A Chinese medicine composition for preventing and treating acute kidney injury and its application

Abstract

The invention discloses a Chinese medicine composition for preventing and treating acute kidney injury and its application. The Chinese medicine composition is composed of green vitriol, alum, mirabilite and herb frost, and its mass ratio is (97-104): (47-52): (23-27): (1-2). The Chinese medicine composition has a more obvious protective effect on acute kidney injury. The results of the acute kidney injury animal model experiment show that the serum urea nitrogen (BUN) and creatinine (CRE) levels of patients with acute kidney injury can be significantly reduced, kidney pathological histological damage can be improved, oxidative stress reaction can be reduced, and it can be used for the prevention and treatment of clinical acute kidney injury. Moreover, the Chinese medicine composition has good safety and can be prepared into common dosage forms such as capsules, water pills, tablets, etc., with specific high clinical value and application prospects.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and more specifically, relates to a Chinese medicine composition for preventing and treating acute kidney injury and its application. Background Art

[0002] Acute kidney injury is a group of clinical syndromes. Different from chronic kidney disease, acute kidney injury refers to a clinical syndrome caused by a rapid decline in renal function due to a variety of causes. Acute kidney injury can lead to a series of problems of rapid decline in renal function. If the course of acute kidney injury is greater than or equal to three months and the condition has not been cured, it will cause acute renal failure. Clinical studies in recent years have confirmed that mild renal dysfunction can lead to a significant increase in the mortality rate of patients. Therefore, the current trend is to rename acute renal failure as acute kidney injury, hoping to identify it as early as possible in the course of the disease and to intervene effectively.

[0003] There are many factors that lead to acute kidney injury, including infection, drugs, urethral obstruction, etc., so it is common in clinical practice. Studies have shown that about 5% of hospitalized patients may suffer from acute kidney injury, and the incidence rate in the intensive care unit (ICU) is as high as 30%, which is one of the common critical illnesses in clinical practice.

[0004] Currently, there is no special method to treat acute kidney injury. Clinically, different measures are taken according to the different symptoms and course of the patient to protect kidney function, slow down the progression of the disease, and treat symptomatically. Therefore, it is urgent to develop drugs that can effectively treat acute kidney injury. Summary of the invention

[0005] The present invention aims to provide a Chinese medicine composition for effectively treating acute kidney injury and nephropathy caused by it and its application in preparing pharmaceutical preparations.

[0006] The above-mentioned purpose of the present invention is achieved through the following technical solutions:

[0007] The inventor has developed a Chinese medicine composition, which is composed of green vitriol, alum, mirabilite, and herb frost in the ratio of (97-104): (47-52): (23-27): (1-2). It has been clinically verified to have a good effect in treating chronic nephritis and nephrotic syndrome. Animal model studies have found that the Chinese medicine composition can significantly reduce the blood CRE, blood BUN and renal IgA deposition in patients with chronic kidney disease, improve the renal pathological histological changes caused by chronic kidney disease; and significantly improve blood CRE, blood BUN, hematuria, urine protein and other indicators. The inventor has applied for invention patent 2024104563292 for this research result, a Chinese medicine compound and pharmaceutical preparation for treating chronic nephritis and nephrotic syndrome.

[0008] Furthermore, the inventor team continued to explore the effects of the Chinese medicine composition on other types of kidney diseases. The latest animal model research results showed that the Chinese medicine composition has a significant protective effect on acute kidney injury, which is mainly manifested in that it can significantly reduce the serum urea nitrogen (BUN) and creatinine (CRE) levels of patients with acute kidney injury, improve renal pathological histological damage, and reduce oxidative stress response. It can be used for the prevention and treatment of clinical acute kidney injury.

[0009] Therefore, the present invention claims protection for:

[0010] A traditional Chinese medicine composition is composed of green vitriol, alum, sodium sulfate and herb frost; the mass ratio of green vitriol, alum, sodium sulfate and herb frost is (97-104): (47-52): (23-27): (1-2).

