Medicine for treating or adjunctively treating chronic renal failure

Abstract

The invention belongs to the field of traditional Chinese medicines, and provides a medicine for treating or adjunctively treating chronic renal failure, which is prepared from the following raw material medicines in parts by weight: 5-15 parts of ginseng; 5-20 parts by weight of bighead atractylodes rhizome; 10-30 parts by weight of wrinkled gianthyssop herb; 10-30 parts by weight of amomum tsao-ko; 5-20 parts by weight of Chinese angelica; 5-25 parts by weight of ligusticum wallichii; 5-20 parts by weight of rheum officinale; 5-20 parts by weight of curcuma zedoary; 5-20 parts by weight of rhizoma sparganii; and 10-30 parts by weight of Radix Astragali. The components in the medicine provided by the invention are reasonable in compatibility and synergistic in effect, can relieve progressive deterioration of renal function and improve biochemical indexes of patients, has an obvious treatment effect on chronic renal failure, does not have obvious toxic or side effects, and is very suitable for popularization and application.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a medicine for treating or adjuvant treating chronic renal failure. BACKGROUND

[0002] The prevalence of chronic kidney disease (CKD) is increasing year by year. The prevalence of CKD in China is about 10.8% in people over 18 years old. Patients who die of CKD are 10 times more than the general population. Chronic renal failure (CRF) is a clinical syndrome that develops in the later stage of CKD, which seriously affects the quality of life of patients. If the condition cannot be effectively controlled, most patients will eventually develop end-stage renal disease, which requires hemodialysis treatment, and the quality of life is reduced, the treatment cost is high, the economic burden is heavy, and the mortality rate is high, which seriously affects the family and work of patients. The number of hemodialysis patients in China is huge, and CKD has become an important disease that endangers human health.

[0003] The treatment of CKD patients in stage 3-4 of western medicine is mainly symptomatic treatment, and there is a lack of effective drugs to delay the progression of renal function. The onset process of chronic renal failure is slow, but overall, this process is irreversible. Chronic renal failure is the common outcome of the continuous development of various kidney diseases, and eventually progresses to end-stage renal failure and can only rely on dialysis or kidney transplantation treatment. For mild and moderate chronic renal failure, in addition to alleviating symptoms such as fatigue and nausea, the main purpose of treatment is to delay the progression of renal failure and protect residual renal function. In contrast, TCM syndrome differentiation treatment has better advantages. How to delay disease progression, improve renal function, reduce the harm of complications, delay the progression to end-stage renal disease, and improve the quality of life of CKD patients has become the focus of current TCM treatment of the disease. Therefore, there is a need for a traditional Chinese medicine for treating or adjuvant treating chronic renal failure in current clinical medicine. SUMMARY

[0004] In order to solve the above problems existing in the prior art, the application provides a medicine for treating or adjuvant treating chronic renal failure, which can effectively slow down the progression of chronic renal failure.

[0005] The application provides a medicine for treating or adjuvant treating chronic renal failure, which is prepared from the following raw materials by weight fraction: 5-15 parts of ginseng, 5-20 parts of atractylodes, 10-30 parts of agastache, 10-30 parts of amomum, 5-20 parts of angelica, 5-25 parts of chuanxiong, 5-20 parts of rhubarb, 5-20 parts of zedoary, 5-20 parts of sparganium, and 10-30 parts of astragalus.

[0006] The application also provides a preparation method of a medicine for treating or assisting in treating chronic renal failure, and the method comprises the following steps:

[0007] The crushing step: the raw materials are weighed according to the proportion, and then are crushed to obtain the coarse particles of the raw materials;

[0008] The soaking step: the coarse particles of the raw materials are soaked in water for 0.5-2 hours, preferably 1 hour, to obtain the soaked coarse particles of the raw materials;

[0009] The mass ratio of the coarse particles of the raw materials to water is 1: (3-10), preferably 1:8;

[0010] The extraction step: the soaked coarse particles of the raw materials are extracted for the first time for 0.5-2 hours, preferably 1 hour, and then are filtered for the first time to obtain the first filtrate and the first filter residue, and the first filtrate is reserved; the first filter residue is extracted for the second time for 0.5-2 hours, preferably 1 hour, to obtain the second filtrate and the second filter residue; the second filtrate is reserved and combined with the first filtrate to obtain the extraction liquid;

[0011] The concentration step: the extraction liquid is evaporated and concentrated to obtain the extract; the extract is subjected to alcohol precipitation to remove impurities, and the impurity-removed extract is obtained; the extract is the medicine for treating or assisting in treating chronic renal failure.

