A traditional Chinese medicine composition for treating early diabetic nephropathy and its preparation method

Abstract

The present invention belongs to the technical field of diabetic nephropathy drugs, and particularly relates to a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof. The traditional Chinese medicine composition comprises the following main components by weight: 20-40 parts of astragalus, 10-20 parts of pseudoginseng, 20-40 parts of raw rehmannia, 10-20 parts of cornus officinalis, 10-20 parts of winter mallow seeds, 10-20 parts of euryale ferox, 9-15 parts of morus alba bark, 10-20 parts of zedoaria, 3-6 parts of leeches, and 3-6 parts of scorpions. The traditional Chinese medicine composition combines kidney-tonifying and spleen-invigorating drugs with blood circulation-activating and collateral-dredging drugs, and is nutritious without being greasy, and attacks pathogens without damaging the body, thereby jointly achieving the functions of invigorating the spleen and replenishing qi, tonifying the kidney, activating blood circulation and dredging collaterals, and having significant therapeutic effects in lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving the quality of life of patients.

Description

Technical Field

[0001] The present invention belongs to the technical field of diabetic nephropathy drugs, and particularly relates to a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof. Background Art

[0002] Diabetic kidney disease (DKD) is a common complication of diabetes mellitus (DM), affecting approximately 25% to 40% of patients with the disease, with a recent increasing incidence. With the increasing prevalence of DM in my country, DKD has become the leading cause of end-stage renal disease. The pathogenesis of DKD is not yet fully understood, but clinically, it is believed to be primarily related to chronic hyperglycemia, leading to impaired renal glucose metabolism, oxidative stress, and altered renal vascular dynamics. Furthermore, immune mechanisms and genetic factors may also play a role.

[0003] The pathological characteristics of DKD patients are primarily characterized by changes in the renal microvasculature and glomeruli. Early on, diffuse thickening of the glomerular capillary basement membrane and an increase in mesangial matrix lead to the development of nodular glomerulosclerosis, a decrease in protein filtration rate, and subsequent symptoms such as microalbuminuria and lower limb edema. As the disease progresses, renal impairment enters the clinical stage, where it becomes progressive, with a persistent decrease in glomerular filtration rate and increasingly severe clinical symptoms. Without timely treatment, renal failure, uremic symptoms, and, in severe cases, death can occur. DKD is a fatal complication of diabetes and a leading cause of death in diabetic patients. It also carries a high risk of disability. In early-stage DKD, before irreversible renal pathological damage has occurred, aggressive treatment is crucial for controlling disease progression, improving patient prognosis, and reducing mortality and disability. End-stage DKD patients can only maintain their lives through continuous hemodialysis, peritoneal dialysis and other renal replacement therapies. The patients' quality of life is poor. Kidney transplantation technology is currently difficult to implement in my country and is expensive, which will also bring a great financial burden to patients.

[0004] Currently, Western medicine lacks specific treatments for early-stage DKD. Treatments primarily focus on lowering blood sugar, lipids, and blood pressure, often using ACE inhibitors / ARBs, to control disease progression. The emergence of newer drugs, such as sodium-glucose co-stimulatory protein 2 inhibitors, has provided new and promising treatment options for DKD patients. Studies have shown that canagliflozin can effectively reduce the risk of renal and cardiovascular events, has a strong safety profile, and can also control patients' blood pressure and blood sugar levels. While these Western medical treatments have a clear role in slowing the progression of DKD, their effectiveness is limited and cannot fully meet the requirements for widespread clinical use.

[0005] Traditional Chinese medicine theory posits that DKD is derived from "diabetes mellitus." Contemporary physicians define it as "diabetes mellitus nephropathy," a syndrome characterized by underlying deficiency and superficial excess, with deficiency of the internal organs, qi, and blood as the underlying condition, and excess of phlegm, damp-heat, and blood stasis as the superficial symptoms. Numerous studies have demonstrated that traditional Chinese medicine (TCM) treatment for early-stage DKD is highly effective in lowering blood glucose and serum creatinine levels, increasing insulin sensitivity, and improving kidney function. It effectively alleviates clinical symptoms, improves prognosis, and delays DKD progression. Furthermore, TCM treatments offer limited adverse reactions, high clinical safety, minimal financial burden on patients, and high patient acceptance. However, a comprehensive consensus on the syndrome differentiation and treatment of DKD using TCM remains elusive. A unified and effective TCM treatment regimen for the prevention and treatment of early-stage DKD remains lacking, and efficacy remains to be improved. Currently, existing TCM compound formulas are used clinically to treat the disease, but their efficacy is modest. While they may have some effect in lowering blood glucose and serum creatinine, their effectiveness in correcting impaired insulin secretion, protecting kidney function, improving overall clinical symptoms, and delaying disease progression remains inconsistent. Summary of the Invention

[0006] In response to the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method thereof. The traditional Chinese medicine composition combines kidney-tonifying and spleen-invigorating drugs with blood-activating and collateral-dredging drugs, which are nourishing without being greasy, attacking pathogens without harming the body, and together have the functions of strengthening the spleen and replenishing qi, nourishing the kidneys, activating blood circulation and dredging collaterals. It has significant therapeutic effects in lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving the quality of life of patients.

[0007] The inventors, in combination with traditional Chinese medicine theory, from the physiological functions of the spleen and kidneys to the basic pathogenesis of early diabetic nephropathy, combined with clinical practice, found that when using prescriptions based on the principles of strengthening the spleen and replenishing qi, tonifying the kidneys and activating blood circulation and unblocking the meridians to treat patients with early diabetic nephropathy that meet the pathogenesis characteristics of spleen and kidney deficiency with blood stasis in traditional Chinese medicine, the symptoms such as fatigue and nausea are significantly improved, and the blood sugar and blood creatinine are significantly reduced. The present invention provides a Chinese medicine composition for treating early diabetic nephropathy, which combines kidney-tonifying and spleen-tonifying drugs with blood circulation and unblocking meridians drugs, to nourish without being greasy, to attack pathogens without damaging the body, and to jointly play the role of strengthening the spleen and replenishing qi, tonifying the kidneys and activating blood circulation and unblocking the meridians, and has a significant therapeutic effect in lowering blood sugar and blood creatinine, improving diabetic nephropathy symptoms, and improving the quality of life of patients.

[0008] Although there is no name for diabetic nephropathy in traditional Chinese medicine, the recognition of it has a long history. It belongs to the pathological syndrome of Xiaoke. The Xiaoke symptoms mentioned in the works of doctors of all dynasties, such as fullness, water disease, asthenia, edema, turbid urine, kidney consumption, and obstruction, are all related symptoms. Therefore, diabetic nephropathy is generally classified as "edema", "turbid urine", "kidney consumption", "stranguria" and "obstruction" in traditional Chinese medicine. Because the location of diabetic nephropathy is always in the kidneys, and this kidney disease is secondary to Xiaoke, some Chinese medicine scholars directly call it "Xiaoke disease nephropathy". The main manifestations of early diabetic nephropathy are dry mouth and thirst, fatigue, soreness of waist and knees, edema, pain and numbness of limbs, polyuria, clear and long or turbid urine, dark tongue or ecchymosis, deep and weak pulse or heavy and astringent pulse, etc. These clinical manifestations suggest to the inventor that spleen and kidney deficiency and blood stasis are actually the main pathogenesis of early diabetic nephropathy.

