Pharmaceutical composition for treating chronic kidney disease stage 1-3 as well as preparation method and application of pharmaceutical composition

Abstract

The invention discloses a pharmaceutical composition for treating chronic kidney disease stage 1-3 as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The composition consists of 40-60 parts of astragalus membranaceus, 40-60 parts of black soybeans, 8-12 parts of angelica sinensis, 24-36 parts of dogwood and 8-12 parts of rhodiola rosea. The preparation method comprises the following steps: pretreating the raw materials, soaking, boiling for several times and filtering to obtain a finished product. Based on the treatment principles of tonifying qi, activating blood, dredging collaterals and removing blood stasis in traditional Chinese medicine, the traditional Chinese medicine composition conforms to the pathogenesis of chronic kidney disease deficiency in root and excess in superficies, all the components synergistically play a role, the serum urea nitrogen, serum creatinine level and glomerular filtration rate of a patient can be improved and edema, weakness and other symptoms can be relieved by combining basic treatment, the total effective rate reaches 83.33%, and the traditional Chinese medicine composition is good in safety, easy and convenient to prepare and suitable for clinical application. The traditional Chinese medicine composition is suitable for long-term administration of patients with spleen and kidney qi deficiency and blood deficiency with stasis syndrome type chronic kidney diseases at 1-3 stages, and has good application value in treatment of related diseases.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically a pharmaceutical composition for treating chronic kidney disease stages 1-3, its preparation method, and its application. Background Technology

[0002] Chronic kidney disease (CKD) is a widespread and progressive disease globally, with its incidence continuing to rise due to population aging and lifestyle changes. According to the World Health Organization, the global prevalence of CKD has reached 8%-16%. Patients' quality of life declines significantly as the disease progresses, potentially leading to end-stage renal disease (ESRD), placing a heavy medical burden and economic pressure on families and society. Stages 1-3 of CKD are critical windows for disease control, with stage 3 being the core turning point from early-stage lesions to ESRD. Kidney function has already shown significant decline at this stage, and effective intervention directly determines the prognosis, making it a top priority in clinical treatment.

[0003] From a pathological perspective, renal fibrosis is the core factor driving the progression of CKD to ESRD, mainly manifested as glomerular sclerosis, tubulointerstitial fibrosis, and renal vascular lesions. These pathological changes gradually destroy the normal structure of the kidney, ultimately leading to irreversible loss of renal function. Modern medicine primarily treats CKD stages 1-3 by controlling blood pressure, blood sugar, and reducing proteinuria to slow disease progression. However, clinical practice shows that some patients respond limitedly to conventional Western medicine treatments, and their renal function continues to decline, making it difficult to effectively halt disease progression.

[0004] Existing research has confirmed that the integration of traditional Chinese medicine and Western medicine in the treatment of CKD has the potential for synergistic effects and can more comprehensively improve patients' conditions. However, current clinically applied combined treatment regimens still lack safe, effective, food-grade, and convenient-to-use traditional Chinese medicines, making it difficult to meet the long-term intervention needs of CKD stage 1-3 patients. Therefore, exploring more effective and safer treatment strategies has become an urgent clinical problem to be solved.

[0005] From the perspective of traditional Chinese medicine physiology, the kidneys are responsible for storing essence, regulating water metabolism, and receiving qi. Like other organs, they also play a role in circulating qi and blood. The kidney collaterals serve as the basic pathways for the circulation of qi and blood in the kidneys, and are also a crucial barrier against the invasion of internal and external pathogenic factors. When external pathogens invade the body or when a chronic illness penetrates the collaterals, it can easily lead to blockage of the kidney collaterals, hindering the flow of qi and blood. This can result in pathological products such as qi stagnation, phlegm obstruction, and blood stasis. These products, mixed with external pathogens, generate phlegm, dampness, heat toxins, and other pathogenic factors that stagnate in the kidney collaterals, further obstructing the ascending, descending, entering, and exiting of qi, while also damaging the essence and qi of the internal organs.

