Traditional Chinese medicine composition for treating diabetic nephropathy and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 28-32 parts of raw radix astragali, 8-12 parts of radix pseudostellariae, 8-12 parts of radix rehmanniae recen, 4-8 parts of rhizoma coptidis from Sichuan of China, 8-12 parts of herba lycopi and 4-8 parts of sliced cornu cervi. The invention also provides application of the traditional Chinese medicine composition in preparation of medicines for treating diabetic nephropathy. Astragalus mongholicus in the formula is a monarch drug, is sweet and bitter in taste and slightly warm in qi, is a major drug for tonifying qi, and can tonify qi, tonify spleen, promote diuresis and promote blood circulation when qi is flourishing; the ministerial drug radix pseudostellariae is sweet, slightly bitter and neutral in nature, and can tonify qi and yin, engender liquid and moisten dryness so as to tonify qi and yin. The radix rehmanniae recen is sweet and cold, is moist in texture, is heavy and declined in nature, can nourish kidney yin, cool blood and promote secretion of saliva or body fluid, and is combined with the radix astragali to achieve the effects of nourishing yin, tonifying qi and ascending and descending. Herba lycopi is bitter, acrid and slightly warm, and has the effects of promoting blood circulation to remove blood stasis and Coptis chinensis clears heat and purges fire, and is combined with radix rehmanniae recen to reduce heart fire and nourish kidney water, so that yin deficiency is tonified, and body fluid is generated; the warming property of the antler slices is also realized. The antler slices are warm in nature and have the effects of tonifying kidney yang, benefiting essence and blood and strengthening muscles and bones.

Description

Technical Field

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

[0002] Diabetic kidney disease is an important complication of diabetic patients. The most characteristic one is diabetic glomerulosclerosis, namely so-called diabetic nephropathy (DN), which is one of the most important microvascular chronic complications of diabetic patients. In addition, diabetes can also lead to renal artery and renal arteriolar sclerosis and significantly increase the chances of occurrence of urinary tract infections and contrast-induced nephropathy, etc.

[0003] Chinese Patent Document CN 104257968A discloses a traditional Chinese medicine composition for treating diabetic nephropathy and its preparation method. The traditional Chinese medicine composition includes the following raw materials in parts by weight: 20 - 35 parts of Astragalus membranaceus; 5 - 10 parts of Schizonepeta tenuifolia Briq.; 5 - 15 parts of Perilla leaf; 5 - 15 parts of Sanguisorba officinalis L. var. longifolia (Bert.) Yü et Li; 5 - 15 parts of stir-fried Sophora japonica L. flower; 5 - 15 parts of Salvia miltiorrhiza Bunge; 5 - 15 parts of Rubia cordifolia L.; 5 - 15 parts of Areca peel; 1 - 5 parts of Rheum palmatum L. The present invention also provides a preparation method of the above-mentioned pharmaceutical composition, including: extracting the volatile oils of Schizonepeta tenuifolia Briq. and Perilla leaf, filtering the aqueous solution after distillation, concentrating the filtrate to obtain a first filtrate; decocting the medicinal residues with Astragalus membranaceus, Sanguisorba officinalis L. var. longifolia (Bert.) Yü et Li, stir-fried Sophora japonica L. flower, Salvia miltiorrhiza Bunge, Rubia cordifolia L., Areca peel and Rheum palmatum L. twice with water, combining the decoctions, filtering, concentrating the filtrate, allowing it to stand at room temperature to obtain a second filtrate, mixing and stirring the first filtrate and the second filtrate evenly to obtain a mixture, adding ethanol, standing, drying to obtain an extract, adding starch, and finally spraying the volatile oils of Schizonepeta tenuifolia Briq. and Perilla leaf to obtain the pharmaceutical composition. The formula of the present invention has a significant effect on treating diabetic nephropathy.