[0009] The spleen and stomach are the foundation of acquired constitution and the source of Qi and blood production. However, the spleen's production and transformation rely on the kidney's yang, while the kidney's storage and preservation rely on the spleen's production of yin and fluids. Urinary protein represents the body's essence of grain and water. Its production and retention are the responsibility of the spleen, while its storage is the responsibility of the kidney. It should serve as energy to nourish the body's limbs and bones, preventing it from being lost. "Suwen: Treatise on the Meridians" states: "Drink enters the stomach, travels above the essence, ascends to the spleen, swirls and disperses the essence, returns to the lungs, regulates the water channels, and descends to the bladder. Water essence is distributed throughout the body, running parallel to the five meridians." This statement, "Food Qi enters the stomach, disperses essence to the liver, and dissipates Qi in the tendons. Food Qi enters the stomach, turbid Qi returns to the heart, and dissipates essence in the meridians. Qi flows through the meridians, and meridian Qi returns to the lungs. The lungs, in turn, connect to the various meridians, distributing essence to the skin and fur," illustrates the process of grain and water essence's transportation, transformation, and absorption. "Essentials of Diagnosis and Treatment" states: "When the three types of diabetes last for a long time and the urine has no odor but a sweet smell, and boils in the urine bucket, the disease is serious. It is like pig fat floating on the urine surface or candle wax splashing on the edge of the bucket. This is exhaustion of essence and is difficult to treat. Water in the universe and in the human body has both sweet and salty flavors. Sweet brings vitality and salty brings death. Urine is dead water. It is originally salty but becomes sweet. This is a loss of vitality, and the vitality of the spleen and stomach has sunk." In "Differentiation Record" by Chen Shize: "The symptoms of diabetes are all caused by spleen and kidney failure. When the spleen is damaged, the earth cannot overcome water. When the kidney is damaged, water cannot overcome fire. The two combine to form the disease." The above explains that spleen and kidney deficiency is the key cause and the key link in the onset of early diabetes and kidney disease.

[0010] In summary, the inventor adheres to the viewpoint of treating the disease from the perspective of spleen and kidney, and believes that tonifying the spleen and benefiting the kidney is the key. In clinical practice, there are many patients with spleen and kidney deficiency and blood stasis syndrome. Spleen and kidney deficiency is the root, and blood stasis is the symptom. Therefore, it is necessary to pay attention to treating the spleen and kidney on the basis of syndrome differentiation and treatment. The spleen is the foundation of acquired constitution, and the kidney is the foundation of innate constitution. The nourishment of qi and blood in the whole body depends on this. Only when the spleen is healthy and the kidney qi is enriched, qi and blood can be sufficient, and the qi movement can be smooth, which is also conducive to the removal of blood stasis, thereby achieving the effect of improving the patient's blood sugar and blood creatinine levels and delaying the progression of diabetic nephropathy. The above is the treatment mechanism proposed by the inventor, and it is applied to the specific treatment process:

[0011] A traditional Chinese medicine composition for treating early diabetic nephropathy, the main components of which are calculated by weight:

[0012] 20-40 parts of Astragalus, 10-20 parts of Pseudostellariae Radix, 20-40 parts of Rehmannia glutinosa, 10-20 parts of Cornus officinalis, 10-20 parts of Malus domestica seeds, 10-20 parts of Euryale ferox, 9-15 parts of Morus alba bark, 10-20 parts of Zedoariae rhizome, 3-6 parts of Hirudo, and 3-6 parts of Scorpio. The optimal therapeutic effect is achieved within this dosage range. Excessive or insufficient dosages can alter the primary and secondary pathological mechanisms underlying the prescription.

[0013] Preferably, the main components of the Chinese medicine composition are as follows by weight:

[0014] 25-35 parts of Astragalus, 12-18 parts of Pseudostellariae Radix, 25-35 parts of Rehmannia glutinosa, 12-18 parts of Cornus officinalis, 10-15 parts of Malus domestica seeds, 12-18 parts of Euryale ferox, 10-15 parts of Morus alba bark, 10-15 parts of Zedoariae rhizome, 3-4 parts of Hirudo, and 3-4 parts of Scorpio.

[0015] In the prescription of the present invention, astragalus and raw rehmannia are used as the main ingredients. Astragalus is sweet and slightly warm, while raw rehmannia is sweet and cold. The sweet and warm properties invigorate qi, while the sweet and cold properties nourish yin. Astragalus and raw rehmannia are used together to invigorate the spleen and invigorate qi, nourish yin and produce body fluid, and mutually assist qi and yin, replenish both qi and blood. When qi is full, blood circulates. This is targeted at the basic pathogenesis of spleen and kidney deficiency and internal blood stasis in early diabetic nephropathy.

[0016] Pseudostellariae, Cornus officinalis, and Euryale ferox serve as assistant ingredients. Pseudostellariae is sweet, slightly bitter, and neutral, invigorating Qi and strengthening the spleen, promoting fluid production and moistening the lungs. Cornus officinalis is sour, astringent, and slightly warm, warming the liver and kidneys, and consolidating and astringing. Euryale ferox is sweet, astringent, and neutral, invigorating the spleen and dispelling dampness, strengthening the kidneys, and consolidating essence. Together, these herbs serve as assistant ingredients, tonifying both yin and yang, aiding the main ingredients in strengthening the spleen and kidneys, while also making the formula nourishing without being greasy, and astringent without retaining dampness.

[0017] The medicine is supplemented with winter melon seeds, mulberry bark, and zedoaria root. Winter melon seeds are sweet and cold, promoting diuresis and relieving stranguria, and promoting bowel movements; mulberry bark is sweet and cold, purging the lungs and relieving asthma, promoting diuresis and reducing swelling; zedoaria root is bitter, pungent, and slightly warm, promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncles, promoting diuresis and reducing swelling. All the herbs act as adjuvants to achieve the effects of promoting blood circulation, promoting menstruation, promoting diuresis and reducing swelling.

[0018] Leeches and scorpions are used as envoys. Leeches, with their salty, bitter, and neutral properties, are effective in dispersing blood stasis and promoting menstruation. Scorpions, with their pungent and neutral properties, are effective in calming wind and relieving spasms, attacking toxins and dispersing stagnation, and unblocking meridians and relieving pain. These two herbs are well-suited to the meridians of the limbs, transmitting the medicinal properties of the other herbs throughout the body. Together, these herbs strengthen the spleen and replenish qi, tonify the kidneys, activate blood circulation, and unclog the meridians.

[0019] The more specific Chinese and Western medicinal mechanisms for each herb are as follows:

[0020] Astragalus: First mentioned in the "Wu Er Bing Fang" (Five-Two Disease Prescriptions), it has a sweet and slightly warm flavor and enters the spleen and lung meridians. Its sweet and warm properties are tonifying and ascending, while its sweet and mild properties are diuretic and diuretic. It is effective in tonifying the middle Qi and elevating the clear Yang, while also tonifying the lung Qi and strengthening the exterior. The "Medical Records of Zhongzhong Canxi" states that it "is the most effective in tonifying Qi... hence the name 'qi'." Astragalus regulates the release of pro-fibrotic factors, increases the secretion of inflammatory factors, and participates in anti-inflammatory responses, thereby regulating the function of the autophagy mechanism and reducing oxidative stress, thereby improving renal function and delaying the progression of DKD patients.

