A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method

Abstract

The present invention belongs to the field of traditional Chinese medicine compositions, and specifically discloses a traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method. The composition is made from four types of raw materials of monarch, minister, assistant and envoy drugs. The monarch drugs include polygonum cuspidatum and smilax glabra, which clear heat and detoxify, promote diuresis, disperse stasis and resolve turbidity. The minister drugs include cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii and excrementum bombycis, which assist the monarch drugs to purge turbidity in the way of promoting bowel movement. The assistant drugs include astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis and polygonatum sibiricum, which replenish qi, strengthen the spleen, nourish blood and promote the ascending of lucid yang, and the promotion of the ascending of lucid yang facilitates the descending of turbidity. The envoy drugs include pinellia ternata and pericarpium citri reticulatae, which strengthen the stomach and regulate qi, and regulate the qi movement of the whole body. This formula focuses on strengthening the spleen for strengthening healthy qi, embodying the theory of "the spleen is the foundation of acquired constitution" in traditional Chinese medicine, and has good preventive and therapeutic effects on the type of chronic renal failure with deficiency of the spleen and kidney and internal accumulation of dampness and turbidity.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine compositions, and specifically discloses a traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method. Background Art

[0002] Chronic renal failure (CRF) refers to a clinical syndrome caused by various reasons of chronic progressive renal parenchymal damage, resulting in obvious atrophy of the kidneys, inability to maintain basic functions, and clinically manifested by the retention of metabolites, disorders of water, electrolyte and acid-base balance, and involvement of various systems of the body. It is a serious disease threatening human life.

[0003] Modern traditional Chinese medicine has found that rhubarb can reduce the levels of serum creatinine and blood urea nitrogen, improve lipid metabolism, inhibit the hypertrophy and hyperplasia of renal tubular epithelial cells, reduce the high metabolism of cells and the high filtration state of glomeruli, and can inhibit the compensatory hypertrophy of the kidneys, reduce glomerulosclerosis, reduce the high metabolism state of the remaining kidneys, and delay the progression of chronic renal failure. Cordyceps sinensis can reduce the levels of bun and scr, increase the plasma protein content, improve anemia and nutritional status, promote the repair and regeneration of renal tubular epithelial cells, correct the disorders of amino acid, protein and lipid metabolism, regulate cellular immunity, improve the body's immunity, protect and restore renal function, and prevent secondary infections. Salvia miltiorrhiza can significantly reduce the contents of bun and scr, increase the clearance rate and filtration volume of scr and bun, increase the survival rate, improve renal blood supply, and reduce renal damage. Tripterygium wilfordii is similar to corticosteroids, but has no side effects of hormones. Its action characteristics are completely different from those of hormones, cyclosporine, etc. Its immunosuppressive effect is achieved by inducing apoptosis of t cells, controlling the cell cycle and inhibiting il2, and does not block the information transmission of the t cell receptor (tcr). It is a new type of immunosuppressive drug. Astragalus membranaceus can significantly improve cellular immunity and humoral immunity functions, increase the body's resistance and the phagocytic function of the reticuloendothelial system, increase the protein synthesis rate, reduce the scr level and free radical production, and can increase the clearance of free radicals and improve renal function.

[0004] At present, there are also some traditional Chinese medicine compositions used to treat chronic renal failure. For example: 1. The aconite and pinellia decoction for treating chronic renal failure: Its functions and effects are to warm the middle-jiao and dispel cold. Traditional Chinese medicine uses this prescription to mainly treat chronic renal failure. The main drugs included are prepared aconite (decocted first), ginger pinellia, raw rhubarb (added later), perilla, mung bean, patrinia scabiosaefolia, serissa japonica, codonopsis pilosula, coptis chinensis, raw licorice, and stir-fried atractylodes macrocephala. The specific usage and dosage are 1 dose per day. All the drugs are decocted in water together, and the residue is removed and taken in two divided doses. 2. Cordyceps sinensis for treating chronic renal failure: Its main functions and effects are to tonify deficiency and damage, replenish essence and qi, and relieve cough and resolve phlegm. It is mainly used in clinical practice to treat chronic renal failure. The main drug is cordyceps sinensis. The usage and dosage of the drug are 1 dose per day. When using it, the patient should decoct it and take it together with the residue. During the period of taking the drug, the patient should eat a diet with high calories and low-protein wheat starch. However, those with exterior pathogens should use it with caution. 3. The astragalus and codonopsis decoction for treating chronic renal failure: Its functions and effects are to warm the kidney and activate blood circulation, dispel wind and clear heat. It can mainly assist in treating chronic renal failure. The drugs included are roasted astragalus, Chinese yam, motherwort, lucid ganoderma, raw rehmannia root, cornel fruit, alisma orientale, poria cocos, moutan bark, schizandra chinensis, morinda officinalis, epimedium, acanthopanax gracilistylus, ophiopogon japonicus, polygonum orientale, perilla leaf, ledebouriella seseloides, cicada slough, leech, and ground beetle. The usage and dosage of this prescription are 1 dose per day. It is decocted three times in water, the residue is removed, and the mixed medicinal liquid is taken in three divided doses. One month is one course of treatment.