[0004] Chinese Patent Document CN 107789433A discloses a traditional Chinese medicine formula for treating diabetic nephropathy, which includes the following traditional Chinese medicine components in parts by weight: 10 g of American ginseng, 30 g of Lycium barbarum L., 50 g of Astragalus membranaceus, 15 g of Rehmannia glutinosa Libosch., 15 g of Leonurus artemisia (Lour.) S. Y. Hu, 15 g of Salvia miltiorrhiza Bunge, 15 g of Pheretima aspergillum (E. Perrier), 10 g of Rheum palmatum L., 10 g of Coptis chinensis Franch., 10 g of Corylus heterophylla Fisch. The preparation and usage method of the traditional Chinese medicine composition of the present invention: first soak it in cold water for 50 - 60 minutes, add water exceeding the medicine by 3 - 5 cm, use strong fire (big fire) before the decoction boils, and change to slow fire (small fire) after boiling, so that the decoction boils slightly. The first decoction takes about 35 minutes, and the second decoction takes about 30 minutes. Then mix the two decocted decoctions together, take it once in the morning and once in the evening, 1 dose per day, 7 doses as a course of treatment, and 4 - 6 courses of treatment are required.

[0005] There are many traditional Chinese medicine compositions for treating diabetic nephropathy, but they all have more or less drawbacks. For example, they have too many medicinal flavors, are difficult to obtain raw materials, and are expensive; the medicinal effects are not obvious, and the treatment effects are poor. Therefore, there is an urgent need for a traditional Chinese medicine composition that has obvious effects in treating diabetic nephropathy, has a small number of medicinal flavors, is practically operable, has high compliance, and is safe and effective. Summary of the Invention

[0006] The object of the present invention is to provide a traditional Chinese medicine composition for treating diabetic nephropathy and its application in view of the deficiencies in the prior art.

[0007] In the first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetic nephropathy, which is made from the following raw materials by weight: 28-32 parts of Astragalus membranaceus, 8-12 parts of Pseudostellaria heterophylla, 8-12 parts of Rehmannia glutinosa, 4-8 parts of Coptis chinensis, 8-12 parts of Lycopus lucidus, and 4-8 parts of Cornu Cervi Pantotrichum.

[0008] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials by weight: 29-31 parts of Astragalus membranaceus, 9-11 parts of Pseudostellaria heterophylla, 9-11 parts of Rehmannia glutinosa, 5-7 parts of Coptis chinensis, 9-11 parts of Lycopus lucidus, and 5-7 parts of Cornu Cervi Pantotrichum.

[0009] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials by weight: 30 parts of Astragalus membranaceus, 10 parts of Pseudostellaria heterophylla, 10 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 10 parts of Lycopus lucidus, and 6 parts of Cornu Cervi Pantotrichum.

[0010] As a preferred example, the medicament of the traditional Chinese medicine composition is a granule, a tablet, a capsule or an oral liquid.

[0011] As a preferred example, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable adjuvant.

[0012] In the second aspect, the present invention provides the application of the traditional Chinese medicine composition in the preparation of a medicament for treating diabetic nephropathy.

[0013] As a preferred example, the diabetic nephropathy is diabetic nephropathy with qi-yin deficiency and blood stasis syndrome.

[0014] As a preferred example, the diabetic nephropathy is early diabetic nephropathy.

[0015] The advantages of the present invention are as follows:

[0016] In the formula of the present invention, Astragalus membranaceus is the monarch drug, which is sweet and bitter in taste, slightly warm in nature, and is the "prime drug for supplementing qi". It can supplement qi, strengthen the spleen, and promote diuresis, enabling qi to be abundant so that blood can circulate smoothly. The ministerial drug Pseudostellaria heterophylla is sweet and slightly bitter, neutral in nature, and can supplement qi and nourish yin, promote the production of body fluid and moisten dryness, to moderately supplement qi and yin. Rehmannia glutinosa is sweet, cold, and moist in nature, and its property is sinking and descending. It can nourish the kidney yin, cool the blood, and promote the production of body fluid. When combined with Astragalus membranaceus, they work together to nourish yin and supplement qi, with the ascending and descending functions interacting with each other. Lycopus lucidus is bitter, pungent, and slightly warm, promoting blood circulation to remove stasis and promoting diuresis to reduce swelling. Coptis chinensis clears heat and purges fire. When combined with Rehmannia glutinosa, it can reduce the heart fire and nourish the kidney water, enabling the yin deficiency to be replenished and body fluid to be generated, and at the same time restraining the warm nature of Cornu Cervi Pantotrichum. The adjuvant drug Cornu Cervi Pantotrichum is warm in nature, tonifying the kidney yang, nourishing essence and blood, strengthening muscles and bones, promoting blood circulation to reduce swelling. It can not only seek yin from yang but also prevent the disease from developing into deficiency of both yin and yang, reflecting the academic thought of treating kidney diseases by applying the theory of "less fire generating qi". The whole formula together exerts the effects of supplementing qi and nourishing yin, using both yin and yang, clearing heat and purging fire, promoting blood circulation and promoting diuresis. Detailed implementation manners

[0017] The present invention will be further described below in conjunction with the detailed implementation manners. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.

