties, and promotes mutual benefit in breaking up and clearing up blood stasis, thus regulating the internal organs and collaterals. Coptis chinensis processed with wine is bitter and cold and acts as a counteracting agent to prevent Astragalus membranaceus and Cuscuta chinensis from warming and tonifying and generating fire, and Rosa laevigata and Euryale ferox from astringing and retaining damp heat. Coptis chinensis processed with wine clears away damp heat, maintaining a balance between astringency and unblocking. Each component complements the others, increasing the effect of reducing urinary albumin and protecting the kidneys. The reasonable combination of each component achieves a synergistic effect.

[0006] The technical solution adopted in this invention is as follows:

[0007] A traditional Chinese medicine compound for reducing proteinuria, composed of the following raw materials by weight:

[0008] Prepared Rehmannia root, 10-30 parts;

[0009] Rehmannia glutinosa, slightly warm in nature and sweet in taste, primarily enters the liver and kidney meridians. In traditional Chinese medicine (TCM) theory, its core functions are nourishing blood and yin, replenishing essence and marrow. TCM believes that "the kidney governs water" and "the kidney stores essence." Chronic kidney disease (CKD) often manifests as "kidney yin deficiency" or "kidney essence deficiency," presenting with symptoms such as lower back and knee weakness, dizziness, tinnitus, night sweats, and proteinuria. Rehmannia glutinosa is a key herb for nourishing kidney yin and replenishing kidney essence. It nourishes the yin essence of the kidney, balances kidney yin and yang, and enhances the kidney's ability to retain essence. When kidney qi is sufficient and its storage capacity is strong, it can reduce the leakage of essential substances (such as protein) in urine, helping to improve proteinuria. Rehmannia glutinosa contains active ingredients such as rehmannia glutinosa alcohol and rehmannia glycosides, which have significant antioxidant effects. They can eliminate excess free radicals in the body and reduce oxidative damage to kidney tissue cells, a common pathway in the progression of various kidney diseases. Rehmannia glutinosa extract can inhibit various inflammatory factors (such as TNF-α, ...). The production and release of IL-6 (and other substances) can reduce the inflammatory response in the kidneys, and chronic inflammation is a major factor leading to kidney damage and persistent proteinuria. Furthermore, Rehmannia glutinosa can indirectly reduce the damage to the kidneys caused by metabolic factors by regulating immune cell function, reducing the deposition of immune complexes in the kidneys and related immune damage, and regulating glucose and lipid metabolism.

[0010] 10-30 parts yam;

[0011] Yam, sweet in taste and warm in nature, has the effects of strengthening the spleen, tonifying the lungs, consolidating the kidneys, and benefiting essence. Traditional Chinese medicine believes that proteinuria is related to deficiency of both the spleen and kidneys; when the spleen's qi is not consolidated, essence is lost; when the kidney's qi is not retained, its function of storing essence is impaired. Yam can tonify the spleen and stomach, nourish kidney yin, and astringe essence to consolidate retention. By restoring the spleen's digestive function and the kidney's ability to store essence, it reduces protein loss. The core active ingredient of yam, "yam polysaccharide," inhibits inflammatory factors, reduces the expression of monocyte chemoattractant protein-1 (MCP-1) in renal tissue, reduces inflammatory cell infiltration, and alleviates kidney inflammation damage; it scavenge free radicals, reducing oxidative stress damage to the glomeruli through antioxidant effects and delaying renal fibrosis; it improves metabolic indicators, reducing blood glucose, 24-hour urinary protein, serum creatinine, and blood urea nitrogen in diabetic nephropathy animals; it enhances the body's immune function and improves the body's resistance to disease; and it protects the kidneys by regulating the intestinal microecology and improving the intestinal flora structure.

[0012] Cornus officinalis 10-30 parts;

[0013] Cornus officinalis, with a sour and astringent taste and slightly warm properties, has the effects of tonifying the liver and kidneys, and astringing and consolidating. It is a traditional Chinese medicine for tonifying the liver and kidneys, and has a significant effect on improving kidney function, especially in diabetic nephropathy and reducing proteinuria. Iridoid glycosides in Cornus officinalis (such as cornusoside and loganin) can significantly reduce the expression of renal inflammatory factors, such as inhibiting the secretion of IL-6, TNF-α, and MCP-1, reducing glomerular and tubular inflammatory damage, thereby reducing protein leakage. Cornus officinalis inhibits the process of renal fibrosis by downregulating the TGF-β1 / Smads signaling pathway, reducing the deposition of extracellular matrix (such as type IV collagen), and protecting the integrity of the glomerular filtration barrier. It also inhibits the Wnt / β-catenin pathway, reduces YKL-40 expression, and delays glomerular sclerosis. Components such as loganin in Cornus officinalis can block the binding of advanced glycation end products (AGEs) to their receptors (RAGE), reducing oxidative stress and podocyte apoptosis, and reducing proteinuria. Cornus officinalis can also significantly reduce serum creatinine (Scr) and blood urea nitrogen (BUN) levels in diabetic nephropathy rats, reduce the metabolic burden on the kidneys, increase the activity of glutathione (GSH) in the kidneys, scavenge free radicals, inhibit oxidative stress pathways such as NF-κB, protect renal tubular epithelial cells, and delay basement membrane thickening and podocyte loss.

[0014] 10-20 parts of Achyranthes bidentata;

[0015] Achyranthes bidentata, bitter and sour in taste, neutral in nature, enters the liver and kidney meridians. It has the effects of dispelling blood stasis and promoting menstruation, tonifying the liver and kidneys, strengthening tendons and bones, promoting diuresis and relieving strangury, and guiding blood downwards. Achyranthes bidentata can reduce kidney inflammation by lowering inflammation-related factors, such as reducing serum TNF-α and IL-6; it can significantly inhibit apoptosis by reducing p53 mRNA expression and increasing mdm2 mRNA expression, protecting the integrity of the glomerular filtration barrier and reducing protein leakage; the AGE-RAGE signaling pathway plays an important role in diabetic nephropathy, and Achyranthes bidentata can protect the kidneys by intervening in this pathway; Achyranthes bidentata extract can also protect the kidneys by reducing the influence of oxidase / reactive oxygen species / ERK signaling pathways, reducing oxidative stress, and lowering blood urea nitrogen (BUN), creatinine (BCr), and 24-hour urinary protein (UPr).

