Traditional Chinese medicine composition for treating diabetic nephropathy and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following raw materials by weight: 10-20 parts of Poria cocos, 10-20 parts of bighead atractylodes rhizome, 5-15 parts of curcuma zedoary, 10-20 parts of motherwort, and 3-10 parts of safflower. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the beneficial effects that the curcuma zedoary is used as a monarch drug and has the effects of promoting the circulation of qi, breaking blood and removing food retention; on the basis of the basic pathogenesis of the disease, motherwort is used for inducing diuresis to alleviate edema, promoting blood circulation to restore menstrual flow, helping curcuma zedoary to break blood and eliminate diseases, promoting diuresis to excrete dampness and eliminating evil, and safflower and curcuma zedoary are used as ministerial drugs for promoting blood circulation to dissipate blood stasis; the rhizoma atractylodis macrocephalae has the effects of invigorating the spleen, replenishing qi, eliminating dampness and promoting diuresis, so that the spleen and qi are healthy, the water is transformed into normal, and the rhizoma atractylodis macrocephalae and the rhizoma atractylodis macrocephalae are used as adjuvant drugs. All the medicines are combined to achieve the effects of promoting blood circulation to remove blood stasis and inducing diuresis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating diabetic nephropathy and application thereof. Background Art

[0002] Diabetic nephropathy is one of the major chronic complications of diabetes and is currently the leading cause of end-stage renal disease. Clinically, it is mainly manifested as persistent proteinuria, and pathologically, it is mainly manifested as widening of the glomerular mesangial area and thickening of the glomerular capillary basement membrane. Both type 1 and type 2 diabetes can develop diabetic nephropathy, and the prognosis is relatively poor. It often progresses quickly to renal insufficiency and uremia.

[0003] Mogensen divides diabetic nephropathy into five stages: stage I, glomerular hyperfiltration stage; stage II, normal albuminuria stage; stage III, microalbuminuria stage (early stage); stage IV, clinical proteinuria stage (middle stage); stage V, renal failure stage (late stage). Stages I and II mainly show changes in renal hemodynamics and mild pathological changes, without specific clinical manifestations, and no special treatment. The main treatment is to strengthen the treatment of the primary disease diabetes and control the inducing factors such as hyperlipidemia and hypertension. After entering stage III, the pathological manifestation is characteristic nodular glomerulosclerosis. In stages III and IV, the main manifestations are different degrees of proteinuria (microalbuminuria, clinical proteinuria, large proteinuria) and early and middle renal failure. The treatment is mainly based on ACEI / ARB to control proteinuria and symptomatic treatment. In stage V, the main manifestations are end-stage renal failure and multi-system complications, with dialysis, kidney transplantation and symptomatic treatment for multi-system complications.

[0004] Western medicine treatment of diabetic nephropathy mainly focuses on controlling blood pressure, blood sugar, and blood lipids. Although there are certain benefits in clinical practice, the use of Western medicine will inevitably be metabolized by the kidneys, which will increase kidney toxicity. In addition, long-term use is expensive and ineffective. Diabetic nephropathy belongs to the category of "Xiaoke Nephropathy" in traditional Chinese medicine. Chinese medicine scholars generally believe that its pathology is blood stasis, dampness, and turbid toxins. In treatment, Chinese medicine with the effects of removing dampness, promoting blood circulation, and removing blood stasis is often used. However, most Chinese medicine compound prescriptions are limited to a single syndrome type, and the scope of treatment objects is relatively narrow, making it difficult to promote. In particular, effective prescriptions for the early stages of diabetic nephropathy need to be studied.

[0005] In view of this, the inventor conducted in-depth research on this demand, and thus the present case was produced. Summary of the invention

[0006] To solve the above problems, the inventors have obtained a Chinese medicine composition for treating diabetic nephropathy and its application through strictly designed animal experiments and clinical research verification. The composition is widely applicable to the prevention and treatment of diabetic nephropathy, especially in the early stages of diabetic nephropathy.

