Traditional Chinese medicine composition for preventing or treating diabetic nephropathy

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for preventing or treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from radix astragali, leech, radix salviae miltiorrhizae, fructus corni, semen plantaginis, semen cuscutae and lumbricus, the formula is proper in compatibility, and in the formula, the radix astragali is used for tonifying qi and spleen and is a monarch drug; leech and salvia miltiorrhiza are used as ministerial drugs for clearing away heat and toxic materials and promoting blood circulation to remove The traditional Chinese medicine composition has the advantages that the traditional Chinese medicine composition is capable of treating both symptoms and root causes, tonifying qi, nourishing yin, eliminating dampness and dispersing blood stasis, and the traditional Chinese medicine composition has great advantages in the aspect of treating diabetic nephropathy and is wide in market application prospect.

Description

Technical Field

[0001] The invention relates to use of a Chinese medicine composition in preparing medicines for preventing and treating diabetic nephropathy, and belongs to the field of Chinese medicines. Background Art

[0002] Diabetic nephropathy (DN) is the most common and most serious microvascular complication of diabetes, manifested by structural and functional changes such as glomerular hypertrophy, basement membrane thickening and damage. 5% to 40% of diabetic patients will develop diabetic nephropathy, which is the main cause of end-stage renal disease and an important factor in the increased incidence of cardiovascular disease in diabetic patients. The progression of diabetic nephropathy is divided into five stages: glomerular hyperfiltration, initial nephropathy, microalbuminuria, overt proteinuria and end-stage renal disease. By controlling the progression of diabetic nephropathy, renal function decline can be delayed, the risk of cardiovascular events can be reduced, the need for dialysis and kidney transplantation can be reduced, and the health status and quality of life of patients can be improved.

[0003] The molecular mechanisms of diabetic nephropathy are complex and diverse, with multiple factors involved, including persistent hyperglycemia, hypertension, insulin resistance, and abnormal lipid metabolism. Hyperglycemia can cause the accumulation of advanced glycation end products, which bind to cell surface receptors to induce inflammation and fibrosis. They can also activate signaling pathways such as PKC, TGF-β, and NF-κB, playing a key role in early damage and late fibrosis in diabetic nephropathy. The renin-angiotensin system in diabetic patients is active, which not only leads to increased blood pressure, but also directly affects kidney structure and function, accelerating disease progression. In addition, endothelial dysfunction, oxidative stress, and micro-inflammatory states are also important factors in the development of diabetic nephropathy.

[0004] At present, the commonly used treatments for diabetic nephropathy are adjusting lifestyle, regulating blood sugar, regulating blood lipids, lowering blood pressure, renal replacement dialysis therapy, etc., which have achieved good results in controlling the disease and alleviating symptoms. However, due to individual differences and related uncertain factors, patients with diabetic nephropathy still face potential risks brought by various complications.

[0005] Chinese herbal compound treatment for diabetic nephropathy has the advantages of multiple targets and multiple pathways, and has the effects of regulating autophagy, anti-oxidation, and anti-inflammatory, which can delay the progression of the disease. Summary of the invention

[0006] The invention discloses a Chinese medicine composition for preventing or treating diabetic nephropathy, a preparation method and use thereof. The Chinese medicine composition of the invention has a significant therapeutic effect on diabetic nephropathy, improves renal function indicators, improves patient symptoms, and is safe and reliable.

[0007] Specifically, the technical objectives of the present invention are achieved through the following technical solutions:

[0008] The invention provides a traditional Chinese medicine composition for preventing or treating diabetic nephropathy. The traditional Chinese medicine composition is prepared from astragalus, leech, salvia miltiorrhiza, cornus officinalis, plantago seed, dodder seed and earthworm.

[0009] Specifically, the Chinese medicine composition comprises the following raw materials in parts by weight:

[0010] 25-35 parts of Astragalus, 25-35 parts of Leech, 10-20 parts of Salvia miltiorrhiza, 6-11 parts of Cornus officinalis, 6-11 parts of Plantago, 6-11 parts of Cuscuta, and 4-8 parts of Pheretima.

[0011] In one embodiment, the Chinese medicine composition comprises the following raw materials in parts by weight:

[0012] 30 parts of Astragalus, 30 parts of Leech, 15 parts of Salvia miltiorrhiza, 9 parts of Cornus officinalis, 9 parts of Plantago, 9 parts of Cuscuta, and 6 parts of Pheretima.