[0011] Acute kidney injury is a common critical illness in clinical practice. The main factor causing acute kidney injury is ischemia and hypoxia in patients. Therefore, the animal model of acute renal ischemia-reperfusion injury is a commonly used acute kidney injury model.

[0012] The present invention explores the therapeutic effect of the Chinese medicine composition of the present invention on acute renal injury in an animal model of acute renal ischemia-reperfusion injury. The research results show that the above-mentioned Chinese medicine composition has a relatively obvious protective effect on acute renal injury, which is mainly manifested in significantly reducing the serum urea nitrogen (BUN) and creatinine (CRE) levels of patients with acute renal injury, improving renal pathological histological damage, and reducing oxidative stress. The Chinese medicine composition can be used to prevent and treat acute renal injury.

[0013] In the Chinese medicine composition, green vitriol is sour, astringent and cool in nature, can dry dampness and resolve phlegm, eliminate stagnation and replenish blood, stop bleeding and detoxify; alum is bitter, sour and cold in nature, can dry dampness and resolve phlegm, stop bleeding and astringe; mirabilite is bitter, salty and wet in nature, can eliminate stagnation and edema; Baicao frost is pungent and warm, can stop bleeding and eliminate stagnation. The combination of the four medicines can have a significant therapeutic effect on acute kidney injury.

[0014] Therefore, the use of the Chinese medicine composition in the preparation of a drug for treating acute kidney injury, or in the preparation of a drug for reducing serum urea nitrogen (BUN) and creatinine (CRE) levels, improving renal pathological histological damage, and reducing oxidative stress response, and in the preparation of a drug for treating kidney disease caused by acute kidney injury, should all be within the scope of protection of the present invention.

[0015] Preferably, in the traditional Chinese medicine composition, the mass ratio of green vitriol, alum, mirabilite and herb frost is (100-102): (48-50): (25-26): (1-2).

[0016] More preferably, in the traditional Chinese medicine composition, the mass ratio of green vitriol, alum, mirabilite and herb frost is 100:50:25:2.

[0017] More preferably, the Chinese medicine composition of the present invention is also processed with vinegar, and the effect and purpose of the vinegar processing are: reducing side effects, enhancing therapeutic effects, and guiding meridians. The method of the vinegar processing is as follows:

[0018] (1) Mix green vitriol, alum and sodium sulfate, grind them into powder, mix them evenly with white vinegar, and the mass ratio of powder to white vinegar is (8-12):1;

[0019] (2) Then place it outdoors for 2-3 months without rain; the purpose of placing it outdoors is to get sunlight and ventilation;

[0020] (3) After drying to a moisture content of less than 8%, add Baicao Frost and grind into a uniform powder.

[0021] In particular, step (2) can be carried out by airing the product in a production workshop simulating outdoor lighting and ventilation conditions for 2-3 months.

[0022] In addition, based on this, the present invention also provides a medicine for treating acute kidney injury and kidney disease caused by acute kidney injury, that is, a medicine containing the above-mentioned Chinese medicine composition.

[0023] Optionally, the pharmaceutical preparation may be in the form of a water pill, a tablet or a capsule.

[0024] When preparing the pharmaceutical preparation, the Chinese medicine composition is firstly processed according to the vinegar-making method, and then made into a pharmaceutical dosage form.

[0025] More specifically, as one of the optional solutions, the present invention provides a water pill, which is obtained by grinding the above-mentioned Chinese medicine composition into powder and processing it.

[0026] Specifically, the preparation method of the water pills is as follows: the powder of the Chinese medicine composition obtained by the vinegar is added with 0.5-1 times of water and stirred evenly to make pills, and then dried at a low temperature of 40°C-50°C to obtain the water pills of the Chinese medicine composition.

[0027] The present invention has the following beneficial effects:

[0028] The Chinese medicine composition of the present invention has a relatively obvious protective effect on acute kidney injury, which is mainly manifested in significantly reducing the serum urea nitrogen (BUN) and creatinine (CRE) levels of patients with acute kidney injury, improving renal pathological histological damage, and alleviating oxidative stress response, and can be used for the treatment of clinical acute kidney injury.

