New application of combination of traditional Chinese medicine composition and fenerenone in treatment of diabetic nephropathy

Abstract

The invention discloses a novel application of a traditional Chinese medicine composition and fenerenone in clinically treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-60 parts of abelmoschus manihot flowers, 5-30 parts of tripterygium hypoglaucum roots, 20-60 parts of astragalus membranaceus and 5-20 parts of wine-prepared fructus corni. The combined use of the traditional Chinese medicine composition and the fenerenone has the attenuated synergistic effects of relieving proteinuria, protecting the renal function, relieving clinical symptoms, improving the side effect of fenerenone hyperkalemia and the like on patients with clinical proteinuria diabetic nephropathy; clinical application proves that the traditional Chinese medicine composition has a better treatment effect on diabetic nephropathy compared with fenerenone, and is higher in safety.

Description

TECHNICAL FIELD

[0001] The application relates to an application of a traditional Chinese medicine composition combined with finerenone, in particular to an application of a traditional Chinese medicine composition combined with finerenone in a medicine for treating clinical proteinuria period diabetic nephropathy. BACKGROUND

[0002] The International Diabetes Federation predicts that the number of diabetes mellitus (DM) patients will gradually increase to 643 million by 2030, and will increase to 784 million by 2045. The total number of diabetes mellitus patients in China is about 141.1 million, and 20-40% of the diabetes mellitus patients are combined with diabetic nephropathy. As one of the most serious microvascular complications of diabetes mellitus, the incidence of diabetic kidney disease (DKD) increases year by year, and because of its insidious onset, low awareness and substandard treatment, it has gradually become the main cause of chronic kidney disease and end-stage kidney disease.

[0003] The pathogenesis of DKD is complex, and it is more difficult to treat than other types of kidney diseases. As an emerging DKD drug approved by the US Food and Drug Administration (FDA), finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), has attracted attention in clinical use. In 2021, the China Diabetes Nephropathy Diagnosis and Treatment Guidelines clearly recommends that finerenone be included in the standardized treatment path for urinary albumin excretion control in DKD patients. The results of the FIDELIO-DKD trial, the FIGARO-DKD trial, and the FIDELITY study, which is a meta-analysis of the two trials, all show that finerenone can effectively reduce the renal composite endpoint events of DKD patients, but the global incidence of DKD and the resulting end-stage kidney disease is still on the rise. In terms of safety, although the incidence of hyperkalemia is lower compared to steroidal MRAs (such as spironolactone), related clinical studies have still found that blood potassium still rises during the use of finerenone, and close monitoring of blood potassium is required during the treatment course. Clinical drug discontinuation often occurs due to high blood potassium. Therefore, how to more effectively improve the proteinuria and renal function of DKD patients in the clinical proteinuria period, while reducing the side effects of related drugs, is still a difficult and bottleneck problem of the disease. SUMMARY

[0004] The purpose of the present application is to provide an application of a traditional Chinese medicine composition combined with a non-steroidal mineralocorticoid receptor antagonist finerenone in the clinical treatment of DKD in the clinical proteinuria period.

[0005] The present application uses a traditional Chinese medicine composition and finerenone together for the clinical treatment of DKD in the clinical proteinuria period, aiming to improve the effect and reduce the side effects, and to improve the clinical problems of poor effect and obvious side effects (such as hyperkalemia) of finerenone alone in the treatment of DKD in the clinical proteinuria period.

[0006] Technical solution: a pharmaceutical composition, including a traditional Chinese medicine composition and finerenone, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum. Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of Abelmoschus flower, 15 parts of fire torch flower root, 30 parts of Astragalus, and 10 parts of wine plum.

[0007] A pharmaceutical preparation, including a traditional Chinese medicine preparation and finerenone, the traditional Chinese medicine preparation being prepared by adding or not adding excipients to the decoction liquid obtained by water decoction and filtration of a traditional Chinese medicine composition, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum.

[0008] Preferably, the pharmaceutical preparation, the excipients include diluents, binders, disintegrants, glidants, lubricants, flavoring agents, inclusion materials, and adsorption materials.