[0013] The preparation method of the Chinese medicine composition for preventing or treating diabetic nephropathy of the present invention is as follows: weighing raw materials, adding purified water, soaking, heating to boiling and keeping slightly boiling, filtering, and obtaining a first filtrate; adding purified water to the residue, heating to boiling and keeping slightly boiling, filtering, and obtaining a second filtrate;

[0014] The two filtrates are combined, the filtrate is concentrated, spray-dried, and the dried fine powder is sieved to obtain the traditional Chinese medicine composition for preventing or treating diabetic nephropathy of the present invention.

[0015] Furthermore, the preparation method of the Chinese medicine composition for preventing or treating diabetic nephropathy of the present invention is as follows: weigh the above raw materials according to the ratio, add 6-10 times the weight of purified water, heat to boiling and keep it slightly boiling for 0.5-1.5 hours, filter to obtain a first filtrate; add 4-8 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 0.5-1.5 hours, filter to obtain a second filtrate;

[0016] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.10-1.25, spray-dried, and the dried fine powder is passed through an 80-100 mesh sieve to obtain the Chinese medicinal composition for preventing or treating diabetic nephropathy of the present invention.

[0017] Furthermore, the preparation method of the Chinese medicine composition for preventing or treating diabetic nephropathy of the present invention is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain a first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain a second filtrate;

[0018] The two filtrates were combined, the filtrate was concentrated to a relative density of 1.20, and spray-dried. The dried fine powder was passed through a 100-mesh sieve to obtain the Chinese medicine composition of the present invention.

[0019] Furthermore, the dosage form of the Chinese medicine composition is decoction, pill, gel, tablet, mixture, capsule, granule, powder or paste, more preferably granule.

[0020] The present invention provides use of the traditional Chinese medicine composition in preparing a medicine for preventing or treating diabetic nephropathy.

[0021] The Chinese medicine composition of the present invention is prepared from astragalus, leech, salvia miltiorrhiza, cornus officinalis, plantago seed, dodder seed and earthworm. The prescription is properly compatible. In the prescription, astragalus invigorates qi and strengthens the spleen, and is the main medicine; leech and salvia miltiorrhiza clear away heat and detoxify, promote blood circulation and remove blood stasis, and are the ministerial medicines; cornus officinalis, plantago seed, dodder seed and earthworm are adjuvant medicines. All the medicines are used together, the main and ministerial medicines work together, the adjuvant medicines complement each other, the symptoms and the root causes are treated simultaneously, and the effects of invigorating qi and nourishing yin, drying dampness and removing blood stasis are achieved. The prescription is an innovation in medicine for treating diabetic nephropathy.

[0022] The early sign of diabetic nephropathy progressing to end-stage renal disease is the occurrence of proteinuria, and once the course of the disease progresses to massive proteinuria and renal failure, kidney damage often presents an irreversible development, so the treatment of early proteinuria is of great significance for the control of the entire course of diabetic nephropathy. The Chinese medicine composition of the present invention significantly reduces the 24h urine protein content of diabetic nephropathy rats, indicating that the Chinese medicine composition of the present invention is of great significance for the control of the entire course of diabetic nephropathy. The Chinese medicine composition of the present invention has a significant effect in treating diabetic nephropathy.

[0023] Compared with the prior art, the present invention has the following advantages:

[0024] (1) The Chinese medicine composition of the present invention significantly reduces the weight loss of diabetic nephropathy patients, increases the amount of water, food and urine, reduces the 24-hour urine protein content, reduces the levels of Scr and BUN, and improves renal function indicators, thereby achieving the purpose of treating diabetic nephropathy.

[0025] (2) The preparation method of the Chinese medicine composition of the present invention is simple, and the obtained Chinese medicine composition has a definite curative effect on the prevention and treatment of diabetic nephropathy, treats both the symptoms and the root cause, is safe and reliable, has great advantages in the treatment of diabetic nephropathy, and has broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 Comparison of body weight of rats in each group after administration

[0027] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Zhibai Dihuang Wan group, @ P<0.05; compared with the Example 1 group, & P<0.05, && P<0.01.

