Traditional Chinese medicine composition for treating chronic kidney failure as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic kidney failure as well as a preparation method and application of the traditional Chinese medicine composition, 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 astragali seu hedysari, 15 to 25 parts of radix salviae miltiorrhizae, 5 to 15 parts of raw radix et rhizoma rhei, 15 to 25 parts of fructus corni, 15 to 25 parts of rhizoma dioscoreae, 15 to 25 parts of poria cocos, 5 to 15 parts of rhizoma chuanxiong, 15 to 25 parts of rhizoma atractylodis macrocephalae, 15 to 25 parts of radix codonopsis, 15 to 25 parts of rhizoma alismatis, 15 to 25 parts of radix sophorae flavescentis and 15 to 25 parts of herba plantaginis. The traditional Chinese medicine composition for treating the chronic kidney failure is scientific and reasonable in formula compatibility, and compared with the prior art, the traditional Chinese medicine composition has an obvious and exact curative effect on the chronic kidney failure and is shorter in treatment cycle.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical compositions, and in particular to a traditional Chinese medicine composition for treating chronic renal failure, and a preparation method and application thereof. Background Art

[0002] Chronic renal failure (CRF) is a clinical syndrome in the late stage of chronic kidney disease with many complications, which seriously affects the quality of life and life expectancy of patients.

[0003] Traditional Chinese medicine (TCM) has a long history of treating kidney disease and has proven to be effective. Li Lianjiang et al. (Study on the efficacy of a Huoxue Yiqi prescription in treating chronic renal failure [J], Clinical Rational Drug Use, 20174, 7(10A), 23-24) reported a Huoxue Yiqi prescription containing Atractylodes macrocephala, Polygonum multiflorum, Codonopsis pilosula, Salvia miltiorrhiza, and Astragalus membranaceus, which significantly improved creatinine, hemoglobin, and urea nitrogen levels, demonstrating significant efficacy in treating chronic renal failure.

[0004] Zhang Xiaoman (Clinical Observation on Modified Shenqi Dihuang Decoction for the Treatment of Qi and Yin Deficiency Syndrome in Chronic Renal Failure [D], Yunnan University of Traditional Chinese Medicine, 2020) disclosed a modified Shenqi Dihuang Decoction, including astragalus, Pseudostellariae Radix, Poria, Rhizoma Alismatis, Radix Rehmanniae, Atractylodes Macrocephalae, Fructus Corni, Radix Ophiopogonis, Chinese Yam, Salvia Miltiorrhiza, Cortex Moutan, Herba Plantaginis, and Licorice. In this formula, astragalus invigorates qi and tonifies the middle meridian, while Pseudostellariae Radix serves as the monarch ingredient, tonifying both qi and yin. Poria strengthens the spleen and eliminates dampness, Rhizoma Alismatis relieves yang fire and eliminates dampness and turbidity, Radix Rehmanniae tonifies the kidney and replenishes essence, Fructus Corni nourishes the liver and kidney and consolidates essence, Rhizoma Atractylodes strengthens the spleen and replenishes qi, eliminates dampness and promotes diuresis, and Radix Ophiopogonis nourishes yin and promotes fluid production. Chinese Yam enhances the functions of invigorating qi and nourishing yin, tonifying the kidney and consolidating essence, while Salvia Miltiorrhiza dispels blood stasis, promotes menstruation and activates blood circulation, Cortex Moutan activates blood circulation, cools blood and resolves stasis, and Herba Plantaginis promotes diuresis and relieves stranguria. Licorice harmonizes the various ingredients. The modified Shenqi Dihuang Decoction can alleviate the clinical symptoms of patients with chronic renal failure of Qi and Yin deficiency type, improve their renal function, increase their endogenous creatinine clearance rate, reduce urine protein and urine red blood cells; it can protect the kidneys and delay the progression of end-stage renal disease.

[0005] CN113304234A discloses a traditional Chinese medicine composition for treating chronic renal failure. The composition is composed of perilla leaf and coptis root decoction combined with fried immature bitter orange, zedoaria, codonopsis, astragalus, raw rehmannia, cistanche, eucommia, cannabinoids, cypress seeds, angelica, liquorice and other drugs. The invention focuses on strengthening the spleen and replenishing qi, regulating the middle and lowering turbidity, and uses both ascending and descending methods, and both attacking and supplementing methods. The combination of various drugs has a significant effect on lowering blood creatinine, improving symptoms of chronic renal failure, and improving the quality of life of patients.

