Traditional Chinese medicine composition for diabetic nephropathy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for diabetic nephropathy as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 to 50 parts of radix astragali seu hedysari, 10 to 15 parts of radix paeoniae rubra, 8 to 12 parts of radix saposhnikoviae, 25 to 35 parts of rhizoma atractylodis macrocephalae stir-fried with bran, 25 to 35 parts of rhizoma imperatae, 10 to 20 parts of fructus rosae laevigatae and 10 to 20 parts of fructus ligustri lucidi stir-fried with wine. The traditional Chinese medicine composition is combined in the whole formula, can tonify the deficiency of the two major organs of the spleen and the kidney, purges excess without forgetting to tonify the foundation of the spleen and the kidney, tonifies deficiency without forgetting to remove the foundation of dampness and heat, and has a remarkable curative effect on prevention and / or treatment of diabetic nephropathy due to sufficient essence and qi of the spleen and the kidney and gradual reduction of proteinuria due to proper fixation and protection.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines and provides a traditional Chinese medicine composition for diabetic nephropathy and a preparation method and application thereof. Background Art

[0002] Diabetic nephropathy is one of the complications of diabetes and an important cause of end-stage renal failure and renal dialysis. In clinical treatment, Western medicine mainly focuses on regulating blood sugar, blood lipids, and blood pressure. It slows down the progression of glomerular sclerosis by lowering blood pressure, blood sugar, and blood lipids with the use of angiotensin-converting enzyme inhibitors (ACEI) / angiotensin II receptor blockers (ARB), hypoglycemic drugs, and statins. This includes lowering blood pressure with ACEI and ARB drugs; using biguanides such as metformin and α-glucosidase inhibitors such as dapagliflozin as common drugs to achieve the purpose of lowering blood sugar; using statins to lower blood lipids and resist atherosclerosis to regulate sugar and lipid metabolism and delay glomerular sclerosis. However, there are still limitations such as uncertain drug efficacy and adverse drug reactions. Moreover, the effect of using Western medicine alone is not ideal, especially in controlling urine protein. Existing drugs all have a certain degree of adverse reactions, and the condition of some patients has progressed.

[0003] A large number of studies have shown that traditional Chinese medicine has significant effects in improving symptoms and delaying the progression of diabetic nephropathy. Traditional Chinese medicine believes that "deficiency of both qi and yin leads to blood stasis and obstruction in the kidney meridians" is the basic pathogenesis of diabetic nephropathy. According to the different pathological characteristics and pathological changes of diabetic nephropathy at different stages, prescriptions are prescribed based on syndrome differentiation and treatment. The staged treatment is mainly based on tonifying the spleen and kidney, promoting blood circulation and detoxifying, and removing dampness and turbidity. Special prescriptions are based on the pathogenesis of deficiency of both qi and yin, and deficiency of both spleen and kidney, and are mainly based on tonifying qi and yin, tonifying the spleen and kidney, and removing blood stasis. In addition, external treatment methods of traditional Chinese medicine (enemas, acupuncture, foot baths, etc.) have also achieved significant results in clinical practice.

[0004] Chinese invention patent CN104721467B discloses a Chinese medicine composition for treating diabetic nephropathy, which is made of the following raw materials: 100 parts by weight of Astragalus, 20-40 parts by weight of Ligustrum lucidum, 25-45 parts by weight of Atractylodes macrocephala, 40-60 parts by weight of Rosa laevigata, 40-60 parts by weight of Hibiscus truncatum, 30-50 parts by weight of Herba Coptidis, 35-55 parts by weight of Paeonia lactiflora, 15-35 parts by weight of Rhizoma Coptidis, and the Chinese medicine composition has a good therapeutic effect on diabetic nephropathy, especially early diabetic nephropathy. However, it contains Hibiscus truncatum and Rhizoma Coptidis, which is not suitable for long-term use for people with spleen and stomach deficiency and coldness; and the therapeutic effect on diabetic nephropathy needs to be further improved.

[0005] Some Chinese herbal compound or single herbal medicines, such as astragalus, ginkgo, tripterygium wilfordii, rhubarb, etc., have been proven to enhance the protection of patients' kidneys, regulate blood sugar and blood lipids, reduce urine protein, delay interstitial fibrosis, improve clinical symptoms, and even have a reversal effect on early diabetic nephropathy. However, it is still in the preliminary research stage and lacks systematic research and clinical data support. Based on this, it is necessary to conduct in-depth research on the compatibility of various Chinese herbal ingredients to promote the standardization of Chinese medicine in the prevention and treatment of diabetic nephropathy and further improve the therapeutic effect of Chinese medicine on diabetic nephropathy. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a Chinese medicine composition for diabetic nephropathy, a preparation method thereof and an application thereof. Based on the traditional Chinese medicine dialectical treatment, the composition has a significant therapeutic effect on the early clinical treatment of diabetic nephropathy, and timely treatment of diabetic nephropathy in the early stage can reduce urine protein, delay the progression of the disease, and even reverse the occurrence and development of diabetic nephropathy in the early stage.

[0007] The technical solution of the present invention is as follows:

[0008] The first aspect of the present invention provides a Chinese medicine composition for treating diabetic nephropathy.

[0009] The Chinese medicine composition comprises the following raw materials in parts by weight: 20-50 parts of astragalus, 10-15 parts of red peony root, 8-12 parts of siler, 25-35 parts of bran-fried atractylodes, 25-35 parts of Imperatae rhizome, 10-20 parts of Rosa laevigatae and 10-20 parts of Ligustrum lucidum.

[0010] Preferably, the Chinese medicine composition comprises the following raw materials in parts by weight: 25-35 parts of Astragalus, 11-13 parts of Red Peony Root, 9-11 parts of Saposhnikovia Divaricata, 28-32 parts of Atractylodes Macrocephala, 28-32 parts of Imperata Rhizome, 12-18 parts of Rosa Laevigatae and 12-18 parts of Ligustrum Lucidum Fruit.

[0011] More preferably, the Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Atractylodes Macrocephala, 30 parts of Imperata Rhizome, 15 parts of Rosa Laevigata Fruit and 15 parts of Ligustrum Lucidum Fruit.