[0009] The pharmaceutical preparation, the dosage form of the traditional Chinese medicine preparation includes decoction, paste, granules, pills, oral liquid, capsules, powder, and tablets.

[0010] The application of a traditional Chinese medicine composition in combination with finerenone in the preparation of a drug for treating diabetic nephropathy, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum.

[0011] The application of a traditional Chinese medicine composition in the preparation of a drug for improving or treating hyperkalemia, a side effect of finerenone, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum.

[0012] The application of a traditional Chinese medicine preparation in combination with finerenone in the preparation of a drug for treating diabetic nephropathy, the traditional Chinese medicine preparation being prepared by adding or not adding excipients to the decoction liquid obtained by water decoction and filtration of a traditional Chinese medicine composition, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum.

[0013] The application of a traditional Chinese medicine preparation in the preparation of a drug for improving or treating hyperkalemia, a side effect of finerenone, the traditional Chinese medicine preparation being prepared by adding or not adding excipients to the decoction liquid obtained by water decoction and filtration of a traditional Chinese medicine composition, the traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20-60 parts of Abelmoschus flower, 5-30 parts of fire torch flower root, 20-60 parts of Astragalus, and 5-20 parts of wine plum.

[0014] Preferably, the application, the adjuvant includes diluent, adhesive, disintegrant, glidant, lubricant, flavoring agent, inclusion material, adsorption material.

[0015] The application, the traditional Chinese medicine preparation includes decoction, paste, granules, pills, oral liquid, capsules, powder, tablets.

[0016] The application of Kunwei Baoshen granules combined with finerenone in the preparation of a drug for treating diabetic nephropathy.

[0017] The application of Kunwei Baoshen granules combined with finerenone in the preparation of a drug for treating high potassium hyperkalemia of finerenone side effects.

[0018] The traditional Chinese medicine combination granules of the application are Kunwei Baoshen granules approved by Jiangsu Provincial Drug Administration for treating diabetic nephropathy, and the batch number is Figure 1 .

[0019] The details of the raw materials in the application are as follows:

[0020] The flower of Abelmoschus moschatus is the flower of the plant Abelmoschus moschatus or Abelmoschus moschatus, mainly produced in central and southern China, southwest China, Hebei, Zhejiang and other places. It tastes sweet and pungent, and is cold in nature, and belongs to the kidney channel. The main effects are clearing damp heat and unblocking collaterals. Research shows that the flower of Abelmoschus moschatus has the effects of inhibiting immune response, reducing inflammatory response, anti-platelet aggregation, improving renal fibrosis and protecting renal tubular epithelial cells.

[0021] The root of Tripterygium regelium is the root of the plant Tripterygium regelium of the family Celastraceae, distributed in the Yangtze River Basin and southwest China. The record of Chinese medicine records that Tripterygium regelium tastes bitter and pungent, and is slightly warm, and belongs to the liver, spleen and kidney channels, and has the effects of dispelling wind and dampness, promoting blood flow and stopping bleeding, clearing heat and detoxifying. Clinical research shows that Tripterygium regelium is a high-efficiency and low-toxicity drug, which has the effects of anti-inflammatory, analgesic, immunosuppressive and other hormone-like effects and cytotoxic drugs. Modern pharmacological research shows that Tripterygium regelium has the effects of regulating immunity and improving microcirculation.

[0022] Radix Astragali tastes sweet and is slightly warm, and belongs to the spleen and lung channels, and is first recorded in Shennong's Herbal Classic, and has the effects of tonifying qi, promoting fluid production, ascending yang, consolidating the exterior, nourishing yin, and stopping sweating, and has the effects of tonifying qi, promoting fluid production, ascending yang, consolidating the exterior, nourishing yin, and stopping sweating. It can also benefit the spleen and lung, and can be used for treating diabetic nephropathy. Modern pharmacological research shows that Radix Astragali has the effects of regulating glucose and lipid metabolism, regulating immunity, improving oxidative stress, inhibiting inflammatory response, and regulating podocytes.