[0005] However, among the above-mentioned traditional Chinese medicines, many contain toxic drugs, such as aconite, and some also include rare traditional Chinese medicine ingredients such as cicada slough, leech, and ground beetle. Moreover, most of them are decoctions, which are inconvenient to take and have insignificant curative effects. Summary of the Invention

[0006] In order to solve the above problems, the present invention discloses a traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method.

[0007] The technical solution of the present invention is as follows:

[0008] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is made from four types of raw materials of monarch, minister, assistant, and courier drugs. The monarch drugs include polygonum cuspidatum and smilax glabra; the minister drugs include cannabis seed, magnolia officinalis, rhubarb, trichosanthes kirilowii, and bombyx mori excrement; the assistant drugs include astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, and polygonatum sibiricum; the courier drugs include pinellia ternata and citrus reticulata blanco.

[0009] Furthermore, the above-mentioned traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is made from the following raw materials in parts by weight: 100 parts of polygonum cuspidatum, 30 - 50 parts of smilax glabra, 20 - 40 parts of cannabis seed, 15 - 35 parts of magnolia officinalis, 10 - 30 parts of rhubarb, 10 - 20 parts of trichosanthes kirilowii, 5 - 10 parts of bombyx mori excrement, 15 - 25 parts of astragalus membranaceus, 10 - 20 parts of codonopsis pilosula, 8 - 16 parts of atractylodes macrocephala, 5 - 10 parts of pueraria lobata, 15 - 25 parts of angelica sinensis, 5 - 10 parts of polygonatum sibiricum, 10 - 30 parts of pinellia ternata, and 20 - 40 parts of citrus reticulata blanco.

[0010] Furthermore, the above-mentioned traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is prepared from the following raw materials by weight: 100 parts of polygonum cuspidatum, 35-45 parts of smilax glabra, 25-35 parts of cannabis seed, 20-30 parts of magnolia officinalis, 15-25 parts of rheum palmatum, 12-18 parts of trichosanthes kirilowii, 6-9 parts of excrementum bombycis, 18-22 parts of astragalus membranaceus, 12-18 parts of codonopsis pilosula, 10-14 parts of atractylodes macrocephala, 6-9 parts of pueraria lobata, 18-22 parts of angelica sinensis, 6-9 parts of polygonatum sibiricum, 15-25 parts of pinellia ternata, 25-35 parts of pericarpium citri reticulatae.

[0011] Furthermore, the preparation method of the above-mentioned traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure comprises the following steps: preparing the traditional Chinese medicine pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata and pericarpium citri reticulatae according to weight parts, pouring them into a reflux extractor, adding 10-20 times the mass of water of the medicinal materials for impregnation, starting heating after all the medicinal materials are fully wetted, keeping boiling for extraction for 1-3 hours when heated to complete boiling, filtering, adding 10-20 times the amount of 85%-95% ethanol to the filter residue, continuing heating, keeping boiling for extraction for 1-3 hours after complete boiling, filtering, combining the filtrates, concentrating to obtain a concentrated solution, and the density of the concentrated solution is 0.9-1.1 g / mL.

[0012] Furthermore, the present invention discloses a traditional Chinese medicine preparation with the efficacy of preventing and treating chronic renal failure, which is made into an oral preparation from the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0013] Furthermore, the present invention discloses a traditional Chinese medicine preparation with the efficacy of preventing and treating chronic renal failure, and the oral preparation includes granules, tablets and capsules.

[0014] Furthermore, the present invention discloses a preparation method of a traditional Chinese medicine granule with the efficacy of preventing and treating chronic renal failure, which comprises the following steps:

[0015] S1 Concentrated solution preparation: preparing the traditional Chinese medicine pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata and pericarpium citri reticulatae according to weight parts, pouring them into a reflux extractor, adding 10-20 times the mass of water of the medicinal materials for impregnation, starting heating after all the medicinal materials are fully wetted, keeping boiling for extraction for 1-3 hours when heated to complete boiling, filtering, adding 10-20 times the amount of 85%-95% ethanol to the filter residue, continuing heating, keeping boiling for extraction for 1-3 hours after complete boiling, filtering, combining the filtrates, concentrating to obtain a concentrated solution, and the density of the concentrated solution is 0.9-1.1 g / mL;

[0016] Preparation of Extract Powder S2: Add excipients to the concentrated solution, with the mass ratio of excipients to the concentrated solution being 1:3 - 5. After mixing evenly, conduct drying to obtain the extract powder. Drying process parameters: drying temperature is 100 - 200 °C, and drying time is 30 - 90 min. The excipients are selected from one or more of dextrin, lactose, pregelatinized starch, or microcrystalline cellulose;

[0017] Preparation of Granules S3: The extract powder is granulated by dry granulation to obtain traditional Chinese medicine granules. The dry granulation process parameters include: granulation pressure is 3 - 4 MPa, feeding speed is 200 - 400 g / min, the mesh number of the upper sieve is 14 - 18 meshes, and the mesh number of the lower sieve is 35 - 45 meshes.

