Traditional Chinese medicine extract compound dropping pill as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine extract compound dropping pill as well as a preparation method and application thereof. The traditional Chinese medicine extract compound dropping pill is prepared from the following components in parts by weight: 6 to 15 parts of panax notoginseng saponins, 2 to 6 parts of breviscapine and 4 to 8 parts of hawthorn leaf extract. The traditional Chinese medicine extract compound dropping pill solves the problems of long onset time and large dosage of medicines for treating hyperlipemia, has obvious curative effects on a mixed hyperlipemia model and an acute hyperlipemia model, and is short in onset time, low in dosage, free of any toxicity and convenient to take, store and carry.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine extract compound dripping pill and a preparation method and application thereof. Background Art

[0002] Hyperlipidemia, also known as hyperlipidemia, refers to elevated triglycerides (TG) and / or total cholesterol (TC) in plasma, and also includes elevated low-density lipoprotein cholesterol (LDL-C) and decreased high-density lipoprotein cholesterol (HDL-C). Excessively high blood lipid levels can cause coronary artery atherosclerosis, hypertension and other diseases.

[0003] At present, lipid-lowering drugs are mainly statins (atorvastatin, lovastatin and simvastatin), fibrates and niacin, among which statins are the first choice, with strong lipid-lowering effect and clear mechanism of action, but they can cause liver damage, muscle disease, skin allergies, digestive system and urinary system diseases. In recent years, more and more studies on traditional Chinese medicine for the treatment of hyperlipidemia have been conducted.

[0004] Panax notoginseng is a plant of the genus Panax in the Araliaceae family. It is sweet, slightly bitter and warm in nature. It has pharmacological effects such as reducing swelling and pain, dispersing blood stasis and stopping bleeding, lowering blood sugar, lowering blood lipids, and anti-tumor. In recent years, in addition to being used to treat coronary heart disease, anti-angina pectoris, diabetes and anti-thrombotic diseases, it has also been used to treat hyperlipidemia.

[0005] The Chinese patent with publication number CN106983786B discloses a Chinese medicine composition for preventing and / or treating hyperlipidemia and its preparation method, which includes 3-12 grams of ginseng, 15-60 grams of scutellaria, 5-20 grams of stir-fried atractylodes, 15-60 grams of stir-fried spiny jujube seeds, 15-60 grams of salvia miltiorrhiza, 6-24 grams of chuanxiong, 15-60 grams of kudzu root, 15-60 grams of hawthorn, 6-24 grams of liquorice, 5-20 grams of panax notoginseng, 2-10 grams of leech and 1-6 grams of rhubarb. The medicine provided by this technical solution can significantly reduce the level of blood lipids in DM hyperlipidemia mice, reduce the content of FBG in model mice, and improve the liver function of DM hyperlipidemia mice. However, since this technical solution contains more medicinal materials, long-term use can easily put a greater burden on the liver, so irradiation treatment is required, which is costly.

[0006] The Chinese patent with publication number CN102727680B discloses a Chinese medicine for lowering blood lipids and a preparation method, wherein the Chinese medicine is composed of a dry extract of extracts extracted by boiling or ethanol reflux extraction of Rhizoma Alismatis, Crataegus pinnatifida, Gynostemma pentaphyllum, Radix Puerariae, and Lycium barbarum and notoginseng powder. The technical scheme screens the prescription according to the principles of promoting dampness and removing turbidity, dispersing blood stasis and unblocking collaterals, which can nourish the yin blood of the liver and kidneys, and prevent the excessive disadvantages of Crataegus pinnatifida and Gynostemma pentaphyllum, providing a new Chinese medicine variety with significant efficacy for treating hyperlipidemia. However, the technical scheme has a significant blood lipid-lowering effect at 0.64g / kg after continuous administration for 10 weeks, and the onset time is long and the dosage is large.

[0007] In addition, since patients with hyperlipidemia need to take medication for a long time, when developing new Chinese medicines, it is necessary to consider whether their dosage forms are convenient for taking, storing and carrying. Summary of the invention

[0008] The present invention aims to solve the problems of long onset time and large dosage of existing drugs for treating hyperlipidemia, and provides a Chinese herbal extract compound dropping pill and a preparation method and application thereof. The Chinese herbal extract compound dropping pill provided by the present invention has significant therapeutic effects on both mixed hyperlipidemia models and acute hyperlipidemia models, and has a short onset time, low dosage, no toxicity, and is convenient to take, store and carry.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0010] The first aspect of the present invention provides a Chinese herbal medicine extract compound dripping pill, which comprises the following components by weight: 6-15 parts of notoginseng total saponins, 2-6 parts of breviscapine and 4-8 parts of hawthorn leaf extract.

[0011] Preferably, the Chinese herbal extract compound dripping pills comprise the following components by weight: 8-12 parts of notoginseng total saponins, 3-5 parts of breviscapine and 5-7 parts of hawthorn leaf extract.

[0012] Preferably, the weight ratio of the notoginseng total saponins, breviscapine and hawthorn leaf extract is 2-3:1:1-2.

[0013] Preferably, the weight ratio of the notoginseng total saponins, breviscapine and hawthorn leaf extract is 2.5:1:1.5.

[0014] Preferably, the drop pill composition further comprises a matrix; the matrix is ​​selected from one or more of polyethylene glycol, poloxamer, gelatin and Tween.

[0015] Preferably, the ratio of the matrix mass to the total mass of Panax notoginseng total saponins, breviscapine and hawthorn leaf extract is 2-4:1-3.

[0016] Preferably, the ratio of the matrix mass to the total mass of Panax notoginseng total saponins, breviscapine and hawthorn leaf extract is 3:2.

[0017] Preferably, the Chinese herbal extract compound dripping pills include the following components by weight: 10 parts of notoginseng total saponins, 4 parts of breviscapine, 6 parts of hawthorn leaf extract and 30 parts of polyethylene glycol 4000.

[0018] The second aspect of the present invention provides a method for preparing the above-mentioned Chinese herbal extract compound dripping pills, comprising the following steps: mixing according to the formula, heating to melt, and dripping into cooled liquid paraffin to obtain the Chinese herbal extract compound dripping pills.

