A Chinese medicine composition for treating chronic kidney disease and its application

Abstract

The present invention discloses a Chinese medicine composition for treating chronic kidney disease and its application. The Chinese medicine composition comprises 30-50 parts of astragalus, 2-10 parts of leech, 50-70 parts of radix scutellariae, 5-20 parts of seaweed and 5-20 parts of turtle shell. The Chinese medicine composition can be used to prepare a preparation for treating chronic kidney disease. The Chinese medicine composition has a good therapeutic effect on the decrease of glomerular filtration rate and deterioration of renal function caused by chronic kidney disease, especially the increase of creatinine, and can significantly improve the clinical symptoms of patients with chronic kidney disease; it has no obvious damage to liver function and coagulation function, has high safety, and has broad application prospects in the field of chronic kidney disease treatment.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition, and in particular to a Chinese medicine composition for treating chronic kidney disease and its application. Background Art

[0002] Chronic kidney disease (CKD) is a chronic progressive destruction of kidney structure and function caused by various reasons. The course of the disease exceeds 3 months, and the clinical manifestations are a group of syndromes such as varying degrees of urine protein, edema, hypertension, and renal function damage. The Lancet published a research report on CKD from 1990 to 2017. In 2017, there were 697.5 million CKD patients in the world, accounting for 9.1% of the world's population. The number of deaths caused by CKD and its complications totaled 2.6 million, accounting for 4.6% of the world's total deaths, making it the 12th leading cause of death in the world. With 132.3 million patients, my country has become the country with the largest number of CKD patients in the world. In 2017, the number of patients with end-stage renal disease (ESRD) in my country reached 2.9 million. It is estimated that by 2030, the number of patients with end-stage renal disease in my country will exceed 4 million. The total number of uremia dialysis in my country is more than 600,000, but the annual medical expenditure on dialysis in my country is as high as more than 40 billion. It can be seen that targeted intervention in the early stage of CKD, improving symptoms such as proteinuria, edema, and hypertension, and preventing CKD patients from progressing to chronic renal failure have important practical significance for prolonging kidney life, protecting labor, and saving economic resources. In developed countries, diabetic nephropathy is the primary factor for end-stage renal disease and the main cause of peritoneal dialysis and hemodialysis. Recent studies in my country have shown that chronic kidney disease caused by diabetes in hospitalized patients has exceeded glomerulonephritis-related chronic kidney disease and has become the primary cause of chronic kidney disease. At present, there is still no specific treatment for chronic kidney disease in clinical practice, and traditional Chinese medicine has the characteristics of multiple components, multiple pathways, and multiple targets. How to give full play to the theoretical advantages of traditional Chinese medicine and deeply explore CKD-specific treatments is a difficult problem that needs to be solved in the current discipline. Summary of the invention

[0003] The primary purpose of the present invention is to overcome the shortcomings and deficiencies of the prior art and to provide a Chinese medicine composition for treating chronic kidney disease.

[0004] Another object of the present invention is to provide an application of the above-mentioned Chinese medicine composition for treating chronic kidney disease.

[0005] The object of the present invention is achieved by the following technical scheme: a traditional Chinese medicine composition for treating chronic kidney disease, comprising the following ingredients in parts by mass: 30-50 parts of astragalus, 2-10 parts of leech, 50-70 parts of yellow grass, 5-20 parts of seaweed, and 5-20 parts of turtle shell; preferably comprising the following ingredients in parts by mass: 35-45 parts of astragalus, 3-7 parts of leech, 55-65 parts of yellow grass, 10-20 parts of seaweed, and 10-20 parts of turtle shell; more preferably comprising the following ingredients in parts by mass: 40 parts of astragalus, 5 parts of leech, 60 parts of yellow grass, 15 parts of seaweed, and 15 parts of turtle shell.

[0006] The use of the Chinese medicine composition for treating chronic kidney disease in the preparation of a preparation for treating chronic kidney disease preferably comprises the following steps: extracting the Chinese medicine composition for treating chronic kidney disease, and preparing the obtained extract into the desired dosage form.

[0007] The extraction includes water extraction and supercritical extraction.

[0008] The steps of water extraction are preferably as follows:

[0009] (1) soaking the above-mentioned Chinese medicine composition for treating chronic kidney disease in water, followed by decocting and solid-liquid separation to obtain a medicinal solution and medicinal residues;

[0010] (2) repeatedly decocting the residue for more than 0 times, wherein the decocting is to better extract the effective ingredients of the traditional Chinese medicine composition for treating chronic kidney disease;

[0011] (3) combining the medicinal liquids obtained in step (1) and step (2) to obtain a water extract; when the number of repeated decoctions is 0, the medicinal liquid obtained in step (1) is the water extract.

[0012] The amount of water described in step (1) is preferably calculated according to the above-mentioned Chinese medicine composition for treating chronic kidney disease: water = solid-liquid ratio of 1:1 to 1:5 (g:mL); more preferably, it is calculated according to the above-mentioned Chinese medicine composition for treating chronic kidney disease: water = solid-liquid ratio of 1:3 (g:mL).

[0013] The decoction time in step (1) is preferably 30 to 60 minutes, more preferably 40 minutes.

[0014] The amount of water used in the repeated decoction described in step (2) is preferably calculated according to the ratio of the above-mentioned Chinese medicine composition for treating chronic kidney disease: water = solid-liquid ratio of 1:1 to 1:5 (g:mL); more preferably, it is calculated according to the ratio of the above-mentioned Chinese medicine composition for treating chronic kidney disease: water = solid-liquid ratio of 1:3 (g:mL).

[0015] The time for repeated decoction in step (2) is preferably 30 to 60 minutes, more preferably 40 minutes.

[0016] The number of repeated decoctions is preferably 1 to 2 times, and more preferably 1 time.

[0017] The dosage form is preferably decoction, pill, powder, paste, pill, granule, oral liquid, capsule, tablet, injection.

[0018] The preparations include common preparations, sustained-release preparations, controlled-release preparations, targeted preparations and microparticle drug delivery systems.

[0019] The chronic kidney disease is preferably diabetic nephropathy.

[0020] A preparation for treating chronic kidney disease is prepared from the above-mentioned traditional Chinese medicine composition for treating chronic kidney disease.

[0021] The method for using the above-mentioned preparation for treating chronic kidney disease comprises the following steps: taking it three times, once every four hours.

[0022] There is currently no specific drug for chronic kidney disease, and patients in the late stage need to rely on blood purification and kidney transplantation to maintain life. Although in recent years, new drugs including sodium-glucose co-transporter 2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists have been reported to have kidney benefits and are recommended for clinical use, their application in people with moderate to severe kidney disease is still very limited, and there is a lack of drugs with definite efficacy to combat renal fibrosis and delay the progression of renal function. The present invention aims to improve the renal function of patients by reducing blood creatinine, reducing blood urea nitrogen, and increasing glomerular filtration rate, so as to expand the unique advantages of traditional Chinese medicine in the treatment of chronic kidney disease.

