Traditional Chinese medicine composition for treating drug-induced renal injury, preparation and application

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating drug-induced renal injury, a preparation and application. The traditional Chinese medicine composition comprises the following raw materials in parts by mass: 20-60 parts of lucid ganoderma, 20-60 parts of dendrobium officinale and 20-60 parts of gynostemma pentaphylla. The preparation method comprises the following steps: (1) taking raw materials, crushing, extracting with water, filtering, concentrating filtrate under reduced pressure, and freeze-drying to obtain water-soluble component fine powder; (2) taking the filter residue in the step (1), extracting with an ethanol solution, filtering, concentrating the filtrate under reduced pressure, freeze-drying, and crushing to obtain alcohol-soluble component particle powder; and (3) uniformly mixing the water-soluble component fine powder obtained in the step (1) and the alcohol-soluble component particle powder obtained in the step (2) to obtain the water-soluble component powder. The traditional Chinese medicine composition provided by the invention has the advantages of easily available raw materials, simplicity in operation, low cost, high safety and the like through proportioning of the traditional Chinese medicinal materials and compatibility of components of different extraction parts, and can remarkably improve the drug-induced renal injury.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition, preparation and application for treating drug-induced renal injury. Background Art

[0002] The kidney is an important organ of the body's urinary system. According to the theory of traditional Chinese medicine, "the kidney stores essence, governs bones, produces marrow that connects to the brain, opens to the ears and the two yin organs, and its beauty is in the hair", "the kidney is the foundation of the innate, the root of the five internal organs, and the door to life", which emphasizes the importance of the kidney. Modern medical research has found that the kidney plays an important role in the body's immune regulation, metabolism, water-electrolyte balance and acid-base balance. However, various factors, such as chronic diseases, drug treatment, infection and aging, can cause kidney damage, among which acute renal failure caused by drugs accounts for about 34.3% of all acute renal failure events. At present, the main Western medical treatment measures for clinical relief of drug-induced kidney damage are: stopping and changing drugs, diuretic treatment, controlling blood pressure, hemodialysis, and kidney transplantation. However, Western medicine treatment has the defect of treating the symptoms but not the root cause, and people have turned their attention to traditional Chinese medicine for the treatment of drug-induced kidney damage.

[0003] Chinese invention patent CN109939200B provides a Chinese medicine composition and its application in the preparation of a drug for treating acute kidney injury. The composition contains borneol, musk, coptis root, scutellaria, gardenia, curcuma, pearl, buffalo horn concentrated powder, and bezoar, and is processed into various preparations through an operable process. The composition has a significant protective effect on acute kidney injury in mice caused by cisplatin and vancomycin. However, borneol is a hazardous chemical, and musk is a national second-level protected Chinese medicinal material, which is difficult to produce on a large scale.

[0004] Chinese invention patent CN106668431B discloses a Chinese medicine composition with the effects of warming the kidney and invigorating qi, and its preparation method and application, which is composed of: Astragalus, Salvia miltiorrhiza, Poria, Rhizoma Alismatis, Herba Leonuri, Radix Aconiti Lateralis, Cynomorium songaricum, Rhizoma Dioscoreae, Eucommia ulmoides and Bulbus Allii. The composition can effectively improve the renal injury of rats induced by gentamicin. However, the composition has complex ingredients, unknown medicinal substances, and the preparation method is a decoction, which causes the waste of alcohol-soluble active substances such as astragaloside, tanshinone, Rhizoma Alismatis triterpenoids, etc., which does not meet the strategic goal of sustainable utilization of Chinese medicine resources.

[0005] Chinese invention patent publication number CN104857228A discloses a pharmaceutical composition for preventing and treating acute kidney injury and its use, which is composed of: five-color plum leaves, raspberry, Morinda officinalis, Polygala tenuifolia, Poria cocos, Cyperus rotundus, Coptis chinensis and Paeonia lactiflora. The composition can effectively alleviate doxorubicin-induced renal injury in rats. The composition also has the disadvantages of complex ingredients and unknown effective substances, and the preparation method is also a decoction, which does not meet the strategic goal of sustainable utilization of Chinese medicine resources.

[0006] Chinese invention patent CN104547289B discloses a Chinese medicine composition for treating cisplatin-induced kidney damage, which includes raw rehmannia root, white honey, poria cocos and ginseng. Animal experiments have shown that the composition can improve the nephrotoxicity caused by cisplatin without affecting the chemotherapy effect of cisplatin. However, chemotherapy can easily lead to cold spleen and stomach in patients, and long-term use of raw rehmannia root may produce toxic reactions.

