A traditional Chinese medicine composition for treating chronic renal failure, a preparation method and application thereof

Abstract

The application discloses 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 comprises the following raw materials in parts by weight: 25-35 parts of radix astragali, 15-25 parts of radix salviae miltiorrhizae, 5-15 parts of raw radix et rhizoma rhei, 15-25 parts of fructus corni, 15-25 parts of radix paeoniae alba, 15-25 parts of poria cocos, 5-15 parts of rhizoma chuanxiong, 15-25 parts of radix atractylodis macrocephalae, 15-25 parts of radix codonopsis, 15-25 parts of radix alismatis, 15-25 parts of radix sophorae flavescentis and 15-25 parts of herba plantaginis. The traditional Chinese medicine composition for treating chronic renal failure is scientifically and reasonably formulated, and the traditional Chinese medicine composition has obvious and exact curative effects on chronic renal failure and has a shorter treatment cycle compared with the prior art.

Description

Technical Field

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

[0002] Chronic renal failure (CRF) is a clinical syndrome that develops in the later stages of chronic kidney disease. It has many complications and seriously affects patients' quality of life and lifespan.

[0003] Traditional Chinese medicine has a long history and good efficacy in treating kidney disease. Li Lianjiang et al. (Study on the efficacy of Huoxue Yiqi Decoction in treating chronic renal failure [J], Clinical Rational Drug Use, 20174, 7(10A), 23-24) disclosed a Huoxue Yiqi Decoction containing Atractylodes macrocephala, Polygonum multiflorum, Codonopsis pilosula, Salvia miltiorrhiza and Astragalus membranaceus, which can significantly improve the levels of creatinine, hemoglobin and blood urea nitrogen, and has a considerable effect on the treatment of chronic renal failure.

[0004] Zhang Xiaoman (Clinical Observation on the Treatment of Chronic Renal Failure with Qi and Yin Deficiency Syndrome by Modified Shenqi Dihuang Decoction [D], Yunnan University of Traditional Chinese Medicine, 2020) disclosed a modified Shenqi Dihuang Decoction, including Astragalus membranaceus, Codonopsis pilosula, Poria cocos, Alisma plantago-aquatica, Rehmannia glutinosa, Atractylodes macrocephala, Cornus officinalis, Ophiopogon japonicus, Dioscorea opposita, Salvia miltiorrhiza, Paeonia suffruticosa, Plantago asiatica, and Glycyrrhiza uralensis. In this formula, Astragalus membranaceus tonifies Qi and strengthens the middle Jiao, while Codonopsis pilosula tonifies both Qi and Yin, serving as the principal herbs; Poria cocos strengthens the spleen and promotes diuresis, Alisma plantago-aquatica clears heat, promotes diuresis and eliminates turbidity, Rehmannia glutinosa tonifies the kidney and replenishes essence, Cornus officinalis tonifies the liver and kidney and consolidates essence, Atractylodes macrocephala strengthens the spleen and tonifies Qi, dries dampness and promotes diuresis, while Ophiopogon japonicus nourishes Yin and generates fluids, serving as the assistant herbs; Dioscorea opposita strengthens the functions of tonifying Qi and nourishing Yin, tonifying the kidney and consolidating essence, Salvia miltiorrhiza removes blood stasis, promotes blood circulation, Paeonia suffruticosa invigorates blood, cools blood and removes blood stasis, and Plantago asiatica promotes diuresis, serving as the adjuvant herbs; Glycyrrhiza uralensis harmonizes all the herbs. The modified Shenqi Dihuang Decoction can alleviate the clinical symptoms of patients with chronic renal failure of the Qi and Yin deficiency type, improve their renal function, increase their endogenous creatinine clearance rate, and reduce urinary protein and urinary 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 consists of Suye Huanglian Decoction combined with stir-fried Citrus aurantium, Curcuma zedoaria, Codonopsis pilosula, Astragalus membranaceus, Rehmannia glutinosa, Cistanche deserticola, Eucommia ulmoides, Cannabis sativa seed, Platycladus orientalis seed, Angelica sinensis, Glycyrrhiza uralensis, and other herbs. This invention focuses on strengthening the spleen and replenishing qi, regulating the middle jiao and reducing turbidity, using both ascending and descending methods, and combining attack and tonification. The combined use of these herbs has significant effects on reducing serum creatinine, improving symptoms of chronic renal failure, and improving the quality of life of patients.