[0012] Spleen and kidney deficiency is the key to the pathogenesis of diabetic nephropathy. "Kidney" is the innate foundation, containing true yang and true yin, and "spleen" is the acquired foundation. Spleen deficiency is unable to transport and transform, the function of separating clear and secreting turbidity is reduced, and proteinuria occurs when the essence and fine substances are not absorbed. The spleen and kidney are mutually dependent on each other in the innate and acquired. The transportation and transformation of the spleen depends on the warming and steaming of kidney yang, and the essence and qi in the kidney depends on the nutrition of the essence and fine substances of water and grain transported and transformed by the spleen. Therefore, kidney deficiency fails to seal and store, the kidney cannot store essence, and the essence and qi are leaked, the kidney (qi) yang is deficient, and the fire does not generate earth, resulting in spleen qi (yang) deficiency. Earth generates gold, and spleen earth does not generate gold, resulting in lung qi deficiency, essence and qi cannot return to the lungs, the lungs fail to spread, and cannot transport essence to the whole body. If the exogenous wind evil causes the lung qi to be evil and depressed, the spread and descent are not good, and the fine substances go directly to the bladder to form turbid urine.

[0013] The functions of the components in the Chinese medicine composition of the present invention are as follows:

[0014] Astragalus is sweet and warm, and belongs to the spleen and lung meridians. It has the effects of invigorating qi and raising yang, promoting diuresis and reducing swelling. It can not only invigorate the spleen and invigorate qi, but also promote diuresis and reduce swelling. It is not only an important medicine for invigorating spleen qi, but also an important medicine for qi deficiency edema. "Ben Jing Feng Yuan" says "Although Astragalus is warm and nourishing, it can regulate blood vessels and meridians without hindering stagnation. Astragalus and ginseng can invigorate qi". Modern pharmacological studies have shown that the medicinal ingredients of Astragalus mainly contain astragalus polysaccharides, astragalus saponins, flavonoids, amino acids, alkaloids, etc. Among them, astragalus polysaccharides, astragalus saponins and flavonoids are the main effective ingredients for the treatment of diabetic nephropathy. Active ingredients of Astragalus treat diabetic nephropathy targets and pathways: mainly improve renal damage through regulating endoplasmic reticulum stress, regulating glucose and lipid metabolism, reducing inflammatory response, improving insulin resistance, reducing cell apoptosis, and inhibiting the process of renal fibrosis.

[0015] Modern pharmacological studies have shown that red peony root contains terpenes and their glycosides, flavonoids and their glycosides, tannins, phenolic acids and their glycosides, polysaccharides, volatile oils and other compounds. It has the effects of lowering blood sugar, reducing insulin resistance, regulating lipid metabolism disorders, improving hemodynamics, inhibiting inflammatory response, improving glomerular sclerosis, protecting kidney tissue and kidney function, thereby reducing the occurrence of diabetic nephropathy and delaying the progression of the disease.

[0016] Fangfeng has a pungent and sweet flavor and is slightly warm in nature. It enters the bladder, liver, and spleen meridians. Fangfeng is pungent, dispersing, warming, and can carry the function of Huangqi to replenish qi throughout the body. Replenishing qi and raising yang can help the spleen qi to transport and transform and raise the clear, and help the kidney qi to transform and consolidate, so that the essence and fine particles can go up instead of leaking down; when used together with Baizhu, it can take advantage of the fact that wind can overcome dampness, dampness can be dispelled and the clear yang can be raised, the spleen and stomach transport and transform dampness, the evil can be eliminated, the essence and fine particles can be consolidated, and the effect of reducing urine protein can be achieved.

[0017] Fried Atractylodes macrocephala with bran tastes bitter and is warm in nature. It invigorates the spleen and stomach qi, nourishes the middle earth to control water, enables the spleen to function, transforms water and dampness, and makes the spleen and stomach rise and fall in an orderly manner. Modern pharmacological studies have shown that its main active ingredients are volatile oils, lipid components, and Atractylodes macrocephala polysaccharides, among which Atractylodes macrocephala volatile oil can effectively lower blood sugar and blood lipids. Adding Rosa laevigata to nourish the kidneys can consolidate the essence and replenish the kidney essence. When the kidney qi is consolidated and the essence is replenished, urine protein can be reduced.

[0018] Modern pharmacological research shows that Rosa laevigata is rich in active substances such as flavonoids, polysaccharides, saponins, tannins, etc., among which Rosa laevigata flavonoids have antioxidant, immune-enhancing, antibacterial and lipid-lowering effects.

[0019] Fructus Ligustri Lucidi tastes sweet and bitter, and is cool in nature. It nourishes the liver and kidneys and has astringent properties. Clinical studies have shown that it can delay renal failure and improve renal function. Pharmacological studies have also shown that it has anti-inflammatory, antioxidant, immunomodulatory, and diabetic effects.

[0020] Rose of Laevigata is good at astringency but lacks tonic effect. When used together with Ligustrum lucidum, it has the effect of both tonic and astringency, and can not only replenish kidney Qi but also strengthen kidney essence, and can be used for targeted treatment of proteinuria.

[0021] When replenishing deficiency, attention should be paid to damp-heat or heat toxicity. It is necessary to use both tonifying and purging methods, and add Imperata root to clear away heat and promote diuresis. The active ingredients of Imperata root mainly include polysaccharides, cyperone, organic acid, imperatae lin, campesterol, etc. Pharmacological studies have shown that Imperata root polysaccharide can improve glucose tolerance, reduce glycated serum protein, promote the synthesis of liver glycogen, regulate blood lipid metabolism disorders and reduce urine protein.

[0022] The whole formula can be used together to replenish the deficiency of the two major organs, the spleen and the kidney. When purging the excess, do not forget to replenish the spleen and kidney, and when replenishing the deficiency, do not forget to eliminate dampness and heat. If properly protected, the spleen and kidney will be sufficient, and if properly consolidated, the proteinuria will gradually decrease.

[0023] In some more preferred embodiments of the present invention, the traditional Chinese medicine composition also includes one or more of turmeric, fried silkworm pupa, cicada shell, pinellia, tangerine peel, fried bitter orange peel with bran, bamboo shavings, fried spiny jujube seeds, Polygonum multiflorum, calcined dragon bone, calcined oyster shell, julibrissin flower and daisy flower.