[0006] At present, traditional Chinese medicine has achieved certain achievements in the treatment of chronic renal failure, but there is still huge room for improvement. Therefore, it is still very important to find drugs with better treatment effects on chronic renal failure. Summary of the Invention

[0007] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating chronic renal failure, and a preparation method and application thereof.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials: astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, poria, ligusticum chuanxiong, atractylodes macrocephala, codonopsis pilosula, oriental watercress, sophora flavescens, and plantain.

[0009] Explanation: The specific medication mechanism of the above-mentioned Chinese medicine composition is as follows: The Chinese medicine composition of the present invention is mainly used to replenish qi and blood, promote blood circulation and remove blood stasis, and promote diuresis and eliminate dampness, and has both ascending and descending effects, and both attacking and replenishing effects. Specifically: Invigorate Qi and nourish blood: Use herbs such as Astragalus and Codonopsis to nourish the spleen and kidneys, enhance the body's transportation and transformation functions and water metabolism capacity, and improve the patient's nutritional status and immunity.

[0010] Promote blood circulation and remove blood stasis: Improve the blood circulation of renal tissue through drugs such as Danshen and Chuanxiong, reduce glomerular sclerosis and renal interstitial fibrosis, and prevent further deterioration of renal function.

[0011] Diuresis and dampness removal: Use drugs such as Poria, Alisma, and Plantago to promote urine excretion, reduce edema, remove dampness and heat in the body, and improve the patient's symptoms. Nourishing the spleen and kidneys: Through drugs such as astragalus and codonopsis, the spleen and stomach functions are enhanced, the spleen and kidneys are nourished, water metabolism is improved, and the patient's condition is fundamentally improved.

[0012] The more specific Chinese and Western medicinal mechanisms for each herb are as follows: Astragalus: Sweet and slightly warm. It enters the spleen and lung meridians. It tonifies qi and raises yang, strengthens the exterior and stops sweating, and promotes diuresis and reduces swelling. The Shennong's Herbal Classic states: "It treats carbuncles, chronic wounds, drains pus, replenishes deficiency, and expels pathogenic qi." Astragalus's main components include polysaccharides, astragaloside IV, and flavonoids. Modern pharmacological research has revealed that astragalus has multiple pharmacological effects, including enhancing immunity, improving renal microcirculation, and alleviating decreased glomerular filtration rate.

[0013] Danshen (Salvia miltiorrhiza): Bitter and slightly cold, it enters the Heart and Liver meridians. It promotes blood circulation, removes blood stasis, cools blood, and eliminates carbuncles. The "Shennong Bencao Jing" states: "It treats evil qi in the heart and abdomen, rumbling bowels like running water, accumulation of cold and heat, relieves restlessness, and nourishes the heart." The main components of Danshen are tanshinone, danshensu, and danshen acid. Modern pharmacological research has shown that Danshen improves renal blood circulation and alleviates glomerulosclerosis and renal interstitial fibrosis.

[0014] Raw rhubarb: Bitter and cold. It enters the spleen, stomach, and large intestine meridians. It has a purgative effect, dispelling heat and purging fire. The Shennong's Herbal Classic states: "It treats blood stasis, blood stasis, cold and heat, resolves lumps and accumulations, removes retained fluid and food, cleanses the intestines and stomach, removes the old and brings in the new, and clears the waterways." The main components of raw rhubarb include anthraquinones, emodin, and rhein. Modern pharmacological research has shown that raw rhubarb can eliminate toxins and reduce the burden on the kidneys.

[0015] Cornus officinalis: Sour, astringent, and slightly warm. It enters the liver and kidney meridians. It nourishes the liver and kidneys, and has astringent and firming properties. The Shennong's Herbal Classic states: "It treats pathogenic qi in the heart, cold and heat, warms the middle, expels cold and dampness, and eliminates the three parasites." Cornus officinalis' main components are cornin, ursolic acid, and oleanolic acid. Modern pharmacological research has shown that cornus officinalis can improve kidney function and increase glomerular filtration rate.

[0016] Chinese Yam: Sweet, neutral. It enters the spleen, lung, and kidney meridians. It nourishes the spleen and stomach, promotes fluid production and benefits the lungs. The Shennong's Herbal Classic states: "It treats injuries to the middle, replenishes deficiency, eliminates cold and heat pathogens, tonifies the middle, strengthens Qi and strength, and builds muscle." Chinese yam's main components include mucin, amylase, and choline. Modern pharmacological research has shown that Chinese yam can enhance spleen and stomach function and improve nutrient absorption.

