Traditional Chinese medicine compound for reducing urine protein, traditional Chinese medicine preparation and preparation method thereof
By using a combination of traditional Chinese medicine to nourish kidney yin, strengthen the kidney and consolidate the foundation, and remove blood stasis and unblock the meridians, the problem of poor long-term efficacy of Western medicine in the treatment of diabetic nephropathy has been solved, and the effects of significantly reducing proteinuria and protecting the kidneys have been achieved.
Patent Information
- Application Number
- CN202511307805.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-15
- Publication Date
- 2025-10-17
- Estimated Expiration
- 2045-09-15
AI Technical Summary
Existing Western medicines have poor long-term efficacy in treating diabetic nephropathy. Symptoms recur after discontinuation of the medicine, the medicine cannot effectively reduce urine protein, and the medicine does not provide adequate protection for the kidneys.
A compound Chinese medicine composition is used, including Rehmannia root, Chinese yam, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta australis, Corn silk, Alisma orientalis, Astragalus membranaceus, stir-fried Rosa laevigata fruit, Euryale ferox, Astragalus membranaceus, Salvia miltiorrhiza, Rhubarb with wine, and Coptis chinensis with wine, which synergistically reduce urine protein and protect the kidneys by nourishing kidney yin, strengthening the kidney and consolidating the foundation, removing blood stasis and unblocking the meridians.
Significantly reduce urine protein, enhance the kidney's retention capacity, reduce the leakage of fine substances, improve renal microcirculation, inhibit inflammatory factors, reduce oxidative stress, protect kidney function, and achieve long-term therapeutic effects.
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Abstract
Description
TECHNICAL FIELD
[0001] The present application belongs to the technical field of traditional Chinese medicine compound, and particularly relates to a traditional Chinese medicine compound for reducing urinary protein, a traditional Chinese medicine preparation and a preparation method thereof. BACKGROUND
[0002] Currently, diabetic nephropathy is one of the main microvascular complications of diabetes, and proteinuria is the main manifestation. With the progression of the disease, the amount of urinary protein gradually increases, and a large amount of proteinuria is the main cause of end-stage kidney disease. Timely diagnosis and effective management of diabetic nephropathy can delay the progression of the disease, which is still a major challenge in current clinical practice. Although the emergence of sodium-glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonists, new non-steroidal salt corticosteroid receptor antagonists, and endothelin antagonists has brought new hope for the management of diabetic nephropathy, the aforementioned western medicine treatment methods for diabetic nephropathy can only produce partial effects, and most of them still mainly adopt symptomatic treatment such as controlling blood glucose, blood pressure, and blood lipids, and improving microcirculation. However, the current western medicine treatment method still has the following problems: although western medicine can reduce the urinary protein level of patients to a certain extent, the long-term efficacy is poor, and the symptoms of patients will obviously recur after drug withdrawal. SUMMARY
[0003] To solve the above technical problems, the present application provides a traditional Chinese medicine compound for reducing urinary protein, a traditional Chinese medicine preparation and a preparation method thereof.
[0004] Kidney is the "sealing base", and it is responsible for storing essence. When kidney yin is deficient, the sealing function is lost, and symptoms of essence leakage such as spermatorrhea, night sweat, frequent urination, and metrorrhagia may occur. Albumin is a kind of "essence substance", and Radix Rehmanniae Preparata is slightly warm, sweet in taste, and belongs to liver and kidney channels. As the monarch drug, it is used to tonify kidney yin and is called "the medicine for tonifying true water". By tonifying kidney yin and restoring the kidney's ability to hold and store essence, the loss of essence is reduced. In combination with other medicinal materials, kidney is tonified and the base is strengthened, the sealing function is restored, and dampness and heat are cleared and the collaterals are dredged. Radix Rehmanniae Preparata, together with Rhizoma Dioscoreae, Fructus Corni, Radix Hedysari, Semen Litchi, Semen Lagenariae, Stigma Maydis, Rhizoma Alismatis, Radix Paeoniae Alba, Fructus Rosae Laevigatae, Semen Euryale, and Semen Astragali Complanati are all ministerial drugs. Radix Rehmanniae Preparata, together with Rhizoma Dioscoreae and Fructus Corni, tonifies kidney yin, fills essence, and supplements three yins, thereby repairing the kidney's sealing function. Radix Hedysari leads the blood downward, and makes the deficiency fire return to the origin, thereby reducing the leakage of essence. Fructus Rosae Laevigatae, Semen Euryale, and Semen Lagenariae are used in combination to form a "sclerosis barrier", thereby reducing the loss of essence. Semen Lagenariae and Semen Astragali Complanati are warm but not dry, and they tonify kidney yang to assist in gasification, and cooperate with Radix Rehmanniae Preparata to "seek yang in yin". Stigma Maydis, Rhizoma Alismatis, and Radix Paeoniae Alba are used in combination to supplement qi and drain water, eliminate edema, raise clear and lower turbid, reduce proteinuria, and treat qi and water simultaneously and regulate ascending and descending. Salvia Miltiorrhiza, Dahuang Jiu, and Huanglian Jiu are all auxiliary drugs. Salvia Miltiorrhiza is cold and can clear blood heat, and Dahuang Jiu is bitter and cold and can remove stasis heat. They can remove stasis heat in two directions. Salvia Miltiorrhiza can activate blood without damaging the normal, and Dahuang Jiu can remove stasis with great force. The wine preparation can reduce the harshness. Salvia Miltiorrhiza can dredge blood vessels, and Dahuang Jiu can dredge intestines and bowels. They can remove stasis from the intestines and blood vessels. The two drugs are used in combination to cool and disperse, remove and dredge, and regulate the bowels and collaterals. Huanglian Jiu is bitter and cold and can prevent Huangqi and Semen Lagenariae from warming and tonifying and causing fire, and can prevent Fructus Rosae Laevigatae and Semen Euryale from causing wet heat to remain. Huanglian Jiu can clear and drain wet heat, and maintain the balance between dredging and astringency. The components are used to complement each other, thereby reducing urinary albumin and protecting the kidney. The components are used in a reasonable combination to achieve the effect of coordination and synergism.
[0005] The technical scheme adopted in the present application is as follows: A traditional Chinese medicine compound for reducing urinary protein, which is composed of the following raw medicinal materials in parts by weight: Radix Rehmanniae Preparata 10-30 parts; Rehmannia glutinosa, slightly warm, sweet, mainly liver, kidney, in the theory of traditional Chinese medicine, its core function is to nourish blood and yin, and to nourish essence and fill marrow. Traditional Chinese medicine 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", with symptoms such as soreness of the waist and knees, dizziness and tinnitus, hot flashes, night sweats, and proteinuria. Rehmannia glutinosa is a key drug for nourishing kidney yin and replenishing kidney essence. It can nourish kidney yin, balance kidney yin and yang, and enhance the kidney's ability to hold and store. When the kidney qi is sufficient and the sealing power is strong, the leakage of fine substances (such as protein) from the urine is reduced, which helps to improve proteinuria. Rehmannia glutinosa contains active ingredients such as catalpol and rehderioside, which have significant antioxidant effects. They can remove excess free radicals in the body and reduce oxidative damage to kidney tissue cells. This is a common pathway for the progression of various kidney diseases. Rehmannia glutinosa extract can inhibit the production and release of various inflammatory factors (such as TNF-α and IL-6), reducing inflammation in the kidney. Chronic inflammation is an important factor in causing kidney damage and persistent proteinuria. In addition, Rehmannia glutinosa can also reduce the deposition of immune complexes in the kidney and related immune damage by regulating immune cell function, and indirectly reduce the damage to the kidney caused by metabolic factors by regulating glucose and lipid metabolism.
