A traditional Chinese medicine extract compound drop pill, a preparation method and application thereof

Abstract

The application 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. The traditional Chinese medicine extract compound dripping pill comprises the following components in parts by weight: panax notoginseng total saponins 6-15 parts, breviscapine 2-6 parts and hawthorn leaf extract 4-8 parts. The application solves the problems of long onset time and large dose of the drug for treating hyperlipidemia. The traditional Chinese medicine extract compound dripping pill has significant effects on mixed hyperlipidemia models and acute hyperlipidemia models, has short onset time, low dose, no toxicity, and is convenient to take, store and carry.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a compound dripping pill made from a traditional Chinese medicine extract, its preparation method, and its application. Background Technology

[0002] Hyperlipidemia, also known as hyperlipidemia, refers to elevated levels of triglycerides (TG) and / or total cholesterol (TC) in the blood plasma. It also includes elevated low-density lipoprotein cholesterol (LDL-C) and decreased high-density lipoprotein cholesterol (HDL-C). High blood lipid levels can lead to diseases such as coronary atherosclerotic heart disease and hypertension.

[0003] Currently, lipid-lowering drugs mainly consist of statins (atorvastatin, lovastatin, and simvastatin), fibrates, and niacin, with statins being the preferred choice due to their strong lipid-lowering effect and clear mechanism of action. However, they can cause adverse reactions such as liver damage, muscle lesions, skin allergies, and digestive and urinary system diseases. In recent years, research on traditional Chinese medicine for treating hyperlipidemia has been increasing.

[0004] Panax notoginseng is a plant belonging to the genus Panax in the family Araliaceae. It is sweet, slightly bitter, and warm in nature, and has pharmacological effects such as reducing swelling and relieving 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, angina pectoris, diabetes, and thrombosis, it has also been used to treat hyperlipidemia.

[0005] Chinese Patent Publication No. CN106983786B discloses a traditional Chinese medicine composition for the prevention and / or treatment of hyperlipidemia and its preparation method. The composition includes 3-12 grams of ginseng, 15-60 grams of Scutellaria baicalensis, 5-20 grams of stir-fried Atractylodes macrocephala, 15-60 grams of stir-fried Ziziphus jujuba var. spinosa, 15-60 grams of Salvia miltiorrhiza, 6-24 grams of Ligusticum chuanxiong, 15-60 grams of Pueraria lobata, 15-60 grams of Crataegus pinnatifida, 6-24 grams of Glycyrrhiza uralensis, 5-20 grams of Panax notoginseng, 2-10 grams of Hirudo medicinalis, and 1-6 grams of Rheum palmatum. This technical solution can significantly reduce blood lipid levels in diabetic hyperlipidemic mice, reduce FBG levels in model mice, and improve liver function in diabetic hyperlipidemic mice. However, due to the large number of medicinal materials contained, long-term use of this technical solution can easily place a significant burden on the liver; therefore, irradiation treatment is required, resulting in high costs.

[0006] Chinese patent CN102727680B discloses a traditional Chinese medicine for lowering blood lipids and its preparation method. The medicine consists of a dry extract obtained by boiling or refluxing a mixture of Alisma plantago-aquatica, hawthorn, Gynostemma pentaphyllum, Pueraria lobata, and Lycium barbarum, and Panax notoginseng powder. This technical solution uses the principles of promoting diuresis and resolving turbidity, dispersing blood stasis and unblocking collaterals to select and formulate the formula. It can nourish the yin and blood of the liver and kidneys while preventing the excessive purging effects of hawthorn and Gynostemma pentaphyllum, providing a new traditional Chinese medicine with significant efficacy for treating hyperlipidemia. However, this technical solution only shows a significant lipid-lowering effect at a dosage of 0.64 g / kg after 10 weeks of continuous administration, indicating a long onset time and high dosage.

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

[0008] This invention addresses the problems of long onset time and large dosage of existing drugs for treating hyperlipidemia. It provides a compound dripping pill made from traditional Chinese medicine extract, its preparation method, and its application. The compound dripping pill made from traditional Chinese medicine extract provided by this invention has significant efficacy in both mixed hyperlipidemia models and acute hyperlipidemia models. It has a short onset time, low dosage, no toxicity, and is convenient to take, store, and carry.

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

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

[0011] Preferably, the compound pills containing traditional Chinese medicine extracts comprise, by weight, the following components: 8-12 parts of total saponins of Panax notoginseng, 3-5 parts of scutellarin, and 5-7 parts of hawthorn leaf extract.

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

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

[0014] Preferably, the pellet composition further includes 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 saponins, scutellarin and hawthorn leaf extract is 2-4:1-3.