[0018] Furthermore, the present invention discloses a preparation method of a traditional Chinese medicine tablet with the efficacy of preventing and treating chronic renal failure, including the following steps:

[0019] Preparation of Concentrated Solution S1: Prepare traditional Chinese medicine decoction pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rhubarb, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and citrus reticulata blanco according to parts by weight, pour them into a reflux extraction tank, add 10 - 20 times the mass of water for impregnation. After all the medicinal materials are fully wetted, start heating. When heated to full boiling, keep boiling for extraction for 1 - 3 hours, filter, add 10 - 20 times the amount of 85% - 95% ethanol to the filter residue, continue heating, when completely boiling, keep boiling for extraction for 1 - 3 hours, filter, combine the filtrates, and concentrate to obtain the concentrated solution. The density of the concentrated solution is 0.9 - 1.1 g / mL;

[0020] Preparation of Extract Powder S2: Add excipients to the concentrated solution, with the mass ratio of excipients to the concentrated solution being 1:3 - 5. After mixing evenly, conduct drying to obtain the extract powder. Drying process parameters: drying temperature is 100 - 200 °C, and drying time is 30 - 90 min. The excipients are selected from one or more of dextrin, lactose, pregelatinized starch, or microcrystalline cellulose;

[0021] Tablet Pressing: Press the extract powder obtained in step S2 into traditional Chinese medicine tablets with the efficacy of preventing and treating chronic renal failure, and the mass of each tablet is 500 - 1000 mg.

[0022] Furthermore, the present invention discloses a preparation method of a traditional Chinese medicine capsule with the efficacy of preventing and treating chronic renal failure, including the following steps:

[0023] Preparation of S1 concentrated solution: Prepare the Chinese herbal pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rhubarb, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and citrus reticulata blanco according to parts by weight, pour them into a reflux extractor, add 10-20 times the mass of water of the medicinal materials for impregnation. After all the medicinal materials are fully moistened, start heating. When it is heated to full boiling, keep boiling for extraction for 1-3 hours, filter, add 10-20 times the amount of 85%-95% ethanol to the filter residue, continue heating. After it is completely boiled, keep boiling for extraction for 1-3 hours, filter, combine the filtrates, and concentrate to obtain a concentrated solution, and the density of the concentrated solution is 0.9-1.1 g / mL;

[0024] Preparation of S2 extract powder: Add excipients to the concentrated solution, and the mass ratio of the excipients to the concentrated solution is 1:3-5. After mixing evenly, carry out drying to obtain an extract powder; Drying process parameters: The drying temperature is 100-200 °C, and the drying time is 30-90 min; The excipients are selected from one or more of dextrin, lactose, pregelatinized starch, or microcrystalline cellulose;

[0025] Preparation of S3 granules: The extract powder is granulated by dry granulation to obtain traditional Chinese medicine granules. The dry granulation process parameters include: The granulation pressure is 3-4 MPa, the feeding speed is 200-400 g / min, the mesh number of the upper sieve is 14-18 meshes, and the mesh number of the lower sieve is 35-45 meshes.

[0026] Preparation of S4 capsules: The granules prepared in step S3 are filled into capsules to prepare capsule preparations, and each capsule contains 200-700 mg of granules.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] Chronic renal failure and uremia are the late stages of chronic kidney disease. In patients with kidney injury, the blood creatinine and blood urea nitrogen increase, and more than a thousand toxins in the body are retained due to excretion disorders. According to traditional Chinese medicine syndrome differentiation, the root deficiency and superficial excess are obvious. The root deficiency is mainly manifested as spleen and kidney deficiency and qi and blood deficiency, and the superficial excess is the internal accumulation of dampness turbidity. According to traditional Chinese medicine theory, the kidney is in charge of opening and closing, and the spleen is in charge of ascending the clear and descending the turbid. If the spleen is weak, it cannot "ascend the clear and descend the turbid". One ascending and one descending, one tonifying and one purging are the "balance axes" throughout the treatment of uremia.

[0029] The present invention discloses a traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method. The composition is made from four categories of raw medicinal materials of monarch, minister, assistant and envoy. The monarch drugs include polygonum cuspidatum and glabrous greenbrier, which clear heat and detoxify, promote diuresis, disperse stasis and remove turbidity. The minister drugs include hemp seed, magnolia officinalis, rhubarb, trichosanthes kirilowii maxim and excrementum bombycis, which assist the monarch drugs to purge turbidity in the way of promoting defecation. The assistant drugs include astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis and polygonatum sibiricum, which replenish qi, strengthen the spleen, nourish blood, promote the rising of lucid yang, and the promotion of the rising of lucid yang promotes the lowering of turbidity. The envoy drugs include pinellia ternata and pericarpium citri reticulatae, which strengthen the stomach and regulate qi, and regulate the qi movement of the whole body. Strengthening the healthy qi in this formula focuses on strengthening the spleen, reflecting the theory in traditional Chinese medicine that "the spleen is the foundation of acquired constitution", and has good preventive and therapeutic effects on the type of spleen-kidney deficiency and internal accumulation of dampness turbidity in chronic renal failure. Moreover, the preparation method of the composition of the present invention is simple, purified and prepared by modern scientific methods, the drug content is stable among batches, and it can be made into various oral dosage forms, which is convenient to take and the patient compliance is good. Description of the Drawings

