Traditional Chinese medicine composition for treating early diabetic nephropathy as well as preparation method and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating early diabetic nephropathy and a preparation method and application thereof. The composition is prepared from 15-45 g of raw radix astragali, 10-15 g of radix pseudostellariae, 9-15 g of radix salviae miltiorrhizae, 9-15 g of radix paeoniae rubra, 10-15 g of radix achyranthis bidentatae, 3-6 g of earthworms, 10-15 g of centella asiatica, 9-12 g of salvia chinensis, 15-30 g of gordon euryale seeds, 9-12 g of fructus broussonetiae, 9-12 g of Chinese holly leaves, 9-12 g of winged euonymus twigs, 10-15 g of poria cocos, 9-12 g of pericarpium citri reticulatae and 15-30 g of corn stigma (decocted in a wrapped mode). The traditional Chinese medicine has the beneficial effects of invigorating spleen and tonifying kidney, reinforcing qi and nourishing yin, promoting blood circulation to remove meridian obstruction, and dispersing blood stasis and discharging turbidity. The traditional Chinese medicine composition is used for treating early diabetic nephropathy caused by deficiency of both qi and yin, insufficiency of spleen and kidney and internal resistance of blood stasis and turbid toxin, and has the following syndromes: turbid urine or foam urine, soreness and weakness of waist and knees, lassitude and weakness, dry mouth and throat, slight edema of limbs (for lower limbs), less lush complexion, or numbness of limbs, light dark or dark red tongue, or stasis spots and ecchymosis, thin white or slightly greasy fur, and the like. The pulse is fine, astringent or fine.

Description

Technical Field

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

[0002] Diabetic Kidney Disease (DKD) is the most common and devastating microvascular complication of diabetes, characterized by complex mechanisms, insidious onset, ultimately debilitating symptoms, and numerous complications. The incidence of DKD in diabetic patients is as high as approximately 40%. Microalbuminuria can develop in the early stages of diabetes, affecting both glomeruli. DKD progresses progressively, manifesting primarily as persistent proteinuria, decreased glomerular filtration rate, and glomerulosclerosis. It is a key prognostic factor for end-stage renal disease (ESRD), accelerating renal failure and significantly increasing the risk of cardiovascular events and death. It severely impacts patients' quality of life and life expectancy, while placing a heavy medical and economic burden on society and families. Diabetic nephropathy falls under the Traditional Chinese Medicine (TCM) category of "xiaokebing nephropathy," or "turbid urine," "edema," and "guange." Current conventional treatments for diabetes and DKD, such as blood sugar control drugs (insulin, oral hypoglycemic drugs), renin-angiotensin system inhibitors (RASi), and new hypoglycemic drugs (SGLT2 inhibitors, GLP-1 receptor agonists), can delay the progression of DKD and control blood sugar and blood pressure to a certain extent, but are difficult to reverse the structural damage to the glomeruli and tubulointerstitium that has already occurred. For mid-to-late stage DKD, there is still a lack of ideal drugs that can effectively restore renal function or prevent its progression to ESRD. Summary of the Invention

[0003] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy.

[0004] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating early diabetic nephropathy.

[0005] The technical solutions adopted by the present invention to achieve the above-mentioned purpose are as follows: The invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy. The raw materials are composed of, by weight: 15-45g of raw astragalus, 10-15g of pseudoginseng, 9-15g of salvia miltiorrhiza, 9-15g of red peony root, 10-15g of cyperus rotundus, 3-6g of earthworm, 10-15g of centella asiatica, 9-12g of lithospermum officinale, 15-30g of euryale ferox, 9-12g of mulberry fruit, 9-12g of magnolia officinalis leaf, 9-12g of euryale ferox, 10-15g of poria, 9-12g of tangerine peel, and 15-30g of corn silk (decoction).