[0021] Radix Pseudostellariae: Sweet, slightly bitter, neutral, enters the spleen and lung meridians, and has the effects of invigorating qi, strengthening the spleen, promoting fluid production and moistening the lungs. Studies have shown that Radix Pseudostellariae homogeneous glucan H-1-2 (172) can enhance insulin secretion, improve blood sugar and blood lipid levels, and improve glucose and insulin tolerance; Radix Pseudostellariae cyclic peptides and Radix Pseudostellariae polysaccharides can exert anti-inflammatory effects by activating different signaling pathways; Radix Pseudostellariae polysaccharides have cytoprotective effects.

[0022] Raw Rehmannia root: First recorded in Shennong's Herbal Classic, it has a sweet and bitter flavor and a cold nature. It primarily enters the heart, liver, and kidney meridians, clearing heat, cooling blood, nourishing yin, and promoting fluid production. "Ming Yi Bie Lu" states: "It nourishes the five internal organs, addresses internal deficiencies, unclogs blood vessels, and strengthens Qi and strength." Entering the kidney meridian, it nourishes kidney yin and reduces internal heat. Studies have shown that the active ingredients of raw Rehmannia root (rehmannia oligosaccharides, rehmannia oligosaccharides, and rehmannia glycosides) can lower blood sugar and improve insulin resistance. Rehmannia oligosaccharides, in particular, rebuild the endocrine regulatory network and maintain blood sugar homeostasis. Raw Rehmannia root exhibits anti-inflammatory effects by protecting against oxidative damage and lipid peroxidation, improving blood rheology, lowering levels of Hs-CRP, IL-6, and TNF-α, and inhibiting the expression of inflammatory pathways.

[0023] Cornus officinalis: Sour, astringent, and slightly warm, it enters the liver and kidney meridians, warming and nourishing the liver and kidneys while also providing astringency and firming properties. It tonifies both kidney yang and kidney essence, serving as a yin-yang tonifying product. "Leigong Paozhi Lun" states: "It nourishes vital energy and secret essence." Modern chemical research indicates that Cornus officinalis contains multiple active ingredients that protect the kidneys by downregulating Akt phosphorylation, thereby reducing inflammation. Among them, total Cornus officinalis glycosides can reduce AGEs in the kidneys and increase superoxide dismutase (SOD) activity. Morroniside can lower blood sugar, triglycerides, and cholesterol, reduce urinary protein, and lower serum urea nitrogen. It protects pancreatic islet cells, prevents endothelial cell, mesangial cell, and podocyte proliferation and degeneration, and has a protective effect against podocyte apoptosis. Loganin inhibits the AGE-RAGE pathway, reducing renal oxidative stress, thereby alleviating the progression of DKD. It also improves endoplasmic reticulum stress in GMCs, alleviating inflammation and organelle damage.

[0024] Winter mallow seeds: Sweet in flavor and cold in nature, they enter the large intestine, small intestine, and bladder meridians. They promote diuresis, relieve stranguria, promote bowel movements, and promote lactation. They are also known to treat edema. Studies have shown that winter mallow seeds, a member of the Malvaceae family, possess anti-inflammatory, antibacterial, and anti-cancer properties. Rich in plant protein, anthocyanins, and polysaccharides, they can enhance immunity and repair tissue damage. They also contain a high amount of linoleic acid, which has a strong inhibitory effect on inflammation.

[0025] Gorgon fruit: Sweet and astringent in nature, it enters the spleen and kidney meridians. Its sweet, tonic, astringent, and neutral properties are mild and balanced. It tonifies the spleen and dispels dampness, benefits the kidneys, and consolidates essence. Its tonifying properties are not greasy, and its astringent properties do not retain dampness. It is primarily used to treat chronic diarrhea caused by spleen deficiency and lower abdominal distension due to kidney deficiency. It tonifies the kidneys and consolidates essence, tonifies the spleen and stops diarrhea, and dispels dampness and stops leukorrhea. The "Compendium of Materia Medica" states: "The sweet flavor tonifies the spleen, thus dispelling dampness and curing diarrhea and abdominal pain. The astringent flavor consolidates the kidneys, thus stabilizing breath and curing leukorrhea and urinary incontinence." Pharmacological studies have shown that an ethanol extract of Gorgon fruit can reduce glomerulosclerosis in DKD rats, decrease 24-hour urine protein and microalbuminuria, and exhibit certain antioxidant properties. Clinical studies have also shown that Gorgon fruit treatment of early-stage DKD results in significantly lower urinary albumin excretion rate, microalbuminuria, and serum creatinine levels in the treatment group than in the control group.

[0026] Morus alba bark: Sweet in flavor and cold in nature, it enters the lung meridian, purging the lungs and relieving asthma, while promoting diuresis and reducing swelling. Podocytes, along with the glomerular basement membrane and vascular endothelial cells, form the kidney's filtration barrier and play a crucial role in maintaining normal glomerular structure and function. Experimental results suggest that a flavonoid extract from Morus alba bark may reduce high-glucose-induced podocyte damage by upregulating miR-223-3p expression.

[0027] Zedoariae: First mentioned in Shennong's Herbal Classic, it has a bitter, pungent, and slightly warm taste and enters the liver and spleen meridians. It promotes blood circulation and regulates menstruation, dispels blood stasis and eliminates carbuncles, and promotes diuresis and reduces swelling. The Rihuazi Materia Medica describes it as "opening the nine orifices, benefiting the joints, nourishing blood and qi, dissolving stagnant blood, and eliminating lumps and masses." Studies have shown that Zedoariae can inhibit the TGF-β1 signaling pathway in mesangial cells and podocytes, downregulate PKCα and PKCβⅠ, reduce mesangial proliferation, upregulate podocyte nephrin expression, alleviate podocyte injury, reduce proteinuria, and improve DKD. Zedoariae serum can upregulate the protein and mRNA expression of Syndecan-1, Glypican-1, and CD31, while inhibiting the expression of α-SMA and its mRNA, suggesting that Zedoariae can alleviate high-glucose-induced GEC damage by protecting glycocalyx core proteins.

[0028] Leeches: Salty, bitter, neutral, and slightly toxic, they enter the liver meridian and are known to dissolve blood, remove blood stasis, and promote menstruation. Zhang Xichun remarked, "All blood-dissolving drugs often damage the Qi, but leeches, with their salty taste, specifically penetrate the blood, leaving them harmless. Furthermore, after taking them, there is no abdominal pain or sensation of a rupture, and blood stasis disappears without a trace. It is truly an effective medicine." Hirudin can enhance the body's sensitivity to insulin, strengthening tissues' ability to reuptake and utilize blood sugar, thereby achieving long-term, stable blood sugar control. Leeches and their extracts can inhibit thrombin activity and reduce podocyte damage, thereby slowing renal fibrosis and promoting kidney protection. Leeches can also improve glomerular filtration function and reduce proteinuria by maintaining the podocyte skeletal morphology and density. Furthermore, leeches and their active ingredients may alleviate and treat blood stasis syndrome by regulating lipid metabolism disorders.

