A traditional Chinese medicine composition for treating chronic renal failure and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating chronic renal failure and its application. The composition is made from Astragalus membranaceus, Epimedium, Salvia miltiorrhiza, Rheum palmatum, Orthosiphon aristatus, Uncaria rhynchophylla, Centella asiatica, Pyrola rotundifolia, Smilax glabra, Euonymus alatus, and Sargassum fusiforme in specific weights. The composition significantly reduces serum creatinine, blood urea nitrogen, and 24-hour urinary protein levels in rats with a chronic renal failure model, effectively improving renal pathological damage. Its mechanism of action may be related to multi-target effects such as regulating local renal inflammatory factors. Through rational formulation, this composition fully utilizes the synergistic effects of its components, exhibiting advantages such as definite efficacy and minimal side effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating chronic renal failure and its application. Background Technology

[0002] Chronic renal failure (CRF) is a clinical syndrome caused by various primary or secondary kidney diseases, characterized by progressive decline in renal function, retention of metabolic products, and imbalances in water, electrolytes, and acid-base balance. The causes of CRF are diverse, including diabetes mellitus, hypertension-related kidney damage, gouty nephropathy, nephrotic syndrome, IgA nephropathy, systemic lupus erythematosus-related nephritis, and polycystic kidney disease. Its pathological mechanisms are complex, involving the interaction of multiple factors such as nephron loss, glomerular hyperfiltration, tubulointerstitial fibrosis, inflammatory responses, and oxidative stress.

[0003] Western medicine primarily treats chronic renal failure with early conservative treatment and end-stage renal replacement therapy, but this approach is hampered by high costs, numerous complications, and a shortage of kidney donors. Traditional Chinese medicine (TCM), on the other hand, has a long history of experience in the prevention and treatment of chronic kidney disease. Based on a holistic approach and the principle of syndrome differentiation and treatment, it leverages its unique advantages through multi-target regulation. TCM categorizes chronic renal failure under the categories of "urinary retention," "dysuria," "kidney fatigue," and "urinary toxicity," with the underlying pathogenesis being spleen and kidney deficiency, and dampness, blood stasis, and toxins as the superficial manifestations. It is often a case of deficiency in the root and excess in the branch, with deficiency of the body's vital energy as the root and excess of pathogenic factors as the branch. Treatment emphasizes strengthening the body's resistance and eliminating pathogenic factors.

[0004] Although traditional Chinese medicine (TCM) has made some progress in the treatment of chronic kidney disease, it still suffers from drawbacks such as complex formulations, unclear mechanisms, and insufficient formulation stability. Therefore, developing TCM compound formulas with rational formulations, significant efficacy, and clear mechanisms is an important direction for the prevention and treatment of chronic kidney disease using TCM. Summary of the Invention

[0005] The compound traditional Chinese medicine composition "Qixian Danhuang Decoction" of this invention is a formula derived by the inventor based on traditional Chinese medicine theory, the basic pathogenesis of chronic kidney disease, and clinical experience. Qixian Danhuang Decoction addresses the root cause of "spleen and kidney deficiency" and the symptoms of "dampness and turbidity obstruction (combined with turbid toxins and phlegm accumulation)," with the therapeutic principles of strengthening the spleen and kidneys, resolving blood stasis and unblocking the meridians, and eliminating turbidity and toxins. The scientific combination of the ingredients in the formula, when used together, can effectively treat chronic renal failure, protect kidney function, reduce blood urea nitrogen, serum creatinine, and urinary protein levels, alleviate micro-inflammatory states, and is safe and effective, possessing significant medical application value.

[0006] This invention provides a traditional Chinese medicine composition for treating chronic renal failure, made from the following raw materials in parts by weight: Astragalus membranaceus 15-35 parts, Epimedium 10-20 parts, Salvia miltiorrhiza 5-15 parts, Rheum palmatum 10-15 parts, Orthosiphon aristatus 25-35 parts, Uncaria rhynchophylla 10-25 parts, Centella asiatica 20-35 parts, Pyrola rotundifolia 10-20 parts, Smilax glabra 10-25 parts, Euonymus alatus 10-20 parts, and Sargassum fusiforme 10-15 parts.