[0006] Furthermore, the Chinese medicine composition provided by the present invention, the raw materials also include: 9-12g of Anemarrhena Rhizoma, 9-12g of Phellodendron Amurense, 3-6g of Coptis chinensis, and 9-12g of Cornus officinalis.

[0007] Furthermore, the raw materials also include: Plantago seeds (wrapped and decocted) 15g, and Big Belly Bark 30g; or, the raw materials also include: Peach kernel 6g, and Leech (ground into powder and taken orally / into decoction) 3g; or, the raw materials also include: Rosa laevigata 15g, and Cicada Periostracum 9g; or, the raw materials also include: Alpinia oxyphylla 12g, and Silkworm Cocoon 12g.

[0008] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: accurately weighing according to the formula, adding 260 ml of water, first decocting for 35 minutes, second decocting for 20 minutes, filtering the residue while hot, and mixing the two decoctions and concentrating them to 150 ml.

[0009] The present invention also provides the use of the traditional Chinese medicine composition in preparing medicine for treating early diabetic nephropathy.

[0010] Treatment principle: Strengthen the spleen and kidney, replenish qi and nourish yin, activate blood circulation and dredge meridians, resolve blood stasis and eliminate turbidity.

[0011] Prescription modification: If Yin deficiency and excessive fire are obvious, add Anemarrhena Rhizoma 9-12g, Phellodendron Amurense 9-12g, Coptis chinensis 3-6g, and Cornus officinalis 9-12g; they can clear away heat from deficiency, moisten dryness, drain kidney fire, and nourish kidney Yin; if edema is severe, add Plantago Seed (wrapped and decocted) 15g and Cibotium bark 30g to promote qi circulation, relieve fullness, and relieve swelling and promote diuresis; if blood stasis is obvious, add Peach Kernel 6g and Leech (ground into powder and taken with water / into decoction) 3g to break up blood, remove blood stasis, dredge meridians and eliminate symptoms; if proteinuria persists, add Rosa Laevigatae 15g and Periostracum Cicadae 9g to consolidate essence and reduce urination; if urination is frequent at night, add Alpinia Oxyphyllae 12g and Sangsilk 12g to warm the kidney, consolidate the bladder, and nourish the kidney and reduce urination.

[0012] The beneficial effects of the present invention are: strengthening the spleen and kidney, replenishing qi and nourishing yin, promoting blood circulation and unblocking meridians, and removing blood stasis and turbidity. It is used for early diabetic nephropathy caused by qi and yin deficiency, spleen and kidney deficiency, and internal obstruction of blood stasis and turbidity, with the following symptoms: turbid or foamy urine, soreness of the waist and knees, fatigue, dry mouth and throat, mild edema of the limbs (especially the lower limbs), pale complexion, or numbness of the limbs, pale or dark red tongue, or with petechiae and ecchymosis, thin white or slightly greasy fur, and thready or deep pulse. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1Changes in blood glucose and renal function related indicators in each group of animal experiments; A. changes in blood glucose; B. changes in urine protein to creatinine ratio (UACR); C is changes in rat serum creatinine (Scr); D is changes in cystatin C (Cysc); E is changes in urea nitrogen (BUN); F is changes in urine microalbumin (mALB); G is changes in β2-microglobulin (β2-MG); H is changes in total cholesterol (TC); Figure 2 Pathological changes of renal tissue in animal experiments. A is kidney HE staining (×400); B is kidney MASSON staining (×400); C is kidney Oil Red O staining (×400). DETAILED DESCRIPTION

[0014] The technical solution of the present invention is further explained and illustrated by means of specific embodiments below.

[0015] Example 1 The recipe is: 15-45g raw astragalus, 10-15g Pseudostellariae, 9-15g Salvia miltiorrhiza, 9-15g Red Peony Root, 10-15g Achyranthes bidentata, 3-6g earthworm, 10-15g Centella asiatica, 9-12g Lithospermum officinale, 15-30g Euryale ferox, 9-12g Cuscuta australis, 9-12g Chinese magnolia vine, 9-12g Euryale ferox, 10-15g Poria, 9-12g Tangerine peel, 15-30g Corn silk (wrapped and decocted).

