Traditional Chinese medicine composition for treating chronic renal failure as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic renal failure and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25 to 35 parts of radix et rhizoma rhei, 25 to 35 parts of herba taraxaci, 25 to 35 parts of radix salviae miltiorrhizae, 25 to 35 parts of concha ostreae, 25 to 35 parts of caulis lonicerae, 25 to 35 parts of flos sophorae, 10 to 20 parts of radix aconiti lateralis preparata, 40 to 60 parts of rhizoma smilacis glabrae and 25 to 35 parts of rhizoma imperatae. The whole formula is clear in compatibility, the rheum officinale serves as a monarch drug, the dandelion, the rhizoma smilacis glabrae and the lalang grass rhizome serve as ministerial drugs, the salvia miltiorrhiza, the oysters, the honeysuckle stems, the sophora flowers and the black prepared common monarch herbs serve as adjuvant and conductant drugs, all the drugs act synergistically, the effects of descending turbid and expelling toxins and removing turbid and removing toxins are achieved, and through the multi-component and multi-target-point synergistic effect, the effects of removing turbid and toxins and giving consideration to both evil and positive pathogen are achieved; and a better choice is provided for clinical treatment of chronic renal failure.

Description

Technical Field

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

[0002] Chronic renal failure is a common outcome of various kidney diseases progressing to their later stages, characterized by a continuous decline in glomerular filtration rate, retention of metabolic products, and disturbances in water, electrolyte, and acid-base balance. Its course is protracted and complex; without timely and effective intervention, it will eventually progress to end-stage renal disease, seriously threatening the patient's life and health.

[0003] Currently, the main clinical treatments for chronic renal failure include dialysis, kidney transplantation, and drug therapy. While dialysis can partially replace kidney function, long-term dialysis can easily lead to infections, cardiovascular complications, and limited quality of life for patients. Kidney transplantation is an effective treatment for end-stage renal disease, but issues such as donor shortages, surgical risks, and postoperative immune rejection remain unresolved. In drug therapy, Western medicine primarily focuses on symptomatic treatment, such as controlling blood pressure and correcting anemia, but it cannot fundamentally improve kidney function, and long-term use can easily lead to drug resistance and adverse reactions.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in the treatment of chronic renal failure. Through holistic regulation and syndrome differentiation, it has demonstrated certain efficacy in improving patients' clinical symptoms and delaying the deterioration of renal function. While various TCM compositions for treating chronic renal failure have been disclosed in existing technologies, many suffer from unstable efficacy, unclear mechanisms of action, and limited administration methods. Some compositions are complex in formulation, have limited sources of medicinal materials, and involve cumbersome preparation processes, hindering large-scale production and clinical application. Furthermore, some compositions have shown limited effectiveness in improving key renal function indicators and reducing proteinuria.

[0005] Therefore, developing a traditional Chinese medicine composition that is rationally formulated, has definite efficacy, few side effects, simple preparation process, and can effectively delay the progression of chronic renal failure has important clinical significance and application value. Summary of the Invention

[0006] In view of this, one of the objectives of the present invention is to provide a traditional Chinese medicine composition for treating chronic renal failure.

[0007] The second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition for treating chronic renal failure.

[0008] A third objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition for treating chronic renal failure in the preparation of a medicament for treating renal failure.

[0009] The fourth objective of this invention is to provide a medicine containing the above-mentioned traditional Chinese medicine composition for treating chronic renal failure.

[0010] To achieve the above-mentioned objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for treating chronic renal failure, comprising the following ingredients by weight: 25-35 parts rhubarb, 25-35 parts dandelion, 25-35 parts salvia miltiorrhiza, 25-35 parts oyster shell, 25-35 parts honeysuckle vine, 25-35 parts sophora japonica flower, 10-20 parts prepared aconite root, 40-60 parts smilax glabra, and 25-35 parts imperata cylindrica root.

[0011] Preferably, the ingredients, by weight, include the following: 28-32 parts rhubarb, 28-32 parts dandelion, 28-32 parts salvia miltiorrhiza, 28-32 parts oyster shell, 28-32 parts honeysuckle vine, 25-35 parts sophora japonica flower, 12-18 parts black aconite root slices, 45-55 parts smilax glabra, and 28-32 parts imperata cylindrica root.

[0012] Preferably, the ingredients, by weight, include the following: 30 parts rhubarb, 30 parts dandelion, 30 parts salvia miltiorrhiza, 30 parts oyster shell, 30 parts honeysuckle vine, 30 parts sophora japonica flower, 15 parts black aconite root slices, 50 parts smilax glabra, and 30 parts imperata cylindrica root.

[0013] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: Soak the sliced ​​black aconite in water, simmer for 30-40 minutes, then add oysters and continue simmering for 40-60 minutes. Collect the simmering liquid. After mixing and crushing the salvia miltiorrhiza and rhubarb, mixture 1 was obtained. Mixture 1 was then mixed with a 40% to 50% ethanol solution and extracted by reflux. Extract 1 was collected. Dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root are mixed and crushed to obtain mixture 2. Mixture 2 is mixed with water and soaked, then refluxed for extraction, and extract 2 is collected. The decoction 1, extract 1 and extract 2 are mixed and concentrated to a relative density of 1.2 to 1.3 to obtain the traditional Chinese medicine composition.

[0014] Preferably, the black shiitake mushroom slices are mixed with water at a mass ratio of 1:(10~12), and the soaking time is 40~60 minutes.

[0015] Preferably, the mixture 1 is mixed with an ethanol solution of 40%~50% by volume at a mass ratio of 1:(8~10); the conditions for reflux extraction of the mixture 1 include: extraction temperature of 40~50℃ and extraction time of 1~2h.

[0016] Preferably, mixture 2 is mixed with water at a mass ratio of 1:(10~12); the soaking time is 20~30 min; the conditions for reflux extraction of mixture 2 include: extraction temperature of 70~80℃ and extraction time of 1.5~3 h.

[0017] The present invention also provides the application of the traditional Chinese medicine composition or the preparation method described herein in the preparation of a drug for treating renal failure.