[0024] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum Lucidum Fruit, 10 parts of Curcuma Longa, 15 parts of Fried Bombyx Batryticatus and 10 parts of Periostracum Cicadae. This preferred embodiment can improve diabetic nephropathy and symptoms such as aversion to cold and fever, chest tightness and discomfort, or vomiting and diarrhea.

[0025] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Fructus Ligustri Lucidi, 9 parts of Pinellia Rhizoma, 10 parts of Citrus Reticulatae, 20 parts of Fructus Aurantii Immaturus and 10 parts of Rhizoma Anemarrhenae. This preferred embodiment can improve diabetic nephropathy and symptoms such as dizziness, palpitations, nausea, hiccups and vertigo.

[0026] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum lucidum, 30 parts of stir-fried Semen Ziziphi Spinosae and 30 parts of Polygonum Multiflorum. This preferred embodiment can improve diabetic nephropathy and insomnia and dreaminess.

[0027] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum Lucidum Fruit, 30 parts of Calcinated Dragon Bone and 30 parts of Calcinated Ostreae Conchae. This preferred embodiment can improve diabetic nephropathy and symptoms such as hot sweating at night.

[0028] Preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum Lucidum Fruit, 30 parts of Flos Albizziae and 30 parts of Flos Daisyae. This preferred embodiment can improve diabetic nephropathy and symptoms such as emotional discomfort.

[0029] The second aspect of the present invention provides a method for preparing a Chinese medicine composition, comprising the following steps:

[0030] (1) crush and sieve all the raw materials for later use;

[0031] (2) adding the raw materials of astragalus, siler, bran-fried atractylodes, Imperatae cylindrica, and Ligustrum lucidum to an ethanol solution for alcohol extraction, and filtering to obtain a filtrate A;

[0032] (3) adding raw materials of red peony root and Rosa laevigata to water for water extraction, adding ethanol for precipitation and filtering to obtain filtrate B;

[0033] (4) combining filtrate A and filtrate B, and concentrating them to obtain the Chinese medicine composition.

[0034] Furthermore, in step (2), the concentration of the ethanol solution is 50-80 vol%; the number of alcohol extractions is 1-4 times, and the time for each extraction is 1-2 hours; the material-liquid ratio of the raw material to the ethanol solution is 1 g:5-10 mL.

[0035] Furthermore, in step (3), the number of water extractions is 1-4 times, and the extraction time for each time is 1-2 hours; the material-liquid ratio of the raw material to water is 1 g:10-20 mL.

[0036] The third aspect of the present invention provides use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of a drug for preventing and / or treating diabetic nephropathy.

[0037] Furthermore, the diabetic nephropathy is type 2 diabetic nephropathy.

[0038] Furthermore, the type 2 diabetic nephropathy is caused by high-fat, high-sugar streptozotocin.

[0039] The fourth aspect of the present invention provides a Chinese medicine preparation, characterized in that it comprises the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method.

[0040] Furthermore, the dosage form of the traditional Chinese medicine preparation is any one of tablets, granules, capsules, decoctions and pastes.

[0041] With respect to the prior art, the beneficial effects of the present invention are:

[0042] Astragalus is the main ingredient, which greatly replenishes the vital energy, promotes the spleen's transportation and transformation, and can strengthen the defensive qi and resist external evil. It can replenish the kidney qi to transform water, replenish the spleen qi to transport and transform water and dampness, and replenish the lung qi to regulate the water channel, which can achieve the effect of diuresis and swelling. The minister is red peony root to promote blood circulation and remove blood stasis, unclog the meridians, and the combination of astragalus and peony root can make the qi sufficient and the blood flow throughout the body. It is assisted by saposhnikovia to raise the yang qi, qi to raise the dampness, replenish qi and raise the yang to help the spleen qi to transport and transform the clear, and the kidney qi to consolidate and restrain, so that the essence and fine particles can go up instead of leaking, so as to achieve the effect of reducing urine protein. The bran-fried white atractylodes is warm in nature and belongs to the spleen and stomach meridians. It is good at diuresis and dampness, and the spleen is strong and helps transportation without hurting the righteous qi. It is combined with golden cherry fruit and Ligustrum lucidum fruit to nourish the kidney and astringe the essence, replenish qi and consolidate the body; Imperata root clears heat and cools blood, nourishes yin and produces body fluid. The whole formula can be used together to replenish the deficiency of the two major organs, the spleen and the kidney. When purging the excess, do not forget to replenish the spleen and kidney, and when replenishing the deficiency, do not forget to eliminate dampness and heat. If properly protected, the spleen and kidney will be sufficient, and if properly consolidated, the proteinuria will gradually decrease. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention. It is worth noting that the raw materials used in the present invention are all common commercial products, and their sources are not specifically limited.

[0044] Among them, the Chinese medicinal raw materials Ligustrum lucidum and stir-fried Atractylodes macrocephala used in the examples were purchased from Hebei Baicao Kangshen Pharmaceutical Co., Ltd.

[0045] Example 1

[0046] A Chinese medicine composition, the prescription of which is: 30g of Astragalus, 12g of Red Peony Root, 10g of Saposhnikovia Divaricata, 30g of Atractylodes Macrocephala, 30g of Imperata Rhizome, 15g of Rosa Laevigata Fruit and 15g of Ligustrum Lucidum Fruit.

[0047] The specific preparation method is as follows:

[0048] The raw materials in the prescription were crushed and passed through a 100-mesh sieve. The prescribed amount of Astragalus, Saposhnikovia, Rhizoma Atractylodis Macrocephalae, Imperatae Rhizoma and Fructus Ligustri Lucidi were taken and added to a 75 vol% ethanol solution at a solid-liquid ratio of 1 g:10 mL. The solution was decocted for 3 times, each time for 2 h. The filtrates were combined to obtain an alcohol extract (ethanol was recovered until no alcohol taste was left). The prescribed amount of Paeonia lactiflora and Fructus Rosa Laevigatae were taken and added to water at a solid-liquid ratio of 1 g:20 mL. The solution was decocted for 3 times, each time for 2 h. Ethanol was added until the amount of ethanol in the solution was 60 vol%. The supernatant was taken and the ethanol was recovered until no alcohol taste was left. The solution was combined with the above-mentioned alcohol extract and concentrated to 5 g crude drug / g extract.