[0018] Example 1 Traditional Chinese medicine composition for treating diabetic nephropathy (one)

[0019] 30 parts of Astragalus membranaceus, 10 parts of Pseudostellaria heterophylla, 10 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 10 parts of Lycopus lucidus, 6 parts of Cornu Cervi Pantotrichum.

[0020] Example 2 Traditional Chinese medicine composition for treating diabetic nephropathy (two)

[0021] 30 parts of Astragalus membranaceus, 9 parts of Pseudostellaria heterophylla, 11 parts of Rehmannia glutinosa, 4 parts of Coptis chinensis, 12 parts of Lycopus lucidus, 6 parts of Cornu Cervi Pantotrichum.

[0022] Example 3 Traditional Chinese medicine composition for treating diabetic nephropathy (three)

[0023] 29 parts of Astragalus membranaceus, 11 parts of Pseudostellaria heterophylla, 8 parts of Rehmannia glutinosa, 8 parts of Coptis chinensis, 10 parts of Lycopus lucidus, 5 parts of Cornu Cervi Pantotrichum.

[0024] Example 4 Traditional Chinese medicine composition for treating diabetic nephropathy (four)

[0025] 31 parts of Astragalus membranaceus, 8 parts of Pseudostellaria heterophylla, 12 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 9 parts of Lycopus lucidus, 7 parts of Cornu Cervi Pantotrichum.

[0026] Example 5 Traditional Chinese medicine composition for treating diabetic nephropathy (five)

[0027] 28 parts of Astragalus membranaceus, 12 parts of Pseudostellaria heterophylla, 10 parts of Rehmannia glutinosa, 5 parts of Coptis chinensis, 11 parts of Lycopus lucidus, 4 parts of Cornu Cervi Pantotrichum.

[0028] Example 6 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Six)

[0029] 32 parts of Astragalus membranaceus, 10 parts of Pseudostellaria heterophylla, 9 parts of Rehmannia glutinosa, 7 parts of Coptis chinensis, 8 parts of Lycopus lucidus, 8 parts of Cornu Cervi Pantotrichum

[0030] Example 7 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Seven)

[0031] 30 parts of Astragalus membranaceus, 11 parts of Pseudostellaria heterophylla, 8 parts of Rehmannia glutinosa, 8 parts of Coptis chinensis, 10 parts of Lycopus lucidus, 5 parts of Cornu Cervi Pantotrichum

[0032] Example 8 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Eight)

[0033] 29 parts of Astragalus membranaceus, 8 parts of Pseudostellaria heterophylla, 12 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 9 parts of Lycopus lucidus, 7 parts of Cornu Cervi Pantotrichum

[0034] Example 9 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Nine)

[0035] 31 parts of Astragalus membranaceus, 12 parts of Pseudostellaria heterophylla, 10 parts of Rehmannia glutinosa, 5 parts of Coptis chinensis, 11 parts of Lycopus lucidus, 4 parts of Cornu Cervi Pantotrichum

[0036] Example 10 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Ten)

[0037] 28 parts of Astragalus membranaceus, 10 parts of Pseudostellaria heterophylla, 9 parts of Rehmannia glutinosa, 7 parts of Coptis chinensis, 8 parts of Lycopus lucidus, 8 parts of Cornu Cervi Pantotrichum

[0038] Example 11 Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy (Eleven)

[0039] 32 parts of Astragalus membranaceus, 9 parts of Pseudostellaria heterophylla, 11 parts of Rehmannia glutinosa, 4 parts of Coptis chinensis, 12 parts of Lycopus lucidus, 6 parts of Cornu Cervi Pantotrichum

[0040] Example 12 Preparation of Traditional Chinese Medicine Composition for Treating Diabetic Nephropathy

[0041] Take any one of the traditional Chinese medicines in Examples 1 - 11, add 500 ml of water, soak for one hour, bring to a boil over high heat, then turn to low heat, keep boiling, decoct for 30 minutes, pour out 200 ml of the decoction; then add 300 ml of cold water, decoct for 30 minutes, pour out 200 ml of the decoction; combine the two doses and divide them for taking.