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

[0017] Preferably, the compound pills containing traditional Chinese medicine extracts comprise, by weight, the following components: 10 parts total saponins of Panax notoginseng, 4 parts scutellarin, 6 parts hawthorn leaf extract, and 30 parts polyethylene glycol 4000.

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

[0019] Preferably, the preparation method is as follows: take Panax notoginseng total saponins, scutellaria baicalensis extract and hawthorn leaf extract conforming to the 2020 edition of the Chinese Pharmacopoeia, mix them to obtain a mixture; take polyethylene glycol 4000, heat and melt it, add it to the mixture, mix it evenly, and drip it into cooled liquid paraffin under heat preservation to obtain compound pills of traditional Chinese medicine extract.

[0020] The third aspect of this invention provides the application of the above-mentioned compound pills made from traditional Chinese medicine extracts in the preparation of drugs for the prevention and / or treatment of hyperlipidemia.

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

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

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

[0024] (1) The components of the compound dripping pills made from traditional Chinese medicine extracts of the present invention have a synergistic effect and a significant lipid-lowering effect on rats with mixed hyperlipidemia and mice with acute hyperlipidemia.

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

[0026] (3) The compound pills made from the Chinese herbal extracts of the present invention are non-toxic and convenient to take, store and carry. Detailed Implementation

[0027] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative and explanatory purposes only and are not intended to limit the present invention.

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

[0029] The raw material sources for the compound herbal extract pills of Examples 1-3 and Comparative Examples 1-7 of this invention are shown in Table 1.

[0030] Table 1 Source of Raw Materials

[0031] source Total saponins of Panax notoginseng Jinqi Pharmaceutical Co., Ltd. lamp-shaped flower plain 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. Sodium Tanshinone IIA Sulfonate Wuhan Huajiu Pharmaceutical Technology Co., Ltd. Safflower yellow pigment Shandong Xinxiong Biotechnology Co., Ltd. Total flavonoids from hawthorn leaves Hubei Sanxin Biotechnology Co., Ltd.

[0032] The compound herbal extract pills of Examples 1-3 and Comparative Examples 1-7, by weight, have the specific formulations shown in Table 2:

[0033] Table 2. Formulas of compound herbal extract drop pills in Examples 1-3 and Comparative Examples 1-7

[0034]

[0035]

[0036] The total amount of 50g of the compound herbal extracts from Examples 1-5 and Comparative Examples 1-7 was used to make 1000 pills.

[0037] The preparation methods of the compound herbal extract drop pills in Examples 1-5 and Comparative Example 6 are as follows:

[0038] Take the total saponins of Panax notoginseng, scutellaria baicalensis extract, and hawthorn leaf extract that conform to the 2020 edition of the Chinese Pharmacopoeia, mix them together to obtain a mixture; take polyethylene glycol 4000, heat and melt it, add it to the mixture, mix well, and drop it into cooled liquid paraffin at 80±10℃ to obtain compound pills of traditional Chinese medicine extract.

[0039] The preparation method of the compound pills of traditional Chinese medicine extract in Comparative Example 1 differs from that in Example 1 only in that it does not contain scutellarin or hawthorn leaf extract; all other aspects are the same.

[0040] The preparation method of the compound pills of traditional Chinese medicine extract in Comparative Example 2 differs from that in Example 1 only in that it does not contain total saponins of Panax notoginseng and hawthorn leaf extract; all other aspects are the same.

[0041] The preparation method of the compound pills of traditional Chinese medicine extract in Comparative Example 3 differs from that in Example 1 only in that it does not contain total saponins of Panax notoginseng and scutellarin; all other aspects are the same.

[0042] The preparation method of the compound pills of traditional Chinese medicine extract in Comparative Example 4 is the same as that in Example 1, except that the scutellarin is replaced with puerarin.

[0043] The preparation method of the compound pills of traditional Chinese medicine extract in Comparative Example 5 differs from that in Example 1 only in that hawthorn leaf extract is replaced with Gynostemma pentaphyllum extract, and all other aspects are the same.

[0044] The preparation method of the compound drop pills of traditional Chinese medicine extract in Comparative Example 7 is as follows:

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

[0046] Experimental Example 1: Hypolipidemic efficacy on animal models of mixed hyperlipidemia

[0047] 1. Samples and materials

[0048] 1.1 Samples

[0049] Compound dropping pills of traditional Chinese medicine extract from Examples 1 - 5 and Comparative Examples 1 - 7.

[0050] 1.2 Experimental animals

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

[0052] 1.3 High - fat model feed

[0053] Add 20% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate to the maintenance feed, and add appropriate amounts of casein, calcium hydrogen phosphate, stone powder, etc. Each index meets the national standard of maintenance feed, provided by Beijing Keao Xieli Feed Co., Ltd., production license number: SCXK(Beijing)2019 - 0003, SPF grade.

