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

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic renal failure as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating chronic renal failure is prepared from the following raw materials: rheum officinale, polygonum cuspidatum, leonurus, astragalus membranaceus, dandelion, poria cocos, plantain herb, herba lycopi, white mulberry root-bark, radix paeoniae alba and eclipta. The traditional Chinese medicine composition adjusts traditional Chinese medicine components, follows the compatibility principle of monarch, minister, assistant and guide and the structure theory, reasonably organizes medicines, enhances the curative effect, reduces toxic and side effects, comprehensively takes care of the illness state, improves the treatment effect of the traditional Chinese medicine composition on chronic renal failure, adjusts the abnormal levels of serum urea nitrogen and serum creatinine, and improves calcium and phosphorus metabolism disorder.

Description

Technical Field

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

[0002] Chronic renal failure (CKD) refers to a clinical syndrome characterized by the progressive development of various chronic kidney diseases (CKD), leading to irreversible damage to kidney structure and function, a decrease in glomerular filtration rate, and the resulting retention of metabolites, disturbances in water, electrolytes, and acid-base balance, with systemic impact. It is the terminal stage of CKD.

[0003] Traditional Chinese medicine (TCM) is widely used in the treatment of chronic renal failure (CRF), particularly in the early and middle stages, often as an adjunct to basic Western medical treatment (such as controlling blood pressure, blood sugar, proteinuria, and dietary management). Its goal is to slow the progression of renal function, improve clinical symptoms, and enhance quality of life. In the end-stage (G5) stage, TCM is primarily used as an adjunct to dialysis or transplantation, alleviating symptoms that cannot be fully alleviated by dialysis (such as itching, fatigue, and loss of appetite).

[0004] Patent 200410026488.1 provides a drug for treating chronic renal failure. The drug is composed of rhubarb and astragalus as the main ingredients, along with other ingredients such as mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria cocos, prepared shouwu root, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, pinellia ternata, plantain, bupleurum, and liquorice. The weight ratios of these ingredients are 3-30:9-30:6-12:4.5-9:9-30:6-12:9-15:6-12:6-15:9-15:3-9:5-9:3-9:9-30:3-9:1.5-9. This drug, based on Traditional Chinese Medicine theory and using a dialectical approach to treatment, has achieved excellent therapeutic effects. However, the prescription contains 16 ingredients, making it relatively large and complex. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating chronic renal failure, which can clear the bowels and reduce turbidity, strengthen the spleen and eliminate dampness, and promote blood circulation and remove blood stasis, and is mainly used for chronic renal failure.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] A traditional Chinese medicine composition for treating chronic renal failure comprises the following raw materials: rhubarb, giant knotweed, motherwort, astragalus, dandelion, tuckahoe, plantain, zedoaria, mulberry bark, white peony root, and eclipta prostrata.

[0008] Preferably, the mass ratio of rhubarb, knotweed, motherwort, astragalus, dandelion, poria, plantain, zedoaria, mulberry bark, white peony root, and eclipta prostrata is 260-390: 260-390: 430-650: 430-650: 350-520: 430-650: 430-650: 350-520: 350-520: 350-520: 350-520.

[0009] Preferably, the mass ratio of rhubarb, giant knotweed, motherwort, astragalus, dandelion, poria, plantain, zedoary herb, mulberry bark, white peony root, and Eclipta prostrata is 326:326:543:543:435:543:543:435:435:435:435:435.

[0010] In the Chinese medicine composition prepared by the present invention:

[0011] Rhubarb is the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., or Rheum officinale Baill., all from the Polygonaceae family. It is harvested in late autumn when the stems and leaves wither or in the following spring before budding, the rootlets are removed, the outer bark scraped off, and the petals or segments are cut and strung into strings for drying or dried directly. It has the effects of purging, clearing away heat and purging fire, cooling the blood and detoxifying, removing blood stasis and promoting menstruation, and promoting dampness and jaundice. It is used for constipation caused by excess heat, vomiting and bleeding due to blood heat, red eyes and swollen throat, carbuncles and furuncles, abdominal pain due to intestinal carbuncle, amenorrhea due to blood stasis, postpartum blood stasis, traumatic injuries, damp-heat dysentery, jaundice and dark urine, stranguria, and edema.