[0016] Schisandra chinensis 5-15 parts;

[0017] Schisandra chinensis, warm in nature and sour and sweet in taste, was first recorded in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica). It possesses astringent, qi-tonifying, fluid-generating, kidney-tonifying, and heart-calming effects. Lignans are important active components of Schisandra chinensis, mainly including schisandrin A and schisandrin C. Schisandrin A has multiple effects, including antioxidant activity, inhibition of apoptosis, and immune regulation. Schisandrin A can alleviate ferroptosis and NLRP3 inflammasome-mediated pyroptosis in renal cells of diabetic nephropathy patients by regulating the AdipoR1 / AMPK-ROS / mitochondrial damage signaling pathway, thereby reducing the severity of kidney damage. Schisandra chinensis can also regulate the Wnt / β-catenin signaling pathway, reduce tubular epithelial-interstitial transdifferentiation (EMT), and decrease extracellular matrix deposition, thus alleviating proteinuria.

[0018] Cuscuta chinensis 5-15 parts;

[0019] Cuscuta seed, with a pungent and sweet taste and neutral properties, possesses the effects of tonifying the liver and kidneys, strengthening essence and reducing urination, calming the fetus, and improving eyesight. The chemical components in cuscuta seed may have anti-inflammatory effects, helping to reduce inflammatory responses in the kidneys. Cuscuta seed polysaccharides and other components have the ability to scavenge free radicals, helping to protect kidney cells from oxidative stress damage; cuscuta seed also has immunomodulatory effects, potentially reducing immune-mediated damage in kidney disease by regulating the immune system. Cuscuta seed methanol extract can lower serum urea, uric acid, blood urea nitrogen, and creatinine, and reduce kidney weight gain and histopathological changes.

[0020] 10-30 parts corn silk;

[0021] Corn silk, slightly warm in nature and sweet and bland in taste, has the effects of promoting diuresis and reducing swelling, and relieving jaundice. It is mainly used to treat edema and jaundice. Corn silk has a strong diuretic and kidney-protective effect, and can improve edema caused by protein loss. The protective effect of corn silk on the kidney function of rats is related to its anti-inflammatory effect. Water extract of corn silk can reduce the levels of blood glucose, kidney index, serum urea nitrogen, serum creatinine, and 24-hour urinary protein in diabetic rats, downregulate the expression of fibrosis factors in the kidney tissue of rats with kidney disease, and regulate the production and degradation of extracellular matrix, thereby alleviating the pathological damage to the kidneys of diabetic nephropathy rats and exerting its kidney-protective effect.

[0022] Alisma plantago-aquatica 10-30 parts;

[0023] Alisma plantago-aquatica, sweet and bland in taste, and cold in nature, has the effects of promoting diuresis and eliminating dampness, clearing heat, resolving turbidity and lowering lipids. The triterpenoids in Alisma plantago-aquatica, especially 23-acetylalizool B, have a significant anti-renal fibrosis effect. It reduces renal fibrosis by affecting the TGF-β / Smad signaling pathway, downregulating the expression of proteins such as α-SMA, collagen I, and fibronectin in renal tissue, and significantly reducing serum creatinine, urea, and urinary protein levels in rats. Alisma plantago-aquatica also has antioxidant and anti-inflammatory effects, reducing oxidative stress and inflammatory responses, which are important factors leading to the progression of kidney disease. It has a diuretic effect, helping to reduce water and sodium retention in the body and reduce the burden on the kidneys. Alisma plantago-aquatica can regulate blood lipids, reduce dyslipidemia, and reduce lipid peroxidation damage to the kidneys. Alisma plantago-aquatica also has immunomodulatory effects, affecting the activity of the reticuloendothelial system and anti-complement activity, thus having a positive impact on immune-mediated kidney diseases.

[0024] 10-30 parts of raw Astragalus membranaceus;

[0025] Raw astragalus, sweet and slightly warm in nature, enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, strengthening the defensive qi and consolidating the exterior, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification. Its sweet and warm nature tonifies and raises, while its bland nature promotes diuresis and eliminates pathogenic factors. Raw astragalus is suitable when there is both tonification and pathogenic factors present. The formation of proteinuria is closely related to the dysfunction of the lungs, spleen, and kidneys. In traditional Chinese medicine theory, the lungs, spleen, and kidneys are important organs for maintaining fluid balance and essential substances in the body, and are the cornerstone of human health. The kidneys, as the root of the body, have the function of governing water and regulating the whole body. The circulation and metabolism of fluids, kidney qi deficiency or blood stasis in the kidney meridians can all lead to dysfunction of the kidney's sealing and storage, resulting in the leakage of essential substances and the formation of proteinuria. In addition, prolonged damp-heat may also interfere with the normal function of the kidneys, further triggering the production of proteinuria. Therefore, the production of proteinuria is a mixed deficiency and excess syndrome, not a purely deficiency syndrome. Thus, raw astragalus is used to replenish qi and tonify deficiency, preventing the loss of essential substances such as protein. On the other hand, raw astragalus can promote diuresis and reduce swelling, allowing damp-heat and turbid pathogens to be excreted through urine, thus achieving the overall effect of eliminating pathogens and supporting the body's resistance.

[0026] Stir-fried rose hips (10-30 servings);

[0027] Stir-fried rosehip pulp is neutral in nature and has a sour and astringent taste. It enters the kidney, bladder, and large intestine meridians and has the effect of consolidating essence and reducing urination. Rosehip contains various chemical components and active substances such as polysaccharides, triterpenes, tannins, flavonoids, glycosides, flavanols, steroids, fatty acids, catechins, and carbohydrates, which play an important role in improving kidney function and reducing proteinuria. Stir-fried rosehip enhances the kidney's ability to store essence and reduces the loss of essential substances (such as protein), making it suitable for seminal emission, frequent urination, and proteinuria caused by kidney deficiency. The polysaccharides and tannins in rosehip can scavenge free radicals, reduce oxidative stress damage, repair the glomerular basement membrane, and reduce protein leakage.

[0028] 10-30 parts of fox nuts;

[0029] Euryale ferox has the effects of tonifying the kidneys and securing essence, strengthening the spleen and stopping diarrhea, and eliminating dampness and stopping leukorrhea. When combined with stir-fried Rosa laevigata, along with rhubarb and Coptis chinensis (both with wine) which have heat-clearing and detoxifying properties, Euryale ferox works together to eliminate proteinuria in kidney disease and reduce inflammatory symptoms. The flavonoids contained in Euryale ferox can fight inflammation, scavenge oxygen free radicals, reduce secondary damage caused by increased oxygen free radicals in kidney disease, and reduce the secretion of renin and angiotensin, thereby helping to reduce proteinuria. In addition, Euryale ferox can also improve microcirculation, improve blood supply to diseased kidneys, and reduce the pressure on the kidneys.