[0029] Scorpion: Pungent, neutral, and toxic, it enters the liver meridian and has the properties of calming wind and relieving spasms, expelling toxins and dispersing stagnation, and dredging meridians and relieving pain. Scorpion may alleviate renal pathological damage in DKD rats by increasing renal BMP-7 expression, reducing renal ECM accumulation, and delaying the progression of renal fibrosis.

[0030] Furthermore, the inventors have rationally optimized the above-mentioned drug components and finally obtained the following technical solution: The main components of the drug are calculated by weight:

[0031] 30 parts of Astragalus, 15 parts of Pseudostellariae Radix, 30 parts of Radix Rehmanniae, 15 parts of Fructus Corni, 12 parts of Fructus Maluse, 15 parts of Euryale ferox, 12 parts of Cortex Mori, 12 parts of Herba Eupatorii, 3 parts of Hirudo, 3 parts of Scorpio.

[0032] First, weigh out each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is 3-5 cm covered, soak for 1.5 hours, boil over high heat, then simmer over low heat for 40-50 minutes, filter out the juice for later use, add water to the residue again, until the surface of the residue is 1-2 cm covered, boil over high heat, then simmer over low heat for 20-30 minutes, filter out the juice and combine it with the previous juice to obtain the Chinese medicine decoction.

[0033] Dosage: 1 dose per day, divided into morning and evening, taken warm 1-2 hours after meals.

[0034] The drug obtained using the formula and preparation method of the present invention has a very significant therapeutic effect in clinical application. The inventors have demonstrated through extensive testing that the pharmaceutical composition of the present invention has a significant effect in lowering blood sugar and blood creatinine, improving symptoms of diabetic nephropathy, and improving patients' quality of life. Therefore, the technical solution of the present invention has significant advantages both in theory and clinical effectiveness. In actual conditions, the formula of the present invention can be used in combination with Western medicine.

[0035] In summary, the present invention combines traditional Chinese medicine theory with the theory of disease-symptom combination to obtain a Chinese medicine composition specifically for the treatment of early diabetic nephropathy. The kidney-tonifying and spleen-invigorating drugs are matched with blood-activating and collateral-dredging drugs. They are nourishing without being greasy, attacking evil without hurting the body, and together they have the functions of strengthening the spleen and replenishing qi, nourishing the kidney and activating blood circulation and collaterals. They have significant therapeutic effects in lowering blood sugar and blood creatinine, improving the symptoms of diabetic nephropathy, and improving the quality of life of patients. DETAILED DESCRIPTION

[0036] The present invention is not limited to the following embodiments. The following embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and improvements may be made to the present invention without departing from the spirit and scope of the present invention. These changes and improvements all fall within the scope of the present invention as claimed.

[0037] Example 1

[0038] A traditional Chinese medicine composition for treating early diabetic nephropathy is prepared from the following drugs:

[0039] Astragalus 30g, Pseudostellaria 15g, Radix Rehmanniae 30g, Fructus Corni 15g, Fructus Maluse 12g, Fructus Euryale 15g, Cortex Mori 12g, Herba Eupatorii 12g, Hirudo 3g, Scorpio 3g;

[0040] The preparation method is as follows:

[0041] (1) First, weigh out each Chinese herbal medicine according to the ratio of raw materials, mix them evenly, add 1200ml of cold water, and soak for 1.5 hours;

[0042] (2) Boil the mixed raw materials over high heat, simmer for 45 minutes, and filter through gauze to obtain the filtrate and residue;

[0043] (3) The medicinal residue obtained in step (2) was mixed with 550 ml of hot water and decocted. The hot water was purified water at a temperature of 80° C. The mixture was boiled over high heat, simmered over low heat for 25 minutes, and then filtered again with gauze to obtain the filtrate and medicinal residue.

[0044] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for treating early diabetic nephropathy.

[0045] Example 2

[0046] A traditional Chinese medicine composition for treating early diabetic nephropathy is prepared from the following drugs:

[0047] Astragalus 20g, Pseudostellaria 12g, Radix Rehmanniae 20g, Fructus Corni 12g, Fructus Sophorae Flavescentis 10g, Euryale ferox 12g, Morus alba bark 9g, Herba Eupatorii 10g, Hirudo 3g, Scorpio 3g;

[0048] The preparation method is as follows:

[0049] (1) First, weigh out each Chinese herbal medicine according to the raw material ratio, mix well, add 900ml of cold water, and soak for 1.5 hours;

[0050] (2) Boil the mixed raw materials over high heat, simmer for 40 minutes, and filter through gauze to obtain the filtrate and residue;

[0051] (3) mixing the medicinal residue obtained in step (2) with 400 ml of hot water and decocting the mixture, wherein the hot water is purified water at a temperature of 80° C., boiling the mixture over high heat, decocting the mixture over low heat for 20 minutes, and filtering the mixture again with gauze to obtain the filtrate and the medicinal residue;

[0052] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for early diabetic nephropathy.

[0053] Example 3

[0054] A traditional Chinese medicine composition for treating early diabetic nephropathy is prepared from the following drugs:

[0055] Astragalus 40g, Pseudostellaria 18g, Radix Rehmanniae 40g, Fructus Corni 18g, Fructus Sophorae Flavescentis 18g, Euryale ferox 18g, Morus alba bark 15g, Herba Eupatorii 18g, Hirudo 6g, Scorpio 6g;

[0056] The preparation method is as follows:

[0057] (1) First, weigh out each Chinese herbal medicine according to the raw material ratio, mix well, add 1500ml of cold water, and soak for 1.5 hours;

[0058] (2) Boil the mixed raw materials over high heat, simmer for 50 minutes, and filter through gauze to obtain the filtrate and residue;

[0059] (3) The medicinal residue obtained in step (2) was mixed with 600 ml of hot water and decocted. The hot water was purified water at a temperature of 80° C. The mixture was boiled over high heat, simmered over low heat for 30 minutes, and then filtered again with gauze to obtain the filtrate and medicinal residue.

[0060] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for early diabetic nephropathy.

[0061] Example 4

[0062] A traditional Chinese medicine composition for treating early diabetic nephropathy is prepared from the following drugs:

[0063] Astragalus 25g, Pseudostellaria 12g, Radix Rehmanniae 25g, Fructus Corni 12g, Fructus Sophorae Flavescentis 10g, Euryale ferox 12g, Morus alba bark 10g, Herba Eupatorii 10g, Hirudo 3g, Scorpio 3g;

[0064] The preparation method is as follows:

[0065] (1) First, weigh out each Chinese herbal medicine according to the raw material ratio, mix well, add 1000ml of cold water, and soak for 1.5 hours;

[0066] (2) Boil the mixed raw materials over high heat, simmer for 40 minutes, and filter through gauze to obtain the filtrate and residue;

[0067] (3) The medicinal residue obtained in step (2) was mixed with 450 ml of hot water and decocted. The hot water was purified water at a temperature of 80° C. The mixture was boiled over high heat, simmered over low heat for 20 minutes, and then filtered again with gauze to obtain a filtrate and medicinal residue.

