Application of traditional Chinese medicine composition in medicine for treating chronic kidney diseases

Abstract

The invention provides an application of a traditional Chinese medicine composition in a medicine for treating chronic kidney diseases. The traditional Chinese medicine composition comprises 10-30 parts of cynomorium songaricum, 15-35 parts of cistanche (steamed), 20-40 parts of prepared radix morindae officinalis, 15-35 parts of fructus psoraleae (fried with salt), 10-30 parts of semen cuscutae, 15-35 parts of eucommia ulmoides (charred), 15-35 parts of illicium verum, 10-30 parts of semen allii tuberosi, 10-30 parts of semen euryales (fried), 10-30 parts of lotus seeds, 15-35 parts of stamen nelumbinis, 7-27 parts of dogwood (prepared), 10-30 parts of oyster (calcined), 10-30 parts of dragon bone (calcined), 10-30 parts of cornu cervi degelatinatum, 20-70 parts of prepared rehmannia root and 5-20 The traditional Chinese medicine is prepared from 30-70 parts of Chinese yam, 5-20 parts of poria cocos, 5-20 parts of rhizoma alismatis, 1-10 parts of rhizoma anemarrhenae, 1-10 parts of cortex phellodendri, 10-30 parts of radix achyranthis bidentatae and 15-35 parts of halite. Through verification, the traditional Chinese medicine composition has a certain treatment effect on chronic kidney diseases and can be further applied to preparation of the medicine for treating the chronic kidney diseases, the application range of the traditional Chinese medicine composition is expanded, and new treatment medicine and means are provided for improving kidney function indexes of CKD people and protecting kidney tissue damage.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and more particularly to the application of a traditional Chinese medicine composition in a medicament for treating chronic kidney disease. Background Technology

[0002] Suoyang Gujing Wan (Cistanche and Sperm-Strengthening Pill) is composed of 24 herbs: Cistanche deserticola (steamed), prepared Morinda officinalis, Psoralea corylifolia (salt-fried), Cuscuta chinensis, Eucommia ulmoides (charred), Illicium verum, Allium tuberosum, Euryale ferox (fried), Nelumbo nucifera, Nelumbo nucifera stamens, calcined Ostrea gigas, Os draconis (calcined), Cornus officinalis (processed), Cervi cornu powder, Rehmannia glutinosa, Paeonia suffruticosa, Dioscorea opposita, Poria cocos, Alisma plantago-aquatica, Anemarrhena asphodeloides, Phellodendron chinense, Achyranthes bidentata, and coarse salt. In this formula, Cistanche deserticola, Morinda officinalis, Cistanche deserticola, Psoralea corylifolia, Cuscuta chinensis, Cervi cornu powder, and Eucommia ulmoides tonify the kidneys and strengthen yang, warming the lower abdomen; Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Paeonia suffruticosa, Alisma plantago-aquatica, and Poria cocos tonify the kidneys and nourish yin, combining yin with yang to achieve the effect of yin generating yang and yin and yang harmonizing. Euryale ferox, Nelumbo nucifera stamens, Ostrea gigas, and Os draconis consolidate essence and astringe semen to stop seminal emission. Anemarrhena asphodeloides and Phellodendron chinense nourish yin and reduce fire, moderating the warming nature of the tonic. Star anise dispels cold and regulates qi; Achyranthes bidentata tonifies the liver and kidneys and guides heat downwards; coarse salt guides the medicine to the kidneys. The combined effects of these herbs warm the kidneys and strengthen essence. Clinically, it is used to treat symptoms such as lower back and knee weakness, dizziness, tinnitus, seminal emission, and premature ejaculation caused by kidney yang deficiency.

[0003] Chronic kidney disease (CKD) refers to diseases caused by various factors that lead to structural changes and dysfunction of the kidneys, including chronic glomerulonephritis, nephrotic syndrome, and chronic renal failure. Kidney diseases are characterized by high incidence, insidious onset, and serious harm to the body. In recent years, CKD has been increasingly affecting younger people, with a reported increase in cases; it is estimated that more than 10% of adults develop CKD annually. The pathogenesis of CKD is mediated by multiple processes, including cytokines, inflammatory responses, oxidative stress, and autophagy, with multiple factors working synergistically to trigger and promote disease progression. CKD patients often exhibit hyperuricemia, renal fibrosis, glomerular sclerosis, renal tubular atrophy, and decreased renal filtration function, leading to the accumulation of toxic metabolic products. Without intervention, long-term CKD can gradually develop into chronic renal failure. Current treatments for CKD primarily involve lifestyle modifications, nutritional therapy, control of hyperuricemia, medication for CKD complications, and dialysis, offering limited options. Therefore, finding effective treatments for CKD remains a pressing challenge.