[0006] Traditional Chinese medicine has made some progress in the treatment of chronic renal failure, but there is still a lot of room for improvement. Therefore, it is still very important to find drugs that are more effective in treating chronic renal failure. Summary of the Invention

[0007] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating chronic renal failure, its preparation method, and its application.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials: Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica.

[0010] Solution:

[0011] The specific mechanism of action of the above-mentioned traditional Chinese medicine composition is as follows:

[0012] The traditional Chinese medicine composition of this invention primarily functions to replenish qi and blood, promote blood circulation and remove blood stasis, and promote diuresis and dampness elimination, employing both ascending and descending methods, and combining tonification and purgation. Specifically:

[0013] Tonifying Qi and Blood: By using herbs such as Astragalus and Codonopsis to tonify the spleen and kidneys, the body's digestive and metabolic functions are enhanced, thereby improving the patient's nutritional status and immunity.

[0014] Promoting blood circulation and removing blood stasis: By using drugs such as Danshen and Chuanxiong to improve blood circulation in kidney tissue, reduce glomerular sclerosis and renal interstitial fibrosis, and prevent further deterioration of kidney function.

[0015] Diuretic and dampness-eliminating effects: Using herbs such as Poria cocos, Alisma plantago-aquatica, and Plantago asiatica promotes urine excretion, reduces edema, clears damp-heat from the body, and improves the patient's symptoms. Treatment for internal dampness, turbidity, and blood stasis.

[0016] Tonifying the spleen and kidneys: By using herbs such as astragalus and codonopsis, the spleen and stomach functions are enhanced, the spleen and kidneys are tonified, and water metabolism is improved, thereby fundamentally improving the patient's condition.

[0017] The more specific mechanisms of action of each herb in both Chinese and Western medicine are as follows:

[0018] Astragalus: Sweet, slightly warm. It enters the spleen and lung meridians. It tonifies qi and raises yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling. The *Shennong Bencao Jing* states: "It treats carbuncles, chronic wounds, drains pus, tonifies deficiency, and expels pathogenic factors." The main components of astragalus are polysaccharides, astragaloside A, and flavonoids. Modern pharmacological studies have found that astragalus has various pharmacological effects, including enhancing the body's immunity, improving renal microcirculation, and reducing the decline in glomerular filtration rate.

[0019] Danshen (Salvia miltiorrhiza): Bitter, slightly cold. It enters the heart and liver meridians. It invigorates blood circulation, removes blood stasis, cools the blood, and eliminates carbuncles. The *Shennong Bencao Jing* states: "It treats evil qi in the heart and abdomen, intestinal rumbling like flowing water, accumulation of cold and heat, relieves irritability, and nourishes heart qi." The main components of Danshen are tanshinone, tanshinone, and tanshinone acid. Modern pharmacological studies have found that Danshen can improve blood circulation in renal tissue and reduce glomerular sclerosis and renal interstitial fibrosis.

[0020] Raw rhubarb: Bitter, cold. It enters the spleen, stomach, and large intestine meridians. It has purgative and detoxifying properties, clearing heat and purging fire. The *Shennong Bencao Jing* states: "It treats blood stasis, amenorrhea, chills and fever, breaks up masses and accumulations, removes retained fluids and undigested food, cleanses the intestines and stomach, promotes metabolism, and facilitates urination." The main components of raw rhubarb are anthraquinones, rhein, and rheinous acid. Modern pharmacological studies have found that raw rhubarb can remove toxins from the body and reduce the burden on the kidneys.

[0021] Cornus officinalis: Sour, astringent, and slightly warm. It enters the liver and kidney meridians. It tonifies the liver and kidneys, and has astringent and consolidating properties. The *Shennong Bencao Jing* states that it "treats evil qi in the epigastrium, chills and fever, warms the middle jiao, expels cold and dampness, and eliminates three types of parasites." The main components of Cornus officinalis are cornoside, ursolic acid, and oleanolic acid. Modern pharmacological studies have found that Cornus officinalis can improve kidney function and increase glomerular filtration rate.

[0022] Yam: Sweet, neutral in nature. It enters the spleen, lung, and kidney meridians. It tonifies the spleen and stomach, generates fluids, and benefits the lungs. The *Shennong Bencao Jing* states: "It treats internal injuries, replenishes deficiencies, eliminates cold and heat pathogens, strengthens the middle jiao, boosts qi and strength, and promotes muscle growth." The main components of yam are mucoprotein, amylase, and choline. Modern pharmacological studies have found that yam enhances spleen and stomach function and improves nutrient absorption.

