A traditional Chinese medicine composition for treating hyperlipidemia and application thereof

Through the rational combination of Chinese medicines, the problems of large side effects of Western medicine and complexity of Chinese medicine are solved, and the effect of treating hyperlipidemia and floaters at the same time is achieved, with significant lipid-lowering and vision-improving effects.

CN118320039BActive Publication Date: 2025-10-17GUANGDONG PHARMA UNIV
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Patent Information

Application Number
CN202410209551.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2023-12-22
Filing Date
2024-02-26
Publication Date
2025-10-17
Estimated Expiration
2044-02-26

AI Technical Summary

Technical Problem

The existing Chinese and Western medicines have serious side effects, the Chinese medicine formula is complicated and cannot effectively treat hyperlipidemia and floaters at the same time.

Method used

An oral preparation is prepared by using a Chinese herbal composition of Panax notoginseng, Broom Threadleaf, Herba Lycopodii, Inula veinosa, Moringa oleifera leaves, White Cardamom, Cassia seed, Ramie root, Schefflera palmatum, and Rhizoma Cistanches, with reasonable compatibility, and adding resistant dextrin, black fungus, blueberry, Polygonatum sibiricum, mulberry and mint.

Benefits of technology

It significantly reduces total cholesterol and triglycerides, increases high-density lipoprotein levels, inhibits the activity of cholesterol esterase and lipase, improves floaters, and has the effects of strengthening the spleen and resolving phlegm, promoting blood circulation and removing blood stasis, clearing turbidity and lowering lipids, and clearing the head, with no toxic side effects.

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Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hyperlipidemia and application thereof. The traditional Chinese medicine composition provided by the present application comprises Pingshuqiu Sanqi, Xianye Jinquehua, Bai Mao Yinluomei, Xiannai Xuanfuhua, Laximu Ye, Baicaomu, Juemingzi, Zama Gen, Ezhangteng, Laogekuaopiao, resistance dextrin, black fungus, blueberry, Huangjing, Sangshen and Bohe. The traditional Chinese medicine composition for treating hyperlipidemia provided by the present application can reduce total cholesterol and triglyceride, reduce low-density lipoprotein, increase high-density lipoprotein level, and significantly inhibit cholesteryl esterase, lipase activity and inflammatory factors, and improve clinical symptoms of flying insect.
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Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hyperlipidemia and application thereof. BACKGROUND

[0002] Hyperlipidemia (HLP) is also called lipid metabolism disorder or dyslipidemia, which is a systemic lipid metabolism disorder caused by various reasons, and is mainly characterized by increased contents of total cholesterol (TC), triglyceride (TG) and low density lipoprotein cholesterol (LDL-C) in blood and / or decreased content of high density lipoprotein cholesterol (HDL-C).

[0003] Hyperlipidemia can aggravate obesity, and further cause intestinal flora disorder, chronic inflammation of adipose tissue and liver, atherosclerosis, diabetes, central nervous system degenerative diseases, metabolic-related fatty liver disease, osteoarthritis, cardiovascular disease and the like, and increase the risk of occurrence of some cancers. The increasing prevalence of hyperlipidemia has become a public health problem threatening human health. Therefore, how to scientifically and effectively prevent and treat hyperlipidemia has become a scientific problem urgently to be solved in the world. At present, statins, fibrates and niacin drugs are commonly used in clinical treatment of hyperlipidemia, but long-term use of the drugs is prone to cause different degrees of side effects, and most of them have the phenomenon of rebound after drug withdrawal.

[0004] Flies are generally caused by vitreous degeneration, and vitreous liquefaction is the main cause of flies. High blood lipids can easily cause vascular lesions, such as arteriosclerosis of the fundus, causing occlusion of blood vessels in the eye, and serious obstacles in blood circulation, and fly is one of the initial manifestations of the disease. Conventional treatment of flies often uses iodine-containing preparations, which can accelerate vitreous metabolism to promote the absorption of vitreous opacity lesions to play a therapeutic role, but long-term use has many adverse reactions.