[0023] According to traditional Chinese medicine, chronic kidney disease belongs to the category of "edema", "shut up", "kidney wind" and so on. According to traditional Chinese medicine, the cause of chronic kidney disease is related to factors such as insufficient endowment, six exogenous pathogens, endogenous toxic evil, improper diet, emotional disorder, and improper work and rest. Its disease nature is deficiency in the root and excess in the superficial, with a mixture of deficiency and excess. The disease is mainly located in the kidney and involves the other four organs. The pathogenesis of chronic renal failure is complex and changeable. Combining modern medical research and the previous foundation of the team, the inventor believes that the location of chronic kidney disease is mainly in the kidney network. The main reason is that the internal and external evils are hidden in the kidney network, which are triggered by inducements and then go out, resulting in "blockage" in the kidney network, making the metabolism of qi, blood and body fluids in the network abnormal, and then producing qi stagnation, phlegm, damp heat, blood stasis and other diseases that consume the positive energy, causing the accumulation and toxicity, forming a rut and accumulation, thus forming the pathogenesis evolution process from chronic kidney disease to chronic renal failure.

[0024] According to the above pathogenesis, the inventor innovatively established the treatment method of "tonifying the kidney and unblocking the meridians, eliminating turbidity and expelling evil", and created the "Yi-tonifying, unblocking and eliminating turbidity prescription" according to the clinical medication rules. The prescription is composed of 40g of Astragalus, 5g of Leech, 60g of Herba Astragali, 15g of Seaweed, and 15g of Beast Shell. The prescription is explained as follows:

[0025] Astragalus: It is an essential herb for replenishing Qi, which can replenish the vital Qi of the five internal organs, benefit the kidney Qi, and has the effect of expelling evil.

[0026] Leeches: break up blood and remove blood stasis, dredge the menstruation and eliminate symptoms, expel bad blood and break up accumulation, and have the effect of dredging the kidney meridians;

[0027] Herba Chrysanthemi: clears away heat and dampness, detoxifies and relieves jaundice, expels evil and turbid toxins, and has the ability to expel evil;

[0028] Seaweed: dissipates stagnation and promotes diuresis, eliminates phlegm, is good at eliminating phlegm and softening hard masses, and has the function of dissipating stagnation and eliminating symptoms;

[0029] Turtle Shell: Nourishes yin and reduces fever, softens and disperses lumps, is good at replenishing yin and qi and breaking up tumors and accumulations, and has the ability to benefit the kidneys, dredge meridians and eliminate accumulations.

[0030] The Astragalus in the formula is sweet and warm, and can benefit the kidneys. It can invigorate qi without being dry. The Herba Astragali can clear away heat and remove turbidity, and it can counteract the disadvantage of Astragalus in promoting fire. The Herba Hirudo can invigorate blood circulation and dredge collaterals without damaging blood. The Shell of Turtle and the Seaweed can disperse nodules and eliminate symptoms, and have the effects of clearing and nourishing. The various medicines in the formula can attack and nourish at the same time, harmonize cold and heat, and take into account both the symptoms and the root cause, and together they can benefit the kidneys and dredge collaterals, remove turbidity and eliminate evil, and disperse nodules and eliminate symptoms.

[0031] The inventor team further proved in clinical experiments that 31 patients with chronic kidney disease were treated comprehensively for 2 months, and the efficacy of the Yiqi Yangyin Tongluo prescription was compared with that of the basic treatment of Western medicine and the Yiqi Yangyin Tongluo prescription by self-before and after control. In addition, the inventor team also used the methods of parallel, split prescription and positive drug control to compare the use of Yiqi Tongluo Xiezhuo prescription, Ganhuangcao group, "Huangqi-Shuizhi" group, and Urea Qing granules in the basic treatment of Western medicine to treat patients with chronic kidney disease. The results showed that Yiqi Tongluo Xiezhuo prescription had a good effect in reducing blood creatinine, blood urea nitrogen, and cystatin C levels, and in improving glomerular filtration rate (eGFR). At the same time, Yiqi Tongluo Xiezhuo prescription was more effective in improving renal function than Ganhuangcao group, "Huangqi-Shuizhi" group, and Urea Qing granules, and it was clinically safe. This prescription can effectively improve renal function, increase glomerular filtration rate, delay the progression of chronic kidney disease, and bring hope to the treatment of chronic kidney disease. At the same time, a rat model of diabetic nephropathy was established by unilateral nephrectomy + intraperitoneal injection of streptozotocin (STZ). The therapeutic effects of the Yiqi Tongluo Xiezhuo prescription group, the Yiqi Tongluo Xiezhuo prescription low-dose group, the Yiqi Tongluo Xiezhuo prescription Astragalus-Huang control group, the Ganhuangcao group, the Huangqi-leech group, and the Biejia-seaweed group were compared to confirm the therapeutic effect of the Yiqi Tongluo Xiezhuo prescription in the treatment of chronic kidney disease, especially diabetic nephropathy. The experimental results showed that this prescription can effectively reduce creatinine in rats with unilateral nephrectomy + intraperitoneal injection of STZ, improve renal function, and delay the progression of the disease, further confirming its clinical effectiveness.

[0032] Compared with the prior art, the present invention has the following advantages and effects:

[0033] (1) The inventors first discovered that the Yiqi Tongluo Xiezhuo recipe has a good therapeutic effect on decreased glomerular filtration rate, deterioration of renal function, and especially increased creatinine caused by chronic kidney disease, and can significantly improve the clinical symptoms of patients with chronic kidney disease.

[0034] (2) The invigorating qi, unblocking collaterals and eliminating turbidity prescription provided by the present invention has the effects of invigorating the kidney and unblocking collaterals, eliminating turbidity and expelling pathogens, dispersing nodules and eliminating symptoms, and has no obvious abnormalities in liver function and coagulation function, and has high safety.

[0035] (3) Compared with the Chinese patent medicine Urea Clearing Granules strongly recommended by the expert consensus guidelines, the Yiqi Tongluo Xiezhuo prescription provided by the present invention has better effects in improving renal function and increasing glomerular filtration rate, and has faster recovery. It has broad application prospects in the field of chronic kidney disease treatment.

[0036] (4) The preparation method is to boil the raw materials with water and take it in three doses. It has the advantages of being adaptable to TCM syndrome differentiation and treatment, adding or subtracting according to symptoms, being quickly absorbed, having a strong effect and lasting for a long time. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 These are the results of renal tissue pathology of rats in each group; A is the control group, B is the model group, C is the Yiqi Tongluo Xiezhuo prescription group, D is the Yiqi Tongluo Xiezhuo prescription low-dose group, E is the Yiqi Tongluo Xiezhuo prescription Astragalus-Huangdi replacement group, F is the Ganhuangcao group, G is the Astragalus-Leech group, H is the Biejia-Seaweed group, A1-H1 are HE staining results; A2-H2 are Masson staining results.