[0012] Polygonum cuspidatum (Polygonum cuspidatum Sieb. et Zucc.) is a plant of the Polygonaceae family. It is harvested in spring and autumn, the fibrous roots removed, washed, cut into short segments or thick slices while fresh, and sun-dried. It has the effects of promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and relieving cough and resolving phlegm. It is used for damp-heat jaundice, stranguria, leucorrhea, rheumatic pain, carbuncles, burns caused by water or fire, amenorrhea, abdominal masses, traumatic injuries, and coughs caused by lung heat.

[0013] Motherwort is the fresh or dried aerial part of Leonurus japonicus Houtt., a plant of the Lamiaceae family. Fresh products are harvested from the seedling stage in spring to the early flowering stage in early summer; dried products are harvested in summer when the stems and leaves are lush and the flowers have not yet opened or are just beginning to open, and then sun-dried or cut into sections and sun-dried. It has the effects of promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, and clearing away heat and detoxifying. It is used to treat irregular menstruation, dysmenorrhea, amenorrhea, lochia retention, edema, oliguria, and sores and swelling.

[0014] Astragalus is the dried root of the leguminous plant Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. It is harvested in spring and autumn, the fibrous roots and root heads are removed, and then sun-dried. It has the effects of tonifying Qi and raising Yang, strengthening the exterior and stopping sweating, promoting diuresis and relieving swelling, promoting the production of body fluids and nourishing blood, promoting the flow of qi and relieving numbness, expelling toxins and draining pus, and healing sores and promoting tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of Qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous perspiration due to deficiency of the exterior, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness in the arthralgia, and carbuncles that are difficult to heal or that do not heal for a long time.

[0015] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealis inense Kitam., or several species of the same genus, all from the Asteraceae family. It is harvested from spring to autumn when the flowers first bloom, removed of impurities, washed, and sun-dried. It has the effects of clearing heat and detoxifying, reducing swelling and dispersing stagnation, and promoting diuresis and relieving stranguria. It is used for carbuncle swelling, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful stranguria caused by heat.

[0016] Poria cocos, the dried sclerotia of the Polyporaceae fungus Poria cocos (Schw.) Wolf, is usually harvested between July and September. After being cleaned of mud and sand, it is piled up to "sweate" and then spread out to air dry. This process is repeated several times until wrinkles appear and most of the internal moisture has been lost. The resulting pieces are then dried in the shade, known as "Poria cocos pieces." Alternatively, fresh Poria cocos can be cut into different parts and dried in the shade, becoming known as "Poria cocos blocks" and "Poria cocos slices." It has the benefits of promoting diuresis, dispelling dampness, strengthening the spleen, and calming the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0017] Plantain, the dried whole herb of Plantago asiatica L. or Plantago depressa Willd., members of the Plantaginaceae family, is harvested in summer, desilted, and sun-dried. It has the properties of clearing heat, promoting diuresis, relieving stranguria, removing phlegm, cooling the blood, and detoxifying. It is used for treating painful stranguria caused by heat, edema, oliguria, diarrhea due to summer heat, cough caused by phlegm and heat, hematemesis, epistaxis, and carbuncles and sores.

[0018] Zedoaria is the dried aerial part of the hairy-leaved sweet potato seedling (Lycopus lucidus Turcz. var. hirtus Regel), a plant of the Lamiaceae family. It is harvested in summer and autumn when the stems and leaves are lush and sun-dried. It has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncles, and promoting diuresis and reducing swelling. It is used for menstrual disorders, amenorrhea, dysmenorrhea, abdominal pain caused by blood stasis after childbirth, sores, carbuncles, swelling, and edema.

[0019] Morus alba bark is the dried root bark of the mulberry plant (Morus alba L.), a member of the Moraceae family. The roots are harvested between late autumn leaf fall and spring budding. The rough, yellow-brown bark is scraped off, the root is split lengthwise, and the root bark is peeled and sun-dried. It has the effects of purging the lungs and relieving asthma, promoting diuresis, and reducing swelling. It is used for treating lung heat, asthma, cough, edema, oliguria, and puffiness of the face and skin.

[0020] White peony root is the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family. It is harvested in summer and autumn, washed, and the head, tail, and rootlets removed. It is boiled in boiling water and then the outer skin removed or peeled and then boiled again, then sun-dried. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, and headaches and dizziness.

[0021] Eclipta prostrata L. is the dried aerial part of the Asteraceae plant. Harvested when the flowers bloom and sun-dried, it nourishes the liver and kidneys, cools the blood, and stops bleeding. It is used to treat liver and kidney yin deficiency, loose teeth, premature graying of hair, dizziness, tinnitus, soreness of the waist and knees, and yin deficiency and blood heat leading to hematemesis, epistaxis, hematuria, bloody diarrhea, metrorrhagia, and bleeding from trauma.