[0028] Figure 2 Comparison of water intake of rats in each group after administration

[0029] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Example 1 group, & P<0.05.

[0030] Figure 3 Comparison of food intake among rats in each group after administration

[0031] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, & P<0.05, && P<0.01.

[0032] Figure 4 Comparison of urine volume in each group of rats after administration

[0033] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Zhibai Dihuang Wan group, @@ P<0.01; compared with Example 1 group, & P<0.05, && P<0.01.

[0034] Figure 5 Comparison of UTP content in rats of each group at 24h after administration

[0035] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Example 1 group, & P<0.05, && P<0.01.

[0036] Figure 6 Comparison of Scr content in rats of each group after administration

[0037] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Example 1 group,& P<0.05.

[0038] Figure 7 Comparison of BUN content in rats of each group after administration

[0039] Compared with the normal control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01; compared with Zhibai Dihuang Wan group, @ P<0.05; compared with the Example 1 group, & P<0.05, && P<0.01. DETAILED DESCRIPTION

[0040] The technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] Example 1

[0042] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0043] 30 parts of Astragalus, 30 parts of Leech, 15 parts of Salvia miltiorrhiza, 9 parts of Cornus officinalis, 9 parts of Plantago, 9 parts of Cuscuta, and 6 parts of Pheretima.

[0044] The preparation method is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate;

[0045] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.20, and spray-dried. The dried fine powder is passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the Chinese medicine composition of the present invention.

[0046] Example 2

[0047] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0048] 25 parts of Astragalus, 35 parts of Leech, 10 parts of Salvia miltiorrhiza, 11 parts of Cornus officinalis, 6 parts of Plantago, 11 parts of Cuscuta, and 4 parts of Pheretima.

[0049] The preparation method is as follows: weigh the above raw materials according to the ratio, add 10 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 4 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 0.5 hour, filter to obtain the second filtrate;

[0050] The two filtrates are combined, and the filtrate is concentrated to a relative density of 1.15, and then spray-dried. The dried fine powder is passed through a 100-mesh sieve, and pharmaceutically acceptable excipients are added through conventional procedures to prepare the Chinese medicine composition capsule of the present invention.

[0051] Example 3

[0052] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0053] 35 parts of Astragalus, 25 parts of Leech, 20 parts of Salvia miltiorrhiza, 6 parts of Cornus officinalis, 11 parts of Plantago, 6 parts of Cuscuta, and 8 parts of Pheretima.

[0054] The preparation method is as follows: weigh the above raw materials according to the ratio, add 6 times the weight of purified water, soak for 1.5 hours, heat to boiling and keep slightly boiling for 1.5 hours, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep slightly boiling for 0.5 hours, filter to obtain the second filtrate;

[0055] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.10, spray-dried, the dried fine powder is passed through an 80-mesh sieve, and pharmaceutically acceptable excipients are added through conventional procedures to prepare the Chinese medicine composition tablets of the present invention.

[0056] Example 4

[0057] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0058] 25 parts of Astragalus, 30 parts of Leech, 18 parts of Salvia miltiorrhiza, 9 parts of Cornus officinalis, 10 parts of Plantago, 8 parts of Cuscuta, and 7 parts of Pheretima.

[0059] The preparation method is as follows: weigh the above raw materials according to the ratio, add 7 times the weight of purified water, soak for 1.5 hours, heat to boiling and keep slightly boiling for 1.5 hours, filter to obtain the first filtrate; add 5 times the weight of purified water to the residue, heat to boiling and keep slightly boiling for 0.5 hours, filter to obtain the second filtrate;

[0060] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.25, spray-dried, the dried fine powder is passed through an 80-mesh sieve, and pharmaceutically acceptable excipients are added through conventional procedures to prepare the Chinese medicine composition pills of the present invention.

[0061] Comparative Example 1

[0062] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0063] 30 parts of ginseng, 30 parts of leeches, 15 parts of salvia miltiorrhiza, 9 parts of cornus officinalis, 9 parts of plantain seeds, 9 parts of dodder seeds, and 6 parts of earthworms.

[0064] The preparation method is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate;

[0065] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.20, and spray-dried. The dried fine powder is passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the Chinese medicine composition of the present invention.

