A traditional Chinese medicine composition for treating acute / chronic kidney injury and a preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition for treating acute / chronic kidney injury and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-45 parts by weight of Astragalus membranaceus, 9-15 parts by weight of Polygonatum, 9-15 parts by weight of Pueraria, 9-30 parts by weight of prepared rhubarb, 9-15 parts by weight of Curcuma, and 3-12 parts by weight of Glycyrrhiza. The traditional Chinese medicine composition for treating acute / chronic kidney injury has remarkable curative effect on acute / chronic kidney injury, is safe in medication, and has positive significance for improving the life quality of patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for treating acute / chronic kidney injury and its preparation method. Background Technology

[0002] Acute kidney injury (AKI) is a syndrome characterized by a sudden decline in kidney function (within 48 hours), resulting in water, electrolyte, and acid-base imbalances, extracellular volume disturbances, and the accumulation of nitrogenous waste products. AKI increases the risk of developing chronic kidney disease (CKD) and can exacerbate pre-existing CKD, ultimately progressing to end-stage renal disease (ESRD) and uremia. Chronic kidney disease (CKD) is a chronic structural and functional disorder of the kidneys caused by various factors (a history of kidney damage longer than 3 months), including pathological damage with normal or abnormal renal glomerular filtration rate (GFR), abnormal blood or urine composition, abnormal imaging findings, or unexplained GFR decline (<60 ml / min·1.73 mcg). 2 If AKI lasts longer than 3 months, it is considered CKD. AKI significantly increases short-term mortality and medical costs, and the long-term risk of CKD is much higher than in healthy individuals. CKD has a long course, which may accompany patients for life, placing a heavy burden on the national economy. However, in treatment, modern medicine addresses the underlying cause of AKI by eliminating the cause and providing supportive care to prevent and control complications. When complications cannot be treated with medication, renal replacement therapy is used. In addition to symptomatic treatments such as removing the inducing factors, nutritional support, and volume control, dopamine agonists, diuretics, and natriuretic peptides may alleviate experimental AKI, but these are not widely accepted or used.

[0003] Western medicine primarily treats kidney injury by removing the underlying causes, providing symptomatic relief, and, when necessary, performing renal replacement therapy. There is a lack of new and effective treatment methods. The key to treatment lies in controlling disease progression, not in completely curing the disease, and Western medicine inevitably brings a series of side effects. While dialysis is more effective, it is relatively expensive, and the procedure requires the creation of a stoma, which can cause some damage to the patient and may lead to infection, bleeding, thrombosis, etc. Furthermore, it can affect the patient's hemodynamics, making it unsuitable for patients with poor cardiopulmonary function.

[0004] Currently, traditional Chinese medicine (TCM) treatments for acute / chronic kidney injury commonly employ methods such as "reducing turbidity," "tonifying deficiency," and "removing blood stasis." However, there is still a lack of optimized TCM treatment plans for kidney injury that are highly effective, practical, and repeatable. Summary of the Invention

[0005] In view of the deficiencies in the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating acute / chronic kidney injury and its preparation method.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for treating acute / chronic kidney injury, which is made from the following raw materials in parts by weight: Astragalus membranaceus 15-45 parts by weight, Polygonatum sibiricum 9-15 parts by weight, Pueraria lobata 9-15 parts by weight, processed rhubarb 9-30 parts by weight, Curcuma zedoaria 9-15 parts by weight, and Glycyrrhiza uralensis 3-12 parts by weight.

[0007] A second aspect of the present invention provides a traditional Chinese medicine composition preparation for treating acute / chronic kidney injury, wherein the traditional Chinese medicine composition preparation is prepared from the above-mentioned traditional Chinese medicine composition; the dosage form of the traditional Chinese medicine composition preparation is selected from one of syrup, tablet, capsule, powder and granule.

[0008] A third aspect of this invention provides a method for preparing a traditional Chinese medicine composition for treating acute / chronic kidney injury, characterized by comprising the following steps:

[0009] S1. Mix the prescribed amounts of Astragalus membranaceus, Polygonatum sibiricum, Pueraria lobata, processed rhubarb, Curcuma zedoaria, and Glycyrrhiza uralensis, add 1.5-3 times the amount of water, soak for 30-40 minutes, decoct for 45-90 minutes, and filter to obtain the medicinal liquid and dregs.

[0010] S2. Add 1-2 times the amount of water to the dregs obtained in step S1, decoct for 30-45 minutes, and filter to obtain the liquid and dregs.

