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

Abstract

This invention belongs to the field of traditional Chinese medicine and relates to a traditional Chinese medicine composition for treating early diabetic nephropathy, its preparation method, and its application. The composition consists of: 15-45g of raw Astragalus membranaceus, 10-15g of Pseudostellaria heterophylla, 9-15g of Salvia miltiorrhiza, 9-15g of Paeonia lactiflora, 10-15g of Achyranthes bidentata, 3-6g of Pheretima aspergillum, 10-15g of Centella asiatica, 9-12g of Hedyotis diffusa, 15-30g of Euryale ferox, 9-12g of Broussonetia papyrifera, 9-12g of Mahonia japonica, 9-12g of Euonymus alatus, 10-15g of Poria cocos, 9-12g of Citrus reticulata peel, and 15-30g of Zea mays silk (wrapped and decocted). The beneficial effects of this invention are: strengthening the spleen and kidneys, replenishing qi and nourishing yin, promoting blood circulation and unblocking collaterals, and resolving blood stasis and eliminating turbidity. This medicine is used for early diabetic nephropathy caused by deficiency of both qi and yin, insufficiency of spleen and kidney, and internal obstruction of blood stasis and turbid toxins. The following symptoms may be observed: cloudy or foamy urine, soreness and weakness of the lower back and knees, fatigue and weakness, 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 tongue coating, and thready or deep and thready pulse.

Description

Technical Field

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

[0002] Diabetic kidney disease (DKD) is the most common and severely harmful refractory microvascular complication of diabetes, characterized by complex mechanisms, strong concealment, ultimate renal failure, and many complications. The incidence of DKD is as high as about 40% in diabetic patients. Microalbuminuria can appear in the early stage of diabetes, involving glomeruli in both kidneys and developing progressively. It is mainly manifested as persistent proteinuria, decreased glomerular filtration rate, and glomerular sclerosis. It is a key precursor factor for end-stage renal disease (ESRD), which can accelerate the renal failure of patients, significantly increase the risk of cardiovascular events and death, seriously affect the quality of life and life expectancy of patients, and at the same time bring a heavy medical and economic burden to society and families. Diabetic nephropathy belongs to the categories of "diabetes-induced nephropathy", "turbid urine", "edema", "guan syndrome" in traditional Chinese medicine. At present, the conventional treatment methods for diabetes and DKD, such as blood glucose control drugs (insulin, oral hypoglycemic drugs), renin-angiotensin system inhibitors (RASi), new hypoglycemic drugs (SGLT2 inhibitors, GLP-1 receptor agonists), etc., although they can delay the progression of DKD and control blood glucose and blood pressure to a certain extent, it is difficult to reverse the existing structural damage of glomeruli and renal tubulointerstitial. There is still a lack of an ideal drug that can effectively restore renal function or prevent its development to ESRD in the middle and late stages of DKD. 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 preparation method of a traditional Chinese medicine composition for treating early diabetic nephropathy.

[0005] The technical solution adopted by the present invention to achieve the above object is as follows:

[0006] The present invention provides a traditional Chinese medicine composition for treating early diabetic nephropathy. The raw material drug composition is, by weight: 15 - 45 g of Astragalus membranaceus, 10 - 15 g of Pseudostellaria heterophylla, 9 - 15 g of Salvia miltiorrhiza, 9 - 15 g of Paeonia lactiflora, 10 - 15 g of Achyranthes bidentata, 3 - 6 g of Pheretima aspergillum, 10 - 15 g of Centella asiatica, 9 - 12 g of Salvia chinensis, 15 - 30 g of Euryale ferox, 9 - 12 g of Broussonetia papyrifera, 9 - 12 g of Loropetalum chinense var. rubrum, 9 - 12 g of Euonymus alatus, 10 - 15 g of Poria cocos, 9 - 12 g of Citrus reticulata Blanco, 15 - 30 g of Cornus officinalis (decocted in a package).

[0007] Furthermore, the traditional Chinese medicine composition provided by the present invention further includes the following raw materials: Anemarrhena asphodeloides 9-12g, Phellodendron chinense 9-12g, Coptis chinensis 3-6g, and Cornus officinalis 9-12g.