[0007] The invention provides a traditional Chinese medicine composition for treating diabetic nephropathy, which comprises the following raw materials by weight: 10-20 parts of Poria cocos, 10-20 parts of Atractylodes macrocephala, 5-15 parts of Curcuma zedoaria, 10-20 parts of Leonurus japonicus and 3-10 parts of Carthamus tinctorius.

[0008] Preferably, the following raw materials are included by weight: 12-18 parts of Poria cocos, 12-18 parts of Atractylodes macrocephala, 7-13 parts of Curcuma zedoaria, 12-18 parts of Leonurus japonicus, and 4-8 parts of Carthamus tinctorius.

[0009] Preferably, the following raw materials are included by weight: 14-16 parts of Poria cocos, 14-16 parts of Atractylodes macrocephala, 9-11 parts of Curcuma zedoaria, 14-16 parts of Leonurus japonicus, and 5-6 parts of Carthamus tinctorius.

[0010] Preferably, the invention is made of at least the following raw materials by weight: 15 parts of Poria cocos, 15 parts of Atractylodes macrocephala, 10 parts of Curcuma zedoaria, 15 parts of Leonurus japonicus, and 5 parts of Carthamus tinctorius.

[0011] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing medicines for treating diabetic nephropathy, especially in medicines for the early stages of diabetic nephropathy.

[0012] The present invention also provides a medicine for treating diabetic nephropathy, comprising the above-mentioned Chinese medicine composition for treating diabetic nephropathy and pharmaceutically acceptable excipients.

[0013] Preferably, the dosage form of the above-mentioned medicine is Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

[0014] The present invention also provides a method for preparing the above-mentioned drug for treating diabetic nephropathy, wherein the drug is a Chinese medicine decoction, and the preparation method thereof is as follows:

[0015] Step 1, weighing the raw materials according to the weight ratio, removing residual pesticides, desulfurization, and heavy metals, mechanically crushing into coarse powder, and mixing evenly;

[0016] Step 2, extracting crude drug powder;

[0017] Step 3, collecting the extract, centrifuging and filtering, and concentrating to obtain.

[0018] Preferably, in the step 2, the crude drug substance powder is extracted using a high-efficiency high-pressure continuous extraction technology, the mobile phase is water, and the extraction is performed twice continuously at 10-40°C with a high pressure difference of 0.1-35MPa and a time of 0.2 seconds, and the two extraction filtrates are combined.

[0019] Preferably, the extract in step 3 needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500 nm ceramic membrane filter.

[0020] The beneficial effects produced by the technical solution of the present invention are as follows:

[0021] In the Chinese medicine composition of the present invention, Curcuma is the main drug, which has the functions of promoting qi, removing blood and eliminating stagnation, and is closely related to the basic pathogenesis of the disease; Leonurus can promote diuresis and reduce swelling, promote blood circulation and regulate menstruation, which can not only help Curcuma to remove blood and eliminate symptoms, but also can promote diuresis and eliminate dampness, and expel pathogens, and safflower is combined with Curcuma to increase the effect of promoting blood circulation and dispersing blood stasis, and the two are altogether the ministerial drugs; Poria can invigorate the spleen, promote diuresis and eliminate dampness, and Atractylodes can invigorate the spleen and replenish qi, dry dampness and promote diuresis, so that the spleen qi can be healthy and the water can be transported and transformed as usual, and they are altogether the adjuvant drugs. All the drugs are used together to achieve the functions of promoting blood circulation, removing stasis and promoting diuresis.

[0022] The prescription composition of the present invention is reasonable, does not contain toxic medicinal materials, and has no incompatibility. It has a good effect of reducing urine protein and delaying the progression of diabetic nephropathy, especially for patients with diabetic nephropathy stage III, it can effectively improve the patient's blood sugar and blood lipid conditions, and the curative effect is remarkable. Previous studies have shown that Curcuma has a significant effect on liver fibrosis and renal interstitial fibrosis. Kaempferol, the effective active ingredient of Leonurus japonicus, can inhibit the inflammatory response mediated by Rho A / Rho kinase activation in renal tubular cells, reduce the expression of proinflammatory factors such as TNF-α and IL-1β, thereby delaying the progression of nephropathy. Poria cocos polysaccharide can also reduce inflammatory response and reduce renal inflammatory infiltration. Its raw materials are all natural soothing ingredients, mild efficacy, safe and reasonable, simple process, reliable clinical efficacy, no obvious toxic and side effects and adverse reactions occur during the application process, ensuring clinical efficacy, and quality controllable. The whole prescription is refined, low-priced, and has a good application prospect and market prospect. DETAILED DESCRIPTION

[0023] 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 the embodiments. Therefore, the following detailed description of the embodiments provided by the present invention is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. 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.