[0012] The medicine provided by the application is prepared by reasonably matching the raw materials, and has the functions of invigorating the spleen and replenishing qi, harmonizing the stomach and resolving dampness, clearing away heat and removing blood stasis, and is used for the treatment of chronic renal failure caused by spleen and stomach qi deficiency, internal accumulation of damp heat, mutual accumulation of dampness and blood stasis, and deficiency in the root and excess in the branch. The medicine provided by the application has the functions of invigorating the spleen and replenishing qi to strengthen the body resistance and promoting blood circulation to remove blood stasis to eliminate evil, and breaks the vicious cycle of mutual accumulation of dampness and blood stasis, so as to achieve the purpose of reducing the progressive deterioration of kidney function. The medicine provided by the application has good curative effect on the symptoms of chronic renal failure, such as pale face, poor appetite, nausea, fatigue, loose stool, halitosis, and blood stasis spots or points on the tongue, has small side effects, and can effectively slow down the progress of chronic renal failure.

[0013] The medicine provided by the application has good improvement effect on the biochemical indicators of patients, such as serum creatinine, serum urea nitrogen, plasma albumin, serum triglyceride, cholesterol, high-density lipoprotein, and hemoglobin. The medicine provided by the application can significantly reduce the levels of blood creatinine and urea nitrogen, or slow down the rising speed of blood creatinine level, improve blood lipid metabolism, relieve or eliminate symptoms such as fatigue, nausea, and halitosis, and improve the appetite of patients.

[0014] The medicine provided by the application has obvious therapeutic effect on chronic renal failure, has no obvious toxic and side effects, and is very suitable for popularization and use. DETAILED DESCRIPTION

[0015] In order to make the technical solutions, objectives and advantages of the present application clearer, the present application will be further described in detail below with specific examples. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present application, and are not intended to limit the present application.

[0016] In a first aspect, the present application provides a medicine for treating or assisting in treating chronic renal failure, which is prepared from the following raw materials in parts by weight:

[0017] Radix ginseng 5-15 parts by weight;

[0018] Atractylodes 5-20 parts by weight;

[0019] Agastache 10-30 parts by weight;

[0020] Amomum 10-30 parts by weight;

[0021] Angelica 5-20 parts by weight;

[0022] Ligusticum 5-25 parts by weight;

[0023] Rhubarb 5-20 parts by weight;

[0024] Curcuma 5-20 parts by weight;

[0025] Rhizoma polygonati 5-20 parts by weight;

[0026] Radix astragali 10-30 parts by weight.

[0027] Among them, Radix ginseng 5-15 parts by weight, for example, can be any one of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts by weight, or a range between any two of them, or can be, for example, any one of 5-7, 8-10, 11-13, 14-15 parts by weight.

[0028] Atractylodes 5-20 parts by weight, for example, can be any one of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts by weight, or a range between any two of them, or can be, for example, any one of 5-7, 8-10, 11-13, 14-15, 16-18, 19-20 parts by weight.

[0029] Agastache 10-30 parts by weight, for example, can be any one of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 parts by weight, or a range between any two of them, or can be, for example, any one of 10-13, 14-15, 16-18, 19-20, 21-23, 24-25, 26-28, 29-30 parts by weight.

[0030] The amount of cardamom is 10 to 30 parts by weight, for example, any one or a range between two of the following: 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 parts by weight, or any one of the following: 10 to 13, 14 to 15, 16 to 18, 19 to 20, 21 to 23, 24 to 25, 26 to 28, and 29 to 30 parts by weight.

[0031] Angelica sinensis can be 5 to 20 parts by weight, for example, any one or two of the following weights: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts by weight, or any one of the following weights: 5 to 7, 8 to 10, 11 to 13, 14 to 15, 16 to 18, 19 to 20 parts by weight.

[0032] The dosage of Ligusticum chuanxiong is 5-25 parts by weight, for example, any one or a range between two of the following: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25 parts by weight, or any one of the following: 5-7, 8-10, 11-13, 14-15, 16-18, 19-20, 21-23, and 24-25 parts by weight.