[0006] Yam 10-30 parts; Yam, sweet, warm, has the effect of invigorating the spleen, tonifying the lungs, and nourishing the kidney and essence. Traditional Chinese medicine believes that proteinuria is related to spleen and kidney deficiency. If the spleen qi is not stable, the fine substances will be excreted, and if the kidney qi is not sealed, the sealing function will be lost. Yam can nourish the spleen and stomach, tonify kidney yin, and astringe essence. By restoring the spleen's transportation function and the kidney's sealing ability, it can reduce protein loss. The core active component of yam, yam polysaccharide, can inhibit inflammatory factors, reduce the expression of monocyte chemoattractant protein-1 (MCP-1) in kidney tissue, reduce inflammatory cell infiltration, and alleviate kidney inflammation damage. It can also clear free radicals, reduce oxidative stress damage to glomeruli through antioxidant effects, and delay renal fibrosis. It can improve metabolic indicators, reduce blood glucose, 24-hour urinary protein, serum creatinine, and urea nitrogen in diabetic nephropathy animals. It can enhance the body's immune function and improve the body's resistance to disease. By regulating the intestinal microecology and improving the intestinal flora structure, it can protect the kidney.
[0007] Cornus officinalis 10-30 parts; Cornus officinalis, bitter and astringent in taste, slightly warm in nature, has the effects of tonifying liver and kidney and astringing and consolidating. Cornus officinalis is a traditional Chinese medicine for tonifying liver and kidney, which has a significant effect on improving kidney function, especially diabetic nephropathy and reducing urinary protein. The iridoid glycosides in Cornus officinalis (such as cornuside and loganin) can significantly reduce the expression of inflammatory factors in the kidney, such as inhibiting the secretion of IL-6, TNF-α, MCP-1, and reducing the inflammatory damage of glomerulus and renal tubule, thereby reducing protein leakage. Cornus officinalis can inhibit the progression of renal fibrosis by down-regulating the TGF-β1 / Smads signaling pathway, reduce the deposition of extracellular matrix (such as type IV collagen), and protect the integrity of the glomerular filtration barrier. At the same time, it can inhibit the Wnt / β-catenin pathway, reduce the expression of YKL-40, and delay glomerular sclerosis. The components such as loganin in Cornus officinalis can block the binding of advanced glycation end products (AGEs) and their receptors (RAGE), reduce oxidative stress and podocyte apoptosis, and reduce proteinuria. Cornus officinalis can also significantly reduce the levels of serum creatinine (Scr) and urea nitrogen (BUN) in diabetic nephropathy rats, reduce the metabolic burden of the kidney, increase the activity of glutathione (GSH) in the kidney, scavenge free radicals, inhibit the oxidative stress pathway such as NF-κB, protect renal tubular epithelial cells, and delay the thickening of the basement membrane and the loss of podocytes.
[0008] Radix Achyranthis Bidentatae 10-20 parts; Radix Achyranthis Bidentatae, bitter and sour in taste, neutral in nature, enters the liver and kidney channels, has the effects of removing blood stasis and unblocking channels, tonifying liver and kidney, strengthening bones and muscles, promoting diuresis and relieving stranguria, and guiding blood downward. Radix Achyranthis Bidentatae can reduce kidney inflammation by reducing inflammation-related factors such as TNF-α and IL-6 in serum; by reducing p53 mRNA expression and increasing mdm2 mRNA expression, it can significantly inhibit apoptosis, protect the integrity of the glomerular filtration barrier, and reduce protein leakage; the AGE-RAGE signaling pathway plays an important role in diabetic nephropathy, and Radix Achyranthis Bidentatae can protect the kidney by interfering with this pathway; Radix Achyranthis Bidentatae extract can also reduce oxidative stress by reducing the influence of the oxidase / active oxygen / ERK signaling pathway, reduce blood urea nitrogen (BUN), creatinine (BCr), and 24-hour urinary protein (UPr), thereby protecting the kidney.
[0009] Schisandra chinensis 5-15 parts; Schisandra, warm, sweet and bitter. The earliest record of Schisandra is in Shennong's Herbal Classic, which has the effects of astringing, tonifying Qi, and nourishing the heart. Lignans are the main active components in Schisandra, including schisantherin A and schisantherin C. Schisantherin A has antioxidant, anti-apoptotic, and immunomodulatory effects. Schisantherin A can reduce the degree of kidney injury in diabetic nephropathy patients by regulating the AdipoR1 / AMPK-ROS / mitochondrial injury signaling pathway to reduce ferroptosis and NLRP3 inflammasome-mediated pyroptosis in kidney cells, and by regulating the Wnt / β-catenin signaling pathway to reduce the epithelial-mesenchymal transition (EMT) and extracellular matrix deposition, thereby reducing proteinuria.
[0010] Cuscuta 5-15 parts; Cuscuta, bitter and sweet, neutral, has the effects of tonifying liver and kidney, astringing essence, reducing urine, preventing miscarriage, and improving eyesight. The chemical components in Cuscuta may have anti-inflammatory effects, which can help reduce inflammation in the kidneys. Cuscuta polysaccharides and other components have the ability to scavenge free radicals, which can help protect kidney cells from oxidative stress damage; Cuscuta has immunomodulatory effects, which may reduce immune-mediated damage in kidney disease by regulating the immune system. Cuscuta methanol extract can reduce serum urea, uric acid, blood urea nitrogen, creatinine, and reduce kidney weight gain and histopathological changes.
[0011] Corn silk 10-30 parts; Corn silk, slightly warm, sweet and bland, has the effects of promoting water excretion and reducing swelling, and reducing dampness and jaundice. It is 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 rat kidney function is related to its anti-inflammatory effect. Corn silk water extract can reduce blood glucose, kidney index, serum urea nitrogen, serum creatinine, and 24-hour urinary protein levels in diabetic rats, down-regulate the expression of fibrosis factors in kidney tissue, and regulate the production and degradation of extracellular matrix, thereby reducing pathological damage to the kidneys of diabetic nephropathy rats and playing a kidney-protective role.
[0012] Alisma 10-30 parts; Alisma orientalis, with its sweet, mild flavor and cold nature, promotes diuresis, dissipates heat, and clears turbidity and reduces lipids. Triterpenoids in Alisma orientalis, particularly 23-acetylalusinol B, have significant anti-renal fibrosis effects. By influencing the TGF-β / Smad signaling pathway, they downregulate the expression of proteins such as α-SMA, collagen I, and fibronectin in renal tissue, reducing renal fibrosis and significantly lowering serum creatinine, urea, and urine protein in rats. Alisma orientalis also possesses antioxidant and anti-inflammatory properties, reducing oxidative stress and inflammation, which are key factors in the progression of kidney disease. Its diuretic properties can help reduce sodium and water retention, alleviating the burden on the kidneys. It can regulate blood lipids, reduce dyslipidemia, and mitigate lipid peroxidation damage in the kidneys. Alisma orientalis also has immunomodulatory effects, influencing the activity of the reticuloendothelial system and anti-complement activity, thus positively impacting immune-related kidney diseases.