[0029] Moreover, the Chinese medicine composition can be prepared into a variety of common pharmaceutical dosage forms with significant efficacy and good safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1. Observation results of body weight (Mean±SD, n=10). Compared with the model group, ns: P>0.05, *: P<0.05.

[0031] Figure 2 .Urine volume and urine biochemical test results (Mean±SD, n=10). Compared with the model group, ns: P>0.05, *: P<0.05, **: P<0.01, ***: P<0.001.

[0032] Figure 3 . Blood biochemical test results (Mean±SD, n=10). Compared with the model group, ns: P>0.05, *: P<0.05, **: P<0.01. **P<0.001.

[0033] Figure 4 . Results of SOD and MDA detection in renal tissue (Mean±SD, n=10). Compared with the model group, ns: P>0.05, *: P<0.05, **: P<0.01, ***: P<0.001.

[0034] Figure 5 . Representative images of renal tissue pathology HE staining (400×). A. Normal group, B. Model group, C. Low-dose Chinese medicine group, D. Medium-dose Chinese medicine group, E. High-dose Chinese medicine group, F. Prednisone acetate group.

[0035] Figure 6 . Renal histopathological scores (Mean±SD, n=10). Compared with the model group, ns: P>0.05, *: P<0.05, **: P<0.01, ***: P<0.001. DETAILED DESCRIPTION

[0036] The present invention is further described below in conjunction with the accompanying drawings and specific examples, but the examples do not limit the present invention in any form. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art.

[0037] Unless otherwise specified, the reagents and materials used in the following examples are commercially available.

[0038] Baicao Frost, a traditional Chinese medicine, also known as Fuqi Mo, is the black ash left after burning rice straw, wheat straw or weeds.

[0039] Sodium Sulfate, a traditional Chinese medicine, is a crystal made by processing and refining the sulfate mineral Sodium Sulfate. It mainly contains hydrated sodium sulfate (Na2SO4·10H2O).

[0040] Alum, a traditional Chinese medicine name, potassium aluminum sulfate dodecahydrate.

[0041] Green vitriol, a traditional Chinese medicine name, is an ore or chemical product containing ferrous sulfate (FeSO4).

[0042] Example 1 Chinese medicine preparation

[0043] A traditional Chinese medicine composition consists of green vitriol, alum, mirabilite and herb frost in a mass ratio of 100:50:25:2.

[0044] A Chinese medicine water pill, the preparation method is as follows:

[0045] (1) Mix green vitriol, alum and sodium sulfate in appropriate proportions, grind into powder, mix evenly with white vinegar, and the mass ratio of powder to white vinegar is 10:1;

[0046] (2) Then place it outdoors for three months without rain. The purpose of placing it outdoors is to get some sun and ventilation (if it rains during this period, it needs to be brought indoors to avoid the rain);

[0047] (3) After drying to a moisture content of less than 8%, add the compound proportion of Baicao Frost and grind into a uniform powder;

[0048] (4) Add 1 times the amount of water to the drug powder obtained in step (3), stir evenly, make pills, and dry at 40° C. to obtain water pills of the Chinese medicine composition. The pill weight is 2 g.

[0049] Example 2 Chinese medicine preparation

[0050] A traditional Chinese medicine composition consists of green vitriol, alum, sodium sulfate and herb frost in a mass ratio of 102:48:26:1.

[0051] A Chinese medicine water pill, the preparation method is as follows:

[0052] (1) Mix green vitriol, alum and sodium sulfate in appropriate proportions, grind into powder, mix evenly with white vinegar, and the mass ratio of powder to white vinegar is 12:1;

[0053] (2) Dry in a lighted and ventilated room for 3 months;

[0054] (3) After drying to a moisture content of less than 8%, add the compound proportion of Baicao Frost and grind into a uniform powder;

[0055] (4) Add 0.8 times water to the drug powder obtained in step (3), stir evenly, make pills, and dry at 50°C to obtain water pills of the Chinese medicine composition. The pill weight is 2g.