[0024] The inventors have obtained a Chinese medicine composition for treating diabetic nephropathy through strictly designed animal experiments and clinical research verification, and its preparation method and application, which are widely applicable to the prevention and treatment of diabetic nephropathy, especially in the early stage of diabetic nephropathy. The specific implementation method is as follows:

[0025] The invention provides a traditional Chinese medicine composition for treating diabetic nephropathy, which comprises the following raw materials by weight: 10-20 parts of Poria cocos, 10-20 parts of Atractylodes macrocephala, 5-15 parts of Curcuma zedoaria, 10-20 parts of Leonurus japonicus and 3-10 parts of Carthamus tinctorius.

[0026] As a preferred embodiment, the following raw materials are included by weight: 12-18 parts of Poria cocos, 12-18 parts of Atractylodes macrocephala, 7-13 parts of Curcuma zedoaria, 12-18 parts of Leonurus japonicus, and 4-8 parts of Carthamus tinctorius.

[0027] As a preferred embodiment, the following raw materials are included by weight: 14-16 parts of Poria cocos, 14-16 parts of Atractylodes macrocephala, 9-11 parts of Curcuma zedoaria, 14-16 parts of Leonurus japonicus, and 5-6 parts of Carthamus tinctorius.

[0028] As a preferred embodiment, the invention is made of at least the following raw materials by weight: 15 parts of Poria cocos, 15 parts of Atractylodes macrocephala, 10 parts of Curcuma zedoaria, 15 parts of Leonurus japonicus, and 5 parts of Carthamus tinctorius.

[0029] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing medicines for treating diabetic nephropathy, especially in medicines for the early stages of diabetic nephropathy.

[0030] The present invention also provides a medicine for treating diabetic nephropathy, comprising the above-mentioned Chinese medicine composition for treating diabetic nephropathy and pharmaceutically acceptable excipients.

[0031] As a preferred embodiment, the dosage form of the above-mentioned medicine is Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

[0032] The present invention also provides a method for preparing the above-mentioned drug for treating diabetic nephropathy, wherein the drug is a Chinese medicine decoction, and the preparation method thereof is as follows:

[0033] Step 1, weighing the raw materials according to the weight ratio, removing residual pesticides, desulfurization, and heavy metals, mechanically crushing into coarse powder, and mixing evenly;

[0034] Step 2, extracting crude drug powder;

[0035] Step 3, collecting the extract, centrifuging and filtering, and concentrating to obtain.

[0036] Preferably, in the step 2, the crude drug substance powder is extracted using a high-efficiency high-pressure continuous extraction technology, the mobile phase is water, and the extraction is performed twice continuously at 10-40°C with a high pressure difference of 0.1-35MPa and a time of 0.2 seconds, and the two extraction filtrates are combined.

[0037] As a preferred embodiment, the extract in step three needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500 nm ceramic membrane filter.

[0038] The present invention is further described in detail below in conjunction with specific embodiments:

[0039] Example 1

[0040] A drug for treating diabetic nephropathy, wherein the raw materials include: 10 parts of Poria cocos, 10 parts of Atractylodes macrocephala, 5 parts of Curcuma zedoaria, 10 parts of Leonurus japonicus, and 10 parts of Carthamus tinctorius. The preparation method of the decoction includes the following steps:

[0041] Step 1, weighing 100 kg of the above raw materials according to the weight ratio, removing residual pesticides, desulfurization, and heavy metals, mechanically crushing into coarse powder, and mixing evenly;

[0042] Step 2: extract the crude powder of the raw material drug by using high-efficiency high-pressure continuous extraction technology, add 1500 mL of water to the crude powder, extract once at a high pressure difference of 0.1-35 MPa, centrifuge, collect the extract, extract the obtained drug residue once again by the same method, and combine the two extraction filtrates;

[0043] Step 3, collecting the extract, first filtering it with a 200-mesh fiber filter, and then filtering it with a 500 nm ceramic membrane filter, and concentrating the filtrate by reverse osmosis to obtain a reverse osmosis concentrate of about 30 to 40 kg, thereby obtaining the embodiment concentrate.