[0049] Example 2

[0050] A Chinese medicine composition, the prescription of which is: 20g of Astragalus, 10g of Red Peony Root, 8g of Saposhnikovia Divaricata, 25g of Rhizoma Atractylodis Macrocephalae stir-fried with bran, 25g of Imperatae Rhizoma, 10g of Rosa Laevigatae and 10g of Ligustrum lucidum.

[0051] The specific preparation method is as follows:

[0052] The raw materials in the prescription were crushed and passed through a 100-mesh sieve. The prescribed amount of Astragalus, Saposhnikovia, Rhizoma Atractylodis Macrocephalae, Rhizoma Imperatae and Fructus Ligustri Lucidi were taken and added to a 50 vol% ethanol solution at a solid-liquid ratio of 1 g:8 mL. The solution was decocted twice for 2 h each time. The filtrates were combined to obtain an alcohol extract (ethanol was recovered until no alcohol taste was left). The prescribed amount of Paeonia lactiflora and Fructus Rosa Laevigatae were taken and added to water at a solid-liquid ratio of 1 g:15 mL. The solution was decocted twice for 2 h each time. Ethanol was added until the amount of ethanol in the solution was 60 vol%. The supernatant was taken and the ethanol was recovered until no alcohol taste was left. The solution was combined with the above-mentioned alcohol extract and concentrated to 5 g crude drug / g extract.

[0053] Example 3

[0054] A Chinese medicine composition, the prescription of which is: 50g of Astragalus, 15g of Red Peony Root, 12g of Saposhnikovia Divaricata, 35g of Rhizoma Atractylodis Macrocephalae stir-fried with bran, 35g of Imperatae Rhizoma, 20g of Rosa Laevigatae and 20g of Ligustrum lucidum.

[0055] The specific preparation method is as follows:

[0056] The raw materials in the prescription were crushed and passed through a 100-mesh sieve. The prescribed amount of Astragalus, Saposhnikovia, Rhizoma Atractylodis Macrocephalae, Imperatae Rhizoma and Fructus Ligustri Lucidi were taken and added to a 75 vol% ethanol solution at a solid-liquid ratio of 1 g:10 mL. The solution was decocted for 4 times, each time for 2 h. The filtrates were combined to obtain an alcohol extract (ethanol was recovered until no alcohol taste was left). The prescribed amount of Paeonia lactiflora and Fructus Rosa Laevigatae were taken and added to water at a solid-liquid ratio of 1 g:20 mL. The solution was decocted for 4 times, each time for 2 h. Ethanol was added until the amount of ethanol in the solution was 60 vol%. The supernatant was taken and the ethanol was recovered until no alcohol taste was left. The solution was combined with the above-mentioned alcohol extract and concentrated to 5 g crude drug / g extract.

[0057] Example 4

[0058] A Chinese medicine composition, the prescription of which is: 30g of Astragalus, 12g of Red Peony Root, 10g of Saposhnikovia Divaricata, 30g of Atractylodes Macrocephala stir-fried with bran, 30g of Imperatae Rhizoma, 15g of Rosa Laevigatae, 15g of Ligustrum Lucidum Fruit, 30g of stir-fried Ziziphus jujuba seeds and 30g of Polygonum multiflorum.

[0059] The specific preparation method is as follows:

[0060] The raw materials in the prescription were crushed and passed through a 100-mesh sieve. The prescribed amount of Astragalus, Saposhnikovia, Rhizoma Atractylodis Macrocephalae with bran, Rhizoma Imperatae, Fructus Ligustri Lucidi, Fructus Ziziphi Spinosae and Rhizoma Polygoni Multiflori were taken and added to a 75 vol% ethanol solution at a solid-liquid ratio of 1 g:10 mL. The solution was decocted for 3 times, each time for 2 h. The filtrates were combined to obtain an alcohol extract (ethanol was recovered until no alcohol taste was left). The prescribed amount of Paeonia lactiflora and Fructus Rosa Laevigatae were taken and added to water at a solid-liquid ratio of 1 g:20 mL. The solution was decocted for 3 times, each time for 2 h. Ethanol was added until the amount of ethanol in the solution was 60 vol%. The supernatant was taken and ethanol was recovered until no alcohol taste was left. The solution was combined with the above-mentioned alcohol extract and concentrated to 6.67 g crude drug / g extract.

[0061] Comparative Example 1

[0062] A Chinese medicine composition, the prescription of which is: 100g of Astragalus, 33.3g of Ligustrum lucidum, 33.3g of Atractylodes macrocephala, 50g of Rosa laevigata fruit, 50g of Abelmoschus alba flower, 40g of Herba Coptidis, 40g of Paeonia lactiflora and 20g of Coptis chinensis.

[0063] The preparation method is as follows:

[0064] Add 8.6 times the amount of 70 vol% ethanol solution to Ligustrum lucidum, Atractylodes macrocephala and Coptis chinensis, extract twice, each time for 2 hours, combine the extracts, recover the ethanol until there is no alcohol taste, and obtain an alcohol extract; add 10.8 times the amount of water to Paeonia lactiflora, Astragalus membranaceus, Hibiscus sibiricum, Herba Lycopodii and Rosa laevigatae, extract twice, each time for 1.5 hours, combine the extracts, concentrate to a relative density of 1.15, add ethanol to make the alcohol content 60 vol%, mix well, let stand for 24 hours, take the supernatant, recover the ethanol until there is no alcohol taste, and obtain a water extract concentrate; mix the obtained alcohol extract and water extract concentrate, and then concentrate to 5 g crude drug / g extract.

[0065] Comparative Example 2

[0066] The only difference from Example 1 is the prescription of the Chinese medicine composition, which is: 25g of Astragalus, 17g of Red Peony Root, 10g of Saposhnikovia Divaricata, 30g of Atractylodes Macrocephala, 30g of Imperata Rhizome, 15g of Rosa Laevigata and 15g of Ligustrum Lucidum.