[0011] S3. Combine the medicinal solutions obtained in steps S1 and S1, mix them evenly, and you will get the traditional Chinese medicine composition for treating acute / chronic kidney injury.

[0012] The fourth aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition, or the above-mentioned traditional Chinese medicine composition preparation, or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of products for treating acute / chronic kidney injury.

[0013] Compared with the prior art, the embodiments of the present invention have the following beneficial effects:

[0014] 1. The traditional Chinese medicine composition for treating acute / chronic kidney injury provided by this invention has significant therapeutic effects and is safe to use, which is of positive significance for improving the quality of life of patients.

[0015] 2. The traditional Chinese medicine composition for treating acute / chronic kidney injury provided by this invention is derived from the classic formula Huangqi Gegen Tang (Astragalus and Kudzu Root Decoction) with modifications, as described in *Zhengzhi Huibu*. Astragalus is the principal herb, possessing the effects of invigorating qi and strengthening the exterior, replenishing qi and nourishing blood, and promoting tissue regeneration and detoxification. Kudzu root is the assistant herb, possessing the effects of generating fluids and raising yang, relieving muscle tension and stopping diarrhea. The two herbs combined work synergistically to invigorate qi and generate fluids, and strengthen the body's foundation. Rhubarb is the adjuvant herb, clearing heat and removing blood stasis, while Curcuma zedoaria promotes qi circulation and breaks up blood stasis, improving the symptoms of dampness and turbidity retention and blood stasis obstructing the collaterals in patients with kidney injury. Polygonatum is added to tonify the kidneys, nourish yin, and strengthen the spleen, while licorice harmonizes the other herbs. The six herbs in this formula, through the combination of principal, assistant, adjuvant, and guide herbs, achieve the effects of invigorating qi and tonifying the kidneys, tonifying both yin and yang, promoting blood circulation and qi flow, and clearing away turbidity. It is characterized by tonifying without causing stagnation, clearing without causing damage, and combining tonification and purgation. Attached Figure Description

[0016] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:

[0017] Figure 1 A graph comparing serum creatinine levels at different time points before and after treatment in the experimental and control groups of patients with acute kidney injury.

[0018] Figure 2 This is a graph comparing 24-hour urinary protein levels at various time points before and after treatment in patients with acute kidney injury in the experimental and control groups. Detailed Implementation

[0019] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0020] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0021] Example 1:

[0022] This embodiment provides a traditional Chinese medicine composition for treating acute / chronic kidney injury, which is made from the following components by weight: Astragalus membranaceus 15g, Polygonatum sibiricum 9g, Pueraria lobata 9g, processed rhubarb 9g, Curcuma zedoaria 9g, and Glycyrrhiza uralensis 3g.

[0023] The traditional Chinese medicine composition for treating acute / chronic kidney injury in this embodiment is prepared through the following steps:

[0024] Step 1: Weigh out the Chinese herbal ingredients according to the prescription. Soak all the Chinese herbal ingredients in cold water for 30-40 minutes, with the water level 2-3 cm above the herbs.

[0025] Step 2: First, bring to a boil over high heat, then simmer over low heat for 50 minutes.

[0026] Step 3: Filter to obtain approximately 200mL of the first medicinal solution and the first medicinal residue;

[0027] Step 4: Add water to the dregs again after the first batch of herbs, enough to cover the herbs, bring to a boil over high heat, then simmer over low heat for 30 minutes.

[0028] Step 5: Filter to obtain approximately 200mL of the second solution;

[0029] Step Six: Combine the two medicinal solutions and mix them thoroughly to obtain a traditional Chinese medicine composition for treating acute / chronic kidney injury.

[0030] Example 2:

[0031] This embodiment provides a traditional Chinese medicine composition for treating acute / chronic kidney injury, which is made from the following components by weight: Astragalus membranaceus 30g, Polygonatum sibiricum 12g, Pueraria lobata 12g, processed rhubarb 21g, Curcuma zedoaria 12g, and Glycyrrhiza uralensis 8g.

[0032] The traditional Chinese medicine composition for treating acute / chronic kidney injury in this embodiment is prepared through the following steps:

[0033] Step 1: Weigh out the Chinese herbal ingredients according to the prescription. Soak all the Chinese herbal ingredients in cold water for 30-40 minutes, with the water level 2-3 cm above the herbs.