[0006] Traditional Chinese medicine (TCM) categorizes CKD under the syndromes of "edema" and "asthenia," with its core pathogenesis being "deficiency of the root and excess of the branch"—deficiency of the kidney collaterals as the root, and excess of pathogenic factors such as dampness, blood stasis, and toxins as the branch. As the disease progresses, these pathogenic factors gradually penetrate deeper into the collaterals, obstructing the flow of qi and blood, leading to "kidney collateral masses," a pathological process highly consistent with modern medical pathological changes such as glomerulosclerosis and renal interstitial fibrosis. Based on these pathological characteristics, the core treatment principle of TCM for CKD is "tonifying qi and activating blood circulation, unblocking collaterals and removing blood stasis, and eliminating masses and nodules." This aims to improve renal microcirculation and alleviate fibrotic lesions by tonifying the root cause of kidney collateral deficiency and clearing the branch of dampness, blood stasis, and toxins, thereby slowing the decline in kidney function.

[0007] Therefore, how to provide a drug composition that is effective, easy to prepare, and suitable for long-term use has become a pressing technical problem in clinical practice. Summary of the Invention

[0008] The purpose of this invention is to provide a pharmaceutical composition for treating chronic kidney disease (CKD) stages 1-3, its preparation method, and its application. Addressing the limited effectiveness of conventional Western medicine interventions in the treatment of CKD stages 1-3, and the lack of mild, safe, long-lasting, and suitable traditional Chinese medicine compositions for long-term use in integrated traditional Chinese and Western medicine treatments, this invention uses Astragalus membranaceus, black soybean, Angelica sinensis, Cornus officinalis, and Rhodiola rosea as raw materials. Through rational formulation, these ingredients achieve a synergistic effect, both tonifying the kidney's deficiency and clearing dampness and toxins. Its application is specifically for CKD stages 1-3, particularly suitable for patients with spleen and kidney qi deficiency and blood deficiency with blood stasis. It can effectively improve serum urea nitrogen and serum creatinine levels, increase glomerular filtration rate, and alleviate clinical symptoms such as edema, fatigue, and lower back and knee weakness, thus improving patients' quality of life. It has good safety, no obvious toxic side effects, and good patient compliance, meeting the needs of long-term intervention for chronic diseases.

[0009] The objective of this invention is achieved through the following technical solution:

[0010] Technical Solution 1:

[0011] A pharmaceutical composition for treating chronic kidney disease stages 1-3, comprising the following raw materials in parts by weight:

[0012] Astragalus membranaceus 40-60 parts, black soybean 40-60 parts, Angelica sinensis 8-12 parts, Cornus officinalis 24-36 parts, Rhodiola rosea 8-12 parts.

[0013] The traditional Chinese medicine theories and modern research basis for each component in the above scheme are as follows:

[0014] Astragalus, first recorded in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), is an important qi-tonifying herb in traditional Chinese medicine, also possessing the functions of invigorating the spleen and lungs, and raising yang to lift prolapse. Multicenter clinical studies have confirmed that it can effectively slow the decline in renal function in patients with type 2 diabetes and chronic kidney disease, and can exert anti-fibrotic effects by regulating related signaling pathways.

[0015] Angelica sinensis is listed as a medium-grade herb in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica). It is warm in nature and has a sweet and pungent taste. Its core functions are to nourish and invigorate blood, and remove blood stasis without harming the body's vital energy. When combined with Astragalus membranaceus, it forms the classic Dang Gui Bu Xue Tang (Angelica Blood-Nourishing Decoction), which can simultaneously nourish both qi and blood. By regulating the TGF-β1 / Smad signaling pathway, it reduces the expression of fibrotic proteins, inhibits extracellular matrix deposition, and slows the progression of renal fibrosis.