[0030] 5-15 portions of Astragalus complanatus;

[0031] Astragalus complanatus seeds, warm in nature and sweet in taste, enters the liver and kidney meridians. It has the effects of tonifying the kidneys and strengthening yang, consolidating essence and reducing urination, and nourishing the liver and improving eyesight. Astragalus complanatus seeds also have lipid-regulating, anti-inflammatory, antioxidant, and immune-regulating effects. Total flavonoids from Astragalus complanatus seeds can significantly reduce serum and renal inflammatory factors (TNF-α, IL-6), alleviate glomerular inflammatory damage, increase renal superoxide dismutase (SOD) activity, reduce malondialdehyde (MDA) content, alleviate oxidative stress damage to podocytes, improve diabetic kidney damage, reduce serum creatinine and blood urea nitrogen levels, and improve kidney morphology.

[0032] Salvia miltiorrhiza 5-30 parts;

[0033] Salvia miltiorrhiza has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, and relieving pain. It also has the effects of anti-oxidative stress, anti-inflammation, anti-tumor, anti-fibrosis, anti-atherosclerosis, lowering blood pressure, and regulating blood lipids. Salvia miltiorrhiza and its active ingredients can reduce systolic blood pressure by inhibiting angiotensin-converting enzyme activity, which has a positive effect on blood pressure control in hypertensive nephropathy. Many components in Salvia miltiorrhiza have antioxidant activity, which can reduce oxidative stress levels and reduce kidney damage. Salvia miltiorrhiza can reduce cell apoptosis and protect the kidneys by regulating the expression of epithelial-mesenchymal transition-related proteins. The combination of Astragalus membranaceus and Salvia miltiorrhiza can improve the extraction rate of active ingredients in Salvia miltiorrhiza, achieve a great synergistic effect, and produce new anti-renal fibrosis active ingredients.

[0034] 3-10 parts of rhubarb in wine;

[0035] Rhubarb processed with wine is a product of rhubarb that has been processed with wine. Its properties are bitter and cold, with a slightly milder purgative effect, while also possessing the effects of promoting blood circulation and removing blood stasis. It has a significant effect on improving kidney function and reducing proteinuria. Rhubarb processed with wine improves renal microcirculation by promoting blood circulation, removing blood stasis, and clearing the bowels, thus reducing renal fibrosis and inflammatory damage. It is suitable for diseases such as chronic renal failure (CRF) and diabetic nephropathy (especially stages III-IV). Rhubarb processed with wine slows glomerular sclerosis and interstitial fibrosis by downregulating the expression of the pro-fibrotic factor TGF-β1 and upregulating the inhibitory factor Smad7, protecting the integrity of the filtration barrier, inhibiting renal fibroblast proliferation, inducing apoptosis (through regulation of c-myc protein), and reducing extracellular matrix deposition. Rhubarb processed with wine can also reduce the release of inflammatory factors (TNF-α, IL-6), alleviate glomerular inflammatory damage, scavenge free radicals, and inhibit oxidative stress damage to podocytes.

[0036] 3-5 parts of Coptis chinensis in wine.

[0037] Coptis chinensis (processed with wine) primarily enters the heart, liver, gallbladder, stomach, and large intestine meridians. It clears damp-heat in the lower burner, detoxifies, and reduces kidney inflammation and metabolic damage, making it particularly suitable for diabetic nephropathy and chronic nephritis (damp-heat type). It inhibits inflammatory damage: Berberine and coptisine in Coptis chinensis significantly reduce kidney inflammatory factors (TNF-α, IL-6, MCP-1), reduce glomerular inflammatory exudation, and decrease protein leakage. It protects podocytes: It regulates the AGE-RAGE signaling pathway, inhibits podocyte apoptosis induced by advanced glycation end products (AGEs) and the loss of cytoskeletal proteins (nephrin, podocin), maintaining the integrity of the filtration barrier. It has anti-fibrotic effects: It inhibits the TGF-β1 / Smads pathway, delaying glomerular sclerosis and interstitial fibrosis. It improves kidney function and regulates glucose and lipid metabolism: It improves insulin resistance, lowers blood glucose, triglycerides (TG), and total cholesterol (TC), and reduces metabolic kidney damage.

[0038] Preferably, a traditional Chinese medicine compound for reducing proteinuria is composed of the following raw materials in parts by weight:

[0039] Prepared Rehmannia Root 30 parts, Dioscorea Rhizome 30 parts, Cornus Fruit 30 parts, Achyranthes Root 15 parts, Schisandra Fruit 10 parts, Cuscuta Seed 10 parts, Corn Silk 20 parts, Alisma Rhizome 20 parts, Raw Astragalus Root 30 parts, Fried Rosa laevigata Fruit 15 parts, Euryale Seed 15 parts, Astragalus Complanatus Seed 10 parts, Salvia miltiorrhiza 20 parts, Wine-processed Rhubarb 5 parts, Wine-processed Coptis Root 3 parts.

[0040] A traditional Chinese medicine preparation for reducing proteinuria is prepared using the above-mentioned compound traditional Chinese medicine formula, including decoction, pills, powder, and ointment.

[0041] A method for preparing a traditional Chinese medicine preparation for reducing proteinuria includes the following steps:

[0042] Step 1: Mix Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta chinensis, Corn silk, Alisma plantago-aquatica, Astragalus membranaceus, Rosa laevigata, Euryale ferox, Astragalus complanatus, Salvia miltiorrhiza, Rheum palmatum (processed with wine), and Coptis chinensis (processed with wine) according to the above weight proportions, and soak in the soaking solution for 30-60 minutes.

[0043] Step 2: Boil the mixed medicine obtained after soaking in Step 1 over high heat, then simmer over low heat for 15-20 minutes, and filter to obtain the liquid and dregs.

[0044] Step 3: Repeat steps 1 and 2 multiple times to obtain the decoction after multiple decoctions. Mix the decoctions and concentrate the mixture to obtain the concentrated decoction.

[0045] Step 4: Prepare a traditional Chinese medicine preparation from the concentrated medicinal liquid obtained in Step 3.

[0046] Preferably, the weight of the soaking solution added in step 1 is 8 times the total weight of the raw material.

[0047] Preferably, the preparation in step 4 is a decoction, pill, powder, or ointment.

[0048] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0049] 1. In terms of treating the root cause, Rehmannia glutinosa, the chief herb, greatly nourishes kidney yin and replenishes kidney essence. Combined with Dioscorea opposita and Cornus officinalis, it forms the core of "three nourishments," strengthening the effects of nourishing kidney yin, replenishing essence, and consolidating kidney qi. When kidney qi is sufficient, its ability to store essence is strong, effectively reducing the leakage of protein and other essential substances from the glomerular filtration barrier. Schisandra chinensis astringes sweat and consolidates essence, Euryale ferox consolidates the kidney and astringes essence, Rosa laevigata fruit reduces urination and stops enuresis, and Astragalus complanatus consolidates essence and reduces urination, forming a powerful astringent array. They act directly on the kidney gate, enhancing the renal tubular reabsorption capacity and reducing protein loss in urine. The classic "two immortals of water and land" herb pair, Rosa laevigata fruit and Euryale ferox fruit, plays a key astringent role in this formula. Dioscorea opposita and Euryale ferox fruit invigorate the spleen and replenish qi, restoring the spleen's function of transporting and transforming clear qi. The spleen governs the control of essence, and a strong spleen can control essence and prevent its leakage, complementing the kidney tonification and astringency, reducing the loss of essence from the source.