[0038] Figure 2 This is a graph showing the effects of the Yiqi Tongluo Xiezhuo recipe and the Ganhuangcao group on the glomerular filtration rate of CKD patients; among them, YQXZTL represents the Yiqi Tongluo Xiezhuo recipe; GHC represents the Ganhuangcao group, the same below.

[0039] Figure 3 This is a graph showing the effects of the Yiqi Tongluo Xiezhuo recipe and the Ganhuangcao group on serum creatinine in CKD patients.

[0040] Figure 4 This is a graph showing the effects of the Yiqi Tongluo Xiezhuo recipe and the Astragalus-leech group on the glomerular filtration rate of CKD patients; where HQSZ represents the Astragalus-leech group, the same below.

[0041] Figure 5 This is a graph showing the effects of the Yiqi Tongluo Xiezhuo recipe and the Astragalus-Leech group on blood creatinine in CKD patients.

[0042] Figure 6 This is a graph showing the effects of the Yiqi Tongluo Xiezhuo recipe and the Astragalus-Leech group on 24-hour urine protein quantification in CKD patients.

[0043] Figure 7This is a graph showing the effects of Yiqitongluoxiezhuo prescription and Urea Clearing Granules on glomerular filtration rate in CKD patients; NDQ represents Urea Clearing Granules; ** indicates p < 0.01 compared with before medication (week 0), the same below.

[0044] Figure 8 This is a graph showing the effects of Yiqi Tongluo Xiezhuo prescription and Urea Clearing Granules on blood creatinine in CKD patients.

[0045] Fig. 9 This is a graph showing the effect of Yiqi Tongluo Xiezhuo prescription on glomerular filtration rate in CKD patients; where * indicates p < 0.05 compared with before medication (0 week); the same below.

[0046] Fig.10 This is a graph showing the effect of the Yiqi Tongluo Xiezhuo recipe on serum creatinine in CKD patients. DETAILED DESCRIPTION

[0047] The present invention is further described in detail below in conjunction with embodiments and drawings, but the embodiments of the present invention are not limited thereto.

[0048] Example 1 Experimental study on the efficacy of Yiqitongluoxiezhuo prescription aqueous extract in treating chronic kidney disease in rats

[0049] Unilateral nephrectomy + intraperitoneal injection of streptozotocin (STZ) is a classic diabetic nephropathy model, which is simple, has a high success rate, has long and stable duration of abnormal renal function and proteinuria, and has the characteristics of stable lesions. The main symptoms are persistent abnormal blood sugar, renal insufficiency, and persistent proteinuria, which are similar to the causes and pathological processes of human diabetic nephropathy. Therefore, the present invention uses unilateral nephrectomy + STZ as an experimental diabetic nephropathy model to explore whether the Yiqi Tongluo Xiezhuo recipe can improve the situation of decreased renal function caused by chronic kidney disease represented by diabetic nephropathy.

[0050] 1. Experimental Materials

[0051] (1) Experimental animals

[0052] 80 healthy male SPF SD rats aged 6-7 weeks, weighing 200±20g / rat, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. (Beijing, China), with a certificate number (SCXK(Su)2018-0008) and were kept in the SPF animal laboratory of Dongzhimen Hospital of Beijing University of Chinese Medicine. After 1 week of adaptive feeding, 70 of the 80 rats were subjected to unilateral (left) nephrectomy + unilateral intraperitoneal injection of STZ for modeling. The results of random blood glucose measurements for 3 days were all >16.7mmol / L, indicating that the modeling was successful. The experimental mice were raised in the Barrier Environment Experimental Animal Center of the Key Discipline Laboratory of Dongzhimen Hospital of Beijing University of Chinese Medicine, and the experimental procedures were carried out in accordance with the guidelines formulated by the Barrier Environment Experimental Animal Center of Dongzhimen Hospital of Beijing University of Chinese Medicine.

[0053] (2) Drugs and reagents

[0054] The following Chinese medicines are from the herbal medicine room of Beijing University of Chinese Medicine Dongzhimen Hospital:

[0055] Recipe for replenishing qi, unblocking channels and eliminating turbidity (per dose): 40g of Astragalus, 5g of Leech, 60g of Herba Chrysanthemi Indici, 15g of Seaweed, and 15g of Carapace of Turtle;

[0056] Low-dose group of Yiqitongluoxiezhuo prescription (per dose): 20g of Astragalus, 2.5g of Leech, 30g of Herba Chrysanthemi Indici, 7.5g of Sargassum, and 7.5g of Carapace of Turtle;

[0057] The yangqi and ganhuangcao substitution group of the Yiqitongluoxizhu prescription (per dose): Heishun tablets 40g, leeches 5g, cooked rehmannia 60g, seaweed 15g, turtle shell 15g;

[0058] Ganhuangcao decoction (per dose): Ganhuangcao 135g;

[0059] "Astragalus-leech" decoction (per dose): 120g of Astragalus, 15g of Leech;

[0060] "Turtle Shell-Seaweed" decoction (per dose): 67.5g seaweed, 67.5g turtle shell.

[0061] Sodium citrate buffer at pH 4.5 (Beijing Solebow Technology Co., Ltd.); streptozotocin (Sigma-Aldrich, USA); serum creatinine (Scr) kit, blood urea nitrogen (UREA), blood uric acid (UA), urine protein quantification (UTP) kit (all provided by Nanjing Jiancheng Bioengineering Institute); blood glucose meter, blood glucose test strips (all provided by Roche, Germany); HE staining kit, Masson staining kit (both provided by Nanjing Jiancheng Bioengineering Institute).

[0062] 2. Experimental Methods

[0063] (1) Preparation of Chinese medicine prescriptions

[0064] 1) Cut the pieces of Chinese medicine in the Yiqitongluoxizhuo prescription group, Yiqitongluoxizhuo prescription low-dose group, Ganhuangcao decoction group, "Huangqi-Shuizhi" decoction group, and "Biejia-Haizao" decoction group into pieces, add water at a material-liquid ratio of 1:3 (g / mL), and boil for 40 minutes to obtain the liquid and residue. Cut the pieces of Chinese medicine in the Yiqitongluoxizhuo prescription Huangqi-Ganhuangcao substitution group into pieces, add water at a material-liquid ratio of 1:3 (g / mL), and boil for 60-90 minutes.

[0065] 2) Re-decocting the residue once according to the step of adding water and decocting in step 1); combining the medicinal solution obtained in step 1) and the aforementioned re-decocting step to obtain the experimental medicinal solution.

