A Chinese medicine composition for treating acute kidney injury and its preparation method and use

Abstract

The present invention belongs to the field of traditional Chinese medicine, and in particular to a Chinese medicine composition for treating acute kidney injury, and its preparation method and use. The Chinese medicine composition is made of the following raw materials: 500-1500 weight portions of Astragalus, 1500-2500 weight portions of Polygonum cuspidatum, 500-1500 weight portions of Angelica sinensis, 300-1000 weight portions of Albizzia rapa, 100-500 weight portions of Ganoderma lucidum, 1500-2500 weight portions of Salvia miltiorrhiza, 1500-2500 weight portions of Leech, 1500-2500 weight portions of Carthamus tinctorius. Through zoological experiments, it can be determined that the Chinese medicine composition of the present invention helps to reduce 24h serum TNF-α, IL-1β, IL-6, BUN, Cr concentrations after cecal ligation and puncture. In addition, the preparation method of the Chinese medicine composition of the present invention is simple, with low cost, but the curative effect of treating acute kidney injury is definite, so it has broad market application prospects, economic benefits and social significance.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating acute kidney injury, and a preparation method and use thereof. Background Art

[0002] Acute kidney injury (AKI) is the sudden loss of kidney function, which refers to the rapid decline of kidney function caused by various pathogenic factors, including acute renal failure (ARF). AKI can be divided into three major categories: prerenal, renal and postrenal. When AKI has developed into ARF, it must be treated in time (including dialysis treatment), otherwise it can be life-threatening. A few AKI may be converted into chronic kidney disease after relief. It involves various causes and pathological physiological processes, with high incidence and mortality, and can cause multi-organ dysfunction in the body. Its pathogenesis is mainly related to inflammatory response, which is one of the main causes of AKI. Although renal replacement therapy is used clinically, the mortality rate of patients with AKI is extremely high.

[0003] The etiology and pathogenesis of acute kidney injury in traditional Chinese medicine are "urinary retention" and "shut-up", which are mostly related to accidental injuries, blood and fluid loss, poisoning and insect bites, drug poisoning and kidney damage, improper diet and other factors, forming heat, dampness, turbidity and stasis, blocking the triple energizer, and causing dysfunction of the bladder and triple energizer. The disease is located in the kidney, involving the lungs, spleen (stomach), triple energizer, and bladder. The pathogenesis is mainly due to the kidney's failure to transform qi, and water, dampness, turbidity and stasis cannot be discharged from the body. In the early stage, it is mainly due to heat, dampness, turbidity and stasis blocking the triple energizer, and the water channel is not good, mostly due to real heat, and in the later stage, it is mainly due to internal organ deficiency. According to the principle of "the six internal organs are used for communication", the treatment of acute kidney injury in traditional Chinese medicine should focus on communication, that is, facilitating urination. The existing acute kidney injury syndrome differentiation and treatment methods mainly include: 1. Treatment method: clearing heat and detoxifying, for symptoms: oliguria or urinary retention, urinary pain and burning, thirst, high fever and delirium, mania, retching, low back pain, red tongue, yellow and scorched fur or thorns, and rapid pulse. 2. Treatment method: clearing heat and dampness, promoting urination, from "Taiping Huimin Hejijufang", for symptoms: urination is not smooth, or the amount is small and short, red and burning, the lower abdomen is bloated, the mouth is bitter and sticky, or thirsty and does not want to drink, or the bowel movement is not smooth, the root of the fur is yellow and greasy, the tongue is red, and the pulse is rapid. 3. Treatment method: blood circulation and dispersing stagnation, from "Yi Zong Jin Jian". For symptoms: short and astringent urination, hematuria and urinary pain, epistaxis, hemoptysis, blood in the stool, skin purpura, fever at night, restlessness and madness, dark red tongue, astringent or fine pulse. 4. Treatment: replenishing qi and consolidating deficiency, consolidating yin and promoting fluid production, from "Treatise on Warm Diseases". Targeted symptoms: less urine and dripping, weak discharge, dark complexion, breathlessness, mental fatigue, sticky and cold sweat, cold limbs and fear of cold, pale tongue with white fur, and weak pulse. 5. Treatment: replenishing qi and strengthening spleen, ascending clear and descending turbidity, transforming qi and promoting urination, from "Zhengzhi Zhunsheng". Symptoms: sometimes wanting to urinate but not being able to, or a small amount but not smooth, shortness of breath, low voice, lower abdominal distension, mental fatigue, loss of appetite, pale tongue, and weak pulse. 6. Treatment: warming and tonifying kidney yang, transforming qi and promoting urination, from "Zhang's Medical Tong", kidney yang is weak. Symptoms: urination is not smooth or dripping, weak discharge, pale complexion, timid spirit, fear of cold, cold waist and knees and soreness and weakness, pale tongue, thin white fur, deep and weak pulse. However, the above existing treatments cannot safely and effectively reduce the inflammatory response.