[0013] 10-30 portions of raw astragalus; Raw Astragalus root is sweet and slightly warm in nature, and enters the spleen and lung meridians. It has the effects of replenishing qi and raising yang, strengthening the body's defense system, promoting diuresis and reducing swelling, and removing toxins and promoting tissue regeneration. It is sweet and warm, replenishing and ascending, and sweet and mild, penetrating and promoting diuresis. It is suitable for treating both pathogenic factors and replenishing. 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 water balance and fine substances in the human body, and are the cornerstones of human health. The kidneys, as the foundation of the human body, have the function of controlling water and regulating the whole body. The circulation and metabolism of fluids, kidney qi deficiency or blood stasis in the kidney meridians can lead to dysfunction of the kidney's sealing and storage function, leakage of fine substances, and the formation of proteinuria. In addition, long-term damp heat may also interfere with the normal function of the kidney, further triggering the production of proteinuria. Therefore, the production of proteinuria is a mixed symptom of deficiency and excess, not a pure deficiency symptom. Therefore, raw astragalus is used to replenish qi and prevent the loss of fine substances such as protein. On the other hand, raw astragalus can promote diuresis and reduce swelling, so that damp heat and turbid evil can be discharged through urine, achieving the overall effect of eliminating evil and strengthening the body.
[0014] 10-30 servings of stir-fried golden cherry meat; Stir-fried Rosa laevigata fruit pulp is neutral in nature, sour and astringent in flavor. It enters the kidney, bladder, and large intestine meridians, and has the effects of consolidating semen and reducing urination. Rosa laevigata fruit contains a variety of chemical components and active substances, including polysaccharides, triterpenes, tannins, flavonoids, glycosides, flavanols, steroids, fatty acids, catechins, and carbohydrates, which play a significant role in improving kidney function and reducing urinary protein. Stir-fried Rosa laevigata fruit enhances the kidney's ability to store essence and reduces the loss of fine substances (such as protein). It is suitable for treating nocturnal emission, frequent urination, and proteinuria caused by kidney deficiency. The polysaccharides and tannins in Rosa laevigata fruit scavenge free radicals, mitigate oxidative stress damage, repair the glomerular basement membrane, and reduce protein leakage.
[0015] 10-30 portions of gorgon fruit; Euryale ferox, has the effects of benefiting kidney and solidifying essence, tonifying spleen and stopping diarrhea, and removing dampness and stopping leucorrhea; Euryale ferox is combined with fried cherry fruit, and cooperates with Rhei Radix et Rhizoma and Coptidis Rhizoma, and acts on eliminating proteinuria of kidney disease and reducing inflammatory symptoms of kidney disease; flavonoids contained in Euryale ferox can resist inflammation, eliminate oxygen free radicals, reduce secondary damage caused by increased oxygen free radicals in kidney disease, and reduce secretion of renin and angiotensin, thereby helping to reduce proteinuria; in addition, Euryale ferox can also improve microcirculation, improve blood supply to the diseased kidney, and reduce the pressure on the kidney.
[0016] Semen astragali complanati 5-15 parts; Semen astragali complanati, warm in nature, sweet in taste, and belonging to liver and kidney channels, has the effects of tonifying kidney and assisting yang, consolidating essence and reducing urine, and nourishing liver and brightening eyes. Semen astragali complanati has the effects of regulating lipid, resisting inflammation, resisting oxidation, and regulating immunity. Total flavonoids of Semen astragali complanati can significantly reduce serum and renal inflammatory factors (TNF-α, IL-6), reduce glomerular inflammatory damage, increase superoxide dismutase (SOD) activity, reduce malondialdehyde (MDA) content, alleviate the damage of oxidative stress to podocytes, improve kidney damage caused by diabetes, reduce serum creatinine and urea nitrogen levels, and improve kidney morphology.
[0017] Salvia miltiorrhiza 5-30 parts; Salvia miltiorrhiza has the effects of activating blood and removing stasis, and relieving pain, and has the effects of resisting oxidative stress, resisting inflammation, resisting tumor, resisting fibrosis, resisting atherosclerosis, reducing blood pressure, and regulating blood lipid; Salvia miltiorrhiza and its active ingredients can inhibit angiotensin converting enzyme activity, reduce systolic blood pressure, and have a positive effect on blood pressure control of hypertensive nephropathy; various components in Salvia miltiorrhiza have antioxidant activity, can reduce oxidative stress level, and reduce kidney damage; Salvia miltiorrhiza can reduce cell apoptosis by regulating the expression of epithelial-mesenchymal transition related proteins, and protect the kidney; the combination of Salvia miltiorrhiza and Astragalus membranaceus can improve the extraction rate of active ingredients in Salvia miltiorrhiza, achieve great synergistic effect, and produce new anti-kidney fibrosis active ingredients.
[0018] Rhei Radix et Rhizoma 3-10 parts; Rhubarb wine is a processed product of Rhubarb, which is processed by wine. It has bitter and cold nature and slightly slow function. Its purgative effect is weakened, and it has the effect of promoting blood circulation and removing blood stasis. It has a significant effect on improving kidney function and reducing urinary protein. Through promoting blood circulation and removing blood stasis, purging the bowels and removing turbidity, Rhubarb wine can improve kidney microcirculation, reduce kidney tissue fibrosis and inflammatory damage, and is suitable for chronic renal failure (CRF), diabetic nephropathy (especially stages III-IV), and other diseases. Rhubarb wine can down-regulate the expression of fibrosis-promoting factor TGF-β1, up-regulate the inhibitory factor Smad7, delay glomerular sclerosis and interstitial fibrosis, protect the integrity of the filtration barrier, inhibit the proliferation of renal fibroblasts, induce apoptosis (by regulating c-myc protein), and reduce extracellular matrix deposition. Rhubarb wine can also reduce the release of inflammatory factors (TNF-α, IL-6), reduce glomerular inflammatory damage, scavenge free radicals, and inhibit oxidative stress damage to podocytes.
[0019] Rhubarb wine 3-5 parts.
[0020] Rhubarb wine mainly enters the heart, liver, gallbladder, stomach, and large intestine channels. It can clear and drain lower jiao damp-heat, purge fire and detoxify, reduce kidney inflammatory response and metabolic damage, and is especially suitable for diabetic nephropathy, chronic nephritis (damp-heat type), and other diseases. Inhibit inflammatory damage: Berberine and coptisine in Rhubarb wine can significantly reduce kidney inflammatory factors (TNF-α, IL-6, MCP-1), reduce glomerular inflammatory exudation, and reduce protein leakage. Protect podocytes: regulate the AGE-RAGE signaling pathway, inhibit late glycosylation end product-induced podocyte apoptosis and loss of skeletal proteins (nephrin, podocin), and maintain the integrity of the filtration barrier. Anti-fibrosis: inhibit the TGF-β1 / Smads pathway, delay glomerular sclerosis and interstitial fibrosis. Improve kidney function and regulate glucose and lipid metabolism: improve insulin resistance, reduce blood glucose, triglycerides (TG), and total cholesterol (TC), and reduce metabolic kidney damage.