[0066] (2) Establishment of animal model

[0067] SD rats were taken and adaptively fed for 1 week, and then randomly divided into sham operation group and operation group. All rats were fasted for 12 hours before surgery, and after intraperitoneal injection of 1% sodium pentobarbital for anesthesia, the left kidney was removed in the operation group, and finally the tissue was sutured layer by layer to close the abdomen. After the left kidney was exposed in the sham operation group, the abdomen was directly closed by suture. Before closing the abdomen, the abdominal fluid was wiped dry with a clean cotton ball, and an appropriate amount of cephalosporin powder was sprinkled on all wounds. Two weeks after surgery, all rats were fasted for 12 hours, and STZ (50 mg / kg) was injected intraperitoneally once in the operation group, while the sham operation group was injected intraperitoneally with an equal volume of sodium citrate buffer. Blood sugar was tested 2 hours after injection. The results for three consecutive days (including the day) were all >16.7mmol / L, indicating that the model was successfully established.

[0068] (3) Experimental grouping and drug administration

[0069] Ten rats were selected from the sham operation group and 70 rats were selected from the operation group. The sham operation group did not receive any intervention, and the same volume of normal saline was gavaged as the model group. And 70 rats with successful modeling were randomly divided into model group and Yiqitongluoxiezhuo prescription group, Yiqitongluoxiezhuo prescription low-dose group, Yiqitongluoxiezhuo prescription astragalus-ganhuangcao substitute group, Ganhuangcao group, "Astragalus-leech" group, "Biejia-seaweed" group. The model group was given equal volume of normal saline by gavage, and the Chinese medicine groups were given Yiqitongluoxiezhuo prescription, Ganhuangcao, Astragalus-leech, and Biejia-seaweed intervention (Yiqitongluoxiezhuo prescription, Yiqitongluoxiezhuo prescription astragalus-ganhuangcao substitute group, Ganhuangcao, Astragalus-leech group, Biejia-seaweed group: water extract 12.42mL / kg / d, equivalent to crude drug 18.64g / kg / d, Yiqitongluoxiezhuo prescription low-dose group: water extract 12.42mL / kg / d, equivalent to crude drug 9.32g / kg / d). The drugs were given continuously for 8 weeks by gavage, once a day.

[0070] (4) Detection method

[0071] 1) General observation

[0072] The general condition of mice, including their mental state, food intake, water intake, urine output, feces output, body weight, body hair, and activity. After administration, general symptoms were continuously observed to see if the animals showed any abnormal symptoms. After sampling, the kidney weight / body weight ratio was measured.

[0073] 2) Blood glucose monitoring

[0074] After the model was successfully established, the 8 groups of rats were fasted but not watered overnight at the 0th, 4th and 8th weeks of administration. After the tail vein was fully congested, 1 mm of the tail tip was cut off with scissors, the first drop of blood was wiped, and the second drop of blood was dropped onto a blood glucose test strip to measure the fasting blood glucose level of the mice.

[0075] 3) Urine protein monitoring

[0076] After the model was successfully established, the 8 groups of rats were placed in metabolic cages for 24 hours before sampling, and the rats' 24-hour urine was collected and the urine volume was recorded. The urine was then mixed and centrifuged (4°C, 3000 rpm for 10 min). The supernatant was taken and the urine sample was tested using a urine albumin quantitative (UTP) detection kit.

[0077] 4) Renal function test

[0078] After 8 weeks of administration, the rats were fasted for 12 h, blood was collected through the abdominal aorta, and after standing for 30 min, the blood was centrifuged at 4°C and 3500 rpm for 15 min. Serum samples were collected and packaged, and tested according to the instructions of the serum creatinine (Scr) kit.

[0079] 5) Kidney pathology test

[0080] After blood collection, rats were dissected and rat kidney tissues were fixed in 4% paraformaldehyde for 48 h, then dehydrated with ethanol gradient, transparentized with xylene, immersed in wax, and embedded in paraffin to prepare 3 μm sections, baked at 60 ° C for 60 min, dewaxed and hydrated, and stained with hematoxylin-eosin (HE) and Masson (MASSON) according to the instructions of the kit. The pathology of kidney tissue was observed under an optical microscope and images were collected.

[0081] (5) Statistical methods

[0082] SPSS26.0 was used for statistics. The measured data were expressed as mean ± standard deviation (x ± s). The inter-group comparison was performed using multivariate F test or nonparametric rank sum analysis based on whether the groups were normally distributed. P < 0.05 indicated statistical significance.

[0083] 3. Experimental results

[0084] (1) Effects of Yiqitongluoxiezhuo prescription on the general condition of rats

[0085] During the administration period, the rats in the sham operation control group grew well, with shiny fur, active spirits, and stable weight gain. The rats in the model group were listless, significantly emaciated, had increased food intake, increased urine output, and dry and falling hair. In the later stage of feeding, various diabetic complications gradually emerged in the rats in the model group. Two cases developed blindness due to possible diabetic fundus lesions, and one case had a more serious hemiplegia. Compared with the rats in the model group, the diabetic complications of the rats in the Yiqi Tongluo Xiezhuo prescription group were milder, without blindness or hemiplegia, and the overall condition tended to be good as the administration time prolonged.

[0086] (2) Effects of Yiqitongluoxiezhuo prescription on body weight and kidney weight / body weight ratio in rats

[0087] During the experimental stage, the weight of rats in the sham operation control group increased steadily, while the weight of rats in the model group and the Yiqi Tongluo Xiezhuo group increased less. In the 0th, 4th, and 8th weeks of the drug administration phase, there was no significant statistical difference in the weight of rats in the model group and the Yiqi Tongluo Xiezhuo group (P>0.05). The kidney weight was weighed after sampling in the 8th week of the experiment. The results showed that the kidney weight / body weight ratio of rats in the model group was significantly higher than that in the sham operation control group, and the difference was statistically significant (P<0.01); compared with the model group, the kidney weight / body weight ratio of rats in the Yiqi Tongluo Xiezhuo group was reduced, and the difference was statistically significant (P<0.05). The specific results are shown in Tables 1 and 2.

[0088] Table 1 Effects of different groups on rat body weight

[0089]

[0090] Table 2 Effects of different groups on the kidney weight / body weight ratio of rats

[0091]

[0092]

[0093] Note: Compared with the sham operation group, **P<0.01; compared with the model group, # P<0.05, ○ P<0.05

[0094] (3) Effect of Yiqitongluoxiezhuo prescription on serum creatinine in rats

[0095] After the 8th week of the experiment, the ELSIA method was used to detect the concentrations of serum creatinine, blood urea nitrogen, and blood uric acid in rats of each group. The results showed that compared with the rats in the sham operation control group, the serum creatinine, blood uric acid, cystatin c (P < 0.01), and blood urea nitrogen (P < 0.05) of the model group rats were significantly increased; compared with the model group rats, the serum creatinine, blood urea nitrogen, and cystatin c of the Yiqi Tongluo Xiezhuo prescription group rats were significantly decreased, and the difference was statistically significant (P < 0.01); the ability of the other groups to reduce serum creatinine, blood urea nitrogen, and cystatin c was weaker than that of the Yiqi Tongluo Xiezhuo prescription (see Table 3).