[0018] Preferably, the renal failure is chronic renal failure.

[0019] The present invention also provides a medicament for treating chronic renal failure, the medicament comprising the aforementioned traditional Chinese medicine composition.

[0020] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a traditional Chinese medicine composition for treating chronic renal failure. The entire formula is clearly defined, with rhubarb as the principal ingredient, dandelion, smilax glabra, and imperata cylindrica as assistant ingredients, and salvia miltiorrhiza, oyster shell, honeysuckle vine, sophora japonica, and aconite as adjuvant ingredients. The various ingredients work synergistically to reduce turbidity and detoxify, achieving the dual elimination of turbidity and toxins and addressing both pathogenic factors and the body's resistance through the synergistic effect of multiple components and multiple targets. This provides a better option for the clinical treatment of chronic renal failure.

[0021] This invention utilizes the characteristics and efficacy differences of each herb in the composition for precise step-by-step processing, which can effectively promote the dissolution of active ingredients, enhance the synergistic effect of the medicine, and improve the efficacy of the traditional Chinese medicine composition in reducing turbidity and detoxifying. Detailed Implementation

[0022] This invention provides a traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials by weight: 25-35 parts rhubarb, 25-35 parts dandelion, 25-35 parts salvia miltiorrhiza, 25-35 parts oyster shell, 25-35 parts honeysuckle vine, 25-35 parts sophora japonica flower, 10-20 parts prepared aconite root, 40-60 parts smilax glabra, and 25-35 parts imperata cylindrica root. Preferably, it comprises the following raw materials: 28-32 parts rhubarb, 28-32 parts dandelion, 28-32 parts salvia miltiorrhiza, 28-32 parts oyster shell, 28-32 parts honeysuckle vine, 25-35 parts sophora japonica flower, 12-18 parts prepared aconite root, 45-55 parts smilax glabra, and 28-32 parts imperata cylindrica root. A more preferred formulation includes the following ingredients: 30 parts rhubarb, 30 parts dandelion, 30 parts salvia miltiorrhiza, 30 parts oyster shell, 30 parts honeysuckle vine, 30 parts sophora japonica flower, 15 parts aconite root slices, 50 parts smilax glabra, and 30 parts imperata cylindrica root. This invention does not impose any specific limitations on the source of the above ingredients; any commercially available products conventional in the field may be used.

[0023] In the composition of this invention, rhubarb is bitter and cold in nature, and enters the spleen, stomach, and large intestine meridians. The bitter and cold properties of rhubarb have a dual effect of clearing heat and promoting bowel movements. It can act on the digestive system and affect blood circulation, clearing heat toxins from the blood, improving blood stasis, and has the effects of promoting blood circulation, stopping bleeding, and reducing swelling. Rhubarb is the principal herb in the formula, directly targeting the accumulation of turbid toxins. Through strong purgation and bowel-clearing, it promotes the elimination of dampness, turbidity, and blood stasis, playing a core role in treating chronic renal failure.

[0024] In the composition of this invention, dandelion is bitter, sweet, and cold in nature, and enters the liver and stomach meridians. Dandelion clears heat and detoxifies, reduces swelling and dissipates nodules, and promotes urination. It is used for boils, carbuncles, mastitis, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful urination due to heat. Smilax glabra is sweet, bland, and neutral in nature, and has the effects of clearing heat and detoxifying, and promoting diuresis and unblocking the meridians. Imperata cylindrica is sweet and cold in nature, and enters the lung, stomach, and bladder meridians. Imperata cylindrica stops bleeding, reduces fever, and promotes urination. It is often used to improve nosebleeds, hemoptysis, hematuria, dysuria, and edema. Dandelion, Smilax glabra, and Imperata cylindrica are used together as assistant herbs. Dandelion clears heat and detoxifies, Smilax glabra promotes diuresis and eliminates turbidity, and Imperata cylindrica cools the blood and promotes urination. The three herbs work together to enhance the "turbidity-reducing" power of the principal herb. At the same time, they precisely target heat toxins, dampness, and blood stasis, forming a dual-channel detoxification mechanism of "intestinal drainage + urinary tract drainage" to enhance the turbidity-removing effect of the formula.

[0025] In the composition of this invention, Salvia miltiorrhiza is bitter and cold in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and eliminating carbuncles. It is used for chest pain, abdominal pain, abdominal masses, pain due to heat, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling. Oyster shell is salty and neutral in nature, and enters the liver and kidney meridians. It has the effects of astringing yin, suppressing yang, stopping sweating, astringing essence, resolving phlegm, and softening hardness. It is mainly used to treat epilepsy, dizziness, spontaneous sweating, night sweats, seminal emission, urinary tract infections, metrorrhagia, leukorrhea, scrofula, and goiter. Honeysuckle vine is sweet and cold in nature, and enters the lung and stomach meridians. It can clear heat toxins from the body, dredge the meridians and relieve joint pain. It is mainly used to treat febrile diseases and joint swelling. Sophora japonica flowers are bitter and slightly cold in nature, and enter the liver and large intestine meridians. They have the effects of cooling the blood and stopping bleeding, clearing the liver and purging fire. They are mainly used to treat hematochezia, hemorrhoidal bleeding, bloody dysentery, metrorrhagia, hematemesis, epistaxis, red eyes due to liver heat, headache and dizziness. Prepared aconite root slices are a processed product of Aconitum carmichaelii. They are pungent, sweet, and very hot in nature, and enter the heart, kidney, and spleen meridians. They have the effects of restoring yang and rescuing from collapse, dispelling cold and relieving pain. They are mainly used to treat collapse due to yang deficiency and wind-cold-dampness arthralgia. Salvia miltiorrhiza, oyster shell, honeysuckle vine, Sophora japonica flowers, and prepared aconite root slices are used together as adjuvant herbs in the formula. Salvia miltiorrhiza invigorates blood and removes blood stasis to promote blood circulation and help eliminate toxins with blood flow; oyster shell softens hardness and dissipates nodules, resolving the clumps of toxins; honeysuckle vine and Sophora japonica flowers work with dandelion to enhance detoxification; prepared aconite root slices warm yang and promote qi circulation, preventing the bitter and cold herbs from damaging spleen yang and promoting qi flow to aid in detoxification. The adjuvant herbs assist the principal and assistant herbs, enabling the entire formula to achieve the effect of "reducing turbidity without leaving blood stasis and detoxifying without harming the body's vital energy".