[0054] 1.4 Instruments and reagents

[0055] Microplate reader (model SpectraMaxi3xplatform) produced by Molecular - Device of the United States and kits for TC, TG, HDL - C, and LDL - C produced by Nanjing Jiancheng Bioengineering Institute.

[0056] 1.5 Dose design

[0057] In Example 1, the compound herbal extract droplets were administered at doses of 0.166 g / kg BW, 0.083 g / kg BW, and 0.042 g / kg BW as the high, medium, and low dose groups, respectively, which are equivalent to 20 times, 10 times, and 5 times the recommended human dose, respectively. In Examples 2-5 and Comparative Examples 1-7, the compound herbal extract droplets were administered at a dose of 0.166 g / kg BW as the high dose group. 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 included, with 10 animals in each group.

[0058] 1.6 Sample Preparation

[0059] Appropriate amounts of the compound herbal extract pills from Examples 1-5 and Comparative Examples 1-7 were ground into powder. 0.83g, 0.415g, and 0.21g of the compound herbal extract pills from Example 1, 0.83g of the compound herbal extract pills from Examples 2-5 and Comparative Examples 1-7, and 0.036g of simvastatin were weighed using an analytical balance. Each was diluted to 50mL with pure water using a volumetric flask, vortexed, and then transferred to a beaker. Animals in the corresponding dosage groups were administered the powder by gavage at a dose of 10mL / kg body weight. The high-fat model control group and the blank control group were given the same volume of pure water. The administration was once daily for 30 consecutive days.

[0060] 1.7 Test Methods

[0061] After animal quarantine and maintenance diet, rats were randomly divided into two groups according to their body weight (202g-220g): a model group (n=160) and a control group (n=10). The model group rats were fed a high-fat model diet, while the control group rats were fed a maintenance diet. Body weight was measured weekly. After 14 days of feeding, blood was collected from the fundus vein without fasting to measure TC, TG, LDL-C, and HDL-C. Based on TC levels, the model group was further divided into 16 subgroups: 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 subgroup. During the experiment, the low-dose group was given model feed and a low dose of the compound herbal extract pills from Example 1; the medium-dose group was given model feed and a medium dose of the compound herbal extract pills from Example 1; the twelve high-dose groups were given model feed and high doses of the compound herbal extract pills from 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. All groups were given the same volume of pure water. At the end of the experiment, the participants were weighed, and blood was collected without fasting to measure four indicators: TC, TG, LDL-C, and HDL-C.

[0062] 1.8 Statistical Analysis of Experimental Data

[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 between 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 homogeneous variance, the transformed data were used for statistics; if the purpose of normality or homogeneous 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 Effects 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 body 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 body weight and body weight gain of rats in the model group (from the start of drug administration to the end of drug administration) were significantly higher than those in the blank control group (P < 0.01); there was no significant difference in the body weight and body 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 traditional Chinese medicine extracts in Example 1 had no obvious effect on the body weight of rats.

[0074] 2.2 Effects 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. Serum HDL-C in rats

[0081]

[0082] Table 8. Serum LDL-C in rats

[0083]

[0084]

[0085] The above is in Table 5-8.

[0086] Compared with the blank control group, the high-fat model control group, ### indicates P<0.001, and ## indicates P<0.01;

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

[0088] Comparison of the high-dose groups in Examples 1-7 with the high-dose group in Example 1, Δ This indicates that P < 0.05. ΔΔ This indicates that P < 0.01.

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

[0090] After the experiment, the serum TC values ​​of rats in the high- 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 differences were statistically significant. The serum TC values ​​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 differences were statistically significant. The serum TC values ​​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] In Examples 1-5, the serum TG levels in the high-dose groups and the positive control group were significantly lower than those in the high-fat model control group; in Comparative Examples 1-6, the serum TG levels in the high-dose groups were significantly higher than those in the high-dose group of Example 1; in Comparative Example 7, the serum TG levels in the high-dose group were not significantly different from those in the high-dose group of Example 1.

[0092] In Example 1, for each dose group, in the high-dose groups of Examples 2-5, and in the positive control group, there were no significant differences in the HDL-C values in the sera of rats compared with those in the high-fat model control group. In the high-dose groups of Comparative Examples 1-7, there were no significant differences in the HDL-C values in the sera of rats compared with those in the high-dose group of Example 1.

[0093] In the high-dose groups of Examples 1-5 and in the positive control group, the LDL-C values in the sera of rats were significantly lower than those in the high-fat model control group, and the differences were significant. In the high-dose groups of Comparative Examples 1-6, the LDL-C values in the sera of rats were significantly higher than those in the high-dose group of Example 1, and the differences were significant. In the high-dose group of Comparative Example 7, there were no significant differences in the LDL-C values in the sera of rats compared with those in the high-dose group of Example 1.