[0067] Comparative Example 3

[0068] The only difference from Example 1 is the prescription of the Chinese medicine composition, which is: 30g of Astragalus, 8g of Red Peony Root, 14g of Saposhnikovia Divaricata, 30g of Atractylodes Macrocephala, 30g of Imperata Rhizome, 15g of Rosa Laevigata and 15g of Ligustrum Lucidum.

[0069] Comparative Example 4

[0070] The only difference from Example 1 is the prescription of the Chinese medicine composition, which is: 30g of Astragalus, 12g of Hibiscus sibiricum flower, 10g of Saposhnikovia divaricata, 30g of Atractylodes macrocephala, 30g of Imperata root, 15g of Rosa laevigata and 15g of Ligustrum lucidum.

[0071] Comparative Example 5

[0072] The only difference from Example 1 is the prescription of the Chinese medicine composition; specifically: 30g of Astragalus, 12g of Red Peony Root, 10g of Saposhnikovia Divaricata, 30g of Atractylodes Macrocephala, 30g of Hibiscus Mulberry Flower, 15g of Rosa Laevigata Fruit and 15g of Ligustrum Lucidum Fruit.

[0073] Comparative Example 6

[0074] The only difference from Example 1 is the prescription of the Chinese medicine composition; specifically: 30g of Astragalus, 12g of Red Peony Root, 10g of Herba Codonopsis, 30g of Atractylodes Macrocephalae with Braised Bran, 30g of Imperata Rhizome, 15g of Rosa Laevigatae and 15g of Ligustrum Lucidum Fruit.

[0075] Experimental Example 1: Therapeutic effect on diabetic nephropathy model rats induced by surgery + high fat + STZ

[0076] 1. Experimental drugs and reagents:

[0077] The test drugs are the Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-6, which are dissolved in citric acid buffer to a concentration of 0.25 g crude drug / mL;

[0078] The positive control drug was valsartan capsules, 80 mg / capsule, purchased from Beijing Novartis Pharmaceuticals Co., Ltd.;

[0079] High-fat feed formula: by mass percentage, it consists of 20% sucrose, 10% lard, 2.5% cholesterol, 1% bile salt, and 66.5% ordinary feed (i.e. type II diabetes model feed), purchased from Beijing Ke'ao Xieli Feed Co., Ltd.;

[0080] Streptozotocin (STZ, product number: S0130-5g) was purchased from Sigma;

[0081] Citrate buffer was purchased from Sinopharm Chemical Reagent Co., Ltd.;

[0082] Urine protein quantification kit (C035-2-1), creatinine (Cr) kit (C011-2-1), alanine aminotransferase (ALT) assay kit (C009-2-1), aspartate aminotransferase (AST) assay kit (C010-2-1), total cholesterol (CHO) assay kit (A111-1-1), triglyceride (TG) assay kit (A110-1-1), high-density lipoprotein (HDL-C) assay kit (A112-1-1), low-density lipoprotein (LDL-C) assay kit (A113-1-1), total protein (TP) assay kit (A045-4-2), and albumin (Alb) assay kit (A028-2-1) were all purchased from Nanjing Jiancheng Bioengineering Institute.

[0083] 2. Experimental Animals

[0084] 160 Wistar rats, SPF grade, male, weighing 180-200 g, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd., license number: SCXK (Beijing) 2012-0001; they were raised in the SPF animal room of Xiyuan Hospital, China Academy of Chinese Medical Sciences.

[0085] 3. Experimental methods:

[0086] Rats were adaptively fed for 4 days and randomly divided into 16 groups, 10 rats in each group, namely sham operation group, blank control group, model group, positive control group and Chinese medicine groups 1-12. Rats in each group first underwent unilateral (left) renal ligation (among which, the unilateral kidney in the sham operation group was directly sutured after incision), and recovered for 1 week after surgery. The sham operation group and the blank control group were given ordinary feed, and the other groups were given high-fat feed for 4 weeks. Intraperitoneal glucose tolerance (IPGTT), serum total cholesterol (CHO), and triglycerides (TG) were measured. Compared with the sham operation group and the blank control group, the IPGTT and CHO of the other groups were increased, which was statistically significant (P<0.01), indicating that abnormal glucose metabolism was induced. The model group, positive control group and Chinese medicine groups 1-12 were once again intraperitoneally injected with 1% STZ 25 mg / kg (solvent was citric acid buffer). After 72 hours, the animals were fasted for 3 hours, and blood was collected from the tip of their tails to measure rapid blood glucose, which was all greater than 12.5 mmol / L. The surgery + high fat + STZ-induced diabetic nephropathy model was completed. The blank control group was injected with an equal amount of citric acid buffer, and the sham operation group was not treated.

[0087] Subsequently, each group of rats was treated with medication: positive control group: valsartan capsule 0.01 g / kg; Chinese medicine group 1: Chinese medicine composition of Example 1 2.5 g / kg; Chinese medicine group 2: Chinese medicine composition of Example 1 5 g / kg; Chinese medicine group 3: 10 g / kg; Chinese medicine groups 4-6: Chinese medicine compositions of Examples 2-4 5 g / kg respectively; Chinese medicine groups 7-12: Chinese medicine compositions of comparative examples 1-6 5 g / kg respectively), sham operation group and blank control group were given the same volume of distilled water; once a day for 8 consecutive weeks.

[0088] 24 hours after the last administration, urine was collected and urine protein and urine creatinine were determined; at the same time, the rats were killed and blood was collected from the peritoneal vein to detect serum ALT, AST, CHO, TG, HDL-C, LDL-C, TP, and Alb. The data between the groups were analyzed using t-test, and P < 0.05 was considered statistically significant.

[0089] IV. Experimental Results

[0090] 1. Effects on urine protein and urine creatinine in rats

[0091] The test results of urine protein and urine creatinine content of rats in each group after 24h are shown in Table 1. It can be seen that compared with the sham operation group and the blank control group, the urine protein content of the model group rats increased significantly and the urine creatinine decreased significantly after 8 weeks of modeling (both P < 0.01, statistically significant), liver function was impaired, and the diabetic nephropathy model was successfully modeled. The Chinese medicine composition (5g / kg) of the present invention can reduce urine protein excretion, promote urine creatinine excretion, and promote urine creatinine excretion The effect is better than the positive control drug valsartan capsule (P < 0.05, statistically significant), close to the level of the sham operation group and the blank control group. Compared with the administration group 2 (administered 5g / kg of the Chinese medicine composition of Example 1), the urine protein excretion of the administration group 7-12 is higher, and the urine creatinine excretion is lower, and both are statistically significant.