[0007] Furthermore, the traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 15-30 parts, Epimedium brevicornu 10-15 parts, Salvia miltiorrhiza 10-15 parts, Rheum palmatum 10-15 parts, Orthosiphon aristatus 25-30 parts, Uncaria rhynchophylla 10-20 parts, Centella asiatica 25-35 parts, Pyrola rotundifolia 15-20 parts, Smilax glabra 10-20 parts, Euonymus alatus 10-15 parts, and Sargassum fusiforme 10-12 parts.

[0008] Furthermore, the traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 20-30 parts, Epimedium brevicornu 10-15 parts, Salvia miltiorrhiza 10-15 parts, Rheum palmatum 10-15 parts, Orthosiphon aristatus 25-30 parts, Uncaria rhynchophylla 10-15 parts, Centella asiatica 25-30 parts, Pyrola rotundifolia 15-20 parts, Smilax glabra 10-15 parts, Euonymus alatus 10-15 parts, and Sargassum fusiforme 10-12 parts.

[0009] More preferably, the traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: 30 parts Astragalus membranaceus, 15 parts Epimedium, 10 parts Salvia miltiorrhiza, 10 parts Rheum palmatum, 30 parts Orthosiphon aristatus, 15 parts Uncaria rhynchophylla, 30 parts Centella asiatica, 15 parts Pyrola rotundifolia, 15 parts Smilax glabra, 15 parts Euonymus alatus, and 10 parts Sargassum.

[0010] Preferably, the number of portions is a mass portion, and the mass unit can be determined according to the scale of implementation; it can be a gram or a kilogram.

[0011] Preferably, the composition is a raw drug powder, an aqueous extract, an alcoholic extract, or a mixture thereof.

[0012] The present invention provides a method for preparing the traditional Chinese medicine composition, the preparation steps of which include taking each traditional Chinese medicine component according to the weight ratio, adding water to decoct, filtering the decoction, repeatedly decocting the medicine, filtering, and mixing the decoction.

[0013] The present invention also provides a traditional Chinese medicine preparation for treating chronic renal failure, the raw materials of which include the traditional Chinese medicine composition described in the present invention.

[0014] Furthermore, the traditional Chinese medicine preparation is in the form of pills, tablets, powders, capsules, granules, oral liquids, or syrups.

[0015] The present invention also provides a method for preparing the traditional Chinese medicine preparation, comprising: mixing raw materials in parts by weight, extracting, concentrating and drying to obtain an extract, and adding pharmaceutically acceptable excipients to form the preparation.

[0016] The present invention also provides the application of the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine preparation in the preparation of a drug for treating chronic renal failure.

[0017] More preferably, the drug is used to reduce serum creatinine, blood urea nitrogen, or urinary protein levels.

[0018] The Qi Xian Dan Huang Tang formula of this application is made from the following ingredients: Astragalus membranaceus, Epimedium, Salvia miltiorrhiza, raw rhubarb, Orthosiphon aristatus, Uncaria rhynchophylla, Centella asiatica, Pyrola rotundifolia, Smilax glabra, Euonymus alatus, and Sargassum. The following is a brief explanation of the efficacy of each ingredient and its role in the formulation of this application:

[0019] Astragalus: Tonifies Qi and raises Yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, promotes the elimination of toxins and pus, and astringes sores and promotes tissue regeneration. In this formula, it serves as the foundation for "strengthening the spleen and benefiting the kidneys," supporting the body's vital energy and boosting Qi to aid in the metabolism of dampness and expel "turbidity."

[0020] Epimedium (also known as Sienya): Tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. It warms and assists kidney yang and strengthens kidney qi, providing the impetus for "benefiting the kidney and resolving turbidity" (when kidney qi is sufficient, qi transformation can proceed and turbidity and dampness can be separated).

[0021] Danshen (Salvia miltiorrhiza): It invigorates blood circulation, removes blood stasis, unblocks meridians, relieves pain, clears the mind and eliminates irritability, cools the blood and reduces swelling. It resolves blood stasis and unblocks meridians to improve the key aspects of "blood stasis and water retention / turbidity and stagnation".