[0021] Preferably, a traditional Chinese medicine compound for reducing urinary protein, consisting of the following raw materials by weight: Rehmannia 30 parts, Chinese yam 30 parts, dogwood 30 parts, Huai Niuxi 15 parts, Schisandra 10 parts, Dodartia 10 parts, corn silk 20 parts, Alisma 20 parts, raw Astragalus 30 parts, fried cherry fruit 15 parts, Gorgon 15 parts, safflower 10 parts, Dan 20 parts, Rhubarb wine 5 parts, Rhubarb wine 3 parts.
[0022] A traditional Chinese medicine preparation for reducing urinary protein is prepared from the above traditional Chinese medicine compound, including decoction, pill, powder, and ointment.
[0023] A preparation method of a traditional Chinese medicine preparation for reducing urinary protein, comprising the following steps: Step 1: Rehmanniae Radix Praeparata, Dioscoreae Rhizoma, Corni Fructus, Radix Hedysari, Schisandrae Fructus, Semen Litchi, Zea Mays, Alisma Orientalis (Franch et Savat) Juzep, Astragali Radix, Rosae Laevigatae Caro, Trapa Bispinosa, Trigonella Foenum Graecum, Salviae Miltiorrhizae Radix et Rhizoma, Rhei Radix et Rhizoma, Coptidis Rhizoma are mixed according to the weight parts above, and soaked for 30-60 minutes with a soaking solution; Step 2: The mixture obtained after soaking in Step 1 is boiled with a strong fire, and kept boiling with a weak fire for 15-20 minutes, and then filtered to obtain a medicinal liquid and a medicinal residue; Step 3: Steps 1 and 2 are repeated for multiple times in sequence to obtain medicinal liquids after multiple times of decocting, and the medicinal liquids after multiple times of decocting are mixed, and the mixed medicinal liquid is concentrated to obtain a concentrated medicinal liquid; Step 4: The concentrated medicinal liquid obtained in Step 3 is prepared into a traditional Chinese medicine preparation.
[0024] Preferably, the adding weight part of the soaking solution in Step 1 is 8 times of the total weight of the raw medicinal materials.
[0025] Preferably, the preparation in Step 4 is a decoction, a pill, a powder, and a paste.
[0026] As described above, due to the adoption of the technical solutions above, the present application has the following beneficial effects: 1. In the present application, Rehmanniae Radix Praeparata is the monarch drug which can tonify kidney yin and kidney essence; Dioscoreae Rhizoma and Corni Fructus are used to form a "three tonifying" core, which can strengthen the effects of tonifying kidney yin, filling essence and consolidating kidney qi; when kidney qi is sufficient and the storage is powerful, the leakage of fine substances such as protein from the glomerular filtration barrier can be effectively reduced; Schisandrae Fructus, Trapa Bispinosa, Rosae Laevigatae Caro and Trigonella Foenum Graecum can form a powerful astringent drug array, which directly acts on the kidney and enhances the reabsorption capacity of the renal tubule to reduce the loss of protein in urine; the "water and land two immortals" classic drug pair composed of Rosae Laevigatae Caro and Trapa Bispinosa plays a key astringent role in the prescription; Dioscoreae Rhizoma and Trapa Bispinosa can strengthen the spleen and restore the spleen's function of transportation, transformation and ascending clear; the spleen can control fine substances when the spleen qi is strong, which can prevent the leakage of fine substances, and the tonification of kidney and astringency are complementary to each other, thus reducing the loss of fine substances from the source; 2. On the symptomatic aspect, corn silk and alisma canis have significant diuretic effect, which can eliminate edema, promote the excretion of metabolic waste and damp-heat turbidity from urine, reduce the burden on the kidney and intraglomerular pressure, and clear damp-heat from the lower energizer. Rhizoma et Radix Rhei can clear heat and promote blood circulation, and alisma can clear heat and resolve turbidity. They can jointly clear damp-heat evil that obstructs the kidney, prevent damp-heat from disturbing the kidney and damaging the kidney collaterals to cause proteinuria, and improve the local blood circulation of the kidney and inhibit platelet aggregation to relieve intraglomerular blood coagulation and hypercoagulability, increase renal blood flow and perfusion. Achyranthes bidentata can guide the drug downward to the kidney, and cooperates with salvia miltiorrhiza and rhizoma et Radix Rhei to dredge the kidney collaterals and improve the microcirculation, which is helpful to repair the damaged filtration barrier and reduce the aggregation of inflammatory factors and the process of fibrosis. Many drugs such as radix rehmanniae preparata, cornus officinalis, achyranthes bidentata, alisma, rhizoma et Radix Rhei, fructus equiseti, salvia miltiorrhiza, etc. can significantly down-regulate key pro-inflammatory factors (such as TNF-α, IL-6, MCP-1) in the kidney, reduce the inflammatory infiltration and damage of the glomerulus and renal interstitium, and inflammation is a key factor leading to the destruction of the filtration barrier and the persistence of proteinuria.
[0027] In summary, radix rehmanniae preparata is warm in nature, sweet in taste, and belongs to the liver and kidney channels, and is used as the monarch drug to specifically nourish kidney yin and is known as "the drug for tonifying true water". By nourishing kidney yin, it can restore the kidney's ability to hold and store essence, thereby reducing the loss of essence, and when used with other medicinal materials, it can tonify the kidney and strengthen the body, enhance the treatment of the root, clear damp-heat and resolve stasis to treat the symptoms. Dioscorea, cornus officinalis, achyranthes bidentata, schisandra chinensis, cuscuta chinensis, corn silk, alisma, astragalus, fructus rosae laevigatae, gordon euryale, and fructus equiseti are all ministerial drugs. Radix rehmanniae preparata, when combined with dioscorea and cornus officinalis, can nourish kidney yin, fill essence, and repair the kidney's function of holding and storing essence. Achyranthes bidentata can guide the drug downward and make the virtual fire return to the origin, thereby reducing the loss of essence. Schisandra chinensis can astringe sweat and consolidate essence, gordon euryale can tonify the kidney and astringe essence, and fructus rosae laevigatae can shrink urine and stop leakage, and the three drugs together form a "astringent barrier" to reduce the loss of essence. Cuscuta chinensis and fructus equiseti are warm but not dry, and they can tonify kidney yang to assist in gasification, and cooperate with radix rehmanniae preparata to "seek yang in yin". Corn silk, alisma, and astragalus are used together to tonify qi and drain water, eliminate edema, raise clear and lower turbid, reduce proteinuria, and treat qi and water simultaneously and regulate ascending and descending. Salvia miltiorrhiza, rhizoma et Radix Rhei, and rhizoma et Radix Rhei are all auxiliary drugs. Salvia miltiorrhiza is cold and can clear blood heat, and rhizoma et Radix Rhei is bitter and cold and can resolve stasis and heat, and they can clear stasis and heat in two directions. Salvia miltiorrhiza can activate blood without damaging the normal, and rhizoma et Radix Rhei can resolve stasis with great force, and the wine can moderate its harshness. Salvia miltiorrhiza can dredge blood vessels, and rhizoma et Radix Rhei can dredge intestines and bowels, and they can resolve stasis and turbidity from both the intestinal tract and blood vessels. The combination of cooling and dispersing, resolving and dredging, and regulating the bowels and collaterals can achieve mutual aid. Rhizoma et Radix Rhei is bitter and cold and can counteract the warm tonification of schisandra chinensis and cuscuta chinensis, and prevent the astringency of fructus rosae laevigatae and gordon euryale from retaining damp-heat, and it can clear damp-heat to maintain the balance between resolving and astringency. Each component takes the advantages and compensates for the disadvantages, which increases the effect of reducing urinary albumin and protecting the kidney, and the reasonable combination of components achieves the effect of coordination and synergistic effect. DETAILED DESCRIPTION
[0028] To make the purpose, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions of the present application will be clearly and completely described below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of this application.