[0066] Comparative Example 2

[0067] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0068] The preparation method is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate;

[0069] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.20, and spray-dried. The dried fine powder is passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the Chinese medicine composition of the present invention.

[0070] Comparative Example 3

[0071] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0072] 30 parts of Radix Astragali, 30 parts of Gadfly, 15 parts of Radix Angelicae Sinensis, 9 parts of Fructus Corni, 9 parts of Semen Plantaginis, 9 parts of Semen Cuscutae, and 6 parts of Pheretima.

[0073] The preparation method is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate;

[0074] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.20, and spray-dried. The dried fine powder is passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the Chinese medicine composition of the present invention.

[0075] Comparative Example 4

[0076] A Chinese medicine composition for preventing or treating diabetic nephropathy, comprising the following raw materials in parts by weight:

[0077] 35 parts of Astragalus, 20 parts of Leech, 15 parts of Salvia miltiorrhiza, 13 parts of Cornus officinalis, 12 parts of Plantago, 5 parts of Cuscuta, and 2 parts of Pheretima.

[0078] The preparation method is as follows: weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate;

[0079] The two filtrates are combined, the filtrate is concentrated to a relative density of 1.20, and spray-dried. The dried fine powder is passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the Chinese medicine composition of the present invention.

[0080] Efficacy Example 1 Protective effect of the Chinese medicine composition of the present invention on renal damage in rats with diabetic nephropathy

[0081] 1. Establishment of diabetic nephropathy rat model

[0082] 72 male SPF SD rats, weighing 180-220g, were fed with free water and diet. The room temperature was maintained at 25±1℃, and the light-dark cycle was 12 hours. After one week of adaptive feeding, 8 rats were randomly selected as the normal control group according to body weight and fed with ordinary feed; the remaining 64 rats were the modeling group, fed with high-sugar and high-fat feed, and the modeling was established after 6 weeks of feeding: the rats were fasted for 12 hours but not water, and then injected with 1% streptozotocin solution at 35mg / kg intraperitoneally. Blood glucose was tested by tail vein blood sampling after 72 hours. The diabetes model was successfully established when blood glucose was ≥16.7mmol / L.

[0083] The rats with successful modeling were randomly divided into a model control group, a Zhibai Dihuang Wan group, an example 1 group, an example 2 group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, and a comparative example 4 group, with 8 rats in each group.

[0084] Rats in the Zhibai Dihuang Wan group were orally administered with 1.62 g / kg of Zhibai Dihuang Wan (Zhibai Dihuang Wan concentrated pills were purchased from Lanzhou Foci Pharmaceutical Co., Ltd. The main raw materials are Rehmannia glutinosa, processed Cornus officinalis, Dioscorea opposita, Paeonia suffruticosa, Poria, Rhizoma Alismatis, Rhizoma Anemarrhenae, and Cortex Phellodendri. The dosage for rats was converted according to the commonly used clinical dosage). Group 1 of Example 1 was orally administered with 0.8 g / kg of the composition of Example 1 every day. Group 2 of Example 2 was orally administered with 0.8 g / kg of the composition of Example 2 every day. Group 1 of Comparative Example 1 was orally administered with 0.8 g / kg of the composition of Example 1 every day. Group 2 of Comparative Example 2 was orally administered with 0.8 g / kg of the composition of Example 2 every day. Group 3 of Comparative Example 3 was orally administered with 0.8 g / kg of the composition of Example 3 every day. Group 4 of Comparative Example 4 was orally administered with 0.8 g / kg of the composition of Example 4 every day.

[0085] Rats in the normal control group and the model control group were intragastrically administered with an equal volume of purified water once a day for 16 consecutive weeks.

[0086] During the intervention period, rats in the normal control group were fed with ordinary feed, and rats in the other groups were fed with high-sugar and high-fat feed; the blood sugar of rats was tested once every 4 weeks, and rats with blood sugar greater than or equal to 16.7mmol / L were selected to continue the experiment.

[0087] 2. Model observation and indicator detection

[0088] 2.1 Specimen collection

[0089] At the end of the 4th, 8th, 12th and 16th week of gavage intervention, 24-hour urine was collected in a metabolic cage and the urine volume was recorded. 1.5 mL of urine was collected, centrifuged and frozen. After the last administration, the rats in each group were fasted for 8 hours and then anesthetized. Blood was collected from the abdominal aorta, centrifuged and the serum was frozen. The renal tissue was quickly separated and the renal cortex was retained in formaldehyde-acetic acid-ethanol fixative, 4% glutaraldehyde fixative and cryopreservation tubes.