[0022] Among them, rhubarb is a purgative, clearing the bowels and reducing turbidity, promoting blood circulation and removing blood stasis, and serves as the main ingredient. Polygonum cuspidatum dissipates dampness, detoxifies, and disperses blood stasis, while Leonurus promotes blood circulation and removes blood stasis, promoting diuresis and reducing swelling, both of which assist the main ingredient and serve as the auxiliary ingredients. Astragalus membranaceus replenishes the middle qi and promotes urination and reduces swelling, while dandelion clears heat, detoxifies, promotes diuresis and reduces swelling, while Poria cocos and Plantago asiatica strengthen the spleen, promotes diuresis and eliminates dampness and reduces swelling, while Zedoaria promotes blood circulation, removes blood stasis, promotes diuresis and reduces swelling, while Morus alba purges the lungs, relieves asthma, promotes diuresis and reduces swelling, while White Peony Root and Eclipta prostrata nourish blood, soften the liver, and tonify the liver and kidneys, serving as auxiliary ingredients to the main ingredient and auxiliary ingredients. Together, these herbs achieve the functions of clearing the bowels and reducing turbidity, strengthening the spleen and removing dampness, and promoting blood circulation and removing blood stasis.

[0023] Another object of the present invention is to provide a method for preparing a Chinese medicine composition for treating chronic renal failure, comprising the following steps:

[0024] (1) Mixing the Chinese medicinal materials according to the mass ratio;

[0025] (2) adding water to the Chinese medicinal raw materials for a first decoction, filtering the decoction, then adding water to the medicinal residue for a second decoction, and filtering the decoction;

[0026] (3) Combine the two decoctions to obtain a Chinese herbal decoction.

[0027] Preferably, the amount of water added in the first decoction is 8-13 times the weight of the Chinese medicinal raw material, and the decoction time is 0.5-1 hour.

[0028] Preferably, the amount of water added in the second decoction is 5-8 times the weight of the Chinese medicinal raw material, and the decoction time is 0.3-0.5 hour.

[0029] Preferably, the Chinese herbal decoction can be made into an ointment by being concentrated under reduced pressure.

[0030] Preferably, the Chinese herbal decoction can be prepared into granules through reduced pressure concentration and spray drying.

[0031] More preferably, the preparation process of the granules is: concentrating the Chinese herbal medicine decoction under reduced pressure to a clear paste with a relative density of 1.06 to 1.09 at 60° C., spray drying, adding 1-5% of the total weight of the raw materials with dextrin, mixing, and preparing granules.

[0032] The third object of the present invention is to provide an application of the traditional Chinese medicine composition for treating chronic renal failure, wherein the traditional Chinese medicine composition is used in medicine for treating chronic renal failure.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] The present invention provides a traditional Chinese medicine composition for treating chronic renal failure, and its preparation method and application. The present invention adjusts the traditional Chinese medicine ingredients, follows the compatibility principle and structural theory of monarch, minister, assistant and envoy, rationally organizes the drugs, enhances the efficacy, reduces toxic and side effects, and comprehensively takes care of the condition, thereby improving the therapeutic effect of the traditional Chinese medicine composition on chronic renal failure, regulating abnormal levels of serum urea nitrogen (BUN) and blood creatinine (Scr), and improving calcium (Ca 2+ ), phosphorus (P 3- )Metabolic disorders. DETAILED DESCRIPTION

[0035] The present invention will be further described below with reference to the embodiments.

[0036] Example 1

[0037] A traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials in parts by weight:

[0038] 326 parts of Rheum officinale, 326 parts of Polygonum cuspidatum, 543 parts of Leonurus japonicus, 543 parts of Radix Astragali, 435 parts of Herba Taraxaci, 543 parts of Poria, 543 parts of Herba Plantaine, 435 parts of Herba Eupatorii, 435 parts of Cortex Mori, 435 parts of Radix Paeoniae Alba, 435 parts of Eclipta prostrata.

[0039] The extraction step screening experiment was carried out according to the recipe of Example 1:

[0040] Experiment 1: Weigh 207.18g of the raw materials in proportion, add 8 times the weight of the raw materials to the water and boil for 0.5 hours. Filter the decoction, then add 5 times the weight of the raw materials to the water and boil for 0.5 hours. Filter the decoction, combine the two decoction filtrates, record the volume, and measure the solids. Calculate the paste yield: paste yield % = solids (g / mL) × filtrate volume (mL) / raw material weight (g) × 100%. At the same time, according to the test method under the determination of rhubarb and motherwort content in the 2020 edition of the Chinese Pharmacopoeia, the content of chrysophanol, emodin, and stachydrine hydrochloride in the solids were respectively tested.