[0029] Example 1
[0030] A traditional Chinese medicine compound for reducing urine protein, comprising the following raw materials by weight: Rehmannia root 30g; 30 g Chinese yam; Cornus officinalis 30 g; Achyranthes bidentata 15 g; Schisandra chinensis 10 g; Cuscuta seeds 10 g; 20 g corn silk; Alisma orientalis 20 g; Raw Astragalus 30 g; Stir-fried Rosa laevigata flesh 15 g; Euryale ferox 15 g; Astragalus Complanatus 10 g; Salvia miltiorrhiza 20g; Wine rhubarb 5 g; Wine-soaked Coptis chinensis 3 g.
[0031] The mutual coordination between the components is analyzed from the component aspect and its mechanism of action is as follows: 1. Rehmannia root Core Function: As a monarch medicine, it specifically replenishes kidney yin and is known as the "drug that greatly replenishes true water." By nourishing kidney yin, it restores the kidney's ability to retain energy, thereby reducing the loss of essence and fine energy.
[0032] Combined with Cornus officinalis and Chinese yam: The three medicines together form the core of "Liuwei Dihuang Wan". Rehmannia glutinosa nourishes kidney yin as the main medicine, Cornus officinalis nourishes liver and consolidates essence as the minister medicine, and Chinese yam strengthens spleen and consolidates the body as the adjuvant medicine. The three medicines work together to repair the kidney's sealing function and reduce the leakage of essence.
[0033] Compatible with Astragalus: It replenishes both Qi and Yin. Astragalus replenishes Qi and enhances the ability to consolidate and control, while Rehmannia nourishes Yin and replenishes kidney essence, and together they reduce proteinuria.
[0034] 2. Yam Core function: Yam can nourish the spleen and stomach, nourish kidney yin, astringe essence and consolidate the body, and reduce protein loss by restoring the spleen's transportation and transformation function and the kidney's storage ability.
[0035] Compatibility with Euryale ferox and Fried Rosa davurica: The three herbs form the "Water and Land Two Immortals Dan" variant, with Shanyao tonifying the spleen and astringing essence, Euryale ferox astringing the kidney and essence, and Fried Rosa davurica reducing urine and preventing leakage. The triple astringent effect reduces protein loss.
[0036] Compatibility with Corn Silk: Shanyao tonifies the spleen and raises clear yang, while Corn Silk promotes urination and reduces turbidity. The combination of ascending and descending functions regulates water metabolism and reduces intraglomerular pressure.
[0037] 3. Cornus officinalis Core function: Cornus officinalis can tonify the liver and kidney, and it has a significant effect on improving kidney function, especially diabetic nephropathy and reducing urinary protein. The iridoid glycosides in Cornus officinalis can significantly reduce the expression of inflammatory factors in the kidney, block the binding of advanced glycosylation end products (AGEs) to their receptors (RAGE), reduce oxidative stress and podocyte apoptosis, and reduce proteinuria.
[0038] Compatibility with Schisandra chinensis: Cornus officinalis tonifies the liver and kidney and astringes essence, while Schisandra chinensis astringes the lung and kidney and astringes essence. The combination of the two herbs enhances the astringent effect of the kidney and reduces protein leakage.
[0039] 4. Radix Achyranthis Bidentatae Core function: Radix Achyranthis Bidentatae can remove blood stasis, tonify the liver and kidney, strengthen the bones and joints, promote urination and relieve stranguria, and guide blood downward. It can reduce inflammation, oxidative stress, and cell apoptosis, protect the integrity of the glomerular filtration barrier, and reduce protein leakage.
[0040] Compatibility with Rhei Radix et Rhizoma with Wine: Radix Achyranthis Bidentatae guides blood downward and promotes blood circulation, while Rhei Radix et Rhizoma with Wine promotes blood circulation and removes blood stasis. The combination of the two herbs improves kidney microcirculation and inhibits fibrosis.
[0041] Compatibility with Alisma orientalis: Radix Achyranthis Bidentatae guides turbid yin downward, while Alisma orientalis promotes urination and removes turbidity. The combination of the two herbs reduces kidney turbidity and alleviates proteinuria.
[0042] 5. Schisandra chinensis Core function: Schisandra chinensis has the effects of astringing, tonifying qi and promoting fluid production, and tonifying the kidney and calming the heart. The polysaccharides and lignans in Schisandra chinensis, such as schisandrin A and schisandrin C, have antioxidant, anti-apoptotic, and immune-regulating effects.
[0043] Compatibility with Semen Euryales and Herba Hedysari: Schisandra chinensis tonifies qi and astringes essence, while Semen Euryales and Herba Hedysari warm yang and astringe essence. The three herbs astringe essence from the aspects of qi, yin, and yang.
[0044] Compatibility with Coptis chinensis with Wine: Schisandra chinensis tonifies qi and nourishes yin, while Coptis chinensis with Wine clears heat and removes dampness. The combination of the two herbs prevents the aggravation of proteinuria caused by damp heat damaging yin.
[0045] 6. Semen Euryales Core function: Semen Euryales tonifies the liver and kidney and astringes essence and urine. The polysaccharide components in Semen Euryales have anti-inflammatory effects, can scavenge oxygen free radicals, and have immune-regulating effects, which can reduce serum urea, uric acid, blood urea nitrogen, and creatinine, and reduce kidney weight gain and histopathological changes.
[0046] Compatibility with Semen Astragali Complanati: Both can tonify the kidney and consolidate essence, but Semen Astragali Complanati is warm and Semen Astragali Milkvetch is good at reducing urine, which can enhance the kidney's sealing power.
[0047] Compatibility with Radix Rehmanniae: Semen Astragali Complanati is tonifying and Semen Astragali Milkvetch is moving and unblocking, which can improve the kidney blood flow without stagnation.
[0048] 4. Corn Silk Core function: Corn Silk has the effect of promoting diuresis and reducing edema. Corn Silk has a strong diuretic effect, which can improve the symptoms of edema caused by protein loss in both lower extremities.
