A hypolipidemic composition, its preparation method and use

Abstract

The present application relates to the field of food and / or medicine technology, and discloses a hypolipidemic composition, a preparation method and application thereof.The hypolipidemic composition comprises Echium seed oil, Nigella seed oil and safflower seed oil.The present application uses specific natural substances, i.e.Echium seed oil, Nigella seed oil and safflower seed oil, as the functional components, and forms a natural composition which can significantly reduce total cholesterol and triglyceride and increase the content of serum apolipoprotein A1, and has obvious hypolipidemic effect, and can be applied to the development and preparation of hypolipidemic medicine and food, especially health food.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of food and / or medicine, in particular to a blood lipid-lowering composition and a preparation method and application thereof. BACKGROUND

[0002] The "cardiovascular" is the life river of human body. However, for decades, the diet content of modern people gradually tends to delicacy from the previous simple nature, and after entering the industrial society, the busy work and life make most of the office workers and labor population rely on "outside food", and efficiency easily replaces the consideration of health. Therefore, the blood lipid in the body begins to appear abnormal state with such changes, and the "river bed" of the blood vessels in the body is also subjected to severe test, and with the "hoarding" of fat in the blood, the blood vessel river bed is "helpless" to raise, and hyperlipidemia is also formed.

[0003] Hyperlipidemia is a "rich disease" derived from modern society, and hyperlipidemia is the source of many diseases, which is called "silent killer", and its damage to the body is hidden, gradual, progressive and systemic. Its direct damage is to accelerate the atherosclerosis of the whole body, and hyperlipidemia leads to atherosclerosis, which is the culprit of cardiovascular and cerebrovascular diseases. Hyperlipidemia can also cause fatty liver, cirrhosis, cholelithiasis, pancreatitis, ocular fundus hemorrhage, blindness, peripheral vascular disease, claudication, hyperuricemia and the like.

[0004] In recent years, people's living standards have improved significantly, and people's consumption concept and health concept have changed a lot. In order to avoid the adverse effects of unhealthy living, people pay more and more attention to the use of nutritional health products. At present, the health care food for improving three high syndrome exists in the form of oral liquid, tablet, animal glue soft capsule. However, oral liquid is not convenient to carry, has poor stability and short storage time; tablets mostly need to add a large amount of auxiliary materials such as starch and hydroxymethyl cellulose during tabletting, and the disintegration time is long; the disintegration time of animal glue soft capsule is long. At the same time, no matter which kind of product, the selection of functional ingredients is not perfect enough. SUMMARY

[0005] Therefore, the purpose of the present application is to provide a blood lipid-lowering composition, so that the composition has excellent blood lipid-lowering effect;

[0006] Another purpose of the present application is to provide the related application of the above-mentioned composition in medicine and / or food, especially health food.

[0007] In order to achieve the above-mentioned purpose of the application, the present application provides the following technical scheme:

[0008] A blood lipid-lowering composition, comprising blue sage seed oil, borage seed oil and safflower seed oil, preferably consisting of blue sage seed oil, borage seed oil and safflower seed oil.

[0009] The present application discloses a natural composition with significant lipid-lowering effect, which comprises Eragrostis pilosa seed oil, Brassica rapa seed oil and safflower seed oil as active ingredients. Preferably, the mass ratio of the Eragrostis pilosa seed oil, Brassica rapa seed oil and safflower seed oil is (95-60):(40-6):(20-2).

[0010] In the embodiment of the present application, the mass ratio of the Eragrostis pilosa seed oil, Brassica rapa seed oil and safflower seed oil is 9:1:1, 8:2:1, 8:1:1 or 7:3:1.

[0011] The composition of the present application is subjected to efficacy detection according to the auxiliary lipid-lowering function test method in the Technical Specifications for Health Food Inspection and Evaluation (2012 updated version). The results show that, compared with the model control group, the serum total cholesterol and triglyceride of each dose group of the composition are reduced, and the differences are significant. Meanwhile, the serum high-density lipoprotein cholesterol of the composition of the present application is higher than that of the model control group. The results show that the composition of the present application has the effect of reducing total cholesterol and triglyceride, and the results are positive. The effect is better than that of the positive control group of commercially available fish oil and atorvastatin calcium.

[0012] Meanwhile, the composition significantly improves the serum apolipoprotein A1 content of SD rats, and the effect is better than that of the positive control group of fish oil and atorvastatin calcium. Apo-A1 protein is the main protein component of high-density lipoprotein and is related to the formation of HDL protein particles. It is also an activator of lecithin-cholesterol acyltransferase and plays a major role in the reverse transport of cholesterol. Therefore, according to the results, it can be known that the composition of the present application can inhibit and improve the formation process of hyperlipidemia by adjusting the content of serum Apo-A1.