[0096] Table 3 Effects of different groups on serum creatinine in rats

[0097]

[0098] Note: Compared with the sham operation group, **P<0.01, *P<0.05; compared with the model group, ## P<0.01, # P<0.01, □ P<0.05, ▲ P<0.05,● P<0.05, ○○ P<0.01, ○ P<0.05, △ P<0.05.

[0099] (4) Effect of Yiqitongluoxiezhuo prescription on 24-hour urine protein in diabetic rats

[0100] In the 8th week of the experiment, 24-hour urine was collected before sampling, and the ELSIA method was used to detect the quantitative 24-hour urine protein of rats in each group. The results showed that compared with the sham operation control group, the 24-hour urine albumin content of the model group rats was significantly increased, and the difference was statistically significant (P < 0.01); compared with the model group rats, the 24-hour urine albumin content of the Yiqi Tongluo Xiezhuo group rats was significantly decreased, and the difference was statistically significant (P < 0.05); the ability of the other groups to reduce the quantitative 24-hour urine protein was weaker than that of the Yiqi Tongluo Xiezhuo (see Table 4).

[0101] Table 4 Effects of different groups on 24h urine protein quantification in rats

[0102]

[0103]

[0104] Note: Compared with the sham operation group, **P<0.01; compared with the model group, # P<0.05, ▲ P<0.05, ● P<0.05, □ P<0.05, ○ P<0.05

[0105] (5) Effect of Yiqitongluoxiezhuo prescription on blood glucose in rats

[0106] The blood glucose levels of the rats were measured at the 0th, 4th and 8th weeks of the treatment phase. The results showed that compared with the rats in the sham operation control group, the blood glucose of the model group was significantly increased (p < 0.01); there was no significant difference in the blood glucose between the rats in the Yiqi Xiezhuo Tongluo prescription, the Yiqi Tongluo Xiezhuo prescription low-dose group, the Yiqi Tongluo Xiezhuo prescription Astragalus-Huang substitution group, the Ganhuangcao group, the Huangqi-Shuizhi group, and the Biejia-Saline group and the model group (p > 0.05); compared with the rats in the model group, there was no significant change in the blood glucose of the rats in the other prescriptions at the 4th and 8th weeks (p > 0.05) (see Table 5).

[0107] Table 5 Effects of different groups on blood glucose in rats

[0108]

[0109] Note: Compared with the sham operation group, **P<0.01

[0110] (6) Anti-aging effect of Yiqitongluoxiezhuo prescription on rat kidney

[0111] Klotho is a protein related to anti-aging discovered in modern times. Klotho protein is mainly expressed in the epithelial cells of the distal tubules of the kidney, and α-klotho is its most important protein subtype and functional type. Klotho can play a renal protective role in a variety of acute and chronic kidney diseases such as acute kidney injury, ischemic nephropathy, hypertensive renal damage, and diabetic nephropathy, and the decrease in serum klotho expression is considered to be one of the signs of kidney disease progression. Studies have shown that serum α-klotho can be reduced in the early stage of DKD and further reduced with the decrease in eGFR. After sampling at the 8th week of the experiment, the ELSIA method was used to detect the expression level of serum α-klotho in rats of each group. The results are shown in Table 6. Compared with the rats in the sham operation control group, the expression level of serum α-klotho in the model group rats was significantly reduced (P < 0.01); compared with the rats in the model group, the expression level of this protein in the Yiqi Tongluo Xiezhuo group rats was significantly increased, and the difference was statistically significant (P < 0.01). Compared with the Yiqi Tongluo Xiezhuo recipe, the other groups had lower anti-kidney aging ability.

[0112] Table 6 α-klotho expression levels in rats of different groups

[0113]

[0114] Note: Compared with the sham operation group, **P<0.01; compared with the model group, # P<0.05

[0115] (7) Effect of Yiqitongluoxiezhuo prescription on renal pathological manifestations in rats

[0116] like Figure 1 As shown: HE staining results showed that the glomerular, interstitial and tubular structures of rats in the sham control group were basically normal, the glomerular loops were clear, and the number of endothelial cells and mesangial cells was normal. The renal tissues of rats in the model group showed thickening of the glomerular basement membrane, proliferation of mesangial cells, and sclerosis of some glomeruli; a small amount of inflammatory cells infiltrated the tubular interstitium, and the tubular epithelial cells showed obvious vacuolar degeneration and shedding, and some tubules had obvious tubular expansion, accompanied by edema. The fibrous tissue of the glomerular interstitium proliferated significantly. Compared with the model group, the above conditions of the renal tissues of rats in the other groups were alleviated to varying degrees, and the Yiqi Tongluo Xiezhuo group was the most obvious. Masson staining results showed that the glomerular and tubular perivascular tissue structures of rats in the sham control group were normal, and there was no blue collagen deposition. There were more blue collagen depositions in the glomeruli and tubular interstitium of rats in the model group. There were fewer blue collagen depositions in the glomeruli and tubular interstitium of rats in the Yiqi Tongluo Xiezhuo group.

[0117] Conclusion: In this experiment, the inventors used the diabetic nephropathy model of rats with STZ combined with unilateral nephrectomy to evaluate the treatment of DKD patients with Yiqi Tongluo Xiezhuo prescription. Kidney hypertrophy is an early change in diabetic nephropathy, and the kidney weight / body weight ratio is a relatively objective indicator for measuring kidney hypertrophy. Proteinuria is a hallmark of glomerular lesions in diabetic nephropathy, and these lesions can gradually develop into tubulointerstitial lesions, leading to renal insufficiency. Therefore, clinically, reducing proteinuria is considered to be the main therapeutic target for improving renal prognosis in patients with diabetic nephropathy. The results of this study suggest that after 8 weeks of treatment, the general condition, kidney weight / body weight ratio, blood creatinine, 24-hour urine albumin quantification and other indicators of the rats in the Yiqi Tongluo Xiezhuo prescription group have improved to a certain extent compared with the rats in the model group; Yiqi Tongluo Xiezhuo prescription (standard amount) reduces creatinine, urea nitrogen, uric acid, cystatin C, and reduces urinary protein more strongly than the low-dose Yiqi Tongluo Xiezhuo prescription; Rehmannia glutinosa and Aconite are one of the most commonly used traditional Chinese medicines in the field of chronic kidney disease, so the use of Heishun Shunzhi The innovativeness and rigor of the prescription were proved by using 40g of slices of Yiqitongluo Xiezhuo and 60g of cooked rehmannia to replace 40g of astragalus and 60g of Ganhuangcao. The effect of Yiqitongluo Xiezhuo prescription on reducing creatinine, urea nitrogen, uric acid, cystatin C and reducing urine protein was stronger than that of Yiqitongluo Xiezhuo prescription with Qi-Huang substitution. The effect of Yiqitongluo Xiezhuo prescription on reducing creatinine, urea nitrogen, uric acid, cystatin C and reducing urine protein was stronger than that of the separated prescription groups (Ganhuangcao group, Huangqi-leech group, and Biejia-seaweed group). Yiqitongluo Xiezhuo prescription was significantly superior to Yiqitongluo Xiezhuo prescription low-dose group, Yiqitongluo Xiezhuo prescription with Qi-Huang substitution group, Ganhuangcao group, Huangqi-leech group, and Biejia-seaweed group in delaying renal aging. It shows that Yiqitongluo Xiezhuo prescription has a good effect in improving renal function of chronic kidney disease, especially diabetic nephropathy, reducing proteinuria and improving renal tissue pathology.