[0068] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for early diabetic nephropathy.

[0069] Example 5

[0070] A traditional Chinese medicine composition for treating early diabetic nephropathy is prepared from the following drugs:

[0071] Astragalus 35g, Pseudostellaria 18g, Radix Rehmanniae 35g, Fructus Corni 18g, Fructus Maluse 15g, Euryale ferox 18g, Morus alba bark 15g, Herba Eupatorii 15g, Hirudo 4g, Scorpio 4g;

[0072] The preparation method is as follows:

[0073] (1) First, weigh out each Chinese herbal medicine according to the raw material ratio, mix well, add 1400ml of cold water, and soak for 1.5 hours;

[0074] (2) Boil the mixed raw materials over high heat, simmer for 45 minutes, and filter through gauze to obtain the filtrate and residue;

[0075] (3) The medicinal residue obtained in step (2) was mixed with 550 ml of hot water and decocted. The hot water was purified water at a temperature of 80° C. The mixture was boiled over high heat, simmered over low heat for 30 minutes, and then filtered again with gauze to obtain a filtrate and medicinal residue.

[0076] (4) The filtrate obtained in step (2) and the filtrate obtained in step (3) are mixed to obtain a Chinese medicine decoction for early diabetic nephropathy.

[0077] Experimental example

[0078] 1. Clinical data

[0079] 1.1 Source of research subjects and sample size

[0080] Case data were collected from outpatients and inpatients of the Endocrinology Department of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2022 to January 2023. A total of 60 patients who had been diagnosed with early diabetic nephropathy and were diagnosed with spleen and kidney deficiency with blood stasis according to Traditional Chinese Medicine and who required drug intervention were selected.

[0081] 1.2 Diagnostic criteria

[0082] 1.2.1 Western medicine diagnostic criteria

[0083] The diabetes criteria refer to the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 edition), see Table 1. The DKD criteria refer to the Clinical Guidelines for the Prevention and Treatment of Diabetic Kidney Disease in China (2019 edition).

[0084] Table 1 Diagnostic criteria for diabetes

[0085]

[0086]

[0087] Diagnostic criteria for DKD: When hyperglycemia is confirmed as the cause of renal damage and other causes of chronic kidney disease are excluded, patients with at least one of the following conditions can be diagnosed with diabetic nephropathy:

[0088] ① Under the condition of excluding the influence of interfering factors, the random urine albumin to creatinine ratio (UACR) is ≥30 mg / g on at least two of three examinations within 3 to 6 months; ② The estimated glomerular filtration rate (eGFR) is <60 ml / (min·1.73 m2) and persists for more than 3 months.

[0089] Diagnostic criteria for early DKD: UAER (Urinary albumin excretion rate, UAER) 20-200 μg / min or 30-300 mg / 24h, persistent microalbuminuria; slightly elevated blood pressure; lowering blood pressure can partially reduce the excretion of urinary microalbumin.

[0090] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0091] According to the "Guiding Principles for Clinical Research of New Chinese Medicines" and referring to the 2011 "Standards for Diabetes Kidney Disease Diagnosis and Treatment in Traditional Chinese and Western Medicine"

[0092] Main symptoms: ① turbid urine ② poor appetite and loose stools ③ soreness and coldness in the waist and knees.

[0093] Secondary symptoms: ① Fatigue; ② Hotness in the palms and soles; ③ Thirst and thirst; ④ Edema of the limbs.

[0094] Tongue and pulse: ① The tongue is dark red, with a thin white coating with ecchymosis and teeth marks on the edges, and the sublingual veins are dark or not deep; ② The pulse is deep, thin or astringent.

[0095] For patients with two main symptoms and one secondary symptom or one main symptom and two or more secondary symptoms, the diagnosis can be confirmed by referring to the tongue and pulse.

[0096] 1.3 Inclusion criteria

[0097] (1) Meet the criteria for diagnosis of type 2 diabetes;

[0098] (2) meeting the diagnostic criteria for DKD and early DKD;

[0099] (3) The TCM diagnosis is spleen and kidney deficiency with blood stasis;

[0100] (4) Age range: 30–75 years old, regardless of gender;

[0101] (5) The patient volunteered and signed the informed consent form.

[0102] 1.4 Exclusion criteria

[0103] (1) The increase in urine microalbumin and the decline in renal function are caused by other kidney diseases;

[0104] (2) Those with serious abnormalities in organs such as the heart, liver, lungs, and blood system;

[0105] (3) Those currently undergoing surgery, trauma, tumor, or concurrent systemic infection;

[0106] (4) Those with allergic constitution or allergic to any of the Chinese herbal ingredients in the Buqi Huoxue Tongluo formula;

[0107] (5) Those who have taken angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists and other related drugs in the past month;

[0108] (6) Patients who are participating in other drug studies or taking other Chinese medicines related to this disease;

[0109] (7) Women who are preparing for pregnancy, are pregnant or breastfeeding;

[0110] (8) Those with a history of mental illness such as depression and schizophrenia.

[0111] 1.5 Shedding Standard

[0112] (1) Patients who voluntarily withdraw from the trial;

[0113] (2) Patients who were lost to follow-up due to various reasons.

[0114] 1.6 Termination Criteria

[0115] Patients who are unable to proceed to further observation due to the presence of more serious adverse reactions.

[0116] 1.7 Elimination Criteria

[0117] (1) Those who do not have relevant data records for this clinical observation;

[0118] (2) Those who have poor compliance and fail to take medication according to regulations, which affects the efficacy assessment.

[0119] 1.8 Possible Situations and Response Plans during the Research

[0120] (1) Treatment of dropout cases

[0121] If there were cases of dropout, the last efficacy was used for clinical evaluation and then included in the analysis, and the reasons for dropout were recorded in detail.

[0122] (2) Treatment of adverse reactions

[0123] During the clinical observation process, if any adverse reaction occurs in the patient, the researcher should contact the researcher immediately and the reaction should be resolved through symptomatic treatment. In severe cases, the drug should be stopped. Finally, the decision on whether to continue the trial study will be made based on the patient's condition.

[0124] 2. Research content

[0125] 2.1 Research Design

[0126] Select the early stage diabetic nephropathy that meets Western medicine diagnostic standard, TCM diagnosis is patient 60 examples of spleen and kidney deficiency with blood stasis syndrome, adopt random number table method that they are randomized and divided into test group and control group, two groups of each 30 examples, one group adopts the pharmaceutical composition treatment by embodiment 1, and another group adopts Western medicine basic treatment, and two groups carry out clinical observation of efficacy.The treatment course for the treatment of is 8 weeks, observes two groups of patients' early stage diabetic nephropathy (spleen and kidney deficiency with blood stasis syndrome) diagnostic scale TCM syndrome quantization score change, experimental value index change before and after treatment.After the course for the treatment of finishes, all data application statistics software SPSS27.0 is carried out statistical analysis process, compares test group and control group before and after treatment and the difference between two groups.