[0090] 2.2 Measurement of rat body weight, water intake, food intake, urine volume, and fasting blood glucose

[0091] After the last administration, the rats in each group were weighed, and their 24-hour water intake, food intake, and urine output were recorded; the tail vein blood of the rats was collected after fasting for 12 hours to test fasting blood glucose.

[0092] 2.3 Detection of 24-hour urine protein in rats at different time points

[0093] Take the 24h urine samples collected under "2.1" and detect the 24h urine protein (24h urine total protein, 24h UTP) of each group of rats at the end of the 16th week of intervention according to the method in the kit instructions.

[0094] 2.4 Detection of renal function indexes in rats

[0095] The serum samples frozen under "2.1" were taken and the serum creatinine (Scr) and blood urea nitrogen (BUN) levels of rats in each group were detected by automatic biochemical analyzer.

[0096] 3. Statistical methods

[0097] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0098] 4. Experimental Results

[0099] 4.1 Effect of the Chinese medicine composition of the present invention on the body weight of diabetic nephropathy model rats

[0100] Compared with the normal control group, the body weight of the rats in the model control group was significantly reduced. Compared with the model control group, the body weight of the rats in the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group was significantly increased. Compared with the Zhibai Dihuang Wan group, the body weight of the rats in the Example 1 group was significantly increased. The effect of improving body weight in the Example 1 group was better than that in the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. The results are shown in Figure 1 .

[0101] 4.2 Effect of the Chinese medicine composition of the present invention on water intake in diabetic nephropathy model rats

[0102] Compared with the normal control group, the water intake of the rats in the model control group increased significantly. Compared with the model control group, the water intake of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group decreased significantly. The effect of the Example 1 group on improving water intake was better than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 2 .

[0103] 4.3 Effect of the Chinese medicine composition of the present invention on the food intake of diabetic nephropathy model rats

[0104] Compared with the normal control group, the diet of the rats in the model control group increased significantly. Compared with the model control group, the water intake of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group was significantly reduced. The effect of the Example 1 group on improving diet was better than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 3 .

[0105] 4.4 Effect of the Chinese medicine composition of the present invention on urine volume in diabetic nephropathy model rats

[0106] Compared with the normal control group, the urine volume of rats in the model control group increased significantly. Compared with the model control group, the urine volume of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group decreased significantly. Compared with the Bai Dihuang Wan group, the urine volume of the Example 1 group decreased significantly. The effect of improving urine volume in the Example 1 group was better than that in the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 4 .

[0107] 4.5 Effect of the Chinese medicine composition of the present invention on 24hUTP content in diabetic nephropathy model rats

[0108] Compared with the normal control group, the 24hUTP of the rats in the model control group increased significantly. Compared with the model control group, the 24hUTP of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group all decreased significantly. The effect of the Example 1 group on improving 24hUTP was better than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 5 .

[0109] 4.6 Effect of the Chinese medicine composition of the present invention on the Scr content in diabetic nephropathy model rats

[0110] Compared with the normal control group, the Scr content of the rats in the model control group increased significantly. Compared with the model control group, the Scr content of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group all decreased significantly. The effect of the Example 1 group on improving the Scr content was better than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 6 .

[0111] 4.7 Effect of the Chinese medicine composition of the present invention on BUN content in diabetic nephropathy model rats

[0112] Compared with the normal control group, the BUN content of the rats in the model control group increased significantly. Compared with the model control group, the BUN content of the Zhibai Dihuang Wan group and the Example 1 group and the Example 2 group decreased significantly. Compared with the Bai Dihuang Wan group, the BUN content of the Example 1 group decreased significantly. The effect of the Example 1 group on improving the BUN content was better than that of the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group and the Comparative Example 4 group. Figure 7 .

[0113] The results of this study showed that compared with the normal control group, the 24hUTP of rats in the model control group was significantly increased, and the renal tissue showed obvious pathological manifestations of diabetic nephropathy, indicating that the modeling of diabetic nephropathy was successful.