[0017] Poria cocos: Sweet, mild, and neutral. It enters the spleen and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. The Shennong's Herbal Classic states: "It treats chest and flank qi reversal, sorrow, palpitations, heart pain, chills and fever, fullness and fullness, cough and reverse breathing, dry mouth and tongue, and promotes urination." The main components of Poria cocos are pachycoryl polysaccharides, pachymic acid, and sterols. Modern pharmacological research has shown that Poria cocos promotes water metabolism and reduces edema.

[0018] Chuanxiong: Pungent and warm. It enters the Liver, Gallbladder, and Pericardium meridians. It promotes blood circulation and qi, dispels wind and relieves pain. The Shennong's Herbal Classic states, "It treats headaches caused by stroke, cold paralysis, muscle spasms, wounds, and blood stasis and infertility in women." The main components of Chuanxiong are ligustrazine, ligustolactone, and volatile oil. Modern pharmacological research has shown that Chuanxiong improves blood supply to renal tissue and reduces inflammation.

[0019] Atractylodes macrocephala: Bitter, sweet, and warm. It enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dispels dampness, and promotes diuresis. The Shennong's Herbal Classic states: "It treats wind-cold-dampness arthritis, muscle weakness, spasms, jaundice, and antiperspirants, as well as heat and digestion." The main components of Atractylodes macrocephala are polysaccharides, atractylodes lactones, and volatile oils. Modern pharmacological research has shown that Atractylodes macrocephala can enhance spleen and stomach function and improve fluid metabolism.

[0020] Codonopsis: Sweet, neutral. It enters the spleen and lung meridians. It tonifies the middle and replenishes qi, promotes the production of body fluids and nourishes the blood. The Shennong's Herbal Classic states: "It tonifies the middle and replenishes qi, strengthens the spleen and lungs, and promotes the production of body fluids and nourishes the blood." Codonopsis's main components include codonopsis polysaccharides, codonopsis lactones, and volatile oils. Modern pharmacological research has shown that codonopsis can enhance immunity and improve nutritional status.

[0021] Alisma: Sweet, light, and cold. It enters the kidney and bladder meridians. It promotes diuresis, dissipates dampness, and relieves heat. The Shennong's Herbal Classic states: "It treats wind-cold-damp arthritis, lactation difficulties, eliminates water retention, nourishes the five internal organs, strengthens Qi and energy, and promotes weight loss and health." Alisma's main components are alisma polysaccharides, alisma alcohol, and volatile oils. Modern pharmacological research has shown that Alisma promotes urine excretion and reduces the burden on the kidneys.

[0022] Sophora flavescens: Bitter and cold. It enters the Heart, Liver, Stomach, and Large Intestine meridians. It clears heat and dampness, kills insects, and promotes urination. The Shennong's Herbal Classic states: "It treats qi stagnation in the heart and abdomen, abdominal masses, adverse qi, diarrhea, and improving eyesight." The main components of Sophora flavescens are matrine, oxymatrine, and matrine. Modern pharmacological research has shown that Sophora flavescens can clear dampness and heat from the body and improve kidney function.

[0023] Plantain: Sweet, cold. It enters the liver, kidney, and bladder meridians. It promotes diuresis, relieves stranguria, clears heat, and improves eyesight. The Shennong Herbal Classic states: "It treats stranguria caused by qi deficiency, relieves pain, and promotes urination." The main components of plantain are plantain polysaccharides, plantagin, and volatile oils. Modern pharmacological research has shown that plantain promotes urine excretion and reduces edema.

[0024] In some embodiments, the Chinese medicine composition includes the following raw materials by weight: 25-35 parts of Astragalus, 15-25 parts of Salvia miltiorrhiza, 5-15 parts of raw rhubarb, 15-25 parts of Cornus officinalis, 15-25 parts of Dioscorea batatas, 15-25 parts of Poria cocos, 5-15 parts of Chuanxiong, 15-25 parts of Atractylodes macrocephala, 15-25 parts of Codonopsis pilosula, 15-25 parts of Alisma orientalis, 15-25 parts of Sophora flavescens, and 15-25 parts of Plantago.

[0025] In some embodiments, the ratio of the total weight of raw rhubarb and Chuanxiong to the total weight of Cornus fruit and Alisma orientalis is 1-3:3-5; preferably 1:2-3; further preferably 1:2; further preferably, the weight ratio of raw rhubarb, Chuanxiong, Cornus fruit and Alisma orientalis is 1:1:2-3:2-3; further preferably 1:1:2:2.