[0016] Effect embodiment (1) Clinical trial data 1. Data Source One hundred patients with early diabetic nephropathy with qi deficiency, dampness and stasis who met the criteria and were admitted to the Nephrology Department of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from December 2023 to March 2025 were included.

[0017] 2. Grouping and treatment plan Patients were randomly divided into an experimental group (50 cases) and a control group (50 cases). The control group received dapagliflozin tablets 5 mg once daily and valsartan capsules 80 mg once daily. The experimental group was given this patented prescription (raw astragalus 30 g, Pseudostellaria 15 g, Salvia miltiorrhiza 12 g, Paeonia lactiflora 9 g, Achyranthes bidentata 15 g, Earthworm 6 g, Centella asiatica 15 g, Lithospermum officinale 9 g, Euryale ferox 15 g, Cuscuta australis 9 g, Malus domestica 12 g, Euryale ferox 9 g, Poria 12 g, Citrus reticulatae 9 g, and Corn Silk 20 g) for an 8-week treatment course.

[0018] 3. Observation indicators The patients' fasting blood glucose (FBG), urine protein-creatinine ratio (UACR), glycated hemoglobin (HbA1C), serum creatinine (Scr), urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), albumin (ALB), superoxide dismutase (SOD), interleukin-6 (IL-6), and urinary N-acetyl-β-glucosaminidase (NAG) were measured; the TCM syndrome score and clinical efficacy were evaluated.

[0019] 4. Statistical results (1) After treatment, the scores of fatigue, dry mouth and throat, limb edema, soreness of waist and knees, and limb numbness in both the experimental and control groups were significantly reduced ( P <0.01), with statistically significant differences. After treatment, the experimental group showed a more significant reduction in fatigue, dry mouth and throat, limb edema, and limb numbness, with statistically significant differences ( P <0.01 or P <0.05).

[0020] Table 1 Comparison of TCM syndrome scores between the two groups of patients before and after treatment ( ±s)

[0021] Note: For comparison within the same group, * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P <0.01.

[0022] (2) After treatment, the urine protein-creatinine ratio, urea nitrogen, and glycated hemoglobin in the experimental and control groups were significantly reduced ( P <0.01 or P <0.05), with statistical significance. After treatment, the experimental group reduced the urine protein creatinine ratio and glycosylated hemoglobin more significantly than the control group, and the difference was statistically significant ( P <0.01 or P <0.05).

[0023] Table 2 Comparison of blood glucose and renal function related indicators before and after treatment between the two groups of patients (P25, P75)

[0024] Note: For comparison within the same group, * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P<0.01.

[0025] (3) After treatment, interleukin-6 levels in both the experimental and control groups were significantly reduced ( P <0.01), with statistically significant differences. Superoxide dismutase and albumin in the experimental group increased significantly after treatment compared with before treatment ( P <0.01 or P<0.05). After treatment, the experimental group showed better results in reducing interleukin-6, increasing superoxide dismutase and albumin ( P <0.01 or P <0.05).

[0026] Table 3 Comparison of renal function related indicators before and after treatment between the two groups of patients ( ±s)

[0027] Note: For comparison within the same group, * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P <0.01.

[0028] (4) After treatment, the experimental group was superior to the control group in improving clinical efficacy ( P <0.05).