[0030] Figure 1 Comparison of the content of blood urea nitrogen (BUN) in rats;

[0031] Figure 2 Comparison of the content of urinary creatinine (Cr) in rats;

[0032] Figure 3 Comparison of the content of 24-hour urinary protein in rats. Detailed Embodiments

[0033] The technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0034] The reagents or instruments used in the embodiments of the present invention that are not marked with the manufacturer can all be conventional reagent products obtained through commercial purchase.

[0035] Example 1

[0036] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is made from the following raw medicinal materials in parts by weight: 100 parts of polygonum cuspidatum, 30 parts of glabrous greenbrier, 20 parts of hemp seed, 15 parts of magnolia officinalis, 10 parts of rhubarb, 10 parts of trichosanthes kirilowii maxim, 5 parts of excrementum bombycis, 15 parts of astragalus membranaceus, 10 parts of codonopsis pilosula, 8 parts of atractylodes macrocephala, 5 parts of pueraria lobata, 15 parts of angelica sinensis, 5 parts of polygonatum sibiricum, 10 parts of pinellia ternata and 20 parts of pericarpium citri reticulatae.

[0037] Example 2

[0038] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure, which is made from the following raw materials by weight: 100 parts of polygonum cuspidatum, 35 parts of glabrous greenbrier rhizome, 25 parts of hemp seed, 20 parts of magnolia officinalis, 15 parts of rheum officinale, 12 parts of trichosanthes kirilowii, 6 parts of excrementum bombycis, 18 parts of astragalus membranaceus, 12 parts of codonopsis pilosula, 10 parts of atractylodes macrocephala, 6 parts of kudzu root, 18 parts of angelica sinensis, 6 parts of polygonatum sibiricum, 15 parts of pinellia ternata, 25 parts of dried tangerine peel.

[0039] Example 3

[0040] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure, which is made from the following raw materials by weight: 100 parts of polygonum cuspidatum, 40 parts of glabrous greenbrier rhizome, 30 parts of hemp seed, 25 parts of magnolia officinalis, 20 parts of rheum officinale, 15 parts of trichosanthes kirilowii, 7.5 parts of excrementum bombycis, 20 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 12 parts of atractylodes macrocephala, 7.5 parts of kudzu root, 20 parts of angelica sinensis, 7.5 parts of polygonatum sibiricum, 20 parts of pinellia ternata, 30 parts of dried tangerine peel.

[0041] Example 4

[0042] It is made from the following raw materials by weight: 100 parts of polygonum cuspidatum, 45 parts of glabrous greenbrier rhizome, 35 parts of hemp seed, 30 parts of magnolia officinalis, 25 parts of rheum officinale, 18 parts of trichosanthes kirilowii, 9 parts of excrementum bombycis, 22 parts of astragalus membranaceus, 18 parts of codonopsis pilosula, 14 parts of atractylodes macrocephala, 9 parts of kudzu root, 22 parts of angelica sinensis, 9 parts of polygonatum sibiricum, 25 parts of pinellia ternata, 35 parts of dried tangerine peel.

[0043] Example 5

[0044] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure, which is made from the following raw materials by weight: 100 parts of polygonum cuspidatum, 50 parts of glabrous greenbrier rhizome, 40 parts of hemp seed, 35 parts of magnolia officinalis, 30 parts of rheum officinale, 20 parts of trichosanthes kirilowii, 10 parts of excrementum bombycis, 25 parts of astragalus membranaceus, 20 parts of codonopsis pilosula, 16 parts of atractylodes macrocephala, 10 parts of kudzu root, 25 parts of angelica sinensis, 10 parts of polygonatum sibiricum, 30 parts of pinellia ternata, 40 parts of dried tangerine peel.

[0045] Control Example 1

[0046] It does not contain polygonum cuspidatum and contains 140 parts of glabrous greenbrier rhizome

[0047] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure, which is made from the following raw materials by weight: 140 parts of glabrous greenbrier rhizome, 30 parts of hemp seed, 25 parts of magnolia officinalis, 20 parts of rheum officinale, 15 parts of trichosanthes kirilowii, 7.5 parts of excrementum bombycis, 20 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 12 parts of atractylodes macrocephala, 7.5 parts of kudzu root, 20 parts of angelica sinensis, 7.5 parts of polygonatum sibiricum, 20 parts of pinellia ternata, 30 parts of dried tangerine peel.