[0007] Therefore, it has broad prospects to deeply explore the treasures of traditional Chinese medicine, combine the characteristics of traditional Chinese medicine such as multiple components, multiple targets, multiple functions, treating both the symptoms and the root causes, having few toxic and side effects, and combining them to enhance the efficacy, and screen out pharmacological substances and their combinations that have the effect of treating drug-induced renal injury. Summary of the invention

[0008] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition, a preparation and an application for treating drug-induced renal injury.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0010] The first aspect of the present invention relates to a Chinese medicine composition for treating drug-induced renal injury, wherein the Chinese medicine composition comprises the following raw materials by weight: 20-60 parts of Ganoderma lucidum, 20-60 parts of Dendrobium officinale, and 20-60 parts of Gynostemma pentaphyllum; the Chinese medicine composition is prepared by the following steps:

[0011] (1) taking raw materials of Ganoderma lucidum, Dendrobium officinale and Gynostemma pentaphyllum, crushing, extracting with water, filtering, concentrating the filtrate under reduced pressure and freeze-drying to obtain a fine powder of a water-soluble component;

[0012] (2) taking the filter residue in step (1), extracting with ethanol solution, filtering, concentrating the filtrate under reduced pressure, freeze-drying and then pulverizing to obtain alcohol-soluble component granular powder;

[0013] (3) Take the water-soluble component fine powder of step (1) and the alcohol-soluble component granular powder of step (2), mix them evenly, and obtain.

[0014] More preferably, the following raw materials are included by weight: 40-60 parts of Ganoderma lucidum, 30-50 parts of Dendrobium officinale, and 20-50 parts of Gynostemma pentaphyllum.

[0015] More preferably, the raw materials include the following components by mass: 50 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum.

[0016] Preferably, the Ganoderma lucidum includes Ganoderma lucidum fruiting body and Ganoderma lucidum spore powder.

[0017] Further preferably, the Ganoderma lucidum fruiting bodies include Ganoderma lucidum and Ganoderma rubrum.

[0018] Further preferably, the Ganoderma lucidum spore powder includes wall-broken Ganoderma lucidum spore powder and wall-removed Ganoderma lucidum spore powder.

[0019] Preferably, the amount of water added for the water extraction in step (1) is 10-30 times the total weight of the raw material, the temperature of the water extraction is 50-70°C, the time of the water extraction is 1-5h, the temperature of the reduced pressure concentration is 30-40°C, and the time of the freeze-drying is 40-50h.

[0020] Further preferably, the amount of water added for the water extraction in step (1) is 20 times the total weight of the raw materials, the temperature of the water extraction is 60° C., the time of the water extraction is 5 h, the temperature of the reduced pressure concentration is 40° C., and the time of the freeze-drying is 48 h.

[0021] Preferably, the volume fraction of the ethanol solution in step (2) is 40-80%, the amount of ethanol used is 5-15 times the total weight of the raw materials, the alcohol extraction temperature is 50-70°C, the alcohol extraction time is 1-3h, the temperature of the reduced pressure concentration is 30-40°C, and the freeze-drying time is 60-75h.

[0022] Further preferably, the volume fraction of the ethanol solution in step (2) is 60%, the amount of ethanol used is 10 times the total weight of the raw materials, the alcohol extraction temperature is 60°C, the alcohol extraction time is 2h, the temperature of the reduced pressure concentration is 40°C, and the freeze-drying time is 60h.

[0023] Preferably, in step (3), the water-soluble component fine powder and the alcohol-soluble component granular powder are mixed in a mass ratio of (0.5-5):1.

[0024] Further preferably, in step (3), the water-soluble component fine powder and the alcohol-soluble component granular powder are mixed in a mass ratio of 3:1.

[0025] The second aspect of the present invention is to provide a preparation containing the above-mentioned Chinese medicine composition, and the preparation also includes pharmaceutically acceptable excipients.

[0026] Preferably, the preparation is in the form of powder, granules, pills, tablets, capsules, or powder aerosols.

[0027] The third aspect of the present invention relates to the use of the above-mentioned Chinese medicine composition or a preparation containing the above-mentioned Chinese medicine composition in the preparation of a drug for treating drug-induced renal injury.

[0028] Preferably, the drugs for drug-induced renal injury include doxorubicin, puromycin, vancomycin, cisplatin or fluorouracil.