[0050] 2. In terms of symptomatic treatment, corn silk and Alisma plantago-aquatica have significant diuretic effects, which can eliminate edema, promote the excretion of metabolic waste and damp-heat turbidity through urine, reduce the burden on the kidneys and intraglomerular pressure, Coptis chinensis (processed with wine) specifically clears damp-heat in the lower burner, rhubarb (processed with wine) invigorates blood and clears heat, and Alisma plantago-aquatica clears heat and resolves turbidity; together they clear damp-heat turbidity trapped in the kidneys, preventing damp-heat from disturbing the kidney gate and damaging the kidney network, leading to proteinuria. Salvia miltiorrhiza and rhubarb (processed with wine) improve local blood circulation in the kidneys, inhibit platelet aggregation, alleviate intravascular coagulation and hypercoagulability in the glomerular capillaries, and increase renal blood flow and perfusion. Achyranthes bidentata guides the medicinal power downward to the kidneys, working synergistically with Salvia miltiorrhiza and rhubarb (processed with wine) to dredge kidney network stagnation. Improved microcirculation helps repair the damaged filtration barrier, reduce the accumulation of inflammatory factors and the process of fibrosis; Rehmannia glutinosa, Cornus officinalis, Achyranthes bidentata, Alisma plantago-aquatica, Coptis chinensis (processed with wine), rhubarb (processed with wine), Astragalus complanatus, Salvia miltiorrhiza, and many other drugs can significantly downregulate key pro-inflammatory factors in the kidneys (such as TNF-α, IL-6, ... MCP-1 reduces inflammatory infiltration and damage to the glomeruli and renal interstitium, which are key factors leading to disruption of the filtration barrier and persistent proteinuria.

[0051] In summary, Rehmannia glutinosa (processed) is slightly warm in nature and sweet in taste, entering the liver and kidney meridians. As the principal herb, it specifically nourishes kidney yin and is known as a "great tonic for true water." By nourishing kidney yin, it restores the kidney's ability to retain essence, thereby reducing the loss of semen. When used in combination with other herbs, it strengthens the kidney's foundation, enhances its ability to store essence, and addresses the root cause, while clearing damp-heat, resolving stasis, and unblocking the meridians to address the symptoms. Dioscorea opposita, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta chinensis, Zea mays, Alisma plantago-aquatica, Astragalus membranaceus, Rosa laevigata (fried), Euryale ferox, and Astragalus complanatus are all assistant herbs. Rehmannia glutinosa, combined with Dioscorea opposita and Cornus officinalis, nourishes kidney yin, replenishes essence, and simultaneously nourishes the three yin meridians, restoring the kidney's function of storing essence. Achyranthes bidentata guides the medicine downwards, directing blood (fire) downwards, restoring the source of deficient fire, and reducing the leakage of semen. Schisandra chinensis astringes sweat and consolidates essence, Euryale ferox consolidates the kidney and astringes essence, and Rosa laevigata reduces urination and stops nocturnal emission. The three herbs together form a "barrier of astringency," reducing the loss of semen (protein). Cuscuta chinensis and Astragalus complanatus are warm but not drying, tonifying kidney yang to aid qi transformation, working synergistically with Rehmannia glutinosa to "seek yang within yin". Corn silk, Alisma plantago-aquatica, and Astragalus membranaceus are used together to tonify qi and promote water metabolism, eliminating edema, clearing the upper and lower turbid fluids, reducing proteinuria, treating both qi and water simultaneously, and regulating the ascending and descending of qi. Salvia miltiorrhiza, rhubarb processed with wine, and Coptis chinensis processed with wine are adjuvants. Salvia miltiorrhiza is slightly cold and clears blood heat, while rhubarb processed with wine is bitter and cold and drains stagnant heat, clearing stagnant heat in both directions. Salvia miltiorrhiza invigorates blood without harming the body's vital energy, while rhubarb processed with wine has a strong effect in breaking up stasis, but the wine processing moderates its intensity. Salvia miltiorrhiza unblocks blood vessels, while rhubarb processed with wine unblocks the intestines, draining stagnant turbidity through both the intestines and blood vessels. The combination of these two herbs combines cooling and dispersing properties, mutually aiding in clearing and unblocking, and regulating the internal organs. Coptis chinensis processed with wine is bitter and cold, acting as a counteracting agent to prevent Astragalus membranaceus and Cuscuta chinensis from warming and tonifying and generating fire, and to prevent Rosa laevigata and Euryale ferox from retaining damp heat. Coptis chinensis processed with wine clears and drains damp heat, maintaining a balance between clearing and astringing. Each component complements the others, increasing the effect of reducing urinary albumin and protecting the kidneys. The combination of components is reasonable, achieving a synergistic effect. Detailed Implementation

[0052] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0053] Example 1

[0054] A traditional Chinese medicine compound for reducing proteinuria, composed of the following raw materials by weight:

[0055] 30g of prepared Rehmannia root;

[0056] 30 g of yam;

[0057] 30 g of Cornus officinalis;

[0058] 15 g of Achyranthes bidentata;

[0059] Schisandra chinensis 10 g;

[0060] 10 g of dodder seed;

[0061] 20 g of corn silk;

[0062] Alisma plantago-aquatica 20 g;

[0063] 30 g of raw Astragalus membranaceus;

[0064] 15 g of stir-fried rosehip flesh;

[0065] 15 g of fox nuts;

[0066] 10 g of Astragalus complanatus seeds;

[0067] 20g of Salvia miltiorrhiza;

[0068] 5 g of rhubarb (processed with wine);

[0069] 3 g of Coptis chinensis (processed with wine).

[0070] The interaction mechanism between the components, analyzed from the perspective of the components, is as follows:

[0071] 1. Rehmannia glutinosa (processed)

[0072] Core function: As the principal herb, it specifically nourishes kidney yin and is known as a "great tonic for true water." By nourishing kidney yin, it restores the kidney's ability to retain essence, thereby reducing the loss of vital substances.