[0042] Example 13 Clinical Efficacy Experiment

[0043] 1 Clinical Data

[0044] 1.1 Case Source

[0045] All the cases observed in this study were from the outpatient and inpatient departments of the Endocrinology Department of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from August 2019 to July 2022.

[0046] 1.2 Diagnostic criteria

[0047] The diagnosis of diabetes refers to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes" promulgated by the Diabetes Branch of the Chinese Medical Association in 2017 [5]. The diagnostic criteria for diabetic nephropathy refer to the guidelines of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K / DOQI) [6]. Clinical staging: Refer to the etiology-glomerular filtration rate-albuminuria (cause-GFR-albuminuria, CGA) staging A2 stage proposed in the Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease issued by KDIGO in 2012 [7]: Urinary albumin / creatinine (UACR) 30-300 mg / g. TCM syndrome differentiation refers to the "Diagnostic, Syndrome Differentiation and Efficacy Evaluation Criteria for Diabetic Nephropathy" promulgated by the Nephrology Branch of the Chinese Association of Chinese Medicine in 2007 [8] and the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)" [9]. Main symptoms: Dry throat and mouth, fatigue; Secondary symptoms: Polyphagia and easy hunger, thirst and preference for drinking, shortness of breath and reluctance to speak, restlessness of the five hearts, fixed or stabbing pain in the waist and back, numbness and stabbing pain in the limbs. Pulse is thready, rapid and weak or thready and unsmooth; There are petechiae and ecchymoses, the tongue is swollen with tooth marks on the edge or the tongue is dull, with little or peeled dry coating. The diagnosis takes the main symptoms as the necessary condition, and it can be diagnosed as the syndrome of qi and yin deficiency with blood stasis as long as more than 2 secondary symptoms are present.

[0048] 1.3 Inclusion criteria

[0049] ① Gender is not limited, age is 30-80 years old; ② Random urine tests were performed 2 times within 3 months, UACR: 30 mg / g - 300 mg / g; ③ Estimated glomerular filtration rate (eGFR) ≥ 45 ml·min-1·(1.73 m-2); ④ Blood pressure is below 140 / 90 mmHg; ⑤ Glycated hemoglobin (HbA1c) is 9% and below; ⑥ Meet the clinical diagnosis of early diabetic nephropathy in the diagnostic criteria; ⑦ The hypoglycemic, antihypertensive and lipid-lowering regimens have been stable for 3 months; ⑧ Sign the informed consent form.

[0050] 1.4 Exclusion criteria

[0051] ① Those who have undergone kidney dialysis, kidney transplantation, or have an eGFR < 45 ml·min-1·(1.73 m-2); ② Patients who have long-term used nephrotoxic drugs, immunosuppressants, or glucocorticoids; ③ Those who were admitted to the hospital due to severe metabolic disorders such as diabetic ketoacidosis within 1 month before study inclusion, or those with concurrent severe infections; ④ Those with increased urinary albumin excretion caused by obvious hyperglycemia, infection, congestive heart failure, strenuous exercise within 24 hours, urinary tract infection, fever, obvious hypertension, and other primary or secondary kidney diseases; ⑤ Those with severe abnormal liver function (ALT, AST ≥ 1.5 times the upper limit of the normal value), rheumatic diseases, malignant tumors, cardiovascular and cerebrovascular diseases, or hematopoietic system diseases; ⑥ Those with mental diseases or cognitive dysfunction who cannot communicate well; ⑦ Pregnant and lactating women or those preparing for pregnancy; ⑧ Those allergic to the components of the study drug; ⑨ Those who participated in other clinical trials within 3 months before study inclusion.

[0052] 1.5 Exclusion Criteria

[0053] ① eGFR < 45 ml·min-1·(1.73 m-2) for two consecutive times (repeated on the 3rd day after the first measurement); or fasting blood glucose (FBG) > 16.7 mmol / L; ② Those with complications, comorbidities, or special physiological changes who are not suitable for continuing the trial; ③ Those with poor compliance, using less than 80% or more than 120% of the prescribed drug amount; ④ Those who have used the prohibited drugs specified in the protocol.

[0054] 1.6 Dropout Cases

[0055] 2 patients were lost to follow-up and dropped out.