[0114] The early sign of diabetic nephropathy progressing to end-stage renal disease is the occurrence of proteinuria, and once the course of the disease progresses to massive proteinuria and renal failure, kidney damage often presents an irreversible development, so the treatment of early proteinuria is of great significance for the control of the entire course of diabetic nephropathy. The Chinese medicine composition of the present invention significantly reduces the 24hUTP of diabetic nephropathy rats, indicating that the Chinese medicine composition of the present invention is of great significance for the control of the entire course of diabetic nephropathy. The Chinese medicine composition of the present invention has a significant effect in treating diabetic nephropathy.

[0115] The Chinese medicine composition of the present invention significantly reduces the body weight of diabetic nephropathy model rats, increases the amount of water consumed, the amount of food consumed, and the amount of urine, reduces 24hUTP, reduces the levels of Scr and BUN, improves renal function indexes, and achieves the purpose of treating diabetic nephropathy. Compared with Zhibai Dihuang Wan, the Chinese medicine composition of the present invention has better effects in increasing the body weight of diabetic nephropathy model rats, reducing urine volume, and reducing BUN content. The therapeutic effect of the Chinese medicine composition of the present invention on diabetic nephropathy is better than that of the Chinese medicine compositions of comparative example 1, comparative example 2, comparative example 3, and comparative example 4.

[0116] The above embodiments are merely examples for clear explanation and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description, and the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for preventing or treating diabetic nephropathy, characterized in that: The traditional Chinese medicine composition is made of astragalus, leech, salvia miltiorrhiza, cornus officinalis, plantain seed, dodder seed and earthworm; the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 25-35 parts of astragalus, 25-35 parts of leech, 10-20 parts of salvia miltiorrhiza, 6-11 parts of cornus officinalis, 6-11 parts of plantain seed, 6-11 parts of dodder seed and 4-8 parts of earthworm.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of astragalus, 30 parts of leech, 15 parts of salvia miltiorrhiza, 9 parts of cornus officinalis, 9 parts of plantain seeds, 9 parts of dodder seeds and 6 parts of earthworm.

3. The Chinese medicine composition according to any one of claims 1 or 2, characterized in that The preparation method of the Chinese medicine composition is as follows: Weigh the raw materials, add purified water, soak, heat to boiling and keep it slightly boiling, filter, and obtain the first filtrate; add purified water to the residue again, heat to boiling and keep it slightly boiling, filter, and obtain the second filtrate; The two filtrates are combined, the filtrate is concentrated, spray-dried, and the dried fine powder is sieved to obtain the traditional Chinese medicine composition for preventing or treating diabetic nephropathy of the present invention.

4. The Chinese medicine composition according to any one of claims 1 or 2, characterized in that The preparation method of the Chinese medicine composition is as follows: Weigh the above raw materials according to the ratio, add 6-10 times the weight of purified water, heat to boiling and keep it slightly boiling for 0.5-1.5h, filter to obtain the first filtrate; add 4-8 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 0.5-1.5h, filter to obtain the second filtrate; The two filtrates are combined, the filtrate is concentrated to a relative density of 1.10-1.25, spray-dried, and the dried fine powder is passed through an 80-100 mesh sieve to obtain the Chinese medicinal composition for preventing or treating diabetic nephropathy of the present invention.

5. The Chinese medicine composition according to any one of claims 1 or 2, characterized in that: The preparation method of the Chinese medicine composition is as follows: Weigh the above raw materials according to the ratio, add 8 times the weight of purified water, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and keep it slightly boiling for 1 hour, filter to obtain the second filtrate; The two filtrates were combined, the filtrate was concentrated to a relative density of 1.20, and spray-dried. The dried fine powder was passed through a 100-mesh sieve to obtain the Chinese medicine composition of the present invention.

6. The Chinese medicine composition according to any one of claims 1 or 2, characterized in that: The dosage form of the Chinese medicine composition is granules, decoctions, tablets, mixtures, pills, gels, capsules, powders or pastes.

7. The Chinese medicine composition according to claim 6, characterized in that: The dosage form of the Chinese medicine composition is granules.

8. Use of the Chinese medicine composition according to any one of claims 1 or 2 in the preparation of a drug for preventing or treating diabetic nephropathy.

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