[0026] The present invention has a reasonable combination of ingredients and has the effects of reducing turbidity and detoxifying, and can effectively treat chronic renal failure.

[0027] The present invention also provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: soaking black aconite slices in water, decocting for 30-40 minutes, adding oyster shell, and continuing to decoct for 40-60 minutes, collecting decoction 1; mixing salvia miltiorrhiza and rhubarb and pulverizing to obtain mixture 1, mixing mixture 1 with a 40%-50% ethanol solution by volume, refluxing and extracting, collecting extract 1; mixing dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root and pulverizing to obtain mixture 2, mixing mixture 2 with water and soaking, refluxing and extracting, collecting extract 2; mixing decoction 1, extract 1 and extract 2, concentrating to a relative density of 1.2-1.3, to obtain the traditional Chinese medicine composition.

[0028] In this invention, aconite slices and water are preferably mixed at a mass ratio of 1:(10~12); the soaking time is preferably 40~60 minutes; oysters are preferably added after the aconite slices have been decocted for 34~36 minutes, and the decoction is preferably continued for 45~55 minutes. This invention promotes the dissolution of active ingredients and reduces the toxicity of aconite slices through soaking, making the medicine safe and effective; adding oysters during the decoction process and decocting them for a long time can fully extract the active ingredients in the medicine.

[0029] In this invention, after pulverization, it is preferable to pass the material through a 20-40 mesh sieve. This invention does not specifically limit the pulverization method; conventional pulverization methods in the art can be used.

[0030] In this invention, ethanol solution is used to reflux extract mixture 1, wherein the volume fraction of the ethanol solution is preferably 40%~50%, more preferably 45%; the mixture 1 and the ethanol solution with a volume fraction of 40%~50% are preferably mixed at a mass ratio of 1:(8~10), more preferably at a mass ratio of 1:9; the reflux extraction temperature is preferably 40~50℃, more preferably 45℃; the reflux extraction time is preferably 1~2h, more preferably 1.5h; and the reflux extraction is preferably performed 1~2 times.

[0031] In this invention, mixture 2 and water are preferably mixed at a mass ratio of 1:(10~12), more preferably at a mass ratio of 1:11; the soaking time is preferably 20~30 min, more preferably 24~26 min; the reflux extraction temperature is preferably 70~80℃, more preferably 75℃; the reflux extraction time is preferably 1.5~3 h, more preferably 2~2.5 h; and the reflux extraction is preferably performed 1~2 times.

[0032] In this invention, the order in which decoction 1, extract 1, and extract 2 are obtained is not important. Decoction 1, extract 1, and extract 2 are mixed and concentrated to a relative density of 1.2~1.3 (20℃). This invention does not have any particular limitation on the concentration method; conventional concentration methods in the art can be used.

[0033] Based on the different characteristics of each herb, this invention performs precise step-by-step extraction, which can promote the dissolution of active ingredients. Compared with a single extraction method, the active ingredients obtained by step-by-step extraction are mixed, and the synergistic effect of each component can significantly enhance the therapeutic effect of the composition on chronic renal failure.

[0034] The present invention also provides the application of the traditional Chinese medicine composition or the preparation method described herein in the preparation of a drug for treating renal failure, wherein the renal failure is chronic renal failure.

[0035] The present invention also provides a medicament for treating chronic renal failure, the medicament containing the aforementioned traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is the sole or one of the effective components in the medicament. The dosage form of the medicament may be an enema, granules, or powder.

[0036] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0037] Example 1 A traditional Chinese medicine composition for treating chronic renal failure, comprising the following ingredients by weight: 30 parts rhubarb, 30 parts dandelion, 30 parts salvia miltiorrhiza, 30 parts oyster shell, 30 parts honeysuckle vine, 30 parts sophora japonica flower, 15 parts black aconite root, 50 parts smilax glabra and 30 parts imperata cylindrica root.

[0038] The preparation method is as follows: Mix the black aconite slices with water at a mass ratio of 1:10, soak for 60 minutes, simmer for 35 minutes, add oysters, continue simmering for 50 minutes, and collect the decoction. After mixing and pulverizing the salvia miltiorrhiza and rhubarb, the mixture was passed through a 30-mesh sieve to obtain mixture 1. Mixture 1 was then mixed with a 45% ethanol solution at a mass ratio of 1:9 and extracted by reflux at a temperature of 45℃ for 1.5 hours for 2 times. The extracts were collected and combined to obtain extract 1. Dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root were mixed and pulverized, and passed through a 30-mesh sieve to obtain mixture 2. Mixture 2 was mixed with water at a mass ratio of 1:11, soaked for 25 minutes, and then extracted by reflux: the extraction temperature was 75℃, the extraction time was 2 hours, the extraction was performed once, and the extract 2 was collected. The decoction 1, extract 1 and extract 2 are mixed and concentrated to a relative density of 1.2 (20°C) to obtain the traditional Chinese medicine composition.

[0039] Example 2 A traditional Chinese medicine composition for treating chronic renal failure, comprising the following ingredients by weight: 35 parts rhubarb, 26 parts dandelion, 26 parts salvia miltiorrhiza, 26 parts oyster shell, 26 parts honeysuckle vine, 26 parts sophora japonica flower, 18 parts black aconite root, 56 parts smilax glabra and 34 parts imperata cylindrica root.