[0005] Many traditional Chinese medicines including single herb, Chinese patent medicine and traditional Chinese medicine compound have good lipid-lowering effect, but the formula is complex, and most of them cannot effectively reduce high blood lipids and flying insect syndrome at the same time. For example, the patent document CN104784446A discloses a traditional Chinese medicine for treating flying insect syndrome, and the formula is 10-20 of psyllium, 10-15 of prepared rehmannia root, 10-20 of dodder seed, 10-15 of anemarrhena, 8-10 of cornus, 10-14 of cortex moutan, 5-8 of alisma, 6-8 of phellodendron, and 5-7 of alhagi, which has no toxic side effects, takes effect quickly, and has good therapeutic effect on flying insect syndrome, but cannot be used for treating hyperlipidemia. The patent document CN108478713A discloses a traditional Chinese medicine for treating hyperlipidemia, and the formula is 70-90g of salvia miltiorrhiza, 70-90g of gastrodia, 10-25g of panax notoginseng, 10-25g of panax quinquefolius, 70-90g of radix falcaliae, 60-80g of hawthorn, and 70-90g of melon pericarp, which can effectively treat hyperlipidemia, has significant curative effect, and has no toxic side effects, but cannot be used for treating flying insect syndrome.

[0006] In summary, the prior art has the technical problems of serious side effects of western medicine, complex formula of traditional Chinese medicine, and inability to treat hyperlipidemia and flying insect syndrome at the same time. SUMMARY

[0007] To solve the above technical problems, the purpose of the present application is to provide a traditional Chinese medicine composition for treating hyperlipidemia and a preparation method thereof. The traditional Chinese medicine composition provided by the present application has reasonable compatibility, no toxic side effects, and can effectively improve flying insect syndrome while treating hyperlipidemia.

[0008] In order to achieve the above purpose, the technical scheme of the present application is as follows:

[0009] A traditional Chinese medicine composition for treating hyperlipidemia, comprising the following components:

[0010] Flat lying three seven, line leaf sparrows, white hair silver dew, obvious vein floscervi, leaf of morinda, white cardamom, cassia seed, ramie root, goose foot, old swallow.

[0011] The ramie root used in the present application is rich in cellulose and various vitamins, which can promote intestinal peristalsis, help digestion and excretion, also can regulate blood lipids, reduce blood pressure and blood sugar, and has certain protective effect on cardiovascular diseases; the effective components contained in the leaf of morinda can achieve the effect of resisting hyperlipidemia through the pathways of inhibiting lipid peroxidation, inhibiting pancreatic lipase activity, inhibiting alpha-glucosidase activity, inducing brown adipose tissue generation, and improving bile acid binding capacity; the goose foot has the effects of promoting blood circulation, relieving pain, activating blood, reducing swelling, and warming and unblocking blood vessels. In the research process, the applicant found that the use of ramie root, leaf of morinda and goose foot together can effectively improve the effect of traditional Chinese medicine composition in reducing blood lipids, and has the effect of 1+1>2.

[0012] Semen Cassiae has the purposes of inhibiting staphylococcus growth, reducing blood pressure, reducing blood fat, reducing cholesterol, and has obvious effects on preventing and treating vascular sclerosis and hypertension; Cytisus scoparius contains flavonoids, quercetin, vitamins and various mineral components, but has certain irritability to gastrointestinal tract. The white nutmeg in the formula has the effects of promoting qi and stimulating appetite, and can treat stomachache and indigestion; the old swallow pip contains rich vitamin A and carotene, which can help improve eyesight, and also has the effects of clearing heat and detoxifying, promoting water and reducing swelling; the addition of the white nutmeg and the old swallow pip can minimize the irritation of Cytisus scoparius to the gastrointestinal tract. The flat lying chrysanthemum three seven is rich in plant gums such as proteins, fats, minerals and various acidic mucopolysaccharides and different amino acids, and can also activate intracellular enzymes and participate in the conduction reaction of the nervous system. The obvious pulse inula has the effects of promoting gastrointestinal peristalsis, preventing constipation and reducing blood lipids. The white hair silver rubus has the effects of antibacterial and anti-inflammatory, relieving cough and reducing phlegm, clearing heat and detoxifying.