[0004] Therefore, there is an urgent need to develop a Chinese medicine formula that is safe and effective in reducing inflammatory responses to treat acute kidney injury in order to improve and prevent mortality from kidney injury. Summary of the invention

[0005] In order to solve the problem that the current Chinese medicine prescriptions for treating acute kidney injury are insufficient or the anti-inflammatory efficacy is poor, the present invention provides a Chinese medicine composition for treating acute kidney injury, and a preparation method and use thereof.

[0006] Specifically, the present invention is realized through the following technical solutions:

[0007] In a first aspect, the present invention provides a Chinese medicine composition for treating acute kidney injury.

[0008] The raw material composition and proportion of the Chinese medicine composition of the present invention are as follows:

[0009] 500-1500 parts by weight of Astragalus, 1500-2500 parts by weight of Polygonum cuspidatum, 500-1500 parts by weight of Angelica sinensis, 300-1000 parts by weight of Albizzia julibrissin, 100-500 parts by weight of Ganoderma lucidum, 1500-2500 parts by weight of Salvia miltiorrhiza, 1500-2500 parts by weight of Leech, 1500-2500 parts by weight of Safflower.

[0010] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials: 600-1100 parts by weight of Astragalus, 1600-2300 parts by weight of Polygonum cuspidatum, 600-1100 parts by weight of Angelica sinensis, 400-800 parts by weight of Albizzia julibrissin, 200-400 parts by weight of Ganoderma lucidum, 1600-2300 parts by weight of Salvia miltiorrhiza, 1600-2300 parts by weight of Leech, and 1600-2300 parts by weight of Carthamus tinctorius.

[0011] As an optional manner, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made of the following raw materials: 1000 parts by weight of Astragalus, 2000 parts by weight of Polygonum cuspidatum, 1000 parts by weight of Angelica sinensis, 500 parts by weight of Albizzia julibrissin, 300 parts by weight of Ganoderma lucidum, 2000 parts by weight of Salvia miltiorrhiza, 2000 parts by weight of Leech, and 2000 parts by weight of Carthamus tinctorius.

[0012] In the second aspect, the present invention provides a Chinese medicine preparation of the Chinese medicine composition described in the first aspect, wherein pharmaceutically acceptable excipients are added to the Chinese medicine composition described in the first aspect and various clinically suitable preparations are prepared according to conventional methods.

[0013] As an optional mode, in the above-mentioned preparation, the dosage form of the drug includes powder, granules, tablets, oral liquid or capsule.

[0014] In a third aspect, the present invention provides a method for preparing the Chinese medicine composition described in the first aspect, the preparation method comprising the following steps:

[0015] (1) washing, removing impurities and crushing the raw materials according to the weight proportions of the first aspect;

[0016] (2) Extracting Polygonum cuspidatum and Angelica sinensis with 5-10 times the amount of 60-80% ethanol under reflux for 2-4 times, each time for 1.5-3.5 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at a temperature of 50-70° C. into a thick paste;

[0017] (3) Take safflower and add water to boil 1-3 times, each time for 1.5-3.5 hours; combine the decoctions and filter; filter out the supernatant, and concentrate it at a temperature of 50-70° C. to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; and concentrate it at a temperature of 50-70° C. to form a thick paste;

[0018] (4) extracting Danshen with 5-10 times the amount of 80-90% ethanol for 2-4 times, each time for 1.5-3.5 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at a temperature of 50-70° C. into a thick paste;

[0019] (5) Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo are decocted in water for 1-3 times, each time for 1.5-3.5 hours; the decoctions are combined and filtered; the supernatant is filtered and concentrated at a temperature of 50-70° C. into a thick paste;

[0020] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0021] In a fourth aspect, the present invention provides use of the Chinese medicine composition described in the first aspect or the Chinese medicine preparation described in the second aspect in the preparation of a drug for treating acute kidney injury.