[0092] Table 1 Results of urine protein and urine creatinine in diabetic nephropathy rats

[0093] Urine protein (mg) Urine creatinine (mmol / L) Sham operation group 16.84±2.15 3.288±0.842 Blank control group 18.11±3.28 3.351±1.055 Model Group <![CDATA[54.96±8.51 **## ]]> <![CDATA[1.579±0.429 **## ]]> Positive control group <![CDATA[33.86±5.30 *& ]]> <![CDATA[2.014±0.386 #& ]]> Treatment group 1 <![CDATA[42.65±5.09 **&△ ]]> <![CDATA[2.531±0.650 #&& ]]> Treatment group 2 <![CDATA[37.12±5.15 *&& ]]> <![CDATA[2.954±0.811 &&△ ]]> Treatment group 3 <![CDATA[30.14±4.28 *&& ]]> <![CDATA[3.112±0.782 &&△ ]]> Treatment group 4 <![CDATA[42.38±5.84 **&△ ]]> <![CDATA[2.355±0.495 #& ]]> Treatment group 5 <![CDATA[43.15±6.03 **&△ ]]> <![CDATA[2.108±0.502 #& ]]> Treatment group 6 <![CDATA[38.44±4.24 *&& ]]> <![CDATA[2.950±0.712 &&△ ]]> Treatment group 7 <![CDATA[51.82±7.44 **△△□□ ]]> <![CDATA[2.431±0.605 #&□ ]]> Treatment group 8 <![CDATA[53.03±6.84 **△△□□ ]]> <![CDATA[1.852±0.545 ##□□ ]]> Treatment group 9 <![CDATA[49.25±6.06 **△△□□ ]]> <![CDATA[2.011±0.617 #&□ ]]> Treatment group 10 <![CDATA[50.25±7.05 **△△□□ ]]> <![CDATA[1.874±0.338 #□□ ]]> Treatment group 11 <![CDATA[46.31±6.33 **&△□ ]]> <![CDATA[2.244±0.615 #&□ ]]> Treatment group 12 <![CDATA[48.39±6.92 **△□ ]]> <![CDATA[1.921±0.457 ##&□ ]]>

[0094] Note: Compared with the sham operation group, * P < 0.05; ** P<0.01; compared with the blank group, # P < 0.05; ## P<0.01; compared with the model group, & P < 0.05; && P<0.01; compared with the positive control group, △ P < 0.05; △△P<0.01; compared with group 2, □ P < 0.05; □□ P<0.01.

[0095] 2. Effects on lipid metabolism in rats

[0096] The test results of lipid metabolism indexes of rats in each group are shown in Table 2. It can be seen that the Chinese medicine composition prepared by each embodiment of the present invention can significantly reduce the levels of total cholesterol, triglycerides, high-density lipoprotein and low-density lipoprotein in diabetic nephropathy model rats; among them, the total cholesterol, triglycerides, high-density lipoprotein and low-density lipoprotein contents of administration group 8 (the Chinese medicine composition prepared in comparative example 2), administration group 10 (the Chinese medicine composition prepared in comparative example 4) and administration group 12 (the Chinese medicine composition prepared in comparative example 6) are statistically different from those of administration group 2 (the Chinese medicine composition prepared in embodiment 1) (P < 0.05 or P < 0.01), which shows that the dosage of monarch drug-Huangqi and minister drug-Chishao in the Chinese medicine composition of the present invention, as well as the use of minister drug-Chishao and adjuvant drug-Saposhnikovia divaricata have a greater effect on the lipid metabolism of diabetic nephropathy model rats.

[0097] Table 2 Lipid metabolism indexes in diabetic nephropathy rats

[0098]

[0099] Note: Compared with the sham operation group, * P < 0.05; ** P<0.01; compared with the blank group, # P < 0.05; ## P<0.01; compared with the model group, & P < 0.05; && P<0.01; compared with the positive control group, △ P < 0.05; △△ P<0.01; compared with group 2, □ P < 0.05; □□ P<0.01.

[0100] 3. Effects on rat liver function and protein synthesis

[0101] The test results of liver function related indexes and serum protein content indexes of rats in each group are shown in Table 3. It can be seen that the Chinese medicine composition prepared by each embodiment of the present invention can significantly reduce the levels of alanine aminotransferase and aspartate aminotransferase in diabetic nephropathy model rats, and the effect is slightly better than the positive control drug valsartan capsule, but there is no significant difference; compared with the administration group 2, the levels of alanine aminotransferase and aspartate aminotransferase in rats in the administration groups 7-12 are significantly improved (P < 0.05 or P < 0.01). It can be determined that the combination and dosage adjustment of each component in the Chinese medicine composition of the present invention achieve the recovery of liver function in diabetic nephropathy model rats.

[0102] Table 3 Liver function indexes and protein synthesis results of diabetic nephropathy rats

[0103]

[0104] Note: Compared with the sham operation group, * P < 0.05; ** P<0.01; compared with the blank group, # P < 0.05; ## P<0.01; compared with the model group, & P < 0.05; && P<0.01; compared with the positive control group, △ P < 0.05; △△ P<0.01; compared with group 2, □ P < 0.05; □□ P<0.01.

[0105] In summary, it can be concluded that the components in the Chinese medicine composition of the present invention are compatible with each other within a certain dosage range, which can improve renal function by reducing urine protein excretion and increasing urine creatinine excretion; at the same time, it can regulate lipid metabolism by reducing total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, and increasing total protein and albumin content; protect liver function by reducing alanine aminotransferase and aspartate aminotransferase; and promote protein synthesis to a certain extent. It has a good therapeutic effect on rats with type 2 diabetic nephropathy caused by high-fat and high-sugar streptozotocin.