[0019] Preferably, the preparation method is specifically as follows: take Panax notoginseng total saponins, breviscapine, and hawthorn leaf extract that comply with the 2020 edition of the "Chinese Pharmacopoeia", mix them to obtain a mixture; take polyethylene glycol 4000, heat it to melt, add it to the mixture, mix it evenly, and drip it into the cooled liquid paraffin while keeping warm to obtain the Chinese medicine extract compound dripping pills.

[0020] The third aspect of the present invention provides the use of the above-mentioned Chinese herbal extract compound dripping pills in the preparation of a drug for preventing and / or treating hyperlipidemia.

[0021] The hyperlipidemia includes one or more of hypercholesterolemia, hypertriglyceridemia, combined hyperlipidemia and low-density lipoprotein cholesterolemia.

[0022] More preferably, the hyperlipidemia is combined hyperlipidemia.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] (1) The components of the Chinese herbal extract compound dripping pills of the present invention have a synergistic effect on both mixed hyperlipidemia rats and acute hyperlipidemia mice, and have a significant lipid-lowering effect.

[0025] (2) The Chinese herbal medicine extract compound dripping pills of the present invention have lower dosage and better effect.

[0026] (3) The compound dripping pills made from the Chinese herbal extracts of the present invention have no toxicity and are convenient to take, store and carry. DETAILED DESCRIPTION

[0027] The present invention is further explained below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0028] In the following examples, unless otherwise specified, all raw materials used were commercially available or prepared by conventional methods in the art.

[0029] The raw material sources of the Chinese herbal medicine extract compound dripping pills of Examples 1-3 of the present invention and Comparative Examples 1-7 are shown in Table 1;

[0030] Table 1 Source of raw materials

[0031] source Total saponins of Panax notoginseng Jinqi Pharmaceutical Co., Ltd. Breviscapine Chuxiong Yunzhi Pharmaceutical Co., Ltd. Hawthorn Leaf Extract Shanxi Kanglisheng Pharmaceutical Co., Ltd. Polyethylene glycol 4000 Liaoning Aoke Pharmaceutical Excipients Co., Ltd. Puerarin Hainan Haishen Tongzhou Pharmaceutical Co., Ltd. Gynostemma pentaphyllum extract Hubei Haijia Biotechnology Co., Ltd. Tanshinone IIA Sulfonate Sodium Wuhan Huajiu Pharmaceutical Technology Co., Ltd. Safflower yellow Shandong Xinxiong Biotechnology Co., Ltd. Total flavonoids from hawthorn leaves Hubei Sanxin Biotechnology Co., Ltd.

[0032] The specific formula compositions of the Chinese herbal extract compound dripping pills of Examples 1-3 and Comparative Examples 1-7 are shown in Table 2, by weight:

[0033] Table 2 Formulas of Chinese herbal medicine extract compound dripping pills of Examples 1-3 and Comparative Examples 1-7

[0034]

[0035]

[0036] The Chinese herbal medicine extract compound dripping pills of Examples 1-5 and Comparative Examples 1-7, totaling 50 g, were made into 1000 pills.

[0037] The preparation method of the Chinese herbal extract compound dripping pills of Examples 1-5 and Comparative Example 6 is as follows:

[0038] Take notoginseng total saponins, breviscapine, and hawthorn leaf extract that comply with the 2020 edition of the "Chinese Pharmacopoeia", mix them to obtain a mixture; take polyethylene glycol 4000, heat it to melt, add it to the mixture, mix well, and drop it into cooled liquid paraffin at 80±10°C to obtain the Chinese medicine extract compound dripping pills.

[0039] The preparation method of the Chinese herbal extract compound dripping pills of Comparative Example 1 is different from that of Example 1 only in that breviscapine and hawthorn leaf extract are not present, and the rest are the same.

[0040] The preparation method of the Chinese herbal extract compound dripping pills of Comparative Example 2 is different from that of Example 1 only in that Panax notoginseng total saponins and hawthorn leaf extract are not present, and the rest are the same.

[0041] The preparation method of the Chinese herbal extract compound dripping pills of Comparative Example 3 is different from that of Example 1 only in that notoginseng total saponins and breviscapine are not present, and the rest are the same.

[0042] The preparation method of the Chinese herbal extract compound dripping pills of Comparative Example 4 is different from that of Example 1 only in that Breviscapine is replaced by Puerarin, and the rest is the same.

[0043] The preparation method of the Chinese herbal extract compound dripping pills of Comparative Example 5 is different from that of Example 1 only in that the hawthorn leaf extract is replaced by the Gynostemma pentaphyllum extract, and the rest is the same.

[0044] The preparation method of the Chinese medicine extract compound dripping pills of Comparative Example 7 is:

[0045] Take notoginseng total saponins, breviscapine, puerarin, sodium tanshinone IIA sulfonate, safflower yellow pigment, and total flavonoids of hawthorn leaves that comply with the 2020 edition of the "Chinese Pharmacopoeia", mix them to obtain a mixture; take polyethylene glycol 4000, heat it to melt, add it to the mixture, mix well, and drip it into cooled liquid paraffin at 80±10°C to obtain the Chinese medicine extract compound dripping pills.

[0046] Experimental Example 1: Lipid-lowering effect on animal model of combined hyperlipidemia

[0047] 1. Samples and Materials

[0048] 1.1 Sample

[0049] The Chinese herbal medicine extract compound dripping pills of Examples 1-5 and Comparative Examples 1-7.

[0050] 1.2 Experimental animals

[0051] 170 SD male rats, weighing 140-160 g, certificate number: 110324231107623984, provided by Sibeifu (Beijing) Biotechnology Co., Ltd., production license number: SCXK (Beijing) 2019-0010, SPF grade. The experimental animal room is a barrier system, use license number: SYXK (Yunnan) K2022-0004, temperature 20-25 ° C, humidity 45%-65%.

[0052] 1.3 High-fat model diet

[0053] The maintenance feed contains 20% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, and appropriate amounts of casein, calcium hydrogen phosphate, stone powder, etc. All indicators meet the national standards for maintenance feed. It is provided by Beijing Keao Xieli Feed Co., Ltd., production license number: SCXK(Beijing)2019-0003, SPF grade.

[0054] 1.4 Instruments and reagents

[0055] The ELISA reader (model: SpectraMaxi3xplatform) produced by Molecular-Device, USA, and the TC, TG, HDL-C, and LDL-C test kits produced by Nanjing Jiancheng Bioengineering Institute.