[0040] The preparation method is as follows: Mix the black aconite slices with water at a mass ratio of 1:12, soak for 50 minutes, simmer for 40 minutes, then add oysters and continue simmering for 50 minutes. Collect the simmering liquid. After mixing and pulverizing the salvia miltiorrhiza and rhubarb, the mixture was passed through a 20-mesh sieve to obtain mixture 1. Mixture 1 was then mixed with a 50% ethanol solution at a mass ratio of 1:8 and extracted by reflux at a temperature of 50°C for 1 hour. The extraction was performed once, and extract 1 was collected. Dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root were mixed and pulverized, and passed through a 20-mesh sieve to obtain mixture 2. Mixture 2 was mixed with water at a mass ratio of 1:10, soaked for 20 minutes, and then extracted by reflux: the extraction temperature was 70℃, the extraction time was 2.5h, the extraction was performed once, and the extract 2 was collected. The decoction 1, extract 1 and extract 2 are mixed and concentrated to a relative density of 1.25 (20°C) to obtain the traditional Chinese medicine composition.

[0041] Example 3 A traditional Chinese medicine composition for treating chronic renal failure, comprising the following ingredients by weight: 28 parts rhubarb, 32 parts dandelion, 32 parts salvia miltiorrhiza, 32 parts oyster shell, 32 parts honeysuckle vine, 32 parts sophora japonica flower, 10 parts black aconite root, 46 parts smilax glabra and 28 parts imperata cylindrica root.

[0042] The preparation method is as follows: Mix the black aconite slices with water at a mass ratio of 1:10, soak for 40 minutes, simmer for 35 minutes, then add oysters and continue simmering for 40 minutes. Collect the simmering liquid 1. After mixing and pulverizing the salvia miltiorrhiza and rhubarb, the mixture was passed through a 40-mesh sieve to obtain mixture 1. Mixture 1 was mixed with a 50% ethanol solution at a mass ratio of 1:10 and extracted by reflux at a temperature of 40℃ for 2 hours and once. The extract 1 was collected. Dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root were mixed and pulverized, and passed through a 40-mesh sieve to obtain mixture 2. Mixture 2 was mixed with water at a mass ratio of 1:12, soaked for 30 minutes, and then extracted by reflux: the extraction temperature was 80℃, the extraction time was 1.5h, and the extraction was performed twice. The extracts were collected and combined to obtain extract 2. The decoction 1, extract 1 and extract 2 are mixed and concentrated to a relative density of 1.3 (20°C) to obtain the traditional Chinese medicine composition.

[0043] Comparative Example 1 The difference between this comparative example and Example 1 is that the preparation method is as follows: Weigh out the following ingredients in the following proportions: 30 parts rhubarb, 30 parts dandelion, 30 parts salvia miltiorrhiza, 30 parts oyster shell, 30 parts honeysuckle vine, 30 parts sophora japonica flower, 15 parts aconite root, 50 parts smilax glabra and 30 parts imperata cylindrica root. After mixing all the raw materials, crush them and pass them through a 30-mesh sieve to obtain a mixture. Mix the mixture with water at a mass ratio of 1:10, soak for 30 minutes, decoct for 75 minutes, and collect the decoction. The decoction was concentrated to a relative density of 1.2 (20°C) to obtain the traditional Chinese medicine composition.

[0044] Comparative Example 2 The difference between this comparative example and Example 1 is that rhubarb was not added.

[0045] Comparative Example 3 The difference between this comparative example and Example 1 is that dandelion is replaced with plantain, and Smilax glabra is replaced with coix seed.

[0046] Comparative Example 4 The difference between this comparative example and Example 1 is that the amount of rhubarb added is 40 parts.

[0047] Example 4 Its role in treating chronic renal failure.

[0048] 1. Cell experiments Human proximal renal tubular epithelial cells (HK-2 cells, SCSP-511) were purchased from the Stem Cell Bank of the Chinese Academy of Sciences.

[0049] After resuscitation, HK-2 cells were cultured in DMEM medium containing 10% fetal bovine serum (FBS) at 37°C in a 5% CO2 incubator. When the cells reached the logarithmic growth phase (cell confluence reached 80%–90%), they were passaged using 0.25% trypsin for subsequent experiments.

[0050] 1.1 Using DMEM culture medium containing 10% fetal bovine serum (FBS), the traditional Chinese medicine compositions of Examples 1-3 and Comparative Examples 1-4 were diluted to obtain solutions with different concentrations (60, 30, 15, 7.5, 3.75, 1.875 mg / mL) based on the mass of the traditional Chinese medicine compositions. HK-2 cells were added to the culture medium containing the traditional Chinese medicine compositions to achieve a cell concentration of 2 × 10⁻⁶ cells / mL. 5Cells were seeded at a density of 1 / mL in 96-well plates, 200 μL per well. A blank control group (containing only DMEM medium with 10% fetal bovine serum (FBS)) was also set up. The plates were incubated at 37°C in a 5% CO2 incubator. After 24 h of incubation, 20 μL of CCK-8 reagent was added to each well, and the plates were incubated for another 2 hours. The absorbance (OD value) at 450 nm was measured using a microplate reader, and the cell viability was calculated as follows: Cell viability (%) = (OD value of experimental group / OD value of blank control group) × 100%.

[0051] The results showed that the survival rate of HK-2 cells in each group was ≥85%, and the cell morphology was normal, indicating that the traditional Chinese medicine composition provided by the present invention is safe and non-toxic.

[0052] 1.2 Take HK-2 cells in the logarithmic growth phase, digest them with 0.25% trypsin, and then use 2×10⁻⁶ cells... 5 HK-2 cells were seeded at a density of 10 cells / mL in 96-well plates and incubated at 37°C with 5% CO2 for 24 h to allow cell adhesion (cell confluence reaching 80%–90%). The HK-2 cells were then randomly divided into 8 groups, with the following treatments for each group: Normal control group: Discard the original culture medium and add 200 μL of DMEM culture medium containing 10% fetal bovine serum; Model group: Discard the original culture medium, add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose, and after culturing for 24 h, replace it with DMEM culture medium containing 10% fetal bovine serum. Example 1 group: Discard the original culture medium, add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose, and after culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition (10 μg / mL) from Example 1. Example 2 group: Discard the original culture medium, add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose, and after culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition (10 μg / mL) of Example 2. Example 3 group: Discard the original culture medium, add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose, and after culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition (10 μg / mL) of Example 3. Comparative Example 1: Discard the original culture medium and add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose. After culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition of Comparative Example 1 (10 μg / mL). Comparative Example 2: Discard the original culture medium and add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose. After culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition (10 μg / mL) of Comparative Example 2. Comparative Example 3: Discard the original culture medium and add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose. After culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum containing the Chinese medicine composition (10 μg / mL) of Comparative Example 3. Comparative Example 4: Discard the original culture medium and add 200 μL of DMEM culture medium containing 10% fetal bovine serum and 30 mM glucose. After culturing for 24 h, replace it with 200 μL of DMEM culture medium containing 10% fetal bovine serum and the Chinese medicine composition (10 μg / mL) of Comparative Example 4.