[0013] Further, the weight parts of each component in the traditional Chinese medicine composition for treating hyperlipidemia are as follows: flat lying chrysanthemum three seven 30-35 parts, Cytisus scoparius 22-31 parts, white hair silver rubus 21-27 parts, obvious pulse inula 17-22 parts, moringa leaf 15-19 parts, white nutmeg 5-12 parts, Semen Cassiae 9-15 parts, ramie root 11-17 parts, goose palm 8-16 parts, and old swallow pip 1-5 parts.

[0014] Further, the traditional Chinese medicine composition for treating hyperlipidemia further comprises resistant dextrin, black fungus, blueberry, polygonatum, mulberry and mint.

[0015] The addition of resistant dextrin in the formula has the effects of invigorating the spleen, promoting digestion, moistening the intestines and defecation; the black fungus has the effects of activating blood and resolving stasis, nourishing yin and blood, clearing heat and moistening the intestines; the blueberry can enhance eyesight, eliminate eye fatigue, soften blood vessels and enhance human immunity; the polygonatum has the effects of tonifying qi and nourishing yin, invigorating the spleen, moistening the lungs and benefiting the kidney; the mint has the effects of dispelling wind and heat, clearing the head and eyes, and dispersing the liver and qi.

[0016] Further, the weight parts of each component in the traditional Chinese medicine composition for treating hyperlipidemia are as follows: resistant dextrin 8-15 parts, black fungus 11-23 parts, blueberry 15-28 parts, polygonatum 20-30 parts, mulberry 10-21 parts and mint 5-15 parts.

[0017] The application further provides application of the traditional Chinese medicine composition for treating hyperlipidemia or flying mosquito disease in preparation of a medicine for treating hyperlipidemia or flying mosquito disease.

[0018] The application further provides application of the traditional Chinese medicine composition for treating hyperlipidemia and flying mosquito disease in preparation of a medicine for treating hyperlipidemia and flying mosquito disease.

[0019] Further, the traditional Chinese medicine composition for treating hyperlipidemia can be prepared into oral preparations.

[0020] Further, the oral preparation is one of granules, tablets, decoctions, pills, capsules and syrup.

[0021] Further, the oral preparation further comprises one or more pharmaceutically acceptable carriers or pharmaceutical excipients.

[0022] Compared with the prior art, the traditional Chinese medicine composition for treating hyperlipidemia and the application thereof have the following technical advantages:

[0023] (1) The traditional Chinese medicine composition for treating hyperlipidemia can reduce total cholesterol and triglyceride, reduce low-density lipoprotein, increase high-density lipoprotein level, and significantly inhibit cholesterol esterase, lipase activity and inflammatory factors, and improve the clinical symptoms of flying insects.

[0024] (2) The traditional Chinese medicine composition for treating hyperlipidemia has the effects of invigorating the spleen, resolving phlegm, promoting blood circulation to remove blood stasis, removing turbidity and reducing fat, and clearing and benefiting the head, and is reasonable and scientific in compatibility.

[0025] (3) The traditional Chinese medicine composition for treating hyperlipidemia does not cause gastrointestinal irritation and has no toxic side effects. DETAILED DESCRIPTION

[0026] The following examples illustrate the present application, but the present application is not limited by these examples. Modifications to the specific embodiments of the present application or equivalent replacements to some technical features are made without departing from the spirit of the present application, and all should be covered in the technical solution range of the present application.

[0027] Example 1, a traditional Chinese medicine composition for treating hyperlipidemia

[0028] The weight parts of each component in the traditional Chinese medicine composition for treating hyperlipidemia are: Pingsheng Chrysanthemum 30 parts, Linye Spirea 22 parts, White Hair Silver Beard 27 parts, Shengmai Inula 22 parts, Moringa Leaf 15 parts, White Cardamom 5 parts, Cassia Seed 15 parts, Ramie Root 11 parts, Goose Palm 16 parts, Old Crow Pipette 5 parts, Resistant Dextrin 8 parts, Black Fungus 23 parts, Blueberry 15 parts, Yellow Milkvetch 20 parts, Mulberry 10 parts and Mint 5 parts.