[0056] 1.5 Dosage design

[0057] The Chinese herbal extract compound dripping pills of Example 1 were set at 0.166 g / kg.BW, 0.083 g / kg.BW and 0.042 g / kg.BW as the high, medium and low dose groups of Example 1, respectively, which were equivalent to 20 times, 10 times and 5 times the recommended human dose, respectively. The Chinese herbal extract compound dripping pills of Examples 2-5 and Comparative Examples 1-7 were set at 0.166 g / kg.BW as the high dose group of Examples 2-5 and Comparative Examples 1-7, respectively. A positive control group (simvastatin 0.0072 g / kg.BW), a high fat model control group and a blank control group (pure water) were also set up, with 10 animals in each group.

[0058] 1.6 Sample preparation

[0059] Take appropriate amount of the compound Chinese medicine extract pills of Examples 1-5 and Comparative Examples 1-7 and grind them into powder, weigh 0.83g, 0.415g, 0.21g of the compound Chinese medicine extract pills of Example 1, 0.83g of the compound Chinese medicine extract pills of Examples 2-5 and Comparative Examples 1-7 and 0.036g of simvastatin on an analytical balance, add pure water to 50mL with a volumetric flask, vortex and move to a beaker. Give the corresponding dose groups animals by gavage at 10mL / kg.BW, and give the same volume of pure water to the high-fat model control group and the blank control group, once a day for 30 consecutive days.

[0060] 1.7 Test methods

[0061] After animal quarantine, rats were fed with maintenance feed. After 5 days of adaptation, they were randomly divided into two groups according to body weight (202g-220g), namely, 160 model group and 10 blank control group. The model group rats were fed with high-fat model feed, and the blank control group rats were fed with maintenance feed. The body weight was weighed once a week. After 14 days of feeding, blood was collected from the fundus vein without fasting to measure TC, TG, LDL-C, and HDL-C. According to the TC level, the model group was divided into 16 groups, one low-dose group, one medium-dose group, twelve high-dose groups, one positive control group, and one high-fat model control group, with 10 rats in each group. During the test, the low-dose group was given model feed and low-dose compound dripping pills of Chinese herbal extracts of Example 1; the medium-dose group was given model feed and medium-dose compound dripping pills of Chinese herbal extracts of Example 1; the twelve high-dose groups were given model feed and high-dose compound dripping pills of Chinese herbal extracts of Examples 1-5 and Comparative Examples 1-7, respectively; the positive control group was given model feed and simvastatin, the high-fat model control group was given model feed, and the blank control group was given maintenance feed, and the same volume of pure water was given at the same time. At the end of the test, the weight was weighed, blood was collected without fasting, and four indicators of TC, TG, LDL-C, and HDL-C were measured.

[0062] 1.8 Test data statistics

[0063] The experimental data were analyzed by analysis of variance. First, a homogeneity of variance test was performed according to the procedure of analysis of variance. If the variances were homogeneous, the F value was calculated. If the F value < F0.05, the conclusion was that there was no significant difference among the means of each group; if the F value ≥ F0.05 and P ≤ 0.05, pairwise comparisons of the means between multiple experimental groups and a control group were used for statistics; for non-normal or heterogeneous variance data, appropriate variable transformations were performed. After meeting the requirements of normality or homogeneity of variance, the transformed data were used for statistics; if the purpose of normality or homogeneity of variance was still not achieved after variable transformation, the rank sum test was used for statistics. All the above statistics were processed using GraphPad Prism software.

[0064] 2. Experimental results

[0065] 2.1 Effect on the body weight of rats

[0066] Table 3 Body weight of rats (during the modeling period)

[0067]

[0068] Note: Compared with the blank control group, P > 0.05 in the model group.

[0069] As can be seen from Table 3, there was no significant difference in the body weight and weight gain of rats in the model group (from adaptation to two weeks after modeling) compared with the blank control group (P > 0.05).

[0070] Table 4 Body weight of rats (during the drug administration period)

[0071]

[0072] Note: Compared with the blank control group, ## indicates P < 0.01 in the high-fat model control group; compared with the high-fat model control group, P > 0.05 in each dose group and the positive control group.

[0073] As can be seen from Table 4, the weight gain of rats in the model group (from the start of drug administration to the end of drug administration) was significantly higher than that of the blank control group (P < 0.01); there was no significant difference in the body weight and weight gain of rats in each dose group of Example 1 and the positive control group (from the start of drug administration to the end of drug administration) compared with the high-fat model control group (P > 0.05), indicating that the compound dropping pills of the traditional Chinese medicine extract in Example 1 had no obvious effect on the body weight of rats.

[0074] 2.2 Effect on the blood lipids of rats

[0075] Table 5 Serum TC of rats

[0076]

[0077] Table 6 Serum TG of rats

[0078]

[0079]

[0080] Table 7 Rat serum HDL-C

[0081]

[0082] Table 8 Rat serum LDL-C

[0083]

[0084]

[0085] Above, in Table 5-8,

[0086] Compared with the blank control group, ### indicates P < 0.001, ## indicates P < 0.01;

[0087] In the comparison between each dose group and the positive control group of Examples 1-5 and the high-fat model control group, * indicates P < 0.05, and ** indicates P < 0.01;

[0088] Compared with the high-dose group of Example 1, the high-dose group of Comparative Examples 1-7 Δ indicates P < 0.05, ΔΔ Indicates P<0.01.

[0089] As shown in Tables 5-8, the TC, TG, and LDL-C values ​​of the high-fat model control group were significantly higher than those of the blank control group, and the differences were extremely significant (P<0.001), indicating that the high-fat model was successfully established.

[0090] After the test, the TC values ​​in the serum of rats in the high-dose and medium-dose groups of Example 1, the high-dose groups of Examples 2-5 and the positive control group were significantly lower than those in the high-fat model control group, and the difference was significant; the TC values ​​in the serum of rats in the high-dose groups of Comparative Examples 1-6 were significantly higher than those in the high-dose group of Example 1, and the difference was significant, and the TC values ​​in the serum of rats in the high-dose group of Comparative Example 7 were not significantly different from those in the high-dose group of Example 1.

[0091] The TG values ​​in the serum of rats in the high-dose groups of Examples 1-5 and the positive control group were significantly lower than those in the high-fat model control group, and the difference was significant; the TG values ​​in the serum of rats in the high-dose groups of Comparative Examples 1-6 were significantly higher than those in the high-dose group of Example 1, and the difference was significant; the TG values ​​in the serum of rats in the high-dose group of Comparative Example 7 were not significantly different from those in the high-dose group of Example 1.