[0016] Cornus officinalis is listed as a medium-grade herb in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica). It is neutral in nature and sweet and sour in taste, a commonly used medicine for nourishing kidney yin. It has the effects of nourishing the liver and kidneys, astringing yin and stopping sweating, and rescuing from collapse. The *Yixue Zhongzhong Canxi Lu* (Records of Integrating Chinese and Western Medicine) highly praises its ability to astringe vital energy and rescue from collapse. Modern research shows that its components, such as cornus officinalis glycosides, loganin, and monosodium glutamate, can improve kidney function, reduce serum creatinine and urea nitrogen levels, and have a certain anti-fibrotic effect on diabetic nephropathy.

[0017] Black soybeans, as a traditional food and medicine, have the effects of diuresis and detoxification, kidney tonification and yin nourishment, and blood circulation promotion and stasis removal. The Compendium of Materia Medica records its effects of "tonifying deficiency" and "diuresis and qi regulation". The TCM theory of "black enters the kidney" gives it the function of guiding the meridian, which can guide the effective ingredients of the whole formula to target the kidney. Modern research has confirmed that it is a high-quality plant protein source, which can make up for the protein loss caused by proteinuria, and has antioxidant and anti-inflammatory effects, which can relieve oxidative stress and protect the kidney structure.

[0018] Rhodiola rosea is listed as a superior herb in the Shennong's Classic of Materia Medica. The Qianjin Yifang and the Four Medical Classics both record that it tonifies the kidneys, regulates qi and nourishes blood, lightens the body and improves eyesight, and long-term use can lead to spiritual rejuvenation and longevity. Its effects of strengthening the body's resistance and adapting to the original state are particularly prominent. Modern research shows that it can dilate blood vessels, improve renal microcirculation, and reduce blood viscosity. It also has anti-aging, anti-hypoxia, and anti-fatigue effects, and can reduce oxidative stress and renal fibrosis.

[0019] The compatibility relationships of the above components are as follows:

[0020] This formula follows the principles of traditional Chinese medicine's monarch-minister-assistant-guide herbal pairing, optimized by modern pharmacological research. The entire formula achieves a synergistic effect of replenishing qi, nourishing blood, benefiting essence, resolving blood stasis, tonifying the kidneys, and combating fibrosis. Astragalus membranaceus (Huang Qi) is the monarch herb, greatly replenishing vital energy to lay the foundation for supporting the body's vital energy, targeting the root cause of kidney deficiency, and forming the basis of the formula's overall efficacy. Black soybean and Cornus officinalis (Shan Zhu Yu) serve as assistant herbs. Black soybean tonifies the kidneys and nourishes yin, promotes diuresis and blood circulation, and guides the active ingredients to the kidneys, targeting them specifically. Cornus officinalis nourishes kidney yin and astringes vital energy. Together, they enhance the effects of tonifying the kidneys and benefiting essence, promoting diuresis and reducing swelling, and clearing the kidney meridians. The Astragalus membranaceus-Cornus officinalis pair is a classic combination for treating diabetic nephropathy, frequently used clinically by modern physician Zhang Xichun. Angelica sinensis (Dang Gui) and Rhodiola rosea (Hong Jing Tian) serve as adjuvant herbs. Angelica sinensis and Astragalus membranaceus form the core combination of "Dang Gui Bu Xue Tang" (Angelica Blood-Nourishing Decoction), exerting kidney-protecting and anti-renal fibrosis effects. Rhodiola rosea, by improving renal microcirculation, resisting hypoxia, and combating fibrosis, helps the entire formula combat kidney aging and delay the decline of kidney function. Modern research has further confirmed that Astragalus membranaceus, Angelica sinensis, and black soybean all have multiple effects such as anti-inflammatory, antioxidant, and improvement of renal microcirculation. These effects complement the pharmacological effects of Cornus officinalis and Rhodiola rosea, which are consistent with the main pathogenesis of chronic kidney disease, namely, deficiency of the root and excess of the branch, masses in the kidney meridians, and elimination of masses and nodules.