[0029] Example 2, a traditional Chinese medicine composition for treating hyperlipidemia

[0030] The weight parts of each component in the traditional Chinese medicine composition for treating hyperlipidemia are: Pingshengju sanqi 33 parts, Xianye jinquehua 28 parts, Bai Mao Yinluo 25 parts, Xianmai Xuanfuchun 20 parts, Laomu leaf 17 parts, Baicaomu 9 parts, Semen Cassiae 12 parts, Ramie root 13 parts, Euphorbia 12 parts, Laogongpiao 3 parts, resistant dextrin 11 parts, black fungus 17 parts, blueberry 22 parts, Huangjing 26 parts, mulberry 17 parts and mint 11 parts.

[0031] Example 3, a traditional Chinese medicine composition for treating hyperlipidemia

[0032] The weight parts of each component in the traditional Chinese medicine composition for treating hyperlipidemia are: Pingshengju sanqi 33 parts, Xianye jinquehua 28 parts, Bai Mao Yinluo 25 parts, Xianmai Xuanfuchun 20 parts, Laomu leaf 17 parts, Baicaomu 9 parts, Semen Cassiae 12 parts, Ramie root 13 parts, Euphorbia 12 parts, Laogongpiao 3 parts, resistant dextrin 11 parts, black fungus 17 parts, blueberry 22 parts, Huangjing 26 parts, mulberry 17 parts and mint 11 parts.

[0033] Comparative Example 1,

[0034] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of Semen Cassiae is used instead of Ramie root in this comparative example.

[0035] Comparative Example 2,

[0036] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of Ramie root is used instead of Laomu leaf in this comparative example.

[0037] Comparative Example 3,

[0038] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of Laomu leaf is used instead of Euphorbia in this comparative example.

[0039] Comparative Example 4,

[0040] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of Baicaomu is used instead of Laogongpiao in this comparative example.

[0041] Comparative Example 5,

[0042] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of Laogongpiao is used instead of Baicaomu in this comparative example.

[0043] Comparative Example 6,

[0044] This comparative example is similar to Example 3, and the difference between this comparative example and Example 3 is that an equal amount of resistant dextrin is used instead of Baicaomu and Laogongpiao in this comparative example.

[0045] Test 1, pharmacodynamic test of traditional Chinese medicine composition on hyperlipidemia

[0046] (1) Lipid-regulating effect test of traditional Chinese medicine composition on hyperlipidemic mice

[0047] 1. Test materials: SPF male C57BL / 6J mice, body weight (20±2) g, provided by Guangdong Experimental Animal Center, experimental mouse license number: SCK (Yue) 2021-0057. The animals were bred in the SPF sterile animal room of the Experimental Animal Center of Guangdong Pharmaceutical University; the traditional Chinese medicine compositions provided in Examples 1-3, Comparative Examples 1-3;

[0048] 2. Preparation of traditional Chinese medicine composition: weigh the above-mentioned traditional Chinese medicine, cut it into pieces, add 8 times the amount of water, extract at 100°C for 45 minutes, filter, then add the same amount of water, extract at 90°C for 38 minutes, filter, and combine the two water decoctions and heat to concentrate to 1 g / mL for standby.

[0049] 3. Test method: 90 SPF male C57BL / 6J mice were adaptively fed for 1 week. Randomly divided into 9 groups, 10 in each group: normal control group, hyperlipidemia model group, positive drug group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. The normal control group was fed with regular diet, while the other groups were fed with high-fat diet (40% high-fat, 2% cholesterol and 0.5% sodium cholate). At the same time, the animals in each administration group were given oral administration, with a gavage volume of 0.2 mL / 10 g, once a day for 8 consecutive weeks. The normal control group and the model group of mice were given physiological saline once a day. After the last administration, the mouse serum was prepared for biochemical index detection, including blood lipid indexes (TC, TG, LDL-C and HDL-C), liver function indexes (ALT, AST), and inflammatory factor indexes (TNF-α, IL-6).