[0044] Example 2

[0045] A medicine for treating diabetic nephropathy, wherein the raw materials include: 14 parts of Poria cocos, 14 parts of Atractylodes macrocephala, 9 parts of Curcuma zedoaria, 14 parts of Leonurus japonicus, and 4 parts of Carthamus tinctorius. The preparation method of the decoction is the same as that of Example 1.

[0046] Example 3

[0047] A medicine for treating diabetic nephropathy, wherein the raw materials include: 15 parts of Poria cocos, 15 parts of Atractylodes macrocephala, 10 parts of Curcuma zedoaria, 15 parts of Leonurus japonicus, and 5 parts of Carthamus tinctorius. The preparation method of the decoction is the same as that of Example 1.

[0048] Example 4

[0049] A medicine for treating diabetic nephropathy, wherein the raw materials include: 16 parts of Poria cocos, 16 parts of Atractylodes macrocephala, 11 parts of Curcuma zedoaria, 16 parts of Leonurus japonicus, and 6 parts of Carthamus tinctorius. The preparation method of the decoction is the same as that of Example 1.

[0050] The concentrated solutions prepared in Examples 1-4 were diluted with water to obtain the maximum concentration, and the maximum concentration and maximum gavage volume were administered to mice once every 24 hours, and the toxic reactions and deaths of the animals were observed.

[0051] 1. Test materials

[0052] 1.1 Drugs

[0053] The maximum concentrations of the concentrated Chinese medicine compositions prepared in Examples 1, 2, 3 and 4 were diluted with water to obtain 2.25 g crude drug / mL, 2.77 g crude drug / mL, 3.01 g crude drug / mL and 3.25 g crude drug / mL, respectively.

[0054] 1.2 Animals

[0055] Kunming mice, clean grade, half male and half female, weighing 18-22g, were provided by Guangdong Experimental Animal Center. The mice were adapted to the observation room at a temperature of 18-25℃ and a humidity of 50-60% for 7 days before the experiment began. The sterilized sawdust was replaced once a day, the UV lamp was sterilized once, and ventilation was performed once in the morning and evening.

[0056] Experimental animal environment: clean grade environment.

[0057] 2. Test methods

[0058] 2.1 Preliminary experiment

[0059] Take mice that have been fasted for 12 hours but not water-deprived, and randomly divide them into 4 groups according to sex and weight, with 6 mice in each group. The 4 groups of Examples 1, 2, 3, and 4 were given oral administration at the above maximum concentration at a dose of 0.4 mL / 10 g body weight, and observed for 5 consecutive days. It is intended to find out the LD100 value (100% mortality), LD0 value (0% mortality and the corresponding dose group value. During this period, it was found that the mice were in good condition and there was no death. Because the LD50 of the drug could not be measured, the maximum tolerated dose (MTD) was determined.

[0060] 2.2 Formal experiment (maximum tolerated dose determination)

[0061] According to the preliminary test results, since LD50 could not be measured, the maximum tolerance was measured. Take 100 mice, half male and half female, and randomly divide them into 5 groups, namely blank control group and embodiment 1, 2, 3, 4 groups, 20 mice in each group, half male and half female. Fasting but not water for 12h, 4 groups of embodiment 1, 2, 3, 4 at the above maximum concentration, one-time oral administration at a dose of 0.4mL / 10g body weight. The blank control group is given distilled water. After administration, continuous observation for 14 days, record poisoning manifestations and symptoms (see Table 1), body weight and death. If there are mice dead, the dead mice are dissected, and the changes of organs such as heart, liver, spleen, lung, kidney, adrenal gland, thymus, stomach, testis, prostate, uterus, ovary are observed with naked eyes. After the 14d observation period, the surviving mice in each group are killed for dissection, and the gross pathological changes of the main organs are observed with naked eyes according to the same method as above, and the wet weight is weighed to calculate the organ index [organ weight (mg) / body weight (g)].