[0033] The amount of rhubarb is 5 to 20 parts by weight, for example, any one or a range between two of the following: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 parts by weight, or any one of the following: 5 to 7, 8 to 10, 11 to 13, 14 to 15, 16 to 18, and 19 to 20 parts by weight.

[0034] The amount of Curcuma zedoaria is 5 to 20 parts by weight, for example, any one or a range between two of the following: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 parts by weight, or any one of the following: 5 to 7, 8 to 10, 11 to 13, 14 to 15, 16 to 18, and 19 to 20 parts by weight.

[0035] The triangular part can be 5 to 20 parts by weight, for example, any one or a range between two of the following: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 parts by weight, or any one of the following: 5 to 7, 8 to 10, 11 to 13, 14 to 15, 16 to 18, 19 to 20 parts by weight.

[0036] Huangqi 10-30 parts by weight, for example, can be any one of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 parts by weight or a range between two of them, or can be, for example, any one of 10-13, 14-15, 16-18, 19-20, 21-23, 24-25, 26-28, 29-30 parts by weight.

[0037] In a preferred embodiment, the mass ratio of Huangqi and Baizhu described above is (1.5-3):1, for example, can be any one of 1.5:1, 1.6:1, 1.7:1, 1.75:1, 1.8:1, 1.9:1, 2.0:1, 2.1:1, 2.2:1, 2.5:1, 2.8:1, 3:1 or a range between two of them, or can be, for example, any one of (1.5-2):1, (1.8-2.2):1, (1.7-2.1):1.

[0038] In a preferred embodiment, the present application provides a medicine for treating or assisting in treating chronic renal failure, which is prepared from raw materials comprising, by weight:

[0039] Renshen 10 parts by weight, Baizhu 12 parts by weight, Huoxiang 21 parts by weight, Caoguo 21 parts by weight, Danggui 9 parts by weight, Chuanqiong 15 parts by weight, Dahuang 12 parts by weight, E'zhu 12 parts by weight, Sanleng 12 parts by weight, Huangqi 21 parts by weight.

[0040] The above components used in the present application are briefly described as follows:

[0041] Renshen, slightly bitter and sweet in taste, neutral in nature, belongs to the spleen, lung and heart channels; it has the functions of tonifying vital energy, restoring pulse and solidifying loss, and producing saliva. It is listed as the monarch drug in the prescription. It is used for body weakness, loss of saliva, internal heat and diabetes, and for symptoms of prolonged illness and emaciation; Shaidai Renshen has a stimulating effect on the pituitary-adrenal cortex function, and can promote the secretion of adrenal cortex hormone.

[0042] Baizhu, sweet and bitter in taste, warm in nature, belongs to the spleen and stomach channels, and has the functions of invigorating the spleen and benefiting qi, drying dampness and promoting water. It is listed as the ministerial drug in the prescription. It is used for spleen deficiency, little food, dizziness and palpitation, edema and self-sweating; Baizhu has obvious and lasting diuretic effect, and also promotes the excretion of electrolytes, especially sodium.

[0043] Huoxiang, pungent in taste, slightly warm in nature, belongs to the spleen and lung channels, and has the functions of aromatizing turbidity, harmonizing the center, stopping vomiting, and relieving summer heat. It is listed as the ministerial drug in the prescription. It is used for wet turbidity, abdominal distension and vomiting, summer heat and fatigue, chest tightness, cold and dampness, abdominal pain and diarrhea, nasal congestion and headache.

[0044] Amomum villosum Lour., pungent in taste, warm in nature, it belongs to the spleen and stomach meridians, dry dampness and warm the middle, dispel phlegm and intercept malaria. It is listed as an auxiliary drug in the prescription. It is used for cold pain in the abdomen, nausea and vomiting, fullness in the chest and abdomen, diarrhea, and malaria.

[0045] Angelica sinensis (Oliv.) Diels, sweet and pungent in taste, warm in nature, it belongs to the liver, heart, and spleen meridians, tonifying blood and activating blood, regulating menstruation and relieving pain, moistening dryness and lubricating the intestines. It is listed as an auxiliary drug in the prescription. It is used for irregular menstruation, rheumatism, and pain due to injury.

[0046] Ligusticum chuanxiong Hort., pungent in taste, warm in nature, it belongs to the liver, gallbladder, and pericardium meridians, activating blood and qi, dispelling wind and relieving pain. It is listed as a ministerial drug in the prescription. It is used for rheumatism and headache; Chuanxiong has inhibitory effects on various gram-negative bacteria, such as Proteus and Salmonella.