[0034] Step 2: First, bring to a boil over high heat, then simmer over low heat for 50 minutes.

[0035] Step 3: Filter to obtain approximately 200mL of the first medicinal solution and the first medicinal residue;

[0036] Step 4: Add water to the dregs again after the first batch of herbs, enough to cover the herbs, bring to a boil over high heat, then simmer over low heat for 30 minutes.

[0037] Step 5: Filter to obtain approximately 200mL of the second solution;

[0038] Step Six: Combine the two medicinal solutions and mix them thoroughly to obtain a traditional Chinese medicine composition for treating acute / chronic kidney injury.

[0039] Example 3:

[0040] This embodiment provides a traditional Chinese medicine composition for treating acute / chronic kidney injury, which is made from the following components by weight: Astragalus membranaceus 45g, Polygonatum sibiricum 15g, Pueraria lobata 15g, processed rhubarb 30g, Curcuma zedoaria 15g, and Glycyrrhiza uralensis 12g.

[0041] The traditional Chinese medicine composition for treating acute / chronic kidney injury in this embodiment is prepared through the following steps:

[0042] Step 1: Weigh out the Chinese herbal ingredients according to the prescription. Soak all the Chinese herbal ingredients in cold water for 30-40 minutes, with the water level 2-3 cm above the herbs.

[0043] Step 2: First, bring to a boil over high heat, then simmer over low heat for 50 minutes.

[0044] Step 3: Filter to obtain approximately 200mL of the first medicinal solution and the first medicinal residue;

[0045] Step 4: Add water to the dregs again after the first batch of herbs, enough to cover the herbs, bring to a boil over high heat, then simmer over low heat for 30 minutes.

[0046] Step 5: Filter to obtain approximately 200mL of the second solution;

[0047] Step Six: Combine the two medicinal solutions and mix them thoroughly to obtain a traditional Chinese medicine composition for treating acute / chronic kidney injury.

[0048] Experimental Example 1

[0049] This experimental example verifies the efficacy of the traditional Chinese medicine composition provided in Example 1 of the present invention in treating acute kidney injury.

[0050] 1. Subject selection criteria

[0051] 1.1 Inclusion Criteria

[0052] (1) Patients diagnosed with AKI and who have signed informed consent. Diagnostic criteria (according to the KDIGO Clinical Practice Guidelines for Acute Kidney Injury): Serum creatinine rises rapidly by 0.3 mg / dL (26.5 μmol / L) or reaches or exceeds 1.5 times the baseline creatinine value within 48 hours, or GFR decreases by 25% or more of the baseline value; and the onset of the disease is no more than 7 days prior to enrollment; (2) Patients are 18-75 years old.

[0053] 1.2 Exclusion Criteria

[0054] (1) Patients with a history of mental illness, or who are confused, unable to cooperate, or who are severely hypoxic, agitated and require resuscitation. (2) Patients with known allergies to the drugs used. (3) Patients who are currently participating in other drug clinical trials or who have taken traditional Chinese medicine compound prescriptions within the past week. (4) Pregnant women and breastfeeding women. (5) Patients with obstructive nephropathy such as urinary tract stones. (6) Patients with tumors. (7) Patients with severe asthma, chronic bronchitis, lung infection or other serious diseases, who are deemed unsuitable for participation in this trial by the researchers. (8) Patients with a history of kidney transplantation.

[0055] 1.3. Test termination criteria

[0056] End-stage renal failure or reaching the follow-up time

[0057] 1.4. Dropping / Rejection Criteria

[0058] Cases that were mistakenly included because they did not meet the inclusion criteria, as well as cases that met the inclusion criteria but were not followed up and treated according to the study design after enrollment, should be excluded.

[0059] 2. Treatment Plan

[0060] 2.1 Integrated Traditional Chinese and Western Medicine Group

[0061] Basic treatment plus the traditional Chinese medicine composition prepared in Example 1. 200ml of the herbal compound each time, twice daily. One course of treatment is 14 days, and two courses are administered.

[0062] 2.2 Western Medicine Treatment Group

[0063] Basic treatment plus a placebo. A placebo was prepared (made from soybean powder, starch, carbon pigment, etc. in a specific ratio) that was identical in appearance, taste, properties, and packaging to ensure that the placebo and the study drug could not be distinguished.

[0064] Basic treatment mainly includes nutritional support, correction of electrolyte and acid-base imbalances, and replenishment of effective blood volume.