[0021] The advantages of the above-mentioned drug composition lie in its scientific and rational formulation, mild and safe medicinal properties, good clinical efficacy, and suitability for long-term needs. Clinical studies have shown that this composition, for patients with stage 3 chronic kidney disease diagnosed with spleen and kidney qi deficiency and blood deficiency with blood stasis, can improve kidney function, alleviate clinical symptoms such as edema, fatigue, and lower back and knee weakness, and improve quality of life. It can also play a synergistic role in integrated traditional Chinese and Western medicine treatment. Furthermore, the raw materials are mild and pose no risk of long-term use. The formulation design balances drug therapy and dietary therapy, ensuring therapeutic efficacy while meeting the needs of long-term, regular intervention for patients with chronic diseases, thus possessing considerable potential for widespread application.

[0022] As some possible embodiments of this application, the pharmaceutical composition comprises the following raw materials in parts by weight:

[0023] Astragalus membranaceus 45-55 parts, black soybean 45-55 parts, Angelica sinensis 9-11 parts, Cornus officinalis 27-33 parts, Rhodiola rosea 9-11 parts.

[0024] As some possible embodiments of this application, the pharmaceutical composition comprises the following raw materials in parts by weight:

[0025] Astragalus membranaceus 50 parts, black soybean 50 parts, Angelica sinensis 10 parts, Cornus officinalis 30 parts, Rhodiola rosea 10 parts.

[0026] Technical Solution Two:

[0027] A method for preparing a pharmaceutical composition for treating chronic kidney disease stages 1-3 includes the following steps:

[0028] S1. Raw material pretreatment: Take Astragalus membranaceus, black soybean, Angelica sinensis, Cornus officinalis and Rhodiola rosea respectively, rinse them with clean water and set aside;

[0029] S2. Soaking: Place the pretreated astragalus, black soybeans and angelica into a container, add water with a solid-liquid ratio of 1:(13-16), and soak for 0.5-2 hours;

[0030] S3. Decoction: Pour the soaked raw materials and soaking liquid into a decoction device and heat and decoct for 0.6-1.5 hours; then add the pretreated Cornus officinalis and Rhodiola rosea and continue to decoct for 5-15 minutes; after stopping heating, let it cool naturally to room temperature, filter to remove the dregs, and the filtrate obtained is the drug composition.

[0031] As some possible implementations of this application, in step S3, the decoction equipment is a kettle, a clay pot, or a traditional Chinese medicine decoction machine, and is kept in a simmering state during the decoction process.

[0032] Technical Solution 3:

[0033] Application of the pharmaceutical composition in the preparation of drugs or food-medicine homologous beverages for treating chronic kidney disease stages 1-3.

[0034] As one possible implementation of this application, the patients with chronic kidney disease in stages 1-3 are of the spleen and kidney qi deficiency and blood deficiency with blood stasis syndrome type.

[0035] As one possible implementation method of this application, one dose is taken daily, divided into three administrations, each dose being 250 ml, taken warm.

[0036] Compared with the prior art, the beneficial effects of the present invention are:

[0037] 1. The pharmaceutical composition of this invention is based on the core pathogenesis of deficiency and excess in traditional Chinese medicine, specifically the stagnation of kidney meridians and masses. Its treatment principle is to invigorate qi and blood circulation, unblock meridians and remove blood stasis, and resolve masses and nodules. Through the synergistic combination of raw materials such as Astragalus membranaceus, black soybean, and Angelica sinensis, it both tonifies the root cause of kidney meridian deficiency and clears away dampness and toxins, making it highly compatible with the pathological progression of chronic kidney disease (CKD) stages 1-3. The components work together to exert anti-inflammatory, antioxidant, renal microcirculation-improving, and anti-renal fibrosis effects, helping to reduce serum creatinine and blood urea nitrogen levels, alleviate clinical symptoms such as edema, fatigue, and lower back and knee weakness, and delay the progression of the disease to end-stage renal disease. It has a positive effect on intervention at the critical turning point of CKD stage 3 and also meets the synergistic effect requirements of integrated traditional Chinese and Western medicine treatment.