[0008] Furthermore, the raw materials also include: 15g of Plantago seed (wrapped and decocted) and 30g of Areca peel; or, the raw materials also include: 6g of peach kernel and 3g of leech (powdered and taken with water / added to decoction); or, the raw materials also include: 15g of Rosa laevigata and 9g of cicada slough; or, the raw materials also include: 12g of Alpinia oxyphylla and 12g of Mantis egg case.

[0009] 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, decocting for 35 minutes for the first decoction, decocting for 20 minutes for the second decoction, filtering the residue while hot, and mixing and concentrating the two decoctions to 150 ml.

[0010] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating early diabetic nephropathy.

[0011] Treatment principle: Strengthen the spleen and kidneys, replenish qi and nourish yin, promote blood circulation and unblock the meridians, and remove blood stasis and turbidity.

[0012] Prescription modifications: If there is significant yin deficiency and excessive fire, add 9-12g of Anemarrhena asphodeloides, 9-12g of Phellodendron chinense, 3-6g of Coptis chinensis, and 9-12g of Cornus officinalis; to clear deficiency heat, moisten dryness, purge kidney fire, and nourish kidney yin; if edema is severe, add 15g of Plantago asiatica (wrapped and decocted) and 30g of Areca catechu to regulate qi, relieve chest tightness, reduce bloating, and promote urination; if blood stasis is significant, add 6g of Prunus persica and 3g of Hirudo medicinalis (powdered and taken with water / added to decoction) to break up blood stasis, clear the channels, and eliminate masses; if proteinuria persists, add 15g of Rosa laevigata and 9g of Cicadae periostracum to strengthen essence and reduce urination; if there is frequent urination at night, add 12g of Alpinia oxyphylla and 12g of Mantis religiosa ootheca to warm the kidneys, strengthen the bladder, and tonify the kidneys to reduce urination.

[0013] The beneficial effects of this invention are: strengthening the spleen and kidneys, replenishing qi and nourishing yin, promoting blood circulation and unblocking collaterals, and resolving blood stasis and eliminating turbidity. It is used for early diabetic nephropathy caused by deficiency of both qi and yin, insufficiency of the spleen and kidneys, and internal obstruction of blood stasis and turbid toxins, with the following symptoms: cloudy or foamy urine, soreness and weakness of the lower back and knees, fatigue and weakness, 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 tongue coating, and thready or deep and thready pulse. Attached Figure Description

[0014] Figure 1Changes in relevant indicators of blood glucose and renal function in various groups of animal experiments; where A. Blood glucose changes; B. Urine protein-to-creatinine ratio (UACR) changes; C. Serum creatinine (Scr) changes in rats; D. Cystatin C (Cysc) changes; E. Blood urea nitrogen (BUN) changes; F. Urine microalbumin (mALB) changes; G. β2-microglobulin (β2-MG) changes; H. Total cholesterol (TC) changes.

[0015] Figure 2 Pathological changes in kidney 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 Implementation

[0016] The technical solution of the present invention will be further explained and described below through specific embodiments.

[0017] Example 1

[0018] The formula is as follows: Astragalus membranaceus 15-45g, Codonopsis pilosula 10-15g, Salvia miltiorrhiza 9-15g, Paeonia lactiflora 9-15g, Achyranthes bidentata 10-15g, Pheretima aspergillum 3-6g, Centella asiatica 10-15g, Lysimachia christinae 9-12g, Euryale ferox 15-30g, Broussonetia papyrifera 9-12g, Mahonia japonica 9-12g, Euonymus alatus 9-12g, Poria cocos 10-15g, Citrus reticulata 9-12g, and Zea mays 15-30g (wrapped and decocted).

[0019] Effect Example

[0020] (a) Clinical trial data

[0021] 1. Data Source

[0022] One hundred patients with early-stage diabetic nephropathy and qi deficiency with dampness stagnation who met the criteria were included in the Department of Nephrology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine from December 2023 to March 2025.

[0023] 2. Grouping and Treatment Plan

[0024] The patients were randomly divided into an experimental group (50 cases) and a control group (50 cases) using a random number table method. The control group was given dapagliflozin tablets 5 mg once daily and valsartan capsules 80 mg once daily. The experimental group was given the patented prescription (raw astragalus 30g, codonopsis 15g, salvia miltiorrhiza 12g, red peony root 9g, achyranthes bidentata 15g, earthworm 6g, centella asiatica 15g, hedyotis diffusa 9g, euryale ferox 15g, paper mulberry fruit 9g, magnolia bark leaf 12g, euonymus alatus 9g, poria cocos 12g, tangerine peel 9g, and corn silk 20g) for 8 weeks.