[0065] 3. Efficacy evaluation criteria

[0066] 3.1 Main efficacy indicators: 24-hour urinary protein quantification change from baseline, serum creatinine change;

[0067] 3.2 Secondary efficacy indicators: evaluation of TCM syndrome efficacy and quality of life index (SF36 scale).

[0068] 4. Statistical processing

[0069] All data were analyzed using SPSS 18.0, and quantitative data were analyzed using... The t-test was used for comparisons between groups, and P < 0.05 was considered statistically significant.

[0070] 5. Overall efficacy evaluation

[0071] Case Data: Thirty-two patients diagnosed with acute kidney injury at the Department of Nephrology, Renji Hospital, were enrolled and screened for this study. They were randomly divided into two groups of 16 patients each. Based on treatment methods, they were further divided into an integrated traditional Chinese and Western medicine treatment group (experimental group) and a Western medicine group (control group). Efficacy indicators (serum creatinine, 24-hour urinary protein, etc.) were observed in each group at weeks 0, 4, and 12 of treatment. Changes in TCM symptom scores and quality of life index (SF36 scale) were also observed at weeks 0, 12, and 24 of treatment.

[0072] 5.1 Comparison of serum creatinine levels at different time points before and after treatment in the two groups of patients

[0073] As the treatment period lengthened, the serum creatinine level in the treatment group showed a gradual decreasing trend, and there were statistically significant differences between the treatment group and other time points before and after treatment (P<0.01); as the treatment period lengthened, there were no statistically significant differences in serum creatinine level between the control group and other time points (P>0.05).

[0074] At week 0, there was no statistically significant difference in serum creatinine levels between the two groups (P>0.05). At weeks 4 and 12, the serum creatinine levels in the treatment group were significantly lower than those in the control group (P<0.01). See details... Figure 1 .

[0075] 5.2 Comparison of 24-hour urinary protein quantification at various time points before and after treatment in the two groups of patients

[0076] Before treatment, there was no significant difference in proteinuria levels between the two groups (P>0.05). With the extension of the treatment period, the 24-hour urinary protein quantification in the treatment group showed a stable decreasing trend with a significant statistical difference (P<0.01), while the 24-hour urinary protein quantification in the control group showed a gradually increasing trend. There were no significant statistical differences in the control group at any time point before and after treatment (P>0.05). After 12 weeks of treatment, compared with the control group, the 24-hour urinary protein quantification in the treatment group showed a significant decrease with a significant statistical difference (P<0.01). See details... Figure 2 .

[0077] 5.3 Comparison of TCM syndrome scores at different time points before and after treatment in the two groups of patients

[0078] At 4 and 12 weeks of treatment, the TCM syndrome scores of the treatment group and the control group were compared. The TCM syndrome scores of the treatment group were lower than those of the control group at all time points, and the differences between the groups were statistically significant (P<0.05 and P<0.01, respectively), as detailed in Table 1.

[0079] Table 1. Comparison of TCM symptom scores at different time points before and after treatment between the two groups.

[0080]

[0081] 5.4 Comparison of the two groups' quality of life index (SF36) before and after treatment

[0082] To assess the improvement in patients' quality of life caused by integrated traditional Chinese and Western medicine treatment, the SF36 Quality of Life Index was used to objectively and quantitatively score the patients before and after treatment.

[0083] At week 0 of treatment, there was no significant difference in quality of life index between the treatment group and the control group (P>0.05). After week 12 of treatment, the quality of life index of the treatment group was significantly higher than before treatment (P<0.05); compared with the control group, the quality of life index of the treatment group was significantly higher (P<0.05), as detailed in Table 2.

[0084] Table 2 Comparison of total scores on the SF36 scale for quality of life assessment before and after treatment in the two groups.

[0085]

[0086]

[0087] Note: *P<0.05 compared with pre-treatment levels in the same group; #P<0.05 compared between the two groups at the same time point.

[0088] Experimental Example 2

[0089] This experimental example verifies the efficacy of the traditional Chinese medicine composition provided in Example 2 of the present invention in treating chronic kidney disease.

[0090] 1. Subject selection criteria

[0091] 1.1 Inclusion Criteria

[0092] (1) Meets the diagnostic criteria for chronic kidney disease (CKD). (2) The patient's age is 18-75 years old.