[0049] Compatibility with Alisma: Corn Silk promotes diuresis and reduces edema, and Alisma can remove kidney turbidity. They work together to promote diuresis and remove turbidity.
[0050] Compatibility with Radix Astragali: Radix Astragali can tonify qi, promote water and consolidate essence, and Corn Silk can promote diuresis and remove turbidity. They work together to reduce edema and reduce urinary protein.
[0051] 5. Alisma Core function: Alisma has the effects of promoting diuresis and removing dampness, reducing heat, and reducing turbidity and lipid. The triterpenoids in Alisma have significant antioxidant, anti-inflammatory, blood lipid regulation, and immune regulation effects.
[0052] Compatibility with Rhei Radix et Rhizoma: Alisma can remove dampness, and Rhei Radix et Rhizoma can unblock the bowels. They work together to remove toxins, such as creatinine and urea nitrogen, and reduce the burden on the kidneys.
[0053] Compatibility with Radix Rehmanniae: Alisma can counteract the greasy and dampness of Radix Rehmanniae, prevent dampness stagnation in the middle jiao, and ensure the efficacy of yin-tonifying herbs.
[0054] 6. Radix Astragali Core function: Radix Astragali can tonify qi and yang, benefit the defensive aspect and consolidate the exterior, promote diuresis and reduce edema, and make turbid pathogens excrete from the urine, achieving the effect of eliminating pathogens and supporting the body.
[0055] Compatibility with Radix Salviae Miltiorrhizae: Radix Astragali can tonify qi and consolidate essence, and Radix Salviae Miltiorrhizae can activate blood and resolve stasis. Qi movement promotes blood flow, which can improve kidney ischemia and hypoxia, and reduce the release of inflammatory factors.
[0056] Compatibility with Coptidis Rhizoma: Radix Astragali can tonify qi and consolidate essence, and Coptidis Rhizoma can activate blood and resolve stasis. Qi movement promotes blood flow, which can improve kidney ischemia and hypoxia, and reduce the release of inflammatory factors.
[0057] 7. Fried Fructus Rosae Laevigatae Core function: It has the effect of consolidating essence and reducing urine. The polysaccharides and tannins in Fructus Rosae Laevigatae can eliminate free radicals, reduce oxidative stress damage, repair the glomerular basement membrane, and reduce protein leakage.
[0058] Compatibility with Euryale: Fructus Rosae Laevigatae can consolidate essence, and Euryale can tonify the kidney. They form a classic pair of "Water and Land Immortals" and directly enhance the reabsorption of the kidney tubules and reduce urinary protein.
[0059] Cherokee rose is good at retaining essence, reducing protein loss through astringency and tonifying the lower jiao; Fructus equiseti is good at tonifying kidney qi and enhancing the sealing function, with both astringency and tonification.
[0060] 8. Euryale ferox Core function: Euryale ferox is good at tonifying kidney and astringing essence, and the flavonoids in it can resist inflammation and eliminate oxygen free radicals, reducing secondary damage caused by increased oxygen free radicals in kidney disease, reducing the secretion of renin and angiotensin, thereby helping to reduce proteinuria; Euryale ferox can also improve microcirculation, improve blood supply to the diseased kidney, and reduce the pressure on the kidney.
[0061] Compatibility with Dioscorea opposita: Euryale ferox tonifies kidney and astringes essence, and Dioscorea opposita invigorates spleen and astringes essence, reducing the loss of subtle essence from the source.
[0062] Compatibility with Zea mays: Euryale ferox astringes and preserves essence, and Zea mays benefits dampness and removes turbidity, with astringency and removal, preventing the loss of subtle essence and removing turbid evil.
[0063] 9. Fructus equiseti Core function: Fructus equiseti tonifies kidney and astringes essence, with the effects of regulating lipid, resisting inflammation, resisting oxidation, regulating immunity, etc.
[0064] Compatibility with Cuscuta chinensis and Schisandra chinensis: Fructus equiseti astringes essence, Cuscuta chinensis warms yang, and Schisandra chinensis astringes yin, with the three balancing yin and yang of kidney, protecting kidney.
[0065] Compatibility with Radix equiseti: Fructus equiseti tonifies and astringes, and Radix equiseti benefits and benefits, preventing warm tonification and stasis.
[0066] 10. Salvia miltiorrhiza Core function: Salvia miltiorrhiza has the effects of activating blood and removing stasis, dredging channels and relieving pain, etc., and various components in it have the effects of resisting oxidative stress, resisting inflammation, resisting tumor, resisting fibrosis, reducing blood pressure, regulating blood lipid, etc.
[0067] Compatibility with Rhei Radix et Rhizoma: Salvia miltiorrhiza activates blood, and Rhei Radix et Rhizoma removes stasis, with both significantly inhibiting renal fibrosis and improving glomerular sclerosis.
[0068] Compatibility with Astragalus membranaceus: Astragalus membranaceus benefits qi and promotes Salvia miltiorrhiza to activate blood, improving hypercoagulable state and increasing renal blood perfusion.
[0069] 11. Rhei Radix et Rhizoma Core function: Rhei Radix et Rhizoma activates blood and removes stasis, dredges bowels and removes turbidity, improves renal microcirculation, and reduces renal tissue fibrosis, oxidative stress and inflammatory damage.
[0070] Compatibility with wine Huanglian: Rhei Radix et Rhizoma dredges bowels and removes turbidity, and wine Huanglian clears heat and removes dampness, eliminating dampness and heat evil and reducing the inflammatory load of the kidney.
[0071] Compatibility with Alisma orientalis and Zea mays: Rhei Radix et Rhizoma promotes defecation, Alisma orientalis and Zea mays promote diuresis, and both defecation and diuresis accelerate the excretion of metabolic waste.
[0072] 12. Huanglian Core function: Huanglian can clear and drain damp-heat from the lower jiao, purge fire and detoxify, and has the effects of inhibiting inflammatory damage, protecting podocytes, resisting fibrosis, improving kidney function, regulating glucose and lipid metabolism, etc.
[0073] Compatibility with Huangqi: Huanglian can clear damp-heat from the lower jiao, while Huangqi can tonify the upper and middle jiaos, so they can be used together to treat proteinuria of the damp-heat type.
[0074] Compatibility with Shudihuang: Huanglian can counteract the greasy and damp nature of Shudihuang, preventing the disease from being aggravated by damp-heat accumulation.
[0075] Example 2 (1) Preparation of raw materials Shudihuang, Shanyao, Shanzhuyu, Huai Niuxi, Wuyi Zi, Tusizi, Yu Cormus, Zexie, Shenghuangqi, Chaojin Yingmei, Qianshi, Shayousi, Danshen, Jiudaohuang, and Huanglian were mixed and weighed according to the weights in Example 1.
[0076] (2) Extraction of concentrated medicinal liquid Soaking: The above-mentioned mixed raw medicinal materials were added with soaking liquid, which was 8 times the total weight of the medicinal materials, to ensure that the medicinal materials were immersed, and soaked for 40 minutes.