[0004] Traditional Chinese medicine (TCM) theory does not have a specific disease name, "chronic kidney disease." Based on clinical symptoms, it can be categorized under "asthenia," "urinary retention," "turbid urine," and "edema." Etiology includes external pathogenic factors (such as wind, cold, dampness, heat, dryness, and fire), overexertion, and emotional distress. It can be summarized as "deficiency, dampness, stagnation, and toxicity." The pathogenesis of deficiency and excess is considered interdependent. The internal basis of the disease is considered to be the weakness of the internal organs, with dampness and stagnation being the main pathological factors, and prolonged entrapment of toxic pathogens being a necessary condition for disease progression. The 2015 Guidelines for the Integrated Traditional Chinese and Western Medicine Treatment of Chronic Renal Failure proposed basic and complex syndrome types. The basic syndrome types include deficiency and excess, with four deficiency syndromes (qi deficiency, blood deficiency, yin deficiency, and yang deficiency) and four excess syndromes (dampness, damp-heat, blood stasis, and urinary tract infection). Complex syndrome types consist of two or more basic syndrome types, and the pathogenesis involves multiple internal organs. Summary of the Invention

[0005] To address the limited treatment options for chronic kidney disease in existing technologies, this invention provides an application of a traditional Chinese medicine composition in the treatment of chronic kidney disease, offering new therapeutic drugs and methods for improving renal function indicators and protecting against kidney tissue damage in CKD patients.

[0006] The traditional Chinese medicine composition, by weight, comprises: 10-30 parts of Cynomorium songaricum, 15-35 parts of Cistanche deserticola (steamed), 20-40 parts of processed Morinda officinalis, 15-35 parts of Psoralea corylifolia (salt-fried), 10-30 parts of Cuscuta chinensis, 15-35 parts of Eucommia ulmoides (charred), 15-35 parts of Illicium verum, 10-30 parts of Allium tuberosum seed, 10-30 parts of Euryale ferox (fried), 10-30 parts of Nelumbo nucifera seed, and lotus seed. 15-35 parts of the following ingredients: Cornus officinalis (processed) 7-27 parts, calcined oyster shell 10-30 parts, calcined dragon bone 10-30 parts, deer antler powder 10-30 parts, prepared rehmannia root 20-70 parts, peony bark 5-20 parts, yam 30-70 parts, poria cocos 5-20 parts, alisma plantago-aquatica 5-20 parts, anemarrhena asphodeloides 1-10 parts, phellodendron chinense 1-10 parts, achyranthes bidentata 10-30 parts, and coarse salt 15-35 parts.

[0007] Verification has shown that the traditional Chinese medicine composition can effectively reverse weight loss and increased kidney wet weight caused by chronic kidney disease, reduce serum levels of BUN, CRE, and ALT, improve hormonal imbalances, exert a protective effect against kidney damage, and slow down the degree of kidney fibrosis, thereby achieving effective treatment for chronic kidney disease.

[0008] In some embodiments, the traditional Chinese medicine composition, by weight, includes: 20 parts of Cynomorium songaricum, 25 parts of Cistanche deserticola (steamed), 30 parts of processed Morinda officinalis, 25 parts of Psoralea corylifolia (salt-fried), 20 parts of Cuscuta chinensis, 25 parts of Eucommia ulmoides (charred), 25 parts of Illicium verum, 20 parts of Allium tuberosum seed, 20 parts of Euryale ferox (fried), 20 parts of Nelumbo nucifera seed, 25 parts of Nelumbo nucifera stamen, 17 parts of processed Cornus officinalis, 20 parts of calcined Ostrea gigas, 20 parts of calcined Os draconis, 20 parts of deer antler powder, 56 parts of Rehmannia glutinosa (processed), 11 parts of Paeonia suffruticosa root bark, 56 parts of Dioscorea opposita, 11 parts of Poria cocos, 11 parts of Alisma plantago-aquatica, 4 parts of Anemarrhena asphodeloides, 4 parts of Phellodendron chinense, 20 parts of Achyranthes bidentata, and 25 parts of coarse salt.

[0009] In some embodiments, the drug comprises 40-100 wt% of the traditional Chinese medicine composition.

[0010] In some embodiments, the drug further includes 0-60 wt% pharmaceutically acceptable excipients.

[0011] In some embodiments, the excipient is selected from at least one of honey, mannitol, sucrose, and zeatin.

[0012] In some embodiments, the dosage form of the drug is tablets, capsules, granules, pills, decoctions, powders, oral liquids, lyophilized powders, or suspensions.

[0013] In some embodiments, the dosage form of the drug is a pill, wherein the drug comprises 40-90 wt% of the traditional Chinese medicine composition and 10-60 wt% of pharmaceutically acceptable excipients.