[0029] Compared with the prior art, the present invention has the following beneficial effects: (1) the Ganoderma lucidum, Dendrobium officinale and Gynostemma pentaphyllum in the Chinese medicine composition of the present invention are all medicinal and edible substances, which have the advantages of easy availability of raw materials, low cost and high safety, and are suitable for industrial production; (2) the present invention combines different components of water extraction and alcohol extraction of Chinese medicinal materials to achieve full utilization of Chinese medicinal materials, which is in line with the strategic goal of sustainable development of Chinese medicine resources.

[0030] Lingzhi: A rare traditional Chinese medicinal material with many health benefits, such as enhancing immunity, replenishing qi and calming the mind, relieving cough and asthma, etc. Lingzhi spores are extremely tiny oval reproductive cells (i.e. spores of Lingzhi) ejected from the gills of Lingzhi during its growth and maturity. Lingzhi spore powder has many pharmacological activities, such as enhancing nonspecific immune function, protecting the liver, anti-cancer, lowering blood alcohol, lowering blood pressure, treating neurasthenia, and improving pancreatic blood circulation.

[0031] Dendrobium candidum: sweet in taste, slightly cold in nature, enters the stomach and kidney meridians, is a yin-tonifying product, has the effects of strengthening the spleen and stomach, soothing the liver and promoting bile secretion, enhancing the body's immunity, lowering blood sugar and anti-aging.

[0032] Gynostemma pentaphyllum: bitter in taste, cold in nature, enters the lung, spleen, and kidney meridians. It is a tonic product with the effects of invigorating qi and strengthening the spleen, removing phlegm and relieving cough, nourishing the heart and calming the mind. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 The effects of composition 1-15 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the fluorouracil group, b P<0.05, c P<0.01, d P<0.001);

[0034] Figure 2 The effects of compositions 4, 16 and 17 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the cisplatin group, d P<0.001);

[0035] Figure 3 The effects of compositions 4 and 18-22 on serum creatinine and urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the puromycin group, c P<0.01, d P<0.001);

[0036] Figure 4The effects of compositions 20, 23-28 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the doxorubicin group, c P<0.01, d P<0.001);

[0037] Figure 5 The effects of compositions 20, 29-36 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the vancomycin group, b P<0.05, c P<0.01, d P<0.001);

[0038] Figure 6 The effects of composition 20, 37-40 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the fluorouracil group, d P<0.001; compared with the combination 20 group, e P<0.05, f P<0.01, g P<0.001);

[0039] Figure 7 The effects of different concentrations of composition 20 on serum creatinine, urea nitrogen content and renal NGAL and KIM-1 gene expression in mice (compared with the control group, a P<0.001; compared with the cisplatin group, b P<0.05, d P<0.001; compared with the high-dose group, f P<0.01, g P<0.001). DETAILED DESCRIPTION

[0040] The present invention is further described below in conjunction with specific examples, and the advantages and features of the present invention will become clearer as the description proceeds. However, these examples are merely exemplary and do not constitute any limitation to the scope of the present invention. The methods, ingredients and amounts involved in the following examples are all conventional methods known to those skilled in the art unless otherwise specified.

[0041] It is worth noting that the raw materials used in the present invention are all common commercially available products, and their sources are not specifically limited. Among them, Ganoderma lucidum fruiting body (red ganoderma), Ganoderma lucidum fruiting body (purity ganoderma), broken wall red ganoderma spore powder (purity 99.99%), broken wall purple ganoderma spore powder (purity 99.99%), wall-removed red ganoderma spore powder (purity 99.99%), and wall-removed purple ganoderma spore powder (purity 99.99%) are all purchased from Zhejiang Shouxiangu Pharmaceutical Co., Ltd.

[0042] Embodiment 1: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0043] (1) Take 20 parts of Ganoderma lucidum, 60 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum, mix, crush, add 20 times the volume of water to extract for 5 hours, and the extraction temperature is 60°C. Filter, concentrate the filtrate under reduced pressure at 40°C, and freeze-dry the concentrate for 48 hours to obtain a fine powder of a water-soluble component.

[0044] (2) Take the filter residue in step (1), add 10 times the volume of 60% ethanol and extract for 3 hours at an extraction temperature of 60° C. Filter, concentrate the filtrate under reduced pressure at 40° C., freeze-dry the concentrate for 60 hours and then pulverize to obtain alcohol-soluble component granular powder.

[0045] (3) The fine powder in step (1) and the granular powder in step (2) are mixed in a ratio of 1:1 to obtain a composition 1.