[0094] Experimental Example 2: Lipid-lowering efficacy on the animal model of acute hyperlipidemia replicated by egg yolk emulsion

[0095] 1. Materials and methods

[0096] 1.1 Samples

[0097] Compound dropping pills of traditional Chinese medicine extracts of Examples 1-5 and Comparative Examples 1-7.

[0098] 1.2 Experimental animals

[0099] 170 SPF-grade male Kunming mice, weighing 18-22 g, certificate number: 110324241100049626, provided by Beijing SpeyFort 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%.

[0100] 1.3 Instruments and reagents

[0101] Microplate reader (model SpectraMaxi3xplatform) produced by Molecular-Device Company of the United States and TC, TG, HDL-C, and LDL-C kits produced by Nanjing Jiancheng Bioengineering Research Institute.

[0102] 1.4 Dose design

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

[0104] 1.5 Sample Preparation

[0105] Appropriate amounts of the compound herbal extract pills from Examples 1-5 and Comparative Examples 1-7 were ground into powder. 0.249 g, 0.083 g, and 0.042 g of the compound herbal extract pills from Example 1, 0.083 g of the compound herbal extract pills from Examples 2-5 and Comparative Examples 1-7, and 0.010 g of simvastatin were weighed using an analytical balance. Each was diluted to 50 mL with physiological saline in a volumetric flask, vortexed, and then transferred to a beaker. Animals in the corresponding dose groups were administered the powder by gavage at a dose of 10 mL / kg body weight (BW). The model group and the normal group were given the same volume of physiological saline. Gavage was performed once daily for 7 consecutive days.

[0106] 1.6 Test Methods

[0107] One hundred and seventy healthy male Kunming rats weighing 18-22g were acclimatized for one week and then randomly divided into 17 groups according to their weight: one high-dose group, twelve medium-dose groups, one low-dose group, a model group, a normal group, and a positive control group (simvastatin 0.010g / kg.BW), with 10 rats in each group. The high-dose group was administered 0.249g / kg.BW of the compound herbal extract pills of Example 1 by gavage. The twelve medium-dose groups were administered 0.083g / kg.BW of the compound herbal extract pills of Examples 1-5 and Comparative Examples 1-7 by gavage. The low-dose group was administered 0.042g / kg.BW of the compound herbal extract pills of Example 1 by gavage. The normal group and the model group were administered the same amount of physiological saline as the treatment group by gavage. The remaining groups were administered the drug by gavage for 7 consecutive days, with a gavage volume of 0.1mL / 10g. Two hours after administration on day 7, the model group and the treatment group were injected intraperitoneally with egg yolk milk, 0.2 mL per 10 g body weight per mouse; the normal group was injected intraperitoneally with an equal volume of physiological saline to establish an acute hyperlipidemic mouse model. The mice were fasted but allowed free water. After 12 hours, the eyeballs were removed and blood was collected. After blood agglutination, the samples were centrifuged at 3500 rpm at 4°C for 15 minutes. The supernatant serum was collected and serum TC, TG, LDL-C, and HDL-C were measured according to the instructions of the respective assay kits.

[0108] 1.7 Statistical Analysis of Experimental Data

[0109] The experimental data were analyzed by analysis of variance. First, the 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, P ≤ 0.05, pairwise comparisons of the means between multiple experimental groups and one 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 homogeneous variance, the transformed data were used for statistics; if the purpose of normality or homogeneous 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 ​​in the model group were significantly higher than those in the normal group, and the differences were all highly significant, indicating that the model was successfully established.

[0126] In Example 1, the serum TC values ​​of mice in each dose group, the medium dose groups in Examples 2-5, and the positive control group were significantly lower than those in the model group, and the differences were highly significant. In Comparative Examples 1-6, the serum TC values ​​of mice in the medium dose groups were significantly higher than those in the medium dose group in Example 1, and the differences were significant. In Comparative Example 7, the serum TC values ​​of mice in the medium dose group were not significantly different from those in the medium dose group in Example 1.

[0127] In Example 1, the serum TG levels of mice in the high-dose group, medium-dose group, medium-dose groups in Examples 2-5, and the positive control group were significantly lower than those in the model group; the differences were statistically significant. In Comparative Examples 1-6, the serum TG levels of mice in the medium-dose group were significantly higher than those in the medium-dose group in Example 1; the differences were statistically significant. In Comparative Example 7, the serum TG levels of mice in the medium-dose group were not significantly different from those in the medium-dose group in Example 1.

[0128] There were no significant differences in HDL-C levels in the serum of mice in each dose group of Example 1, the medium dose groups of Examples 2-5, and the positive control group compared with the model group; there were no significant differences in HDL-C levels in the serum of mice in the medium dose groups of Comparative Examples 1-7 compared with the medium dose group of Example 1.