[0092] There was no significant difference in the HDL-C values ​​in the serum of rats in each dose group of Example 1, the high dose groups of Examples 2-5 and the positive control group compared with the high fat model control group; there was no significant difference in the HDL-C values ​​in the serum of rats in the high dose groups of Comparative Examples 1-7 compared with the high dose group of Example 1

[0093] The LDL-C values ​​in the serum of rats in the high-dose groups of Examples 1-5 and the positive control group were significantly lower than those in the high-fat model control group, and the difference was significant; the LDL-C values ​​in the serum of rats in the high-dose groups of Comparative Examples 1-6 were significantly higher than those in the high-dose group of Example 1, and the difference was significant; the LDL-C values ​​in the serum of rats in the high-dose group of Comparative Example 7 were not significantly different from those in the high-dose group of Example 1.

[0094] Experimental Example 2: Lipid-lowering effect of egg yolk milk on acute hyperlipidemia animal model

[0095] 1. Materials and Methods

[0096] 1.1 Sample

[0097] The Chinese herbal medicine extract compound dripping pills of Examples 1-5 and Comparative Examples 1-7.

[0098] 1.2 Experimental animals

[0099] 170 SPF grade Kunming male mice, weighing 18-22g, certificate number: 110324241100049626, provided by Sibeifu (Beijing) Biotechnology Co., Ltd., production license number: SCXK (Beijing) 2019-0010, SPF grade. The experimental animal room is a barrier system, use license number: SYXK (Yunnan) K2022-0004, temperature 20-25℃, humidity 45%-65%.

[0100] 1.3 Instruments and reagents

[0101] The ELISA reader (model: SpectraMaxi3xplatform) produced by Molecular-Device, USA, and the TC, TG, HDL-C, and LDL-C test kits produced by Nanjing Jiancheng Bioengineering Institute.

[0102] 1.4 Dosage design

[0103] The Chinese herbal extract compound dripping pills of Example 1 were set at 0.249 g / kg.BW, 0.083 g / kg.BW and 0.042 g / kg.BW as the high, medium and low dose groups of Example 1, respectively, which were equivalent to 30 times, 10 times and 5 times the recommended human dose, respectively. The Chinese herbal extract compound dripping pills of Examples 2-5 and Comparative Examples 1-7 were set at 0.083 g / kg.BW as the medium dose groups of Examples 2-5 and Comparative Examples 1-7, respectively. A positive control group (simvastatin 0.010 g / kg.BW), a model group and a normal group (normal saline) were also set up, with 10 animals in each group.

[0104] 1.5 Sample preparation

[0105] Take appropriate amount of the compound Chinese medicine extract pills of Examples 1-5 and Comparative Examples 1-7 and grind them into powder, weigh 0.249g, 0.083g, 0.042g of the compound Chinese medicine extract pills of Example 1, 0.083g of the compound Chinese medicine extract pills of Examples 2-5 and Comparative Examples 1-7 and 0.010g of simvastatin on an analytical balance, add physiological saline to 50mL with a volumetric flask, vortex and move to a beaker. Give the animals in the corresponding dose groups oral administration at 10mL / kg.BW, and give the model group and the normal group the same volume of physiological saline, once a day for 7 consecutive days.

[0106] 1.6 Test methods

[0107] 170 healthy Kunming male mice weighing 18-22g were taken and adaptively fed for 1 week, and then randomly divided into 17 groups according to body weight: a high-dose group, twelve medium-dose groups, a low-dose group, a model group, a normal group and a positive control group (simvastatin 0.010g / kg.BW), with 10 mice in each group; the high-dose group was given 0.249g / kg.BW of the Chinese medicine extract compound dripping pills of Example 1 by gavage; the twelve medium-dose groups were given 0.083g / kg.BW of the Chinese medicine extract compound dripping pills of Examples 1-5 and Comparative Examples 1-7 by gavage; the low-dose group was given 0.042g / kg.BW of the Chinese medicine extract compound dripping pills of Example 1 by gavage; the normal group and the model group were given an equal amount of physiological saline by gavage to the drug-administered group, and the remaining groups were given continuous gavage for 7 days, and the gavage volume was 0.1mL / 10g. On the 7th day, 2 hours after administration, the model group and the treatment group were intraperitoneally injected with egg yolk milk, 0.2 mL egg yolk milk / 10 g body weight per mouse; the normal group was intraperitoneally injected with an equal volume of saline to establish an acute hyperlipidemia mouse model. Fasting but not water, 12 hours later, the eyeballs were removed and blood was collected. After the blood sample agglutinated, it was centrifuged at 3500r / min and 4℃ for 15 minutes, and the upper serum was taken to measure serum TC, TG, LDL-C, and HDL-C according to the operating instructions of each test kit.

[0108] 1.7 Test data statistics

[0109] The experimental data were analyzed by analysis of variance. First, the homogeneity of variance test was carried out according to the procedure of analysis of variance. If the variances were homogeneous, the F value was calculated. If the F value < F0.05, the conclusion was that there was no significant difference among the means of each group; if the F value ≥ F0.05 and P ≤ 0.05, pairwise comparisons of the means between multiple experimental groups and a control group were used for statistics; for non-normal or heterogeneous variance data, appropriate variable transformations were performed. After meeting the requirements of normality or homogeneity of variance, the transformed data were used for statistics; if the purpose of normality or homogeneity of variance was still not achieved after variable transformation, the rank sum test was used for statistics. All the above statistics were processed using GraphPad Prism software.

[0110] 2. Experimental results

[0111] Table 9 Mouse serum TC

[0112]

[0113]

[0114] Table 10 Mouse serum TG

[0115]

[0116] Table 11 Mouse serum HDL-C

[0117]

[0118]

[0119] Table 12 Mouse serum LDL-C

[0120]

[0121] Above, in Tables 9 - 12,

[0122] When comparing the model group with the normal group, indicates P < 0.001 and ## indicates P < 0.01;

[0123] When comparing each dose group of Examples 1 - 5 and the positive control group with the model group, *** indicates P < 0.001, ** indicates P < 0.01, and * indicates P < 0.05;

[0124] When comparing the medium dose group of Comparative Examples 1 - 7 with the medium dose group of Example 1, ΔΔ indicates P < 0.01, Δ indicates P < 0.05.