[0106] Experimental Example 2: Effects on Sleep in Mice

[0107] 1. Experimental drugs and reagents:

[0108] The test drug is the Chinese medicine composition prepared in Example 1-4, which is dissolved in citric acid buffer to a concentration of 0.25 g crude drug / mL;

[0109] Sodium citrate buffer and sodium pentobarbital were purchased from Sinopharm Chemical Reagent Co., Ltd.

[0110] 2. Experimental Animals

[0111] Fifty KM mice, SPF grade, half male and half female, weighing 18-22 g, were purchased from the SPF Experimental Animal Center of Kunming Medical University, license number: SCXK (Yunnan) K2015-0002; they were raised in the SPF animal room of Xiyuan Hospital, China Academy of Chinese Medical Sciences.

[0112] 3. Experimental methods:

[0113] After one week of adaptive feeding, KM mice were randomly divided into 5 groups, 10 mice in each group, namely blank group (normal saline), and drug administration groups 1-4 (Chinese medicine compositions prepared in Example 1, Example 4, Comparative Example 1, and Comparative Example 2).

[0114] A 48-hour acute sleep-promoting experiment was used, i.e., the drug was administered by gavage three times within 48 hours. One hour after the last gavage, a sleep experiment was induced by the minimum upper dose of sodium pentobarbital (each group of mice was intraperitoneally injected with 50 mg / kg of sodium pentobarbital) to measure the sleep latency and sleep duration of mice (sleep latency: the period from the injection of sodium pentobarbital to the disappearance of the righting reflex of the mouse. Sleep duration: the time from entering sleep to waking up (the appearance of the righting reflex)).

[0115] One week later, the drug was administered intragastrically three times within 48 hours. One hour after the last oral administration, the sleep incidence of mice was determined by a sleep occurrence experiment induced by a maximum subthreshold dose of sodium pentobarbital (each group of mice was intraperitoneally injected with 35 mg / kg of sodium pentobarbital) (the disappearance of the righting reflex was used as the judgment indicator. The mice were placed upside down in a dorsal position. If the mice fell asleep, they could not right themselves immediately, otherwise they would right themselves. Generally, if the mice did not right themselves for more than 30-60 seconds, the righting reflex disappeared, which means they entered a sleep state).

[0116] 4. Experimental results:

[0117] The sleep improvement results of the above groups of mice are shown in Table 4. It can be seen that the Chinese medicine composition of the present invention has a significant effect on improving sleep, especially the drug administration group 2 (the Chinese medicine composition prepared in Example 4, the Chinese medicine composition with stir-fried spiny jujube seeds and Polygonum multiflorum vine added); the drug administration groups 3 and 4 have extremely significant differences in sleep latency and sleep duration compared with the drug administration group 1 (P < 0.01), and the incidence of sleep is also reduced to varying degrees. It can be seen that the Chinese medicine composition of the present invention also has a significant effect on improving sleep.

[0118] Table 4 Effects on sleep in mice

[0119]

[0120] Note: Compared with the blank group, * P < 0.05; **P<0.01; compared with group 1, # P < 0.05; ## P<0.01.

[0121] Experimental Example 3: Clinical Experiment

[0122] 1. A total of 60 DKD subjects who met the diagnostic criteria for DKD (patients aged 44-74 years old admitted to the Xiyuan Hospital of China Academy of Chinese Medical Sciences between July 2020 and September 2023) were randomly divided into an experimental group (30 cases) and a control group (30 cases). Both groups received conventional Western medicine treatment, including a reasonable diet, appropriate exercise, blood sugar control, blood pressure control, and blood lipid control.

[0123] On the basis of conventional western medicine therapy, the experimental group took the Chinese medicine composition of the present invention (the Chinese medicine composition of Example 1, granules were prepared by dry granulation process, specifically: the extract prepared in Example 1 was dried to a moisture content of less than 2wt%, and mixed with dextrin in a mass ratio of 1:1, and the whole granules were obtained.), and the control group took Qishu granules (the Chinese medicine composition prepared in Comparative Example 1 was prepared into granules in the same way). Both the experimental group and the control group took the medicine three times a day, 1 bag each time (10g per bag), and the course of treatment was 3 months. The changes in urine microalbumin and urine microalbumin creatinine ratio (ACR) were monitored before and after the intervention of the two groups of subjects.

[0124] 2. Diagnostic criteria for DKD

[0125] 1. Western medicine diagnostic criteria

[0126] Refer to the diagnostic criteria formulated in the 2019 "Clinical Guidelines for the Prevention and Treatment of Diabetic Kidney Disease in China":

[0127] ① There is a definite history of diabetes, and the course of the disease is usually more than 5 years;

[0128] ② Repeated urine albumin-to-creatinine ratio (ACR) within 3-6 months, with ACR > 30 mg / g for 2 out of 3 times; or urine albumin excretion rate (UAER) > 20 μg / min; and / or estimated glomerular filtration rate (eGFR) < 60 mL·min -1 1.73m -2 ; Lasts longer than 3 months;

[0129] ③ And it can rule out other kidney diseases that may cause increased urine protein.

[0130] 2. TCM syndrome diagnostic criteria

[0131] The diagnostic criteria are formulated with reference to the 2011 "Guidelines for the Prevention and Treatment of Diabetic Nephropathy in Traditional Chinese Medicine" as follows:

[0132] Main symptoms: fatigue, shortness of breath, laziness to speak, spontaneous sweating and night sweats.

[0133] Secondary symptoms: fever in the five parts of the body, restlessness and insomnia, frequent urination at night, thirst and desire to drink.

[0134] Associated symptoms: numbness or pain in the limbs, fixed pain, and skin and nail discoloration.

[0135] Tongue and pulse: The tongue is light red or dark purple or has ecchymosis, the tongue coating is scanty or peeling, the veins under the tongue are bluish purple or varicose, the pulse is moist, thin and weak or deep, stringy and astringent.

[0136] There are at least 2 main symptoms, 1 secondary symptom and 1 combined symptom; the diagnosis can be made by combining the tongue and pulse.