[0029] Table 4 Comparison of clinical efficacy between the two groups of patients ( ±s)

[0030] (2) Basic experiments 1. Experimental methods and results SD rats were randomly divided into a normal group, a model group, an experimental group (patented formula group), and a valsartan group, with 8 rats in each group. A diabetic nephropathy rat model was established by intraperitoneal injection of streptozotocin. The experimental group was given a patented formula (raw astragalus 30g, Pseudostellaria 15g, Salvia miltiorrhiza 12g, Paeonia lactiflora 9g, Achyranthes bidentata 15g, Pheretima chinensis 6g, Centella asiatica 15g, Lithospermum officinale 9g, Euryale ferox 15g, Cuscuta australis 9g, Malus domestica 12g, Euphorbia pulex 9g, Poria 12g, Citrus reticulatae 9g, and Corn Silk 20g) at a dose of 19.5g·kg -1 ·d -1The normal and model groups were gavage-treated with equal volumes of saline, while the valsartan group was given valsartan for 6 weeks. Blood glucose levels were monitored during the experiment. Twenty-four hours after the last administration, the rats were anesthetized and blood was drawn from the inferior vena cava. Serum was separated and renal function-related markers were measured. Kidney tissue was obtained and stained with hematoxylin-eosin (HE), Masson's staining, and Oil Red O to observe renal pathological changes.

[0031] 2. The results show that: (1) Compared with the normal group, the blood glucose, UACR, BUN, CysC, TC, β2-MG, and mALB levels of the rats in the model group were significantly increased ( P <0.01), compared with the model group, the above indicators in the experimental group were improved to varying degrees after the patent prescription intervention ( P <0.01 or P <0.05), there was no significant difference in Scr among the three groups.

[0032] Figure 1 A. Changes in blood glucose; B. Changes in urine protein-creatinine ratio (UACR); CH. Changes in serum creatinine (Scr), cystatin C (Cysc), urea nitrogen (BUN), urine microalbumin (mALB), β2-microglobulin (β2-MG), and total cholesterol (TC) in rats, respectively; compared with the model group, *P < 0.05, **P < 0.01.

[0033] (2) HE staining of the kidneys of rats in the model group showed thickening of the glomerular basement membrane and vacuolar degeneration of the renal tubules. Masson staining showed fibrous tissue proliferation, and Oil Red O staining showed lipid accumulation. After drug intervention in the experimental group, pathological damage to the glomeruli and tubules was alleviated, and fibrous deposition and lipid accumulation were reduced.

[0034] Figure 2 Middle A. HE staining of kidney (×400); B. Masson staining of kidney (×400); C. Oil red O staining of kidney (×400).

[0035] (3) Treatment cases Case 1 Patient information: Mr. Wu, male, 41 years old, had elevated blood sugar for more than 6 years and proteinuria for 1 year. He had taken metformin, dapagliflozin, Xiaoke pills and other hypoglycemic drugs for 6 years. When he came to the hospital for treatment, his UACR was 120 (mg·g -1 ), Scr 66 (μmol·L -1 ), BUN 4.25 (mmol·L -1 ), FBG 6.1 (mmol·L -1 ), HbA1C 6.5%, eGFR 132.54 mL·min -1 (1.73m 2 ) -1, ALB 41 (g·L -1 ), diagnosed with diabetic kidney disease. Currently taking dapagliflozin, blood sugar control is acceptable. Symptoms at presentation: dry mouth and bitter taste, most pronounced in the morning; foamy urine; soreness in the waist and knees; fatigue; no significant lower limb edema; red, thin, yellow tongue with cracks; and a thready, rapid pulse. Diagnosis: early diabetic kidney disease. Prescription: Raw Astragalus 30g, Pseudostellaria 10g, Salvia miltiorrhiza 10g, Paeonia lactiflora 12g, Achyranthes bidentata 12g, Earthworm 3g, Centella asiatica 15g, Lithospermum officinale 9g, Euryale ferox 15g, Cuscuta australis 9g, Malus laureata 12g, Psoralea corylifolia 9g, Poria 9g, Tangerine peel 9g, Corn silk 20g (wrapped and decocted), Anemarrhena 9g, Phellodendron amurense 9g, Coptis chinensis 6g, and Cornus officinalis 12g. Dosage and Administration: 14 doses, ordinary decoction, accurately weighed according to the formula, add 260 ml of water, boil for 35 minutes for the first decoction, and 20 minutes for the second decoction, filter the residue while hot, mix the two decoctions and concentrate them into 150 ml, take twice a day. Effect: After taking it for half a month, there was no obvious dry mouth and bitter taste, foamy urine was reduced, soreness of waist and knees was relieved, fatigue was reduced, and there was no edema in lower limbs. When the above treatment was repeated, the above treatment was mainly added or subtracted. After the symptoms were relieved, the dose was changed to every other day. After taking it regularly for 3 months, the patient had no obvious foamy urine, no edema, no dry mouth, and normal bowel movements. The UACR was 75 (mg·g -1 ), FBG 5.5 (mmol·L -1 ), HbA1C 6.5%.