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

[0130] Test Example 3: Acute Toxicity Test

[0131] 1. Materials and Methods

[0132] 1.1 Sample

[0133] Example 1: Compound Droplets of Traditional Chinese Medicine Extracts.

[0134] 1.2 Experimental Animals

[0135] Twenty SD rats, with 10 males and 10 females, weighing 160 - 180 g, quality certificate number (male): 110324231107726346, quality certificate number (female): 110324231107726018; twenty Kunming mice, with 10 males and 10 females, weighing 14 - 18 g, quality certificate number (male): 110324231107692031, quality certificate number (female): 110324231107691943. Provided by Speveto (Beijing) Biotechnology Co., Ltd., production license number: SCXK(Beijing)2019 - 0010, SPF grade. Laboratory animal housing license number: SYXK(Yunnan)K2022 - 0004, temperature 20 - 25 °C, humidity 45% - 65%.

[0136] 1.3 Instruments and reagents

[0137] 1.3.1 Main instruments and items

[0138] Electronic balance, dissection instruments, etc.

[0139] 1.3.2 Main reagents

[0140] Paraformaldehyde (biosharp company, batch number: 23130618)

[0141] 1.4 Acute oral toxicity test (for rats and mice)

[0142] For the acute oral toxicity test of rats, 20 SD rats were selected, with 10 males and 10 females, weighing 160 - 180 g; for the acute oral toxicity test of mice, 20 Kunming mice were selected, with 10 males and 10 females, weighing 14 - 18 g. On the basis of the preliminary test, in the formal test, 10.0 g / kg.BW (equivalent to 1200 times the human recommended dose) was set as the gavage dose according to the limit method. Rats were fasted for 16 h before gavage, with unrestricted drinking water, and the sample was administered by oral gavage twice at 20 mL / kg.BW at an interval of 6 h; mice were fasted for 6 h before gavage, with unrestricted drinking water, and the sample was administered by oral gavage once at 40 mL / kg.BW. The poisoning symptoms and death conditions of the animals were continuously observed for 14 days after gavage. The weights of rats and mice were measured at the start of the test, on the 7th day, and on the 14th day. After the test ended, the animals were sacrificed for gross dissection.

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

[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 Tables 13 and 14, after administering the sample to rats and mice via gavage at a dose of 10.0 g / kg BW (equivalent to 1200 times the recommended human dose) according to the limit method, the animals grew well, their weight was not affected, and no obvious symptoms of poisoning were observed. No animals died during the 14-day observation period. At the end of the experiment, the animals were dissected, and gross examination revealed no significant abnormalities in the major organs, including the liver, kidneys, spleen, heart, lungs, stomach, and intestines. The results indicate that the acute oral LD50 of this sample for both male and female rats and mice is greater than 10.0 g / kg BW, and the compound herbal extract pills from 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] Example 1: Compound Droplets of Traditional Chinese Medicine Extracts.

[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 Spf Biotechnology (Beijing) Co., Ltd., production license number: SCXK (Beijing) 2019 - 0010, SPF grade. Laboratory animal house 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] Automatic coagulation analyzer (C3100), animal - specific automatic biochemical analyzer (CatalystOne), animal five - classification hematology analyzer (ProCyteDX), urine analyzer (UC - 200B), microplate reader (SpectraMaxI3X), electrolyte analyzer (K - Lite8G), electronic balance, microscope, centrifuge, constant temperature water bath, dissection instruments, ophthalmoscope, pathological slicer, etc.

[0159] 1.3.2 Main Reagents

[0160] Biochemical assay kits (produced by Nanjing Jiancheng Bioengineering Institute), hematology 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 Youlit Medical Electronics Co., Ltd.), etc.

[0161] 1.4 Long - term Oral Toxicity Test

[0162] One hundred SD rats (half male and half female), weighing 50-70g, were selected. Dosage design: three dosage groups were established: 0.83g / kg BW, 0.42g / kg BW, and 0.21g / kg BW (equivalent to 100, 50, and 25 times the recommended human dose, respectively). A negative control group (pure water) was also included. Each group consisted of 20 rats (half male and half female). Additionally, a high-dose group and a negative control group were established for the recovery period, with 10 rats (half male and half female) in each group. Preparation of compound herbal extract pills: An appropriate amount of the compound herbal extract pills from Example 1 was ground into powder. Samples of 3.32g, 1.66g, and 0.83g were added, and pure water was added to 40mL. The powder was mixed thoroughly to prepare suspensions of 8.3%, 4.2%, and 2.1% for gavage in the high, medium, and low dose groups, respectively. Pure water was used as a negative control. The gavage volume was 10 mL / kg BW, administered orally once daily for 90 consecutive days. The recovery observation group was observed for 14 days after discontinuation of the test substance. General manifestations, behavior, poisoning symptoms, and mortality of the animals were observed daily. Food intake and body weight were measured weekly, and food utilization rate was calculated based on food intake. Before and at the end of the experiment, ocular examinations (cornea, conjunctiva, iris) were performed on the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group). At the end of the experiment, the fasting body weight of rats after 16 hours of fasting was measured. Blood was collected after anesthesia, and the animals were sacrificed. Hematological parameters were measured using a ProCyteDX hematology analyzer and a C3100 fully automated coagulation analyzer. Blood biochemical parameters were measured using a CatalystOne fully automated biochemical analyzer and reagent kits produced by Nanjing Jiancheng Bioengineering Institute. UC-