[0047] Rheum officinale Baill., bitter in taste, cold in nature, it belongs to the spleen, stomach, large intestine, liver, and pericardium meridians, with the functions of purging fire, relieving constipation, breaking accumulation, and removing blood stasis. It is listed as an auxiliary drug in the prescription. It is used for constipation due to excess heat, abdominal mass, edema, and hot urinary frequency; Rheum officinale, Rheum officinale acid, and Rheum officinale have diuretic effects; Rheum officinale also has the effect of reducing blood urea nitrogen.

[0048] Curcuma zedoaria Rosc., pungent and bitter in taste, warm in nature, it belongs to the liver and spleen meridians, moving qi and breaking blood, resolving accumulation and relieving pain. It is listed as an auxiliary drug in the prescription. It is used for abdominal mass, blood stasis, and irregular menstruation.

[0049] Sparganium stoloniferum Buch.-Ham., pungent and astringent in taste, cool in nature, it belongs to the liver and spleen meridians, breaking blood, moving qi, resolving accumulation, and relieving pain. It is listed as an auxiliary drug in the prescription. It is used for abdominal mass, blood stasis, irregular menstruation, dysmenorrhea, food accumulation, and pain due to injury.

[0050] Radix Astragali, sweet and warm, it belongs to the lung and spleen meridians, tonifying qi and consolidating the exterior, diuresis and removing toxins, pus, and astringing and promoting tissue regeneration. It is listed as an auxiliary drug in the prescription. It is used for qi deficiency, middle-qi collapse, and exterior deficiency with spontaneous sweating; it is used as a complementary drug in the prescription. Modern research has found that Radix Astragali can be used for hyperlipidemia and angina pectoris.

[0051] The above raw materials mutually cooperate, gain from each other, and play a good therapeutic effect: ginseng greatly supplements qi, restores pulse and solidifies loss, and generates fluid; angelica supplements blood, activates blood, moistens intestines and relieves constipation; it can improve the anemia symptoms of CRF patients, relieve blood stasis, and also relieve constipation and remove turbidity and toxicity. Huangqi supplements qi and raises yang, benefits water and eliminates edema, and is particularly suitable for CRF patients with spleen and kidney deficiency, water retention, and low immunity. Dahuang removes turbidity and toxicity, removes blood stasis, and removes turbidity and toxicity, which is beneficial to relieve the "turbidity, toxicity, and stasis" caused by CRF. Modern pharmacology shows that Dahuang can reduce the degree of glomerular sclerosis and delay the progression of CRF by inhibiting the proliferation of mesangial cells. Huangqi and Dahuang are combined to supplement and remove toxicity simultaneously, and attack and tonify at the same time. Baizhu supplements qi, benefits the spleen, benefits water and dries dampness, and the use of this drug in the treatment of CRF can enhance the function of the spleen and stomach, and also dry water and dampness. The five drugs are used to supplement qi, benefit the spleen, nourish yin, enrich kidney essence, benefit water and eliminate edema. Chuanxiong and Angelica have the effects of activating blood, removing blood stasis, and relieving pain, and the combination can effectively help patients to dredge collaterals, remove blood stasis, and relieve pain. It can also remove phlegm and dampness, and benefit water. The above-mentioned effects of each drug and clinical observations show that the product has good effects on anorexia, nausea, pale complexion, fatigue, loose stool, and tongue with stasis spots or stasis points caused by chronic renal failure, and also has good improvement effects on various physiological indicators of chronic renal failure patients.

[0052] The cause of the chronic renal failure can be primary chronic glomerulonephritis, secondary chronic glomerular disease (such as diabetic nephropathy and hypertensive nephropathy), chronic interstitial nephritis, chronic pyelonephritis, etc.

[0053] In a second aspect, the present application further provides a preparation method of the medicine for treating or assisting in treating chronic renal failure provided in the first aspect, which comprises the following steps:

[0054] S1, crushing: according to the above-mentioned ratio, each raw material is weighed and then crushed to obtain coarse particles of each raw material.

[0055] S2, soaking: the coarse particles of the above-mentioned raw materials are soaked in water for 0.5-2 hours (preferably 1 hour) to obtain the coarse particles of the raw materials after soaking.