[0046] Embodiment 2: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0047] The raw material composition of the composition in Example 1 was replaced with: 30 parts of Ganoderma lucidum, 50 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 2 was obtained.

[0048] Embodiment 3: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0049] The raw material composition of the composition in Example 1 was replaced with: 40 parts of Ganoderma lucidum, 40 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and Composition 3 was obtained.

[0050] Embodiment 4: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0051] The raw material composition of the composition in Example 1 was replaced with: 50 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 4 was obtained.

[0052] Embodiment 5: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0053] The raw material composition of the composition in Example 1 was replaced with: 60 parts of Ganoderma lucidum, 20 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 5 was obtained.

[0054] Example 6: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0055] The raw material composition of the composition in Example 1 was replaced with: 50 parts of Ganoderma lucidum, 20 parts of Dendrobium officinale, and 30 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 6 was obtained.

[0056] Example 7: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0057] The raw material composition of the composition in Example 1 was replaced with: 40 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale, and 30 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 7 was obtained.

[0058] Embodiment 8: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0059] The raw material composition of the composition in Example 1 was replaced with: 30 parts of Ganoderma lucidum, 40 parts of Dendrobium officinale, and 30 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 8 was obtained.

[0060] Example 9: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0061] The raw material composition of the composition in Example 1 was replaced with: 20 parts of Ganoderma lucidum, 50 parts of Dendrobium officinale, and 30 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 9 was obtained.

[0062] Embodiment 10: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0063] The raw material composition of the composition in Example 1 was replaced with: 40 parts of Ganoderma lucidum, 20 parts of Dendrobium officinale, and 40 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 10 was obtained.

[0064] Example 11: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0065] The raw material composition of the composition in Example 1 was replaced with: 30 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale, and 40 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 11 was obtained.

[0066] Example 12: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0067] The raw material composition of the composition in Example 1 was replaced with: 20 parts of Ganoderma lucidum, 40 parts of Dendrobium officinale, and 40 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 12 was obtained.

[0068] Example 13: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0069] The raw material composition of the composition in Example 1 was replaced with: 30 parts of Ganoderma lucidum, 20 parts of Dendrobium officinale, and 50 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 13 was obtained.

[0070] Example 14: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0071] The raw material composition of the composition in Example 1 was replaced with: 20 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale, and 50 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 14 was obtained.

[0072] Example 15: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0073] The raw material composition of the composition in Example 1 was replaced with: 20 parts of Ganoderma lucidum, 20 parts of Dendrobium officinale, and 60 parts of Gynostemma pentaphyllum. The rest was the same as Example 1, and a composition 15 was obtained.

[0074] Example 16: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0075] The raw material composition of the composition in Example 4 was replaced with: 50 parts of broken wall Ganoderma lucidum spore powder, 30 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 4, and a composition 16 was obtained.

[0076] Example 17: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0077] The composition of the composition in Example 4 was replaced with: 50 parts of de-walled Ganoderma lucidum spore powder, 30 parts of Dendrobium officinale, and 20 parts of Gynostemma pentaphyllum. The rest was the same as Example 4, and a composition 17 was obtained.

[0078] Example 18: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0079] The ratio of step (3) in Example 4 was changed to 0.5:1. The rest was the same as Example 4 to obtain composition 18.

[0080] Example 19: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0081] The ratio of step (3) in Example 4 was changed to 2:1. The rest was the same as Example 4 to obtain composition 19.

[0082] Example 20: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0083] The ratio of step (3) in Example 4 was changed to 3:1. The rest was the same as Example 4 to obtain composition 20.

[0084] Example 21: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0085] The ratio of step (3) in Example 4 was changed to 4:1. The rest was the same as Example 4 to obtain composition 21.

[0086] Example 22: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0087] The ratio of step (3) in Example 4 was changed to 5:1. The rest was the same as Example 4 to obtain composition 22.

[0088] Example 23: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0089] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 10 times the total weight of the raw medicinal materials, the water extraction temperature was 60° C., and the water extraction time was 5 h. The rest was the same as Example 20, and composition 23 was obtained.

[0090] Example 24: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0091] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 30 times the total weight of the raw medicinal materials, the water extraction temperature was 60° C., and the water extraction time was 5 h. The rest was the same as Example 20, and composition 24 was obtained.

[0092] Example 25: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0093] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 20 times the total weight of the raw medicinal materials, the water extraction temperature was 50° C., and the water extraction time was 5 h. The rest was the same as Example 20, and composition 25 was obtained.