[0022] Raw rhubarb: It purges stagnation, clears heat and fire, cools the blood and detoxifies, removes blood stasis and unblocks menstruation, and promotes diuresis and relieves jaundice. In this formula, it is based on the principle of "clearing the bowels and purging turbidity / guiding turbidity downwards", and also "removing blood stasis" to help the collaterals to be unobstructed.

[0023] Cat's whiskers (Kidney Tea): It promotes urination and relieves strangury, clears heat and detoxifies. It tends to act on the lower burner, promoting urination and eliminating dampness to "remove turbidity through urine", forming a "separation of urine and feces" with rhubarb.

[0024] Cat's Claw Herb: Resolves phlegm and dissipates nodules, detoxifies and reduces swelling. In this formula, it targets the symptoms of "phlegm and blood stasis intertwining and accumulating into stagnation," working synergistically to detoxify, dissipate nodules, and reduce swelling and lumps.

[0025] Centella asiatica: Clears heat and promotes diuresis, detoxifies and reduces swelling. Combined with Orthosiphon aristatus, it enhances the "dampness-clearing and turbidity-eliminating" effect.

[0026] Deer Antler Grass: Dispels wind and dampness, strengthens muscles and bones, stops bleeding, and relieves cough. In this formula, it is intended to tonify the kidneys, strengthen muscles and bones, and dispel dampness, while also addressing weakness due to prolonged illness.

[0027] Smilax glabra: Detoxifies, removes dampness, and promotes joint mobility. It detoxifies and removes dampness, helps to expel "turbid toxins" externally, and is used in combination with Pyrola rotundifolia to "remove dampness and unblock the meridians".

[0028] Euonymus alatus: It breaks up blood stasis, promotes blood circulation, detoxifies, reduces swelling, and kills parasites. In this formula, it is more focused on "breaking up blood stasis and removing blood stasis." When combined with Salvia miltiorrhiza, one is warm and the other is cool, making its blood-activating effect more specific, in order to break up blood stasis caused by "prolonged illness entering the collaterals."

[0029] Seaweed: It resolves phlegm, softens hard masses, dissipates nodules, promotes diuresis, and reduces swelling. In this formula, it works in the same direction as cat's claw herb to "dissipate nodules" and also helps to eliminate "water and dampness accumulation".

[0030] This application's formula, Qi Xian Dan Huang Tang, is based on "spleen and kidney deficiency" as the root cause and "dampness and turbidity obstruction (combined with turbid toxins and phlegm accumulation)" as the symptoms. The treatment principle is to strengthen the spleen and kidneys, resolve blood stasis and unblock the meridians, and eliminate turbidity and detoxify. In this formula, Astragalus membranaceus (Huang Qi) is the chief ingredient, tonifying Qi and raising Yang, and promoting water metabolism. Epimedium (Xian Ling Pi) is the chief ingredient, warming and tonifying kidney Yang and assisting kidney Qi transformation, ensuring that a healthy spleen enables proper digestion and transformation, and warm kidneys facilitate Qi transformation. The assistant ingredients include Orthosiphon aristatus (Mao Xu Cao) for diuresis, clearing heat and detoxifying, combined with Rheum palmatum (Sheng Da Huang) to purge turbidity, eliminate dampness and reduce jaundice, achieving "separate elimination of turbidity through urination and defecation." Additionally, Salvia miltiorrhiza (Dan Shen) invigorates blood and removes blood stasis, while Euonymus alatus (Gui Jian Yu) breaks up blood stasis and removes blood stasis, resolving stasis and unblocking the meridians, ensuring that "when stasis is removed, the meridians are unblocked, and when the meridians are unblocked, turbidity is easily expelled." The formula is supplemented with Centella asiatica to clear heat, promote diuresis, detoxify, and reduce swelling, and Smilax glabra to detoxify, remove dampness, and promote joint mobility, thus assisting in clearing away turbid toxins and dampness. Uncaria rhynchophylla is used to resolve phlegm and dissipate nodules, and Sargassum is used to resolve phlegm, soften hardened masses, dissipate nodules, promote diuresis, and reduce swelling, addressing the symptoms of phlegm and blood stasis accumulating and causing stagnation. Pyrola rotundifolia dispels wind and dampness, strengthens muscles and bones, and protects against chronic illness and physical weakness. The combined effects of these herbs work synergistically to support the body's resistance without lingering on pathogenic factors, and to attack pathogenic factors without harming the body's resistance, embodying the principle of "strengthening the spleen and kidneys, re