[0022] The pharmacological properties of each raw material in the Chinese medicine composition of the present invention are as follows:

[0023] Astragalus: Nature and flavor: sweet, slightly warm. Meridians: lung, spleen, liver, kidney. Modern medical research shows that Astragalus can enhance the body's immune function, protect the liver, promote diuresis, resist aging, resist stress, and reduce blood pressure. It can eliminate experimental nephritis proteinuria.

[0024] Polygonum cuspidatum: Nature and flavor: slightly bitter, slightly cold. Meridians: liver, gallbladder, lung meridians. It has the effects of promoting blood circulation, dispersing blood stasis, promoting menstruation, and relieving cough. Functions and indications: dispelling wind and dampness, dispersing blood stasis and relieving pain, relieving cough and reducing phlegm. It is used for joint pain, damp-heat jaundice, amenorrhea, abdominal masses, burns caused by water or fire, injuries caused by falls, carbuncles, sores, and cough with phlegm.

[0025] Angelica sinensis: Nature and flavor: sweet, warm, non-toxic. Indications: cough, reverse breathing, warming the middle and relieving pain, treating all wind, all blood, replenishing all fatigue, breaking bad blood, nourishing new blood, treating headaches, heart and stomach pains, moistening the intestines, stomach, muscles, bones and skin, treating carbuncle, draining pus and relieving pain, harmonizing blood and replenishing blood. Its root can be used as medicine and is one of the most commonly used Chinese medicines. It has the effects of nourishing blood, regulating menstruation and relieving pain, moisturizing and lubricating the intestines, anti-cancer, anti-aging and immunity.

[0026] Albizzia rapa: Nature and flavor: sweet; slightly bitter; neutral; Functions and indications: nourishing the heart and calming the mind; regulating blood and relieving pain. Treats palpitations, insomnia, forgetfulness, dreaminess, toothache, tendon and bone pain, numbness of waist and legs, and pain from falls.

[0027] Lingzhi: Nature and flavor: warm, light, properties: special smell, slightly bitter. Functions and indications: restlessness, insomnia, palpitations, cough, asthma, sputum, asthenia, cold hands and feet.

[0028] Danshen: Nature and flavor: bitter, slightly cold, non-toxic. Indications: nourishing blood, removing chronic diseases of the heart and abdomen, strengthening the waist and spine, removing wind evil and heat, nourishing the mind and calming the mind, stopping bleeding, regulating uneven menstruation in women, irritability caused by blood evil, malignant sores, scabies, goiters, swellings, toxic erysipelas, discharging pus and relieving pain, growing flesh. Activating blood circulation, unblocking the pericardium, treating hernia pain.

[0029] Leech: Other name: leech; horse turtle, nature and flavor: salty, bitter, flat, poisonous, "Bielu" says: slightly cold. Afraid of forging stone, salt. Indications: expel evil blood stasis, blood stasis, amenorrhea, break up blood accumulation, infertility, and promote urination ("Benjing").

[0030] Safflower: Other names: red and blue flower, thorny safflower, nature and flavor: pungent, warm. Meridians: enter the heart and liver meridians. The flowers of safflower are used as medicine to regulate menstruation and promote blood circulation. Functions and indications: promote blood circulation and regulate menstruation, remove blood stasis and relieve pain. Treat amenorrhea, abdominal masses, dystocia, stillbirth, postpartum lochia, blood stasis and pain, carbuncle, and injuries from falls.

[0031] The invention follows the principle of "monarch, minister, assistant and messenger" in traditional Chinese medicine, using astragalus, salvia miltiorrhiza and polygonum cuspidatum as monarch drugs; using safflower, angelica and ganoderma lucidum as minister drugs; using radix albizziae and leech as assistant and messenger drugs. All the drugs are combined to have the effect of dredging collaterals, and have a definite effect on the treatment of acute kidney injury without toxic side effects.

[0032] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here.