[0094] Example 26: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0095] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 20 times the total weight of the raw medicinal materials, the water extraction temperature was 70° C., and the water extraction time was 5 h. The rest was the same as Example 20, and composition 26 was obtained.

[0096] Example 27: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0097] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 20 times the total weight of the raw medicinal materials, the water extraction temperature was 60° C., and the water extraction time was 3 h. The rest was the same as Example 20, and composition 27 was obtained.

[0098] Example 28: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0099] The conditions of water extraction in step (1) of Example 20 were changed to: the amount of water added for water extraction was 20 times the total weight of the raw medicinal materials, the water extraction temperature was 60° C., and the water extraction time was 1 h. The rest was the same as Example 20, and composition 28 was obtained.

[0100] Example 29: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0101] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 40%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 3 h. The rest was the same as Example 20, and composition 29 was obtained.

[0102] Example 30: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0103] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 80%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 3 h. The rest was the same as Example 20, and composition 30 was obtained.

[0104] Example 31: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0105] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 5 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 3 h. The rest was the same as Example 20, and composition 31 was obtained.

[0106] Example 32: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0107] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 15 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 3 h. The rest was the same as Example 20, and composition 32 was obtained.

[0108] Example 33: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0109] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 2 h. The rest was the same as Example 20, and composition 33 was obtained.

[0110] Example 34: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0111] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 60° C., and the time of ethanol extraction was 1 hour. The rest was the same as Example 20, and composition 34 was obtained.

[0112] Example 35: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0113] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 50° C., and the time of ethanol extraction was 2 h. The rest was the same as Example 20, and composition 35 was obtained.

[0114] Example 36: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0115] The conditions of ethanol extraction in step (2) of Example 20 were changed to: the volume fraction of ethanol was 60%, the amount of ethanol was 10 times the total weight of the raw medicinal materials, the temperature of ethanol extraction was 70° C., and the time of ethanol extraction was 2 h. The rest was the same as Example 20, and composition 36 was obtained.

[0116] Comparative Example 1: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0117] Take 50 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale and 20 parts of Gynostemma pentaphyllum, mix and crush, add 20 times volume of water to extract for 5 hours, the extraction temperature is 60°C, filter, concentrate the filtrate under reduced pressure at 40°C, and freeze-dry the concentrate for 48 hours to obtain composition 37.

[0118] Comparative Example 2: A Chinese medicine composition for treating drug-induced renal injury and a preparation method thereof, comprising the following steps:

[0119] Take 50 parts of Ganoderma lucidum, 30 parts of Dendrobium officinale and 20 parts of Gynostemma pentaphyllum, mix and crush, add 10 times volume of 60% ethanol to extract for 3 hours, the extraction temperature is 60°C, filter, concentrate the filtrate under reduced pressure at 40°C, freeze-dry the concentrate for 60 seconds, and obtain composition 38.

[0120] Comparative Example 3: A composition was obtained according to the components and preparation method described in Example 1 in the comparative document CN202311772717.3. The specific preparation method is as follows:

[0121] Weigh the raw materials rhubarb, salvia miltiorrhiza, cyperus rotundus and mulberry in a mass ratio of 1:1:1:1, add 75% ethanol (ethanol aqueous solution with a volume fraction of 75%) in an amount 10 times the total weight of the raw materials, soak for 1 hour, reflux extraction twice, each extraction for 1 hour, add 75% ethanol in an amount 10 times the total weight of the raw materials for reflux extraction for the second reflux extraction, filter after reflux extraction, combine the two filtrates, and concentrate the filtrate under reduced pressure (freeze-dry the concentrate for 60 hours) to obtain composition 39.

[0122] Comparative Example 4: A composition obtained according to the Chinese medicine formula and preparation method recorded in Example 1 of the comparative document CN201910827314.1, the specific preparation method is:

[0123] The raw materials chrysanthemum, liquorice and honeysuckle were weighed in a mass ratio of 1:4:1, decocted and extracted twice with 10 times the amount of water, each time for 1 hour, the filtrate was collected, concentrated under reduced pressure and then freeze-dried into powder to obtain composition 40.