[0041] Experiment 2: Weigh a total of 207.42 g of raw materials in proportion, add 8 times the weight of the raw materials in water and boil for 1 hour. Filter the decoction, then add 5 times the weight of the raw materials in water and boil for 0.5 hours. Filter the decoction, combine the two decoction filtrates, record the volume, and determine the solid content. Calculate the paste yield: paste yield % = solids (g / mL) × filtrate volume (mL) / raw material weight (g) × 100%. At the same time, according to the test method under the determination of rhubarb and motherwort content in the 2020 edition of the Chinese Pharmacopoeia, the content of chrysophanol, emodin, and stachydrine hydrochloride in the solids were respectively tested.

[0042] Experiment 3: Weigh a total of 207.22g of raw materials in proportion, add 11 times the weight of the raw materials to water and boil for 0.5 hours, filter the decoction, then add 8 times the weight of the raw materials to water and boil for 0.5 hours, filter the decoction, combine the two decoction filtrates, record the volume, and measure the solids. Calculate the paste yield, paste yield % = solids (g / mL) × filtrate volume (mL) / raw material weight (g) × 100%. At the same time, according to the test method under the determination of rhubarb and motherwort content in the 2020 edition of the Chinese Pharmacopoeia, the content of chrysophanol and emodin, and stachydrine hydrochloride in the solids were respectively tested.

[0043] Experiment 4: Weigh 207.26 g of the raw materials proportionally, add 13 times the weight of the raw materials in water, and boil for 1 hour. Filter the decoction, record the volume, and determine the solids. Calculate the paste yield: paste yield (%) = solids (g / mL) × filtrate volume (mL) / raw material weight (g) × 100%. Simultaneously, test the solids for chrysophanol, emodin, and stachydrine hydrochloride, respectively, according to the method for determining rhubarb and motherwort content in Part 1 of the 2020 Chinese Pharmacopoeia.

[0044] The experimental results are shown in Table 1.

[0045] Table 1

[0046]

[0047] Note: Comprehensive score = cream yield rate ÷ maximum cream yield rate among the four groups of experiments × 40% + chrysophanol and emodin content ÷ maximum chrysophanol and emodin content among the four groups of experiments × 30% + stachydrine hydrochloride content ÷ maximum stachydrine hydrochloride content among the four groups of experiments × 30%

[0048] The process of experimental group 2 with the highest comprehensive score is the best.

[0049] The raw materials of the Chinese medicine composition of Example 1 were extracted according to the extraction process of Experiment 2 to prepare granules. The specific preparation method was as follows: all the raw materials were mixed in proportion, 8 times the weight of water of the raw materials were added and decocted for 1 hour, the decoction was filtered, and then 5 times the weight of water of the raw materials were added and decocted for 0.5 hours, the decoction was filtered, the filtrates of the two decoctions were combined, and the filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.06 (60°C), spray-dried, 5% dextrin of the total weight of the raw materials was added, mixed, and granulated by dry method to obtain the product.

[0050] Example 2

[0051] A traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials in parts by weight:

[0052] 260 parts of Rheum officinale, 390 parts of Polygonum cuspidatum, 430 parts of Leonurus japonicus, 650 parts of Radix Astragali, 350 parts of Herba Taraxaci, 650 parts of Poria, 430 parts of Herba Plantaine, 520 parts of Herba Eupatorii, 350 parts of Cortex Mori, 520 parts of the Radix Paeoniae Alba, 350 parts of Eclipta prostrata.

[0053] The Chinese medicine composition was prepared into granules according to the method of Example 1.

[0054] Example 3

[0055] A traditional Chinese medicine composition for treating chronic renal failure, comprising the following raw materials in parts by weight:

[0056] 390 parts of Rheum officinale, 260 parts of Polygonum cuspidatum, 650 parts of Leonurus japonicus, 430 parts of Radix Astragali, 520 parts of Herba Taraxaci, 430 parts of Poria, 650 parts of Herba Plantaine, 350 parts of Herba Eupatorii, 520 parts of Cortex Mori, 350 parts of the Radix Paeoniae Alba, 520 parts of Eclipta prostrata.

[0057] The Chinese medicine composition was prepared into granules according to the method of Example 1.