[0077] Decoction and concentration: The mixed medicinal materials obtained after soaking were placed in a decoction container, and boiled with a strong fire, and maintained boiling with a weak fire for 20 minutes. The medicinal liquid and residue were filtered. The above-mentioned soaking and decoction steps were repeated twice to obtain the decocted medicinal liquid. The medicinal liquids obtained after multiple decoctions were mixed, and the mixed medicinal liquid was concentrated to obtain the concentrated medicinal liquid.
[0078] (3) Preparation of traditional Chinese medicine preparation Preparation of decoction: The concentrated medicinal liquid was divided into sterile packaging bags, and an appropriate amount of flavoring agent was added, sealed, and sterilized.
[0079] Preparation of pills: The concentrated medicinal liquid was added with an appropriate amount of starch or other excipients, stirred to form a soft material, then sieved, uniformly cut, dried, and prepared into pills of the Decrea Protein Recipe.
[0080] Preparation of powder: The concentrated medicinal liquid was spray-dried or vacuum-dried to obtain dried extract powder. The extract powder was mixed with an appropriate amount of medicinal excipient, crushed and sieved to ensure the fineness and uniformity of the powder. The powder was divided into sterile containers, sealed, and the Decrea Protein Recipe powder was obtained.
[0081] Preparation of ointment: The concentrated medicinal liquid was transferred to a jacketed kettle, and a specified amount of honey or syrup was added as a base, and stirred and mixed uniformly. The mixture was heated to a specified temperature and maintained, and continuously stirred and concentrated until the specified relative density was reached. The mixture was filtered while hot, divided into sterile containers, sealed, and cooled to obtain the Decrea Protein Recipe ointment.
[0082] (4) Quality inspection The prepared protein-lowering prescription is subjected to quality inspection to ensure that the quality of the preparation meets the relevant standards.
[0083] (5) Packaging and storage The protein-lowering prescription that passes the inspection is packaged, with information such as the name of the drug, specifications, usage and dosage, expiration date, storage conditions, etc. being indicated, and is stored according to the prescribed storage conditions to ensure the stability of the quality of the drug.
[0084] Through the above steps, the protein-lowering prescription that meets the requirements can be prepared. In actual operation, the requirements of the Good Manufacturing Practice (GMP) for drugs should be strictly followed to ensure the safety and effectiveness of the drug.
[0085] In order to further verify the effect of the protein-lowering prescription, an animal experiment was conducted: Adult rats of 6 weeks old and weighing 220 g were used, and a single intraperitoneal injection of freshly prepared streptozotocin solution (dissolved in 0.1 mol / L sodium citrate buffer, pH 4.5) was performed, with a dose of 55 mg / kg. Blood samples were taken from the tail vein 72 hours and 1 week after injection to measure fasting blood glucose. ① Rats with fasting blood glucose values ≥ 16.7 mmol / L were selected as successful models of diabetes; the successfully modeled rats were fed with high-sugar high-fat feed to induce diabetic nephropathy; at 6 weeks after modeling, 24-hour urine was collected using a metabolic cage to detect urine protein levels, and rats with 24-hour urine protein > 30 mg were selected as qualified intervention groups; the number of rats in each group was 8, and they were randomly allocated according to the following specifications: 1 group of positive control (given irbesartan), 1 group of model, 1 group of protein-lowering prescription, and 13 groups of single-factor variable control experiment; ② 8 rats with fasting blood glucose < 7.0 mmol / L were selected as normal control group; the rats in each group were adaptively fed for one week.
[0086] Normal control group: no gavage; Positive control group: given irbesartan for gavage, with a dosage of 15 mg / kg.
[0087] Protein-lowering prescription group (S1) and single-factor variable control experiment group (D1~13): gavage with the traditional Chinese medicine composition in Table 1, with a drug dosage of 8 g / kg.d for each rat after area conversion of humans and rats.
[0088] Model group: given an equal volume of sterile water for gavage.
[0089] The positive control group, the protein-reducing formula group, the single factor variable control experiment group and the model group are given timed gavage once a day, and the gavage is continuously given for 6 weeks, and then the gavage is stopped for 6 weeks; the urine protein of a single rat in the normal control group, the positive control group, the protein-reducing formula group and the single factor variable control experiment group is measured once a week, and other conditions of the rats are observed; Table 1: each experimental change factor table in the protein-reducing formula group (S1) and the single factor variable control experiment group (D1~13)
[0090] All urine protein data are recorded, statistical analysis is carried out, and the results are shown in Tables 2~3.
[0091] Table 2: 24-hour urine protein (mg) of rats in each group at different time points of intervention (Mean±SD)
[0092] Note: the model group is compared with the control group:* P <0.05,** P <0.01; the protein-reducing formula group and the positive (irbesartan) control group are compared with the model group:# P <0.05,## P <0.01; the S1 protein-reducing formula group is compared with the positive (irbesartan) control group& P <0.05,&& P <0.01. As shown in Table 2, compared with each control group, the urine protein level of the model group of rats is significantly increased (P<0.01); compared with the model group, the urine protein level of the S1 protein-reducing formula group is obviously reduced at the third week and the sixth week of intervention, and the difference is statistically significant (P<0.01). P <0.01). P
[0093] In order to reflect the role of each component in the formula, the single factor variable animal experiment is carried out, the change factors of the comparison experiment are shown in Table 1, and the detection results are shown in Table 3: Table 3
[0094] Note: each group is compared with the protein-reducing formula group at the same time point:# P <0.05,## P <0.01.
[0095] As shown in Table 3, each formula in the application plays a synergistic role, and is indispensable, and the effect of mutual promotion is achieved.
[0096] The treatment effect data of the traditional Chinese medicine composition in the application on the human body are as follows: A total of 86 patients with diabetic nephropathy (stage A2) were selected from inpatient and endocrinology clinic, including 45 males and 41 females, aged 45-80 years, with a disease duration of 1 month to 5 years. All patients met the urinary albumin creatinine ratio (UACR>30mg / g) and were randomly divided into 2 groups: 43 cases in the treatment group and 43 cases in the control group; there was no significant difference in age, gender, disease duration and other aspects between the two groups, and all the subjects received basic lifestyle intervention; Exclusion criteria: Patients who have received dialysis or plan to undergo dialysis / renal transplantation in the near future; Uncontrolled hypertension (such as systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg); Severe cardiovascular disease (such as recent myocardial infarction, unstable angina pectoris); Active liver disease (ALT / AST>3 times the upper limit of normal) or cirrhosis; Malignant tumor (not cured within 5 years or receiving radiotherapy and chemotherapy); Severe infection; Patients with type 1 diabetes; Pregnancy-induced diabetes or pregnant women; Severe endocrine diseases (such as Cushing's syndrome, acromegaly, etc.); Using other experimental drugs or participating in other clinical trials; Known allergic to the drugs or ingredients in the study; Poor compliance or unable to cooperate with the study.
[0097] Treatment group: oral administration of the decoction prepared from the drug of the present application, 1 dose per day, taken in the morning and evening, for 8 weeks of continuous administration; Control group: placebo was given, the dose and method of taking were the same as those of the treatment group, for 8 weeks; Efficacy evaluation: urinary albumin / urinary creatinine ratio (UACR) was detected before and after treatment in the two groups.