[0014] In some embodiments, the dosage form of the drug is a large honey pill, comprising 40.0-50.0 wt% of the traditional Chinese medicine composition and 50-60 wt% of pharmaceutically acceptable excipients.

[0015] In some embodiments, the drug is a water-honey pill comprising 70-90 wt% of the traditional Chinese medicine composition and 10-30 wt% of pharmaceutically acceptable excipients.

[0016] In some embodiments, patients with the chronic kidney disease include at least one of the following clinical symptoms: edema of the kidneys, elevated serum creatinine, blood urea nitrogen, and ALT levels, disordered T and FSH hormone levels, kidney tissue damage, and kidney tissue fibrosis.

[0017] This invention establishes a clinically relevant CKD animal model by oral administration of adenine via gavage. The model exhibits general symptoms such as significant weight loss and poor mental state, significantly elevated rat kidney index, obvious kidney edema, significantly elevated serum creatinine and urea nitrogen, disordered levels of hormones such as T and FSH, significant kidney tissue damage, and severe fibrosis. These characteristics are consistent with clinical CKD symptoms and can be used as an evaluation system to detect the pharmacodynamic effects of drugs on chronic kidney disease.

[0018] Verification has shown that the traditional Chinese medicine composition has a certain therapeutic effect on CKD and can be further applied to the preparation of drugs for treating chronic kidney disease, thus expanding the scope of application of the traditional Chinese medicine composition and providing new therapeutic drugs and methods for improving renal function indicators and protecting renal tissue damage in CKD patients. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0020] Figure 1 This is one of the technical roadmaps for verifying the pharmacodynamic effects of the traditional Chinese medicine composition provided by the present invention in the treatment of chronic kidney disease.

[0021] Figure 2 This is one of the histopathological staining results of kidney tissue from CKD rats in the application of the traditional Chinese medicine composition provided by the present invention in the treatment of chronic kidney disease. Detailed Implementation

[0022] Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this invention.

[0023] The inventors discovered that chronic kidney disease generally presents with clinical CKD symptoms such as significantly elevated renal index, obvious kidney edema, significantly elevated serum creatinine, blood urea nitrogen, and ALT levels, disordered levels of hormones such as T and FSH, significant kidney tissue damage, and severe fibrosis.

[0024] Based on this, the present invention provides an application of a traditional Chinese medicine composition in a medicament for treating chronic kidney diseases. Among them, calculated by weight份, the traditional Chinese medicine composition includes: Cynomorium songaricum 10 - 30份, Cistanche deserticola (steamed) 15 - 35份, Morinda officinalis prepared 20 - 40份, Psoralea corylifolia (salt-fried) 15 - 35份, Cuscuta chinensis 10 - 30份, Eucommia ulmoides (charred) 15 - 35份, Illicium verum 15 - 35份, Allium tuberosum seeds 10 - 30份, Euryale ferox (fried) 10 - 30份, Nelumbo nucifera seeds 10 - 30份, Nelumbo nucifera stigma 15 - 35份, Cornus officinalis prepared 7 - 27份, Concha Ostreae calcined 10 - 30份, Os Draconis calcined 10 - 30份, Cornu Cervi Degelatinatum 10 - 30份, Rehmannia glutinosa cooked 20 - 70份, Paeonia suffruticosa 5 - 20份, Dioscorea opposita 30 - 70份, Poria cocos 5 - 20份, Alisma orientale 5 - 20份, Anemarrhena asphodeloides 1 - 10份, Phellodendron chinense 1 - 10份, Achyranthes bidentata 10 - 30份, Natrii Chloridum 15 - 35份.

[0025] In some embodiments, calculated by weight份, the traditional Chinese medicine composition includes: Cynomorium songaricum 20份, Cistanche deserticola (steamed) 25份, Morinda officinalis prepared 30份, Psoralea corylifolia (salt-fried) 25份, Cuscuta chinensis 20份, Eucommia ulmoides (charred) 25份, Illicium verum 25份, Allium tuberosum seeds 20份, Euryale ferox (fried) 20份, Nelumbo nucifera seeds 20份, Nelumbo nucifera stigma 25份, Cornus officinalis prepared 17份, Concha Ostreae calcined 20份, Os Draconis calcined 20份, Cornu Cervi Degelatinatum 20份, Rehmannia glutinosa cooked 56份, Paeonia suffruticosa 11份, Dioscorea opposita 56份, Poria cocos 11份, Alisma orientale 11份, Anemarrhena asphodeloides 4份, Phellodendron chinense 4份, Achyranthes bidentata 20份, Natrii Chloridum 25份.