[0056] The mass ratio of the coarse particles of the above-mentioned raw materials to water is 1: (3-10), and is preferably 1:8.

[0057] S3, extraction: the coarse particles of the raw materials after soaking are subjected to first extraction for 0.5-2 hours (preferably 1 hour), and then subjected to first filtration to obtain a first filtrate and a first filter residue, and the first filtrate is retained; the first filter residue is subjected to second extraction for 0.5-2 hours (preferably 1 hour) to obtain a second filtrate and a second filter residue; the second filtrate is retained and combined with the first filtrate to obtain an extraction liquid.

[0058] The preferred extraction process is atmospheric pressure reflux treatment.

[0059] S4. Concentration: The above extract is evaporated and concentrated to obtain an extract; the extract is then precipitated with alcohol to remove impurities, resulting in a purified extract.

[0060] The above-mentioned purified extract is a drug used to treat or assist in the treatment of chronic renal failure. This drug can be prepared into any commonly used dosage form, such as granules, tablets, powders, capsules, oral liquids, etc.

[0061] When the drug of the present invention is in granule form, the following operations can also be performed on the purified extract:

[0062] S5. Mixing: Mix the purified extract with the excipients evenly to obtain a granulation mixture.

[0063] The above-mentioned excipients are one or more of dextrin, starch, microcrystalline cellulose, and lactose.

[0064] The preferred particle size of the dextrin is less than or equal to 40 mesh.

[0065] The mass ratio of the purified extract to the excipients is 1:(1~3), preferably 1:2.

[0066] S6. Preparation of finished drug product:

[0067] The above granulation mixture is subjected to granulation, sizing, and drying processes to obtain the finished drug product.

[0068] The above granulation process includes: spraying an ethanol solution into the above granulation mixture to obtain a soft material; and then preparing the soft material into large particles with a particle size of 14 mesh or less.

[0069] The above granulation process includes: spraying an ethanol solution into the large particles to prepare small particles with a particle size of 12 mesh or less; and then drying the small particles to obtain the finished drug product.

[0070] The concentration of the ethanol solution is preferably 60%. The drying temperature is preferably 60-70°C.

[0071] Unless otherwise specified, all reagents and materials used in the following examples are products that can be obtained from commercial channels; unless otherwise specified, all testing and detection methods used in the following examples are conventional testing and detection methods in the field and can be obtained from textbooks, reference books or academic journals.

[0072] Example 1

[0073] This embodiment illustrates the preparation of the medicament provided by the present invention for treating or adjuvant treatment of chronic renal failure.

[0074] (1) Respectively take 10 kg of ginseng, 12 kg of white atractylodes, 21 kg of agastache, 21 kg of cardamom, 9 kg of angelica, 15 kg of chuanxiong, 12 kg of rhubarb, 12 kg of curcuma, 12 kg of sparganium stoloniferum, and 21 kg of astragalus; The above-mentioned raw materials are crushed to obtain coarse particles of each raw material.

[0075] (2) After mixing the coarse particles of the above-mentioned raw materials, water is added (the mass ratio of coarse particles to water is 1:8) and soaked for 1 hour to obtain the soaked raw material coarse particles.

[0076] (3) The soaked raw material coarse particles are subjected to first normal pressure reflux treatment for 1 hour, then subjected to first filtration treatment to obtain first filtrate and first filter residue, and the first filtrate is retained; The first filter residue is subjected to second normal pressure reflux treatment for 1 hour to obtain second filtrate and second filter residue; The second filtrate is retained and combined with the first filtrate to obtain the extraction liquid.

[0077] (4) The extraction liquid is subjected to evaporation concentration treatment to obtain extract; The extract is subjected to alcohol precipitation treatment to remove impurities to obtain the impurity-removed extract.

[0078] (5) The impurity-removed extract and the dextrin which has passed through the 40-mesh sieve are mixed uniformly according to the weight ratio of 1:2 to obtain the granulation mixture.

[0079] (6) 60% ethanol solution is sprayed into the above-mentioned granulation mixture to obtain soft material; The soft material is granulated into large particles; The large particles are passed through the 14-mesh sieve; Ethanol solution is sprayed into the large particles, and the whole is granulated into small particles; The small particles are passed through the 12-mesh sieve; After drying at 60-70%, the small particles are obtained to obtain the finished product of medicine, i.e. the traditional Chinese medicine granules for slowing down chronic renal failure.