[0125] As shown in Tables 9-12, the TC, TG, and LDL-C values ​​of the model group were significantly higher than those of the normal group, and the differences were extremely significant, indicating that the model group was successfully established.

[0126] The TC values ​​in the serum of mice in each dosage group of Example 1, the medium dosage group of Examples 2-5 and the positive control group were significantly lower than those in the model group, and the difference was extremely significant; the TC values ​​in the serum of mice in the medium dosage group of Comparative Examples 1-6 were significantly higher than those in the medium dosage group of Example 1, and the difference was significant, and the TC values ​​in the serum of mice in the medium dosage group of Comparative Example 7 were not significantly different from those in the medium dosage group of Example 1.

[0127] The TG values ​​in the serum of mice in the high-dose group, medium-dose group, medium-dose group of Examples 2-5 and the positive control group were significantly lower than those in the model group, and the difference was significant; the TG values ​​in the serum of mice in the medium-dose group of Comparative Examples 1-6 were significantly higher than those in the medium-dose group of Example 1, and the difference was significant; the TG values ​​in the serum of mice in the medium-dose group of Comparative Example 7 were not significantly different from those in the medium-dose group of Example 1.

[0128] There was no significant difference in the HDL-C values ​​in the serum of mice in each dosage group of Example 1, the medium dosage groups of Examples 2-5 and the positive control group compared with the model group; there was no significant difference in the HDL-C values ​​in the serum of mice in the medium dosage groups of Comparative Examples 1-7 compared with the medium dosage group of Example 1.

[0129] The LDL-C values ​​in the serum of mice in each dosage group of Example 1, the middle dosage groups of Examples 2-5 and the positive control group were significantly lower than those in the model group, and the differences were significant; the LDL-C values ​​in the serum of mice in the middle dosage groups of Comparative Examples 1-6 were significantly higher than those in the middle dosage group of Example 1, and the differences were significant; the LDL-C values ​​in the serum of mice in the middle dosage group of Comparative Example 7 were not significantly different from those in the middle dosage group of Example 1.

[0130] Test Example 3: Acute toxicity test

[0131] 1. Materials and Methods

[0132] 1.1 Sample

[0133] The Chinese herbal extract compound dripping pills of Example 1.

[0134] 1.2 Experimental animals

[0135] SD rats, 20, half male and half female, weight 160-180g, quality certificate number (male): 110324231107726346, quality certificate number (female): 110324231107726018; Kunming mice, 20, half male and half female, weight 14-18g, quality certificate number (male): 110324231107692031, quality certificate number (female): 110324231107691943. Provided by Sibeifu (Beijing) Biotechnology Co., Ltd., production license number: SCXK (Beijing) 2019-0010, SPF grade. Experimental animal room license number: SYXK (Yunnan) K2022-0004, temperature 20-25℃, humidity 45%-65%.

[0136] 1.3 Instruments and reagents

[0137] 1.3.1 Main instruments and items

[0138] Electronic balance, dissecting instruments, etc.

[0139] 1.3.2 Main reagents

[0140] Paraformaldehyde (BioSharp, lot number: 23130618)

[0141] 1.4 (Rats and mice) acute oral toxicity test

[0142] For the acute oral toxicity test of rats, 20 SD rats were selected, half of which were male and half were female, weighing 160-180g; for the acute oral toxicity test of mice, 20 Kunming mice were selected, half of which were male and half were female, weighing 14-18g. Based on the preliminary test, the formal test set the oral dose of 10.0g / kg.BW (equivalent to 1200 times the recommended dose for humans) according to the limit method. Rats were fasted for 16 hours before oral gavage, with unlimited drinking water. The samples were given orally twice at an interval of 6 hours at 20mL / kg.BW; mice were fasted for 6 hours before oral gavage, with unlimited drinking water. The samples were given orally once at 40mL / kg.BW. After gavage, the poisoning symptoms and deaths of the animals were observed continuously for 14 days. The rats and mice were weighed at the beginning of the test, on the 7th day and on the 14th day. The animals were killed for gross autopsy after the test.

[0143] Preparation of test samples: ① Acute oral toxicity test (rat): Take an appropriate amount of the compound dripping pills of the Chinese herbal extract of Example 1 and grind them into powder, weigh 5g of the sample on an analytical balance, add pure water to a volumetric flask to 10mL, transfer to a beaker, vortex and prepare a suspension with a concentration of 50.0%, and set aside. ② Acute oral toxicity test (mice): Take an appropriate amount of the compound dripping pills of the Chinese herbal extract of Example 1 and grind them into powder, weigh 2.5g of the sample on an analytical balance, add pure water to a volumetric flask to 10mL, transfer to a beaker, vortex and prepare a suspension with a concentration of 25.0%, and set aside.

[0144] 2. Results

[0145] Table 13 Results of acute toxicity test in rats

[0146]

[0147] Table 14 Results of acute toxicity test in mice

[0148]

[0149] As shown in Table 13 and Table 14, after the sample was given to rats and mice by gavage at a dose of 10.0g / kg.BW (equivalent to 1200 times the recommended dosage for humans) according to the limit method, the animals grew well, their body weight was not affected, and no animals had obvious symptoms of poisoning. No animals died after 14 days of observation. After the test, the animals were dissected, and no obvious abnormal changes were found in the liver, kidney, spleen, heart, lung, stomach, intestine and other major organs. The results show that the acute oral toxicity LD50 of the sample to male and female rats and mice is greater than 10.0g / kg.BW, and the Chinese medicine extract compound dripping pills of Example 1 are safe to use at this dose.

[0150] Test Example 4: Long-term toxicity test

[0151] 1. Materials and Methods

[0152] 1.1 Sample

[0153] The Chinese herbal extract compound dripping pills of Example 1.

[0154] 1.2 Experimental animals

[0155] 100 SD male rats, weighing 50-70 g, quality certificate number (male): 110324230103955127, quality certificate number (female): 110324230103955057. Provided by Sibeifu (Beijing) Biotechnology Co., Ltd., production license number: SCXK (Beijing) 2019-0010, SPF grade. Laboratory animal room license number: SYXK (Yunnan) K2022-0004, temperature 20-25 ° C, humidity 45%-65%.