[0026] In some embodiments, the mass ratio of Chinese yam, Codonopsis pilosula and Sophora flavescens is 1:1:1.

[0027] In some embodiments, the Chinese medicine composition comprises the following raw materials in parts by weight: 28.5-31.5 parts of Astragalus, 19-21 parts of Salvia miltiorrhiza, 9.5-10.5 parts of Rhubarb, 19-21 parts of Cornus officinalis, 19-21 parts of Dioscorea batatas, 19-21 parts of Poria, 9.5-10.5 parts of Ligusticum chuanxiong, 19-21 parts of Atractylodes macrocephala, 19-21 parts of Codonopsis pilosula, 19-21 parts of Alisma orientalis, 19-21 parts of Sophora flavescens, and 19-21 parts of Plantago.

[0028] In some embodiments, the Chinese medicine composition includes the following raw materials by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 10 parts of raw rhubarb, 20 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 10 parts of chuanxiong, 20 parts of atractylodes, 20 parts of codonopsis, 20 parts of oriental zedoaria, 20 parts of sophora flavescens and 20 parts of plantain.

[0029] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: decocting a formula amount of astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, poria, ligusticum chuanxiong, atractylodes, codonopsis, oriental water chestnut, sophora flavescens and plantain, separating the solid and liquid, and concentrating and drying the filtrate.

[0030] In some embodiments, the decoction is performed by adding water and decocting at least once, each time for 0.5-2 hours, and the amount of water added each time is 8-15 times the total amount of astragalus, salvia, raw rhubarb, cornus fruit, yam, poria, ligusticum, atractylodes, codonopsis, oriental water, sophora flavescens and plantain; preferably, the decoction is performed twice, each time for 1 hour.

[0031] In some embodiments, the solid-liquid separation is conventional solid-liquid separation means in the art, including filtration, centrifugation or filter pressing.

[0032] In some embodiments, the drying is drying to a water content of less than 10%. Preferably, the drying is spray drying, vacuum drying or freeze drying.

[0033] In a third aspect, the present invention provides use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating chronic renal failure.

[0034] In a fourth aspect, the present invention provides a pharmaceutical preparation for treating chronic renal failure, comprising the above-mentioned Chinese medicine composition and pharmaceutically acceptable excipients.

[0035] The beneficial effects of the present invention are: (1) The Chinese medicine composition for treating chronic renal failure of the present invention has a scientific and reasonable formulation. It has been verified that, compared with the existing technology, the Chinese medicine composition of the present invention has a significant and definite therapeutic effect on chronic renal failure and a shorter treatment period.

[0036] (2) During the screening process of the present invention's prescription, it was unexpectedly discovered that a specific amount of raw rhubarb, Chuanxiong, Cornus officinalis, and Alisma orientalis combined with Chinese yam, Codonopsis pilosula, and Sophora flavescens can better reduce the levels of creatinine, Cys-C, α1-microglobulin, and 24-hour urine protein, and has a better effect in treating chronic renal failure.

[0037] (3) The Chinese medicine composition of the present invention is industrially prepared by sampling and decocting, which has a simple preparation method, is convenient to take, and has low treatment costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1The kidney morphology of mice in each group.

[0039] Figure 2 Statistical graphs of weight changes and renal index of mice in each group, A is the statistical graph of weight changes, B is the statistical graph of renal index, among which, compared with the CRF group, *, p < 0.05; **, p < 0.01; ***, p < 0.001, ns indicates no significant difference, p > 0.05.

[0040] Figure 3 The statistical graphs of the changes in urine and serum indicators of mice in each group, A is the statistical graph of urine protein, B is the statistical graph of creatinine content, C is the statistical graph of urea nitrogen content, D is the statistical graph of cystatin C content, and E is the statistical graph of α1 microglobulin content. Compared with the CRF group, *, p<0.05; **, p<0.01; ***, p<0.001, ns indicates no significant difference, p>0.05.

[0041] Figure 4 HE, MASSON, and PAS staining images of kidney pathological sections of mice in each group, scale: 100 μm. DETAILED DESCRIPTION

[0042] The following examples are only intended to help understand the methods of the present invention and their core concepts. It should be noted that, for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications may be made to the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention. The following description of the disclosed embodiments enables professionals in this field to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but may be applied to a wider range consistent with the principles and novel features disclosed herein. Although any methods and materials similar or equivalent to those described in the present invention may be used in the practice or testing of the present invention, preferred methods and materials are listed herein.