[0050] 4. Test results:

[0051] Table 1 Effect of traditional Chinese medicine composition on blood lipid levels in mouse serum (X±S, n=10)

[0052]

[0053] Compared with the normal control group, ## p<0.01; compared with the model group, *p<0.05; **p<0.01

[0054] From Table 1, compared with the normal control group, the TC, TG and LDL-C levels in the serum of the model group mice were significantly increased, and the HDL-C was significantly decreased (P<0.01), indicating that the high-fat mouse model was successfully constructed in the experiment. Compared with the model group, the TC, TG and LDL-C levels in the serum of the positive drug group and the example 1-3 groups were significantly reduced, and the HDL-C level was significantly increased (P<0.01, P<0.05), which indicated that the traditional Chinese medicine composition provided by the application had a significant effect of improving blood lipid level.

[0055] Compared with Example 3, the TC, TG and LDL-C levels in the serum of the comparative example 1-3 group mice were increased, and the HDL-C was decreased.

[0056] Table 2 Effect of traditional Chinese medicine composition on serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of mice (X±S, n=10)

[0057] Activity (X±S, n=10)

[0058]

[0059] Compared with the normal control group, ## p<0.01; compared with the model group, *p<0.05; **p<0.01

[0060] From Table 2, the AST and ALT contents in the serum of the model group mice were significantly higher than those of the normal control group (P<0.01). Compared with the model group, the AST and ALT contents in the serum of the positive drug group and the example 1-3 groups were significantly reduced (P<0.01), which indicated that the composition provided by the application could improve the abnormal liver function caused by hyperlipidemia, and had a significant liver protection effect.

[0061] Compared with Example 3, the AST and ALT contents in the serum of the comparative example 1-3 group mice were significantly increased.

[0062] Table 3 Effect of traditional Chinese medicine composition on serum inflammatory factors TNF-α and IL-6 of mice (X±S, n=10)

[0063]

[0064] Compared with the normal control group, ## p<0.01; compared with the model group, *p<0.05; **p<0.01

[0065] As shown in Table 3, the serum TNF-α and IL-6 levels of the model group mice were significantly higher than those of the normal control group mice (P < 0.01). Compared with the model group, the serum TNF-α and IL-6 levels of the positive drug group and Example 1-3 groups were significantly reduced (P < 0.01), indicating that the traditional Chinese medicine composition provided by the present invention has the effect of resisting chronic inflammation caused by a high-fat diet.

[0066] Compared with Example 3, the levels of TNF-α and IL-6 in the serum of mice in Comparative Examples 1-3 groups were significantly increased.

[0067] In summary, it can be seen from Tables 1-3 that compared with Example 3, in Comparative Examples 1-3, equal amounts of Cassia seeds were used instead of ramie roots, equal amounts of ramie roots were used instead of Moringa leaves, and equal amounts of Moringa leaves were used instead of Schefflera chinensis, but the experimental results were all worse, which shows that the combined use of ramie roots, Moringa leaves and Schefflera chinensis can effectively improve the efficacy of the traditional Chinese medicine composition in lowering blood lipids, achieving the effect of 1+1>2.

[0068] (2) Experiment on the inhibitory effect of Chinese herbal medicine combination on cholesterol esterase and pancreatic lipase activity in vitro

[0069] 1. Cholesterol esterase (Cease) activity inhibition test

[0070] An appropriate amount of cholesterol esterase was weighed using a precision balance and dissolved in phosphate buffer (pH 7.2-7.4) to prepare an enzyme solution at a concentration of 1.05 μg / mL. A 5.16 mmol sodium taurocholate solution was then added. An appropriate amount of 4-nitrophenyl butyrate (PNPB) was precisely pipetted and added to the phosphate buffer containing 5.16 mmol sodium taurocholate to prepare a 1 mmol PNPB substrate solution. To a 96-well plate, 50 μL of the enzyme solution (1.05 μg / mL), 50 μL of phosphate buffer, and 50 μL of a traditional Chinese medicine composition solution at varying concentrations (5, 10, 15, 20, 25, 30, 35, and 40 mg / mL) were added, mixed thoroughly, and incubated in an oven at 37°C for 10 minutes. 50 μL of the PNPB solution was added as a substrate, mixed thoroughly, and incubated for 5 minutes. The absorbance of the mixture was measured at 405 nm. Three replicate wells were set up for each concentration, and the measurements were repeated three times. The enzyme inhibition rate was calculated according to the formula: Inhibition rate (%) = [1-(A1-A2) / (A3-A4)] × 100%. Note: A1: absorbance of the combination and enzyme; A2: absorbance of the enzyme replaced by buffer solution; A3: absorbance of the sample replaced by buffer solution; A4: absorbance of the combination and enzyme replaced by buffer solution.