[0026] It can be seen that the traditional Chinese medicine composition is actually the effective active ingredients in the existing Suoyang Gujing Pills. As recorded in the Chinese Pharmacopoeia, Suoyang Gujing Pills are composed of 24 herbs, namely Cynomorium songaricum, Cistanche deserticola (steamed), Morinda officinalis prepared, Psoralea corylifolia (salt-fried), Cuscuta chinensis, Eucommia ulmoides (charred), Illicium verum, Allium tuberosum seeds, Euryale ferox (fried), Nelumbo nucifera seeds, Nelumbo nucifera stigma, Concha Ostreae calcined, Os Draconis calcined, Cornus officinalis prepared, Cornu Cervi Degelatinatum, Rehmannia glutinosa cooked, Paeonia suffruticosa, Dioscorea opposita, Poria cocos, Alisma orientale, Anemarrhena asphodeloides, Phellodendron chinense, Achyranthes bidentata, and Natrii Chloridum. In the formula, Cynomorium songaricum, Morinda officinalis, Cistanche deserticola, Psoralea corylifolia, Cuscuta chinensis, Cornu Cervi Degelatinatum, and Eucommia ulmoides tonify the kidney and strengthen yang, warming the lower energizer; Rehmannia glutinosa cooked, Cornus officinalis, Dioscorea opposita, Paeonia suffruticosa, Alisma orientale, and Poria cocos nourish the kidney yin, combining yin with yang to achieve the effect of yin engendering yang growth and yin-yang mutual nourishment. Euryale ferox, Nelumbo nucifera stigma, Concha Ostreae, and Os Draconis solidify and secure essence qi, arresting seminal emission. Anemarrhena asphodeloides and Phellodendron chinense nourish yin and reduce fire, supervising the warm nature of the tonifying herbs. Illicium verum dispels cold and regulates qi; Achyranthes bidentata can both tonify the liver and kidney and lead heat downward; Natrii Chloridum guides the medicine to enter the kidney. All the herbs are combined to achieve the effect of warming the kidney and securing essence. Clinically, it is used to treat symptoms such as weakness in the waist and knees, dizziness and tinnitus, premature ejaculation due to insufficient kidney yang. It can be seen that Suoyang Gujing Pills are mainly used to treat diseases of the reproductive system, while the clinical symptoms of chronic kidney diseases are mainly high uric acid levels, polyuria, and abnormal kidney histology, which are mainly diseases of the urinary system and metabolic system, with a large difference from the main treatment functions of Suoyang Gujing Pills.

[0027] In some embodiments, the drug comprises 40-100 wt% of the traditional Chinese medicine composition. For example, 100 wt%, 99 wt%, 98 wt%, 97 wt%, 96 wt%, 95 wt%, 90 wt%, 80 wt%, 70 wt%, 60 wt%, 50 wt%, 40 wt%, etc., or specific ranges of these contents, such as 95-100 wt%, 80-95 wt%, 80-90 wt%, 40-90 wt%, 40-60 wt%, 70-90 wt%, etc. Depending on actual needs, in addition to the traditional Chinese medicine composition, the drug may also contain other active pharmaceutical ingredients or excipients.

[0028] In some embodiments, the drug further includes 0-60 wt% pharmaceutically acceptable excipients. Adding excipients, while ensuring an effective dosage of the traditional Chinese medicine composition, allows for processing into different dosage forms, facilitates preservation, and can improve taste, aroma, etc., making the drug more acceptable and potentially expanding its application range. For example, by adding excipients, the drug can be formulated into compressed candy, which is more easily accepted by some younger patients.

[0029] In some embodiments, the excipient is selected from at least one of honey, mannitol, sucrose, and zeatin.

[0030] In some embodiments, the dosage form of the drug is tablets, capsules, granules, pills, or decoction.

[0031] In some embodiments, the dosage form of the drug is a pill; wherein the drug comprises 40-90 wt% of the traditional Chinese medicine composition and 10-60 wt% of refined honey.

[0032] In some embodiments, the dosage form of the drug is a large honey pill, comprising 40.0-50.0 wt% of the traditional Chinese medicine composition and 50-60 wt% of pharmaceutically acceptable excipients. That is, the drug for treating chronic kidney disease can be Suoyang Gujing Pill, which is a traditional Chinese medicine preparation listed in the Chinese Pharmacopoeia and has advantages such as stable source and reliable quality.

[0033] In some embodiments, the medicine is a water-honey pill comprising 70-90 wt% of the traditional Chinese medicine composition and 10-30 wt% of refined honey and water.

[0034] In some embodiments, patients with the chronic kidney disease include at least one of the following clinical symptoms: edema of the kidneys, elevated serum creatinine, blood urea nitrogen, and ALT levels, disordered T and FSH hormone levels, kidney tissue damage, and kidney tissue fibrosis.