[0023] Shuyu Rou is a kind of traditional Chinese medicine prepared by using yellow rice, which is one of the commonly used traditional Chinese medicines in clinical practice, and belongs to the liver and kidney channels, and has the effects of warming and tonifying liver and kidney, and astringing and consolidating. Modern pharmacological research shows that Cornus officinalis has insulin-like effect to reduce blood sugar, and also has the effects of immune regulation, antioxidant, anti-renal fibrosis, etc.

[0024] In the composition of the present application, Spatholobus suberectus is used as the monarch drug to clear damp-heat and dissolve stasis. Spatholobus suberectus is mainly distributed in the kidney and liver in the animal body, and pharmacological studies show that it has the effects of anti-oxidative stress, anti-inflammation, and anti-fibrosis. The root of Impatiens bhangura is used as the minister drug to assist the monarch drug in clearing heat and activating collaterals. Studies have shown that the root of Impatiens bhangura can inhibit inflammatory factors, regulate the related pathways of NF-κB and TGF-β1, and has the effects of anti-inflammation and anti-fibrosis. The mechanism of action of the root of Impatiens bhangura is similar to that of Spatholobus suberectus. The two drugs are used together to reduce urinary protein and improve kidney damage. Astragalus is used to tonify qi and nourish yin, drain water and reduce swelling, so that the drug has the effect of purgation in tonification, eliminating pathogenic factors without damaging the normal body. Jiumeurou is used to warm the liver and kidney, and is used together with Astragalus as the auxiliary drug. The combination of the two drugs has the effects of tonifying qi and yin, and the effect of tonifying qi and astringing is enhanced. Jiumeurou and Astragalus are the commonly used drug pair in the treatment of diabetic nephropathy by Zhang Xichun. The combination of the above drugs has the effects of tonifying qi and nourishing yin, clearing and dissolving collaterals.

[0025] Beneficial effects: Compared with the prior art, the traditional Chinese medicine composition of the present application is composed of Spatholobus suberectus, the root of Impatiens bhangura, Astragalus, and Jiumeurou, combined with finerenone. This treatment regimen can effectively improve the clinical proteinuria period DKD. According to clinical experience combined with modern pharmacological composition, it has the effects of relieving clinical symptoms, reducing proteinuria, protecting renal function, and improving drug side effects for the clinical proteinuria period DKD. Clinical studies have shown that the treatment of clinical proteinuria period DKD has good therapeutic effect and high safety. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 The preparation batch number of Kunkui Baoshen Granules of Jiangsu Provincial Hospital of Traditional Chinese Medicine. DETAILED DESCRIPTION

[0027] Example 1

[0028] The use method of finerenone (producing enterprise: Bayer Company of Germany, approval number: GMP of China HJ20220057) is shown in Tables 1 and 2.

[0029] The traditional Chinese medicine composition: Spatholobus suberectus 30g, the root of Impatiens bhangura 15g, Astragalus 30g, and Jiumeurou 10g.

[0030] Clinical research:

[0031] 240 patients with type 2 diabetic nephropathy admitted to the outpatient or ward of Jiangsu Provincial Hospital of Traditional Chinese Medicine from June 2023 to December 2024 were enrolled. The inclusion criteria were: (1) meeting the DKD diagnosis standard of Western medicine in “China Diabetes Nephropathy Prevention and Treatment Guidelines (2021 Edition)”; (2) the estimated glomerular filtration rate (eGFR) of the patient was ≥25ml·min -1 ·(1.73m 2 )-1 (3) The reference for TCM syndrome type diagnosis is "Technical Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine for Diabetic Kidney Disease (2020)", "Guidelines for Diagnosis and Treatment of Diabetic Kidney Disease in Combination with Traditional Chinese and Western Medicine". The clinical syndrome is "dampness and blood stasis blocking the collaterals, deficiency of both qi and yin"; (4) Age between 18 and 80 years old, gender unrestricted; (5) Serum potassium ≤5.0 mmol / L. Exclusion criteria: (1) Use of other kidney-protecting drugs during the treatment period; (2) Missing medication or replacing the enrolled drug for more than 1 week during the treatment period; (3) Occurred diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, infection, severe diabetic foot gangrene, etc. within one month; (4) History of critical illness such as malignant hypertension, myocardial infarction, cerebrovascular accident, etc. within six months; (5) Cancer, pregnancy, and allergy to related drugs in the treatment plan, etc. not suitable for receiving this treatment plan. According to the medication regimen, 240 "dampness and blood stasis blocking the collaterals, deficiency of both qi and yin" syndrome DKD patients were divided into combination group, traditional Chinese medicine composition group and finerenone group. This study was approved by the hospital medical ethics committee (ethics approval number: 2023NL-106-02).