[0056] 2 Research Methods

[0057] 2.1 Grouping Method

[0058] This study used random grouping. The random number sequence was generated by professional statisticians not involved in this study through computer software, and the generated sequence was sealed in an opaque envelope. The researcher assigned 90 subjects to the control group and the experimental group according to the random number numbers drawn by the subjects, with 45 cases in each group.

[0059] 2.2 Treatment Method

[0060] Basic treatment: All subjects were given popular science on diabetes knowledge, reasonable and regular exercise, high-quality low-protein diet (protein intake should be about 0.8 g·kg-1·d-1), salt intake should be restricted (< 6 g / d), smoking cessation, alcohol restriction, and blood glucose lowering, blood pressure lowering, and lipid lowering. During the study period, the use of other traditional Chinese medicine preparations and nephrotoxic drugs was prohibited. During the study period, MRA drugs such as finerenone were not used in combination.

[0061] 3.1 The experimental group received basic treatment combined with a traditional Chinese medicine compound for the treatment of diabetic nephropathy (Example 1 of the present invention). Each dose was divided into 2 small bags, produced by Jiangyin Tianjiang Pharmaceutical Co., Ltd., batch number: 1810334, specification: 12 g / bag. It was taken twice a day, one bag each time, and taken after dissolving in boiling water. The treatment course was 6 months. If the antihypertensive effect was not satisfactory, a calcium antagonist could be added. If blood pressure control was still not good, a diuretic could be added.

[0062] 3.2 The control group received basic treatment combined with valsartan capsules (Beijing Novartis Pharmaceutical Co., Ltd., national drug approval number H20040217, 80 mg / tablet), once a day, one tablet each time, taken orally. The treatment course was 6 months. If the antihypertensive effect was not satisfactory, a calcium antagonist could be added. If blood pressure control was still not good, a diuretic could be added.

[0063] 2.3 Treatment plan

[0064] The 90 patients with early diabetic nephropathy (syndrome of qi and yin deficiency complicated with stasis) collected were randomly divided into an experimental group and a control group, with 45 cases in each group. Both groups were given basic treatment. The experimental group was treated with a traditional Chinese medicine compound for the treatment of diabetic nephropathy, and the control group was treated with valsartan capsules. The treatment course for both groups was 6 months. The changes in urinary albumin / creatinine (UACR), 24-hour urinary protein quantification, blood urea nitrogen (BUN), serum creatinine (SCr), blood uric acid (UA), cystatin C (Cys-C), estimated glomerular filtration rate (eGFR), urinary retinol-binding protein (RBP), urinary N-acetyl-β-D-glucosaminidase (NAG), fasting blood glucose (FBG), glycated hemoglobin (HbA1c), and blood lipids (TC, TG, HDL, LDL) before and after treatment in both groups were observed. A decrease in UACR of ≥30% was defined as effective.

[0065] 2.4 Evaluation method

[0066] The efficacy evaluation criteria referred to the "Diagnosis, Syndrome Differentiation and Efficacy Evaluation Criteria for Diabetic Nephropathy (Trial Scheme)" formulated by the Nephrology Branch of the Chinese Association of Chinese Medicine [8]. Obvious alleviation of clinical symptoms and a decrease in UACR of ≥50% were defined as marked efficacy; some alleviation of clinical symptoms and a 30% ≤ decrease in UACR < 50% were defined as effective; no improvement in clinical symptoms, a decrease in UACR < 30% or continuous increase were defined as ineffective. The total effective rate = (number of marked efficacy cases + number of effective cases) / total number of cases.

[0067] 2.5 Clinical observation indicators

[0068] 1 The main efficacy indicators were UACR and 24-hour urinary protein quantification.

[0069] Secondary efficacy indicators: urinary retinol-binding protein (RBP), urinary N-acetyl-β-D-glucosaminidase (NAG), serum creatinine (SCr), blood urea nitrogen (BUN), uric acid (UA), cystatin C (Cys-C), eGFR; FBG, HbA1c; total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL).

[0070] 2.6 Observation time and follow-up method

[0071] The treatment course is 6 months.

[0072] Statistical methods

[0073] The data of this study were analyzed using SPSS 22.0 statistical software. Count data were expressed as percentages (%), and the χ2 test was used for comparison between groups. The rank sum test was used for comparison of ranked data. Measurement data were expressed as, and the t-test for grouped design data was used for comparison between groups that conformed to the normal distribution; the Wilcoxon rank sum test was used for those that did not conform to the normal distribution. A P < 0.5 was considered statistically significant for the difference.