[0163] A 200B urine analyzer was used to measure urine parameters. Animals were dissected to observe changes in internal organs; the liver, spleen, kidneys, adrenal glands, heart, thymus, and testes were weighed, and their organ-to-body ratio was calculated. Histopathological examinations were performed on the brain, thyroid gland, thymus, heart, liver, spleen, kidneys, adrenal glands, stomach, duodenum, colon, pancreas, mesenteric lymph nodes, ovaries, testes, and bladder. Animals had free access to food and water during the experiment.

[0164] 1.5 Statistical Analysis of Experimental Data

[0165] Long-term oral toxicity test data were subjected to homogeneity of variance testing. If the variances were homogeneous, one-way ANOVA 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 variances were not homogeneous, appropriate variable transformations were performed on the data. After satisfying the homogeneity of variance test, the transformed data were used for statistical analysis. If the transformed data still did not meet the homogeneity of variance requirement, the rank-sum test was used for statistical analysis.

[0166] 2 Results

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

[0168] During the experiment, the animals were in good health and their weight continued to increase. No obvious poisoning symptoms were observed in rats in each dose group after they were given different doses of the sample every day, and no animals died.

[0169] 2.1.1 Effects on rat body weight

[0170] Table 15 (Experimental Group) Rats' Body Weight and Fasting Weight

[0171]

[0172]

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

[0174] Table 16 (Recovery Period Observation Group) Rats' Body Weight and Fasting Weight

[0175]

[0176]

[0177] As shown in Tables 15 and 16, the differences between the medium-dose group and the negative control group in weeks 1, 4, 5, 6, 9, 10, 11, 12, and 13 of the experimental group were statistically significant (P<0.05); the differences between the low-dose group and the negative control group in weeks 3, 4, 7, and 8, as well as in total weight gain, were statistically significant (P<0.05); and the differences between the low-dose group and the negative control group in weeks 6, 9, 11, 12, and 13 were statistically significant (P<0.01). In the experimental group, the high-dose group showed a significant difference compared with the negative control group in week 1 (P<0.05); the medium-dose group showed a significant difference compared with the negative control group in week 4 (P<0.01); and the low-dose group showed significant differences compared with the negative control group in weeks 1 and 4 (P<0.01). During the recovery period, there were no significant differences in initial body weight, weekly body weight, total weight gain, and fasting weight between the male and female rats in each dose group and the negative control group (P>0.05).

[0178] 2.3.2 Effect on food intake in rats

[0179] Table 17 (Experimental Group) Food Intake and Total Food Intake of Rats at Each Week

[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 Period Observation Group) Food Intake and Total Food Intake of Rats at Each Week

[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 shown in Tables 17 and 18, the differences between the high-dose group and the negative control group in the experimental group were statistically significant (P<0.05) at weeks 1, 5, and 12, and significantly different (P<0.001) at weeks 2, 3, 4, and 13. The differences between the medium-dose group and the negative control group were statistically significant (P<0.05) at weeks 5, 7, and 11, and significantly different (P<0.01) at week 13, and significantly different (P<0.001) at weeks 2, 3, and 4. During the recovery period (recovery observation group), the food intake of female mice in weeks 2, 3, and 4 was significantly different (P<0.05) compared to the negative control group.

[0188] 2.3.3 Effect on food utilization rate in rats

[0189] Table 19 (Experimental Group) Food Utilization Rate of Rats

[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 Period Observation Group) Food Utilization Rate of Rats

[0194]

[0195]

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

[0197] As shown in Tables 19 and 20, in the experimental groups, the high-dose group of female mice showed significant differences compared with the negative control group at week 2 (P<0.05); the high-dose group of male mice showed significant differences compared with the negative control group at weeks 4, 8, and 10 (P<0.05); the medium-dose group showed significant differences compared with the negative control group at weeks 4, 5, and 8 (P<0.01); and the low-dose group showed significant differences compared with the negative control group at weeks 1, 2, 4, 5, 8, and 11 (P<0.01). In the recovery period, there were no significant differences between the male mice in the observation group and the negative control group at weeks 4, 5, and 8 (P<0.001).