[0032] All three groups were given basic treatment, including improving lifestyle, controlling blood sugar, blood pressure, blood lipids, etc. Finerenone group: basic treatment combined with finerenone tablet treatment, initial dose and dose adjustment see Table 1, Table 2. Traditional Chinese medicine composition group: basic treatment combined with traditional Chinese medicine composition treatment (uniformly decocted to 400 mL, 200 mL each time, 1 time after breakfast and dinner, half an hour after meal) ; Combination group treatment regimen: basic treatment combined with finerenone tablet and traditional Chinese medicine composition treatment. Three groups were treated for 3 months continuously.

[0033] Table 1 Finerenone initial dose

[0034]

[0035]

[0036] Table 2 Detection and dose adjustment

[0037]

[0038] After screening by inclusion and exclusion criteria, 240 patients were enrolled. During the observation period, 5 patients were lost to follow-up, 8 patients had poor compliance and stopped taking medicine by themselves, 3 patients refused to take kidney function test, and the data was missing, leading to dropouts. Finally, the clinical data of 224 patients were analyzed, the total dropout rate was 6.67%, and the final effective cases were combined group (63 cases), traditional Chinese medicine composition group (78 cases) and finerenone group (83 cases). There was no statistical difference in gender, age, body mass index (BMI), diabetes mellitus (DM) duration, systolic blood pressure (SBP), diastolic blood pressure (DBP), family history of diabetes, history of smoking and drinking, and related laboratory examination baseline data of the three groups of patients (P>0.05), which were comparable. See Table 3 for details.

[0039] Table 3 Baseline data of general information of three treatment groups

[0040]

[0041] Note: BMI: body mass index: weight (kg) divided by height (m) squared; SBP: systolic blood pressure, DBP: diastolic blood pressure.

[0042] (1) Comparison of urine protein indicators of the three groups of patients before and after treatment:

[0043] Urine protein efficacy: According to the "Diagnosis, Syndrome Differentiation and Efficacy Evaluation Criteria (Trial Program) for Diabetic Nephropathy" issued by the Kidney Disease Branch of Chinese Medicine Association and the definition of UACR reversal in FIDELITY study, the proteinuria efficacy evaluation criteria were developed: ① Recent remission: UACR reduction ≥ 50%, or decreased to normal range; ② Marked effect: UACR reduction ≥ 30%, but less than 50%; ③ Effective: UACR reduction, but less than 30%; ④ Ineffective: UACR increased or unchanged.

[0044] Total effective rate = (recent remission + marked effect + effective) / total number of cases x 100%.

[0045] Table 4 Comparison of changes in urine protein before and after treatment in three groups

[0046]

[0047] Note: a, b, c are used to show whether there is statistical difference in multiple comparisons between groups. Groups marked with the same letter have no statistical difference between groups (P>0.05), and groups marked with different letters have statistical difference between groups (P<0.05).

[0048] Results: After treatment, the UACR of the three groups was significantly lower than before treatment (all P<0.001), the improvement range (ΔUACR) of the combined group was significantly better than the other two groups (P<0.01), and better than the numerical value of the improvement range of the other two groups, indicating that the combination of traditional Chinese medicine composition and finerenone has a synergistic effect.