[0025] 3. Observation Indicators

[0026] The following parameters were measured in patients: fasting blood glucose (FBG), urine protein-to-creatinine ratio (UACR), glycated hemoglobin (HbA1C), serum creatinine (Scr), blood urea nitrogen (BUN), glomerular filtration rate (eGFR), albumin (ALB), superoxide dismutase (SOD), interleukin-6 (IL-6), and urinary N-acetyl-β-glucosidase (NAG); TCM syndrome scores and clinical efficacy were assessed.

[0027] 4. Statistical Results

[0028] (1) After treatment, the scores for fatigue, dry mouth and throat, limb edema, soreness of the waist and knees, and numbness of the limbs were significantly reduced in both the experimental group and the control group. P <0.01), indicating a statistically significant difference. Compared to the control group 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).

[0029] Table 1 Comparison of TCM syndrome scores before and after treatment in the two groups of patients ( ±s)

[0030]

[0031] Note: Comparisons are made within the same group. * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P <0.01.

[0032] (2) After treatment, the ratio of urinary protein to creatinine, blood urea nitrogen, and glycated hemoglobin were significantly reduced in both the experimental and control groups. P <0.01 or P <0.05, indicating a statistically significant difference. Compared to the control group after treatment, the experimental group showed a more significant reduction in the urine protein-to-creatinine ratio and glycated hemoglobin, with statistically significant differences. P <0.01 or P <0.05).

[0033] Table 2 Comparison of blood glucose and renal function-related indicators before and after treatment in the two groups (M (P25, P75)).

[0034]

[0035] Note: Comparisons are made within the same group. * P <0.05,** P<0.01; compared with the control group, # P <0.05, ## P <0.01.

[0036] (3) After treatment, interleukin-6 levels were significantly reduced in both the experimental and control groups. P <0.01, indicating a statistically significant difference. In the experimental group, superoxide dismutase and albumin levels were significantly increased after treatment compared to 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 levels. P <0.01 or P <0.05).

[0037] Table 3 Comparison of renal function-related indicators before and after treatment in the two groups of patients ( ±s)

[0038]

[0039] Note: Comparisons are made within the same group. * P <0.05,** P <0.01; compared with the control group, # P <0.05, ## P <0.01.

[0040] (4) After treatment, the experimental group was superior to the control group in improving clinical efficacy. P <0.05).

[0041] Table 4 Comparison of clinical efficacy between the two groups of patients ( ±s)

[0042]

[0043] (II) Basic Experiments

[0044] 1. Experimental methods and results

[0045] 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 rat model of diabetic nephropathy was established by intraperitoneal injection of streptozotocin. The experimental group was given the patented formula (30g Astragalus membranaceus, 15g Codonopsis pilosula, 12g Salvia miltiorrhiza, 9g Paeonia lactiflora, 15g Achyranthes bidentata, 6g Pheretima aspergillum, 15g Centella asiatica, 9g Lysimachia christinae, 15g Euryale ferox, 9g Broussonetia papyrifera, 12g Mahonia fortunei, 9g Euonymus alatus, 12g Poria cocos, 9g Citrus reticulata, 20g Zea mays), 19.5g·kg. -1 ·d-1 Rats were administered equal volumes of physiological saline via gavage to the normal and model groups, while the valsartan group received valsartan, for a total of 6 weeks. Blood glucose levels were monitored during the experiment. Twenty-four hours after the last administration, rats were anesthetized, and blood was collected from the inferior vena cava. Serum was separated, and renal function-related indicators were detected. Kidney tissue was collected from rats and stained with hematoxylin-eosin (HE), Masson's red, and Oil Red O to observe pathological changes in the kidneys.

[0046] 2. The results show that:

[0047] (1) Compared with the normal group, the model group rats showed significantly increased blood glucose, UACR, BUN, CysC, TC, β2-MG, and mALB levels. P <0.01), compared with the model group, the above indicators in the experimental group showed varying degrees of improvement after the patent holder's intervention. P <0.01 or P <0.05), there was no significant difference in Scr among the three groups.