[0035] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all commercially available conventional products.

[0036] The present invention will now be described with reference to specific embodiments. It should be noted that these embodiments are merely descriptive and do not limit the present invention in any way.

[0037] Example 1 This embodiment provides the application of a traditional Chinese medicine composition in the treatment of chronic kidney disease, wherein the traditional Chinese medicine composition includes: 20 parts of Cynomorium songaricum, 25 parts of Cistanche deserticola (steamed), 30 parts of processed Morinda officinalis, 25 parts of Psoralea corylifolia (salt-fried), 20 parts of Cuscuta chinensis, 25 parts of Eucommia ulmoides (charred), 25 parts of Illicium verum, 20 parts of Allium tuberosum seed, 20 parts of Euryale ferox (fried), 20 parts of Nelumbo nucifera seed, 25 parts of Nelumbo nucifera stamen, 17 parts of Cornus officinalis (processed), 20 parts of calcined Ostrea gigas, 20 parts of calcined Os draconis, 20 parts of deer antler powder, 56 parts of Rehmannia glutinosa (processed), 11 parts of Paeonia suffruticosa root bark, 56 parts of Dioscorea opposita, 11 parts of Poria cocos, 11 parts of Alisma plantago-aquatica, 4 parts of Anemarrhena asphodeloides, 4 parts of Phellodendron chinense, 20 parts of Achyranthes bidentata, and 25 parts of coarse salt; wherein 1 part is 1g.

[0038] This embodiment also provides a method for preparing the drug for treating chronic kidney disease as follows: the traditional Chinese medicine composition is pulverized and powdered, passed through an 80-mesh sieve, 100g of the raw powder of the traditional Chinese medicine composition is added to 110-130g of refined honey to make large honey pills. That is, the drug for treating chronic kidney disease in this embodiment is Suoyang Gujing Pill (produced by Beijing Tongrentang Co., Ltd., batch number 22011103).

[0039] Experimental Example 1: Animal Experiment on the Efficacy of Suoyang Gujing Pill in Treating Chronic Kidney Disease Experimental design: See technical route Figure 1Sixty male SPF-grade SD rats, aged 7-8 weeks, were selected. After 7 days of quarantine, 60 rats were randomly selected and administered 2% adenine via gavage at a volume of 10 mL / kg. The remaining 12 rats served as a control group and were administered the same volume of the solvent via gavage for 21 consecutive days to establish a CKD rat model. During the modeling process, animal weight, general condition, and other indicators were monitored to assess the establishment of the model. When a significant difference in weight was observed between the model group and the control group, the model group was randomly divided into a model group, a low-, medium-, and high-dose Suoyang Gujing Wan group, with 12 rats in each group. The rats were administered the drug via gavage according to the prescribed dosage. The control group was administered the same volume of purified water via gavage for 3 consecutive weeks. During the drug administration period, animal weight and general condition were monitored. At the end of the drug administration period, the animals were necropsized, and the wet weight of the organs was measured. Serum and plasma were collected, stored at -40℃, and the levels of biochemical factors and sex hormones were measured. The kidneys were fixed for pathological tissue examination. The effects of Suoyang Gujing Pill on the general condition, serum renal function indicators, hormone levels, renal histopathology, and MASSON staining results of renal tissue in CKD rats were investigated to evaluate the pharmacodynamics of Suoyang Gujing Pill in the treatment of CKD.

[0040] 1. Materials 1.1 Animals Sixty qualified, sexually mature male SD rats, aged 7-8 weeks and weighing 220-240g, were used.

[0041] 1.2 Drugs and Reagents Suoyang Gujing Pills (produced by Beijing Tongrentang Co., Ltd., batch number 22011103, i.e., the drug in Example 1), adenine (produced by Shanghai Aladdin Biochemical Technology Co., Ltd., batch number K2111426), 0.9% sodium chloride injection (produced by Shijiazhuang No. 4 Pharmaceutical Co., Ltd., batch number 2105092004), laboratory animal marker staining solution (Shanghai Yuanye Biotechnology Co., Ltd., J11HR188212), paraformaldehyde (Xilong Chemical Co., Ltd., 1210092); urea assay kit (batch number: 231211), creatinine assay kit (batch number: 231101), aspartate aminotransferase assay kit (batch number: 231031), alanine aminotransferase assay kit (batch number: 231101), and multiple biochemical standards (batch number: 210171) were all purchased from Sinopharm Group Co., Ltd.