[0118] Example 2 Clinical study on the efficacy of Yiqitongluoxizhuo prescription, Ganhuangcao group and "Huangqi-Shuizhi" group in the treatment of chronic kidney disease

[0119] The inventor team used a parallel and controlled method in this stage to compare the use of Yiqi Tongluo Xiezhuo prescription or the Ganhuangcao group and the "Astragalus-leech" group decoctions in the treatment of chronic kidney disease patients based on Western medicine basic treatment. The control drugs selected were Ganhuangcao decoction and "Huangqi-leech" decoction.

[0120] (1) Preparation of Yiqitongluoxiezhu prescription: add 40g of Astragalus, 5g of Leech, 60g of Herba Astragali, 15g of Sargassum, and 15g of Carapace of Turtle, add water at a material-liquid ratio of 1:3 (g / mL), decoct twice, each time for 40 min, obtain the medicinal solution and the residue, and combine the filtrate to obtain the medicinal solution.

[0121] Preparation of the Herba Glehniae group: 100 g of Herba Glehniae was added with water at a solid-liquid ratio of 1:3 (g / mL), and decocted twice, each time for 40 min, to obtain the medicinal solution and residue, and the filtrate was combined.

[0122] Preparation of Astragalus-Leech Group: 90g Astragalus and 9g Leech were added with water at a solid-liquid ratio of 1:3 (g / mL), and decocted twice, each time for 40 min, to obtain the medicinal solution and residue, and the filtrate was combined.

[0123] (2) Subjects and inclusion criteria: Patients diagnosed with chronic kidney disease who visited the Dongzhimen Hospital of Beijing University of Chinese Medicine between September 2022 and June 2023 were included. The patient medical records were retrospectively analyzed.

[0124] Inclusion criteria: ① Meet the diagnostic criteria of CKD stage II-IV of the KIDIGO guidelines and effectively control reversible factors that may lead to disease aggravation or progression: such as infection, electrolyte imbalance, hypertension, hyperglycemia, etc.; ② Age 18-75 years old; ③ Secondary chronic renal failure caused by systemic lupus erythematosus, patients who have received or are receiving dialysis treatment, and renal transplant patients are not included in the inclusion criteria; ④ Patients with severe primary diseases of organs or systems such as heart, liver, brain, and blood, or patients with wasting diseases such as tumors, hyperthyroidism, and severe inflammation are not included in the inclusion criteria; ⑤ Patients who have participated in clinical trials within 3 months or have used glucocorticoids, immunosuppressive drugs, and tripterygium preparations, or are receiving the above treatments are not included in the inclusion criteria; ⑥ Patients with 24-hour urine protein ≥3.0g and serum albumin ≤25g / L are not included in the inclusion criteria; ⑦ Pregnant or lactating women and those known to be allergic to drug ingredients are not included in the inclusion criteria; ⑧ Patients with a GFR fluctuation range of ≥30% within the first 3 months of the group are not included in the inclusion criteria.

[0125] (3) Methods: The study adopted a parallel, split-prescription control method to compare the differences in the treatment of patients with Yiqi Tongluo Xiezhuo prescription or the Ganhuangcao group and the "Huangqi-Shuizhi" group on the basis of Western medicine treatment. Before the treatment with Yiqi Tongluo Xiezhuo prescription or the Ganhuangcao group or the "Huangqi-Shuizhi" group, the patients were mainly treated with Western medicine. Those who had taken Chinese patent medicine were given a 4-week clinical washout period to eliminate the influence. The treatment with Yiqi Tongluo Xiezhuo prescription was the addition of Yiqi Tongluo Xiezhuo prescription to the basis of Western medicine treatment; the Ganhuangcao group was the addition of Ganhuangcao decoction to the basis of Western medicine treatment; the "Huangqi-Shuizhi" group was the addition of Huangqi and leech decoction to the basis of Western medicine treatment. The Yiqi Tongluo Xiezhuo prescription, the Ganhuangcao group, and the "Huangqi-Shuizhi" group were taken as one dose per day, divided into three doses, with 28 days as one course of treatment, and each medicine was treated for 2 courses.

[0126] (4) Main observation indicators:

[0127] Main efficacy index: Glomerular filtration rate (eGFR), glomerular filtration formula: eGFR = 170 × (Scr) - 1.234 × (age) - 0.179 × (0.79 female / 1 male);

[0128] Secondary efficacy indicators: serum creatinine (Scr), urea nitrogen (BUN), serum uric acid (UA), 24h urine protein (24h-UTP), and blood lipids (TC, TG);

[0129] Safety indicators: liver function (ALT, AST).

[0130] (5) Statistical methods

[0131] SPSS26.0 was used for statistical analysis. The measured data were expressed as mean ± standard deviation (x ± s). Depending on whether the two groups of samples were normally distributed, two-sample t-test or rank sum test was used. P < 0.05 indicated statistical significance.

[0132] (6) Results

[0133] (A) Comparison of efficacy and safety between Yiqitongluoxiezhuo prescription and Ganhuangcao group

[0134] The test results are shown in Tables 8 to 11 and Figures 2-3 As shown:

[0135] Table 7 Comparison of general data between Yiqitongluoxiezhuo prescription and Ganhuangcao group

[0136]

[0137] Table 8 Effects of Yiqitongluoxizhuo prescription and Ganhuangcao group on glomerular filtration rate

[0138]

[0139] Table 9 Effects of Yiqitongluoxizhuo prescription and Ganhuangcao group on renal function and 24-hour urine protein

[0140]

[0141]

[0142] Table 10 Effects of Yiqitongluoxizhuo prescription and Ganhuangcao group on blood lipids in the treatment of chronic kidney disease

[0143]

[0144] Table 11 Safety indexes of Yiqitongluoxiezhuo prescription and Ganhuangcao group

[0145]

[0146] (B) Comparison of efficacy and safety between Yiqitongluoxiezhuo prescription and Huangqi-leech group

[0147] The test results are shown in Tables 13 to 16 and Figures 4 to 6 As shown:

[0148] Table 12 Comparison of general data between the Yiqi Tongluo Xiezhuo prescription and the Huangqi-Shuizhi group

[0149]

[0150] Table 13 Effects of Yiqitongluoxizhuo prescription and Huangqi-leech group on glomerular filtration rate

[0151]

[0152] Table 14 Effects of Yiqitongluoxiezhuo prescription and Huangqi-leech group on renal function and 24-hour urine protein