[0080] Test example

[0081] This test example is used to illustrate the therapeutic effect of the traditional Chinese medicine granules for slowing down chronic renal failure of Example 1 on patients with chronic renal failure.

[0082] The Department of Nephrology of the 920th Hospital of Joint Logistics Support Force treated 50 patients with chronic renal failure mainly with the traditional Chinese medicine granules for slowing down chronic renal failure of Example 1. The clinical observation effect is satisfactory, and the data of 39 cases are summarized as follows.

[0083] 1. Case selection

[0084] There are 27 inpatients and 12 outpatients with follow-up conditions in this group, totaling 39 cases; Among them, 25 are male and 14 are female, aged 19-46 years old. All are primary chronic glomerulonephritis.

[0085] 2. Informed consent and medical ethics requirements

[0086] (1) The investigator should submit the protocol approved by the ethics committee before the start of the trial, and can be implemented after the consent.

[0087] (2) This study must comply with the Declaration of Helsinki and in accordance with the GCP guidelines of our country, before the start of the clinical trial plan, the subjects must sign a written informed consent form.

[0088] 3. Treatment method

[0089] During the treatment, the acute factors were removed first, and then the patients were included in this study after the disease was stable.

[0090] (1) Randomly divided into two groups:

[0091] Group A: 18 cases, 12 males and 6 females; age 19-43 years; course of disease 3-14 months; 15 cases of hypertension (blood pressure 160 / 95 mmHg).

[0092] Group B: 21 cases, 13 males and 8 females; age 20-46 years; course of disease 3-10 months; 17 cases of hypertension.

[0093] The difference between the two groups was not significant, and they were comparable.

[0094] (2) Both groups used low-protein diet (0.6 g / kg body weight), controlled blood pressure at the ideal level (systolic pressure 120-155 mmHg, diastolic pressure 80-85 mmHg); antihypertensive drugs selected Yoningding (Enalapril Maleate Tablets) 5-20 mg / d or (and) Xintongding (Nifedipine) 5-60 mg / d for symptomatic treatment.

[0095] Group B was added with 10 g of the traditional Chinese medicine granules of Example 1, twice a day, for 10-18 months, with an average of (13.5+5.4) months.

[0096] 4. Observation index

[0097] All patients were detected every two months for serum creatinine (Scr), serum urea nitrogen (BUN), plasma albumin (Alb), serum triglyceride (TG), cholesterol (TC), high-density lipoprotein (HDL), and hemoglobin (Hb). All biochemical items were detected by automatic biochemical analyzer.

[0098] The reciprocal of serum creatinine (1 / Scr) was used as the vertical coordinate, and the course of disease time (months) was used as the horizontal coordinate. The linear regression slope (b value) of the two was calculated to evaluate the progress speed of CRF.

[0099] 5. Efficacy determination

[0100] Marked effect: after the first course of treatment, 3 or more symptoms and signs were significantly improved.

[0101] Effective: after the first course of treatment, only 1-3 symptoms and signs are improved;

[0102] Improved: after treatment, symptoms and signs are slightly improved;

[0103] Ineffective: after treatment, symptoms and signs are not improved.

[0104] The above symptoms and signs refer to: pale complexion, loss of appetite, nausea, fatigue, loose stools, bad breath, and tongue with ecchymosis or petechiae.

[0105] 6. Adverse reaction evaluation

[0106] Based on preclinical toxicology, drug action site, etc. data, the occurrence of adverse reactions should be estimated. If serious adverse reactions occur, the drug should be stopped in time and appropriate treatment should be given to ensure safety.

[0107] 7. Results

[0108] Statistical method: t test was used to compare the differences between groups. The results are shown in Table 1 below:

[0109] Table 1: Comparison of biochemical index determination results before and after treatment of the granules for slowing down chronic renal failure in Example 1: ±s)

[0110]

[0111] Note: *p<0.01 compared with the treatment group before treatment; ▲p<0.05, ▲▲p<0.01 compared with group A after treatment.