[0023] Poria cocos: Sweet, bland, and neutral in nature. It enters the spleen and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. The *Shennong Bencao Jing* states that it "treats chest and rib pain, melancholy, palpitations, epigastric pain, chills and fever, restlessness, cough, dry mouth and tongue, and promotes urination." The main components of Poria cocos are polysaccharides, pachymic acid, and sterols. Modern pharmacological studies have found that Poria cocos promotes water metabolism and reduces edema.

[0024] Chuanxiong (Ligusticum striatum): pungent, warm. It enters the liver, gallbladder, and pericardium meridians. It invigorates blood circulation, promotes qi flow, dispels wind, and relieves pain. The *Shennong Bencao Jing* states that it "treats stroke with headache, cold-induced numbness and muscle spasms, traumatic injuries, and amenorrhea in women." The main components of Chuanxiong are ligustrazine, ligustrazine lactone, and volatile oil. Modern pharmacological studies have found that Chuanxiong improves blood supply to the kidneys and reduces inflammatory responses.

[0025] Atractylodes macrocephala: Bitter, sweet, and warm in nature. It enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis. The *Shennong Bencao Jing* states that it "treats wind-cold-dampness arthralgia, dead muscle, spasms, jaundice, stops sweating, clears heat and aids digestion." The main components of Atractylodes macrocephala are polysaccharides, atractylodes lactones, and volatile oils. Modern pharmacological studies have found that Atractylodes macrocephala enhances spleen and stomach function and improves water metabolism.

[0026] Codonopsis pilosula: Sweet, neutral. It enters the spleen and lung meridians. It tonifies the middle energizer and replenishes qi, generates fluids and nourishes blood. The *Shennong Bencao Jing* states: "It primarily tonifies the middle energizer and replenishes qi, strengthens the spleen and benefits the lungs, generates fluids and nourishes blood." The main components of Codonopsis pilosula are polysaccharides, codonopsis lactones, and volatile oils. Modern pharmacological studies have found that Codonopsis pilosula enhances the body's immunity and improves nutritional status.

[0027] Alisma plantago-aquatica: Sweet, bland, and cold in nature. It enters the kidney and bladder meridians. It promotes diuresis, eliminates dampness, and clears heat. The *Shennong Bencao Jing* states that it "treats wind-cold-dampness arthralgia, difficulty in lactation, eliminates edema, nourishes the five internal organs, strengthens qi and energy, and promotes robust health." The main components of Alisma plantago-aquatica are polysaccharides, alismosiderin, and volatile oils. Modern pharmacological studies have found that Alisma plantago-aquatica promotes urine excretion and reduces the burden on the kidneys.

[0028] Sophora flavescens: Bitter, cold. It enters the heart, liver, stomach, and large intestine meridians. It clears heat and dries dampness, kills parasites and promotes urination. The *Shennong Bencao Jing* states that it "treats abdominal distension, masses, rebellious qi, diarrhea, and improves eyesight." The main components of Sophora flavescens are matrine, oxymatrine, and matrine. Modern pharmacological studies have found that Sophora flavescens has the effects of clearing damp-heat from the body and improving kidney function.

[0029] Plantain: Sweet, cold. It enters the liver, kidney, and bladder meridians. It promotes urination, clears heat, and improves eyesight. The *Shennong Bencao Jing* states, "It treats urinary retention, relieves pain, and promotes urination." The main components of plantain are plantain polysaccharides, plantainin, and volatile oils. Modern pharmacological studies have found that plantain promotes urination and reduces edema.

[0030] In some embodiments, the traditional Chinese medicine composition comprises, by weight, the following raw materials: 25-35 parts Astragalus membranaceus, 15-25 parts Salvia miltiorrhiza, 5-15 parts Rheum palmatum, 15-25 parts Cornus officinalis, 15-25 parts Dioscorea opposita, 15-25 parts Poria cocos, 5-15 parts Ligusticum chuanxiong, 15-25 parts Atractylodes macrocephala, 15-25 parts Codonopsis pilosula, 15-25 parts Alisma plantago-aquatica, 15-25 parts Sophora flavescens, and 15-25 parts Plantago asiatica.

[0031] In some embodiments, the total weight ratio of raw rhubarb and chuanxiong to the total weight of cornus officinalis and alisma plantago-aquatica is 1-3:3-5; preferably 1:2-3; more preferably 1:2; even more preferably, the weight ratio of raw rhubarb, chuanxiong, cornus officinalis and alisma plantago-aquatica is 1:1:2-3:2-3; even more preferably 1:1:2:2.

[0032] In some implementations, the mass ratio of the yam, codonopsis, and sophora flavescens is 1:1:1.