[0073] When combined with Cornus officinalis and Dioscorea opposita, the three herbs together form the core of "Liuwei Dihuang Wan" (Six-Ingredient Rehmannia Pill). Rehmannia glutinosa nourishes kidney yin as the principal herb, Cornus officinalis tonifies the liver and consolidates essence as the assistant herb, and Dioscorea opposita strengthens the spleen and consolidates essence as the adjuvant herb. The three herbs work together to repair the kidney's function of storing essence and reduce the leakage of semen.

[0074] When combined with Astragalus: It nourishes both Qi and Yin. Astragalus replenishes Qi and enhances the body's ability to retain fluids, while Rehmannia nourishes Yin and replenishes kidney essence, together reducing proteinuria.

[0075] 2. Yam

[0076] Key functions: Yam can invigorate the spleen and stomach, nourish kidney yin, and astringe essence and consolidate essence. By restoring the spleen's digestive function and the kidney's ability to store essence, it can reduce protein loss.

[0077] When combined with fox nuts and stir-fried rosehips, the three herbs form a modified version of the "Water and Land Two Immortals Pill". Dioscorea strengthens the spleen and retains essence, fox nuts strengthen the kidneys and astringe essence, and rosehips reduce urination and stop enuresis. The triple astringency reduces protein loss.

[0078] When combined with corn silk: Yam tonifies the spleen and promotes the upward movement of clear qi, while corn silk promotes diuresis and reduces turbidity. The combination of these two ingredients regulates fluid metabolism and reduces intraglomerular pressure.

[0079] 3. Cornus officinalis

[0080] Core Functions: Cornus officinalis can nourish the liver and kidneys, and it has a significant effect on improving kidney function, especially in diabetic nephropathy and reducing proteinuria. The iridoid glycosides in Cornus officinalis can significantly reduce the expression of renal inflammatory factors, block the binding of advanced glycation end products (AGEs) to their receptors (RAGE), reduce oxidative stress and podocyte apoptosis, and reduce proteinuria.

[0081] When combined with Schisandra chinensis: Cornus officinalis tonifies the liver and kidneys and consolidates essence, while Schisandra chinensis astringes the lungs, nourishes the kidneys, and astringes essence. Together, they enhance the kidney's ability to retain essence and reduce protein leakage.

[0082] 4. Achyranthes bidentata

[0083] Core functions: Achyranthes bidentata promotes blood circulation, removes blood stasis, tonifies the liver and kidneys, strengthens tendons and bones, promotes urination, and guides blood downwards. It can reduce inflammatory factors, decrease oxidative stress, inhibit apoptosis, protect the integrity of the glomerular filtration barrier, and reduce protein leakage.

[0084] When combined with rhubarb in wine: Achyranthes bidentata guides blood downward and invigorates blood circulation, while rhubarb in wine invigorates blood circulation, removes blood stasis, and unblocks the bowels. Together, they improve renal microcirculation and inhibit fibrosis.

[0085] When combined with Alisma plantago-aquatica: Achyranthes bidentata guides turbid Yin downwards, while Alisma plantago-aquatica promotes diuresis and eliminates turbidity. Together, they reduce kidney turbidity and alleviate proteinuria.

[0086] 5. Schisandra chinensis

[0087] Core functions: Schisandra chinensis has astringent, qi-tonifying, fluid-generating, kidney-tonifying, and heart-calming effects. The polysaccharides and lignans in Schisandra chinensis, such as schisandrin A and schisandrin C, have various effects including antioxidant activity, inhibition of apoptosis, and immune regulation.

[0088] When combined with Cuscuta chinensis and Astragalus complanatus, Schisandra chinensis' sourness benefits Qi and astringes essence, while Cuscuta chinensis and Astragalus complanatus warm Yang and consolidate essence. The three herbs consolidate and retain essence from the three dimensions of Qi, Yin and Yang.

[0089] When combined with Coptis chinensis (processed with wine): Schisandra chinensis nourishes Qi and Yin, while Coptis chinensis (processed with wine) clears heat and dries dampness, preventing damp-heat from damaging Yin and aggravating proteinuria.

[0090] 6. Cuscuta

[0091] Core functions: Cuscuta chinensis nourishes the liver and kidneys, strengthens essence and reduces urination. The polysaccharide components in Cuscuta chinensis have anti-inflammatory effects, scavenge oxygen free radicals, and have immunomodulatory effects. They can reduce serum urea, uric acid, blood urea nitrogen, and creatinine, and reduce the increase in kidney weight and histopathological changes.

[0092] When combined with Astragalus complanatus: Both tonify the kidneys and consolidate essence. Cuscuta chinensis is warming to the yang, while Astragalus complanatus is good at reducing urination. Together, they enhance the kidney's ability to store essence.

[0093] When combined with Achyranthes bidentata: Cuscuta chinensis nourishes and strengthens, while Achyranthes bidentata promotes circulation and unblocks the flow of qi, thus nourishing without causing stagnation and improving renal blood flow.

[0094] 4. Corn silk

[0095] Key function: Corn silk has diuretic and swelling-reducing effects. It has a strong diuretic effect and can improve symptoms of lower limb edema caused by protein loss.

[0096] When combined with Alisma plantago-aquatica: Corn silk promotes diuresis and reduces swelling, while Alisma plantago-aquatica drains kidney turbidity; the two work together to promote diuresis and eliminate turbidity.

[0097] When combined with Astragalus: Astragalus tonifies Qi, promotes water metabolism, and strengthens essence; corn silk promotes diuresis and eliminates turbidity. This combination of tonifying and purging helps reduce edema and proteinuria.

[0098] 5. Alisma plantago-aquatica

[0099] Key functions: Alisma orientalis has the effects of promoting diuresis and eliminating dampness, clearing heat, resolving turbidity and lowering lipids. The triterpenoids in Alisma orientalis have significant antioxidant, anti-inflammatory, lipid-regulating, and immune-regulating effects.

[0100] When combined with rhubarb in alcohol: Alisma promotes diuresis and rhubarb in alcohol clears the bowels. The two work together to eliminate toxins, namely creatinine and urea nitrogen, and reduce the burden on the kidneys.

[0101] When combined with Rehmannia glutinosa: Alisma plantago-aquatica counteracts the cloying nature of Rehmannia glutinosa, prevents dampness from stagnating in the middle jiao, and ensures the efficacy of yin-nourishing medicine.

[0102] 6. Raw Astragalus

[0103] Core functions: Raw astragalus replenishes qi and raises yang, strengthens the body's defenses and consolidates the exterior, promotes diuresis and reduces swelling, allowing the pathogenic factors to be expelled through urination, thus achieving the overall effect of eliminating pathogenic factors and supporting the body's resistance.

[0104] When combined with Danshen: Astragalus membranaceus replenishes Qi and nourishes essence, while Danshen invigorates blood and removes blood stasis. When Qi flows, blood flows, improving renal ischemia and hypoxia and reducing the release of inflammatory factors.