[0112] (1) The determination results of the two groups before and after treatment are shown in Table 1. There was no significant difference before treatment. After treatment, Scr and BUN in group A increased significantly (t values were 3.593 and 3.449, respectively), P<0.01, Alb and Hb decreased significantly (t values were 3.225 and 2.511, respectively, P<0.01); Scr and HDL in group B increased significantly (t values were 1.688 and 3.231, respectively, P<0.05), BUN increased, but the difference was not significant (t value was 1.549, P>0.05), but Scr and BUN were significantly lower than those in group A (t values were 2.193 and 1.971, respectively, P<0.05), and HDL was significantly higher than that in group A (t value was 7.431, P<0.01). The above shows that the granules for slowing down chronic renal failure in Example 1 have improvement effect on Scr, BUN and HDL indexes of patients with renal failure.

[0113] (2) Comparison of the linear regression slope between the two groups: the regression slope of group A was -0.0124±0.0072, and that of group B was -0.0041±0.0028. The difference between the two groups was significant (P<0.05), indicating that the progression of chronic renal failure was significantly slowed down in the treatment group.

[0114] (3) Side effects: 39 patients in this group took the Chinese medicine granules for slowing down chronic renal failure for 10-18 months, with an average of (13.5±5.4) months. No toxic side effects were found.

[0115] Example 2-3

[0116] In the following examples, in order to save the use amount of medicinal materials and reduce the cost, the use amount of each component is reduced to one-tenth of that in Example 1. For example, the use amount of Agastache rugosa in Example 1 is 21 kg, and the use amount of Agastache rugosa in the following examples is 2.1 kg.

[0117] Except for the differences listed in Table 2 below, other aspects are the same as in Example 1.

[0118] Table 2 Component allocation ratio of Example 2 and Example 3

[0119]

[0120] The drugs in Examples 2 and 3 are prepared by the same method as in Example 1. Then, according to the method in the test example, 10 patients with primary chronic glomerulonephritis are selected in each group, and the treatment scheme in group B in the test example is used for the treatment of diabetes, with each course being 15 months.

[0121] After one course of treatment, the efficacy of the drugs in Examples 2 and 3 is as follows: the Scr, BUN, and HDL indicators of patients in each group are significantly improved.

[0122] Comparative Example

[0123] In the following comparative examples, in order to save the use amount of medicinal materials and reduce the cost, the use amount of each component is reduced to one-tenth of that in Example 1. For example, the use amount of Agastache rugosa in Example 1 is 21 kg, and the use amount of Agastache rugosa in the following examples is 2.1 kg.

[0124] Except for the differences listed in Table 3 below, other aspects are the same as in Example 1.

[0125] Table 3 Comparative Example (differences from Example 1)

[0126]

[0127] The medicines in the above-mentioned Comparative Examples 1-8 are prepared by the same method as in Example 1, and then according to the method in the Test Example, 10 patients with primary chronic glomerulonephritis are selected in each group, and the treatment scheme in Group B in the Test Example is used to treat diabetes, and each treatment course is 15 months.

[0128] After one course of treatment, the curative effects of the medicines in Comparative Examples 1-8 are as follows: the Scr, BUN and HDL indexes of the patients in each group are not obviously improved.

[0129] From the above Test Example, Examples 1-3 and Comparative Examples 1-8, it can be seen that the medicine provided by the present application has obvious curative effect on chronic renal failure, and can obviously improve the physiological indexes of Scr, BUN and HDL.

[0130] In the medicine provided by the present application for treating or assisting in treating chronic renal failure, the dosages of ginseng, astragalus and rhubarb are the most important, and if the dosages of the three are reduced or increased, the treatment effect will be greatly reduced. In addition, the matching of the dosages of astragalus and atractylodes is also important, and changing the matching of the two will also obviously reduce the curative effect.

[0131] The above only describes the preferred embodiments of the present application and is not used to limit the present application, and for those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A drug for treating or adjuvant treatment of chronic renal failure, characterized in that: The drug is prepared using the following active pharmaceutical ingredients in parts by weight: Ginseng 5-15 parts by weight; 5-20 parts by weight of Atractylodes macrocephala; Patchouli 10-30 parts by weight; 10-30 parts by weight of cardamom; Angelica sinensis 5-20 parts by weight; 5-25 parts by weight of Ligusticum chuanxiong; 5-20 parts by weight of rhubarb; Curcuma zedoaria 5-20 parts by weight; 5-20 parts by weight of triangular prism; Astragalus membranaceus, 10-30 parts by weight.

2. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1, characterized in that: The mass ratio of Astragalus membranaceus to Atractylodes macrocephala is (1.5~3):

1.

3. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1 or 2, characterized in that: The drug is prepared using the following active pharmaceutical ingredients in parts by weight: Ginseng 6-12 parts by weight; 8-16 parts by weight of Atractylodes macrocephala; Patchouli 17-25 parts by weight; 17-25 parts by weight of cardamom; Angelica sinensis 5-13 parts by weight; Chuanxiong (Ligusticum striatum) 7-23 parts by weight; 6-18 parts by weight of rhubarb; Curcuma zedoaria 6-18 parts by weight; 7-16 parts by weight of triangular prism; Astragalus membranaceus 16-26 parts by weight.

4. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1 or 2, characterized in that: The drug is prepared using the following active pharmaceutical ingredients in parts by weight: 10 parts by weight of ginseng; 12 parts by weight of Atractylodes macrocephala; Patchouli 21 parts by weight; 21 parts by weight of cardamom; Angelica sinensis 9 parts by weight; 15 parts by weight of Ligusticum chuanxiong; 12 parts by weight of rhubarb; Curcuma zedoaria 12 parts by weight; 12 parts by weight of triangular prism; Astragalus membranaceus 21 parts by weight.

5. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1 or 2, characterized in that: The mass ratio of Astragalus membranaceus to Atractylodes macrocephala is (1.5~2):

1.

6. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1 or 2, characterized in that: The mass ratio of Astragalus membranaceus to Atractylodes macrocephala is 1.75:

1.

7. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1 or 2, characterized in that: The drug is prepared using the following active pharmaceutical ingredients in parts by weight: 5 parts by weight of ginseng; 5 parts by weight of Atractylodes macrocephala; 10 parts by weight of patchouli; 10 parts by weight of cardamom; Angelica sinensis 5 parts by weight; Five parts by weight of Ligusticum chuanxiong; 20 parts by weight of rhubarb; Curcuma zedoaria 20 parts by weight; 20 parts by weight of triangular prism; Astragalus membranaceus 15 parts by weight.

8. The medicament for treating or adjuvant treatment of chronic renal failure according to claim 1, characterized in that: The drug is prepared using the following active pharmaceutical ingredients in parts by weight: 15 parts by weight of ginseng; 20 parts by weight of Atractylodes macrocephala; Patchouli, 30 parts by weight; 30 parts by weight of cardamom; Angelica sinensis 20 parts by weight; 25 parts by weight of Ligusticum chuanxiong; 5 parts by weight of rhubarb; Curcuma zedoaria, 5 parts by weight; Five parts by weight of triangular prism; Astragalus membranaceus, 30 parts by weight.

9. A method for preparing the medicament for treating or adjuvant treatment of chronic renal failure according to any one of claims 1-8, characterized in that: The method includes the following steps: Pulverization step: Weigh each raw material according to the ratio, and then pulverize them to obtain coarse particles of each raw material. Soaking step: Soak the coarse particles of the raw material in water for 0.5 to 2 hours, preferably 1 hour, to obtain soaked coarse particles of the raw material; The mass ratio of the raw material coarse particles to water is 1:(3~10), preferably 1:8; Extraction steps: The soaked raw material coarse particles are subjected to a first extraction treatment for 0.5 to 2 hours, preferably 1 hour, followed by a first filtration treatment to obtain a first filtrate and a first filter residue. The first filtrate is retained. The first filter residue is then subjected to a second extraction treatment for 0.5 to 2 hours, preferably 1 hour, to obtain a second filtrate and a second filter residue; the second filtrate is retained and combined with the first filtrate to obtain an extract. Concentration step: The extract is evaporated and concentrated to obtain an extract; the extract is then subjected to alcohol precipitation to remove impurities, resulting in a purified extract; the extract is a drug used to treat or as an adjunct treatment of chronic renal failure.

10. The method for preparing a medicament for treating or adjuvant treatment of chronic renal failure according to claim 9, characterized in that: When the dosage form of the drug used for treating or adjuvant treatment of chronic renal failure is granules, its preparation method further includes the following steps: Mixing step: Mix the purified extract with the excipients evenly to obtain a granulation mixture; The excipients are one or more of dextrin, starch, microcrystalline cellulose, and lactose; The mass ratio of the purified extract to the excipients is 1:(1~3), preferably 1:2; Drug product preparation steps: The above granulation mixture is subjected to granulation, sizing, and drying to obtain the drug product.

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