[0048] Control Example 2

[0049] It does not contain glabrous greenbrier rhizome and contains 140 parts of polygonum cuspidatum

[0050] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is made from the following raw materials by weight: 140 parts of polygonum cuspidatum, 30 parts of cannabis seed, 25 parts of magnolia officinalis, 20 parts of rheum officinale, 15 parts of trichosanthes kirilowii, 7.5 parts of excrementum bombycis, 20 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 12 parts of atractylodes macrocephala, 7.5 parts of pueraria lobata, 20 parts of angelica sinensis, 7.5 parts of polygonatum sibiricum, 20 parts of pinellia ternata, 30 parts of pericarpium citri reticulatae.

[0051] Comparative Example 3

[0052] Does not contain smilax glabra and polygonum cuspidatum

[0053] A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure is made from the following raw materials by weight: 30 parts of cannabis seed, 25 parts of magnolia officinalis, 20 parts of rheum officinale, 15 parts of trichosanthes kirilowii, 7.5 parts of excrementum bombycis, 20 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 12 parts of atractylodes macrocephala, 7.5 parts of pueraria lobata, 20 parts of angelica sinensis, 7.5 parts of polygonatum sibiricum, 20 parts of pinellia ternata, 30 parts of pericarpium citri reticulatae.

[0054] Preparation Example

[0055] The traditional Chinese medicine compositions of Examples 1-5 and Comparative Examples 1-3 were prepared into traditional Chinese medicine preparations according to the following method.

[0056] A preparation method of a traditional Chinese medicine tablet with the efficacy of preventing and treating chronic renal failure includes the following steps:

[0057] S1 Concentrate preparation: Prepare the traditional Chinese medicine decoction pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rheum officinale, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and pericarpium citri reticulatae according to the weight parts, pour them into a reflux extraction tank, add 15 times the mass of water of the medicinal materials for impregnation, start heating after all the medicinal materials are fully wetted, keep boiling for 1-3 hours when heated to complete boiling, filter, add 15 times the amount of 90% ethanol to the filter residue,

[0058] Continue heating, keep boiling for 1-3 hours after complete boiling, filter, combine the filtrates, and concentrate to obtain a concentrate, and the density of the concentrate is 1.05 g / mL;

[0059] S2 Extract powder preparation: Add excipients to the concentrate, and the mass ratio of the excipients to the concentrate is 1:4. After mixing evenly, dry to obtain an extract powder; the drying process parameters are: the drying temperature is 150 °C and the drying time is 60 min; the excipients are selected from pregelatinized starch;

[0060] S3 Tabletting: Tablettize the extract powder obtained in step S2 to prepare a traditional Chinese medicine tablet with the efficacy of preventing and treating chronic renal failure, and the mass of each tablet is 500 mg.

[0061] Test Example 1

[0062] Perform toxicological experiments on the traditional Chinese medicine tablets prepared in Examples 1-5 according to the preparation examples

[0063] In the acute toxicity test, there was no toxic reaction in NIH mice at 80 times the human dose (the human dose is 2 g / d); in the subacute toxicity test, juvenile rats were gavaged at 20 g / kg and 40 g / kg for 3 months, which did not affect growth and development, had no significant effect on biochemical indexes, and no abnormalities were found in the internal organ system.

[0064] The test shows that the traditional Chinese medicine tablets prepared by the present invention for preventing and treating chronic renal failure have high safety.

[0065] Test Example 2

[0066] In order to understand the therapeutic effect of the traditional Chinese medicine composition of the present invention, an animal experiment was conducted on 220 rats with a traditional Chinese medicine composition for treating chronic renal failure. The experimental method is as follows:

[0067] 1. Experimental materials:

[0068] Experimental animals: 220 male Wistar rats, weighing 200 ± 10 g.

[0069] Experimental drugs: Traditional Chinese medicine tablets of Examples 1-5 and Comparative Examples 1-3.

[0070] Positive control drug: Niaoduqing Granules (Guangzhou Kangchen Pharmaceutical Co., Ltd.).

[0071] Adenine was provided by Sinopharm Chemical Reagent Co., Ltd. Adenine feed: Adenine was added to ordinary feed and thoroughly mixed to make solid feed.

[0072] 2. Grouping and modeling: The 220 rats were randomly divided into a normal group of 20 rats and a modeling group of 200 rats. The rats in the modeling group were given the above adenine feed, and adenine was given at 300 mg / kg according to body weight. The normal group was given ordinary feed. After modeling for 15 days, two days before the end of the experiment, the rats were placed in a metabolic cage, fasted but not water-deprived, urine was collected, and urine volume, urinary creatinine, urea nitrogen, and urinary protein were measured.