[0042] 1.3 Instruments BT124S electronic analytical balance (SYSB82), Multifuge X4R Pro centrifuge (61-11-11), AU480 chemical analyzer (63-49-04), Leica TP1020 tissue dehydrator (SYSB190), Leica EG 1150H tissue embedding machine, Olympus BX53 optical microscope.

[0043] 2. Test methods 2.1 Establishment of CKD model and animal grouping and drug administration information Sixty qualified, sexually mature male SD rats, 7–8 weeks old and weighing 220–240 g, were used. Except for a control group of 12 animals, all other animals were administered 2% adenine solution orally via gavage at a dose of 200 mg / kg. The control group was administered an equal volume of the solution orally via gavage. Administered daily in the morning for 21 consecutive days. The general condition of the animals was observed daily, and their weight was measured weekly. The rats were observed for significant weight loss and other abnormalities to assess the model's replication.

[0044] The animals in the model group had significantly lower body weight than the control group. The animals in the model group were randomly divided into a model group and high, medium, and low dose groups of Suoyang Gujing Pill according to their body weight, with 12 animals in each group. The control group and the model group were given the same volume of purified water. The high, medium, and low dose groups of Suoyang Gujing Pill (see Table 1) were administered the pills every afternoon according to the dosage settings for 21 consecutive days.

[0045] Table 1 Animal Dosing Information

[0046] 2.2 Animal euthanasia and material collection Animals were fasted for 12 hours after the last administration. After anesthesia according to body weight, blood was collected from the abdominal aorta. After the blood was allowed to stand at low temperature, it was centrifuged to separate serum and plasma, which were then frozen at -40°C for later testing. The wet weight of major organs such as the kidneys and thymus was measured. The ipsilateral kidney was fixed with paraformaldehyde for histopathological examination.

[0047] 2.3 Detection of serum biochemical factors and hormone levels Rat serum was collected, and alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), and creatinine (CRE) were measured using an OLYMPUS AU480 fully automated biochemical analyzer. The effects of the drug on liver and kidney function in CKD rats were evaluated.

[0048] Following the ELISA kit instructions, serum levels of hormones such as testosterone (T), follicle-stimulating hormone (FSH), and human growth hormone (HGH) in rats were measured. Differences in hormone levels among groups were compared to evaluate the regulatory effect of the drug on hormone levels in CKD rats.

[0049] 2.4 HE staining for histopathological examination of rat kidney tissue The ipsilateral kidney was fixed in 4% neutral formaldehyde solution. Tissue and organs were harvested, dehydrated with graded ethanol, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), Masson stain, and mounted to prepare tissue sections. Histological changes in each organ were observed under a microscope. Images were acquired using OLYMPUS DP Controller image acquisition software.

[0050] 2.5 Statistical Methods Quantitative data are expressed as mean ± standard deviation (x̄ ± s). Independent samples t-tests were used to assess differences between two groups; for multiple comparisons, one-way ANOVA was used, followed by Tukey's post-hoc test. P < 0.05 was considered statistically significant.

[0051] 3. Test Results 3.1 Effects of Suoyang Gujing Pill on Body Weight of Model Animals Table 2 shows the body weight of rats after different treatment groups for different durations.

[0052] Table 2. Rat body weight statistics (X±SD, n=12)

[0053] Note: Compared with the model group, ** p < 0.01, * p < 0.05; compared with the control group, ## p < 0.01, # p < 0.05.

[0054] As shown in Table 2, after one week of adenine administration at a dose of 200 mg / kg to induce CKD, the rats in the model group showed a significantly lower body weight compared to the control group, indicating that adenine can induce CKD and cause weight loss in animals, thus successfully establishing the model. During weeks 2-3, the animals were given adenine to maintain the model, during which the body weight of both the model group and the drug-treated group was significantly lower than that of the control group. After successful model establishment, drug administration was carried out in week 2. Compared to the model group, the body weight of animals in all dosage groups of Suoyang Gujing Wan showed an increasing trend. The body weight of the medium and high dose groups of Suoyang Gujing Wan was significantly higher than that of the model group (P < 0.05), with growth rates of 6.0% and 9.0%, respectively, indicating that Suoyang Gujing Wan has a certain therapeutic effect on the weight loss in adenine-induced CKD rats.

[0055] 3.2 Effects of Suoyang Gujing Pill on Organ Indices of Model Animals The results of the major organ indices of rats treated in different groups for 21 days are shown in Table 3.

[0056] Table 3. Statistical table of major organ indices in rats (X±SD, n=12)

[0057] Note: Compared with the model group, ** p < 0.01, * p < 0.05; compared with the control group, ## p < 0.01, # p < 0.05.