[0049] The short-term remission rate of the combined group after treatment was 27%, the significant efficiency was 33.3%, the effective rate was 33.3%, the ineffective rate was 6.3%, and the total effective rate was 93.7%. The short-term remission rate of the finerenone group after treatment was 16.9%, the significant efficiency was 24.1%, the effective rate was 30.1%, the ineffective rate was 28.9%, and the total effective rate was 71.1%. The short-term remission rate of the traditional Chinese medicine composition group after treatment was 15.4%, the significant efficiency was 21.8%, the effective rate was 30.8%, the ineffective rate was 32.1%, and the total effective rate was 67.9%. In summary, the effective rate of the combined group in treating proteinuria was significantly higher than that of the traditional Chinese medicine composition group and the finerenone group (P<0.001), and there was no significant statistical difference in the reduction of UACR between the finerenone group and the traditional Chinese medicine composition group (P>0.05), indicating that the combination of traditional Chinese medicine composition and finerenone has better effect in reducing urinary protein than finerenone alone.

[0050] (2) Comparison of renal function indexes of the three groups before and after treatment:

[0051] Renal function efficacy: According to the "Diabetic Nephropathy Staging and Treatment Efficacy Evaluation Criteria and Research", the renal function efficacy evaluation criteria were developed: ① Marked effect: eGFR increased by ≥20% or serum creatinine decreased by ≥20%; ② Effective: eGFR increased by 10%-20% or serum creatinine decreased by 10%-20%; ③ Stable: eGFR did not decrease and increased by <10%, or serum creatinine did not increase and decreased by <10%; ④ Ineffective: eGFR decreased or serum creatinine increased. Total effective rate = (marked effect + effective + stable) / total number of cases x 100%.

[0052] Table 5 Comparison of changes in renal function before and after treatment in the three groups

[0053]

[0054]

[0055] Note: a, b, c are used to show whether there is a statistical difference between groups, groups marked with the same letter have no statistical difference between groups (P>0.05), and groups marked with different letters have statistical difference between groups (P<0.05).

[0056] Results: After treatment, Scr and cystatin C showed a decreasing trend, while eGFR showed an increasing trend. Only the combined treatment group showed a significant increase in eGFR (P<0.05), while the others showed no significant statistical differences (P>0.05).

[0057] After treatment, the combined treatment group showed a significant improvement in renal function with an effective rate of 22.2%, an effective rate of 20.6%, a stable renal function rate of 30.2%, an ineffective rate of 27%, and a total effective rate of 73%. In the fenelazol group, the significant improvement was 14.5%, the effective rate was 13.3%, the stable renal function rate was 43.4%, the ineffective rate was 28.9%, and the total effective rate was 71.1%. In the traditional Chinese medicine combination group, the significant improvement was 17.9%, the effective rate was 15.4%, the stable renal function rate was 37.2%, the ineffective rate was 29.5%, and the total effective rate was 70.5%. In summary, the combined treatment group showed a higher effective rate in improving renal function than the traditional Chinese medicine combination group and the fenelazol group, but the difference was not statistically significant (P > 0.05).

[0058] (3) Comparison of TCM syndrome scores among the three groups of patients

[0059] Traditional Chinese Medicine (TCM) syndrome indicators: TCM syndrome score. Referring to the "Staging and Differentiation Standards and Efficacy Evaluation Schemes for Diabetic Nephropathy and Their Research": ① Markedly effective: Significant improvement in TCM clinical symptoms and signs, with a total syndrome score reduction of ≥50%; ② Effective: Improvement in TCM clinical symptoms and signs, with a ≥30% reduction in the total syndrome score (50% > 30%); ③ Ineffective: No significant improvement or worsening of TCM clinical symptoms and signs, with a <30% reduction in the total syndrome score. Calculation formula:

(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score

[0060] For the detailed criteria for syndrome scoring, please refer to Appendix 1.

[0061] Table 6 Comparison of TCM syndrome scores before and after treatment in the three groups

[0062]

[0063]

[0064] Note: a, b, and c are used to indicate whether there are statistically significant differences between multiple comparisons. Groups labeled with the same letter have no statistically significant differences (P>0.05), while groups labeled with different letters have statistically significant differences (P<0.05).