[0033] In some embodiments, the traditional Chinese medicine composition comprises, by weight, the following raw materials: Astragalus membranaceus 28.5-31.5 parts, Salvia miltiorrhiza 19-21 parts, Rheum palmatum 9.5-10.5 parts, Cornus officinalis 19-21 parts, Dioscorea opposita 19-21 parts, Poria cocos 19-21 parts, Ligusticum chuanxiong 9.5-10.5 parts, Atractylodes macrocephala 19-21 parts, Codonopsis pilosula 19-21 parts, Alisma plantago-aquatica 19-21 parts, Sophora flavescens 19-21 parts, and Plantago asiatica 19-21 parts.

[0034] In some embodiments, the traditional Chinese medicine composition comprises, by weight, the following raw materials: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 10 parts Rheum palmatum, 20 parts Cornus officinalis, 20 parts Dioscorea opposita, 20 parts Poria cocos, 10 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 20 parts Alisma plantago-aquatica, 20 parts Sophora flavescens, and 20 parts Plantago asiatica.

[0035] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: decocting the prescribed amounts of Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica, separating the solid and liquid, concentrating and drying the filtrate, and then obtaining the final product.

[0036] In some implementations, the decoction is performed by adding water and decocting at least once, each time for 0.5-2 hours. The amount of water added each time is 8-15 times the total amount of Astragalus membranaceus, Salvia miltiorrhiza, Rheum palmatum, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica. Preferably, the decoction is performed twice, each time for 1 hour.

[0037] In some implementations, the solid-liquid separation is a conventional solid-liquid separation method in the art, including filtration, centrifugation, or pressure filtration.

[0038] In some embodiments, the drying process involves drying to a moisture content of less than 10%. Preferably, the drying process is spray drying, vacuum drying, or freeze drying.

[0039] Thirdly, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating chronic renal failure.

[0040] Fourthly, the present invention provides a pharmaceutical preparation for treating chronic renal failure, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0041] The beneficial effects of this invention are as follows:

[0042] (1) The traditional 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 prior art, the traditional Chinese medicine composition of the present invention has a significant and definite curative effect on chronic renal failure and a shorter treatment cycle.

[0043] (2) During the screening process of the prescription of this invention, it was unexpectedly discovered that a specific amount of raw rhubarb, chuanxiong, cornus officinalis, alisma plantago-aquatica, yam, codonopsis pilosula and sophora flavescens can better reduce the levels of creatinine, Cys-C, α1-microglobulin and 24h urinary protein, and have a better therapeutic effect on chronic renal failure.

[0044] (3) The traditional Chinese medicine composition of the present invention is produced by sampling and decoction industry. The preparation method is simple, convenient to take, and the treatment cost is low. Attached Figure Description

[0045] Figure 1 The image shows the morphology of the kidneys of mice in each group.

[0046] Figure 2 The graphs show the changes in body weight and kidney index of mice in each group. A is the graph of body weight change, and B is the graph of kidney index. Compared with the CRF group, *, p<0.05; **, p<0.01; ***, p<0.001. ns indicates no significant difference, p>0.05.

[0047] Figure 3 The following are statistical graphs showing the changes in urine and serum indicators in each group of mice: A is the urine protein graph, B is the creatinine content graph, C is the blood urea nitrogen content graph, D is the cystatin C content graph, and E is the α1-microglobulin content graph. Among them, compared with the CRF group, *, p<0.05; **, p<0.01; ***, p<0.001, ns indicates no significant difference, p>0.05.

[0048] Figure 4 HE, MASSON, and PAS staining images of kidney pathological sections from each group of mice, at a scale of 100 μm. Detailed Implementation

[0049] The following description of the embodiments is merely to aid in understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from its principles, and these improvements and modifications also fall within the scope of the claims. The following description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not limited to the embodiments shown herein, but can be applied to a wider scope consistent with the principles and novel features disclosed herein. While any methods and materials similar to or equivalent to those described herein may be used in the implementation or testing of the present invention, preferred methods and materials are listed herein.

[0050] Unless otherwise defined, 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 pertains.

[0051] The “pharmaceutical preparation” described in this invention includes a traditional Chinese medicine composition and pharmaceutically acceptable excipients. In a specific embodiment, the traditional Chinese medicine composition described in this invention is provided in the pharmaceutical preparation in an effective amount (e.g., a therapeutically effective amount).