[0058] Comparative Example 1

[0059] A traditional Chinese medicine composition for treating chronic renal failure, which differs from Example 1 in that the dosage of Polygonum cuspidatum and White Peony Root is reduced in Comparative Example 1, and the dosage of Leonurus japonicus and Eclipta prostrata is increased. The traditional Chinese medicine composition in Comparative Example 1 is composed of the following raw materials in parts by weight:

[0060] 326 parts of Rheum officinale, 250 parts of Polygonum cuspidatum, 700 parts of Leonurus japonicus, 543 parts of Radix Astragali, 435 parts of Herba Taraxaci, 543 parts of Poria, 543 parts of Herba Plantaine, 435 parts of Herba Eupatorii, 435 parts of Cortex Mori, 300 parts of Radix Paeoniae Alba, 550 parts of Eclipta prostrata.

[0061] The Chinese medicine composition was prepared into granules according to the method of Example 1.

[0062] Comparative Example 2

[0063] A traditional Chinese medicine composition for treating chronic renal failure, which differs from Example 1 in that, in Comparative Example 2, Atractylodes macrocephala is used instead of Polygonum cuspidatum, and Salvia miltiorrhiza is used instead of Leonurus japonicus. The traditional Chinese medicine composition in Comparative Example 2 is composed of the following raw materials in parts by weight:

[0064] 326 parts of Rhubarb, 326 parts of Atractylodes macrocephala, 543 parts of Salvia miltiorrhiza, 543 parts of Astragalus, 435 parts of Taraxacum, 543 parts of Poria, 543 parts of Plantago, 435 parts of Zedoaria, 435 parts of Morus alba bark, 435 parts of White Peony Root, 435 parts of Eclipta prostrata.

[0065] The Chinese medicine composition was prepared into granules according to the method of Example 1.

[0066] Comparative Example 3

[0067] A traditional Chinese medicine composition for treating chronic renal failure, which differs from Example 1 in that, in Comparative Example 3, Sophora flavescens replaces Taraxacum mongolicum and Polygonum multiflorum processed replaces Eclipta prostrata. The traditional Chinese medicine composition in Comparative Example 3 is composed of the following raw materials in parts by weight:

[0068] 326 parts of Rheum officinale, 326 parts of Polygonum cuspidatum, 543 parts of Leonurus japonicus, 543 parts of Radix Astragali, 435 parts of Sophora flavescens, 543 parts of Poria, 543 parts of Herba Plantaginis, 435 parts of Herba Eupatorii, 435 parts of Cortex Mori, 435 parts of Radix Paeoniae Alba, 435 parts of Radix Polygoni Multiflori Processed.

[0069] The Chinese medicine composition was prepared into granules according to the method of Example 1.

[0070] Comparative Example 4

[0071] The granules of the Chinese medicine composition were prepared according to the raw material composition of Example 1 of Patent 200410026488.1;

[0072] The raw materials are as follows: 40 parts of rhubarb, 36 parts of liquorice, 160 parts of astragalus, 120 parts of mulberry bark, 80 parts of sophora flavescens, 120 parts of codonopsis pilosula, 200 parts of atractylodes, 200 parts of poria, 120 parts of white peony root, 100 parts of chrysanthemum, 200 parts of processed radix polygoni multiflori, 120 parts of ligusticum chuanxiong, 200 parts of salvia miltiorrhiza, 80 parts of pinellia ternata, 200 parts of plantain, and 60 parts of bupleurum. Granules are prepared according to the preparation method of Example 1 of the present invention.

[0073] Test Example 1

[0074] Animal experiments were conducted using the Chinese medicine granules prepared in Examples 1-3 and Comparative Examples 1-4. The experimental method was as follows:

[0075] Healthy SD rats weighing 180 ± 20 g were selected and fed with rat maintenance feed (provided by Beijing Keao Xieli Feed Co., Ltd., product number: 1016706714625204224) for 1 week (during the feeding period, the food intake was sufficient and there was no limit on the amount of food available). Then, they were randomly divided into 9 groups, namely, a normal control group, a model group, Example 1-3 groups, and Comparative Example 1-4 groups, with 8 rats in each group.

[0076] After one week of adaptive feeding, the normal control group continued to be fed a rat maintenance diet. The remaining groups of rats were fed a high-phosphorus and high-adenine diet (provided by Jiangsu Collaborative Pharmaceutical Bioengineering Co., Ltd., catalog number XTM03-003). During this period, the rats were fed an adequate diet and had unlimited access to food. This was continued for four consecutive weeks to establish a rat model of chronic renal failure.