[0048] Figure 1 A. Changes in blood glucose; B. Changes in urine protein-to-creatinine ratio (UACR); C. Serum creatinine (Scr), cystatin C (Cysc), blood urea nitrogen (BUN), urinary microalbumin (mALB), β2-microglobulin (β2-MG), and total cholesterol (TC), respectively, in rats; Compared with the model group, *P<0.05, **P<0.01.

[0049] (2) HE staining of the kidneys of rats in the model group showed thickening of the glomerular basement membrane, vacuolar degeneration of the renal tubules, Masson staining showed fibrous tissue proliferation, and Oil Red O staining showed lipid accumulation. After drug intervention, the pathological damage to the glomeruli and tubules in the experimental group was reduced, as were the fibrous deposition and lipid accumulation.

[0050] Figure 2 A. Kidney HE staining (×400); B. Kidney MASSON staining (×400); C. Kidney Oil Red O staining (×400).

[0051] (III) Treatment Cases

[0052] Case 1: Patient Information: Mr. Wu, male, 41 years old, had a history of elevated blood glucose for over 6 years and proteinuria for 1 year. During the 6 years prior, he had taken metformin, dapagliflozin, and Xiaoke pills (a traditional Chinese medicine for diabetes). At the time of consultation, 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 The patient was diagnosed with "diabetic nephropathy" and is currently taking dapagliflozin, with relatively good blood sugar control. Symptoms at the time of consultation included: dry mouth and bitter taste, especially noticeable in the morning; foamy urine; lower back and knee weakness; fatigue; no significant lower limb edema; red, thin yellow tongue with cracks; and a thready, rapid pulse. Diagnosis: Early-stage diabetic nephropathy. Prescription: Astragalus membranaceus 30g, Codonopsis pilosula 10g, Salvia miltiorrhiza 10g, Paeonia lactiflora 12g, Achyranthes bidentata 12g, Pheretima aspergillum 3g, Centella asiatica 15g, Hedyotis diffusa 9g, Euryale ferox 15g, Broussonetia papyrifera 9g, Mahonia japonica 12g, Euonymus alatus 9g, Poria cocos 9g, Citrus reticulata 9g, Zea mays 20g (wrapped and decocted), Anemarrhena asphodeloides 9g, Phellodendron chinense 9g, Coptis chinensis 6g, Cornus officinalis 12g. Dosage and administration: 14 doses, decocted in plain water. Accurately weigh the ingredients according to the prescription, add 260 ml of water, decoct for 35 minutes for the first decoction and 20 minutes for the second. Filter the dregs while hot, mix the two decoctions and concentrate to 150 ml. Divide into two doses and take one dose daily. Effects: After half a month of use, there was no significant dry mouth or bitter taste, foamy urine decreased, lower back and knee pain was relieved, fatigue decreased, and there was no lower limb edema. Upon re-consultation, the above prescription was used as the main treatment with modifications. After symptom relief, the dosage was changed to one dose every other day. After 3 months of regular use, the patient had no significant foamy urine, no edema, no dry mouth, and normal bowel movements. Urinary tract infection rate (UACR) was 75 mg / g. -1 ), FBG 5.5 (mmol·L) -1 HbA1C 6.5%.