[0058] Table 3 shows that compared with the control group, the renal index of the CKD model group was significantly increased, while the renal index of each dose group of Suoyang Gujing Wan was significantly decreased compared with the model group (P < 0.01). Compared with the control group, the adrenal index of the model group was significantly increased, while the adrenal index of the low-dose group of Suoyang Gujing Wan was significantly decreased compared with the model group (P < 0.05). Compared with the control group, the thymus index of the model group was significantly decreased, while the thymus index of each dose group of Suoyang Gujing Wan was increased compared with the model group (P < 0.01, P < 0.05). <0.05); Compared with the control group, the thymus index of the model group was significantly decreased, while the thymus index of each dose group of Suoyang Gujing Wan was significantly increased compared with the model group (P<0.01, P<0.05); Compared with the control group, the spleen index of the model group was significantly increased, while the thymus index of each dose group of Suoyang Gujing Wan was significantly decreased compared with the model group, with the high-dose group showing a significant decrease (P<0.05); Compared with the control group, the liver index of the model group was significantly increased, while there was no significant difference between each dose group of Suoyang Gujing Wan and the model group.

[0059] 3.3 Effects of Suoyang Gujing Pill on Renal Function Indicators in Model Animals The results of liver and kidney function indicators of rats treated with different treatment groups for 21 days are shown in Table 4.

[0060] Table 4. Data on liver and kidney function indicators in rats of each group (X±SD, n=12)

[0061] Note: Compared with the model group, ** p < 0.01, * p < 0.05; compared with the control group, ## p < 0.01, # p < 0.05.

[0062] Table 4 shows that compared with the control group, the model group had significantly increased levels of BUN, CRE, and ALT, while AST showed no significant difference. Compared with the model group, the low, medium, and high doses of Suoyang Gujing Wan significantly reduced the levels of BUN and CRE in the serum of CKD rats (P < 0.01), and the low dose of Suoyang Gujing Wan significantly reduced the level of ALT (P < 0.05). This suggests that adenine can induce disorders in BUN and CRE in the serum of rats and increase ALT concentration, and that Suoyang Gujing Wan intervention has a certain ameliorative effect.

[0063] 3.4 Effects of Suoyang Gujing Pill on Serum Hormones in CKD Rats The hormone levels of rats treated with different treatment groups for 21 days are shown in Table 5.

[0064] Table 5 Effects on Hormone Levels in CKD Rats (X±SD, n = 10)

[0065] Note: Compared with the model group, **p < 0.01, *p < 0.05; compared with the control group, ##p < 0.01, #p < 0.05.

[0066] As can be seen from Table 5, compared with the control group, the levels of follicle-stimulating hormone and adrenocorticotropic hormone in the serum of CKD rats in the model group were significantly increased (P < 0.01), while the levels of thyroid-stimulating hormone (P < 0.01) and testosterone were significantly decreased (P < 0.05); compared with the model group, different degrees of reversal occurred in each dose group of animals after administration of Suoyang Gujing Pills, suggesting that Suoyang Gujing Pills can effectively improve the disorder of hormone levels in CKD rats.

[0067] 3.5 Effects of Suoyang Gujing Pills on Renal Histopathology The pathological diagrams of HE and Masson staining of various organs of rats after 21 days of administration in different treatment groups are as Figure 1 shown.

[0068] As can be seen from Figure 1 it, long-term oral administration of adenine to SD rats at a dose of 200 mg / kg can significantly induce kidney injury, mainly manifested in glomerular atrophy, sclerosis, and fewer numbers in the model group animals, and a large number of inflammatory cells infiltrated and vacuolization occurred in the renal tubules and interstitium; Masson staining showed a large amount of fibrosis in the kidneys of the model group animals, with basement membrane and mesangial hyperplasia. Compared with the model group, the histopathological results of each group of animals treated with Suoyang Gujing Pills showed that the pathological degree improved and the degree of pathological change decreased. The Masson results showed that Suoyang Gujing Pills intervention reduced the degree of renal fibrosis.

[0069] To sum up, under the conditions of this experiment, continuous intragastric administration of adenine to rats at a dose of 200 mg / kg for 21 days can replicate the CKD rat model. CKD rats showed general conditions such as significantly reduced body weight and poor spirit, a significant increase in the kidney index of rats, obvious edema in the kidney morphology, a significant increase in the levels of creatinine, urea nitrogen, and ALT in the serum, disorder of hormone levels such as T and FSH, obvious damage to the kidney tissue, and severe fibrosis, indicating that a CKD animal model in line with clinical characteristics was successfully established, which can be used to evaluate the effects of drugs on renal function indexes, hormone levels, renal histopathology, and fibrosis degree in CKD rats, and clarify the pharmacodynamics of Suoyang Gujing Pills on CKD.