[0036] Case 2 Patient information: Zhang, male, 61 years old, had elevated blood sugar for 5 years and intermittent lower limb edema for more than 1 month. He had taken metformin, linagliptin, and Chinese patent medicine hypoglycemic drugs. When he was diagnosed, UACR was 650 (mg·g -1 ), Scr 74 (μmol·L -1 ), BUN 4.55 (mmol·L -1 ), FBG 6.5 (mmol·L -1 ), HbA1C 7.2%, eGFR 100.29 mL·min -1 ·(1.73m 2 ) -1 , ALB 35 (g·L -1), previously diagnosed with diabetic nephropathy, he now takes metformin irregularly, with poor fasting blood sugar control. Symptoms at presentation: moderate pitting edema in the lower limbs, foamy urine, occasional low back pain, fatigue, intermittent dry mouth, pale complexion, dark, thin, white, greasy tongue, and a deep, slow pulse. Diagnosis: early diabetic nephropathy. Prescription: Raw Astragalus 20g, Pseudostellaria 12g, Salvia miltiorrhiza 12g, Red Peony 10g, Achyranthes bidentata 15g, Earthworm 5g, Centella asiatica 12g, Lithospermum officinale 9g, Euryale ferox 15g, Cuscuta australis 9g, Malus laureata 12g, Psoralea corylifolia 9g, Poria 15g, Tangerine peel 9g, Corn silk 20g (wrapped and decocted), Plantago seed (wrapped and decocted) 15g, and Citrus grandis 30g. Dosage and Administration: 14 doses, ordinary decoction, accurately weighed according to the formula, add 260 ml of water, boil for 35 minutes for the first decoction, and 20 minutes for the second decoction, filter the residue while hot, mix the two decoctions and concentrate them into 150 ml, take twice a day. Effect: After taking it for half a month, the patient's edema was reduced, there was no obvious back pain, fatigue was reduced, dry mouth was reduced, and foamy urine was reduced. When he came to the hospital again, the above treatment was mainly modified. After the symptoms were relieved, the dose was changed to every other day. After taking it regularly for 2 months, the patient had no edema, less foamy urine, no dry mouth, and regular bowel movements. The UACR was 75 (mg·g -1 ), FBG 6.1 (mmol·L -1 ), HbA1C 6.5%.