[0043] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0044] The "pharmaceutical preparation" described in the present invention comprises a Chinese medicine composition and pharmaceutically acceptable excipients. In a specific embodiment, the Chinese medicine composition described in the present invention is provided in the pharmaceutical preparation in an effective amount (e.g., a therapeutically effective amount).

[0045] For purposes of this invention, "acceptable" ingredients are substances suitable for use in humans and / or animals without undue adverse side effects (e.g., toxicity, irritation, and allergic reactions), that is, substances with a reasonable benefit / risk ratio. "Pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants, and / or oils. Excipients (e.g., cocoa butter and suppository wax), colorants, coating agents, sweeteners, and flavoring agents may also be present in the traditional Chinese medicine composition.

[0046] The "pharmaceutical preparations" described herein can be prepared by any method known in pharmacy. Generally speaking, these preparation methods include associating the composition (hereinafter referred to as the active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then, if necessary and / or desired, shaping and / or packaging the product into a desired single-dose or multi-dose unit.

[0047] The pharmaceutical preparations of the present invention can be prepared according to known methods, such as those described in the general rules for preparation of the Chinese Pharmacopoeia (2020 edition), the Japanese Pharmacopoeia (16th edition), the United States Pharmacopoeia (USP), and the European Pharmacopoeia (EP), 9th edition. The specific preparation method depends on the dosage form.

[0048] The active ingredient and pharmaceutically acceptable excipients in the "pharmaceutical formulations" of the present invention will vary depending on the identity, size, and / or condition of the subject being treated and further depending on the route of administration of the active ingredient. The pharmaceutical formulation may contain between 0.1% and 100% (w / w) active ingredient.

[0049] As used herein, "treating," unless otherwise indicated, means reversing, alleviating, inhibiting the progression of, or preventing the condition or disorder to which the term applies, or one or more symptoms of such condition or disorder. The term "treating," as used herein, refers to the act of treating, as "treating" is defined immediately above.

[0050] As used herein, an "effective amount" refers to an amount sufficient to elicit a desired biological response. The effective amount of the active ingredients of the present invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the mode of administration, and the age and health of the subject. In certain embodiments, an effective amount is a therapeutically effective amount. An effective amount is the amount of the only active ingredient described herein in a single dose. In certain embodiments, an effective amount is the combined amount of the only active ingredients described herein in multiple doses.

[0051] As used herein, a "therapeutically effective amount" is an amount sufficient to provide a therapeutic benefit in the treatment of a condition or sufficient to delay or minimize one or more symptoms associated with the condition. A therapeutically effective amount of an active ingredient means an amount of a therapeutic agent, alone or in combination with other therapies, that provides a therapeutic benefit in the treatment of a condition. The term "therapeutically effective amount" may encompass an amount that improves overall therapy, reduces or avoids symptoms, signs, or causes of a condition, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, a therapeutically effective amount is an amount sufficient to treat any of the diseases or conditions described.

[0052] Unless otherwise specified, all raw materials used were commercially available products, and their sources were not specifically limited. Unless otherwise specified, all operations were performed at room temperature, which was 20-25°C.

[0053] Example 1 A Chinese medicine composition The Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 10 parts of raw rhubarb, 20 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 10 parts of ligusticum chuanxiong, 20 parts of atractylodes, 20 parts of codonopsis pilosula, 20 parts of oriental zedoaria, 20 parts of sophora flavescens and 20 parts of plantain.

[0054] The preparation method is as follows: add water to the formula amount of astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, Poria, Chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma orientalis, Sophora flavescens and plantain, and boil twice for 1 hour each time. The amount of water added for the first time is 12 times the total amount of astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, Poria, Chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma orientalis, Sophora flavescens and plantain, and the amount of water added for the second time is 8 times the total amount of astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, Poria, Chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma orientalis, Sophora flavescens and plantain. Filter, combine the filtrate, and concentrate and dry at 60°C.

[0055] Example 2 A Chinese medicine composition The Chinese medicine composition comprises the following raw materials in parts by weight: 35 parts of astragalus, 25 parts of salvia miltiorrhiza, 15 parts of raw rhubarb, 25 parts of cornus fruit, 25 parts of yam, 25 parts of poria, 15 parts of ligusticum chuanxiong, 25 parts of atractylodes, 25 parts of codonopsis pilosula, 25 parts of oriental zedoaria, 25 parts of sophora flavescens and 25 parts of plantain.

[0056] The preparation method is the same as that of Example 1.