[0071] 2. Pancreatic lipase (PL) activity inhibition experiment

[0072] Take an appropriate amount of lipase with a precision balance, dissolve it with a phosphate buffer solution with a pH value of 7.2-7.4, and prepare an enzyme solution with a concentration of 0.35 ug / mL. Take an appropriate amount of 4-nitrophenyl butyrate (PNPB) with a pipette, add a phosphate buffer solution with a pH value of 7.2-7.4, and prepare a PNPB substrate solution with a concentration of 1 mmol / L. Add 50 μL of enzyme solution (0.35 ug / mL), 50 μL of phosphate buffer solution, and 50 μL of different concentrations (5, 10, 15, 20, 25, 30, 35, 40 mg / mL) of traditional Chinese medicine composition solution to a 96-well plate and mix evenly, and incubate in an oven at 37℃ for 10 min. Add 50 μL of PNPB solution as a substrate, mix evenly, incubate for 5 min, and measure the absorbance of the above mixture at 405 nm. Three replicates are set for each concentration, and the enzyme inhibition rate is calculated by measuring three times in parallel. The calculation formula of the enzyme inhibition rate is: Inhibition rate (%) = [1- (A1-A2) / (A3-A4)] x 100%; Note: A1: absorbance of sample and enzyme; A2: absorbance of enzyme replaced by buffer solution; A3: absorbance of sample replaced by buffer solution; A4: absorbance of sample and enzyme replaced by buffer solution, respectively.

[0073] The preparation method of the traditional Chinese medicine composition solution in the test example is as follows: weigh the traditional Chinese medicine formula in examples 1-3, cut it into pieces, add 8 times the amount of water, extract at 100℃ for 45 minutes, filter, add the same amount of water again, extract at 90℃ for 38 minutes, filter, and heat and concentrate the combined water decoction to 1 g / mL.

[0074] 3. Test results:

[0075] Table 4 Effect of traditional Chinese medicine composition on Cease and PL inhibition activity (IC 50 )(X±S, n=10)

[0076]

[0077] Compared with the normal control group, *p<0.05; **p<0.01

[0078] As can be seen from table 4, compared with the normal control group, the Cease and PL activity IC 50 of examples 1-3 provided by the application is significantly reduced (P<0.01, P<0.05), which shows that the traditional Chinese medicine composition provided by the application has a significant effect of inhibiting lipase activity in vitro.

[0079] Test example two, toxicity test

[0080] The pre-experiment shows that the traditional Chinese medicine composition has very low toxicity, and the LD50 cannot be measured, so the maximum tolerance test is carried out to observe the toxicity of the medicine.

[0081] 1. Test material: The traditional Chinese medicine composition formula medicines provided in Examples 1-3 and Comparative Examples 4-6 are cut into pieces, 8 times the amount of water is added, and extraction is carried out at 100 ℃ for 45 minutes, filtration is carried out, the same amount of water is added, and extraction is carried out at 90 ℃ for 38 minutes, filtration is carried out, and the two times of water decoction are combined and heated to concentrate to 1 g / mL to prepare a traditional Chinese medicine water extract.

[0082] 2. Test object: NIH mice, ordinary grade, body weight (20±2) g, provided by the Guangdong Experimental Animal Center.

[0083] 3. Test method:

[0084] 60 mice with a body weight of (20±2) g, half male and half female, are fasted (not water restricted) for 12 hours, and are evenly divided into 6 groups, 10 mice in each group. Each mouse is orally administered with the test sample according to the body weight (0.4 mL / 10 g). The administration is carried out once every 4 hours, and the administration is carried out for three times in succession. After the administration, the reaction of the mice to the medicine is observed, including appearance behavior, respiration, fur, mental state, shape of urine and stool, abnormal secretions of mouth, nose and eyes, and animal death. The animals that do not die are continuously observed for 7 days.