[0065] Results: All three groups showed significant improvement in TCM syndrome scores after treatment (P<0.001). The effective rates of TCM syndrome treatment in the fenelazol group, the combined group, and the TCM combination group were 37.3%, 93.7%, and 70.5%, respectively. Statistically significant differences were found between each group (P<0.05). The combined group showed significantly better improvement in TCM syndrome compared to the other two groups. This suggests that the combination of TCM and fenelazol is more effective than fenelazol alone in improving clinical syndromes.

[0066] (4) Security assessment

[0067] Table 7 Changes in safety indicators before and after treatment in the three groups

[0068]

[0069] Note: a, b, and c are used to indicate whether there are statistically significant differences between multiple comparisons. Groups labeled with the same letter have no statistically significant differences (P>0.05), while groups labeled with different letters have statistically significant differences (P<0.05).

[0070] Results: There were no statistically significant differences in liver function, blood routine and other related indicators before and after treatment in the three groups (P>0.05). After treatment, serum potassium in the fenelazol group increased significantly compared with that before treatment (P<0.05), while there were no statistically significant differences in serum potassium before and after treatment in the combined group and the traditional Chinese medicine composition group (P>0.05). During the treatment period, 9 cases (10.84%) of hyperkalemia occurred in the fenelazol group, which was significantly higher than the 2 cases (3.17%) in the combined group and the 1 case (1.28%) in the traditional Chinese medicine composition group, and the inter-group comparison was statistically significant (P<0.05); there was no statistically significant difference in the incidence of hyperkalemia between the combined group and the traditional Chinese medicine composition group (P>0.05). These findings suggest that the combination of traditional Chinese medicine composition and fenelazol can reduce the incidence of hyperkalemia and has a higher safety profile than fenelazol alone.

[0071] Appendix 1: Quantitative Table of Traditional Chinese Medicine Syndrome Grading

[0072]

[0073]

Claims

1. A pharmaceutical composition, characterized in that, The product includes a traditional Chinese medicine composition and fenelone, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

2. A pharmaceutical preparation, characterized in that, The traditional Chinese medicine preparations include fenelone. The traditional Chinese medicine preparations are prepared by decocting and filtering a traditional Chinese medicine composition with or without the addition of excipients. The traditional Chinese medicine composition includes the following raw materials in the following weight proportions: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

3. The pharmaceutical preparation according to claim 2, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, pastes, granules, pills, oral liquids, capsules, powders, and tablets.

4. The application of a traditional Chinese medicine composition in combination with fenelone in the preparation of a drug for treating diabetic nephropathy, wherein the traditional Chinese medicine composition comprises the following raw materials in the following weight proportions: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

5. The use of a traditional Chinese medicine composition in the preparation of a drug for improving or treating hyperkalemia, a side effect of felindone, wherein the traditional Chinese medicine composition comprises the following raw materials in the following weight proportions: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

6. The application of a traditional Chinese medicine preparation combined with fenelazol in the preparation of a drug for treating diabetic nephropathy, wherein the traditional Chinese medicine preparation is prepared by adding or not adding excipients from a decoction obtained by decocting and filtering a traditional Chinese medicine composition, and wherein the traditional Chinese medicine composition comprises the following raw materials in the following weight proportions: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

7. The application of a traditional Chinese medicine preparation in the preparation of a drug for improving or treating hyperkalemia, a side effect of felindone, wherein the traditional Chinese medicine preparation is prepared by decocting and filtering a traditional Chinese medicine composition with or without the addition of excipients, and wherein the traditional Chinese medicine composition comprises the following raw materials in the following weight proportions: 20-60 parts of Hibiscus syriacus flower, 5-30 parts of Torchflower root, 20-60 parts of Astragalus membranaceus, and 5-20 parts of Cornus officinalis.

8. The application according to claim 6 or 7, characterized in that, The traditional Chinese medicine preparations include decoctions, pastes, granules, pills, oral liquids, capsules, powders, and tablets.

9. Application of Kunkui Kidney-Protecting Granules in combination with feneperidine in the preparation of drugs for treating diabetic nephropathy.

10. Application of Kunkui Kidney-Protecting Granules in combination with feneperidine in the preparation of a drug for treating hyperkalemia, a side effect of feneperidine.

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