[0062] Table 1 Observation items of mice

[0063]

[0064]

[0065] 3. Test results

[0066] 3.1 Symptoms of poisoning in mice

[0067] Blank control group: During the 1-14 days of observation, the mice moved freely and reacted normally. Their fur was shiny, their skin color was normal, their diet and bowel movements were normal, and they grew normally. No abnormal conditions were observed.

[0068] Drug administration group: 15-60 minutes after drug administration, some mice showed reduced activity, reduced food intake and water intake, and alternated between lying and moving, but no animals showed twisting, tremor, unsteady gait, or symptoms such as runny nose, tears, runny nose, difficulty breathing, diarrhea, constipation, and intestinal gas; 1-2 hours later, the mice walked more and were more active, climbing in the cage and sniffing food and water; 3-4 hours later, the mice returned to normal, and during the subsequent 14 days of observation, the mice moved freely, reacted normally, had shiny fur, normal skin color, and normal diet and bowel movements, without any abnormal conditions.

[0069] 3.2 Mouse mortality

[0070] From the time of administration to the 14th day of observation, all mice in the blank control group and the drug administration group survived, and no mouse in each group died.

[0071] 3.3 Changes in mouse body weight

[0072] Blank control group: The weight of mice increased normally.

[0073] Drug administration group: The weight gain of mice was normal, with no significant difference compared with the control group (see Table 2).

[0074] Table 2 Effects on the body weight of mice

[0075]

[0076] 3.4 Autopsy and organ index

[0077] After the experiment, all mice in each group were killed by dislocating the cervical vertebrae, and the internal organs of the mice were observed with the naked eye. The results showed that the color and texture of the heart, liver, spleen, lung, kidney, adrenal gland, thymus, stomach, testis, prostate, uterus, ovary and other organs were normal. As shown in Table 2, the wet weight of the above organs was weighed and the organ index [organ weight (mg) / body weight (g)] was calculated. There was no significant difference in the organ index of the mice in Example 1, 2, 3, and 4 groups compared with the blank control group.

[0078] Therefore, no obvious acute toxicity was found in the above Examples 1, 2, 3, and 4 when administered to animals. The results show that Examples 1, 2, 3, and 4 are basically safe and non-toxic when taken in large doses, and are safe to use at clinical doses.

[0079] Next, the Chinese medicine compositions prepared in the above four embodiments were administered to mice once every 24 hours to observe the efficacy on diabetic nephropathy.

[0080] 1. Materials and Methods

[0081] 1.1 Experimental animals

[0082] 140 SD rats, male, weighing 250±50 g, were provided by Guangdong Provincial Animal Experimental Animal Center.

[0083] 1.2 Drugs and reagents

[0084] Examples 1, 2, 3, 4 Chinese medicine formula; dapagliflozin tablets; streptozotocin (STZ); Coomassie blue; biochemical test reagents, etc.

[0085] 1.3 Instruments

[0086] DFM-96 16-tube radioimmunoassay analyzer; semi-automatic biochemical analyzer; LG-R-80 series blood viscosity tester; LG-B-190 cell rheology tester; DV990 microplate reader; optical microscope; transmission electron microscope; metabolic cage; balance, etc.

[0087] 2. Experiment and Methods

[0088] Modeling: 120 SD rats weighing 250±50g were selected and weighed before the experiment. After fasting for 12 hours, STZ citrate buffer solution was intraperitoneally injected at a dose of 64 mg / kg body weight for modeling. Blood glucose was measured after 72 hours, and animals with blood glucose values ​​between 13.8-25mmol after modeling were selected for the experiment.