[0038] 2. The raw materials used in this composition are all food and medicine homologous (black soybeans) or conventional Chinese herbal medicines that meet the standards of the Pharmacopoeia of the People's Republic of China. The composition is mild in nature, has good safety, and no obvious toxic side effects have been found, thus solving the problem of insufficient safety for long-term use of some existing therapeutic drugs. No adverse reactions such as allergic reactions or gastrointestinal discomfort have been observed in clinical applications. It is suitable for the long-term intervention and progression-delay treatment characteristics of chronic kidney disease, and patients can take it regularly for a long time with good compliance.

[0039] 3. The preparation method of this invention requires no complex equipment or special processes. It can be completed through simple steps such as raw material pretreatment, soaking, decoction in stages, and filtration. Conventional equipment such as kettles, earthenware pots, and traditional Chinese medicine decoction machines can meet the requirements, and it can be prepared independently by families or small medical institutions. At the same time, the soaking time and decoction time can be flexibly adjusted within a reasonable range, without the need for strict control of harsh conditions. The operation threshold is low, making it easy to promote and use in primary healthcare settings and homes.

[0040] 4. This invention is specifically designed for patients with chronic kidney disease in stages 1-3, and is especially suitable for people with spleen and kidney qi deficiency and blood deficiency with blood stasis syndrome. Through the guiding effect of black soybeans, the kidney targeting can be enhanced, allowing the effective ingredients to act more concentratedly on the kidney lesion site. This avoids the problems of insufficient targeting and dispersed efficacy of general drugs, and helps to improve the accuracy and effectiveness of treatment. Attached Figure Description

[0041] Figure 1 Comparison of BUN and Scr levels before and after treatment in two groups of patients;

[0042] Figure 2 Comparison of eGFR before and after treatment in two groups of patients;

[0043] Figure 3 Comparison of UACR before and after treatment in two groups of patients. Detailed Implementation

[0044] Example 1

[0045] S1. Raw material pretreatment: Take 40g of Astragalus membranaceus, 60g of black soybean, 8g of Angelica sinensis, 36g of Cornus officinalis, and 12g of Rhodiola rosea, rinse them three times with clean water, drain the surface water and set aside.

[0046] S2. Soaking: Place the pretreated astragalus, black soybeans, and angelica into a ceramic container, add 1450ml of water, and soak for 0.8 hours.

[0047] S3. Decoction: Pour the soaked raw materials and all the soaking liquid into a clay pot, cover the pot, heat to boiling, then reduce to a simmer and cook for 0.8 hours. Then add the pretreated Cornus officinalis and Rhodiola rosea, and continue to simmer for 15 minutes. Stop heating, let it cool naturally to room temperature, filter with sterile gauze to remove the dregs, and obtain the filtrate, which is the drug composition. Store in a sterile container under cold storage.

[0048] Example 2

[0049] S1. Raw material pretreatment: Take 45g of Astragalus membranaceus, 55g of black soybean, 9g of Angelica sinensis, 27g of Cornus officinalis, and 11g of Rhodiola rosea, rinse them three times with clean water, drain the surface water and set aside.

[0050] S2. Soaking: Place the pretreated astragalus, black soybeans, and angelica into a glass container, add 1526ml of water, and soak for 1 hour.

[0051] S3. Decoction: Pour the soaked raw materials and soaking liquid into a traditional Chinese medicine decoction machine, heat to a simmer and decoct for 1 hour; add Cornus officinalis and Rhodiola rosea, and continue to simmer for 10 minutes. After cooling to room temperature, filter to obtain the filtrate, which is the drug composition, and store it in a sterile container under cold storage.