[0124] Effect Experiment

[0125] 1. Effect of Chinese herbal medicine combination on renal injury induced by fluorouracil in mice

[0126] (1) Experimental Materials

[0127] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0128] Experimental samples: The compositions prepared in Examples 1-15 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0129] (2) Experimental methods

[0130] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, a fluorouracil group and a sample group according to their body weight (the corresponding groups were given sample solutions of groups 1-15 of the composition, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged to day 11, each mouse in the fluorouracil group and the sample group was intraperitoneally injected with 200 μL (30 mg / kg) of fluorouracil solution, once every 2 days, for a total of 5 times. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0131] (3) Experimental results

[0132] Depend on Figure 1 The results show that compared with the control group mice, the creatinine and urea nitrogen content in the serum of the fluorouracil group mice and the expression of NAGL and KIM-1 genes in the kidney tissue were significantly increased. Compared with the fluorouracil group mice, each sample group had a certain protective effect on the renal injury caused by fluorouracil, which was manifested by reducing the content of creatinine and urea nitrogen in the serum and the expression level of NAGL and KIM-1 genes in the kidney tissue, and the effect of Example 4 (Ganoderma lucidum: Dendrobium officinale: Gynostemma pentaphyllum = 50:30:20) was the best.

[0133] 2. Effect of Chinese herbal medicine combination on cisplatin-induced renal injury in mice

[0134] (1) Experimental Materials

[0135] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0136] Experimental samples: The compositions prepared in Examples 4 and 16-17 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0137] (2) Experimental methods

[0138] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, a cisplatin group and a sample group according to their body weight (the corresponding groups were given sample solutions of composition 4, composition 16 and composition 17, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged for 15 days, each mouse in the cisplatin group and the sample group was intraperitoneally injected with 200 μL (20 mg / kg) of cisplatin solution, once a day, for a total of 4 times. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0139] (3) Experimental results

[0140] Depend on Figure 2 The results show that compared with the control group mice, the creatinine and urea nitrogen content in the serum of the cisplatin group mice and the expression of NAGL and KIM-1 genes in the kidney tissue were significantly increased. Compared with the cisplatin group mice, each sample group had a certain protective effect on the renal injury caused by cisplatin, which was manifested by reducing the content of creatinine and urea nitrogen in the serum and the expression level of NAGL and KIM-1 genes in the kidney tissue, and the effect of Example 17 (de-walled Ganoderma lucidum spore powder: Dendrobium officinale: Gynostemma pentaphyllum = 50:30:20) was the best, indicating that the effect of de-walled Ganoderma lucidum spore powder was better than that of broken wall Ganoderma lucidum spore powder, and the effect of broken wall Ganoderma lucidum spore powder was better than that of Ganoderma lucidum fruiting body.

[0141] 3. Effect of Chinese herbal medicine combination on renal injury induced by puromycin in mice

[0142] (1) Experimental Materials

[0143] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0144] Experimental samples: The compositions prepared in Examples 4 and 18-22 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0145] (2) Experimental methods

[0146] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, a puromycin group and a sample group according to their body weight (the corresponding groups were given sample solutions of composition 4 and composition 18-22, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged for 4 days, each mouse in the puromycin group and the sample group was subcutaneously injected with 300 μL (15 mg / kg) of puromycin solution, once a day, for a total of 8 times. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0147] (3) Experimental results

[0148] Depend on Figure 3 The results show that compared with the control group mice, the levels of creatinine and urea nitrogen in the serum of the puromycin group mice and the expression of NAGL and KIM-1 genes in the kidney tissue were significantly increased. Compared with the puromycin group mice, each sample group had a certain protective effect on the renal injury caused by puromycin, which was manifested by reducing the levels of creatinine and urea nitrogen in the serum and the expression levels of NAGL and KIM-1 genes in the kidney tissue, and the effect of Example 20 (water-soluble fine powder: alcohol-soluble granular powder = 3:1) was the best.

[0149] 4. Effect of Chinese herbal medicine combination on adriamycin-induced renal injury in mice

[0150] (1) Experimental Materials

[0151] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0152] Experimental samples: The compositions prepared in Examples 20 and 23-28 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0153] (2) Experimental methods

[0154] Grouping: C57BL / 6 mice were adaptively raised for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, an adriamycin group and a sample group according to their body weight (the corresponding groups were given sample solutions of composition 20 and composition 23-28, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged for 15 days, 200 μL (10 mg / kg) of adriamycin solution was injected into the tail vein of each mouse in the adriamycin group and the sample group. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0155] (3) Experimental results

[0156] Depend on Figure 4 The results show that compared with the control group mice, the levels of creatinine and urea nitrogen in serum and the expression of NAGL and KIM-1 genes in kidney tissue of the mice in the adriamycin group were significantly increased. Compared with the mice in the adriamycin group, each sample group had a certain protective effect on the renal injury caused by adriamycin, which was manifested by reducing the levels of creatinine and urea nitrogen in serum and the expression levels of NAGL and KIM-1 genes in kidney tissue, and the effect of Example 20 (extracting for 5 hours with 20 times the volume of water and the extraction temperature of 60°C) was the best.