[0053] After culturing for 48 hours at 37℃ and 5% CO2, 20 μL of CCK-8 reagent was added to each well. The culture plate was gently shaken to distribute the reagent evenly, and the cells were incubated for another 2 hours at 37℃ and 5% CO2. The absorbance (OD value) at 450 nm was measured using a microplate reader, and the cell viability was calculated as follows: Cell viability (%) = (OD value of experimental group / OD value of normal control group) × 100%. The protective effect of the traditional Chinese medicine composition on the activity of HK-2 cells after high glucose injury was evaluated. The results are shown in Table 1.

[0054] Table 1 Cell viability

[0055] As shown in Table 1, the traditional Chinese medicine composition provided by the present invention can effectively alleviate the damage to HK-2 cells caused by high glucose.

[0056] 2. Clinical efficacy.

[0057] Based on clinical symptoms (primary symptoms including shortness of breath, lethargy, poor appetite, and weakness in the lower back and knees; secondary symptoms including loose stools, abdominal distension, pale tongue with teeth marks, bland taste in the mouth without thirst, and deep, thready pulse), 280 patients with chronic renal failure were selected and randomly divided into 7 groups. Each group received the traditional Chinese medicine composition provided in Examples 1-3 and Comparative Examples 1-4, respectively. The method of administration was as follows: the extracted traditional Chinese medicine composition was dissolved in distilled water to a concentration of 5g / 200mL, and then administered as an enema. 200mL of the solution was given every 12 hours. The efficacy was assessed after one month of continuous treatment.

[0058] Based on the content of the "Efficacy Evaluation Criteria for Treating Chronic Renal Failure" in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," efficacy evaluation criteria are summarized and proposed as follows: Significant effect: Clinical symptom score reduced by ≥60%, estimated glomerular filtration rate (eGFR) increased by ≥30%, or serum creatinine (SCr) decreased by ≥30%; Effective: Clinical symptom score reduced by ≥30%, eGFR increased by ≥15%, or SCr decreased by ≥15%; Stable: Clinical symptoms have improved, with a clinical symptom score reduction of <30%, eGFR increase of <15%, and SCr decrease of <15%; Ineffective: Clinical symptoms do not improve or worsen, eGFR decreases or SCr increases.

[0059] Overall effectiveness (%) = (Number of cases with significant effect + Number of cases with effect) / Total number of cases in the group × 100%. The results are shown in Table 2.

[0060] Table 2 Clinical efficacy

[0061] As shown in Table 2, the traditional Chinese medicine composition provided by the present invention is reasonably formulated, and the preparation method of the present invention can effectively extract the effective components. Moreover, the components work synergistically to improve the therapeutic effect on chronic renal failure.

[0062] Typical case: 1. Ms. Wan, female, 72 years old, was admitted on July 7, 2025, with a clinical diagnosis of stage 5 chronic kidney disease. Admission symptoms included fatigue, edema, dizziness, chills, and nausea. Her serum creatinine level was 315 μmol / L, urea level was 15 mmol / L, and uric acid level was 438 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 18 consecutive days before discharge. Discharge symptoms included reduced fatigue, improved edema, reduced nausea, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 276 μmol / L, urea level was 13.6 mmol / L, and uric acid level was 388 μmol / L.

[0063] 2. Ms. Zhao, female, 36 years old, was admitted on July 7, 2025, with a clinical diagnosis of stage 5 chronic kidney disease. Admission symptoms included fatigue, edema, cold hands and feet, lower back pain, loss of appetite, dizziness, and oliguria. Her serum creatinine level was 561 μmol / L, urea level was 17.1 mmol / L, and uric acid level was 441 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 10 consecutive days before discharge. Discharge symptoms included reduced fatigue, improved edema, reduced cold hands and feet, reduced lower back pain, fair appetite, reduced dizziness, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 517 μmol / L, urea level was 15.1 mmol / L, and uric acid level was 284 μmol / L.

[0064] 3. Ms. Yu, female, 36 years old, was admitted on May 18, 2025, with a clinical diagnosis of stage 5 chronic kidney disease. Admission symptoms included fatigue, shortness of breath, cold intolerance, poor appetite, abdominal distension, and oliguria. Her serum creatinine level was 621 μmol / L, urea level was 21.4 mmol / L, and uric acid level was 430 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 13 consecutive days before discharge. Discharge symptoms included reduced fatigue, occasional shortness of breath, improved cold intolerance, and a decrease in clinical symptom score of ≥30%; appetite was fair, and abdominal distension was reduced. At discharge, her serum creatinine level was 598 μmol / L, urea level was 20.2 mmol / L, and uric acid level was 421 μmol / L.

[0065] 4. Mr. Wang, male, 43 years old, was admitted on July 8, 2025. His admission symptoms included fatigue, lower back pain, spontaneous sweating, and oliguria. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 187 μmol / L, urea level was 18.2 mmol / L, and uric acid level was 420 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 15 consecutive days before discharge. Upon discharge, his symptoms included improved fatigue, reduced lower back pain, adequate urine output, and a clinical symptom score reduction of ≥60%. At discharge, his serum creatinine level was 136 μmol / L, urea level was 11.7 mmol / L, and uric acid level was 355 μmol / L.