[0052] The "acceptable" ingredients described in this invention are substances suitable for human and / or animal use without excessive adverse side effects (such as toxicity, irritation, and allergic reactions), i.e., having a reasonable benefit / risk ratio. The "pharmaceuticalally acceptable excipients" include inert diluents, dispersants and / or granulators, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants, and / or oils. The traditional Chinese medicine composition may also contain excipients (e.g., cocoa butter and suppository waxes), colorants, coating agents, sweeteners, and flavoring agents.

[0053] The “pharmaceutical formulation” described in this invention can be prepared by any method known in pharmaceutical science. Generally, these preparation methods involve 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 desired and / or expected, shaping and / or packaging the product into desired single-dose or multi-dose units.

[0054] The pharmaceutical formulations of the present invention can be prepared according to known methods, such as those described in the general rules for preparation in the Chinese Pharmacopoeia 2020, the Japanese Pharmacopoeia 16th Edition, the United States Pharmacopoeia, and the European Pharmacopoeia 9th Edition. The specific preparation method depends on the dosage form.

[0055] The active ingredient and pharmaceutically acceptable excipients in the "pharmaceutical formulation" described in this invention will vary depending on the identity, body type, and / or condition of the treated subject and further on the route of administration of the active ingredient. The pharmaceutical formulation may contain between 0.1% and 100% (w / w) of the active ingredient.

[0056] As used herein, “treatment” means, unless otherwise stated, reversing or alleviating the condition or disease to which the term applies, or one or more symptoms of such condition or disease, inhibiting the progression of said condition or disease or one or more symptoms thereof, or preventing said condition or disease or one or more symptoms thereof. As used in this invention, the term “treatment” refers to a therapeutic act, as defined above.

[0057] The term "effective amount" as used in this invention refers to an amount sufficient to elicit the desired biological response. The effective amount of the active ingredient of this invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the administration pattern, and the age and health status of the subject. In some embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the sole active ingredient described in this invention in a single dose. In some embodiments, the effective amount is a combination of the sole active ingredient described in this invention in multiple doses.

[0058] The term "therapeuticly effective amount" as used in this invention refers to an amount sufficient to provide therapeutic benefit in the treatment of a condition or sufficient to delay or minimize one or more symptoms associated with that condition. A therapeutically effective amount of an active ingredient means an amount in which the therapeutic agent, alone or in combination with other therapies, provides therapeutic benefit in the treatment of a condition. The term "therapeuticly effective amount" may encompass amounts that improve overall therapy, reduce or avoid symptoms, signs, or causes of a condition, and / or enhance the therapeutic efficacy of another therapeutic agent. In some embodiments, a therapeutically effective amount is an amount sufficient to treat any of the diseases or conditions described.

[0059] Unless otherwise specified, all raw materials used are commercially available products, and their sources are not specifically limited. Unless otherwise specified, all operations are performed at room temperature, specifically 20-25℃.

[0060] Example 1: A Traditional Chinese Medicine Composition

[0061] The traditional Chinese medicine composition comprises the following raw materials by weight: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 10 parts Rheum palmatum, 20 parts Cornus officinalis, 20 parts Dioscorea opposita, 20 parts Poria cocos, 10 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 20 parts Alisma plantago-aquatica, 20 parts Sophora flavescens, and 20 parts Plantago asiatica.

[0062] The preparation method is as follows: Add water to the prescribed amounts of Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica and decoct twice, 1 hour each time. For the first decoction, add water equal to 12 times the total amount of Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica. For the second decoction, add water equal to 8 times the total amount of Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica. Filter, combine the filtrates, concentrate and dry at 60℃, and the product is ready.

[0063] Example 2: A Traditional Chinese Medicine Composition

[0064] The traditional Chinese medicine composition comprises the following raw materials by weight: Astragalus membranaceus 35 parts, Salvia miltiorrhiza 25 parts, Rheum palmatum 15 parts, Cornus officinalis 25 parts, Dioscorea opposita 25 parts, Poria cocos 25 parts, Ligusticum chuanxiong 15 parts, Atractylodes macrocephala 25 parts, Codonopsis pilosula 25 parts, Alisma plantago-aquatica 25 parts, Sophora flavescens 25 parts, and Plantago asiatica 25 parts.

[0065] The preparation method is the same as in Example 1.

[0066] Example 3 A Traditional Chinese Medicine Composition

[0067] The traditional Chinese medicine composition comprises the following raw materials by weight: Astragalus membranaceus 25 parts, Salvia miltiorrhiza 15 parts, Rheum palmatum 5 parts, Cornus officinalis 15 parts, Dioscorea opposita 15 parts, Poria cocos 15 parts, Ligusticum chuanxiong 5 parts, Atractylodes macrocephala 15 parts, Codonopsis pilosula 15 parts, Alisma plantago-aquatica 15 parts, Sophora flavescens 15 parts, and Plantago asiatica 15 parts.