[0031] The "Qixiandan Huang Decoction" of this invention is suitable for patients with chronic renal failure whose TCM diagnosis is "deficiency of spleen and kidney as the root cause", accompanied by "internal accumulation of dampness (or damp heat) and blood stasis", and may also be accompanied by "water and dampness overflow" or "internal accumulation of turbid toxins". Its treatment principle is "tonifying qi and strengthening spleen, warming and nourishing kidney qi, resolving blood stasis and unblocking collaterals, dredging the triple burner, clearing the bowels and eliminating turbidity, and promoting diuresis and eliminating turbidity".

[0032] The efficacy experiments of this application show that the composition can significantly reduce serum creatinine, blood urea nitrogen, and 24-hour urinary protein levels in rats with chronic renal failure, effectively improving renal pathological damage. Its mechanism of action may be related to the synergistic effect of multiple targets, such as regulating the inflammatory cytokine network. Simultaneously, comparative experiments highlight the scientific validity and necessity of the original formula. This composition, through rational formulation, fully leverages the synergistic effects of its components, exhibiting advantages such as definite efficacy and minimal side effects. Attached Figure Description

[0033] Figure 1 The results of HE staining of rat kidney tissue are shown.

[0034] Figure 2 The results of serum creatinine and blood urea nitrogen biochemical indicators in each group of rats are shown; among them Figure 2 A represents the serum creatinine level. Figure 2 B represents the urea nitrogen content.

[0035] Figure 3The results show the 24-hour urinary protein levels in each group of rats.

[0036] Note: Compared with the model group, * P < 0.05 ** P<0.01. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. The description of the disclosed embodiments enables those skilled in the art to implement or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not limited to the embodiments shown herein.

[0038] Example 1

[0039] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 15 parts, Epimedium 10 parts, Salvia miltiorrhiza 5 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 25 parts, Uncaria rhynchophylla 10 parts, Centella asiatica 20 parts, Pyrola rotundifolia 10 parts, Smilax glabra 10 parts, Euonymus alatus 10 parts, Sargassum fusiforme 10 parts.

[0040] Example 2

[0041] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in the indicated weight ratios: Astragalus membranaceus 30 parts, Epimedium brevicornu 15 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 30 parts, Pyrola rotundifolia 15 parts, Smilax glabra 15 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0042] Example 3

[0043] A traditional Chinese medicine composition for treating chronic renal failure, characterized in that it is made from the following raw materials in the indicated weight ratios: Astragalus membranaceus 35 parts, Epimedium brevicornu 20 parts, Salvia miltiorrhiza 15 parts, Rheum palmatum 15 parts, Orthosiphon aristatus 35 parts, Uncaria rhynchophylla 25 parts, Centella asiatica 35 parts, Pyrola rotundifolia 20 parts, Smilax glabra 25 parts, Euonymus alatus 20 parts, and Sargassum fusiforme 15 parts.

[0044] Example 4

[0045] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 15 parts, Epimedium 10 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 25 parts, Uncaria rhynchophylla 10 parts, Centella asiatica 25 parts, Pyrola rotundifolia 15 parts, Smilax glabra 10 parts, Euonymus alatus 10 parts, and Sargassum fusiforme 10 parts.

[0046] Example 5

[0047] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Epimedium brevicornu 15 parts, Salvia miltiorrhiza 15 parts, Rheum palmatum 15 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 20 parts, Centella asiatica 35 parts, Pyrola rotundifolia 20 parts, Smilax glabra 20 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0048] Example 6

[0049] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Epimedium brevicornu 10 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 25 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 25 parts, Pyrola rotundifolia 15 parts, Smilax glabra 20 parts, Euonymus alatus 10 parts, and Sargassum fusiforme 15 parts.