[0053] Case 2 Patient Information: Mr. Zhang, male, 61 years old, with a 5-year history of elevated blood sugar and intermittent lower extremity edema for over a month. He had previously taken metformin, linagliptin, and traditional Chinese medicine hypoglycemic agents. At the time of consultation, his 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) -1The patient, previously diagnosed with diabetic nephropathy, is currently taking metformin irregularly, resulting in poor fasting blood glucose control. Upon presentation, symptoms included moderate pitting edema of the lower extremities, foamy urine, occasional lower back pain, fatigue, occasional dry mouth, pale complexion, dark, thin, greasy tongue coating, and a deep, slow pulse. Diagnosis: Early-stage diabetic nephropathy. Prescription: Astragalus membranaceus 20g, Codonopsis pilosula 12g, Salvia miltiorrhiza 12g, Paeonia lactiflora 10g, Achyranthes bidentata 15g, Pheretima aspergillum 5g, Centella asiatica 12g, Hedyotis diffusa 9g, Euryale ferox 15g, Broussonetia papyrifera 9g, Mahonia japonica 12g, Euonymus alatus 9g, Poria cocos 15g, Citrus reticulata 9g, Zea mays 20g (wrapped and decocted), Plantago asiatica (wrapped and decocted) 15g, Areca catechu 30g. Dosage and administration: 14 doses, decocted in plain water. Accurately weigh the ingredients according to the prescription, add 260 ml of water, decoct for 35 minutes for the first decoction, and 20 minutes for the second decoction. Filter the dregs while hot, mix the two decoctions and concentrate to 150 ml. Divide into two doses and take one dose daily. Effects: After half a month of treatment, the patient's edema decreased, there was no significant lower back pain, fatigue decreased, dry mouth decreased, and urine foam decreased. Upon re-consultation, the above prescription was used as the main treatment with modifications. After the symptoms subsided, the dosage was changed to one dose every other day. After two months of regular use, the patient's edema disappeared, foamy urine decreased, dry mouth subsided, bowel movements became normal, and the UACR was consistently 75 mg / g. -1 ), FBG 6.1 (mmol·L) -1 HbA1C 6.5%.

[0054] Case 3 Patient Information: Mr. Liu, male, 55 years old, with a history of elevated blood glucose for over 8 years and proteinuria for over 2 years. At the time of consultation, his 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) -1Two years ago, the patient underwent a kidney biopsy, and reported a pathology report of "diabetic nephropathy," but the report was unavailable. Currently, the patient is taking metformin, Xiaoke Pills, dapagliflozin, and alisartan, and blood sugar control is adequate. Upon presentation, the patient presented with: occasional numbness and swelling in the limbs, foamy urine, occasional lower back pain, fatigue, dry mouth, mild lower limb edema, pale complexion, dry stools, foamy urine, dark tongue with petechiae on the edges, dark purple sublingual veins, thin yellow and greasy tongue coating, and a deep, thready, and rapid pulse. Diagnosis: Early-stage diabetic nephropathy. Prescription: Astragalus membranaceus 30g, Codonopsis pilosula 12g, Salvia miltiorrhiza 12g, Paeonia lactiflora 9g, Achyranthes bidentata 15g, Pheretima aspergillum 6g, Centella asiatica 15g, Hedyotis diffusa 9g, Euryale ferox 15g, Broussonetia papyrifera 9g, Mahonia japonica 12g, Euonymus alatus 9g, Poria cocos 12g, Citrus reticulata 9g, Zea mays silk 20g (wrapped and decocted), Prunus persica 6g, Hirudo medicinalis (powdered and taken with water / added to decoction) 3g. Dosage and Administration: 14 doses, decocted in ordinary water. Accurately weigh the ingredients according to the prescription, add 260ml of water, decoct 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 to 150ml. Take in two divided doses, one dose per day. Effects: After one month of use, foamy urine decreased, numbness and swelling in the limbs decreased, no significant dry mouth, occasional lower back pain, reduced fatigue, no lower limb edema, and regular bowel movements. The patient returned for a second consultation and was treated with the same prescription, with modifications as needed. After the symptoms subsided, the patient continued taking the medication regularly for two months. Following this, the patient experienced no more foamy urine, edema, or dry mouth; bowel movements and urination were normal; and the tongue ecchymosis disappeared. At the follow-up visit three months later, the UACR was 70 mg / g. -1 ), FBG 5.5 (mmol·L) -1 HbA1C 6.5%.