[0068] The preparation method is the same as in Example 1.

[0069] Comparative Example 1: A Traditional Chinese Medicine Composition

[0070] The difference between this comparative example and Example 1 includes that the total weight ratio of the raw rhubarb and chuanxiong is different from the total weight ratio of the cornus officinalis and alisma plantago-aquatica.

[0071] Specifically, the Chinese herbal composition comprises the following raw materials by weight: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 25 parts Rheum palmatum, 10 parts Cornus officinalis, 20 parts Dioscorea opposita, 20 parts Poria cocos, 15 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 10 parts Alisma plantago-aquatica, 20 parts Sophora flavescens, and 20 parts Plantago asiatica.

[0072] The preparation method is the same as in Example 1.

[0073] Comparative Example 2: A Traditional Chinese Medicine Composition

[0074] The difference between this comparative example and Example 1 is that the weight ratio of the raw rhubarb, chuanxiong, cornus officinalis, and alisma is different.

[0075] Specifically, the Chinese herbal composition comprises the following raw materials by weight: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 2 parts Rheum palmatum, 30 parts Cornus officinalis, 20 parts Dioscorea opposita, 20 parts Poria cocos, 18 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 10 parts Alisma plantago-aquatica, 20 parts Sophora flavescens, and 20 parts Plantago asiatica.

[0076] The preparation method is the same as in Example 1.

[0077] Comparative Example 3: A Traditional Chinese Medicine Composition

[0078] The difference between this comparative example and Example 1 is that the mass ratio of the yam, codonopsis, and sophora flavescens is different.

[0079] Specifically, the Chinese herbal composition comprises the following raw materials by weight: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 10 parts Rheum palmatum, 20 parts Cornus officinalis, 30 parts Dioscorea opposita, 20 parts Poria cocos, 10 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 20 parts Alisma plantago-aquatica, 10 parts Sophora flavescens, and 20 parts Plantago asiatica.

[0080] The preparation method is the same as in Example 1.

[0081] Efficacy verification of traditional Chinese medicine composition

[0082] 1. Modeling

[0083] SPF-grade male C57BL / 6J mice, 8 weeks old, were housed in an environment with a temperature of 22-25℃ (maximum daily temperature difference <4℃), relative humidity of 50%-75%, 12 hours of light per day, and regular UV sterilization. Each cage contained 4 to 5 mice with free access to food and water.

[0084] The model was established by dividing mice into a control (CON) group and a model (CRF) group. The model group was fed a diet containing 0.1 wt% adenine for 4 weeks, while the control group was fed a normal diet. At the end of the 4th week, a certain number of mice were randomly selected and anesthetized with 2 wt% pentobarbital. Blood was collected from the abdominal aorta and centrifuged at 4°C, 3000 rpm / min for 15 min. Serum was then separated for testing. Mice in the model group with blood urea nitrogen > 50 mg / L, creatinine > 1.1 mg / L, and urinary creatinine clearance < 20%-50% within 24 h were considered to have successfully established the model.

[0085] 2. Administration

[0086] CRF mice were randomly and evenly divided into four groups: a model (CRF) group, a positive control drug (Active Control, Uremic Clearing Granules, purchased from Kangchen Pharmaceutical) group (0.6g / mouse / day), an Example 1 (SSL1) group (0.6g / mouse / day), an Example 2 (SSL2) group (0.6g / mouse / day), an Example 3 (SSL3) group (0.6g / mouse / day), a Comparative Example 1 (DBL1) group (0.6g / mouse / day), a Comparative Example 2 (DBL2) group (0.6g / mouse / day), and a Comparative Example 3 (DBL3) group (0.6g / mouse / day), with three mice in each group. The control group and the model group were administered distilled water by gavage, while the other groups were administered the corresponding drug by gavage. The administration was continued for 4 weeks.

[0087] Mice body weight was recorded weekly during the experiment. At week 8, 24-hour urine samples were collected to measure urinary protein levels. At week 8, orbital venous blood was collected from mice to measure serum creatinine (CRE), blood urea nitrogen (BUN), α1-microglobulin (α1-MG), and cystatin C (Cys-C) levels. After week 8, the animals were sacrificed, and kidneys were collected for pathological examination.