[0073] 3. Treatment

[0074] The modeling group was divided into a model group (given normal saline) of 20 rats, 20 rats each of Examples 1-5 and Comparative Examples 1-3, and a positive control group (given Niaoduqing Granules) of 20 rats. They were respectively given a traditional Chinese medicine composition for treating chronic renal failure of the present invention at low, medium, and high doses of 0.5 g / 100 g body weight by gavage once a day. The positive control group was gavaged with Niaoduqing Granules at 0.5 g / 100 g body weight of rats once a day. After continuous administration for 6 weeks, two days before the end of the experiment, the rats were placed in a metabolic cage, fasted but not water-deprived, urine was collected, and related indexes were detected. Blood was taken one hour after the last administration for biochemical index detection.

[0075] 4. Observation indexes

[0076] Tests: urine creatinine (Cr), urea nitrogen (BUN), 24h urine protein quantification (mg), all the above results are average values.

[0077] The results are shown in Table 1 and Figures 1-3 shown.

[0078] Table 1 Blood biochemical indexes

[0079] BUN (mmol / L) CR (μmol / L) 24-hour urinary protein (mg) Normal group 5.67 48.23 4.32 Example 1 8.40 71.33 7.89 Example 2 8.28 70.12 7.67 Example 3 8.13 68.23 7.21 Example 4 8.02 69.11 7.11 Example 5 8.08 67.98 7.19 Comparative Example 1 13.24 103.21 13.23 Comparative Example 2 14.11 106.19 14.29 Comparative Example 3 15.31 112.45 15.18 Positive control group 9.31 89.32 12.12 Model group 22.3 160.2 19.21

[0080] From the results in Table 1, it can be seen that the Chinese medicine composition disclosed in the present invention can produce a good synergistic effect by compounding Polygonum cuspidatum and Rhizoma Smilacis Glabrae. From the data of Examples 1-5 and the model group, it can be seen that the addition of Polygonum cuspidatum and Rhizoma Smilacis Glabrae as the main medicine can significantly reduce the urine creatinine (Cr), urea nitrogen (BUN), and 24h urine protein of the model mice, and the adverse indicators can be reduced by more than 60% compared with the model group without drug treatment; from the data of Examples 1-5 and Comparative Examples 1-3, it can be seen that Example 1-5 with the addition of Rhizoma Smilacis Glabrae and Polygonum cuspidatum can reduce the adverse indicators by more than 40% compared with Comparative Example 1-3.

[0081] Test Example 3

[0082] In order to verify the actual effect of this Chinese medicine composition, volunteers were recruited in our hospital to conduct the following clinical experiments.

[0083] Case 1

[0084] Patient Jin, male, 77 years old. Cadre Special Clinic 1. Bed 35, Area 7. Hospital number 80369246

[0085] Summary of medical condition: Admitted to hospital with "abdominal pain, diarrhea and fever for 9 days." The diagnosis upon admission: sepsis, acute renal failure. The highest creatinine level was 854umol / L. Anti-infection hemodialysis and other treatments were given. The creatinine level was lower than before. After leaving dialysis, the blood creatinine level was maintained at 294. Comprehensive internal medicine treatment was ineffective, so a consultation with the Department of Traditional Chinese Medicine was requested. Urine volume was 2200-2500ml / L, stool was formed, blood pressure was under normal control, no edema, clear mind and speech, fatigue, poor appetite, no abdominal pain, no fever. The tongue was pale red with yellow greasy fur and slippery pulse.

[0086] Syndrome differentiation: Qi and blood deficiency, dampness and heat in the lower part of the body

[0087] Treatment: replenishing qi and blood, clearing away turbidity, clearing away dampness and heat

[0088] Prescription: 100 parts of Polygonum cuspidatum, 40 parts of Smilax glabra, 30 parts of Cannabis sativa seed, 25 parts of Magnolia officinalis, 20 parts of Rheum palmatum, 15 parts of Trichosanthes kirilowii, 7.5 parts of Bombyx mori excrement, 20 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 7.5 parts of Pueraria lobata, 20 parts of Angelica sinensis, 7.5 parts of Polygonatum sibiricum, 20 parts of Pinellia ternata, 30 parts of Citrus reticulata Blanco.

[0089] Prepared into 0.5g tablets according to the method of the preparation example, 4 tablets per day.

[0090] After 2 months of treatment, the serum creatinine decreased from 294 μmol / L to 128 μmol / L (normal value 57 - 111 μmol / L). The patient's hemoglobin increased to normal, and the mind was peaceful.

[0091] Case 2

[0092] Name: Chen XX Male: 74 years old Medical record number: 2013227899

[0093] Chief complaint: Repeated elevation of serum creatinine for 5 years.

[0094] Medical history: The patient has various chronic diseases, including hypertension, prostatitis, post - lung cancer surgery, post - cardiac stent surgery, coronary heart disease, hyperuricemia, chronic heart failure, asthma, kidney stones, and chronic nephritis. In the past 5 years, serum creatinine has repeatedly increased, accompanied by proteinuria, hematuria, and edema. The highest creatinine value can reach 235 - 175 μmol / l (57 - 111), Tongue and pulse: The tongue is pale red, the coating is thin, and the pulse is slippery.