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

[0034] The composition of the present invention has a good effect in treating acute kidney injury. The results of the main pharmacodynamic experiments fully support the good effect of treating acute kidney injury, have no side effects, and can also regulate the patient's body state as a whole and improve other comprehensive indicators. Therefore, it has a good therapeutic effect, relatively low cost and great social benefits. DETAILED DESCRIPTION

[0035] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0036] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0037] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0038] Example 1: Oral Liquid

[0039] Astragalus 1000g Polygonum cuspidatum 2000g Angelica 1000g Albizzia rapa 500g Ganoderma lucidum 300g Salvia miltiorrhiza 2000g Leech 2000g Safflower 2000g

[0040] (1) washing, removing impurities and crushing the raw materials according to the above weight proportions;

[0041] (2) Extract Polygonum cuspidatum and Angelica sinensis with 8 times the amount of 75% ethanol for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste;

[0042] (3) Take safflower and add 8 times the amount of water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at a temperature of 60°C to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at a temperature of 60°C to form a thick paste;

[0043] (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste;

[0044] (5) Add 8 times the amount of water to Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo to boil twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste;

[0045] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0046] Add appropriate amount of flavor correctives to the above Chinese medicine composition to prepare 1000mL oral solution. Take orally 3 times a day, 1 bottle each time.

[0047] Example 2: Tablets

[0048] Astragalus 800g Polygonum cuspidatum 1800g Angelica 800g Albizzia rapa 800g Ganoderma lucidum 400g Salvia miltiorrhiza 1800g Leech 1800g Safflower 1800g

[0049] (1) washing, removing impurities and crushing the raw materials according to the above weight proportions;

[0050] (2) Extract Polygonum cuspidatum and Angelica sinensis with 8 times the amount of 75% ethanol for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste;

[0051] (3) Take safflower and add 8 times the amount of water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at a temperature of 60°C to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at a temperature of 60°C to form a thick paste;

[0052] (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste;

[0053] (5) Add 8 times the amount of water to Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo to boil twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste;

[0054] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0055] Add appropriate amount of filler and disintegrant to the above Chinese medicine composition, mix well and compress into tablets to make 1000 tablets. Take orally 3 times a day, 2 tablets each time.

[0056] Example 3: Granules

[0057] Astragalus 1200g Polygonum cuspidatum 2400g Angelica 1400g Albizzia 600g Ganoderma lucidum 200g Salvia miltiorrhiza 1600g Leech 1600g Safflower 1600g

[0058] (1) washing, removing impurities and crushing the raw materials according to the above weight proportions;

[0059] (2) Extract Polygonum cuspidatum and Angelica sinensis with 8 times the amount of 75% ethanol for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste;

[0060] (3) Take safflower and add 8 times the amount of water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at a temperature of 60°C to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at a temperature of 60°C to form a thick paste;

[0061] (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste;

[0062] (5) Add 8 times the amount of water to Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo to boil twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste;

[0063] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0064] The above Chinese medicine composition was spray-dried, added with an appropriate amount of dextrin and mixed to form 1000 g of granules. The granules were taken orally 3 times a day, 1 bag each time.

[0065] Comparative Example 1:

[0066] Astragalus 1000g Angelica 1000g Albizzia 500g Ganoderma lucidum 300g Salvia miltiorrhiza 2000g Leech 2000g Safflower 2000g

[0067] (1) washing, removing impurities and crushing the raw materials according to the above weight proportions;

[0068] (2) Extract the angelica sinensis with 8 times the amount of 75% ethanol under reflux for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste;

[0069] (3) Take safflower and add 8 times the amount of water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at a temperature of 60°C to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at a temperature of 60°C to form a thick paste;

[0070] (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste;

[0071] (5) Add 8 times the amount of water to Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo to boil twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste;

[0072] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0073] Add appropriate amount of flavor correctives to the above Chinese medicine composition to prepare 1000mL oral solution. Take orally 3 times a day, 1 bottle each time.

[0074] Comparative Example 2:

[0075] Astragalus 1000g Polygonum cuspidatum 1000g Angelica 1000g Albizzia rapa 1000g Ganoderma lucidum 1000g Salvia miltiorrhiza 1000g Leech 1000g Safflower 1000g

[0076] (1) washing, removing impurities and crushing the raw materials according to the above weight proportions;

[0077] (2) Extract Polygonum cuspidatum and Angelica sinensis with 8 times the amount of 75% ethanol for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste;

[0078] (3) Take safflower and add 8 times the amount of water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at a temperature of 60°C to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at a temperature of 60°C to form a thick paste;

[0079] (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste;

[0080] (5) Add 8 times the amount of water to Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo to boil twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste;

[0081] (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain the Chinese medicine composition.