[0093] 1.2 Exclusion Criteria

[0094] (1) Patients with a history of mental illness, or who are confused, unable to cooperate, or who are severely hypoxic, agitated and require resuscitation. (2) Patients with known allergies to the drugs used. (3) Patients who are currently participating in other drug clinical trials or who have taken traditional Chinese medicine compound prescriptions within the past week. (4) Pregnant women and breastfeeding women. (5) Patients with obstructive nephropathy such as urinary tract stones. (6) Patients with tumors. (7) Patients with severe asthma, chronic bronchitis, lung infection or other serious diseases, who are deemed unsuitable for participation in this trial by the researchers. (8) Patients with a history of kidney transplantation.

[0095] 1.3. Test termination criteria

[0096] End-stage renal failure or reaching the follow-up time

[0097] 1.4. Dropping / Rejection Criteria

[0098] Cases that were mistakenly included because they did not meet the inclusion criteria, as well as cases that met the inclusion criteria but were not followed up and treated according to the study design after enrollment, should be excluded.

[0099] 2. Treatment Plan

[0100] 2.1 Integrated Traditional Chinese and Western Medicine Group

[0101] The basic treatment was combined with the traditional Chinese medicine composition prepared in Example 2. The herbal formula was administered in doses of 200ml twice daily. One course of treatment lasted 90 days, and two courses were administered.

[0102] 2.2 Western Medicine Treatment Group

[0103] Basic treatment plus a placebo. A placebo was prepared (made from soybean powder, starch, carbon pigment, etc. in a specific ratio) that was identical in appearance, taste, properties, and packaging to ensure that the placebo and the study drug could not be distinguished.

[0104] Basic treatment mainly includes controlling underlying diseases such as blood pressure, blood sugar, and blood lipids.

[0105] 3. Efficacy evaluation criteria

[0106] 3.1 Main efficacy indicators: 24-hour urinary protein change from baseline and serum creatinine change;

[0107] 3.2 Secondary efficacy indicators: evaluation of TCM syndrome efficacy and quality of life index (SF36 scale).

[0108] 4. Statistical processing

[0109] The obtained data were analyzed using SPSS 22.0 software. [n(%)] represents continuous data and categorical data, respectively. The t-test and χ2 test were used, and P<0.05 was considered statistically significant.

[0110] 5. Overall efficacy evaluation

[0111] 5.1 General characteristics of the study population

[0112] A total of 114 patients with chronic kidney disease from various campuses of Renji Hospital and Ningbo Hangzhou Bay Hospital were selected and divided into a traditional Chinese medicine (TCM) and Western medicine group and a Western medicine group according to their treatment methods. After the randomization table was unblinded, the Western medicine treatment group (control group) had 55 patients, and the TCM and Western medicine combined treatment group (experimental group) had 59 patients. The mean age of the subjects was 58.78 ± 14.00 years, of which 78 were male (69.6%) and 36 were female (30.4%). There were no differences in age and sex between the experimental and control groups. There were no significant differences in baseline serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen, albumin, and 24-hour urinary protein levels between the two groups (Table 3).

[0113] Table 3 General information of the study population

[0114]

[0115] 5.2 Changes in renal function in the two groups of patients

[0116] The study results showed that after 90 days of treatment, the experimental group had a higher eGFR than the control group, while the experimental group had lower levels of serum creatinine, blood urea nitrogen, and 24-hour urinary protein, but there were no statistically significant differences between the two groups. After one month of treatment, the experimental group's eGFR increased by 9.13 ml / min compared to before treatment, with a recovery rate of 23.08% from baseline; the control group's eGFR increased by 4.04 ml / min, with a recovery rate of 8.51% from baseline, but there was no statistically significant difference between the two groups. The decrease in serum creatinine was also greater in the experimental group. After one month of treatment, the average serum creatinine in the experimental group decreased by 21.0 umol / L from baseline, accounting for 13.67% of the baseline value. In the control group, the serum creatinine decreased by 7.0 umol / L (5.19%) after one month. The absolute value and percentage of the decrease in serum creatinine were significantly different between the two groups (P=0.014; P=0.016), indicating that the integrated traditional Chinese and Western medicine treatment plan had a significant effect on the recovery of serum creatinine levels after one month of follow-up.

[0117] After 180 days of treatment, the serum creatinine level in the experimental group was lower than that in the control group (156.08±99.02 vs. 191.79±202.01), but the difference was not statistically significant. At the 6-month follow-up, there were no statistically significant differences in the absolute values ​​and rates of change of eGFR, blood urea nitrogen, albumin, and 24-hour urinary protein between the two groups (Table 4).