[0153]

[0154] Table 15 Effects of Yiqitongluoxiezhuo prescription and Huangqi-leech group on blood lipids in the treatment of chronic kidney disease

[0155]

[0156] Table 16 Safety indexes of Yiqitongluoxiezhuo prescription and Huangqi-leech group

[0157]

[0158] Conclusion: Through clinical research, the inventor found that the Yiqi Tongluo Xiezhuo prescription is clinically superior to the Ganhuangcao decoction and the "Huangqi-Shuizhi" decoction in the treatment of chronic kidney disease. Modern pharmacological studies on Ganhuangcao have confirmed that it has the effects of reducing proteinuria, lowering creatinine, and protecting liver function; "Huangqi-Shuizhi" is a commonly used drug pair in modern clinical practice, which can be used to treat cardiovascular and cerebrovascular, respiratory and kidney diseases. Studies have shown that this drug pair has the effects of inhibiting inflammation, alleviating fibrosis, and protecting renal function. This study shows that the Yiqi Tongluo Xiezhuo prescription has advantages in improving glomerular filtration rate and reducing blood creatinine. Both can reduce urine protein, blood uric acid, and blood urea nitrogen levels; at the same time, compared with the "Huangqi-Shuizhi" decoction, the Yiqi Tongluo Xiezhuo prescription not only has advantages in improving glomerular filtration rate, reducing creatinine levels, and reducing proteinuria, but also shows that the Yiqi Tongluo Xiezhuo prescription has a certain lipid-lowering ability. In addition, safety studies have shown that the Yiqi Tongluo Xiezhuo recipe, Ganhuangcao and "Huangqi-Shuizhi" are all clinically safe. The results suggest that the Yiqi Tongluo Xiezhuo recipe is more effective and safer than Ganhuangcao or "Huangqi-Shuizhi" alone in improving renal function in chronic kidney disease, especially diabetic nephropathy, and is worthy of clinical application and promotion.

[0159] Example 3 Clinical study on the comparative efficacy of Yiqitongluoxiezhuo prescription and Urea Clearing Granule in the treatment of chronic kidney disease

[0160] The inventor team used a parallel, positive drug control method to compare the use of Yiqi Tongluo Xiezhuo prescription or Urea Qing granules in the treatment of chronic kidney disease patients based on Western medicine basic treatment. Urea Qing granules were selected as the positive control drug.

[0161] (1) Preparation of Yiqitongluoxiezhuo prescription: same as Example 2(1).

[0162] Urea Clearing Granules: Specification: 5g / bag, 18 bags / box, produced by Guangxi Yulin Pharmaceutical Group Co., Ltd. and purchased by Dongzhimen Hospital of Beijing University of Chinese Medicine.

[0163] (2) Subjects and inclusion criteria: Same as Example 2(2).

[0164] (3) Methods: The study used the parallel, split prescription and positive drug control methods to compare the treatment differences of using Yiqi Tongluo Xiezhuo prescription or Urea Duqing granules on the basis of Western medicine treatment. Before the treatment with Yiqi Tongluo Xiezhuo prescription or Urea Duqing granules, the main treatment was Western medicine basic treatment. Those who had taken Chinese patent medicine were given a 4-week clinical washout period to eliminate the effects. The treatment with Yiqi Tongluo Xiezhuo prescription was the addition of Yiqi Tongluo Xiezhuo prescription to the basic treatment of Western medicine; the treatment with Urea Duqing granules was the addition of Urea Duqing granules to the basic treatment of Western medicine. The method of taking Yiqi Tongluo Xiezhuo prescription was the same as that in Example 2 (3). The method of taking Urea Duqing granules was 4 times a day, 1 bag each at 6, 12 and 18 o'clock, and 2 bags at 22 o'clock. 28 days was a course of treatment, and the two medicines were taken for 2 courses each.

[0165] (4) Main observation indicators: Example 2(4).

[0166] (5) Statistical methods

[0167] SPSS26.0 was used for statistical analysis. The measured data were expressed as mean ± standard deviation (x ± s). Depending on whether the two groups of samples were normally distributed, two-sample t-test or rank sum test was used. The inter-group data were compared using F test or nonparametric rank sum analysis. P < 0.05 indicated statistical significance.

[0168] (6) Results

[0169] (A) Comparison of general data of patients with chronic kidney disease treated with Urea Clearing Granules

[0170] Table 17 Comparison of general data between Yiqitongluoxiezhuo prescription and Urea clearing granules

[0171]

[0172] (B) Comparison of efficacy indicators of Yiqi Tongluo Xiezhuo prescription and Niaodu Qing granules in the treatment of chronic kidney disease, see Tables 18-21 and Figures 7-8 :

[0173] Table 18 Effects of Yiqitongluoxiezhuo prescription and Urea clearing granules on glomerular filtration rate

[0174]

[0175]

[0176] Table 19 Effects of Yiqitongluoxiezhuo Decoction and Urea Clearing Granules on Renal Function

[0177]

[0178] Table 20 Effects of Yiqitongluoxiezhuo Decoction and Urea Clearing Granules on 24-hour urine protein

[0179]

[0180] Table 21 Comparison of the effective rate of Yiqitongluoxiezhuo prescription and Urea Clearing Granules in the treatment of 24-hour urine protein

[0181]

[0182] (C) Comparison of secondary efficacy indicators between Yiqitongluoxiezhuo prescription and Niaoduqing granules in the treatment of chronic kidney disease

[0183] Table 22 Comparison of secondary efficacy indicators between Yiqitongluoxiezhuo prescription and Urea clearing granules in the treatment of chronic kidney disease

[0184]

[0185]

[0186] (D) Comparison of safety indicators between the two groups of patients

[0187] Table 23 Comparison of safety indicators between Yiqitongluoxiezhuo prescription and Urea clearing granules in the treatment of chronic kidney disease

[0188]

[0189] There were no obvious changes in the electrocardiogram of patients taking Yiqi Tongluo Xiezhuo prescription and Niaodu Qing granules before and after medication, and no significant statistical difference was found between the two.

[0190] Conclusion: After clinical exploration, the inventors found that the Yiqi Tongluo Xiezhuo prescription is clinically superior to the Urea Qing granules in the treatment of chronic kidney disease. Urea Qing granules are composed of rhubarb, astragalus, mulberry bark, sophora flavescens, plantain, atractylodes, tuckahoe, white peony root, processed Polygonum multiflorum, and salvia miltiorrhiza. They have the effects of clearing the abdomen and eliminating turbidity, strengthening the spleen and removing dampness, and promoting blood circulation and removing blood stasis. They are strongly recommended drugs in the 2020 Chinese patent medicine clinical application guidelines for the treatment of chronic kidney disease stages 3 to 5 (non-dialysis). The guidelines indicate that on the basis of standardized Western medicine treatment, the addition of Urea Qing granules can reduce serum creatinine levels, delay the decline of eGFR, and may delay the progression of CKD. Yiqi Tongluo Xiezhuo prescription has therapeutic advantages over Urea Qing granules in improving glomerular filtration rate, reducing blood creatinine, reducing blood uric acid, and reducing urine protein. In addition, Yiqi Tongluo Xiezhuo prescription is better than Urea Qing granules in reducing blood urea nitrogen and cystatin C levels. The research results suggest that the Yiqi Tongluo Xiezhuo prescription is more effective and safer than the guideline-strongly recommended drug Urea Clearing Granules in improving renal function in chronic kidney disease, especially diabetic nephropathy, and is worthy of clinical application and promotion.