[0037] Case 3: Patient information: Mr. Liu, male, 55 years old, had elevated blood sugar for more than 8 years and proteinuria for more than 2 years. UACR was 350 (mg·g -1 ), Scr 65 (μmol·L -1 ), BUN 6.32 (mmol·L -1 ), FBG 6.1 (mmol·L -1 ), HbA1C6.6%, eGFR 122.37 mL·min -1 ·(1.73m 2 ) -1 , ALB 35 (g·L -1), who had undergone a renal biopsy two years prior and reported pathology as "diabetic nephropathy," which was not reported in the medical records. He is currently taking metformin, Xiaoke Pills, dapagliflozin, and Alisartan, with adequate blood sugar control. Symptoms at presentation included occasional numbness and swelling in the limbs, foamy urine, occasional lower back pain, fatigue, dry mouth, mild edema in the lower limbs, a pale complexion, dry stools, foamy urine, a dark tongue with petechiae, dark purple, thin, yellowish, and greasy sublingual veins, and a deep, thready pulse. Diagnosis: early-stage diabetic kidney disease. Prescription: 30g raw Astragalus, 12g Pseudostellariae Radix, 12g Salviae Miltiorrhizae, 9g Paeoniae Rubra, 15g Achyranthes bidentata, 6g Earthworm, 15g Centella asiatica, 9g Lithospermum officinale, 15g Euryale ferox, 9g Cuscuta australis, 12g Mahoniae laurel, 9g Euphorbia pulex, 12g Poria, 9g Tangerine peel, 20g Corn Silk (wrapped and decocted), 6g Peach Kernel, 3g Leech (ground into powder and taken with water / decoction). Dosage: 14 doses. Decoction according to the recipe. Accurately weigh the amount, add 260ml of water, simmer for 35 minutes for the first decoction and 20 minutes for the second decoction. Filter the residue while hot, combine the two decoctions, and concentrate to 150ml. Take one dose twice daily. Results: After one month of use, foamy urine decreased, numbness and swelling in the limbs decreased, dry mouth disappeared, occasional back pain occurred, fatigue decreased, lower limb edema disappeared, and bowel movements became regular. The patient was treated with the above prescription with modifications. After the symptoms were relieved, the prescription was taken regularly for 2 months. The patient had no obvious foamy urine, no edema, no dry mouth, normal bowel movements, and the tongue ecchymosis disappeared. At the follow-up visit 3 months later, the UACR was 70 (mg·g -1 ), FBG 5.5 (mmol·L -1 ), HbA1C 6.5%.

[0038] Case 4 Patient Information: Huang, female, 52 years old, had elevated blood sugar levels for over 3 years, proteinuria for over 1 year, and recurrent lower limb edema for 1 month. She was diagnosed with diabetic nephropathy at a local hospital. She took hypoglycemic medications such as Bailing Capsules, valsartan, and dapagliflozin intermittently, without regular monitoring of blood sugar and proteinuria. At the time of consultation, UACR was 1520 (mg·g -1 ), Scr 60 (μmol·L -1 ), BUN 6.51 (mmol·L -1 ), FBG 7.1 (mmol·L -1 ), HbA1C 8.2%, eGFR 103.76 mL·min -1 ·(1.73m 2 ) -1 , ALB 31 (g·L -1The patient was advised to be admitted for renal biopsy, but declined. Symptoms included foamy urine, lower back and knee pain, significant fatigue, dry mouth, moderate lower limb edema, pale complexion, dark, thin, white, greasy tongue, and a deep, thready pulse. The diagnosis was "early diabetic kidney disease." Prescription: 45g raw Astragalus, 15g Pseudostellariae Radix, 12g Salvia miltiorrhiza, 9g Red Peony Root, 12g Achyranthes bidentata, 6g Earthworm, 15g Centella asiatica, 9g Lithospermum officinale, 30g Euryale ferox, 9g Cuscuta australis, 9g Euryale ferox, 9g Euryale ferox, 9g Poria, 12g Tangerine peel, 15g Corn Silk (wrapped and decocted), 15g Rosa laevigata Fruit, and 9g Cicada Periostracum. Dosage and Administration: 14 doses. Decoction in plain water. Accurately weigh the amount according to the recipe, add 260ml of water, and simmer for 35 minutes for the first decoction and 20 minutes for the second decoction. Filter the residue while hot. Combine the two decoctions and concentrate to 150ml. Take twice daily. Effect: After taking the medicine for one month, the patient's foamy urine was relieved, fatigue was relieved, lower limb edema was not obvious, waist and knee pain was relieved, and dry mouth was relieved. The above treatment was mainly modified. After the symptoms were relieved, the patient was treated once every other day. After taking the medicine regularly for 4 months, the patient had no obvious foamy urine, no edema, no bitter taste in the mouth, and bowel movements were normal. The UACR was 100 (mg·g -1 ), FBG 6.2 (mmol·L -1 ), HbA1C 7.1%.