[0052] Example 3

[0053] S1. Raw material pretreatment: Take 50g of Astragalus membranaceus, 50g of black soybean, 10g of Angelica sinensis, 30g of Cornus officinalis, and 10g of Rhodiola rosea, rinse them three times with clean water, drain the surface water and set aside.

[0054] S2. Soaking: Place the pre-treated astragalus, black soybeans, and angelica into a ceramic container, add 1500ml of water, and soak for 1 hour.

[0055] S3. Decoction: Pour the soaked raw materials and soaking liquid into a kettle, bring to a boil, then reduce to a simmer and simmer for 1 hour; add Cornus officinalis and Rhodiola rosea, and continue to simmer for 10 minutes. After cooling to room temperature, filter to obtain the filtrate, which is the drug composition, and store it in a sterile container under cold storage.

[0056] Experimental Example

[0057] I. Experimental Objective.

[0058] To verify the clinical efficacy and safety of the pharmaceutical composition prepared in Example 3 in treating patients with stage 3 chronic kidney disease (spleen and kidney qi deficiency and blood deficiency with blood stasis).

[0059] II. Experimental Subjects.

[0060] Sixty-six patients with stage 3 chronic kidney disease admitted to the Department of Nephrology, Nanchong Central Hospital from January 2024 to May 2025 were selected. All patients met the diagnostic criteria for spleen-kidney qi deficiency and blood deficiency with blood stasis, and their estimated glomerular filtration rate (eGFR) was between 30-59 ml / min / 1.73 m³ / min. 2 Scope. Patients were randomly divided into a treatment group and a control group using a random number table, with 33 patients in each group.

[0061] During the study, 3 patients in the treatment group were lost to follow-up (2 withdrew due to self-discontinuation of medication, and 1 was lost to contact), and 3 patients in the control group were lost to follow-up due to loss of contact. In the end, 60 patients completed treatment and follow-up (30 in the treatment group and 30 in the control group).

[0062] III. Treatment methods.

[0063] 1. Control group: Received only basic treatment, including blood pressure control (target blood pressure <130 / 80 mmHg), blood glucose control (fasting blood glucose <7.0 mmol / L, glycated hemoglobin <7.0%), low-salt, low-fat, high-quality protein diet, correction of electrolyte imbalance and other routine symptomatic treatments, for a course of 12 weeks.

[0064] 2. Treatment group: In addition to the basic treatment of the control group, the treatment group took the drug composition prepared in Example 3. The method of administration was to take one dose daily, divided into three warm doses, 250ml each time, for a course of 12 weeks.

[0065] IV. Observation Indicators

[0066] 1. Evaluation of clinical efficacy: Based on the improvement of TCM symptoms (edema, fatigue, soreness of the waist and knees, etc.), the efficacy is divided into four levels: significant effect, effective, stable, and ineffective. The total effective rate is calculated.

[0067] 2. Renal function indicators: Serum blood urea nitrogen (BUN), serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and urine albumin / creatinine ratio (UACR) were measured before treatment and at 4, 8, and 12 weeks of treatment.

[0068] 3. Quality of life assessment: The SF-36 scale was used to evaluate the quality of life across eight dimensions: physical health (physiological functioning, physiological functioning, bodily pain, general health status) and mental health (vitality, social functioning, emotional functioning, mental health status).

[0069] 4. Safety indicators: Blood routine, coagulation function, and liver function were tested before and after treatment, and adverse reactions were recorded.

[0070] V. Experimental Results.

[0071] 1. Evaluation of treatment efficacy before and after treatment in the two groups of patients.

[0072] After 12 weeks of treatment, the overall effective rate in the treatment group was 83.3%, significantly higher than that in the control group (46.7%), and the difference between the groups was statistically significant (P < 0.05). This result suggests that the combined treatment has a significant effect in improving clinical symptoms (see table).