[0127] 2.2 Treatment methods

[0128] (1) Control group: given standard DKD Western medicine basic treatment

[0129] ① General treatment: DKD patients should reasonably control protein intake, protein intake should be about 0.8g / kg -l、 d -1 , salt intake should be limited (<6g / d), and according to one's own situation, reasonable and regular exercise and smoking cessation should be carried out.

[0130] ② Reasonable blood sugar control: According to the patient's actual blood sugar situation, adjust the dosage of conventional hypoglycemic drugs (metformin) to control the patient's blood sugar, control the patient's fasting blood sugar (FBG) at 5-8mmol / L, control blood sugar 2 hours after a meal at below 11.0mmol / L, and control glycosylated hemoglobin at below 9%, while avoiding hypoglycemia.

[0131] ③ Regulate blood pressure: The general target value is below 130 / 80 mmHg. ACEI / ARB is the first choice for antihypertensive drugs for DKD patients. If blood pressure cannot be maintained below 130 / 80 mmHg, other non-ACEI / ARB antihypertensive drugs should be added.

[0132] ④ Correction of lipid metabolism disorders: statins are the first choice. The target of lipid therapy in patients with DKD is patients with a history of ASCVD or eGFR < 60 ml·min -1 1.73m -2 For extremely high-risk patients, the LDL-C level should be less than 1.8 mmol / L, and for other patients it should be less than 2.6 mmol / L.

[0133] (2) Treatment group: treated with the pharmaceutical composition of Example 1 in addition to the treatment of the control group (200 ml of Chinese medicine decoction was obtained by decocting using the process and dosage of Example 1, and taken warm twice a day, morning and evening, 100 ml each time).

[0134] 2.3 Observation indicators

[0135] 2.3.1 General Information

[0136] Gender, age, disease course, and body mass index (BMI).

[0137] 2.3.2 Safety indicators

[0138] (1) Four vital signs: body temperature, respiration, heart rate, and blood pressure;

[0139] (2) General examination items: electrocardiogram, routine blood, urine and stool examinations, ion determination, and liver function test.

[0140] 2.3.3 Efficacy indicators

[0141] (1) TCM syndrome score, based on the standards in the "Guiding Principles for Clinical Research of New Chinese Medicines": the degree of manifestation of the main symptoms and secondary symptoms is divided into four levels (points): main symptoms are absent (0), mild (2), moderate (4), severe (6); secondary symptoms are absent (0), mild (1), moderate (2), severe (3), and the total score is calculated. The evaluation is done once before and after the test; (2) Laboratory indicators:

[0142] ① Urinary protein indicators: 24-hour urinary protein quantity (24h-Upro), urinary albumin excretion rates (UAER), and urinary microalbumin (UMA).

[0143] ② Glucose metabolism indicators: fasting blood glucose (FBG), 2-hour postprandial glucose (2hPG), glycosylated hemoglobin (HbA1c). ③ Lipid metabolism indicators: triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C). ④ Renal function indicators: eGFR, serum creatinine (Scr), cystatin C (CysC).

[0144] The results were checked and recorded before and after treatment.

[0145] 2.4 Criteria for determining efficacy

[0146] 1) Criteria for determining efficacy of TCM syndromes:

[0147] The therapeutic effect is comprehensively determined based on the changes in the patient's TCM symptoms and signs (the former) and the degree of reduction in the score (the latter).

[0148] Markedly effective: major clinical symptoms and signs improved significantly, with syndrome scores reduced by ≥70%;

[0149] Effective: The main clinical symptoms and signs have improved, and the syndrome score has decreased by ≥30%;

[0150] Ineffective: The main clinical symptoms and signs have no significant improvement or even worsen, and the syndrome score decreases by <30%;

[0151] Syndrome efficacy rate (nimodipine method): [(score before treatment - score after treatment) / score before treatment] * 100%

[0152] 2) Clinical efficacy evaluation criteria

[0153] Refer to the "Diagnosis, Syndrome Differentiation and Therapeutic Effect Evaluation Criteria for Diabetic Nephropathy" as follows:

[0154] (1) Markedly effective: Clinical symptoms improved significantly; 24Upro and UACR decreased to normal or decreased by more than half, and renal function was within the normal range;

[0155] (2) Effective: clinical symptoms improved compared with those before treatment; 24Upro and UACR decreased, but did not reach the standard of marked effect; renal function was within the normal range;

[0156] (3) Ineffective: Clinical symptoms did not improve or even worsened; related physical and chemical indicators did not change or even increased.

[0157] 2.5 Safety Assessment Standards

[0158] The safety assessment criteria are as follows:

[0159] Determined based on the severity of adverse reactions experienced by the subjects.

[0160] Grade 1: no adverse reaction;

[0161] Grade 2: mild, tolerable, no impact on treatment, no special treatment required;

[0162] Grade 3: moderate, unbearable, requiring drug withdrawal or special treatment;

[0163] Level 4: Severe, life-threatening, withdraw the drug immediately or seek emergency treatment.

[0164] 2.6 Statistical analysis

[0165] All data in this experiment were statistically analyzed using SPSS 27.0 statistical software. If the measurement data obeys the normal distribution, the t test is used. The independent sample t test is used for the comparison between groups before and after treatment, and the paired sample t test is used for the comparison within the group before and after treatment. If the measurement data do not obey the normal distribution, the rank sum test is used. The categorical data is compared by X-test. 2 The rank sum test was used for the rank data. 0.01 < P < 0.05 was considered to be statistically significant, and P < 0.01 was considered to be a very significant difference.

[0166] 3 Results and Analysis

[0167] 3.1 General Information

[0168] 1) Before treatment, the gender, age, and disease course data of the two groups were statistically analyzed using chi-square tests and two independent sample t-tests. The results showed no significant differences (P>0.05), indicating that the baseline data of the two groups were basically comparable. The details are as follows (see Tables 2, 3, and 4).

[0169] Table 2 Comparison of gender distribution of patients in the two groups

[0170]

[0171] Table 3 Comparison of age distribution of patients in the two groups

[0172]

[0173] Table 4 Comparison of disease course distribution between the two groups

[0174]

[0175] 3.2 Comparison of observation indicators

[0176] 1) Urine protein index

[0177] (1)24hUpro

[0178] Before treatment, there was no statistically significant difference in 24h Upro levels between the two groups (P>0.05), indicating comparability. After treatment, 24h Upro levels in both groups decreased significantly compared to before treatment (P<0.05), and the decrease in the treatment group was greater than that in the control group (P<0.05). (See Table 5)

[0179] Table 5 Comparison of 24h Upro levels between the two groups of patients

[0180]

[0181] (2)UACR

[0182] Before treatment, there was no statistically significant difference in UACR levels between the two groups (P>0.05), indicating comparability. After treatment, the UACR level in the treatment group was significantly lower than that before treatment (P<0.05). (See Table 6)

[0183] Table 6 Comparison of UACR levels between the two groups of patients

[0184]

[0185] (3)UMA

[0186] Before treatment, there was no statistically significant difference in UMA levels between the two groups (P>0.05), indicating comparability. After treatment, UMA levels in both groups improved significantly compared to before treatment (P<0.05), and the reduction effect in the treatment group was significantly better than that in the control group (P<0.05). (See Table 7)

[0187] Table 7 Comparison of UMA levels between the two groups of patients

[0188]