[0105] When combined with Coptis chinensis (processed with wine): Astragalus membranaceus is sweet and warm, which helps to clear heat and clear the mind; Coptis chinensis (processed with wine) is bitter and cold, which helps to clear turbidity and harmonize cold and heat, and inhibit immune inflammation and damage.

[0106] 7. Stir-fried Rosehips with Pork

[0107] Core function: It has the effect of consolidating essence and reducing urination. The polysaccharides, tannins and other components in Rosa laevigata can scavenge free radicals, reduce oxidative stress damage, repair the glomerular basement membrane and reduce protein leakage.

[0108] When combined with Euryale ferox: Rosa laevigata astringes semen and Euryale ferox strengthens the kidneys, forming a classic "two immortals from water and land" medicinal pair, which directly enhances renal tubular reabsorption and reduces proteinuria.

[0109] Rosa laevigata excels at consolidating essence by reducing protein loss through astringency and retention, thus consolidating the lower abdomen; Astragalus complanatus excels at tonifying kidney qi and enhancing the function of sealing and storing, thus addressing both the root cause and the symptoms.

[0110] 8. Gorgon fruit

[0111] Core functions: Gorgon fruit benefits the kidneys and strengthens essence, invigorates the spleen and stops diarrhea. The flavonoids in gorgon fruit can fight inflammation, scavenge oxygen free radicals, reduce secondary damage caused by increased oxygen free radicals in kidney disease, and reduce the secretion of renin and angiotensin, thereby helping to reduce proteinuria. Gorgon fruit can also improve microcirculation, improve blood supply to diseased kidneys, and reduce the pressure on the kidneys.

[0112] When combined with yam: Euryale ferox strengthens the kidneys and astringes essence, while yam invigorates the spleen and retains essence. By regulating the spleen and kidneys, the loss of essence is reduced from the source.

[0113] When combined with corn silk: Euryale ferox astringes and preserves essence, while corn silk promotes diuresis and eliminates turbidity. The combination of astringency and release prevents the loss of essence and eliminates turbidity.

[0114] 9. Sha Yuan Zi

[0115] Core functions: Astragalus complanatus tonifies the kidneys and strengthens yang, consolidates essence. It also has effects such as regulating lipids, anti-inflammation, anti-oxidation, and immune regulation.

[0116] When combined with Cuscuta chinensis and Schisandra chinensis: Astragalus complanatus reduces urination and strengthens essence, Cuscuta chinensis warms yang, and Schisandra chinensis astringes yin. The three herbs balance the yin and yang of the kidney and protect the kidney gate together.

[0117] When combined with Achyranthes bidentata: Astragalus complanatus tonifies and astringes, while Achyranthes bidentata promotes circulation and relieves stagnation. It prevents stagnation and replenishes stagnant blood.

[0118] 10. Salvia miltiorrhiza

[0119] Core functions: Danshen has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain. Many components in Danshen have the effects of anti-oxidative stress, anti-inflammation, anti-tumor, anti-fibrosis, lowering blood pressure and regulating blood lipids.

[0120] When combined with rhubarb in wine: Salvia miltiorrhiza promotes blood circulation, while rhubarb in wine removes blood stasis. The two complement each other and significantly inhibit renal fibrosis and improve glomerular sclerosis.

[0121] When combined with Astragalus: Astragalus invigorates Qi and promotes the blood circulation of Salvia miltiorrhiza, improving hypercoagulable state and increasing renal blood perfusion.

[0122] 11. Rhubarb in wine

[0123] Core functions: Rhubarb infused with wine promotes blood circulation, removes blood stasis, clears the bowels and eliminates turbidity, improves renal microcirculation, and reduces renal tissue fibrosis, oxidative stress and inflammatory damage.

[0124] When combined with wine-processed Coptis chinensis: wine-processed rhubarb promotes bowel movement and eliminates turbidity, while wine-processed Coptis chinensis clears heat and dries dampness, thus eliminating damp-heat toxins and reducing the inflammatory burden on the kidneys.

[0125] Combined with Alisma plantago-aquatica and corn silk: Rhubarb promotes bowel movement, while Alisma plantago-aquatica and corn silk promote urination. This combination of urination and defecation accelerates the excretion of metabolic waste.

[0126] 12. Coptis chinensis (processed with wine)

[0127] Core functions: Coptis chinensis in wine clears damp-heat in the lower burner, detoxifies and relieves fire, and has the effects of inhibiting inflammatory damage, protecting foot cells, anti-fibrosis, improving kidney function, and regulating glucose and lipid metabolism.

[0128] When combined with Astragalus: Coptis chinensis (processed with wine) clears damp-heat in the lower burner, while Astragalus tonifies the Qi in the middle and upper burners, thus treating damp-heat type proteinuria by combining tonification and purgation.

[0129] When combined with Rehmannia glutinosa: Coptis chinensis can counteract the richness and greasiness of Rehmannia glutinosa, preventing the accumulation of damp-heat from aggravating the condition.

[0130] Example 2

[0131] (1) Preparation of raw materials

[0132] Prepared Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta chinensis, Corn silk, Alisma plantago-aquatica, raw Astragalus membranaceus, stir-fried Rosa laevigata, Euryale ferox, Astragalus complanatus, Salvia miltiorrhiza, Rheum palmatum (processed with wine), and Coptis chinensis (processed with wine) were mixed and weighed according to the weight ratio in Example 1.

[0133] (2) Extraction of concentrated drug solution

[0134] Soaking: Add the above mixed raw materials and soaking solution to water with a total weight of 8 times that of the medicinal materials, ensuring that the medicinal materials are submerged, and soak for 40 minutes.

[0135] Decoction and concentration: Place the mixed herbs obtained after soaking in a decoction container, bring to a boil over high heat, then simmer over low heat for 20 minutes. Filter to obtain the decoction and dregs. Repeat the soaking and decoction steps above twice to obtain the decocted decoction. Mix the decoctions obtained from multiple decoctions and concentrate the mixture to obtain the concentrated decoction.

[0136] (3) Preparation of traditional Chinese medicine preparations

[0137] Preparation of decoction: The concentrated medicinal liquid is dispensed into sterile packaging bags, an appropriate amount of flavoring agent is added, and the bags are sealed and sterilized.

[0138] Pill preparation: Add an appropriate amount of starch or other excipients to the concentrated medicinal liquid, stir to form a soft mass, then sieve, cut evenly, dry, and make into pills of the protein-lowering formula.

[0139] Preparation of powder: The concentrated drug solution is spray-dried or vacuum-dried to obtain a dried extract powder. This extract powder is mixed evenly with an appropriate amount of pharmaceutical excipients, pulverized and sieved to ensure the fineness and uniformity of the powder, and then packaged into sterile containers and sealed to obtain the protein-lowering powder.