[0191] Example 4 Clinical study on the Yiqitongluoxiezhuo prescription in the treatment of chronic kidney disease

[0192] (1) Preparation of Yiqitongluoxiezhuo prescription: same as Example 2(1).

[0193] (2) Object: Same as Example 2(2).

[0194] (3) Methods: The study used a self-control before and after to compare the differences between basic Western medicine treatment and Yiqi Tongluo Xiezhuo prescription treatment. Before the Yiqi Tongluo Xiezhuo prescription treatment, the patients were mainly treated with basic Western medicine treatment. Those who had taken Chinese patent medicine were given a 2-week clinical washout period to eliminate the influence. The Yiqi Tongluo Xiezhuo prescription treatment was a combination of basic Western medicine treatment and Yiqi Tongluo Xiezhuo prescription. Yiqi Tongluo Xiezhuo prescription was decocted in water (the decocting method is shown in Example 2 (1)), one dose per day, divided into three doses, 28 days as one course of treatment, and at least 2 courses of treatment.

[0195] (4) Main observation indicators:

[0196] Main efficacy outcome measures: estimated glomerular filtration rate (eGFR);

[0197] Secondary efficacy indicators: serum creatinine (Scr), urea nitrogen (BUN), serum uric acid (UA), 24h urine protein (24h-UTP), four blood lipids (TC, TG, HDL-C, LDL-C), hemoglobin (HGB);

[0198] Safety indicators: liver function (ALT, AST), electrocardiogram, four coagulation tests (TP, APTT, TT, FIB).

[0199] (5) Statistical methods

[0200] SPSS26.0 was used for statistical analysis. The measured data were expressed as mean ± standard deviation (x ± s). Paired sample t-test was used before and after treatment. P < 0.05 indicated statistical significance.

[0201] (6) Results

[0202] (A) General information on the Yiqi Tongluo Xiezhuo prescription for the treatment of chronic kidney disease

[0203] Table 24 General information of patients with Yiqitongluoxiezhuo prescription

[0204]

[0205] (B) The efficacy indicators of Yiqi Tongluo Xiezhuo prescription in treating chronic kidney disease are shown in Tables 25-27 and Figures 9-10 :

[0206] Table 25 Effect of Yiqitongluoxiezhuo prescription on glomerular filtration rate

[0207]

[0208] Table 26 Effect of Yiqitongluoxiezhuo prescription on renal function

[0209]

[0210] Table 27 Effect of Yiqitongluoxiezhuo prescription on 24-hour urine protein

[0211]

[0212] (C) Secondary efficacy indicators of Yiqitongluoxiezhuo prescription in the treatment of chronic kidney disease

[0213] Table 28 Secondary efficacy indicators of Yiqitongluoxiezhuo prescription in the treatment of chronic kidney disease

[0214]

[0215] (D) Safety indicators of Yiqitongluoxiezhuo prescription in the treatment of chronic kidney disease

[0216] Table 29 Safety indicators of Yiqitongluoxiezhuo prescription in the treatment of chronic kidney disease

[0217]

[0218]

[0219] There were no obvious lesions in the electrocardiogram of patients taking Yiqitongluoxiezhuo prescription before and after medication. Conclusion: After years of clinical exploration, the inventor found that Yiqitongluoxiezhuo prescription has significant clinical effect in the treatment of chronic kidney disease. It can not only improve the patient's fatigue, edema, increased urine foam, sticky stool, thick and greasy tongue coating and other discomfort symptoms, but also improve the patient's renal function, increase glomerular filtration rate, reduce blood creatinine, blood uric acid, blood urea nitrogen, cystatin C levels, etc., and reduce proteinuria. The inventor took patients with chronic kidney disease as the research group, and especially selected diabetic nephropathy with a high incidence rate for clinical and basic research. The results show that Yiqitongluoxiezhuo prescription has good efficacy and high safety in the treatment of chronic kidney disease, especially diabetic nephropathy, and is worthy of clinical application and promotion.

[0220] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications made without departing from the spirit and principles of the present invention shall be equivalent replacement methods and shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating chronic kidney disease, characterized in that The invention is composed of the following ingredients by weight: 35-45 parts of astragalus, 3-7 parts of leech, 55-65 parts of yellow grass, 10-20 parts of seaweed and 10-20 parts of turtle shell.

2. Use of the Chinese medicine composition for treating chronic kidney disease according to claim 1 in the preparation of a preparation for treating chronic kidney disease.

3. The use according to claim 2, characterized in that The method comprises the following steps: extracting the Chinese medicine composition for treating chronic kidney disease according to claim 1, and preparing the desired dosage form with the obtained extract.

4. The use according to claim 3, characterized in that: The extraction is water extraction.

5. The use according to claim 4, characterized in that: The steps of water extraction are as follows: (1) soaking the above-mentioned Chinese medicine composition for treating chronic kidney disease in water, followed by decocting and solid-liquid separation to obtain a medicinal solution and medicinal residues; (2) Repeat the decoction of the medicinal residue for more than 0 times; (3) The medicinal liquids obtained in step (1) and step (2) are combined to obtain a water extract; when the number of repeated decoctions is 0, the medicinal liquid obtained in step (1) is the water extract.

6. The use according to claim 5, characterized in that: The amount of water in step (1) is calculated according to the Chinese medicine composition for treating chronic kidney disease according to claim 1 or 2: water = solid-liquid ratio of 1:1 to 1:5 g / mL; The decoction time in step (1) is 30 to 60 minutes; The amount of water used in the repeated decoction in step (2) is calculated according to the Chinese medicine composition for treating chronic kidney disease according to claim 1 or 2: water = solid-liquid ratio of 1:1 to 1:5 g / mL; The time for repeated decoction in step (2) is 30 to 60 minutes.

7. The use according to claim 3, characterized in that: The dosage form is decoction, pill, powder, paste, pill, granule, oral liquid, capsule or tablet; The preparations include ordinary preparations, sustained-release preparations, controlled-release preparations, and targeted preparations.

8. The use according to any one of claims 2 to 7, characterized in that: The chronic kidney disease is diabetic nephropathy.

9. A preparation for treating chronic kidney disease, characterized in that: It is prepared from the Chinese medicine composition for treating chronic kidney disease as described in claim 1.

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