[0057] Example 3 A Chinese medicine composition The Chinese medicine composition comprises the following raw materials in parts by weight: 25 parts of astragalus, 15 parts of salvia miltiorrhiza, 5 parts of raw rhubarb, 15 parts of cornus fruit, 15 parts of yam, 15 parts of poria, 5 parts of ligusticum chuanxiong, 15 parts of atractylodes, 15 parts of codonopsis pilosula, 15 parts of oriental zedoaria, 15 parts of sophora flavescens and 15 parts of plantain.

[0058] The preparation method is the same as that of Example 1.

[0059] Comparative Example 1 A Chinese medicine composition The difference between this comparative example and Example 1 is that the ratio of the total weight of the raw rhubarb and Chuanxiong to the total weight of Cornus officinalis and Alismatis rhizome is different.

[0060] Specifically, the Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 25 parts of raw rhubarb, 10 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 15 parts of ligusticum chuanxiong, 20 parts of atractylodes, 20 parts of codonopsis pilosula, 10 parts of oriental zedoaria, 20 parts of sophora flavescens and 20 parts of plantain.

[0061] The preparation method is the same as that of Example 1.

[0062] Comparative Example 2 A Chinese medicine composition The difference between this comparative example and Example 1 is that the weight ratios of the raw rhubarb, Chuanxiong, Cornus officinalis and Alisma orientalis are different.

[0063] Specifically, the Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 2 parts of raw rhubarb, 30 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 18 parts of chuanxiong, 20 parts of atractylodes, 20 parts of codonopsis, 10 parts of oriental zedoaria, 20 parts of sophora flavescens and 20 parts of plantain.

[0064] The preparation method is the same as that of Example 1.

[0065] Comparative Example 3 A Chinese medicine composition The difference between this comparative example and Example 1 is that the mass ratios of the Chinese yam, Codonopsis pilosula and Sophora flavescens are different.

[0066] Specifically, the Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 10 parts of raw rhubarb, 20 parts of cornus fruit, 30 parts of yam, 20 parts of poria, 10 parts of ligusticum, 20 parts of atractylodes, 20 parts of codonopsis, 20 parts of oriental zedoaria, 10 parts of sophora flavescens and 20 parts of plantain.

[0067] The preparation method is the same as that of Example 1.

[0068] Efficacy verification of traditional Chinese medicine compositions 1. Modeling SPF male C57BL / 6J mice, 8 weeks old, were housed in an environment with a temperature of 22-25°C (maximum daily temperature difference <4°C), a relative humidity of 50%-75%, 12 hours of light per day, and regular ultraviolet sterilization. Four to five mice were housed in each cage with free access to food and water.

[0069] The model was divided into a control (CON) group and a model (CRF) group. The model group was fed a 0.1wt% adenine diet for 4 weeks, while the control group was fed a normal diet. At the end of the fourth week, a random number of mice were anesthetized with 2wt% pentobarbital and blood was collected from the abdominal aorta. The blood was centrifuged at 3000 rpm at 4°C for 15 minutes, and serum was separated for testing. Successful modeling was considered when urea nitrogen (BUN) in the model group was >50 mg / L, creatinine >1.1 mg / L, and urinary creatinine clearance (CRF) was <20%-50% within 24 hours.

[0070] 2. Administer medication CRF mice were randomly and evenly divided into model (CRF) group, positive drug (Active Control, Urea Clearing Granules, purchased from Kangchen Pharmaceutical) group (0.6 g / mouse / d), Example 1 (SSL1) group (0.6 g / mouse / d), Example 2 (SSL2) group (0.6 g / mouse / d), Example 3 (SSL3) group (0.6 g / mouse / d), Comparative Example 1 (DBL1) group (0.6 g / mouse / d), Comparative Example 2 (DBL2) group (0.6 g / mouse / d), Comparative Example 3 (DBL3) group (0.6 g / mouse / d), with 3 mice in each group. The control group and model group were gavaged with distilled water, and the other groups were gavaged with corresponding drugs for 4 consecutive weeks.

[0071] Mouse body weights were recorded weekly throughout the experiment. Urine samples were collected for 24 hours at week 8 to measure urine protein levels. Orbital venous blood was also collected at week 8 to measure serum creatinine (CRE), blood urea nitrogen (BUN), α1-microglobulin (α1-MG), and cystatin C (Cys-C). At the end of week 8, the animals were sacrificed and their kidneys were harvested for pathological examination.

[0072] 3. Results 3.1 Effects of the Chinese herbal medicine composition on kidney morphology in C57 mice The results are as follows Figure 1 shown.