[0140] Ointment preparation: Transfer the concentrated medicinal liquid to a jacketed kettle, add the specified amount of refined honey or syrup as a base, stir and mix evenly, heat to the specified temperature and maintain it, stir continuously to concentrate until the specified relative density is reached, filter while hot, dispense into sterile containers, seal, and cool to obtain the protein-lowering ointment.

[0141] (4) Quality inspection

[0142] The prepared protein-lowering formula is subjected to quality inspection to ensure that the quality of the formula meets relevant standards.

[0143] (5) Packaging and storage

[0144] The qualified protein-lowering preparations should be packaged, and the drug name, specifications, usage and dosage, expiration date, storage conditions and other information should be clearly indicated. The preparations should be stored in accordance with the prescribed storage conditions to ensure the stability of drug quality.

[0145] By following the above steps, a protein-lowering formula that meets the requirements can be prepared. In practice, the requirements of Good Manufacturing Practices (GMP) should be strictly followed to ensure the safety and efficacy of the drug.

[0146] To further verify the protein-lowering efficacy of this invention, animal experiments were conducted:

[0147] Six-week-old adult rats (220g each) were injected intraperitoneally with a single dose of freshly prepared streptozotocin solution (dissolved in 0.1 mol / L sodium citrate buffer, pH 4.5) at a dose of 55 mg / kg. Fasting blood glucose was measured by tail vein sampling at 72 hours and 1 week post-injection. ① Rats with a fasting blood glucose level ≥ 16.7 mmol / L were considered to have successfully established a diabetic model. These rats were then fed a high-sugar, high-fat diet to continuously induce diabetic nephropathy. At week 6 post-modeling, 24-hour urine was collected using metabolic cages to detect urinary protein levels. Rats with 24-hour urinary protein > 30 mg were selected as the qualified intervention group. The qualified intervention group consisted of one positive control group (administered irbesartan), one model group, one protein-lowering formula group, and 13 single-factor variable control experimental groups, with eight rats randomly assigned to each group. ② Eight rats with a fasting blood glucose level < 7.0 mmol / L were selected as the normal control group. All rats in each group underwent acclimatization for one week.

[0148] Normal control group: No gavage was administered;

[0149] Positive control group: Irbesartan was administered by gavage at a dose of 15 mg / kg.

[0150] The protein-lowering formula group (S1) and the single-factor variable control experimental group (D1~13): The Chinese herbal medicine composition in Table 1 was administered by gavage. After converting the surface area of ​​humans and rats, the drug weight per rat was 8g / kg.d.

[0151] Model group: Administered an equal volume of sterile water by gavage.

[0152] The positive control group, the protein-lowering formula group, the single-factor variable control experimental group, and the model group were administered gavage once daily for 6 consecutive weeks, and gavage was stopped for the following 6 weeks. The urinary protein of each rat in the normal control group, the positive control group, the protein-lowering formula group, and the single-factor variable control experimental group was measured weekly, and other conditions of the rats were observed at the same time.

[0153] Table 1: Table of experimental variation factors in the protein-lowering group (S1) and the single-factor variable control group (D1~13)

[0154]

[0155] All urine protein data were recorded and statistically analyzed. The results are shown in Tables 2 and 3.

[0156] Table 2. 24-hour urinary protein (mg) in rats at different time points after intervention (Mean±SD)

[0157]

[0158] Note: Comparison between the model group and the control group: *P <0.05,** P <0.01; Comparison between the protein-lowering formula group, the positive (irbesartan) control group, and the model group: # P <0.05, ## P <0.01; Comparison between the S1 protein-lowering formula group and the positive (irbesartan) control group & P <0.05, && P <0.01. As shown in Table 2, compared with the control groups, the urinary protein level in the model group rats was significantly increased ( P <0.01); Compared with the model group, the S1 protein-lowering formula group showed a significant reduction in urinary protein levels at weeks 3 and 6 of intervention, which was statistically significant. P <0.01).

[0159] To demonstrate the role of each component in the formulation, a single-factor animal experiment was conducted. The factors affecting the comparative experiment are shown in Table 1, and the results are shown in Table 3.

[0160] Table 3

[0161]

[0162] Note: Each group was compared with the protein-lowering formula group at the same time point: # P <0.05, ## P <0.01.

[0163] As can be seen from Table 3, the various formulations in this invention work synergistically and are indispensable, achieving a mutually reinforcing effect.

[0164] The therapeutic efficacy data of the herbal composition of this invention on the human body are as follows:

[0165] A total of 86 patients with diabetic nephropathy (stage A2 or higher) were selected from inpatient and endocrinology outpatient clinics. Among them, 45 were male and 41 were female, aged 45-80 years, with a disease duration of 1 month to 5 years. All patients met the urinary albumin-to-creatinine ratio (UACR>30mg / g) requirement and were randomly divided into two groups: a treatment group (n=43) and a control group (n=43). There were no significant differences between the two groups in terms of age, sex, and disease duration, making them comparable. All participants received basic lifestyle interventions.

[0166] Medical record exclusion criteria:

[0167] Patients who are already on dialysis or plan to undergo dialysis / kidney transplantation in the near future;

[0168] Uncontrolled hypertension (e.g., systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);

[0169] Severe cardiovascular disease (such as recent myocardial infarction, unstable angina);

[0170] Active liver disease (ALT / AST > 3 times the upper limit of normal) or cirrhosis;

[0171] Malignant tumors (not cured within 5 years or currently undergoing radiotherapy and chemotherapy);

[0172] Severe infection;

[0173] Patients with type 1 diabetes;

[0174] Gestational diabetes or pregnant women;

[0175] Severe endocrine disorders (such as Cushing's syndrome, acromegaly, etc.);

[0176] They are currently using other experimental drugs or participating in other clinical trials;

[0177] Those known to be allergic to the Chinese medicine or its components being studied;

[0178] Poor compliance or inability to cooperate with the study.

[0179] Treatment group: The decoction prepared from the drug of this invention was taken orally, one dose per day, divided into two doses, one in the morning and one in the evening, for 8 weeks.

[0180] Control group: Received placebo, with the same dosage and administration method as the treatment group, for 8 weeks;

[0181] Efficacy assessment: The urine albumin / creatinine ratio (UACR) was measured in both groups of patients before and after treatment.

[0182] Adverse reactions include significant liver and kidney damage, myocardial damage, skin reactions, and gastrointestinal reactions.

[0183] The treatment results are shown in Table 4:

[0184] Table 4: Comparison of UACR levels before and after treatment in the two groups (mg / g, Mean±SD)

[0185]

[0186] Note: Compared with the control group, ** P <0.01, * P <0.05; Comparison of the control group before and after treatment (compared to week 0), # P <0.05, ## P <0.01; Comparison of treatment group before and after treatment (compared to week 0), & P <0.05, && P <0.01.