[0056] Example 3 Chinese medicine preparation

[0057] A traditional Chinese medicine composition consists of green vitriol, alum, sodium sulfate and herb frost in a mass ratio of 97:52:27:1.

[0058] A traditional Chinese medicine capsule is prepared by the following method: obtaining medicinal powder according to steps (1)-(3) in the preparation method of Example 1, and then filling it into capsules to obtain the product.

[0059] Traditional Chinese medicine preparation in Example 4

[0060] A traditional Chinese medicine composition is composed of melanterite, alum, mirabilite, and carbon black of 104:47:23:2 by mass ratio.

[0061] A traditional Chinese medicine tablet is prepared by the following method: obtaining medicinal powder according to steps (1)-(3) in the preparation method of Example 1, then adding an acceptable carrier for the medicine, mixing, granulating, drying, and tabletting to obtain the product.

[0062] Animal model experiment on the treatment of acute kidney injury with the traditional Chinese medicine preparation in Example 5

[0063] I. Experimental method

[0064] 1. Experimental materials

[0065] (1) Animals

[0066] SPF-grade SD rats, male, are raised and managed by personnel with the qualification recognition for experimental animal management.

[0067] Breeding unit: Guangdong Provincial Center for Laboratory Animals, the production license number of experimental animals is: SCXK (Guangdong) 2018-0002, and the animal quality certificate: 44007200092746.

[0068] Raising conditions: Sun Yat-sen University Cancer Center (Experimental Animal Center), the experimental animal use license number: SYXK (Guangdong) 2020-0102.

[0069] Temperature: 20-25°C; humidity: 40%-70%.

[0070] Ventilation frequency: more than 10 times / hour.

[0071] Raising density: 3 rats / cage.

[0072] Illumination time: 12 hours (lights on at 7:00 am - lights off at 7:00 pm).

[0073] Feed: SPF-grade mouse and rat feed

[0074] Drinking water: High-quality water sterilized at 121°C (1.0 kg / cm 2 ) for 30 minutes, meeting the "Drinking Purified Water Quality Standard" (CJ94-2005).

[0075] (2) Medicines

[0076] Test drug: the Chinese medicine water pill prepared in Example 1; during the test, an appropriate amount of the Chinese medicine composition powder was weighed, and 1% vinegar solution was added to prepare low, medium and high dose suspensions with concentrations of 0.07, 0.14 and 0.28 g / mL, respectively.

[0077] Positive drug: Prednisone acetate tablets, purchased from Zhejiang Xianjun Pharmaceutical Co., Ltd., batch number 210128.

[0078] (3) Reagents:

[0079] Ethyl carbamate, Sinopharm Group;

[0080] Lipid oxidation (MDA) detection kit, Biotime;

[0081] Total SOD activity detection kit (WST-8 method), Bio-Tech Company;

[0082] HE dye, Servicebio company.

[0083] 2. Dosage and route of administration

[0084] The dose and route of administration of the tested drug were as follows: high dose 2.8 g / kg / d, medium dose 1.4 g / kg / d, and low dose 0.7 g / kg / d. The administration volume of each dose was 10 mL / kg, and the drug was administered orally once a day.

[0085] Dosage and administration route of prednisone acetate tablets: 6 mg / kg / d, administration volume is 10 mL / kg, oral administration once a day.

[0086] 3. Animal grouping and modeling

[0087] (1) Grouping

[0088] 72 SPF SD rats, male, weighing 200-250 g, were randomly divided into the following 6 groups according to body weight, with 12 rats in each group:

[0089] A. Normal group,

[0090] B. Model group,

[0091] C. Low-dose Chinese medicine group (0.7 g / kg / d),

[0092] D. Chinese medicine medium dose group (1.4g / kg / d),

[0093] E. High-dose Chinese medicine group (2.8 g / kg / d),

[0094] F. Prednisone acetate group (6 mg / kg / d).