[0089] Grouping: The animals after modeling were divided into a model control group, a positive drug control group, and Example 1, 2, 3, and 4 groups, with 20 animals in each group, and a normal control group of 20 animals. The drugs were administered once a day for 6 consecutive weeks. The Example 1, 2, 3, and 4 groups were administered by gavage at a dose of 10 mL / kg body weight, the positive drug control group was administered by gavage at a dose of 10 mg / kg body weight by dissolving dapagliflozin in distilled water, and the model control group was administered with distilled water. The normal control group was not modeled and was administered with distilled water.

[0090] Indicators: 24-hour urine was collected at 3, 5, 7, 10, and 12 weeks after modeling to measure the 24-hour volume and total 24-hour urine protein. The animals were dissected at 3, 7, and 12 weeks after administration to observe the following indicators: body weight, blood sugar, blood creatinine, and urine protein.

[0091] Table 3 Effects on serum creatinine in rats with diabetic nephropathy

[0092]

[0093]

[0094] Compared with the model control group b P<0.05, c P<0.01

[0095] Compared with normal control group a P<0.01

[0096] Table 4 Effect on the total amount of urinary protein in 24 hours in rats with diabetic nephropathy

[0097]

[0098] Compared with the model control group b P<0.05, c P<0.01

[0099] Compared with normal control group a P<0.01

[0100] Table 5 Effect on body weight of rats with diabetic nephropathy

[0101]

[0102]

[0103] Compared with the model control group b P<0.05, c P<0.01

[0104] Compared with normal control group a P<0.01

[0105] Table 6 Effects on blood glucose in rats with diabetic nephropathy

[0106]

[0107] Compared with the model control group b P<0.05, c P<0.01

[0108] Compared with normal control group a P<0.01

[0109] As can be seen from Tables 3-6, from the third week of administration, the blood creatinine, urine protein and blood sugar of the model control group were significantly increased compared with the normal control group, but the body weight was lower than that of the normal control group, while the urine protein of the drug-dosing groups of Examples 1, 2, 3, and 4 was significantly reduced compared with the model control group, and there was no significant difference in body weight, blood creatinine, urine protein and blood sugar between the drug-dosing groups and the positive drug control group.

[0110] At the beginning of the 7th week of administration, the blood creatinine, urine protein and blood sugar of the model control group increased compared with the 3rd week, and the body weight also decreased, while the various indicators of the drug-administered groups of Examples 1, 2, 3, and 4 were still close to those of the positive drug control group, and the blood creatinine, urine protein and blood sugar were lower than the data of the model control group. At the beginning of the 12th week of administration, the blood creatinine, body weight and blood sugar of the model control group increased compared with the 7th week, but the blood creatinine decreased, and the various indicators of the drug-administered groups of Examples 1, 2, 3, and 4 were still close to those of the positive drug control group. From the above results, it can be seen that the above-mentioned Examples 1, 2, 3, and 4 can significantly improve the levels of blood creatinine and urine protein in rats with diabetic nephropathy, and can delay the pathological changes of renal tissue to a certain extent, and have a protective effect on the kidneys.

[0111] Next, the clinical efficacy experiment on diabetic nephropathy patients was observed by combining the Chinese medicine prepared in the preferred embodiment 3.

[0112] 1. Source of cases

[0113] This study population is diabetic nephropathy G3A3 stage patients, meet the diagnostic criteria and inclusion criteria, and exclude patients who do not meet the standards, and finally randomly assign patients a total of 30 cases, including 15 cases in the treatment group and the control group, all using dapagliflozin tablets (10mg / tablets) as basic treatment, one tablet each time, 1 tablet per day, 4 weeks as a course of treatment, a total of 3 courses of treatment. On this basis, the treatment group is given with the Chinese medicine of embodiment 3, each person is given the equivalent of crude drug 12g each time, 2 times a day, 4 weeks as a course of treatment, a total of 3 courses of treatment, while the control group gives a simulant without drug effect. 0 cases fell off during the test, and 30 cases were finally completed.