[0198] 2.3.4 Effects on rat hematology

[0199] Table 21 (Experimental Group) Hematological Indicators of Rats

[0200]

[0201]

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

[0203] Table 22 (Hematological Indicators of Rats in the Recovery Period Observation Group)

[0204]

[0205] Note: *P indicates <0.05 compared with the negative control group.

[0206] As shown in Tables 21 and 22, in the experimental group, the high-dose group of female mice showed highly significant differences in granulocytes and lymphocytes compared with the negative control group (P<0.01); the medium-dose and low-dose groups showed significant differences in platelet counts compared with the negative control group (P<0.05); and the low-dose group showed significant differences in hemoglobin compared with the negative control group (P<0.05). In the experimental group, the high-dose and low-dose groups of male mice showed highly significant differences in hematocrit compared with the negative control group (P<0.01). The high-dose group showed significantly higher granulocyte counts and lymphocyte counts compared with the negative control group. Compared with the negative control group, the lymphocyte counts in the medium-dose group showed significant differences (P<0.05). The granulocyte and lymphocyte counts in the medium-dose group also showed significant differences compared with the negative control group (P<0.01). The hemoglobin levels in female mice in the recovery period observation group showed extremely significant differences compared with the negative control group (P<0.01), and the monocyte counts in male mice also showed extremely significant differences compared with the negative control group (P<0.01). All of the above values ​​were within the normal range. There were no significant differences in the remaining hematological indicators compared with the negative control group.

[0207] 2.3.5 Effects on rat blood biochemistry

[0208] Table 23 (Experimental Group) Blood Biochemical Indicators of Rats

[0209]

[0210]

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

[0212] Table 24 (Recovery Period Observation Group) Blood Biochemical Indicators of Rats

[0213]

[0214]

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

[0216] As shown in Tables 23 and 24, the total protein, serum urea, chloride ion, and sodium ion levels in the high-dose group of female mice were significantly different from those in the negative control group (P<0.01). The total cholesterol levels in the high- and medium-dose groups were significantly different from those in the negative control group (P<0.001). The aspartate aminotransferase and blood glucose levels in the medium-dose group were significantly different from those in the negative control group (P<0.01). The triglycerides and blood glucose levels in the low-dose group were significantly different from those in the negative control group (P<0.05). Compared with the negative control group, the total protein, albumin / globulin ratio, blood glucose, blood glucose, and gamma-glutamyl transferase in the high-dose group and the medium-dose group of the experimental male rats were significantly different (P<0.01). The alanine aminotransferase, aspartate aminotransferase, total protein, serum urea, and potassium ions in the high-dose and medium-dose groups were all significantly different (P<0.05) compared with the negative control group. All of the above values ​​were 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) Urine Indicators of Rats

[0219]

[0220]

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

[0222] Table 26 (Recovery Period Observation Group) Urine Indicators in Rats

[0223]

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

[0225] As shown in Tables 25 and 26, the pH and occult blood levels in the high-dose female rats of the experimental group were significantly different from those in the negative control group (P<0.01). The urine specific gravity, pH, and occult blood levels in the high-dose male rats of the experimental group were significantly different from those in the negative control group (P<0.01). The urine protein and occult blood levels in the female rats of the recovery period observation group were significantly different from those in the negative control group (P<0.01). The urine protein levels in the male rats of the recovery period observation group were significantly different from those in the negative control group (P<0.01). There were no significant differences in the urine test results of the remaining groups of male and female rats compared with the negative control group (P>0.05).

[0226] 2.3.7 Effect on the organ-to-body ratio in rats

[0227] Table 27 (Experimental Group) Visceral-to-body Ratio of Rats

[0228]

[0229]

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

[0231] Table 28 (Recovery Period Observation Group) Visceral-to-body Ratio of Rats

[0232]

[0233]

[0234] Note: *P indicates <0.05 compared with the negative control group.

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

[0236] 2.3.8 Effects on rat histopathology

[0237] Table 29 Scoring table for pathological and histological examination of various organs of experimental rats

[0238]

[0239] Table 30 Scoring table for pathological and histological examination of various organs of experimental rats

[0240]

[0241] Table 31 Scoring table for pathological and histological examination of various organs of experimental rats

[0242]

[0243] Table 32 Scoring table for pathological and histological examination of various organs of rats in the experiment.

[0244]

[0245] Table 33 Scoring table for pathological and histological examination of various organs of rats in the experiment.

[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 condition, and no obvious abnormalities were found in any organ.