[0157] 5. Effect of Chinese herbal medicine combination on renal injury induced by vancomycin in mice

[0158] (1) Experimental Materials

[0159] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0160] Experimental samples: The compositions prepared in Examples 20 and 29-36 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0161] (2) Experimental methods

[0162] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, a vancomycin group and a sample group according to their body weight (the corresponding groups were given sample solutions of composition 20 and composition 29-36, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged for 8 days, the model group and the sample group mice were intraperitoneally injected with 200 μL (400 mg / kg) of vancomycin solution, once a day, for a total of 7 times. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0163] (3) Experimental results

[0164] Depend on Figure 5 The results show that compared with the control group mice, the levels of creatinine and urea nitrogen in the serum and the expression of NAGL and KIM-1 genes in the kidney tissue of the vancomycin group mice were significantly increased. Compared with the vancomycin group mice, each sample group had a certain protective effect on the renal injury caused by vancomycin, which was manifested by reducing the levels of creatinine and urea nitrogen in serum and the expression levels of NAGL and KIM-1 genes in the kidney tissue, and the best effects were obtained by composition 20 (extracted for 3 hours with 10 times the volume of 60% ethanol, and the extraction temperature was 60°C) and composition 32 (extracted for 3 hours with 15 times the volume of 60% ethanol, and the extraction temperature was 60°C), and the effect of composition 20 was better than that of composition 32.

[0165] 6. Effect of Chinese herbal medicine combination on renal injury induced by fluorouracil in mice

[0166] (1) Experimental Materials

[0167] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0168] Experimental samples: The compositions prepared in Example 20 and Comparative Examples 1-4 were prepared into 10 mg / mL sample solutions with sterile water for later use.

[0169] (2) Experimental methods

[0170] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into a control group, a fluorouracil group and a sample group according to their body weight (the corresponding groups were given sample solutions of composition 20 and composition 37-40, respectively), with 10 mice in each group. The sample group was gavaged with an equal dose (400 mg / kg) of sample solution for 21 consecutive days, once a day. When the sample was gavaged for 11 days, the fluorouracil group and the sample group were intraperitoneally injected with 200 μL (30 mg / kg) of fluorouracil solution, once every 2 days, for a total of 5 times. The mice were killed 24 hours after the last gavage of the sample solution, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0171] (3) Experimental results

[0172] Depend on Figure 6 From the results, it can be seen that compared with the control group mice, the creatinine and urea nitrogen contents in the serum of the fluorouracil group mice and the expression of NAGL and KIM-1 genes in the kidney tissue were significantly increased. Compared with the fluorouracil group mice, each sample group had a certain protective effect on the renal damage caused by fluorouracil, which was manifested by reducing the contents of creatinine and urea nitrogen in serum and the expression levels of NAGL and KIM-1 genes in kidney tissue. Among them, the effect of composition 40 (comparative example 4) was relatively poor. Compared with comparative examples 1-4, composition 20 prepared by Example 20 can better reduce the contents of creatinine and urea nitrogen in serum and the expression levels of NAGL and KIM-1 genes in kidney tissue.

[0173] 7. Effect of Chinese herbal medicine combination on cisplatin-induced renal injury in mice

[0174] (1) Experimental Materials

[0175] Experimental mice: Male C57BL / 6 mice were purchased from the Experimental Animal Center of Zhejiang Academy of Medical Sciences, animal license: SYXK2018-0011, weighing 18-22 g, and were raised in the SPF-grade experimental animal environment of Zhejiang Shouxiangu Botanical Medicine Research Institute Co., Ltd. The optimal temperature was 20-26 °C, the relative humidity was 50%-60%, and the mice were free to eat.

[0176] Experimental sample: The composition prepared in Example 20 was prepared into a 10 mg / mL sample solution with sterile water for later use.