[0066] 5. Ms. Yi, female, 63 years old, was admitted on July 13, 2025. Admission symptoms included fatigue, edema, chills, oliguria, and shortness of breath. She was clinically diagnosed with stage 4 chronic kidney disease. Her serum creatinine level was 158 μmol / L, urea level was 14.9 mmol / L, and uric acid level was 390 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 12 consecutive days before discharge. Discharge symptoms included reduced fatigue, reduced edema, normal urination, improved shortness of breath, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 142 μmol / L, urea level was 12.1 mmol / L, and uric acid level was 371 μmol / L.

[0067] 6. Mr. Lou, male, 71 years old, was admitted on July 13, 2025. His admission symptoms included fatigue, dry mouth, dizziness, chest tightness, poor appetite, and lower back pain. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 566 μmol / L, urea level was 28.4 mmol / L, and uric acid level was 395 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 11 consecutive days before discharge. Upon discharge, his symptoms included improved fatigue, reduced dizziness, occasional chest tightness, fair appetite, reduced lower back pain, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 500 μmol / L, urea level was 23.4 mmol / L, and uric acid level was 325 μmol / L.

[0068] 7. Mr. Shi, male, 59 years old, was admitted on June 13, 2025. His admission symptoms included fatigue, lower back pain, and bitter taste in the mouth. He was clinically diagnosed with stage 4 chronic kidney disease. His serum creatinine level was 198 μmol / L, urea level was 19.8 mmol / L, and uric acid level was 397 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 16 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, improved lower back pain, reduced bitter taste in the mouth, and a clinical symptom score reduction of ≥60%. At discharge, his serum creatinine level was 157 μmol / L, urea level was 13.5 mmol / L, and uric acid level was 350 μmol / L.

[0069] 8. Ms. Xu, female, 69 years old, was admitted on July 9, 2025. Admission symptoms included fatigue, bitter taste in the mouth, nausea, poor appetite, dizziness, chest tightness, and shortness of breath. She was clinically diagnosed with stage 5 chronic kidney disease. Four days after admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL per enema, every 12 hours. Before the enema, her serum creatinine level was 697 μmol / L, urea level was 30.6 mmol / L, and uric acid level was 743 μmol / L. She was discharged after 15 consecutive days of enemas. Discharge symptoms included reduced fatigue, improved bitter taste in the mouth, occasional nausea, improved appetite, reduced chest tightness and shortness of breath, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 576 μmol / L, urea level was 32.7 mmol / L, and uric acid level was 326 μmol / L.

[0070] 9. Mr. Zhang, male, 64 years old, was admitted on May 19, 2025. His admission symptoms included fatigue, pain in the first metatarsophalangeal joint of his left foot, and lower back pain. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 120 μmol / L, urea level was 8.1 mmol / L, and uric acid level was 447 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 10 consecutive days before discharge. Upon discharge, his symptoms included improved fatigue, improved pain in the first metatarsophalangeal joint of his left foot, reduced lower back pain, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 102 μmol / L, urea level was 7.4 mmol / L, and uric acid level was 330 μmol / L.

[0071] 10. Mr. Tian, ​​male, 51 years old, was admitted on May 15, 2025. His admission symptoms included fatigue, shortness of breath, chest tightness, dry mouth with a bitter taste, and lower back pain. He was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours. Before the enema, his serum creatinine level was 695μmol / L, urea level was 20.1mmol / L, and uric acid level was 496μmol / L. He was discharged after 15 consecutive days of enemas. Upon discharge, his symptoms included reduced fatigue and shortness of breath, occasional chest tightness, reduced dry mouth, bitter taste, and lower back pain; his clinical symptom score decreased by ≥30%. At discharge, his serum creatinine level was 645μmol / L, urea level was 17.6mmol / L, and uric acid level was 407μmol / L.

[0072] 11. Ms. Zang, female, 67 years old, was admitted on May 19, 2025. Admission symptoms included fatigue, edema, dizziness, and nausea. The clinical diagnosis was stage 5 chronic kidney disease. Serum creatinine was 367 μmol / L, urea was 21.2 mmol / L, and uric acid was 285 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 12 consecutive days before discharge. Discharge symptoms included reduced fatigue, reduced edema, improved dizziness, improved nausea, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine was 317 μmol / L, urea was 13.4 mmol / L, and uric acid was 237 μmol / L.

[0073] 12. Ms. Zhao, female, 61 years old, was admitted to the hospital on May 26, 2025. Upon admission, she presented with fatigue, shortness of breath, chest tightness, and poor appetite. She was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours. Before the enema, her serum creatinine level was 363 μmol / L, urea level was 25.3 mmol / L, and uric acid level was 346 μmol / L. She was discharged after 15 consecutive days of enemas. Upon discharge, her fatigue had lessened, chest tightness had improved, her appetite was fair, and her clinical symptom score had decreased by ≥30%. At discharge, her serum creatinine level was 346 μmol / L, urea level was 18.8 mmol / L, and uric acid level was 264 μmol / L.

[0074] 13. Mr. Yu, male, 66 years old, was admitted on May 14, 2025. His admission symptoms included fatigue, edema, chest tightness, and lower back pain. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 555 μmol / L, urea level was 28.2 mmol / L, and uric acid level was 356 μmol / L. He was given enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1 starting on the day of admission. Each enema consisted of 200mL of the mixture, administered every 12 hours for 16 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, improved edema, reduced chest tightness, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 527 μmol / L, urea level was 27 mmol / L, and uric acid level was 319 μmol / L.

[0075] 14. Mr. Li, male, 67 years old, was admitted on May 27, 2025. His admission symptoms included fatigue, lower back pain, cold hands and feet, and frequent urination at night. He was clinically diagnosed with stage 4 chronic kidney disease. His serum creatinine level was 251 μmol / L, urea level was 17.6 mmol / L, and uric acid level was 353 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 14 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, reduced lower back pain, improved cold hands and feet, reduced frequent urination at night, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 232 μmol / L, urea level was 12.2 mmol / L, and uric acid level was 321 μmol / L.