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

[0251] Negative control group: Chronic inflammatory changes were observed in the lungs in 3 cases (3 / 10, 1 / 5 in females, 2 / 5 in males); inflammatory cell infiltration was observed in the trachea in 3 cases (3 / 10, 2 / 5 in females, 1 / 5 in males); localized inflammatory cell infiltration was observed in the liver in 3 cases (3 / 10, 1 / 5 in females, 2 / 5 in males); hepatocellular steatosis was observed in 1 case (1 / 10, 0 / 5 in females, 1 / 5 in males); splenic congestion was observed in 1 case (1 / 10, 1 / 5 in females, 0 / 5 in males); and inflammatory cell infiltration was observed in the renal cortex in 1 case (1 / 10, 1 / 5 in females, 0 / 5 in males). No obvious abnormalities were observed in the gastrointestinal tract, ovaries, testes, brain, thyroid gland, pituitary gland, thymus, adrenal gland, prostate, mesenteric lymph nodes, pancreas, uterus, breast, esophagus, arteries, spinal cord, bone marrow, sciatic nerve, epididymis, bladder, and other organs.

[0252] High-dose group: Chronic inflammatory changes were observed in the lungs in 5 cases (5 / 10, 2 / 5 females, 3 / 5 males); inflammatory cell infiltration was observed in the trachea in 1 case (1 / 10, 1 / 5 females, 1 / 5 males); localized inflammatory cell infiltration was observed in the liver in 2 cases (2 / 10, 2 / 5 females, 0 / 5 males); hepatocellular steatosis was observed in 1 case (1 / 10, 1 / 5 females, 0 / 5 males); and localized basophilic renal tubules were observed in the renal cortex in a few animals in 1 case (1 / 10, 0 / 5 females, 1 / 5 males). One case of thyroid follicular cell hyperplasia (1 / 10, female 1 / 5, male 0 / 5), one case of renal cortical inflammatory cell infiltration (1 / 10, female 0 / 5, male 1 / 5), and one case of glomerular congestion (1 / 10, female 0 / 5, male 1 / 5) were observed. No obvious abnormalities were found in the spleen, gastrointestinal tract, ovary, testis, brain, pituitary gland, thymus, adrenal gland, prostate, mesenteric lymph nodes, pancreas, uterus, mammary gland, esophagus, arteries, spinal cord, bone marrow, sciatic nerve, epididymis, bladder, and other organs.

[0253] The 90-day feeding trial results showed inflammatory changes in the lungs, trachea, and liver of rats, but there was no significant difference between the high-dose group and the negative control. Histological pathological changes in other organs were not obvious. The compound herbal extract pills from Example 1 did not have a significant effect on the rat organs.

[0254] 2.3.9 Eye examination

[0255] Table 35 Results of rat ocular examination before the experiment

[0256]

[0257] Table 36 Results of rat ocular examination after the experiment

[0258]

[0259] As shown in Tables 35 and 36, no ocular abnormalities were found in the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group) before and at the end of the experiment.

[0260] 3. Summary

[0261] The compound herbal extract pills from Example 1 were administered to rats at three dosage groups: 0.83 g / kg BW, 0.42 g / kg BW, and 0.21 g / kg BW (equivalent to 100, 50, and 25 times the recommended human dose, respectively). A negative control group (pure water) was also included, along with a recovery observation group. Rats were continuously administered the pills via gavage for an extended period. During the experiment, the animals showed good growth and development. No significant adverse effects were found on the 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 experiment, ocular examinations (cornea, conjunctiva, and iris) were performed on the high-dose group (including the recovery observation group) and the negative control group (including the recovery observation group), and no ocular abnormalities were found. Gross anatomical observation revealed no abnormal changes related to the compound herbal extract pills; histopathological changes were not significant. No toxic side effects were observed in rats at the dosage range of 0.21 g / kg.BW-0.83 g / kg.BW for any of the observed indicators.

[0262] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A compound dripping pill made from a traditional Chinese medicine extract for treating hyperlipidemia, characterized in that, By weight, it consists of the following components: 6-15 parts total saponins of Panax notoginseng, 2-6 parts scutellarin, 4-8 parts hawthorn leaf extract, and 30 parts polyethylene glycol 4000.

2. The compound dripping pills of traditional Chinese medicine extract for treating hyperlipidemia according to claim 1, characterized in that, The compound pills containing traditional Chinese medicine extracts are composed of the following components by weight: 10 parts total saponins of Panax notoginseng, 4 parts scutellarin, 6 parts hawthorn leaf extract, and 30 parts polyethylene glycol 4000.

3. A method for preparing a compound dripping pill of traditional Chinese medicine extract for treating hyperlipidemia as described in claim 1 or 2, characterized in that, The process includes the following steps: mixing the ingredients according to the formula, heating and melting the mixture, and then dripping it into cooled liquid paraffin to obtain compound pills made from traditional Chinese medicine extracts.

4. The use of the compound dripping pills of traditional Chinese medicine extract for treating hyperlipidemia as described in claim 1 or 2 in the preparation of a drug for treating hyperlipidemia.

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