[0077] The Example group and the Comparative Example group were gavaged with the granules prepared in the corresponding Examples and Comparative Examples, respectively, at a dose of 2.5 g / kg and a volume of 10 mL / kg. The Normal Control Group and the Model Group were gavaged with the same volume of normal saline. The administration was continued for 4 weeks.

[0078] After the last administration, the rats were anesthetized with 10% chloral hydrate intraperitoneally, and blood was collected through the abdominal aorta. The blood was kept at room temperature for 2 hours and centrifuged at 3500 r / min for 5 minutes. The supernatant was collected and the renal function indicators serum urea nitrogen (BUN) and serum creatinine (Scr), as well as calcium (Ca) were measured by an automatic biochemical analyzer. 2+ ), phosphorus (P 3- ) indicators. The results are shown in Table 2.

[0079] Table 2

[0080]

[0081] Note: Compared with the normal control group, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01; compared with the Example 1 group, △ P<0.05, △△ P<0.01.

[0082] As can be seen from Table 2, the serum urea nitrogen and blood creatinine levels of the rats in the model group were significantly higher than those in the normal control group, with statistically significant differences (P < 0.01), indicating that the rats' renal function was impaired and the rat renal failure model was successfully established. The serum urea nitrogen, blood creatinine, and phosphorus levels of each administration group were significantly lower than those in the model group (P < 0.01), and the calcium level was significantly increased (P < 0.05, P < 0.01). The Example 1 group was significantly different from the comparative example groups (P < 0.05, P < 0.01).

[0083] This indicates that the composition of the present invention can improve the renal function of rats with chronic renal failure, delay the progression of the disease, and alleviate calcium and phosphorus metabolism disorders.

[0084] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating chronic renal failure, characterized in that: The invention comprises the following raw materials: rhubarb, knotweed, motherwort, astragalus, dandelion, poria, plantain, zedoaria, mulberry bark, white peony root, and eclipta prostrata.

2. The Chinese medicine composition for treating chronic renal failure according to claim 1, characterized in that The mass ratios of the rhubarb, polygonum cuspidatum, motherwort, astragalus, dandelion, poria, plantain, zedoaria, mulberry bark, white peony root and eclipta prostrata are 260-390: 260-390: 430-650: 430-650: 350-520: 430-650: 430-650: 350-520: 350-520: 350-520: 350-520.

3. The Chinese medicine composition for treating chronic renal failure according to claim 1 or 2, characterized in that: The mass ratio of the rhubarb, giant knotweed, motherwort, astragalus, dandelion, poria, plantain, zedoaria, mulberry bark, white peony root and Eclipta prostrata is 326:326:543:543:435:543:543:435:435:435:435:

435.

4. The method for preparing the Chinese medicine composition for treating chronic renal failure according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Mixing the Chinese medicinal materials according to the mass ratio; (2) adding water to the Chinese medicinal raw materials for a first decoction, filtering the decoction, then adding water to the medicinal residue for a second decoction, and filtering the decoction; (3) Combine the two decoctions to obtain a Chinese herbal decoction.

5. The method for preparing the Chinese medicine composition for treating chronic renal failure according to claim 4, characterized in that: The amount of water added in the first decoction is 8-13 times the weight of the Chinese medicinal raw material, and the decoction time is 0.5-1 hour.

6. The method for preparing the Chinese medicine composition for treating chronic renal failure according to claim 4, characterized in that: The amount of water added in the second decoction is 5-8 times the weight of the Chinese medicinal raw material, and the decoction time is 0.3-0.5 hours.

7. The method for preparing the Chinese medicine composition for treating chronic renal failure according to claim 4, characterized in that: The Chinese medicinal decoction can be prepared into an ointment through reduced pressure concentration.

8. The method for preparing the Chinese medicine composition for treating chronic renal failure according to claim 4, characterized in that: The Chinese medicinal decoction can be prepared into granules through reduced pressure concentration and spray drying.

9. The method for preparing the Chinese medicine composition for treating chronic renal failure according to claim 8, characterized in that: The preparation process of the granules is as follows: the Chinese medicine decoction is concentrated under reduced pressure to a clear paste with a relative density of 1.06-1.09 at 60° C., spray-dried, and 1-5% of the total weight of the raw materials is added with dextrin, mixed, and made into granules.

10. Use of the traditional Chinese medicine composition for treating chronic renal failure according to any one of claims 1 to 3, characterized in that: The traditional Chinese medicine composition is used in medicine for treating chronic renal failure.

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