[0073] Table 1: Evaluation of treatment efficacy before and after treatment in the two groups of patients

[0074] Grouping Number of examples Significant effect / cases (%) Effective (%) Stable / cases (%) Ineffective / cases (%) Total effective cases (%) Treatment group 30 9(30.00) 16(53.33) 3(10.00) 2(6.67) 83.33 control group 30 4(13.33) 10(33.33) 7(23.33) 9(30.00) 46.67 Z-value 2.879 p-value 0.004

[0075] 2. Comparison of renal function indicators before and after treatment in the two groups of patients.

[0076] (1) After treatment, the levels of BUN and Scr in the treatment group decreased significantly (P<0.05). Intergroup comparisons showed that the improvement in BUN and Scr in the treatment group was significantly greater than that in the control group, and the difference was statistically significant (P<0.01). (See...) Figure 1 Figures A and C show the levels of blood urea nitrogen (BUN) and serum creatinine (Scr) in the treatment and control groups at different time points. Figures B and D compare the differences between the treatment and control groups at each time point. (* indicates P < 0.05, ** indicates P < 0.01, and "ns" indicates no significant difference. The X-axis represents time (weeks), and the Y-axis represents the concentrations of the indicators: BUN (mmol / L) and Scr (μmol / L)).

[0077] (2) Changes in eGFR before and after treatment in the two groups of patients.

[0078] The eGFR of patients in the treatment group increased significantly after treatment (P<0.001). Although the eGFR of the control group also increased, the difference was not statistically significant (P>0.05). The eGFR of the treatment group at both 8 and 12 weeks was significantly higher than that of the control group (P<0.05, P<0.001), see [link to relevant documentation]. Figure 2 Figure A shows the eGFR levels of the treatment and control groups at each time point. Figure B compares the differences in eGFR between the treatment and control groups at each time point. The eGFR of the treatment group was significantly higher than that of the control group at week 12, and showed significant improvement during the treatment period. (* indicates P<0.05, *** indicates P<0.001, "ns" indicates no significant difference. X-axis represents time (weeks), Y-axis represents eGFR value (mL / min / 1.73m) 2 )】.

[0079] (3) Changes in UACR before and after treatment in the two groups of patients.

[0080] The UACR in the treatment group was significantly lower than that in the control group at week 8 (P<0.05); at week 12, the decrease in UACR in the treatment group was further amplified (P<0.01), indicating that the combined treatment had a good effect on reducing proteinuria. Figure 3Figure A shows the changes in UACR in the treatment group and the control group at different time points. Figure B compares the differences in UACR between the treatment group and the control group at each time point. (* indicates P<0.05, ** indicates P<0.01, "ns" indicates no significant difference. The X-axis represents time (weeks), and the Y-axis represents UACR value (mg / g)).

[0081] 3. Comparison of quality of life scores between the two groups of patients.

[0082] After treatment, both groups of patients showed improvement in multiple dimensions of quality of life, but the improvement in the treatment group was greater than that in the control group. In particular, the advantage of the treatment group was more significant in physical health (such as physical function, role of body, and bodily pain) and mental health (such as vitality, role of emotional function, and mental well-being) (P<0.01), as shown in Table 2.

[0083] Table 2: Comparison of Quality of Life Scores Between the Two Groups of Patients

[0084]

[0085]

[0086] Note: Compared with the group before treatment. * P < 0.05 ** P < 0.01; compared with the control group, # P < 0.05 ## P < 0.01.

[0087] 4. Safety and adverse reactions.

[0088] No serious adverse reactions occurred in either group of patients during treatment. Blood routine tests, coagulation function, and liver function indicators fluctuated within the normal range before and after treatment. A few patients experienced mild gastrointestinal discomfort, but this did not affect the continuation of treatment, and no drug-related serious adverse events were observed.

[0089] VI. Experimental Conclusions.