[0189] 2) Sugar metabolism indicators

[0190] (1)FBG

[0191] Before treatment, there was no statistically significant difference in FBG levels between the two groups (P>0.05), indicating comparability. After treatment, FBG levels in both groups improved significantly compared to before treatment (P<0.05), and the FBG decrease in the treatment group was significantly better than that in the control group (P<0.05). (See Table 8)

[0192] Table 8 Comparison of FBG levels between the two groups of patients

[0193]

[0194] (2) 2hPG

[0195] Before treatment, there was no statistically significant difference in 2hPG levels between the two groups (P>0.05), indicating comparability. After treatment, 2hPG levels in both groups improved significantly compared to before treatment (P<0.05), and the magnitude of the decrease in 2hPG in the treatment group was significantly greater than that in the control group (P<0.05). (See Table 9)

[0196] Table 9 Comparison of 2hPG levels in the two groups of patients

[0197]

[0198] (3) HbA1c

[0199] Before treatment, there was no statistically significant difference in HbA1c levels between the two groups (P>0.05), indicating comparability. After treatment, HbA1c levels in both groups improved significantly compared to before treatment, and the magnitude of improvement in the treatment group was greater than that in the control group (P<0.05). (See Table 10)

[0200] Table 10 Comparison of HbA1c levels between the two groups of patients

[0201]

[0202]

[0203] 3) Lipid metabolism indicators

[0204] (1)TG

[0205] Before treatment, there was no statistically significant difference in TG levels between the two groups (P>0.05), indicating comparability. After treatment, TG levels in both groups decreased significantly compared to before treatment (P<0.05), and the magnitude of decrease in the treatment group was significantly greater than that in the control group (P<0.05). (See Table 11)

[0206] Table 11 Comparison of TG levels between the two groups of patients

[0207]

[0208] (2)TC

[0209] Before treatment, there was no statistically significant difference in TC levels between the two groups (P>0.05), indicating comparability. After treatment, TC levels in the treatment group were significantly lower than those before treatment (P<0.05). (See Table 12)

[0210] Table 12 Comparison of TC levels between the two groups of patients

[0211]

[0212] (3)LDL-C

[0213] Before treatment, there was no statistically significant difference in LDL-C levels between the two groups (P>0.05), indicating comparability. After treatment, LDL-C levels in both groups decreased significantly compared to those before treatment (P<0.05), but there was no significant difference in LDL-C levels between the two groups after treatment (P>0.05). (See Table 13)

[0214] Table 13 Comparison of LDL-C levels between the two groups of patients

[0215]

[0216]

[0217] 4) Renal function indicators

[0218] (1) eGFR

[0219] Before treatment, there was no statistically significant difference in eGFR levels between the two groups (P>0.05), indicating comparability. After treatment, the eGFR level in the treatment group improved significantly compared with that before treatment (P<0.05), while the eGFR level in the control group showed no statistically significant difference compared with that before treatment (P>0.05). After treatment, the improvement in eGFR level in the treatment group was significantly greater than that in the control group (P<0.05). (See Table 14)

[0220] Table 14 Comparison of eGFR levels between the two groups of patients Unit:

[0221] [ml / (min·1.73m 2 )]

[0222]

[0223] (2)Scr

[0224] Before treatment, there was no statistically significant difference in the Scr levels between the two groups (P>0.05), indicating comparability. After treatment, the Scr level in the treatment group was significantly improved compared with that before treatment (P<0.05), while the Scr level in the control group was not significantly different compared with that before treatment (P>0.05). However, there was no significant difference in the Scr levels between the two groups after treatment (P>0.05). (See Table 15)

[0225] Table 15 Comparison of Scr levels between the two groups of patients

[0226]

[0227] (3) CysC

[0228] Before treatment, there was no statistically significant difference in CysC levels between the two groups (P>0.05), indicating comparability. After treatment, there was no statistically significant difference in CysC levels between the two groups compared with those before treatment (P>0.05). There was no significant difference in CysC levels between the two groups after treatment (P>0.05). (See Table 16)

[0229] Table 16 Comparison of CysC levels between the two groups of patients

[0230]

[0231] 5) Comparison of TCM syndrome scores

[0232] Before treatment, there was no statistically significant difference in the TCM syndrome score between the two groups (P>0.05), indicating comparability. After treatment, the TCM syndrome score in both groups decreased significantly compared with that before treatment (P<0.05), and the decrease in TCM syndrome score in the treatment group was significantly greater than that in the control group (P<0.05). (See Table 17)

[0233] Table 17 Comparison of TCM syndrome score levels between the two groups of patients

[0234]

[0235] 3.3 Comparison of efficacy

[0236] 1) Comparison of TCM syndrome efficacy

[0237] According to the TCM efficacy evaluation criteria, the changes in TCM syndrome scores in the two groups were statistically analyzed to determine whether the treatment was markedly effective, effective, or ineffective, and the effective rate was calculated. After comparison, the effective rate in the treatment group was significantly better than that in the control group, and the difference was statistically significant (P<0.05). (See Table 18)

[0238] Table 18 Comparison of TCM syndrome efficacy

[0239]

[0240] 2) Comparison of clinical efficacy

[0241] According to the clinical efficacy judgment criteria and combined with the changes in laboratory indicators, the effective, effective and ineffective groups were judged and the effective rate was calculated. After comparison, the effective rate of the treatment group was significantly better than that of the control group, and the difference was statistically significant (P<0.05).

[0242] (See Table 19)

[0243] Table 19 Comparison of clinical efficacy

[0244]

[0245] 3.4 Recurrence rate

[0246] Twelve weeks after the end of treatment, 2 patients in the treatment group relapsed, with a relapse rate of 6.67%, while 8 patients in the control group relapsed, with a relapse rate of 26.67%. The difference between the treatment group and the control group was statistically significant (P<0.05). (See Table 20) Table 20 Comparison of clinical relapse rates

[0247]

[0248] 3.5 Security

[0249] No adverse drug reactions occurred in either group of patients during the treatment, and no abnormalities were found in the safety index tests, indicating that the safety of the study was acceptable.

[0250] Specific cases

[0251] Case 1

[0252] Wang, male, 50 years old, first diagnosed on March 4, 2022. Chief complaint: abnormal renal function for 5 months, accompanied by mild edema in both lower limbs for 6 days. The patient's renal function test 5 months ago showed blood urea nitrogen (BUN) 11.37mmol / L, creatinine (Scr) 134μmol / L, uric acid (UA) 589μmol / L, and estimated glomerular filtration rate (eGFR)