[0137] 3. Clinical Experimental Results

[0138] The ratio of urine microalbumin to creatinine (ACR) reflects early proteinuria and is one of the important indicators for early screening of chronic kidney disease and diabetes. The ACR of the two groups of patients was tested before and after treatment, and the ACR of each group was taken. The results are shown in Table 5.

[0139] Table 5 Comparison of ACR (mg / g) before and after treatment between the two groups of patients / M (Q25, Q75)

[0140] Group Control group Experimental Group Before treatment 88.21(50.85,137.43) 75.69(45.90,205.91) After treatment 121.78(21.54,187.67) 43.06(22.33,123.24) P-value 0.432 0.007

[0141] It can be seen from Table 5 that the ACR result after treatment with the Chinese medicine composition of the present invention is significantly lower than that before treatment, with a statistically significant difference (P<0.01); while the control group was treated with the Chinese medicine composition of Comparative Example 1, and the ACR result of the patient increased after treatment; thus, it can be seen that the present invention achieves the control of early proteinuria by optimizing the compatibility relationship and dosage of each component in the Chinese medicine composition, and has a good therapeutic effect on chronic kidney disease and diabetes.

[0142] To further compare the treatment of diabetic nephropathy patients with the Chinese medicine composition of Example 1 of the present invention and Comparative Example 1, the urine microalbumin quantification and the urine microalbumin-to-creatinine ratio before and after taking the prescription were used as standards, and SPSS11.0 statistical software was used. After rank sum test analysis, the results were statistically significant. The results are shown in Table 6.

[0143] Table 6 Therapeutic effects of two groups of patients with diabetic nephropathy

[0144]

[0145] Notes: a. After intervention, the urinary microalbumin quantification or the urinary microalbumin-to-creatinine ratio decreased (the treatment effect was effective);

[0146] b. After intervention, the urine microalbumin quantification or urine microalbumin-to-creatinine ratio increases (the treatment effect is ineffective).

[0147] It can be seen from Table 6 that the Chinese medicine composition prepared by the present invention has a therapeutic efficacy of more than 80% for patients with diabetic nephropathy, and the effect is remarkable.

[0148] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for diabetic nephropathy, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 20-50 parts of astragalus, 10-15 parts of red peony root, 8-12 parts of siler, 25-35 parts of bran-fried atractylodes, 25-35 parts of Imperatae rhizome, 10-20 parts of Rosa laevigatae and 10-20 parts of Ligustrum lucidum.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 25-35 parts of astragalus, 11-13 parts of red peony root, 9-11 parts of siler, 28-32 parts of bran-fried atractylodes, 28-32 parts of Imperatae rhizome, 12-18 parts of Rosa laevigatae and 12-18 parts of Ligustrum lucidum.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 12 parts of red peony root, 10 parts of siler, 30 parts of bran-fried atractylodes, 30 parts of Imperata rhizome, 15 parts of Rosa laevigata fruit and 15 parts of Ligustrum lucidum fruit.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The Chinese medicine composition also includes one or more of turmeric, fried silkworm pupa, cicada shell, pinellia tuber, tangerine peel, fried bitter orange peel with bran, bamboo shavings, fried spiny jujube seeds, Polygonum multiflorum, calcined dragon bone, calcined oyster shell, julibrissin flower and daisy flower.

5. The Chinese medicine composition according to claim 4, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae with bran, 30 parts of Rhizoma Imperatae, 15 parts of Fructus Rosae Laevigatae, 15 parts of Fructus Ligustri Lucidi, 10 parts of Curcuma Longa, 15 parts of Fried Bombyx Batryticatus and 10 parts of Periostracum Cicadae; Or 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Atractylodes Macrocephala, 30 parts of Imperata Rhizome, 15 parts of Rosa Laevigata Fruit, 15 parts of Ligustrum Lucidum Fruit, 9 parts of Pinellia Rhizome, 10 parts of Tangerine Peel, 20 parts of Fructus Aurantii Immaturus and 10 parts of Rhizoma Anemarrhenae; Or 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Atractylodes Macrocephala with bran, 30 parts of Imperatae Rhizoma, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum Lucidum Fruit, 30 parts of stir-fried Semen Ziziphi Spinosae and 30 parts of Polygonum Multiflorum Caulis; Or 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Rhizoma Atractylodis Macrocephalae with bran, 30 parts of Rhizoma Imperatae, 15 parts of Fructus Rosae Laevigatae, 15 parts of Fructus Ligustri Lucidi, 30 parts of calcined Dragon Bone and 30 parts of calcined Ostreae Conchae; Or 30 parts of Astragalus, 12 parts of Red Peony Root, 10 parts of Saposhnikovia Divaricata, 30 parts of Atractylodes Macrocephalae stir-fried with bran, 30 parts of Imperata Rhizome, 15 parts of Rosa Laevigatae, 15 parts of Ligustrum Lucidum Fruit, 30 parts of Flos Albizia Julibrissin and 30 parts of Flos Daidai.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) crush and sieve all the raw materials for later use; (2) adding the raw materials of astragalus, siler, bran-fried atractylodes, Imperatae cylindrica, and Ligustrum lucidum to an ethanol solution for alcohol extraction, and filtering to obtain a filtrate A; (3) adding raw materials of red peony root and Rosa laevigata to water for water extraction, adding ethanol for precipitation and filtering to obtain filtrate B; (4) combining filtrate A and filtrate B, and concentrating them to obtain the Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that: In step (2), the concentration of the ethanol solution is 50-80 vol%; the number of alcohol extractions is 1-4 times, and the extraction time for each time is 1-2 hours; the material-liquid ratio of the raw material to the ethanol solution is 1 g:5-10 mL.

8. The preparation method according to claim 6, characterized in that: In step (3), the water extraction times are 1-4 times, and the extraction time for each time is 1-2 hours; the material-liquid ratio of the raw material to water is 1 g:10-20 mL.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to any one of claims 6 to 8 in preparing a drug for preventing and / or treating diabetic nephropathy.

10. A Chinese medicine preparation, characterized in that: It includes the Chinese medicine composition described in any one of claims 1-5 or the Chinese medicine composition prepared by the preparation method described in any one of claims 6-8; the dosage form of the Chinese medicine preparation is any one of tablets, granules, capsules, decoctions and pastes.

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