[0095] Syndrome differentiation: Deficiency of qi and blood, internal accumulation of damp - turbidity

[0096] Treatment: Tonifying qi and strengthening the spleen, clearing and promoting damp - heat, purging the stomach and removing turbidity

[0097] Prescription: 100 parts of Polygonum cuspidatum, 40 parts of Smilax glabra, 30 parts of Cannabis sativa seed, 25 parts of Magnolia officinalis, 20 parts of Rheum palmatum, 15 parts of Trichosanthes kirilowii, 7.5 parts of Bombyx mori excrement, 20 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 7.5 parts of Pueraria lobata, 20 parts of Angelica sinensis, 7.5 parts of Polygonatum sibiricum, 20 parts of Pinellia ternata, 30 parts of Citrus reticulata Blanco.

[0098] Prepared into 0.5g tablets according to the method of the preparation example, 4 tablets per day.

[0099] After continuous traditional Chinese medicine treatment, the serum creatinine has been maintained at 72 - 84 μmol / l (normal value 57 - 111 μmol / L) for nearly 2 months, and the treatment effect is good.

[0100] As can be seen from the above embodiments, the present invention discloses a traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure and its preparation method. The composition is made from four types of raw materials of monarch, minister, assistant, and courier drugs. The monarch drugs include polygonum cuspidatum and smilax glabra, which clear heat and detoxify, promote diuresis, disperse stasis, and remove turbidity. The minister drugs include cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii, and excrementum bombycis, which assist the monarch drugs to remove turbidity by purging the fu-organs. The assistant drugs include astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, and polygonatum sibiricum, which replenish qi, strengthen the spleen, nourish blood, and promote the ascending of lucid yang, and the promotion of the ascending of lucid yang facilitates the descending of turbidity. The courier drugs include pinellia ternata and pericarpium citri reticulatae, which strengthen the stomach, regulate qi, and smooth the qi movement of the whole body. This formula focuses on strengthening the spleen for strengthening the healthy qi, embodying the theory in traditional Chinese medicine that "the spleen is the foundation of acquired constitution", and has good preventive and therapeutic effects on the type of chronic renal failure with deficiency of the spleen and kidney and internal accumulation of dampness and turbidity. Moreover, the preparation method of the composition of the present invention is simple, purified and prepared by modern scientific methods, the drug content is stable among batches, and it can be made into various oral dosage forms, which are convenient to take and have good patient compliance.

[0101] The above are several preferred embodiments of the present invention, which are described in a relatively specific and detailed manner, but should not be construed as limiting the scope of the patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure, It is characterized in that which is made from the following raw materials in parts by weight: 100 parts of polygonum cuspidatum, 30 - 50 parts of smilax glabra, 20 - 40 parts of cannabis seed, 15 - 35 parts of magnolia officinalis, 10 - 30 parts of rheum palmatum, 10 - 20 parts of trichosanthes kirilowii, 5 - 10 parts of excrementum bombycis, 15 - 25 parts of astragalus membranaceus, 10 - 20 parts of codonopsis pilosula, 8 - 16 parts of atractylodes macrocephala, 5 - 10 parts of pueraria lobata, 15 - 25 parts of angelica sinensis, 5 - 10 parts of polygonatum sibiricum, 10 - 30 parts of pinellia ternata, 20 - 40 parts of pericarpium citri reticulatae.

2. The traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure according to claim 1, characterized in that, which is made from the following raw materials in parts by weight: 100 parts of polygonum cuspidatum, 35 - 45 parts of smilax glabra, 25 - 35 parts of cannabis seed, 20 - 30 parts of magnolia officinalis, 15 - 25 parts of rheum palmatum, 12 - 18 parts of trichosanthes kirilowii, 6 - 9 parts of excrementum bombycis, 18 - 22 parts of astragalus membranaceus, 12 - 18 parts of codonopsis pilosula, 10 - 14 parts of atractylodes macrocephala, 6 - 9 parts of pueraria lobata, 18 - 22 parts of angelica sinensis, 6 - 9 parts of polygonatum sibiricum, 15 - 25 parts of pinellia ternata, 25 - 35 parts of pericarpium citri reticulatae.

3. The preparation method of the traditional Chinese medicine composition with the efficacy of preventing and treating chronic renal failure according to any one of claims 1-2, characterized in that, Prepare the traditional Chinese medicine decoction pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and pericarpium citri reticulatae according to parts by weight, pour them into a reflux extraction tank, add 10 - 20 times the mass of water to soak the medicinal materials. After all the medicinal materials are fully moistened, start heating. When it reaches a full boil, keep boiling for 1 - 3 hours, filter. Then add 10 - 20 times the amount of 85% - 95% ethanol to the filter residue, continue heating. After it reaches a full boil, keep boiling for 1 - 3 hours, filter, combine the filtrates, concentrate to obtain a concentrated solution, and the density of the concentrated solution is 0.9 - 1.1 g / mL.