[0088] 3. Results

[0089] 3.1 Effects of Traditional Chinese Medicine Composition on Kidney Morphology in C57 Mice

[0090] The results are as follows Figure 1 As shown.

[0091] The results showed that, compared with the CON group, the CRF group had significantly smaller kidneys. The kidneys of the CON group mice were reddish-brown and shiny, while the kidneys of the CRF group mice were significantly smaller, grayish-white, dull, and had a noticeably granular surface. After drug treatment, compared with the model group, the kidney color, luster, and degree of atrophy in the SSL1-SSL3 groups of mice were significantly improved.

[0092] 3.2 Effects of the traditional Chinese medicine composition on body weight and kidney index of C57 mice

[0093] The results are as follows Figure 2 As shown.

[0094] The results showed that mice in the CON group had good mental condition, strong activity, and glossy fur. Mice in the CRF group had poor mental condition, reduced activity, dull fur, and were noticeably thin. Figure 2 As shown in A, compared to the CON group, the body weight (g) of mice in the model group significantly decreased from week 1 after administration of adenine-fed diet. Compared to the CRF group, the body weight of the herbal combination group significantly increased from week 5, trending towards the body weight of mice in the CON group. Figure 2 As shown in Figure B, after adenine-based diet modeling, the renal index (%) of CRF group mice was significantly reduced, showing a highly significant difference compared to the CON group mice (P < 0.001). After drug intervention, the renal index of SSL1 and SSL3 groups mice was significantly increased compared to the CRF group mice (P < 0.001), and basically the same as that of the CON group mice. The renal index of DBL1-DBL3 groups mice was not significantly different from that of the CRF group mice (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of this invention can improve the renal index of chronic renal failure (CRF) model mice and have a repairing or reversing effect on CRF-induced renal atrophy, while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 did not have the above effects.

[0095] 3.3 Effects of Traditional Chinese Medicine Composition on Urine and Serum Indicators in C57 Mice

[0096] The results are as follows Figure 3 As shown.

[0097] The results show that: Figure 3As shown in A, after adenine-based diet modeling, the urinary protein (mg) level in the CRF group mice significantly increased, showing a highly significant difference compared to the CON group mice (P < 0.001). After drug intervention, except for the DBL3 group, the urinary protein levels in the other groups were significantly lower than those in the CRF group mice (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 this invention have the effect of reducing urinary protein levels in mice with chronic renal failure (CRF).

[0098] like Figure 3 As shown in B, after adenine-based diet modeling, the blood urea nitrogen (BUN, mmol / L) content in the CRF group mice increased significantly, showing a highly significant difference compared to the CON group mice (P < 0.01). After drug intervention, the BUN content in the SSL1 and SSL3 groups was significantly lower than that in the CRF group mice (P < 0.05); the BUN content in the DBL1-DBL3 groups was not significantly different from that in the CRF group mice (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of this invention have the effect of reducing BUN levels in mice with chronic renal failure (CRF), while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have the above-mentioned effects.

[0099] like Figure 3 As shown in Figure C, after adenine-based diet modeling, the creatinine content (CRE, μmol / L) of CRF group mice increased significantly, showing a highly significant difference compared to the CON group mice (P < 0.001). After drug intervention, the urea nitrogen content of SSL1 and SSL3 groups mice was significantly lower than that of CRF group mice (P < 0.05), and basically the same as that of CON group mice; the creatinine content of DBL1-DBL3 groups mice was not significantly different from that of CRF group mice (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of this invention have the effect of reducing creatinine levels in chronic renal failure (CRF) model mice, while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have the above-mentioned effects.

[0100] like Figure 3As shown in Figure D, after adenine-based diet modeling, the cystatin C content (Cys-C, mg / L) in the CRF group mice significantly increased, showing a highly significant difference compared to the CON group mice (P < 0.001). After drug intervention, the cystatin C content in the SSL1 and SSL3 groups was significantly lower than that in the CRF group mice (P < 0.05), and basically the same as that in the CON group mice; the cystatin C content in the DBL1-DBL3 groups mice was not significantly different from that in the CRF group mice (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1 and 3 of this invention have the effect of reducing cystatin C levels in mice with chronic renal failure (CRF), while the traditional Chinese medicine compositions prepared in Comparative Examples 1-3 do not have the above-mentioned effects.