[0114] 2. Observation of therapeutic effects

[0115] 2.1 Comparison of overall efficacy between the two groups (see Table 7)

[0116] According to the Guiding Principles for Clinical Research of New Chinese Medicines, markedly effective means that clinical symptoms improve or disappear, the TCM syndrome score decreases by ≥50%, and the symptoms disappear or improve significantly; effective means that symptoms improve, and the score decreases by 30% to 49%; ineffective means that there is no improvement or the symptoms worsen, and the score decreases by <30%. Among them, the total effective rate = (number of markedly effective cases + number of effective cases) / total number of cases × 100%. The total effective rate of the treatment group was 86.7%, and the effective rate of the control group was 66.7%.

[0117] Table 7 Comparison of the efficacy of the two groups before and after treatment

[0118]

[0119] 2.2 Comparison of renal function between the two groups before and after treatment (see Table 8)

[0120] Table 8 Serum creatinine, glomerular filtration rate and urea nitrogen levels in the two groups before and after treatment

[0121]

[0122] Compared with the same group before treatment, a P<0.05, compared with the control group after treatment, b P<0.05.

[0123] 2.3 Comparison of 24-hour urine protein between the two groups before and after treatment (see Table 9)

[0124] Table 9 24h urine protein levels in the two groups before and after treatment

[0125]

[0126] As can be seen from Tables 7-9, both the treatment group and the control group used dapagliflozin tablets as the basic treatment, and the overall efficacy, three indicators of renal function and 24-hour urine protein of the treatment group were better than those of the control group. It can significantly reduce the blood creatinine and urine protein levels of patients with diabetic nephropathy and improve the clinical symptoms of patients.

[0127] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating diabetic nephropathy, characterized in that: The raw materials are as follows, measured by weight: 10-20 parts of Poria cocos, 10-20 parts of Atractylodes macrocephala, 5-15 parts of Curcuma zedoaria, 10-20 parts of Leonurus japonicus and 3-10 parts of Carthamus tinctorius.

2. The Chinese medicine composition for treating diabetic nephropathy according to claim 1, characterized in that: The raw materials are as follows, measured by weight: 12 to 18 parts of Poria cocos, 12 to 18 parts of Atractylodes macrocephala, 7 to 13 parts of Curcuma zedoaria, 12 to 18 parts of Leonurus japonicus and 4 to 8 parts of Carthamus tinctorius.

3. The Chinese medicine composition for treating diabetic nephropathy according to claim 1, characterized in that: The raw materials are as follows, measured by weight: 14-16 parts of Poria cocos, 14-16 parts of Atractylodes macrocephala, 9-11 parts of Curcuma zedoaria, 14-16 parts of Leonurus japonicus and 5-6 parts of Carthamus tinctorius.

4. Use of the Chinese medicine composition for treating diabetic nephropathy according to any one of claims 1 to 3 in the preparation of a medicine for treating diabetic nephropathy.

5. A drug for treating diabetic nephropathy, characterized in that: The invention comprises the Chinese medicine composition for treating diabetic nephropathy according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

6. The drug for treating diabetic nephropathy according to claim 5, characterized in that: The dosage form of the medicine is Chinese medicine decoction, decoction, granules, pills, capsules, tablets, tea, suspension, powder or oral solution.

7. The method for preparing the drug for treating diabetic nephropathy according to claim 5 or 6, characterized in that: The medicine is a Chinese medicine decoction, and its preparation method is as follows: Step 1, weighing the raw materials according to the weight ratio, removing residual pesticides, desulfurization, and heavy metals, mechanically crushing into coarse powder, and mixing evenly; Step 2, extracting crude drug powder; Step 3, collecting the extract, centrifuging and filtering, and concentrating to obtain.

8. The preparation method according to claim 7, characterized in that: In the step 2, the crude drug powder is extracted using an efficient high-pressure continuous extraction technology, with water as the mobile phase. The extraction is performed twice at 10-40° C. with a high pressure difference of 0.1-35 MPa and a time of 0.2 seconds, and the two extraction filtrates are combined.

9. The preparation method according to claim 7, characterized in that: The extract in step 3 needs to be filtered twice, first with a 200-mesh fiber filter and then with a 500nm ceramic membrane filter.

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