[0156] 1.3 Instruments and reagents

[0157] 1.3.1 Main instruments and items

[0158] Fully automatic coagulation analyzer (C3100), fully automatic biochemical analyzer for animals (Catalyst One), five-category animal blood cell analyzer (ProCyte DX), urine analyzer (UC-200B), microplate reader (SpectraMax I3X), electrolyte analyzer (K-Lite 8G), electronic balance, microscope, centrifuge, constant temperature water bath, dissecting instruments, ophthalmoscope, pathology slicer, etc.

[0159] 1.3.2 Main reagents

[0160] Biochemical assay kits (produced by Nanjing Jiancheng Bioengineering Research Institute), blood cell analyzer assay reagents (produced by IDEXX Laboratories, USA), coagulation assay kits (produced by Shanghai Changdao Biotechnology Co., Ltd.), electrolyte assay reagents (produced by Meizhou Kangli High-tech Co., Ltd.), urine test strips (produced by Guilin Youlite Medical Electronics Co., Ltd.), etc.

[0161] 1.4 Long-term oral toxicity test

[0162] 100 SD rats were selected, half of which were male and half were female, and the body weight was 50-70g. The dosage design was as follows: three dosage groups of 0.83g / kg.BW, 0.42g / kg.BW, and 0.21g / kg.BW were set (equivalent to 100, 50, and 25 times of the recommended dosage for human body, respectively), and a negative control group (pure water) was set up separately, with 20 rats in each group, half of which were male and half were female. A high-dose group and a negative control group of the recovery observation group were set up at the same time, with 10 rats in each group, half of which were male and half were female. Preparation of Chinese medicine extract compound dripping pills: Take an appropriate amount of the Chinese medicine extract compound dripping pills of Example 1 and grind them into powder, take 3.32g, 1.66g, and 0.83g of samples respectively, add pure water to 40mL, mix well, and prepare 8.3%, 4.2%, and 2.1% suspensions as the intragastric solutions for high, medium, and low dosage groups, for standby use. Pure water was used as a negative control. The oral gavage volume was 10mL / kg.BW once a day for 90 consecutive days. The recovery observation group was observed for 14 days after the test substance was stopped. The general performance, behavior, poisoning symptoms and death of the animals were observed every day. The food intake and body weight were weighed every week. The food utilization rate was calculated based on the food intake. Before and at the end of the experiment, the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group) were examined for eyes (cornea, conjunctiva, iris). At the end of the experiment, the fasting weight of the rats after fasting for 16 hours was weighed, blood was collected after anesthesia, and the animals were killed. The hematological indices were determined using the ProCyteDX blood cell analyzer and the C3100 fully automatic coagulation analyzer. The blood biochemical indices were determined using the CatalystOne fully automatic biochemical analyzer and the kits produced by Nanjing Jiancheng Bioengineering Institute. The UC-

[0163] 200B urine analyzer was used to measure urine indexes, animals were dissected to observe changes in internal organs, liver, spleen, kidney, adrenal gland, heart, thymus, and testicles were weighed, and their organ-to-body ratio was calculated. The brain, thyroid gland, thymus gland, heart, liver, spleen, kidney, adrenal gland, stomach, duodenum, colon, pancreas, mesenteric lymph nodes, ovaries, testicles, bladder, etc. were taken for histopathological examination. During the experiment, animals were free to eat and drink.

[0164] 1.5 Test data statistics

[0165] The data of long-term oral toxicity test were subjected to the variance homogeneity test. If the variance was homogeneous, one-way analysis of variance was used for overall comparison. If differences were found, Dunnett's test was used for pairwise comparisons between the means of multiple dose groups and the control group. If the variance was not homogeneous, the data were appropriately transformed. After the variance homogeneity test was met, the transformed data were used for statistics; if the transformed data still did not meet the variance homogeneity requirement, the rank sum test was used for statistical analysis.

[0166] 2 Results

[0167] 2.1 Long-term oral toxicity study in rats

[0168] During the experiment, the animals were in good health and their weight continued to increase. After the rats in each dosage group were given different doses of samples every day, no obvious symptoms of poisoning occurred and no animal deaths were observed.

[0169] 2.1.1 Effects on rat body weight

[0170] Table 15 (experimental group) rat body weight and fasting weight

[0171]

[0172]

[0173] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0174] Table 16 (Recovery observation group) rat body weight and fasting weight

[0175]

[0176]

[0177] As can be seen from Tables 15 and 16, there were significant differences in weight gain between the female mice in the medium-dose group and the negative control group at weeks 1, 4, 5, 6, 9, 10, 11, 12, and 13 (P<0.05); there were significant differences in weight gain between the female mice in the low-dose group and the negative control group at weeks 3, 4, 7, and 8 (P<0.05); there were significant differences in weight gain between the female mice in the low-dose group and the negative control group at weeks 6, 9, 11, 12, and 13 (P<0.01). In the experimental group, there was a significant difference in the first week between the high-dose group and the negative control group (P<0.05); there was a significant difference in the fourth week between the high-dose group and the negative control group (P<0.01); there was a significant difference in the fourth week between the medium-dose group and the negative control group (P<0.01); there was a significant difference in the first and fourth weeks between the low-dose group and the negative control group (P<0.01). There was no significant difference in the initial body weight, weekly weekend body weight, total weight gain and fasting weight of male and female rats in each dose group of the recovery observation group compared with the negative control group (P>0.05).

[0178] 2.3.2 Effect on food intake of rats

[0179] Table 17 (Experimental group) Weekly food intake and total food intake of rats

[0180]

[0181]

[0182] Note: Compared with the negative control group, *** indicates P < 0.001, ** indicates P < 0.01, and * indicates P < 0.05.

[0183] Table 18 (Recovery observation group) Weekly food intake and total food intake of rats

[0184]

[0185]

[0186] Note: Compared with the negative control group, *** indicates P < 0.001, ** indicates P < 0.01, and * indicates P < 0.05.

[0187] As can be seen from Tables 17 and 18, there were significant differences in the 1st, 5th and 12th weeks between the high-dose group and the negative control group (P<0.05), and there were significant differences in the 2nd, 3rd, 4th and 13th weeks between the high-dose group and the negative control group (P<0.001); there were significant differences in the 5th, 7th and 11th weeks between the medium-dose group and the negative control group (P<0.05), there were significant differences in the 13th week between the medium-dose group and the negative control group (P<0.01), and there were significant differences in the 2nd, 3rd and 4th weeks between the medium-dose group and the negative control group (P<0.001); there were significant differences in the food intake of the female mice in the recovery observation (recovery observation group) at weeks 2, 3 and 4 compared with that of the negative control group (P<0.05).