[0073] The results showed that compared with the CON group, the kidneys of the CRF group were significantly atrophied. The CON group's kidneys were reddish-brown and shiny, while the CRF group's kidneys were significantly atrophied, grayish-white, dull, and had a granular surface. After drug treatment, the color, luster, and degree of atrophy of the kidneys of the SSL1-SSL3 groups were significantly improved compared with the model group.

[0074] 3.2 Effects of the Chinese herbal medicine composition on body weight and renal index in C57 mice The results are as follows Figure 2 shown.

[0075] The results showed that the mice in the CON group were in good spirits, active, and had shiny fur. The mice in the CRF group were in poor spirits, had reduced activity, had dull fur, and were noticeably thin. Figure 2 As shown in A, compared with the CON group, the body weight (weight, g) of the model group mice showed a significant downward trend from the first week of adenine feed administration. Compared with the CRF group, the body weight of the Chinese medicine composition group showed a significant upward trend from the fifth week, tending to the body weight of the CON group mice. Figure 2 As shown in Figure B, after modeling with adenine feed, the renal index (Renal Index, %) of mice in the CRF group was significantly reduced, with a highly significant difference compared to the CON group (P < 0.001). After drug intervention, the renal index of mice in the SSL1 and SSL3 groups was significantly increased compared to that of mice in the CRF group (P < 0.001), and was basically the same as that of mice in the CON group. The renal index of mice in the DBL1-DBL3 groups was not significantly different from that of mice in the CRF group (P > 0.05). This indicates that the Chinese herbal compositions prepared in Examples 1 and 3 of the present invention can improve the renal index of mice with chronic renal failure (CRF) models and have a repairing or reversing effect on renal atrophy caused by CRF, while the Chinese herbal compositions prepared in Comparative Examples 1-3 do not have the above-mentioned effects.

[0076] 3.3 Effects of Chinese herbal medicine combination on urine and serum parameters of C57 mice The results are as follows Figure 3 shown.

[0077] The results show that: Figure 3 As shown in Figure A, after modeling with adenine feed, the urine protein (mg) of mice in the CRF group increased significantly, with a highly significant difference compared to the CON group (P < 0.001). After drug intervention, the urine protein of mice in all groups except the DBL3 group was significantly reduced compared to the CRF group (P < 0.001, P < 0.01, or P < 0.05), indicating that the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-2 of the present invention have the effect of reducing urine protein levels in mice with chronic renal failure (CRF) model.

[0078] like Figure 3 As shown in Figure B, after the adenine diet was established, the urea nitrogen content (BUN, mmol / L) of mice in the CRF group increased significantly, with a highly significant difference compared to the CON group (P < 0.01). Following drug intervention, the urea nitrogen content of mice in the SSL1 and SSL3 groups was significantly reduced compared to the CRF group (P < 0.05). The urea nitrogen content of mice in the DBL1-DBL3 groups was not significantly different from that in the CRF group (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of the present invention can reduce urea nitrogen levels in mice with chronic renal failure (CRF) models, while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have this effect.

[0079] like Figure 3 As shown in the C, after modeling with an adenine diet, the creatinine content (CRE, μmol / L) of mice in the CRF group increased significantly, with a highly significant difference compared to the CON group (P < 0.001). Following drug intervention, the urea nitrogen content of mice in the SSL1 and SSL3 groups was significantly reduced compared to that of the CRF group (P < 0.05), remaining essentially the same as that of the CON group. The creatinine content of mice in the DBL1-DBL3 groups was not significantly different from that of the CRF group (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of the present invention have the effect of lowering creatinine levels in mice modeled with chronic renal failure (CRF), while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have this effect.

[0080] like Figure 3 As shown in D, after modeling with an adenine diet, the cystatin C content (Cys-C, mg / L) in the CRF group mice increased significantly, with a highly significant difference compared to the CON group (P < 0.001). Following drug intervention, the cystatin C content in the SSL1 and SSL3 groups was significantly lower than that in the CRF group (P < 0.05), remaining essentially the same as that in the CON group. The cystatin C content in the DBL1-DBL3 groups was not significantly different from that in the CRF group (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of the present invention have the effect of reducing cystatin C levels in chronic renal failure (CRF) model mice, while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have this effect.