[0070] Animal experiments have verified that administration of Suoyang Gujing Pills significantly alleviates symptoms of adenine-induced CKD in rats. Suoyang Gujing Pills can reverse weight loss and increased kidney wet weight in CKD rats, reduce serum levels of BUN, CRE, and ALT, improve hormonal imbalances, exert a protective effect against kidney damage, and slow the progression of renal fibrosis. In summary, Suoyang Gujing Pills have a certain therapeutic effect on adenine-induced CKD in rats. Therefore, this invention expands the applicability of Suoyang Gujing Pills, providing a new therapeutic drug and method for improving renal function indicators and protecting renal tissue from damage in CKD individuals.

[0071] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in the manufacture of a medicament for treating chronic kidney disease, wherein, The traditional Chinese medicine composition comprises, by weight parts, 10-30 parts of Herba Cynomorii, 15-35 parts of Herba Cistanche (steamed), 20-40 parts of Radix Lycii, 15-35 parts of Fructus Psoraleae (salt-fried), 10-30 parts of Semen Euryale Ferox, 15-35 parts of Radix Morindae Officinalis, 10-30 parts of Semen Astragali Complanati, 10-30 parts of Semen Aesculi, 10-30 parts of Semen Platycladi, 10-30 parts of Semen Allii Macrostemonis, 10-30 parts of Semen Nelumbinis, 10-30 parts of Semen Nelumbinis, 15-35 parts of Fructus Corni (processed), 10-30 parts of Concha Arcae (calcined), 10-30 parts of Cornu Saigae Tataricae (calcined), 10-30 parts of Cornu Saigae Tataricae (calcined), 20-70 parts of Radix Rehmanniae Preparata, 5-20 parts of Cortex Moutan, 30-70 parts of Rhizoma Dioscoreae, 5-20 parts of Poria, 5-20 parts of Rhizoma Alismatis, 1-10 parts of Rhizoma Anemarrhenae, 1-10 parts of Cortex Phellodendri, 10-30 parts of Radix Hedysari, 15-35 parts of Radix Isatidis.

2. Use according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight parts, 20 parts of Herba Cynomorii, 25 parts of Herba Cistanche (steamed), 30 parts of Radix Lycii, 25 parts of Fructus Psoraleae (salt-fried), 20 parts of Semen Euryale Ferox, 25 parts of Radix Morindae Officinalis, 20 parts of Semen Allii Macrostemonis, 20 parts of Semen Nelumbinis, 20 parts of Semen Platycladi, 20 parts of Semen Astragali Complanati, 20 parts of Semen Aesculi, 20 parts of Semen Allii Macrostemonis, 20 parts of Semen Nelumbinis, 25 parts of Fructus Corni (processed), 20 parts of Concha Arcae (calcined), 20 parts of Cornu Saigae Tataricae (calcined), 20 parts of Cornu Saigae Tataricae (calcined), 56 parts of Radix Rehmanniae Preparata, 11 parts of Cortex Moutan, 56 parts of Rhizoma Dioscoreae, 11 parts of Poria, 11 parts of Rhizoma Alismatis, 4 parts of Rhizoma Anemarrhenae, 4 parts of Cortex Phellodendri, 20 parts of Radix Hedysari, 25 parts of Radix Isatidis.

3. Use according to claim 1 or 2, characterized in that, The medicine comprises 40-100 wt% of the traditional Chinese medicine composition.

4. The use according to claim 1, characterized in that, The medicine further comprises 0-60 wt% of pharmaceutically acceptable excipients.

5. Use according to claim 4, characterized in that, The excipients are selected from at least one of honey, mannitol, sucrose, and corn protein.

6. Use according to any one of claims 1 to 5, characterized in that, The medicine is in the form of tablets, capsules, granules, pills, decoctions, powders, oral liquids, lyophilized powder, and suspensions.

7. Use according to claim 5, characterized in that, The medicine is in the form of pills, wherein the medicine comprises 40-90 wt% of the traditional Chinese medicine composition and 10-60 wt% of pharmaceutically acceptable excipients.

8. Use according to claim 7, characterized in that, The medicine is in the form of large honeyed pills, wherein the medicine comprises 40.0-50.0 wt% of the traditional Chinese medicine composition and 50-60 wt% of refined honey.

9. Use according to claim 7, characterized in that, The medicine is in the form of water honeyed pills, wherein the medicine comprises 70-90 wt% of the traditional Chinese medicine composition and 10-30 wt% of refined honey and water.

10. Use according to any one of claims 1 to 9, characterized in that, The patient suffering from the chronic kidney disease comprises at least one of the following clinical symptoms: edema in kidney morphology, increased levels of creatinine, urea nitrogen, and ALT in serum, hormone level disorder of T and FSH, kidney tissue damage, and kidney tissue fibrosis.

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