[0055] Case 4 Patient Information: Ms. Huang, female, 52 years old, had a history of elevated blood sugar for over 3 years, proteinuria for over 1 year, and recurrent lower extremity edema for 1 month. She was diagnosed with "diabetic nephropathy" at a local hospital. She had been irregularly and intermittently taking hypoglycemic drugs such as valsartan, dapagliflozin, etc., without regularly monitoring her blood sugar and proteinuria. At the time of consultation: UACR 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 undergo a renal biopsy, but refused. Presenting symptoms included foamy urine, lower back and knee pain, significant fatigue, dry mouth, moderate lower extremity edema, pale complexion, dark, thin, greasy tongue coating, and a deep, thready, rapid pulse. The diagnosis was "early diabetic nephropathy." Prescription: Astragalus membranaceus 45g, Codonopsis pilosula 15g, Salvia miltiorrhiza 12g, Paeonia lactiflora 9g, Achyranthes bidentata 12g, Pheretima aspergillum 6g, Centella asiatica 15g, Hedyotis diffusa 9g, Euryale ferox 30g, Broussonetia papyrifera 9g, Mahonia japonica 9g, Euonymus alatus 9g, Poria cocos 12g, Citrus reticulata 9g, Zea mays silk 15g (wrapped and decocted), Rosa laevigata 15g, Cicadae periostracum 9g. Dosage and administration: 14 doses, decocted in plain water. Accurately weigh the ingredients according to the prescription, add 260ml of water, decoct 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 to 150ml, take twice daily. Effects: After one month of use, the patient's foamy urine decreased, fatigue lessened, lower limb edema disappeared, lower back and knee pain subsided, and dry mouth lessened. Upon re-visit, the above formula was used with modifications. After symptom relief, the dosage was reduced to one dose every other day. After four months of regular use, the patient no longer experienced significant foamy urine, edema, or bitter taste in the mouth. Bowel movements and urination were normal, and the UACR was consistently above 100 mg / g. -1 ), FBG 6.2 (mmol·L) -1 HbA1C 7.1%.

[0056] Case 5 Patient Information: Mr. Zhang, male, 35 years old, with elevated blood sugar for more than 5 years. He had been irregularly taking hypoglycemic drugs for the past 5 years. At the time of consultation, 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) -1The patient, who had not undergone a renal biopsy, was diagnosed with "diabetic nephropathy" and was currently taking metformin and other medications, but her blood sugar control was poor. Upon consultation, her symptoms included: foamy urine, nocturia 3-5 times, lower back and knee weakness, fatigue, dry mouth and throat, mild lower limb edema, pale complexion, pale and dark tongue with a thin, greasy white coating, and a deep, thready pulse. Diagnosis: Early-stage diabetic nephropathy. Prescription: Astragalus membranaceus 30g, Codonopsis pilosula 12g, Salvia miltiorrhiza 12g, Paeonia lactiflora 9g, Achyranthes bidentata 15g, Pheretima aspergillum 6g, Centella asiatica 15g, Hedyotis diffusa 9g, Euryale ferox 15g, Broussonetia papyrifera 9g, Mahonia japonica 12g, Euonymus alatus 9g, Poria cocos 12g, Citrus reticulata 9g, Zea mays silk 20g (wrapped and decocted), Alpinia oxyphylla 12g, Mantis religiosa ootheca 12g. Dosage and administration: 14 doses, decocted in plain water. Accurately weigh the ingredients according to the prescription, add 260 ml of water, decoct for 35 minutes for the first decoction and 20 minutes for the second. Filter the dregs while hot, mix the two decoctions and concentrate to 150 ml. Take in two divided doses, one dose per day. Effects: After half a month of use, foamy urine decreased, urinary frequency decreased, lower back and knee weakness improved, fatigue decreased, dry mouth and throat improved, and lower limb edema disappeared. Upon re-consultation, the above prescription was used with modifications. After symptom relief, the dose was changed to once every other day. After 3 months of regular use, the patient no longer had significant foamy urine, edema, or dry mouth; bowel movements were normal; and UACR was consistently 80 mg / g. -1 FBG 5.9 (mmol·L) -1 HbA1C 6.7%.

Claims

1. A traditional Chinese medicine composition for treating early-stage diabetic nephropathy, characterized in that, It is composed of the following raw medicinal materials by weight: Astragalus membranaceus 15-45g, Codonopsis pilosula 10-15g, Salvia miltiorrhiza 9-15g, Paeonia lactiflora 9-15g, Achyranthes bidentata 10-15g, Pheretima aspergillum 3-6g, Centella asiatica 10-15g, Lysimachia christinae 9-12g, Euryale ferox 15-30g, Broussonetia papyrifera 9-12g, Mahonia japonica 9-12g, Euonymus alatus 9-12g, Poria cocos 10-15g, Citrus reticulata 9-12g, and Zea mays 15-30g.

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

3. The traditional Chinese medicine composition for treating early diabetic nephropathy according to claim 1, characterized in that, The raw materials also include: 15g of Plantago asiatica seed and 30g of Areca peel.

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

5. The traditional 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 Cicadae periostracum.

6. The traditional 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 Mantis egg case.

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

Images