[0098] Adverse reactions include obvious liver and kidney damage, myocardial damage, skin reactions, gastrointestinal reactions, etc.
[0099] The treatment results are shown in Table 4: Table 4: Comparison of UACR levels (mg / g, Mean±SD) in the two groups before and after treatment
[0100] Note: compared with the control group, P <0.01, P <0.05; comparison between the control group before and after treatment (compared with week 0), P <0.05, P<0.01; comparison of treatment group before and after treatment (compared with week 0), & P <0.05, && P <0.01.
[0101] In summary, Rehmannia root (Shengdihuang) is mildly warm in nature and sweet in flavor, belonging to the Liver and Kidney Meridians. As the main herb, it specifically tonifies kidney yin and is known as the "great tonic for true water." By nourishing kidney yin and restoring the kidney's ability to retain and retain essence, it reduces the loss of essence and fine particles. When used in conjunction with other herbs, it strengthens the kidneys and strengthens the body's foundation, enhancing its ability to retain and retain essence, while clearing dampness and heat, dissolving blood stasis, and unblocking the meridians to address the symptoms. Chinese yam, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta australis, Corn silk, Alisma orientalis, Astragalus membranaceus, stir-fried Rosa laevigata fruit pulp, Euryale ferox, and Astragalus complanatus serve as assistant herbs. When combined with Chinese yam and Cornus officinalis, Rehmannia root nourishes kidney yin, replenishes essence and marrow, and tonifies the three yin elements, restoring the kidney's function of retaining and retaining essence. Achyranthes bidentata guides the herbs downward, drawing blood (fire) downward, returning deficient fire to its source and reducing forced semen loss. Schisandra chinensis astringes perspiration and retains essence, Euryale ferox strengthens the kidneys and astringes essence, and Rosa laevigata fruit reduces urination and stops nocturnal emission. Together, these three herbs form a "solidifying barrier" that reduces the loss of essence and fine particles (protein). Cuscuta and Astragalus membranaceus are warming but not drying, tonifying kidney yang and promoting qi transformation, synergizing with Rehmannia glutinosa to "seek yang within yin." Corn silk, Alisma orientalis, and Astragalus membranaceus work together to tonify qi and promote water circulation, eliminate edema, raise the clear and lower the turbid, and reduce proteinuria, treating both qi and water, and harmonizing ascending and descending. Salvia miltiorrhiza, Rhubarb (wine-infused rhubarb), and Coptis chinensis (wine-infused coptis root) serve as adjuvants. Salvia miltiorrhiza is slightly cold and clears blood heat, while Rhubarb (wine-infused rhubarb) is bitter and cold, relieving stagnant heat. This dual-action approach clears stagnant heat. Salvia miltiorrhiza activates blood circulation without harming vital energy, while Rhubarb (wine-infused rhubarb) has a powerful stasis-busting effect, mitigated by the alcohol. Salvia miltiorrhiza unclogs the blood vessels, while Rhubarb (wine-infused rhubarb) clears the intestines and viscera, relieving stasis and turbidity through both the intestines and blood vessels. The two herbs combine cooling and dispersing properties, promoting both activating and unblocking, and harmonizing the internal organs. The bitter and cold nature of Coptis chinensis counteracts the warming and tonifying effects of Astragalus membranaceus and Cuscuta chinensis, which tend to retain dampness and heat. While Rosa laevigata and Euryale ferox (Gorgon fruit) tend to astringe and retain dampness and heat, Coptis chinensis (wine-infused coptis root) clears dampness and heat, maintaining a balanced balance between activating and astringing. Each component complements its own strengths and weaknesses, increasing the effect of reducing urinary albumin and protecting the kidneys. The components are reasonably matched to achieve a coordinated and synergistic effect.
[0102] It should be noted that: The above-described embodiments merely represent specific implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of protection of the present application. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the technical concept of the present application, and all such variations and improvements fall within the scope of protection of the present application.
Claims
1. A Chinese medicinal compound for reducing urinary protein, characterized in that: By weight, it is composed of the following raw materials: 10-30 parts of Rehmannia root, 10-30 parts of Chinese yam, 10-30 parts of Cornus officinalis, 10-20 parts of Achyranthes bidentata, 5-15 parts of Schisandra chinensis, 5-15 parts of Cuscuta seed, 10-30 parts of Corn silk, 10-30 parts of Alisma orientalis, 10-30 parts of raw Astragalus, 10-30 parts of stir-fried Rosa laevigata flesh, 10-30 parts of Euryale ferox, 5-15 parts of Astragalus membranaceus, 5-30 parts of Salvia miltiorrhiza, 3-10 parts of wine-boiled Rhubarb, and 3-5 parts of wine-boiled Coptis chinensis.
2. A Chinese medicinal compound for reducing urinary protein according to claim 1, characterized in that: By weight, it is composed of the following raw materials: 30 parts of Rehmannia root, 30 parts of Chinese yam, 30 parts of Cornus officinalis, 15 parts of Cyathula root, 10 parts of Schisandra chinensis, 10 parts of Cuscuta seed, 20 parts of Corn silk, 20 parts of Alisma orientalis, 30 parts of raw Astragalus, 15 parts of stir-fried Rosa laevigata flesh, 15 parts of Euryale ferox, 10 parts of Astragalus membranaceus, 20 parts of Salvia miltiorrhiza, 5 parts of Rhubarb with wine, and 3 parts of Coptis chinensis with wine.
3. A Chinese medicine preparation for reducing urine protein, characterized in that: The preparation is prepared using the Chinese medicinal compound according to claim 1 or 2, including decoctions, pills, powders and pastes.
4. A method for preparing a Chinese medicine preparation for reducing urinary protein, characterized in that: The following steps are involved: Step 1: mixing Rehmannia root, Chinese yam, Cornus officinalis, Achyranthes bidentata, Schisandra chinensis, Cuscuta australis, Corn silk, Rhizoma Alismatis, raw Astragalus, stir-fried Rosa laevigata fruit, Euryale ferox, Astragalus complanatus, Salvia miltiorrhiza, Rhubarb wine, and Coptis chinensis wine according to the weight parts of claim 1 or 2, and soaking in soaking liquid for 30 to 60 minutes; Step 2: Boil the mixed medicine obtained after soaking in step 1 over high heat, then keep boiling over low heat for 15 to 20 minutes, and filter to obtain the medicinal liquid and medicinal residue; Step 3: Repeat steps 1 and 2 multiple times to obtain multiple decoctions of the medicinal liquid, mix the multiple decoctions of the medicinal liquid, and concentrate the mixed medicinal liquid to obtain a concentrated medicinal liquid; Step 4: Prepare the concentrated medicinal solution obtained in step 3 into a traditional Chinese medicine preparation.
5. The method for preparing a traditional Chinese medicine preparation for reducing urine protein according to claim 4, wherein: The added weight of the soaking liquid in step 1 is 8 times the total weight of the raw material.
6. The method for preparing a traditional Chinese medicine preparation for reducing urine protein according to claim 4, characterized in that: The preparations in step 4 are decoctions, pills, powders and ointments.
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