[0050] Example 7

[0051] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Epimedium 15 parts, Salvia miltiorrhiza 5 parts, Rheum palmatum 15 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 20 parts, Pyrola rotundifolia 10 parts, Smilax glabra 15 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0052] Comparative Example 1

[0053] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Codonopsis pilosula 30 parts, Morinda officinalis 15 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 30 parts, Pyrola rotundifolia 15 parts, Smilax glabra 15 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0054] Comparative Example 2

[0055] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Epimedium 15 parts, Ligusticum chuanxiong 10 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 30 parts, Pyrola rotundifolia 15 parts, Smilax glabra 15 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0056] Comparative Example 3

[0057] A traditional Chinese medicine composition for treating chronic renal failure is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Epimedium 15 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 30 parts, Smilax glabra 30 parts, Euonymus alatus 15 parts, and Sargassum fusiforme 10 parts.

[0058] Example 1 of efficacy: The invention is further illustrated by specific animal efficacy experiments:

[0059] The animal efficacy experiment in this application involved administering high-concentration adenine via gavage to rats. The adenine deposited in the renal tubules, disrupting their structure and thus replicating an animal model of chronic renal failure. All reagents and raw materials used in the experiment were commercially available, conventional products.

[0060] Animal model establishment: Male SD rats, 7-8 weeks old, SPF grade, weighing (220±30) g, were selected. Adenine suspension 230 mg / kg was administered by gavage once daily for 21 consecutive days.

[0061] Animal grouping: Rats with successfully established chronic renal failure model were randomly divided into model group, Example 1-3 group, and Comparative Example 1-3 group, with 10 rats in each group. Another 10 rats were used as blank control group.

[0062] Administration method: The drug treatment groups were prepared with the traditional Chinese medicine compositions of the examples and comparative examples, and were administered by gavage at the dosage of the composition (6.5 g / kg) for 30 days. The model group and the blank control group were administered the same volume of physiological saline by gavage for 30 days. All rats were placed in metabolic cages one day before the end of the experiment to collect urine from each group. After the drug intervention, serum was collected, and kidney specimens were also collected.

[0063] Detection indicators and methods: Serum samples were collected and serum creatinine (Scr) and blood urea nitrogen (BUN) were measured using a fully automated biochemical analyzer to detect renal function indicators. Urine samples were collected and 24-hour urine protein was measured using a fully automated biochemical analyzer to detect quantitative urinary protein.

[0064] (1) Effects on serum creatinine (SCr) and blood urea nitrogen (BUN) levels in rats with chronic renal failure

[0065] In the progression of chronic kidney disease, the progressive loss of nephrons leads to a decline in excretory function, resulting in an increase in serum creatinine and blood urea nitrogen levels. The magnitude of this increase is positively correlated with the degree of renal impairment. Therefore, monitoring the trends of these indicators helps assess the severity of renal damage, and observing the dynamic changes in serum creatinine and blood urea nitrogen levels provides crucial pharmacodynamic evidence for verifying the effects of traditional Chinese medicine compositions on improving renal function.

[0066] As shown in Table 1 and Figure 2The results showed that after intervention with high concentrations of adenine in rats, the Scr and BUN levels in the model group were significantly higher than those in the blank control group, with statistically significant differences (P<0.01), indicating that a renal failure model was successfully established. After drug intervention in Examples 1-3 of this application, the Scr and BUN levels were significantly lower than those in the model group, demonstrating that the herbal composition of this application effectively alleviates renal tissue pathological damage through multiple pathways and has a protective effect against kidney injury. However, in Comparative Example 1, where Codonopsis pilosula and Morinda officinalis were used instead of Astragalus membranaceus and Epimedium, the Scr and BUN levels did not show a significant decrease compared to the model group (no statistical difference). Similarly, in Comparative Example 2, where Ligusticum chuanxiong was used instead of Salvia miltiorrhiza and Rheum palmatum was omitted, and in Comparative Example 3, where Pyrola rotundifolia was omitted and the dosage of Smilax glabra was adjusted, no significant therapeutic effect was observed. This indicates that the raw material components of this application exhibit significant synergistic effects within their respective dosage ranges, and the rationality of the formulation is crucial for the efficacy of the drug.