[0095] (2) Modeling and processing

[0096] On days 1 to 5, each group was orally administered the above dosage once a day; the normal group and the model group were given an equal amount of distilled water as a control.

[0097] On the 4th day, rats in each group were anesthetized by intraperitoneal injection of 10% ulactose at 13 mL / kg. A lumbar incision was made to separate the bilateral kidneys and remove the right kidney of the rat. The left renal artery and vein blood flow were blocked with an artery clamp for 45 minutes and then restored and the incision was sutured. The normal group received no treatment.

[0098] After surgery, 10 rats were randomly selected from each group for subsequent experiments.

[0099] 4. Experimental inspection

[0100] (1) General condition and weight observation

[0101] The rats' diet, stool, hair, respiration, mental state and other general conditions and behavioral performance were observed every day. The rats' body weights were measured on days 0 and 4.

[0102] (2) Urine biochemical examination

[0103] On the 4th day after surgery, the rats were placed in a metabolic cage, their urine was collected, and the 24-hour urine volume was recorded. The urine was stored at -80°C, and after thawing, the contents of urine creatinine, urea nitrogen, and total protein were determined using an automatic urine biochemical analyzer.

[0104] (3) Plasma and kidney tissue collection

[0105] On the 5th day, after 24 hours of ischemia-reperfusion, the rats in each group were anesthetized again in the same way as above, the abdominal cavity was opened, and about 1.5 mL of blood was collected from the inferior vena cava, anticoagulated with EDTA; centrifuged at 10000RPM for 1 min, plasma was separated, and stored at -80°C. After blood was collected from each group of rats, the left kidney was taken and divided into two parts, one of which was stored at -80°C for the detection of biochemical indicators; the other was fixed with 4% paraformaldehyde for more than 24 hours for pathological examination.

[0106] (4) Blood biochemical test

[0107] The creatinine, urea nitrogen, albumin, total protein, potassium and sodium in plasma were detected by automatic biochemical analyzer.

[0108] (5) Detection of SOD and MDA in renal tissue

[0109] The kidney tissue was homogenized according to the kit method, and the levels of SOD and MDA were determined respectively.

[0110] (6) Renal histopathological examination

[0111] The renal tissue was fixed with 4% paraformaldehyde for more than 24 hours, and 5um paraffin sections were made and stained with HE; observed with an optical microscope (400×) and pathological scoring was performed. Renal pathology scoring standard (Paller method): tubules were obviously dilated, and epithelial cell degeneration or necrosis was considered abnormal tubules. No dilation of tubules and normal epithelial cell structure were scored as 0 points; abnormal tubules accounted for about 1 / 4 of all tubules in the field of view, scored 1 point; abnormal tubules accounted for about 2 / 4 of all tubules in the field of view, scored 2 points; abnormal tubules accounted for about 3 / 4 of all tubules in the field of view, scored 3 points; almost all tubules in the field of view were abnormal tubules, scored 4 points.

[0112] (7) Data processing

[0113] The experimental data were statistically processed using GraphPad Prism9 biostatistics software: the quantitative data were expressed as Mean±SD and analyzed using analysis of variance combined with Dunnett's multiple comparison method; the categorical data were analyzed using the Kruskal-Wallis rank sum test combined with Dunnett's multiple comparison method.

[0114] 2. Experimental Results

[0115] 1. General condition and weight observation

[0116] During the experiment, the fur of the rats in the normal group was dense, neat and shiny, and there were no obvious abnormalities in their growth, eating and spontaneous activities.

[0117] On the fourth day of the experiment (the fourth day of drug administration), compared with the normal group, the fur of the rats in the prednisone acetate group was duller, the diet was reduced, and the body weight decreased significantly (P<0.05). The general condition of the rats in the other groups did not change significantly, and the body weight did not differ significantly from that in the normal group (P>0.05). Figure 1 shown.