[0074] 3.1 Research results

[0075] 1. Comparison of case dropout and baseline data

[0076] During the trial, 2 patients were lost to follow-up, with 1 case dropped out in each of the experimental group and the control group. There was no statistically significant difference in the baseline data (age, gender, BMI, waist circumference, diabetes duration, hypertension, blood pressure) between the two groups (P > 0.05), and they were comparable. See Table 1.

[0077] Table 1 Comparison of baseline data between the two groups

[0078]

[0079] 2. Results of observation indicators in the two groups

[0080] After 6 months of treatment, the levels of UACR and RBP in the experimental group were significantly lower than those in the control group (P<0.01), and the differences were statistically significant compared with those before treatment (P<0.05); the level of BUN in the experimental group was significantly lower than that in the control group (P<0.01), and there was no statistical significance in the comparison before and after treatment within the group (P>0.05); the level of Cys-C in the experimental group decreased significantly (P<0.05), and the differences were statistically significant in the comparison between groups after treatment (P<0.05). After 3 months and 6 months of treatment, the levels of HbA1c in the experimental group were lower than those in the control group (P<0.05), and the differences in HbA1c in the experimental group were statistically significant after 6 months of treatment compared with those before treatment (P<0.05). When comparing the two groups after 6 months of treatment with those before treatment, there were no statistical significance in the levels of 24-hour urinary protein quantification, NAG, BUN, UA, SCr, eGFR, FPG, TC, TG, HDL, and LDL (P>0.05); when comparing the two groups after 6 months of treatment, there were no statistical significance in the levels of 24-hour urinary protein quantification, NAG, UA, SCr, eGFR, FPG, TC, TG, HDL, and LDL (P>0.05). See Tables 2 and 3.

[0081] Table 2 Comparison of kidney-related indicators and blood glucose between the two groups

[0082]

[0083]

[0084] Note: Compared with before treatment in this group, *P<0.05, **P<0.01; compared with the control group after 6 months of treatment, # P<0.05, ## P<0.01.

[0085] Table 3 Comparison of urine RBP, urine NAG, and blood lipid-related indicators between the two groups

[0086]

[0087] Note: Compared with before treatment in this group, *P<0.05; compared with the control group after 6 months of treatment, # P<0.05, ## P<0.01.

[0088] 3. Comparison of clinical efficacy between the two groups

[0089] The total effective rate of clinical treatment in the experimental group was 54.55%, and that in the control group was 22.72%. In the comparison of curative effects between groups, the experimental group was significantly superior to the control group (P<0.05), as shown in Table 4.

[0090] Table 4 Comparison of clinical efficacy between the two groups (cases)

[0091]

[0092] 4. Safety indicators

[0093] The blood routine and liver function of both groups were within the normal range, no obvious abnormalities were found in the electrocardiogram, and no adverse events occurred.

[0094] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the method of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic nephropathy, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials by weight: 28-32 parts of astragalus membranaceus, 8-12 parts of pseudostellaria heterophylla, 8-12 parts of rehmannia glutinosa, 4-8 parts of coptis chinensis, 8-12 parts of lycopus lucidus, and 4-8 parts of cornua cervi degelatinatum.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials by weight: 29-31 parts of astragalus membranaceus, 9-11 parts of pseudostellaria heterophylla, 9-11 parts of rehmannia glutinosa, 5-7 parts of coptis chinensis, 9-11 parts of lycopus lucidus, and 5-7 parts of cornua cervi degelatinatum.

3. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials by weight: 30 parts of astragalus membranaceus, 10 parts of pseudostellaria heterophylla, 10 parts of rehmannia glutinosa, 6 parts of coptis chinensis, 10 parts of lycopus lucidus, and 6 parts of cornua cervi degelatinatum.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The medicament of the traditional Chinese medicine composition is a granule, a tablet, a capsule or an oral liquid.

5. The traditional Chinese medicine composition according to claim 4, wherein The traditional Chinese medicine composition further comprises a pharmaceutically acceptable adjuvant.

6. Use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating diabetic nephropathy.

7. The application according to claim 6, characterized in that, The diabetic nephropathy is diabetic nephropathy with syndrome of deficiency of both qi and yin complicated with stasis.

8. The application according to claim 6, wherein The diabetic nephropathy is early diabetic nephropathy.

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