[0188] 2.3.3 Effects on food utilization in rats

[0189] Table 19 (Test group) rat food utilization

[0190]

[0191]

[0192] Note: Compared with the negative control group, *** indicates P < 0.001, ** indicates P < 0.01, and * indicates P < 0.05.

[0193] Table 20 (Recovery observation group) Food utilization rate of rats

[0194]

[0195]

[0196] Note: Compared with the negative control group, *** indicates P < 0.001, ** indicates P < 0.01.

[0197] As shown in Table 19 and Table 20, the difference between the high-dose group of female mice in the experimental group and the negative control group at the 2nd week was significant (P<0.05), and the difference between the high-dose group of male mice and the negative control group at the 4th, 8th and 10th week was significant (P<0.05); the difference between the medium-dose group and the negative control group at the 4th, 5th and 8th week was significant (P<0.01); the difference between the low-dose group and the negative control group at the 1st, 2nd, 4th, 5th, 8th and 11th week was significant (P<0.01). There was no significant difference between the male mice in the recovery observation group and the negative control group at the 4th, 5th and 8th week (P<0.001).

[0198] 2.3.4 Effects on rat hematology

[0199] Table 21 (experimental group) hematological parameters of rats

[0200]

[0201]

[0202] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0203] Table 22 (Convalescence observation group) rat hematological parameters

[0204]

[0205] Note: Compared with the negative control group, *P < 0.05.

[0206] As shown in Table 21 and Table 22, the granulocytes and lymphocytes of the high-dose group of the female rats in the experimental group were significantly different from those of the negative control group (P<0.01), the platelet counts of the medium-dose and low-dose groups were significantly different from those of the negative control group (P<0.05), and the hemoglobin of the low-dose group was significantly different from that of the negative control group (P<0.05); the hematocrit of the high-dose and low-dose groups of the male rats in the experimental group was significantly different from that of the negative control group (P<0.01), the granulocytes, There were significant differences in lymphocytes compared with the negative control group (P<0.05). There were significant differences in granulocytes and lymphocytes between the medium-dose group and the negative control group (P<0.01). There were extremely significant differences in hemoglobin between the female rats in the recovery observation group and the negative control group (P<0.01). There were extremely significant differences in monocytes between the male rats and the negative control group (P<0.01). The above numerical changes were all within the normal range. There were no significant differences in the other hematological indicators compared with the negative control group.

[0207] 2.3.5 Effects on rat blood biochemistry

[0208] Table 23 (Experimental group) Blood biochemical parameters of rats

[0209]

[0210]

[0211] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0212] Table 24 (Convalescence observation group) blood biochemical indexes of rats

[0213]

[0214]

[0215] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0216] As shown in Table 23 and Table 24, the total protein, serum urea, chloride ion, and sodium ion of the high-dose group of the female rats in the experimental group were significantly different from those of the negative control group (P<0.01); the total cholesterol of the high- and medium-dose groups were significantly different from those of the negative control group (P<0.001); the aspartate aminotransferase and blood glucose of the medium-dose group were significantly different from those of the negative control group (P<0.01); the triglyceride and blood glucose of the low-dose group were significantly different from those of the negative control group (P<0.05); There were extremely significant differences in total protein, albumin / globulin, blood sugar in the high-dose group and blood sugar and glutamyl transpeptidase in the medium-dose group compared with the negative control group (P<0.01). There were significant differences in alanine aminotransferase, aspartate aminotransferase, total protein in the medium-dose group, serum urea in the high- and medium-dose groups, and potassium ions in the medium- and low-dose groups compared with the negative control group (P<0.05). The above numerical changes were all within the normal range. There were no significant differences in the other hematological indicators compared with the negative control group.

[0217] 2.3.6 Effects on rat urine

[0218] Table 25 (experimental group) rat urine index

[0219]

[0220]

[0221] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0222] Table 26 (Recovery observation group) Urine indexes of rats

[0223]

[0224] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0225] As can be seen from Tables 25 and 26, the pH value and occult blood of the high-dose group of female rats in the experimental group were significantly different from those of the negative control group (P<0.01); the urine specific gravity value, pH value and occult blood of the high-dose group of male rats in the experimental group were significantly different from those of the negative control group (P<0.01); the urine protein and occult blood of female rats in the recovery observation group were significantly different from those of the negative control group (P<0.01); the urine protein of male rats in the recovery observation group was significantly different from that of the negative control group (P<0.01); there was no significant difference in the urine test results of male and female rats in other groups compared with those of the negative control group (P>0.05).

[0226] 2.3.7 Effects on organ-to-body ratios in rats

[0227] Table 27 (experimental group) rat organ-body ratio

[0228]

[0229]

[0230] Note: Compared with the negative control group, ** indicates P < 0.01, * indicates P < 0.05.

[0231] Table 28 (Convalescence observation group) rat organ-body ratio

[0232]

[0233]

[0234] Note: Compared with the negative control group, *P < 0.05.

[0235] As can be seen from Tables 27 and 28, the adrenal wet weight, adrenal / body ratio, adrenal / body ratio and brain / body ratio of the female rats in the experimental group at the medium dose were significantly different from those of the negative control group (P<0.05); the brain wet weight, brain / body ratio, lung wet weight and lung wet weight / body ratio of the male rats in the high dose were significantly different from those of the negative control group (P<0.05); the lung / body ratio of the male rats in the recovery observation group was significantly different from that of the negative control group (P<0.05).

[0236] 2.3.8 Effects on rat histopathology

[0237] Table 29 Histopathological examination score table of each organ of experimental rats

[0238]

[0239] Table 30 Histopathological examination score table of each organ of experimental rats

[0240]

[0241] Table 31 Histopathological examination score table of each organ of experimental rats

[0242]

[0243] Table 32 Histopathological examination score table of each organ of experimental rats

[0244]

[0245] Table 33 Histopathological examination score table of each organ of experimental rats

[0246]

[0247] Table 34 Summary of pathological scores of experimental rats

[0248]

[0249] Gross anatomical findings: The male and female rats in each experimental dose group and the blank control group were in good mental state, and no obvious abnormalities were observed in their organs.

[0250] Microscopic findings: See Tables 29-34.