[0253] 98ml / (min·1.73m 2), urinalysis: protein (positive). Six days ago, the patient developed mild edema in both lower extremities, accompanied by soreness in the waist and knees, shortness of breath after activity, poor spirits, normal appetite, good sleep, slightly loose stools, and foamy urine. There has been no significant change in weight recently. The tongue is pale, with a thin white coating, and a deep, weak pulse. Past medical history: a history of diabetes for over 10 years, with treatment with repaglinide and dapagliflozin, which maintains fasting blood sugar at approximately 7 mmol / L and 2-hour postprandial blood sugar at 10-11 mmol / L. A three-year history of hypertension, with a peak blood pressure of 180 / 100 mmHg, is reported to be adequately controlled with valsartan and amlodipine. Ancillary tests: 24-hour Upro 178.49 mg / 24 hours, UACR 89.93 mg / g, UMA 102.94 mg / L, FBG 7.36 mmol / L, 2-hour PG 10.13 mmol / L, HbA1c 7.24%, TG 2.45 mmol / L, TC 5.37 mmol / L, LDL-C 3.64 mmol / L, eGFR 97.34 ml / (min / 1.73 m²), Scr 80.73 μmol / L, CysC 1.35 mg / L. Western medicine diagnosis: Stage III diabetic nephropathy. Traditional Chinese medicine diagnosis: Xiaoke nephropathy (Spleen and Kidney Deficiency with Stasis). Treatment: Invigorate the spleen and replenish qi, tonify the kidney, activate blood circulation, and unclog the meridians. Prescription: 30g of Astragalus, 15g of Pseudostellariae Radix, 30g of Rehmannia glutinosa, 15g of Cornus officinalis, 12g of Malus domestica seeds, 15g of Euryale ferox, 12g of Morus alba bark, 12g of Eupatorium herba, 3g of Hirudo, 3g of Scorpio. The Chinese medicine decoction is prepared according to the method of Example 1. Take one dose of 200ml per day, warm and take twice a day in the morning and evening, 100ml each time, for 28 doses.

[0254] Follow-up on April 1, 2022: The patient's lower limb edema improved slightly, fatigue decreased, and bowel movements were normal. Auxiliary examinations: FBG 6.94mmol / L, 2hPG 9.82mmol / L. The above prescription was continued for 28 doses.

[0255] Follow-up visit on April 29, 2022: The patient's lower extremity edema had significantly improved, with less foamy urine and less soreness in the lower back and knees. He remained in good spirits, had good appetite and sleep, and normal bowel movements. Ancillary examinations showed: 24-hour Upro 136.72 mg / 24 h, UACR 69.43 mg / g, UMA 72.21 mg / L, FBG 6.35 mmol / L, 2-hour PG 7.20 mmol / L, HbA1c 6.91%, TG 1.98 mmol / L, TC 4.88 mmol / L, LDL-C 3.02 mmol / L, eGFR 102.51 ml / (min·1.73 m²), Scr 77.07 μmol / L, CysC 1.18 mg / L. He continued taking the above formula for 7 doses.

[0256] Case 2

[0257] Mr. Liu, a 47-year-old male, was first diagnosed on August 10, 2022. His chief complaint: elevated blood sugar levels for over 15 years. A physical examination 15 years ago revealed a fasting blood sugar level of 8 mmol / L and a blood pressure of 150 / 95 mmHg. He is currently taking gliquidone and irbesartan / hydrochlorothiazide and complains of recent unstable blood sugar control. He also has dry mouth, edema in both lower extremities, slightly cold hands and feet, fatigue, occasional dizziness, a good appetite and sleep, foamy urine, loose stools, and 2-3 bowel movements per day. His tongue is pale, with a thin white coating and tooth marks on the edges, and a deep, thready pulse. Auxiliary examinations: 24h Upro192.75mg / 24h, UACR93.47mg / g, UMA108.52mg / L, FBG8.45mmol / L, 2h PG9.75mmol / L, HbA1c7.84%, TG2.24mmol / L, TC5.75mmol / L, LDL-C2.96mmol / L, eGFR92.82ml / (min·1.73m 2 ), Scr 76.38 μmol / L, Cys C 1.50 mg / L. Western medicine diagnosis: diabetic nephropathy stage III. Traditional Chinese medicine diagnosis: Xiaoke nephropathy (spleen and kidney deficiency with blood stasis syndrome). Treatment: Invigorate the spleen and replenish qi, tonify the kidney and activate blood circulation and dredge the meridians. Prescription: Astragalus 30g, Pseudostellaria 15g, Rehmannia glutinosa 30g, Cornus officinalis 15g, Fructus Malvae 12g, Euryale ferox 15g, Morus alba bark 12g, Herba Lycopodii 12g, Hirudo 3g, Scorpio 3g. Prepare the Chinese medicine decoction prepared according to the method of Example 1. Take one dose of 200 ml daily, warm twice a day, morning and evening, 100 ml each time, for 28 doses.

[0258] Follow-up visit on September 7, 2022: The patient had mild edema in the left lower limb, dry mouth relieved, fatigue reduced, dizziness decreased, and stools remained loose, with two bowel movements per day. Auxiliary examinations: FBG 7.36mmol / L, 2hPG 9.05mmol / L. The above prescription was continued for 28 doses.

[0259] Follow-up on October 5, 2022: The patient's edema was significantly reduced, and symptoms such as dry mouth and fatigue were significantly relieved. The urine foam decreased and the bowel movements were normal. Auxiliary examinations: 24h Upro132.57mg / 24h, UACR65.21mg / g, UMA74.53mg / L, FBG6.98mmol / L, 2h PG7.60mmol / L, HbA1c7.01%, TG1.83mmol / L, TC4.81mmol / L, LDL-C2.43mmol / L, eGFR100.32ml / (min·1.73m 2 ), Scr 68.25μmol / L, CysC 1.24mg / L. Continue taking the above prescription for 7 doses.

[0260] It can be seen that the traditional Chinese medicine composition obtained by the present invention, which is specifically used for the treatment of early diabetic nephropathy, mainly strengthens the spleen and replenishes qi, nourishes the kidney, activates blood circulation and dredges the meridians, nourishes without being greasy, attacks the evil without damaging the body, and has significant therapeutic effects in lowering blood sugar and blood creatinine, improving the symptoms of diabetic nephropathy, and improving the quality of life of patients.

Claims

1. A Chinese medicine composition for treating early diabetic nephropathy, characterized in that: The components are calculated by weight as follows: 25-35 parts of astragalus, 12-18 parts of pseudoginseng, 25-35 parts of raw rehmannia, 12-18 parts of cornus officinalis, 10-15 parts of winter mallow seeds, 12-18 parts of euryale ferox, 10-15 parts of mulberry bark, 10-15 parts of zedoaria, 3-4 parts of leech and 3-4 parts of scorpion.

2. A Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that: The components are calculated by weight as follows: 30 parts of astragalus, 15 parts of pseudoginseng, 30 parts of raw rehmannia, 15 parts of cornus officinalis, 12 parts of winter mallow seeds, 15 parts of euryale ferox, 12 parts of mulberry bark, 12 parts of zedoaria, 3 parts of leech and 3 parts of scorpion.

3. A method for preparing a Chinese medicine composition for treating early diabetic nephropathy according to claim 1 or 2, characterized in that: The specific steps of the preparation method are as follows: first, weigh each Chinese medicine according to the ratio of the raw materials, then add water until the surface of the medicine is 3-5 cm high, soak for 1.5-2 hours, boil over high heat, then simmer over low heat for 40-50 minutes, filter out the medicinal juice for later use, add water to the medicinal residue again until the surface of the medicinal residue is 1-2 cm high, boil over high heat, then simmer over low heat for 20-30 minutes, filter out the medicinal juice and combine it with the above medicinal juice to obtain the product.

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