[0118] On the fifth day of the experiment (one day after the operation), compared with the normal group, the rats in the model group and each drug group were listless and their spontaneous activities were significantly reduced.

[0119] 2. Urine biochemical examination

[0120] like Figure 2 As shown in the figure, compared with the normal group, the postoperative urine volume and urine urea nitrogen in the model group were significantly reduced (P<0.001), and urine creatinine and urine total protein were significantly increased (P<0.001). Compared with the model group, urine creatinine in the high-dose Chinese medicine preparation group and prednisone acetate group was significantly reduced (P<0.05). Compared with the model group, there was no significant difference in urine volume, urine urea nitrogen and urine total protein in each dose group of Chinese medicine preparation and prednisone acetate group (P>0.05).

[0121] 3. Blood biochemical test

[0122] like Figure 3 As shown in the figure, compared with the normal group, the serum creatinine and blood urea nitrogen in the model group increased significantly (P<0.001), serum albumin and blood sodium decreased significantly (P<0.05 or 0.001), and there were no significant differences in total protein and blood potassium (P>0.05). Compared with the model group, the serum creatinine in the high-dose group of Chinese medicine preparation and the prednisone acetate group decreased significantly (P<0.05). Compared with the model group, there were no significant differences in blood urea nitrogen, serum albumin, total protein, blood sodium, and blood potassium in the various dose groups of Chinese medicine preparation and the prednisone acetate group (P>0.05).

[0123] 4. Detection of SOD and MDA in kidney tissue

[0124] like Figure 4 As shown in the figure, compared with the normal group, the SOD activity of renal tissue in the model group was significantly reduced (P<0.001), and the MDA content of renal tissue was significantly increased (P<0.01). Compared with the model group, the SOD activity of renal tissue in the high-dose Chinese medicine preparation group and the prednisone acetate group was significantly increased (P<0.05). Compared with the model group, the MDA content of renal tissue in the medium- and high-dose Chinese medicine preparation groups and the prednisone acetate group was significantly reduced (P<0.05 or 0.01).

[0125] 5. Renal histopathological examination

[0126] Macroscopic observation showed that the kidneys of rats in the normal control group were smooth without swelling, reddish brown, soft and shiny; the kidneys of rats in the model group and each drug-treated group were dark brown and hard.

[0127] HE staining and observation under a 400× microscope showed that the normal control group had normal kidney structure, no swelling or degeneration of the renal tubules, and normal glomeruli; the model group had significant changes in kidney structure, dilation of the renal tubules, and visible protein casts; compared with the model group, the above pathological changes in the prednisone acetate group were significantly improved, and the pathological changes in each dose group of the Chinese medicine preparation were improved. Representative figures are shown in Figure 5 shown.

[0128] Compared with the normal group, the renal pathology score of the model group increased significantly (P<0.001). Compared with the model group, the scores of each dose group of the Chinese medicine preparation were significantly reduced, and the score of the prednisone acetate group was significantly reduced (P<0.05). Figure 6 shown.

[0129] In summary, on the fourth day of the experiment (the fourth day of administration), compared with the normal group, the prednisone acetate group had duller fur, less food intake, and significantly decreased body weight (P<0.05), indicating that prednisone acetate has a certain effect on the health of rats. However, the general state of rats in each Chinese medicine preparation group did not change significantly, and there was no significant difference in body weight compared with the normal group (P>0.05), indicating that the Chinese medicine preparation of the present invention has no significant effect on the health of rats.

[0130] Decreased urine volume or anuria is one of the main manifestations of acute kidney injury. Compared with the normal group, the postoperative urine volume in the model group was significantly reduced (P<0.001). Compared with the model group, there was no significant difference in urine volume among the different dose groups of Chinese medicine preparations (P>0.05). This suggests that Chinese medicine preparations may not have a significant effect on urine volume in acute kidney injury.