[0076] 15. Mr. Li, male, 34 years old, was admitted on May 26, 2025. His admission symptoms included fatigue, lower back pain, nausea, and oliguria. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 795 μmol / L, urea level was 32.3 mmol / L, and uric acid level was 472 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 14 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, reduced lower back pain, improved nausea, increased urine output, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 730 μmol / L, urea level was 30.1 mmol / L, and uric acid level was 445 μmol / L.

[0077] 16. Ms. Lü, female, 52 years old, was admitted on May 31, 2025. Admission symptoms included fatigue, shortness of breath, and lower back pain. The clinical diagnosis was stage 3 chronic kidney disease. Serum creatinine was 166 μmol / L, urea was 11.7 mmol / L, and uric acid was 474 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 11 consecutive days before discharge. Discharge symptoms included reduced fatigue, improved shortness of breath, reduced lower back pain, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine was 160 μmol / L, urea was 9.3 mmol / L, and uric acid was 443 μmol / L.

[0078] 17. Mr. Liu, male, 81 years old, was admitted on June 6, 2025. His admission symptoms included fatigue, chest tightness, shortness of breath, dizziness, and frequent urination at night. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 311 μmol / L, urea level was 18.6 mmol / L, and uric acid level was 426 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 5 consecutive days before discharge. Upon discharge, his symptoms included reduced fatigue, chest tightness, shortness of breath, dizziness, and frequent urination at night; his clinical symptom score decreased by ≥30%. At discharge, his serum creatinine level was 289 μmol / L, urea level was 17.9 mmol / L, and uric acid level was 361 μmol / L.

[0079] 18. Mr. Qi, male, 74 years old, was admitted on June 3, 2025. His admission symptoms included fatigue, lower back pain, chest tightness, and shortness of breath. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 211 μmol / L, urea level was 12 mmol / L, and uric acid level was 391 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 13 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, improved lower back pain, reduced chest tightness, improved shortness of breath, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 179 μmol / L, urea level was 10.9 mmol / L, and uric acid level was 378 μmol / L.

[0080] 19. Mr. Liu, male, 66 years old, was admitted on June 4, 2025. His admission symptoms included fatigue, lower back pain, shortness of breath, and dizziness. He was clinically diagnosed with stage 4 chronic kidney disease. Starting on the second day of admission, he received enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours. Before the enema, his serum creatinine level was 257μmol / L, urea level was 18.6mmol / L, and uric acid level was 454μmol / L. He was discharged after 6 consecutive days of enemas. His discharge symptoms included reduced fatigue, reduced lower back pain, improved shortness of breath, reduced dizziness, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 221μmol / L, urea level was 14.8mmol / L, and uric acid level was 415μmol / L.

[0081] 20. Mr. Liu, male, 67 years old, was admitted on June 3, 2025. His admission symptoms included fatigue, edema, shortness of breath, and chest tightness. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 610 μmol / L, urea level was 29.6 mmol / L, and uric acid level was 523 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 6 consecutive days before discharge. Upon discharge, his symptoms included reduced fatigue, improved edema, reduced shortness of breath, and chest tightness; his clinical symptom score decreased by ≥30%. At discharge, his serum creatinine level was 498 μmol / L, urea level was 44.4 mmol / L, and uric acid level was 463 μmol / L.

[0082] 21. Mr. Li, male, 73 years old, was admitted on June 4, 2025. His admission symptoms included fatigue, lower back pain, cold intolerance, and frequent urination at night. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 210 μmol / L, urea level was 14 mmol / L, and uric acid level was 349 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 7 consecutive days before discharge. Upon discharge, his symptoms included reduced fatigue, reduced lower back pain, improved cold intolerance, reduced frequent urination at night, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 198 μmol / L, urea level was 12.6 mmol / L, and uric acid level was 319 μmol / L.

[0083] 22. Mr. Cai, male, 64 years old, was admitted on July 7, 2025. His admission symptoms included fatigue, shortness of breath, and lower back pain. He was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL per enema, every 12 hours. Before the enema, his serum creatinine level was 593 μmol / L, urea level was 23.2 mmol / L, and uric acid level was 471 μmol / L. He was discharged after 15 consecutive days of enemas. Upon discharge, his symptoms included reduced fatigue, reduced shortness of breath, improved lower back pain, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 553 μmol / L, urea level was 20.2 mmol / L, and uric acid level was 461 μmol / L.

[0084] 23. Mr. Zhang, male, 54 years old, was admitted on June 5, 2025. His admission symptoms included fatigue, chest tightness, dry mouth, and decreased urination. He was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours. Before the enema, his serum creatinine level was 371 μmol / L, urea level was 20 mmol / L, and uric acid level was 496 μmol / L. He was discharged after 11 consecutive days of enemas. Upon discharge, his symptoms included reduced fatigue, improved chest tightness, reduced dry mouth, and normal urination; his clinical symptom score decreased by ≥30%. At discharge, his serum creatinine level was 355 μmol / L, urea level was 14.8 mmol / L, and uric acid level was 465 μmol / L.

[0085] 24. Mr. Gao, male, 68 years old, was admitted on June 6, 2025. His admission symptoms included fatigue, edema, and lower back pain. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 170 μmol / L, urea level was 11.9 mmol / L, and uric acid level was 461 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 17 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, reduced edema, improved lower back pain, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 154 μmol / L, urea level was 8.2 mmol / L, and uric acid level was 436 μmol / L.

[0086] 25. Ms. Wang, female, 75 years old, was admitted on June 15, 2025. Admission symptoms included fatigue, chest tightness, shortness of breath, lower back pain, and frequent urination at night. She was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, she began receiving enemas with the herbal composition extracted in Example 1 (5g / 200mL distilled water), 200mL per enema, every 12 hours. Before the enema, her serum creatinine level was 435μmol / L, urea level was 18mmol / L, and uric acid level was 273μmol / L. She was discharged after 11 consecutive days of enemas. Discharge symptoms included: reduced fatigue, improved chest tightness, reduced shortness of breath, reduced lower back pain, reduced frequent urination at night, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 414μmol / L, urea level was 16.4mmol / L, and uric acid level was 232μmol / L.