[0082] Add appropriate amount of flavor correctives to the above Chinese medicine composition to prepare 1000mL oral solution. Take orally 3 times a day, 1 bottle each time.

[0083] Effect embodiment:

[0084] 1. Materials and Methods

[0085] 1. Animals and reagents: 48 male specific pathogen-free (SPF) SD rats, 6 weeks old, weighing 180±20g, were purchased from the Experimental Animal Center of Heilongjiang University of Chinese Medicine. All animals were housed and raised in accordance with the "Heilongjiang University of Chinese Medicine Laboratory Animal Management Measures (Trial)", and animal experiments were carried out in accordance with the "Heilongjiang University of Chinese Medicine Animal Experiment Ethics Review Guide (Trial)".

[0086] 2. Establishment and grouping of animal model: The sepsis model was established by cecal ligation and puncture, and the animals were randomly divided into 6 groups, with 8 animals in each group: Group A was a sham operation control group, Group B was a cecal ligation and puncture + normal saline group, Group C was a cecal ligation and puncture + vehicle group, Group D was a cecal ligation and puncture + Example 1 of the present invention, Group E was a cecal ligation and puncture + Comparative Example 1 of the present invention, and Group F was a cecal ligation and puncture + Comparative Example 2 of the present invention.

[0087] 3. Administration method: Group A was a sham operation control group: the cecum was not ligated or perforated after cecal ligation and puncture, and no treatment was performed; the BCDEF group was intravenously injected with 1 mL of normal saline, 1 mL of solvent, 50 mg / kg of the Chinese medicine composition of Example 1, 50 mg / kg of the Chinese medicine composition of Comparative Example 1, and 50 mg / kg of the Chinese medicine composition of Comparative Example 2 after cecal ligation and puncture.

[0088] 4. Statistical analysis: The measurement data were normally distributed and expressed as mean ± standard deviation. Two-tailed Student's t-test was used to analyze the significant difference. One-way analysis of variance was used to analyze the difference between groups. SPSS13.0 statistical software was used for statistical analysis.

[0089] 2. Results

[0090] 1. Effect of the pretreatment of the present invention on renal function of model rats:

[0091] As shown in Table 1: 24 hours after cecal ligation and puncture, the serum TNF-α, IL-1β and IL-6 concentrations of rats increased, indicating that the body had a strong inflammatory response during sepsis AKI; after treatment with the Chinese medicine composition of Example 1, the serum IL-1β and IL-6 concentrations were significantly reduced, indicating that the Chinese medicine composition of the present application has an anti-inflammatory effect, and the effect of Example 1 is better than that of Comparative Examples 1 and 2.

[0092] Table 1 Comparison of serum TNF-α, IL-1β, and IL-6 concentrations in six groups of rats 24 hours after cecal ligation and puncture

[0093]

[0094] Note: Compared with group A, a P<0.01, compared with group B b P<0.01, compared with group C C P<0.01.

[0095] As shown in Table 2: 24 hours after cecal ligation and puncture, rats developed renal damage, which was manifested by a significant increase in serum creatinine (Cr) and serum urea nitrogen (BUN). After treatment with the Chinese medicine composition of Example 1, the occurrence of renal damage caused by modeling was effectively prevented, as manifested by a significant decrease in Cr and BUN compared with groups C, D, E, and F (p<0.01), which had a significant renal protective effect.

[0096] Table 2 Comparison of serum BUN and Cr concentrations in six groups of rats 24 hours after cecal ligation and puncture

[0097]

[0098] Note: Compared with group A, a P<0.01, compared with group B b P<0.01, compared with group C C P<0.01.

[0099] In summary, the experimental results show that the Chinese medicine composition of the present invention helps to reduce the serum TNF-α, IL-1β, IL-6, BUN, and Cr concentrations 24 hours after cecal ligation and puncture, and treats acute kidney injury. The preparation method of the Chinese medicine composition of the present invention is simple, low-cost, and has a definite therapeutic effect on acute kidney injury. Therefore, it has broad market application prospects, economic benefits and social significance.