[0039] Case 5: Zhang, male, 35 years old, had elevated blood sugar for more than 5 years. He had been taking hypoglycemic drugs irregularly for 5 years. When he visited the hospital, his UACR was 350 (mg·g -1 ), Scr 71 (μmol·L -1 ), BUN 6.71 (mmol·L -1 ), FBG 6.6 (mmol·L -1 ), HbA1C 7.5%, eGFR 126.57 mL·min -1 ·(1.73m 2 ) -1 , ALB 38 (g·L -1), no renal biopsy was performed, and the patient was diagnosed with diabetic kidney disease. He is currently taking metformin and other medications, but his blood sugar control is poor. Symptoms at presentation included foamy urine, 3-5 nocturia, soreness in the lower back and knees, fatigue, dry mouth and throat, mild edema in the lower extremities, a pale complexion, a pale, thin, white, greasy tongue, and a deep, thready pulse. Diagnosis: Early diabetic kidney disease. Prescription: Raw Astragalus 30g, Pseudostellaria 12g, Salvia miltiorrhiza 12g, Paeonia lactiflora 9g, Achyranthes bidentata 15g, Earthworm 6g, Centella asiatica 15g, Lithospermum officinale 9g, Euryale ferox 15g, Cuscuta australis 9g, Malus domestica 12g, Psoralea corylifolia 9g, Poria 12g, Tangerine peel 9g, Corn silk 20g (wrapped and decocted), Alpinia oxyphylla 12g, and Silkworm cocoon 12g. Dosage and Administration: 14 doses, decoct in ordinary water, weigh accurately according to the formula, add 260 ml of water, boil for 35 minutes for the first decoction and 20 minutes for the second decoction, filter the residue while hot, mix the two decoctions and concentrate them into 150 ml, take twice a day. Effect: After taking it for half a month, the foamy urine was reduced, the urinary frequency was reduced, the soreness of the waist and knees was relieved, the fatigue was reduced, the dry mouth and throat were reduced, and there was no edema in the lower limbs. The above treatment was mainly used for the next visit, and after the symptoms were relieved, the treatment was changed to one dose every other day. After taking it regularly for 3 months, the patient had no obvious foamy urine, no edema, no dry mouth, and normal bowel movements. The UACR was 80 (mg·g -1 ), FBG 5.9 (mmol·L -1 ), HbA1C 6.7%.

Claims

1. A Chinese medicine composition for treating early diabetic nephropathy, characterized in that: The composition of the raw materials is calculated by weight: raw astragalus 15-45g, pseudoginseng 10-15g, salvia miltiorrhiza 9-15g, red peony root 9-15g, cyperus rotundus 10-15g, earthworm 3-6g, Centella asiatica 10-15g, lithospermum officinale 9-12g, euryale ferox 15-30g, paper mulberry fruit 9-12g, magnolia officinalis leaf 9-12g, euphorbia pulex 9-12g, poria 10-15g, tangerine peel 9-12g, and corn silk 15-30g.

2. The Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that The raw materials also include: 9-12g of Anemarrhena Rhizoma, 9-12g of Phellodendron Amurense, 3-6g of Coptis chinensis, and 9-12g of Cornus officinalis.

3. The Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that The raw materials also include: 15g of Plantago seeds and 30g of Pilosula officinalis.

4. The Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that The raw materials also include: 6g peach kernel and 3g leech.

5. The Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that The raw materials also include: 15g of Rosa laevigata fruit and 9g of cicada shell.

6. The Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that The raw materials also include 12g of Alpinia oxyphylla and 12g of Ophiopogon japonicus.

7. A method for preparing a traditional Chinese medicine composition for treating early diabetic nephropathy according to any one of claims 1 to 6, characterized in that: The method comprises the following steps: accurately weighing according to the formula, adding 260 ml of water, first decocting for 35 minutes, second decocting for 20 minutes, filtering the residue while hot, mixing the two decoctions, and concentrating to 150 ml.

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