[0067] Table 1. Results of serum creatinine and blood urea nitrogen biochemical indicators in rats of each group ( ±s)

[0068]

[0069] Note: Compared with the model group, * P < 0.05 ** P<0.01.

[0070] (2) Effects on 24-hour urinary protein levels in rats with chronic renal failure

[0071] Urinary protein levels are a key indicator for assessing glomerular filtration barrier function. Under normal physiological conditions, the glomerular filtration membrane functions as a molecular sieve and charge barrier, effectively preventing the leakage of plasma proteins. When kidney function is pathologically impaired, abnormal podocyte structure and thickening of the basement membrane lead to increased filtration pore size and impaired barrier function, resulting in increased urinary protein excretion. Urinary protein levels are significantly positively correlated with the rate of progression of kidney function impairment.

[0072] As shown in Table 2 and Figure 3 The results showed that, compared with the blank control group, the 24-hour urinary protein level in the chronic renal failure model group was significantly increased (P<0.01), indicating significant damage to the glomerular filtration barrier. Compared with the model group, the 24-hour urinary protein level in rats treated with the drugs in Examples 1-3 was significantly reduced (P<0.01), which may be related to its protection of the glomerular filtration barrier and improvement of renal tubular reabsorption function. Although the 24-hour urinary protein level in Comparative Examples 1-3 also showed a certain decreasing trend compared with the model group, only Comparative Example 1 showed a statistically significant difference (P<0.05), while the other comparative examples showed no significant difference from the model group. This result further confirms that Examples 1-3 are significantly superior to the comparative examples in reducing urinary protein levels, highlighting their unique formulation advantages.

[0073] Table 2. Results of 24-hour urinary protein levels in rats of each group ( ±s)

[0074]

[0075] Note: Compared with the model group, * P < 0.05 ** P<0.01.

[0076] Pharmacological Example 2: The composition of Example 2 was used to study the morphology and mechanism of action of renal tissue in rats with chronic renal failure.

[0077] (1) Morphological observation of kidney tissue in rats with chronic renal failure:

[0078] Kidney tissue specimens from the blank control group, model group, and rats in Example 2 were used for pathological sectioning. After preparing paraffin sections, they were stained with hematoxylin and eosin (HE). The pathological changes of renal tubules, glomeruli, and renal interstitium in each group of rats were observed and photographed under a microscope.

[0079] The results of the observation of renal tissue morphology are as follows: Figure 1 As shown, the kidney tissue structure of rats in the blank control group was clear and no obvious changes were observed in histological examination; the glomeruli of rats in the model group were smaller, the kidney tissue structure was destroyed or even necrotic, fibrosis appeared in the periglomerular tissue and renal interstitium, and there was inflammatory cell infiltration; compared with the model group, the degree of disorder and fibrosis of kidney tissue structure in the drug administration group of Example 2 was reduced, the structure of glomeruli was clearer, and inflammatory cell infiltration was effectively reduced.

[0080] (2) Study on the mechanism of action in rats with chronic renal failure:

[0081] Modern pharmacological studies have found that the specific pathological internal environment of patients with chronic kidney disease (CKD) can activate peripheral blood mononuclear cells to release inflammatory cytokines such as IL-6 and TNF-α. Interleukin-6 (IL-6), as a key pro-inflammatory factor, participates in and promotes the occurrence and development of various kidney diseases. Its level is closely related to the progression rate of chronic renal failure (CRF). IL-6 participates in the inflammatory response of renal tissue in CRF and can exacerbate CRF. Tumor necrosis factor-α (TNF-α), as an inflammatory mediator and a major pathogenic factor in kidney disease, is a pro-inflammatory cytokine secreted by Th1 cells. TNF-α plays an important role in the development of renal fibrosis, driving its occurrence and progression.

[0082] The expression of IL-6, IL-10 and TNF-α in rat kidney tissue was detected by ELISA: rat kidney tissue from the blank control group, model group and Example 2 was taken, the surface membrane was removed, weighed, chopped, and homogenized after adding 0.9% NaCl solution. The supernatant was collected by freezing and centrifugation, and the contents of IL-6, IL-10 and TNF-α in the kidney tissue were determined according to the kit instructions.