[0177] (2) Experimental methods

[0178] Grouping: C57BL / 6 mice were adaptively fed for 7 days and fed with ordinary feed (4% fat, 20% carbohydrates and 20% protein). The mice were randomly divided into control group, cisplatin group, sample high-dose group (400 mg / kg), sample medium-dose group (200 mg / kg) and sample low-dose group (100 mg / kg) according to body weight, with 10 mice in each group. The sample group was given the specified dose of sample solution by gavage for 21 consecutive days, once a day. When the sample was gavaged to 15 days, the cisplatin group and the sample group were intraperitoneally injected with 200 μL (20 mg / kg) of cisplatin solution, once a day, for a total of 4 times. The mice were killed 24 hours after the last gavage treatment, and blood was collected from the abdominal aorta. The serum was separated to detect the concentrations of creatinine and urea nitrogen; the kidneys were taken, and the expression levels of the renal injury markers neutrophil gelatinase-associated alcohol protein (NAGL) and kidney injury molecule 1 (KIM-1) genes were detected by qRT-PCR.

[0179] (3) Experimental results

[0180] Depend on Figure 7 The results showed that compared with the control group, the creatinine and urea nitrogen levels in the serum of the mice in the cisplatin group and the expression of NAGL and KIM-1 genes in the kidney tissue were significantly increased. Compared with the cisplatin group, the sample dose groups had a good protective effect against cisplatin-induced renal injury, which was manifested by reducing the creatinine and urea nitrogen levels in the serum and the expression levels of NAGL and KIM-1 genes in the kidney tissue, and it was obviously dose-dependent.

[0181] The above results indicate that the composition for treating drug-induced renal injury obtained by adjusting the proportion of Chinese medicinal materials and combining the Chinese medicinal components of the present invention can significantly improve the renal injury of mice caused by fluorouracil, cisplatin, doxorubicin, vancomycin and puromycin.

[0182] The above description is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several modifications or equivalent substitutions can be made to the technical solution without departing from the principle of the present invention. These modifications or equivalent substitutions should also be regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating drug-induced renal injury, characterized in that: The Chinese medicine composition comprises the following raw materials by weight: 20-60 parts of Ganoderma lucidum, 20-60 parts of Dendrobium officinale, and 20-60 parts of Gynostemma pentaphyllum; the Chinese medicine composition is prepared by the following steps: (1) taking raw materials of Ganoderma lucidum, Dendrobium officinale and Gynostemma pentaphyllum, crushing, extracting with water, filtering, concentrating the filtrate under reduced pressure and freeze-drying to obtain a fine powder of a water-soluble component; (2) taking the filter residue in step (1), extracting with ethanol solution, filtering, concentrating the filtrate under reduced pressure, freeze-drying and then pulverizing to obtain alcohol-soluble component granular powder; (3) Take the water-soluble component fine powder of step (1) and the alcohol-soluble component granular powder of step (2), mix them evenly, and obtain.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials by weight: 40-60 parts of ganoderma lucidum, 30-50 parts of dendrobium officinale, and 20-50 parts of gynostemma pentaphyllum.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following raw materials by weight: 50 parts of ganoderma lucidum, 30 parts of dendrobium officinale and 20 parts of gynostemma pentaphyllum.

4. The preparation method according to claim 1, characterized in that: The amount of water added in the water extraction in step (1) is 10-30 times the total weight of the raw materials, the water extraction temperature is 50-70°C, the water extraction time is 1-5h, the reduced pressure concentration temperature is 40°C, and the freeze drying time is 48h.

5. The preparation method according to claim 1, characterized in that: The volume fraction of the ethanol solution in step (2) is 40-80%, the amount of ethanol used is 5-15 times the total weight of the raw materials, the temperature of ethanol extraction is 50-70° C., the time of ethanol extraction is 1-3 h, the temperature of the reduced pressure concentration is 40° C., and the time of freeze drying is 60 h.

6. The preparation method according to claim 1, characterized in that: In the step (3), the water-soluble component fine powder and the alcohol-soluble component granular powder are mixed in a mass ratio of 0.5-5:

1.

7. A preparation containing the Chinese medicine composition for treating drug-induced renal injury as claimed in any one of claims 1 to 6, characterized in that: The preparation also includes pharmaceutically acceptable excipients.

8. The preparation according to claim 7, characterized in that The dosage form of the preparation is powder, granule, pill, tablet, capsule, powder aerosol.

9. Use of a traditional Chinese medicine composition for treating drug-induced renal injury as claimed in any one of claims 1 to 6 or a preparation as claimed in any one of claims 7 to 8 in the preparation of a drug for treating drug-induced renal injury.

10. The use according to claim 9, characterized in that: The drugs for drug-induced renal injury include doxorubicin, puromycin, vancomycin, cisplatin or fluorouracil.

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