[0081] like Figure 3As shown in E, after adenine diet modeling, the α1-microglobulin (α1-MG, mg / L) content of mice in the CRF group increased significantly, with a highly significant difference compared to the CON group (P < 0.001). Following drug intervention, the α1-microglobulin C content of mice in the SSL1-SSL3 groups was significantly decreased compared to the CRF group (P < 0.05), remaining essentially the same as that of the CON group. The α1-microglobulin C content of mice in the DBL1 and DBL2 groups was not significantly different from that of the CRF group (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1-3 of the present invention have the effect of reducing α1-microglobulin levels in mice with chronic renal failure (CRF) models, while the traditional Chinese medicine compositions prepared in Comparative Examples 1 and 2 do not have this effect.

[0082] In summary, the traditional Chinese medicine composition prepared by the present invention has a comprehensive protective effect on kidney damage in CRF model mice.

[0083] 3.4 Effects of Chinese herbal medicine combination on renal pathology in C57 mice The results are as follows Figure 4 shown.

[0084] The results showed that compared with the CON group, HE, PAS, and MASSON staining of the CRF group mice showed glomerular sclerosis and atrophy, accompanied by tubular dilatation or atrophy, a large number of inflammatory cell infiltration in the renal interstitium, deeper blue staining of the glomerular basement membrane and renal interstitial collagen fibers, and the presence of fibrosis. After drug intervention, the degree of glomerular sclerosis and atrophy of the SSL1 group-SSL3 group mice was significantly alleviated, the number of inflammatory cell infiltration in the renal interstitium was significantly reduced, and the blue staining of the glomerular basement membrane and renal interstitial collagen fibers became lighter, indicating that the Chinese medicine composition prepared in Examples 1 to 3 of the present invention is effective in improving the pathological structure of the kidneys of CRF mice, and can effectively reduce damage to the glomeruli and renal tubules, and inhibit renal interstitial inflammation and fibrosis.

[0085] The above further describes the present invention in conjunction with specific embodiments. However, these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solutions of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, and such modifications and replacements shall fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating chronic renal failure, characterized in that: The following raw materials are included by weight: 25-35 parts of astragalus, 15-25 parts of salvia miltiorrhiza, 5-15 parts of raw rhubarb, 15-25 parts of cornus fruit, 15-25 parts of yam, 15-25 parts of poria, 5-15 parts of chuanxiong, 15-25 parts of atractylodes, 15-25 parts of codonopsis, 15-25 parts of oriental rhizome, 15-25 parts of sophora flavescens and 15-25 parts of plantain; The ratio of the total weight of the raw rhubarb and Chuanxiong to the total weight of the cornus fruit and oriental rhizome is 1-3:3-5; and the mass ratio of the yam, codonopsis and sophora flavescens is 4:3-5:3-5.

2. The Chinese medicine composition according to claim 1, characterized in that The ratio of the total weight of the raw rhubarb and Chuanxiong to the total weight of the cornus fruit and oriental rhizome is 1:2-3; The mass ratio of the Chinese yam, codonopsis pilosula and sophora flavescens is 1:1:

1.

3. The Chinese medicine composition according to claim 1, characterized in that The total weight ratio of the raw rhubarb and Chuanxiong to the total weight of Cornus fruit and Alismatis rhizome is 1:

2.

4. The Chinese medicine composition according to claim 1, characterized in that The weight ratio of the raw rhubarb, chuanxiong, cornus fruit and orientalis is 1:1:2-3:2-3.

5. The Chinese medicine composition according to claim 1, characterized in that The weight ratio of the raw rhubarb, chuanxiong, cornus fruit and orientalis is 1:1:2:

2.

6. The Chinese medicine composition according to claim 1, characterized in that The preparation comprises the following raw materials by weight: 30 parts of astragalus, 20 parts of salvia miltiorrhiza, 10 parts of raw rhubarb, 20 parts of cornus fruit, 20 parts of yam, 20 parts of poria, 10 parts of ligusticum chuanxiong, 20 parts of atractylodes, 20 parts of codonopsis pilosula, 20 parts of oriental rhizome, 20 parts of sophora flavescens and 20 parts of plantain.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 6, characterized in that: The method comprises the following steps: decocting astragalus, salvia miltiorrhiza, raw rhubarb, cornus fruit, yam, poria, ligusticum chuanxiong, atractylodes macrocephala, codonopsis pilosula, oriental water chestnut, sophora flavescens and plantain in a prescribed amount, separating the solid from the liquid, and concentrating and drying the filtrate.

8. The preparation method according to claim 7, characterized in that The decoction is performed by adding water and decocting at least once, each time for 0.5-2 hours.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating chronic renal failure.

10. A pharmaceutical preparation for treating chronic renal failure, characterized in that: The invention comprises the traditional Chinese medicine composition according to any one of claims 1 to 6 and pharmaceutically acceptable excipients.

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