4. A traditional Chinese medicine preparation with the efficacy of preventing and treating chronic renal failure, characterized in that, Take the traditional Chinese medicine composition according to any one of claims 1 - 2 and pharmaceutically acceptable excipients to prepare an oral preparation.

5. A traditional Chinese medicine preparation with the efficacy of preventing and treating chronic renal failure according to claim 4, characterized in that, The oral preparation includes granules, tablets, and capsules.

6. A method for preparing a traditional Chinese medicine granule using the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: S1 Preparation of concentrated solution: Prepare the traditional Chinese medicine decoction pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rheum palmatum, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and pericarpium citri reticulatae according to parts by weight, pour them into a reflux extraction tank, add 10 - 20 times the mass of water to soak the medicinal materials. After all the medicinal materials are fully moistened, start heating. When it reaches a full boil, keep boiling for 1 - 3 hours, filter. Then add 10 - 20 times the amount of 85% - 95% ethanol to the filter residue, continue heating. After it reaches a full boil, keep boiling for 1 - 3 hours, filter, combine the filtrates, concentrate to obtain a concentrated solution, and the density of the concentrated solution is 0.9 - 1.1 g / mL; S2 Preparation of extract powder: Add excipients to the concentrated solution, and the mass ratio of the excipients to the concentrated solution is 1:3 - 5. After mixing evenly, dry to obtain extract powder; the drying process parameters are: the drying temperature is 100 - 200 °C, and the drying time is 30 - 90 min; the excipients are selected from one or more of dextrin, lactose, pregelatinized starch, or microcrystalline cellulose; S3 Preparation of granules: The extract powder is granulated by dry granulation to obtain traditional Chinese medicine granules. The dry granulation process parameters include: the granulation pressure is 3 - 4 MPa, the feeding speed is 200 - 400 g / min, the mesh number of the upper sieve is 14 - 18 meshes, and the mesh number of the lower sieve is 35 - 45 meshes.

7. A method for preparing a traditional Chinese medicine tablet using the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: Preparation of S1 concentrated solution: Prepare Chinese herbal pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rhubarb, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and citrus reticulata blanco according to parts by weight, pour them into a reflux extraction tank, add 10-20 times the mass of water of the medicinal materials for impregnation. After all the medicinal materials are fully moistened, start heating. When it is heated to full boiling, keep boiling and extract for 1-3 hours, filter. Then add 10-20 times the amount of 85%-95% ethanol to the filter residue, continue heating. After it is fully boiled, keep boiling and extract for 1-3 hours, filter, combine the filtrates, and concentrate to obtain a concentrated solution, and the density of the concentrated solution is 0.9-1.1 g / mL; Preparation of S2 extract powder: Add excipients to the concentrated solution, and the mass ratio of the excipients to the concentrated solution is 1:3-5. After mixing evenly, carry out drying to obtain extract powder; Drying process parameters: The drying temperature is 100-200 °C, and the drying time is 30-90 min; The excipients are selected from one or more of dextrin, lactose, pregelatinized starch or microcrystalline cellulose; S3 Tabletting: Tablettize the extract powder obtained in step S2 to prepare a Chinese medicinal tablet with the efficacy of preventing and treating chronic renal failure, and the mass of each tablet is 500-1000 mg.

8. A method for preparing a traditional Chinese medicine capsule using the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: Preparation of S1 concentrated solution: Prepare Chinese herbal pieces of polygonum cuspidatum, smilax glabra, cannabis seed, magnolia officinalis, rhubarb, trichosanthes kirilowii, excrementum bombycis, astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, pueraria lobata, angelica sinensis, polygonatum sibiricum, pinellia ternata, and citrus reticulata blanco according to parts by weight, pour them into a reflux extraction tank, add 10-20 times the mass of water of the medicinal materials for impregnation. After all the medicinal materials are fully moistened, start heating. When it is heated to full boiling, keep boiling and extract for 1-3 hours, filter. Then add 10-20 times the amount of 85%-95% ethanol to the filter residue, continue heating. After it is fully boiled, keep boiling and extract for 1-3 hours, filter, combine the filtrates, and concentrate to obtain a concentrated solution, and the density of the concentrated solution is 0.9-1.1 g / mL; Preparation of S2 extract powder: Add excipients to the concentrated solution, and the mass ratio of the excipients to the concentrated solution is 1:3-5. After mixing evenly, carry out drying to obtain extract powder; Drying process parameters: The drying temperature is 100-200 °C, and the drying time is 30-90 min; The excipients are selected from one or more of dextrin, lactose, pregelatinized starch or microcrystalline cellulose; S3 Preparation of granules: The extract powder is granulated by dry granulation to obtain Chinese medicinal granules. The dry granulation process parameters include: The granulation pressure is 3-4 MPa, the feeding speed is 200-400 g / min, the mesh number of the upper sieve is 14-18 meshes, and the mesh number of the lower sieve is 35-45 meshes, S4 Capsule preparation: Load the granules prepared in step S3 into capsules to prepare capsule agents, and each capsule contains 200-700 mg of granules.

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