[0118] Table 4. Changes in renal function in the study population during the follow-up period.

[0119]

[0120] 5.3 Baseline characteristics of subgroup populations

[0121] During the initial application of this experimental drug, researchers found that it was more effective in patients with primary chronic kidney disease. Therefore, the patients were divided into two subgroups according to the etiology of chronic kidney disease: patients with primary chronic kidney disease were classified as subgroup one, and patients with secondary chronic kidney disease were classified as subgroup two.

[0122] In subgroup 1, there were 31 participants in the control group and 22 participants in the experimental group. There were no statistically significant differences between the two groups in terms of age, sex, serum creatinine, eGFR, blood urea nitrogen, albumin, and 24-hour urinary protein levels. In subgroup 2, there were 24 participants in the control group and 37 participants in the experimental group. There were also no statistically significant differences between the two groups in terms of age, sex, serum creatinine, eGFR, blood urea nitrogen, albumin, and 24-hour urinary protein levels (Table 5).

[0123] Table 5 Baseline data for subgroup populations

[0124]

[0125] 5.4 Endpoint events in patients with primary chronic kidney disease

[0126] The primary endpoint was a 25% or greater recovery in eGFR from baseline after 90 days of treatment. The secondary endpoint was an absolute eGFR value greater than 75 ml / min after 90 days of treatment. A composite endpoint was considered achieved if either the primary or secondary endpoint was met. In subgroup 1, the incidence of primary, secondary, and composite endpoints in both the experimental and control groups was statistically analyzed and compared. The results are shown in Table 6. In the experimental group (22 patients), 13 (72.2%) achieved the primary endpoint, 6 (33.3%) achieved the secondary endpoint, and 13 (72.2%) achieved the composite endpoint. In the control group (31 patients), 4 (16.7%) achieved the primary endpoint, 3 (12.5%) achieved the secondary endpoint, and 5 (20.0%) achieved the composite endpoint. The significantly higher proportion of patients achieving the primary and composite endpoints in the experimental group compared to the control group indicates that the combined traditional Chinese and Western medicine treatment, compared to Western medicine treatment alone, enables more patients with chronic kidney disease to achieve better renal function recovery.

[0127] Table 6. Endpoint events in subgroup 1 patients.

[0128] Control group (n=31) Experimental group (n=22) p-value Primary endpoint, n (%) 4(16.7％) 13(72.2％) <0.001* Secondary endpoints, n (%) 3(12.5％) 6(33.3％) 0.212 Composite endpoint, n (%) 5(20.0％) 13(72.2％) 0.002*

[0129] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A traditional Chinese medicine composition for treating acute kidney injury or primary chronic kidney disease, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 15-45 parts by weight, Polygonatum sibiricum 9-15 parts by weight, Pueraria lobata 9-15 parts by weight, processed rhubarb 9-30 parts by weight, Curcuma zedoaria 9-15 parts by weight, and Glycyrrhiza uralensis 3-12 parts by weight.

2. A traditional Chinese medicine composition for treating acute kidney injury or primary chronic kidney disease, characterized in that, The traditional Chinese medicine composition preparation is prepared from the traditional Chinese medicine composition according to claim 1; the dosage form of the traditional Chinese medicine composition preparation is selected from one of syrup, tablet, capsule, powder and granule.

3. The method for preparing the traditional Chinese medicine composition for treating acute kidney injury or primary chronic kidney disease according to claim 1, characterized in that, Includes the following steps: S1. Mix the prescribed amounts of Astragalus membranaceus, Polygonatum sibiricum, Pueraria lobata, processed rhubarb, Curcuma zedoaria, and Glycyrrhiza uralensis, add 1.5-3 times the amount of water, soak for 30-40 minutes, decoct for 45-90 minutes, and filter to obtain the medicinal liquid and dregs. S2. Add 1-2 times the amount of water to the dregs obtained in step S1, decoct for 30-45 minutes, and filter to obtain the liquid and dregs. S3. Combine the medicinal solutions obtained in steps S1 and S1, mix them evenly, and you will get the traditional Chinese medicine composition for treating acute kidney injury or primary chronic kidney disease.

4. The use of the traditional Chinese medicine composition according to claim 1, or the traditional Chinese medicine composition preparation according to claim 2, or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 in the preparation of products for treating acute kidney injury or primary chronic kidney disease.

Images