[0100] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating acute kidney injury, characterized in that: The Chinese medicine composition is made from the following raw materials: 500-1500 parts by weight of Astragalus, 1500-2500 parts by weight of Polygonum cuspidatum, 500-1500 parts by weight of Angelica sinensis, 300-1000 parts by weight of Albizzia julibrissin, 100-500 parts by weight of Ganoderma lucidum, 1500-2500 parts by weight of Salvia miltiorrhiza, 1500-2500 parts by weight of Leech, 1500-2500 parts by weight of Safflower.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is made from the following raw materials: 600-1100 parts by weight of Astragalus, 1600-2300 parts by weight of Polygonum cuspidatum, 600-1100 parts by weight of Angelica sinensis, 400-800 parts by weight of Albizzia julibrissin, 200-400 parts by weight of Ganoderma lucidum, 1600-2300 parts by weight of Salvia miltiorrhiza, 1600-2300 parts by weight of Leech, 1600-2300 parts by weight of Safflower.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is made from the following raw materials: 1000 parts by weight of Astragalus, 2000 parts by weight of Polygonum cuspidatum, 1000 parts by weight of Angelica sinensis, 500 parts by weight of Albizzia julibrissin, 300 parts by weight of Ganoderma lucidum, 2000 parts by weight of Salvia miltiorrhiza, 2000 parts by weight of Leech, and 2000 parts by weight of Safflower.

4. A Chinese medicine preparation for treating acute kidney injury, characterized in that: Pharmaceutically acceptable excipients are added to the Chinese medicine composition according to any one of claims 1 to 3, and various clinically suitable preparations are prepared according to conventional methods.

5. The Chinese medicine preparation according to claim 4, characterized in that: The preparation includes powder, granule, tablet, oral solution or capsule.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) washing, removing impurities and crushing the bulk drug according to any one of claims 1 to 3; (2) Extracting Polygonum cuspidatum and Angelica sinensis with 5-10 times the amount of 60-80% ethanol under reflux for 2-4 times, each time for 1.5-3.5 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at a temperature of 50-70° C. into a thick paste; (3) Take safflower and add water to boil 1-3 times, each time for 1.5-3.5 hours; combine the decoctions and filter; filter out the supernatant, and concentrate it at a temperature of 50-70° C. to form a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; and concentrate it at a temperature of 50-70° C. to form a thick paste; (4) extracting Danshen with 5-10 times the amount of 80-90% ethanol for 2-4 times, each time for 1.5-3.5 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at a temperature of 50-70° C. into a thick paste; (5) Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo are decocted in water for 1-3 times, each time for 1.5-3.5 hours; the decoctions are combined and filtered; the supernatant is filtered and concentrated at a temperature of 50-70° C. into a thick paste; (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain a product.

7. The method for preparing the Chinese medicine composition according to claim 6, characterized in that: The following steps are involved: (1) washing, removing impurities and crushing the bulk drug according to claim 3; (2) Extract Polygonum cuspidatum and Angelica sinensis with 8 times the amount of 75% ethanol for 3 times, each time for 2 hours; combine the ethanol extracts and filter; filter out the supernatant; and concentrate at a temperature of 65°C into a thick paste; (3) Take safflower and add water to boil twice, each time for 2 hours; combine the decoctions and filter; filter out the supernatant and concentrate it at 60°C to a thick paste; add ethanol to an alcohol content of 70%; stir and let stand overnight; filter out the supernatant; concentrate it at 60°C to a thick paste; (4) extracting Danshen with 8 times the amount of 85% ethanol for 3 times, each time for 2 hours; combining the ethanol extracts, filtering; filtering the supernatant; and concentrating at 60° C. into a thick paste; (5) Take Astragalus, Albizzia julibrissin, Ganoderma lucidum, and Hirudo and boil them in water twice, each time for 2 hours; combine the decoctions and filter; filter the supernatant and concentrate it at 60°C into a thick paste; (6) The thick pastes obtained in the above steps (2) to (5) are mixed, blended, dried, and crushed to obtain a product.

8. The method for preparing the Chinese medicine composition according to claim 6 or 7, characterized in that: The method also includes adding pharmaceutically acceptable excipients to the obtained traditional Chinese medicine composition and preparing various clinically suitable preparations according to conventional methods.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating acute kidney injury.

10. Use of the Chinese medicine preparation according to any one of claims 4 to 5 in preparing a medicament for treating acute kidney injury.

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