[0085] 4. Test result:

[0086] Table 5 Toxicity test result

[0087]

[0088] According to the calculation, the cumulative administration amount for three times is 310 g / kg, which is equivalent to 272 times of the clinical daily dosage (1.14 g crude drug / kg) of an adult (70 kg). As can be seen from Table 5, after the mice take the traditional Chinese medicine composition provided in Examples 1-3, there is no abnormal condition, which shows that the traditional Chinese medicine composition provided in the application is safe for clinical use. In Comparative Examples 4-6, the amount of Bai Douchong and Laokengpiao in the formula is changed, but the toxicity test result shows that different numbers of mice have loose stool, which shows that Bai Douchong and Laokengpiao in the formula can effectively reduce the stimulation of Linyejiquhua in the traditional Chinese medicine composition to the gastrointestinal tract.

[0089] Test Example Three, Efficacy Experiment on Flying Ants

[0090] 1. Preparation of traditional Chinese medicine composition granules: The traditional Chinese medicine composition provided in Examples 1-3 is weighed according to the weight ratio, placed in a sand pot, and decocted with water, 5 times the weight of the medicine is added, and decoction is carried out on a low fire for 2 hours, and filtration is carried out to obtain a filtrate. The two times of water decoction are combined and heated to concentrate to 1 g / mL, and then corresponding excipients are added to prepare granules. 1-2 grams are taken three times a day, and are taken with warm water.

[0091] 2. Efficacy criteria: cure: floaters disappeared; effective: floaters improved; ineffective: floaters unchanged.

[0092] 3. Treatment regimen

[0093] The control group was given amidoiodide eye drops, 3 times / day, 2 drops / time, for continuous treatment for 10 weeks. The treatment group was given the above-mentioned drug orally, 3 times / day, half an hour after meals with warm water, for continuous treatment for 10 weeks.

[0094] 120 patients with floaters were selected and randomly divided into 4 groups, namely the control group, the example 1 group, the example 2 group and the example 3 group, which were treated according to the above-mentioned treatment regimen. After the treatment, the effective rate of each group of patients was counted.

[0095] 4. Clinical observation results:

[0096] Table 6. Results of floaters efficacy experiment

[0097]

[0098] As shown in Table 6, the effective rate of the traditional Chinese medicine composition provided by the present application on floaters is greatly improved compared with the control group, and the total effective rate after 10 weeks of taking is as high as 100%.

[0099] The above description of examples is for the convenience of the ordinary skilled person in the art to understand and use the present application. Those skilled in the art can easily make various modifications to these examples, and apply the general principles described herein to other examples without creative labor. Therefore, the present application is not limited to the above examples, and the improvements and modifications made by those skilled in the art according to the disclosure of the present application without departing from the scope of the present application should be within the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating hyperlipidemia, characterized in that: The invention is composed of the following raw materials in parts by weight: 30-35 parts of Panax notoginseng procumbens, 22-31 parts of broom thread-leaf, 21-27 parts of silver clover, 17-22 parts of inula flower, 15-19 parts of moringa leaves, 5-12 parts of white cardamom, 9-15 parts of cassia seeds, 11-17 parts of ramie roots, 8-16 parts of Schefflera chinensis, 1-5 parts of larix serrata, 8-15 parts of resistant dextrin, 11-23 parts of black fungus, 15-28 parts of blueberry, 20-30 parts of polygonatum, 10-21 parts of mulberry and 5-15 parts of mint.

2. The Chinese medicine composition for treating hyperlipidemia according to claim 1, characterized in that The traditional Chinese medicine composition can be prepared into an oral preparation.

3. The Chinese medicine composition for treating hyperlipidemia according to claim 2, characterized in that The oral preparations include granules, tablets, decoctions, pills, capsules, and syrups.

4. The Chinese medicine composition for treating hyperlipidemia according to claim 3, characterized in that The oral formulation further includes one or more pharmaceutically acceptable carriers.

5. Use of the Chinese medicine composition according to claim 1 in preparing a drug for treating hyperlipidemia.

6. Use of the Chinese medicine composition according to claim 1 in preparing a medicine for treating floaters.

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