[0131] Creatinine and urea nitrogen are the end products of nitrogen-containing organic matter and protein metabolism, respectively, and are filtered out from the glomerulus. When the glomerular filtration function is impaired, blood creatinine and urea nitrogen increase due to retention. Urine total protein refers to the protein content in urine. The higher the content, the worse the renal filtration function. Compared with the normal group, the urine urea nitrogen in the model group was significantly reduced (P<0.001), urine creatinine and urine total protein were significantly increased (P<0.001), and blood creatinine and blood urea nitrogen were significantly increased (P<0.001). Compared with the model group, urine creatinine and blood creatinine in the high-dose Chinese medicine preparation group were significantly reduced (P<0.05). It is suggested that Chinese medicine preparations can correct creatinine abnormalities in acute kidney injury.

[0132] Serum total protein includes serum albumin, which can reflect protein loss caused by kidney disease. On the other hand, acute kidney injury can cause imbalance of potassium and sodium in the blood. Compared with the normal group, the serum albumin and serum sodium in the model group were significantly reduced (P<0.05 or 0.001), and there were no significant differences in total blood protein and serum potassium (P>0.05). Compared with the model group, there were no significant differences in the above indicators in each dose group of Chinese medicine preparation (P>0.05). It suggests that the effect of Chinese medicine preparation on the above indicators is not obvious.

[0133] SOD is one of the main antioxidant enzymes, which can catalyze the dismutation reaction of superoxide anion free radicals, block the toxic reaction of free radicals, remove superoxide anion free radicals, and protect cells from damage. MDA, as a metabolite of lipid peroxidation, can reflect the amount of free radicals produced by the body and the degree of lipid peroxidation. Compared with the normal group, the SOD activity in the renal tissue of the model group was significantly reduced (P<0.001), and the MDA content was significantly increased (P<0.01). Compared with the model group, the SOD activity in the renal tissue of the high-dose group of traditional Chinese medicine preparations was significantly increased (P<0.05), and the MDA content was significantly decreased (P<0.05). This suggests that traditional Chinese medicine preparations may alleviate acute kidney injury by reducing oxidative damage.

[0134] Comprehensive results show that the Chinese medicine preparation of the present invention has a more obvious protective effect on acute kidney injury, and its effect may be related to correcting abnormal creatinine metabolism and reducing oxidative damage.

[0135] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for treating acute kidney injury, characterized in that: The traditional Chinese medicine composition is composed of green vitriol, alum, mirabilite and herb frost, and the mass ratio thereof is (97-104): (47-52): (23-27): (1-2); wherein the green vitriol, alum and mirabilite are processed by vinegar.

2. Use of a Chinese medicine composition in the preparation of a drug for treating nephropathy caused by acute kidney injury, characterized in that: The traditional Chinese medicine composition is composed of green vitriol, alum, mirabilite and herb frost, and the mass ratio thereof is (97-104): (47-52): (23-27): (1-2); wherein the green vitriol, alum and mirabilite are processed by vinegar.

3. The use according to claim 1 or 2, characterized in that: The drug can reduce serum urea nitrogen and creatinine levels, improve renal pathological histological damage, and alleviate oxidative stress response.

4. The use according to claim 1 or 2, characterized in that: The mass ratio of green vitriol, alum, sodium sulfate and herb frost is (100-102):(48-50):(25-26):(1-2).

5. The use according to claim 4, characterized in that: The mass ratio of green vitriol, alum, sodium sulfate and herb frost is 100:50:25:

2.

6. The use according to claim 1 or 2, characterized in that: The preparation method of the drug is as follows: (1) Mix green vitriol, alum and sodium sulfate, grind them into powder, mix them evenly with white vinegar, and the mass ratio of powder to white vinegar is (8-12):1; (2) Then place it outdoors for 2-3 months without rain; (3) After drying to a moisture content of less than 8%, add Baicao Frost and grind into a uniform powder; then prepare into a pharmaceutical dosage form.

7. The use according to claim 6, characterized in that: The dosage form is a water pill.

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