[0187] In summary, Rehmannia glutinosa (processed) is slightly warm in nature and sweet in taste, entering the liver and kidney meridians. As the principal herb, it specifically nourishes kidney yin and is known as a "great tonic for true water." By nourishing kidney yin, it restores the kidney's ability to retain essence, thereby reducing the loss of semen. When used in combination with other herbs, it strengthens the kidney's foundation, enhances its ability to store essence, and addresses the root cause, while clearing damp-heat, resolving stasis, and unblocking the meridians to address the symptoms. Dioscorea opposita, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta chinensis, Zea mays, Alisma plantago-aquatica, Astragalus membranaceus, Rosa laevigata (fried), Euryale ferox, and Astragalus complanatus are all assistant herbs. Rehmannia glutinosa, combined with Dioscorea opposita and Cornus officinalis, nourishes kidney yin, replenishes essence, and simultaneously nourishes the three yin meridians, restoring the kidney's function of storing essence. Achyranthes bidentata guides the medicine downwards, directing blood (fire) downwards, restoring the source of deficient fire, and reducing the leakage of semen. Schisandra chinensis astringes sweat and consolidates essence, Euryale ferox consolidates the kidney and astringes essence, and Rosa laevigata reduces urination and stops nocturnal emission. The three herbs together form a "barrier of astringency," reducing the loss of semen (protein). Cuscuta chinensis and Astragalus complanatus are warm but not drying, tonifying kidney yang to aid qi transformation, working synergistically with Rehmannia glutinosa to "seek yang within yin". Corn silk, Alisma plantago-aquatica, and Astragalus membranaceus are used together to tonify qi and promote water metabolism, eliminating edema, clearing the upper and lower turbid fluids, reducing proteinuria, treating both qi and water simultaneously, and regulating the ascending and descending of qi. Salvia miltiorrhiza, rhubarb processed with wine, and Coptis chinensis processed with wine are adjuvants. Salvia miltiorrhiza is slightly cold and clears blood heat, while rhubarb processed with wine is bitter and cold and drains stagnant heat, clearing stagnant heat in both directions. Salvia miltiorrhiza invigorates blood without harming the body's vital energy, while rhubarb processed with wine has a strong effect in breaking up stasis, but the wine processing moderates its intensity. Salvia miltiorrhiza unblocks blood vessels, while rhubarb processed with wine unblocks the intestines, draining stagnant turbidity through both the intestines and blood vessels. The combination of these two herbs combines cooling and dispersing properties, mutually aiding in clearing and unblocking, and regulating the internal organs. Coptis chinensis processed with wine is bitter and cold, acting as a counteracting agent to prevent Astragalus membranaceus and Cuscuta chinensis from warming and tonifying and generating fire, and to prevent Rosa laevigata and Euryale ferox from retaining damp heat. Coptis chinensis processed with wine clears and drains damp heat, maintaining a balance between clearing and astringing. Each component complements the others, increasing the effect of reducing urinary albumin and protecting the kidneys. The combination of components is reasonable, achieving a synergistic effect.

[0188] It should be noted that:

[0189] The embodiments described above merely illustrate specific implementation methods of this application, and while the descriptions are detailed and specific, they should not be construed as limiting the scope of protection of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the technical solution of this application, and these modifications and improvements all fall within the scope of protection of this application.

Claims

1. A traditional Chinese medicine compound for reducing proteinuria in diabetic nephropathy, characterized in that, By weight, it consists of the following active pharmaceutical ingredients: Prepared Rehmannia Root 10-30 parts, Dioscorea Rhizome 10-30 parts, Cornus Fruit 10-30 parts, Achyranthes Root 10-20 parts, Schisandra Fruit 5-15 parts, Cuscuta Seed 5-15 parts, Corn Silk 10-30 parts, Alisma Rhizome 10-30 parts, Raw Astragalus Root 10-30 parts, Fried Rosa laevigata Fruit 10-30 parts, Euryale Seed 10-30 parts, Astragalus Complanatus Seed 5-15 parts, Salvia miltiorrhiza 5-30 parts, Wine-processed Rhubarb 3-10 parts, Wine-processed Coptis Root 3-5 parts.

2. A traditional Chinese medicine compound for reducing proteinuria in diabetic nephropathy according to claim 1, characterized in that, By weight, it consists of the following active pharmaceutical ingredients: Prepared Rehmannia Root 30 parts, Dioscorea Rhizome 30 parts, Cornus Fruit 30 parts, Achyranthes Root 15 parts, Schisandra Fruit 10 parts, Cuscuta Seed 10 parts, Corn Silk 20 parts, Alisma Rhizome 20 parts, Raw Astragalus Root 30 parts, Fried Rosa laevigata Fruit 15 parts, Euryale Seed 15 parts, Astragalus Complanatus Seed 10 parts, Salvia miltiorrhiza 20 parts, Wine-processed Rhubarb 5 parts, Wine-processed Coptis Root 3 parts.

3. A traditional Chinese medicine preparation for reducing proteinuria in diabetic nephropathy, characterized in that, Prepared using the traditional Chinese medicine compound formula described in claim 1 or 2, including decoctions, pills, powders, and ointments.

4. A method for preparing a traditional Chinese medicine preparation for reducing proteinuria in diabetic nephropathy, characterized in that, Includes the following steps: Step 1: Mix Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta chinensis, Corn silk, Alisma plantago-aquatica, Astragalus membranaceus, Rosa laevigata, Euryale ferox, Astragalus complanatus, Salvia miltiorrhiza, Rheum palmatum (processed with wine), and Coptis chinensis (processed with wine) according to the weight proportions described in claim 1 or 2, and soak in the soaking solution for 30-60 minutes. Step 2: Boil the mixed medicine obtained after soaking in Step 1 over high heat, then simmer over low heat for 15-20 minutes, and filter to obtain the liquid and dregs. Step 3: Repeat steps 1 and 2 multiple times to obtain the decoction after multiple decoctions. Mix the decoctions and concentrate the mixture to obtain the concentrated decoction. Step 4: Prepare a traditional Chinese medicine preparation from the concentrated medicinal liquid obtained in Step 3.

5. The method for preparing a traditional Chinese medicine preparation for reducing proteinuria in diabetic nephropathy according to claim 4, characterized in that, In step 1, the weight of the soaking solution added is 8 times the total weight of the raw material.

6. The method for preparing a traditional Chinese medicine preparation for reducing proteinuria in diabetic nephropathy according to claim 4, characterized in that, The preparations in step 4 include decoctions, pills, powders, and ointments.

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