[0251] Negative control group: 3 cases (3 / 10, female 1 / 5, male 2 / 5) showed chronic inflammatory changes in the lungs, 3 cases (3 / 10, female 2 / 5, male 1 / 5) showed inflammatory cell infiltration in the trachea, 3 cases (3 / 10, female 1 / 5, male 2 / 5) showed local inflammatory cell infiltration in the liver, 1 case (1 / 10, female 0 / 5, male 1 / 5) showed fatty degeneration of hepatocytes, 1 case (1 / 10, female 1 / 5, male 0 / 5) showed congestion of the spleen, 1 case (1 / 10, female 1 / 5, male 0 / 5) showed inflammatory cell infiltration in the renal cortex, and no obvious abnormalities were found in the gastrointestinal tract, ovary, testis, brain, thyroid, pituitary, thymus, adrenal gland, prostate, mesenteric lymph nodes, pancreas, uterus, breast, esophagus, artery, spinal cord, bone marrow, sciatic nerve, epididymis, bladder and other organs.

[0252] In the high-dose group, chronic inflammatory changes occurred in the lungs in 5 cases (5 / 10, 2 / 5 females, 3 / 5 males), inflammatory cell infiltration occurred in 1 case (1 / 10, 1 / 5 females, 1 / 5 males) in the trachea, and a small amount of inflammatory cell infiltration occurred in 2 cases (2 / 10, 2 / 5 females, 0 / 5 males); fatty degeneration of hepatocytes occurred in 1 case (1 / 10, 1 / 5 females, 0 / 5 males); basophilia occurred in the renal cortex of individual animals in 1 case (1 / 10, 0 / 5 females, 1 / 5 males). ); thyroid follicular cell hyperplasia in 1 case (1 / 10, female 1 / 5, male 0 / 5), renal cortical inflammatory cell infiltration in 1 case (1 / 10, female 0 / 5, male 1 / 5), glomerular congestion in 1 case (1 / 10, female 0 / 5, male 1 / 5); no obvious abnormalities were found in spleen, gastrointestinal tract, ovary, testis, brain, pituitary gland, thymus, adrenal gland, prostate, mesenteric lymph nodes, pancreas, uterus, breast, esophagus, artery, spinal cord, bone marrow, sciatic nerve, epididymis, bladder and other organs.

[0253] The results of the 90-day feeding test showed that the rats had inflammatory changes in the lungs, trachea and liver, but there was no significant difference between the high-dose group and the negative control. The histological pathological changes of other organs were not obvious. The Chinese medicine extract compound dripping pills of Example 1 did not cause significant effects on the rat organs.

[0254] 2.3.9 Eye examination

[0255] Table 35 Results of eye examination of rats before the test

[0256]

[0257] Table 36 Results of eye examination of rats after the test

[0258]

[0259] As can be seen from Tables 35 and 36, before and at the end of the experiment, eye (cornea, conjunctiva, iris) examinations were performed on the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group), and no eye abnormalities were found in the animals.

[0260] 3. Summary

[0261] The Chinese herbal extract compound dripping pills of Example 1 were set into three dosage groups of 0.83g / kg.BW, 0.42g / kg.BW, and 0.21g / kg.BW (equivalent to 100, 50, and 25 times the recommended dose for humans, respectively), a negative control group (pure water) was set up, and a recovery observation group was added. The rats were given oral administration for a long time. During the test, the animals grew and developed well, and no obvious adverse effects were found in the tests of the relevant indicators of the animal body weight, food intake, food utilization rate, hematological indicators, blood biochemical indicators, urine indicators, organ wet weight, and organ / body weight ratio in each dosage group; before and at the end of the test, the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group) were examined for the eyes (cornea, conjunctiva, iris), and no abnormalities were found in the eyes of the animals; no abnormal changes related to the Chinese herbal extract compound dripping pills were found in gross anatomical observation; and no obvious histopathological changes were found. Within the dosage range of 0.21g / kg.BW-0.83g / kg.BW, the compound dripping pills of Chinese herbal extract did not produce any toxic or side effects on the observed indicators of rats.

[0262] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese herbal medicine extract compound dripping pill, characterized in that: The invention comprises the following components by weight: 6-15 parts of notoginseng total saponins, 2-6 parts of breviscapine and 4-8 parts of hawthorn leaf extract.

2. The Chinese herbal medicine extract compound dripping pill according to claim 1, characterized in that: The Chinese herbal medicine extract compound dripping pills include the following components by weight: 8-12 parts of notoginseng total saponins, 3-5 parts of breviscapine and 5-7 parts of hawthorn leaf extract.

3. The Chinese herbal medicine extract compound dripping pill according to claim 1, characterized in that: The weight ratio of the notoginseng total saponins, breviscapine and hawthorn leaf extract is 2-3:1:1-2.

4. The Chinese herbal medicine extract compound dripping pill according to claim 3, characterized in that: The weight ratio of the notoginseng total saponins, breviscapine and hawthorn leaf extract is 2.5:1:1.

5.

5. The Chinese herbal medicine extract compound dripping pill according to claim 1, characterized in that: The drop pill composition further comprises a matrix; the matrix is ​​selected from one or more of polyethylene glycol, poloxamer, gelatin and Tween.

6. The Chinese herbal medicine extract compound dripping pill according to claim 5, characterized in that: The ratio of the matrix mass to the total mass of notoginseng total saponins, breviscapine and hawthorn leaf extract is 2-4:1-3.

7. The Chinese herbal medicine extract compound dripping pill according to claim 6, characterized in that: The ratio of the matrix mass to the total mass of notoginseng total saponins, breviscapine and hawthorn leaf extract is 3:

2.

8. The Chinese herbal medicine extract compound dripping pill according to claim 7, characterized in that: The Chinese herbal medicine extract compound dripping pills include the following components by weight: 10 parts of notoginseng total saponins, 4 parts of breviscapine, 6 parts of hawthorn leaf extract and 30 parts of polyethylene glycol 4000.

9. A method for preparing the Chinese herbal extract compound dripping pills according to any one of claims 1 to 8, characterized in that: The method comprises the following steps: mixing evenly according to the formula, heating to melt, and dripping into cooled liquid paraffin to obtain the compound dripping pills of Chinese medicine extract.

10. Use of the Chinese herbal extract compound dripping pill according to any one of claims 1 to 8 in the preparation of a medicament for preventing and / or treating hyperlipidemia.

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