[0083] Table 3: Results of IL-6, IL-10, and TNF-α levels in rat kidney tissue of each group ( ±s, n=10)

[0084]

[0085] Note: Compared with the blank control group * P < 0.05 ** P<0.01; compared with the model group, # P < 0.05.

[0086] Table 3 above shows the detection results of renal cytokines IL-6, IL-10, and TNF-α in the kidney tissue of rats in the model group. Compared with the blank control group, the expression levels of IL-6, IL-10, and TNF-α in the kidney tissue of rats in the model group were significantly increased (P<0.01). This indicates that the inflammatory factors in rats with renal failure in the model group were significantly increased compared with those in the blank group, and a significant micro-inflammatory state existed in the model rats. Compared with the model group, after administration of the traditional Chinese medicine composition of Example 2, the expression levels of IL-6, IL-10, and TNF-α in the kidney tissue were significantly decreased compared with the model group (P<0.05), showing a good anti-inflammatory effect. It is evident that the composition of this application may exert a renal protective effect through mechanisms such as regulating the inflammatory factor network and inhibiting the fibrosis process, thereby delaying the pathological damage of the kidney.

[0087] The above experimental results demonstrate that the traditional Chinese medicine composition described in this application has a significant therapeutic effect on a rat model of chronic renal failure (CRF) induced by high concentrations of adenine. Specifically, the composition effectively reduces key renal function indicators such as blood urea nitrogen (BUN), creatinine (SCr), and urinary protein levels in the serum of model animals, significantly improving the damage caused by chronic renal failure. Observation of renal pathological structure shows that the composition exhibits a significant effect in improving the renal pathological morphology of CRF model mice, indicating that the composition has a definite protective effect on renal tissue structure. At the mechanism level, this composition may exert its renal protective effect through mechanisms such as reducing local renal inflammatory responses.

[0088] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic renal failure, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 15-35 parts, Epimedium 10-20 parts, Salvia miltiorrhiza 5-15 parts, Rheum palmatum 10-15 parts, Orthosiphon aristatus 25-35 parts, Uncaria rhynchophylla 10-25 parts, Centella asiatica 20-35 parts, Pyrola rotundifolia 10-20 parts, Smilax glabra 10-25 parts, Euonymus alatus 10-20 parts, Sargassum fusiforme 10-15 parts.

2. The traditional Chinese medicine composition for treating chronic renal failure according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 15-30 parts, Epimedium 10-15 parts, Salvia miltiorrhiza 10-15 parts, Rheum palmatum 10-15 parts, Orthosiphon aristatus 25-30 parts, Uncaria rhynchophylla 10-20 parts, Centella asiatica 25-35 parts, Pyrola rotundifolia 15-20 parts, Smilax glabra 10-20 parts, Euonymus alatus 10-15 parts, Sargassum fusiforme 10-12 parts.

3. The traditional Chinese medicine composition for treating chronic renal failure according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Epimedium 15 parts, Salvia miltiorrhiza 10 parts, Rheum palmatum 10 parts, Orthosiphon aristatus 30 parts, Uncaria rhynchophylla 15 parts, Centella asiatica 30 parts, Pyrola rotundifolia 15 parts, Smilax glabra 15 parts, Euonymus alatus 15 parts, Sargassum fusiforme 10 parts.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The composition is a raw drug powder, water extract, alcohol extract, or a mixture thereof.

5. A traditional Chinese medicine preparation for treating chronic renal failure, characterized in that, The raw materials include the composition according to any one of claims 1-3.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparations are pills, tablets, powders, capsules, granules, oral liquids, or syrups.

7. A method for preparing a traditional Chinese medicine preparation according to claim 5, characterized in that, include: The active pharmaceutical ingredients are mixed in parts by weight, and the extract is obtained by extraction, concentration and drying. Pharmaceutically acceptable excipients are then added to form the final product.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine preparation according to any one of claims 5-6 in the preparation of a drug for treating chronic renal failure.

9. The application according to claim 8, characterized in that, The drug is used to lower serum creatinine, blood urea nitrogen, or urinary protein levels.

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