[0087] 26. Mr. Qi, male, 65 years old, was admitted on June 12, 2025. His admission symptoms included fatigue, lower back pain, chest tightness, poor appetite, and loose stools. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 127 μmol / L, urea level was 12.5 mmol / L, and uric acid level was 480 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 16 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, improved lower back pain, reduced chest tightness, fair appetite, fair bowel movements, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 122 μmol / L, urea level was 11.3 mmol / L, and uric acid level was 454 μmol / L.

[0088] 27. Ms. Wang, female, 71 years old, was admitted on June 17, 2025. Upon admission, she presented with fatigue, chest tightness, lower back pain, and cold intolerance. She was clinically diagnosed with stage 5 chronic kidney disease. Starting the second day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL per enema, every 12 hours. Before the enema, her serum creatinine level was 691 μmol / L, urea level was 23.3 mmol / L, and uric acid level was 578 μmol / L. She was discharged after 19 consecutive days of enemas. Upon discharge, her symptoms included reduced fatigue, reduced chest tightness, improved lower back pain, reduced cold intolerance, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine level was 602 μmol / L, urea level was 19.8 mmol / L, and uric acid level was 492 μmol / L.

[0089] 28. Ms. Xu, female, 48 years old, was admitted on June 16, 2025. Admission symptoms included fatigue, chest tightness, and dizziness. The clinical diagnosis was stage 3 chronic kidney disease. Serum creatinine was 153 μmol / L, urea was 7.3 mmol / L, and uric acid was 336 μmol / L. On the day of admission, she began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 8 consecutive days before discharge. Discharge symptoms included reduced fatigue, reduced chest tightness, improved dizziness, and a clinical symptom score reduction of ≥30%. At discharge, her serum creatinine was 132 μmol / L, urea was 7.1 mmol / L, and uric acid was 288 μmol / L.

[0090] 29. Mr. Zhu, male, 79 years old, was admitted on June 16, 2025. His admission symptoms included fatigue, shortness of breath, chest tightness, lower back pain, poor appetite, and oliguria. He was clinically diagnosed with stage 5 chronic kidney disease. His serum creatinine level was 357 μmol / L, urea level was 20 mmol / L, and uric acid level was 425 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 13 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, reduced shortness of breath, reduced chest tightness and lower back pain, fair appetite, fair urine output, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 327 μmol / L, urea level was 16.4 mmol / L, and uric acid level was 359 μmol / L.

[0091] 30. Mr. Wang, male, 70 years old, was admitted on June 17, 2025. His admission symptoms included fatigue, lower back pain, and dizziness. He was clinically diagnosed with stage 3 chronic kidney disease. His serum creatinine level was 169 μmol / L, urea level was 8.9 mmol / L, and uric acid level was 387 μmol / L. On the day of admission, he began receiving enemas with the traditional Chinese medicine composition (5g / 200mL distilled water) obtained in Example 1, 200mL each time, every 12 hours, for 14 consecutive days. He was discharged afterward. His discharge symptoms included reduced fatigue, reduced lower back pain, improved dizziness, and a clinical symptom score reduction of ≥30%. At discharge, his serum creatinine level was 160 μmol / L, urea level was 8.2 mmol / L, and uric acid level was 380 μmol / L.

[0092] 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, The ingredients, by weight, include the following: 25-35 parts rhubarb, 25-35 parts dandelion, 25-35 parts salvia miltiorrhiza, 25-35 parts oyster shell, 25-35 parts honeysuckle vine, 25-35 parts sophora japonica flower, 10-20 parts black aconite root slices, 40-60 parts smilax glabra, and 25-35 parts imperata cylindrica root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients, by weight, include the following: 28-32 parts rhubarb, 28-32 parts dandelion, 28-32 parts salvia miltiorrhiza, 28-32 parts oyster shell, 28-32 parts honeysuckle vine, 25-35 parts sophora japonica flower, 12-18 parts black aconite root slices, 45-55 parts smilax glabra, and 28-32 parts imperata cylindrica root.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients, by weight, include the following: 30 parts rhubarb, 30 parts dandelion, 30 parts salvia miltiorrhiza, 30 parts oyster shell, 30 parts honeysuckle vine, 30 parts sophora japonica flower, 15 parts black aconite root slices, 50 parts smilax glabra, and 30 parts imperata cylindrica root.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: Soak the sliced ​​black aconite in water, simmer for 30-40 minutes, then add oysters and continue simmering for 40-60 minutes. Collect the simmering liquid. After mixing and crushing the salvia miltiorrhiza and rhubarb, mixture 1 was obtained. Mixture 1 was then mixed with a 40% to 50% ethanol solution and extracted by reflux. Extract 1 was collected. Dandelion, honeysuckle vine, sophora japonica flower, smilax glabra and imperata cylindrica root are mixed and crushed to obtain mixture 2. Mixture 2 is mixed with water and soaked, then refluxed for extraction, and extract 2 is collected. The decoction 1, extract 1 and extract 2 are mixed and concentrated to a relative density of 1.2 to 1.3 to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, The black shiitake mushroom slices are mixed with water at a mass ratio of 1:(10~12), and the soaking time is 40~60 minutes.

6. The preparation method according to claim 4, characterized in that, The mixture 1 is mixed with an ethanol solution of 40%~50% by volume at a mass ratio of 1:(8~10); the reflux extraction conditions of the mixture 1 include: extraction temperature of 40~50℃ and extraction time of 1~2h.

7. The preparation method according to claim 4, characterized in that, Mixture 2 is mixed with water at a mass ratio of 1:(10~12); the soaking time is 20~30 min; the conditions for reflux extraction of mixture 2 include: extraction temperature of 70~80℃ and extraction time of 1.5~3 h.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the preparation method according to any one of claims 4 to 7 in the preparation of a medicament for treating renal failure.

9. The application according to claim 8, characterized in that, The kidney failure mentioned is chronic kidney failure.

10. A drug for treating chronic renal failure, characterized in that, The drug contains the traditional Chinese medicine composition according to any one of claims 1 to 3.

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