[0090] The pharmaceutical composition prepared in Example 3, combined with basic treatment, demonstrates definite efficacy and good safety in patients with stage 3 chronic kidney disease (spleen and kidney qi deficiency, blood deficiency, and blood stasis syndrome). Clinical trial results show that this pharmaceutical composition significantly improves the overall clinical effective rate (83.33% in the treatment group vs. 46.67% in the control group), effectively improves core renal function indicators—significantly reducing serum urea nitrogen (BUN) and serum creatinine (Scr) levels, and significantly increasing estimated glomerular filtration rate (eGFR). Simultaneously, the improvement in the urine albumin / creatinine ratio (UACR) is evident at 8 weeks of treatment, and the effect continues to enhance with the progression of treatment. Regarding symptom relief and quality of life improvement, this pharmaceutical composition effectively alleviates TCM symptoms such as edema, fatigue, and lower back and knee weakness, while significantly improving scores on physiological health (physiological function, physiological role, etc.) and mental health (emotional role, social function, etc.) dimensions of the SF-36 questionnaire, comprehensively improving patients' quality of life. In terms of safety, no serious adverse reactions occurred during treatment. Key indicators such as blood routine, coagulation function, and liver function remained within the normal range. Only a few patients experienced mild gastrointestinal discomfort, which did not affect the continuation of treatment, and patient compliance was good. In summary, this drug composition is significantly effective in improving renal function, alleviating clinical symptoms, and improving quality of life in patients with stage 3 chronic kidney disease. It also has high safety and good patient tolerance, making it highly valuable for clinical application.

Claims

1. A pharmaceutical composition for treating chronic kidney disease stage 1-3, characterized by, It is composed of the following raw materials by weight: Radix Astragali 40-60 parts, black soybean 40-60 parts, Angelica 8-12 parts, Cornus 24-36 parts, Rhodiola 8-12 parts.

2. The pharmaceutical composition for treating chronic kidney disease stage 1-3 according to claim 1, characterized by, It is composed of the following raw materials by weight: Radix Astragali 45-55 parts, black soybean 45-55 parts, Angelica 9-11 parts, Cornus 27-33 parts, Rhodiola 9-11 parts.

3. The pharmaceutical composition for treating chronic kidney disease stage 1-3 according to claim 2, characterized by, It is composed of the following raw materials by weight: Radix Astragali 50 parts, black soybean 50 parts, Angelica 10 parts, Cornus 30 parts, Rhodiola 10 parts.

4. A process for the preparation of a pharmaceutical composition as claimed in any one of claims 1 to 3, wherein, It comprises the following steps: S1. Raw material pretreatment: Radix Astragali, black soybean, Angelica, Cornus and Rhodiola are taken respectively, washed with clean water, and prepared for use; S2. Soaking: the pretreated Radix Astragali, black soybean and Angelica are put into a container, and clean water with a solid-liquid ratio of 1: (13-16) is added for soaking for 0.5-2 hours; S3. Decoction: the soaked raw materials and soaking liquid are poured into a decoction device together, heated and decocted for 0.6-1.5 hours; then pretreated Cornus and Rhodiola are added, and decoction is continued for 5-15 minutes; after stopping heating, it is naturally cooled to room temperature, the dregs are removed by filtration, and the obtained filtrate is the pharmaceutical composition.

5. The preparation method according to claim 4, characterized in that, In step S3, the decoction device is a kettle, a sand pot or a traditional Chinese medicine decoction machine, and a micro-boiling state is maintained during the decoction process.

6. Use of the pharmaceutical composition of any one of claims 1-4 in the preparation of a medicine or a food and medicine drink for treating chronic kidney disease stage 1-3.

7. Use according to claim 6, characterized in that, The chronic kidney disease stage 1-3 patient is of the spleen and kidney qi deficiency, blood deficiency and blood stasis type.

8. Use according to claim 6, characterized in that, The method for taking the pharmaceutical composition is: 1 dose per day, taken 3 times, 250ml each time, and taken warm.

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