[0101] like Figure 3 As indicated by E in the figure, after adenine-based diet modeling, the α1-microglobulin content (α1-MG, mg / L) in the CRF group mice significantly increased, showing a highly significant difference compared to the CON group mice (P < 0.001). After drug intervention, the α1-microglobulin C content in the SSL1-SSL3 groups was significantly lower than that in the CRF group mice (P < 0.05), and essentially the same as that in the CON group mice; the α1-microglobulin C content in the DBL1 and DBL2 groups mice showed no significant difference compared to the CRF group mice (P > 0.05). This indicates that the traditional Chinese medicine compositions prepared in Examples 1-3 of this invention have the effect of reducing α1-microglobulin levels in mice with chronic renal failure (CRF), while the traditional Chinese medicine compositions prepared in Comparative Examples 1 and 2 do not have the above-mentioned effects.

[0102] In summary, the traditional Chinese medicine composition prepared in this invention has a comprehensive protective effect against kidney damage in CRF model mice.

[0103] 3.4 Effects of Traditional Chinese Medicine Composition on Kidney Pathology in C57 Mice

[0104] The results are as follows Figure 4 As shown.

[0105] The results showed that, compared with the CON group, the HE, PAS, and MASSON staining of CRF mice showed glomerular sclerosis and atrophy, accompanied by renal tubular dilation or atrophy, a large number of inflammatory cell infiltrations in the renal interstitium, and increased blue staining of glomerular basement membrane and renal interstitial collagen fibers, indicating fibrosis. After drug intervention, the degree of glomerular sclerosis and atrophy in SSL1-SSL3 mice was significantly reduced, the number of inflammatory cell infiltrations in the renal interstitium was significantly reduced, and the blue staining of glomerular basement membrane and renal interstitial collagen fibers was lighter. This indicates that the traditional Chinese medicine composition prepared in Examples 1-3 of this invention has a significant effect on improving the renal pathological structure of CRF mice, and can effectively reduce glomerular and renal tubular damage, inhibit renal interstitial inflammation and fibrosis.

[0106] The above description, in conjunction with specific embodiments, further illustrates the present invention. However, these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. Those skilled in the art should understand that modifications or substitutions to the details and form of the technical solutions of the present invention can be made without departing from the spirit and scope of the invention, and all such modifications and substitutions fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic renal failure, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 25-35 parts, Salvia miltiorrhiza 15-25 parts, raw rhubarb 5-15 parts, Cornus officinalis 15-25 parts, Dioscorea opposita 15-25 parts, Poria cocos 15-25 parts, Ligusticum chuanxiong 5-15 parts, Atractylodes macrocephala 15-25 parts, Codonopsis pilosula 15-25 parts, Alisma plantago-aquatica 15-25 parts, Sophora flavescens 15-25 parts, and Plantago asiatica 15-25 parts; The ratio of the total weight of raw rhubarb and chuanxiong to the total weight of cornus officinalis and alisma plantago-aquatica is 1:2-3; The weight ratio of raw rhubarb, Sichuan lovage rhizome, cornus officinalis and alisma plantago-aquatica is 1:1:2-3:2-3; The mass ratio of the yam, codonopsis, and sophora flavescens is 1:1:

1.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The total weight ratio of raw rhubarb and Sichuan lovage to the total weight ratio of cornus officinalis and alisma plantago-aquatica is 1:

2.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight ratio of raw rhubarb, Sichuan lovage rhizome, cornus officinalis, and alisma plantago-aquatica is 1:1:2:

2.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following ingredients by weight: 30 parts Astragalus membranaceus, 20 parts Salvia miltiorrhiza, 10 parts Rheum palmatum, 20 parts Cornus officinalis, 20 parts Dioscorea opposita, 20 parts Poria cocos, 10 parts Ligusticum chuanxiong, 20 parts Atractylodes macrocephala, 20 parts Codonopsis pilosula, 20 parts Alisma plantago-aquatica, 20 parts Sophora flavescens, and 20 parts Plantago asiatica.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The process includes the following steps: Take the following ingredients by weight: Astragalus membranaceus, Salvia miltiorrhiza, raw rhubarb, Cornus officinalis, Dioscorea opposita, Poria cocos, Ligusticum chuanxiong, Atractylodes macrocephala, Codonopsis pilosula, Alisma plantago-aquatica, Sophora flavescens, and Plantago asiatica. Add water and decoct. Separate the solid and liquid components. Concentrate and dry the filtrate.

6. The preparation method according to claim 5, characterized in that, The decoction process involves adding water and decocting at least once, for 0.5-2 hours each time.

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

8. A pharmaceutical preparation for treating chronic renal failure, characterized in that, It is made from the traditional Chinese medicine composition according to any one of claims 1-4 and pharmaceutically acceptable excipients.

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