[0013] Based on the results of the above tests, the present application proposes the use of the lipid-lowering composition in the preparation of lipid-lowering drugs and / or food, in particular health food. Preferably, the food is health food, such as soft capsules, oral liquids, tablets and various forms of health food.

[0014] In the specific application process, the present application provides a lipid-lowering soft capsule, the content of which comprises the lipid-lowering composition of the present application, and other substances which do not affect the efficacy of the lipid-lowering composition can also be added.

[0015] The soft capsule of the present application is preferably prepared by wrapping the content with plant glue, wherein the plant glue contains carrageenan, oxidized starch, glycerol and water. The raw materials of the soft capsule are derived from plants, and are suitable for a wide range of people. Meanwhile, the disintegration time is shorter than that of gelatin soft capsules, and is more suitable for the preparation of the lipid-lowering soft capsule of the present application.

[0016] In addition, the application further provides a preparation method of the blood lipid-lowering composition. The Eupatorium adenophorum seeds, Brassica rapa seeds and safflower seeds are respectively crushed, pressed and the like to prepare oil, and the Eupatorium adenophorum seed oil, Brassica rapa seed oil and safflower seed oil are obtained after filtration. The blood lipid-lowering composition is obtained after mixing. In addition to the above preparation, the commercially available Eupatorium adenophorum seed oil, Brassica rapa seed oil and safflower seed oil can also be directly mixed.

[0017] The mixed blood lipid-lowering composition is filtered, filled with antioxidant gas and stored, and soft capsules can be prepared through a soft capsule technology.

[0018] As known from the above technical solution, the application uses specific natural substances, i.e., Eupatorium adenophorum seed oil, Brassica rapa seed oil and safflower seed oil, as efficacy components to form a natural composition which can significantly reduce total cholesterol and triglyceride and increase the content of serum apolipoprotein A1, and has obvious blood lipid-lowering efficacy. The natural composition can be applied to blood lipid-lowering drugs and / or food, and is particularly suitable for the development and preparation of health food. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 The figure is a line graph showing the influence of the composition of the application on the body weight of SD rats. Control represents a blank control group, M-control represents a model control group, H, M and L represent three dose groups of the composition of the application in order. DETAILED DESCRIPTION

[0020] The application discloses a blood lipid-lowering composition, a preparation method and application thereof. Those skilled in the art can refer to the content of the present application and appropriately improve process parameters. It should be particularly pointed out that all similar replacements and changes are obvious to those skilled in the art, and they are regarded as being included in the application. The composition, the preparation method and the application thereof have been described through examples, and relevant personnel can obviously make changes or appropriate changes and combinations to the composition, the preparation method and the application thereof described in the present application without departing from the content, spirit and scope of the application, so as to realize and apply the technology of the present application.

[0021] Unless otherwise specified, the same raw materials of the same source and quality are used in the specific embodiments of the application, and the test conditions are consistent except for the necessary differences.

[0022] The application provides a blood lipid-lowering composition, a preparation method and application thereof.

[0023] Example 1: The composition of the application

[0024] Eupatorium adenophorum seed oil 405 mg, Brassica rapa seed oil 45 mg and safflower seed oil 45 mg;

[0025] Example 2: The composition of the application

[0026] Bassia butyracea seed oil 400 mg, Brassica campestris seed oil 50 mg, and Crocus sativus seed oil 50 mg;

[0027] Example 3: The composition according to the present application

[0028] Bassia butyracea seed oil 360 mg, Brassica campestris seed oil 90 mg, and Crocus sativus seed oil 45 mg;

[0029] Example 4: The composition according to the present application

[0030] Bassia butyracea seed oil 315 mg, Brassica campestris seed oil 135 mg, and Crocus sativus seed oil 45 mg;

[0031] Example 5: Hypolipidemic efficacy test

[0032] Test subjects: Example 1-4 compositions, single-dose group (Bassia butyracea seed oil 500 mg), commercially available fish oil (EPA 180 mg, DHA 120 mg per 1000 mg fish oil, manufacturer Amway), and atorvastatin calcium (20 mg per tablet, active ingredient atorvastatin calcium 10 mg, manufacturer Pfizer Pharmaceutical Co., Ltd.) two positive control groups;

[0033] Reference is made to the auxiliary hypolipidemic function test method in the Technical Specifications for Inspection and Evaluation of Health Foods. SPF male SD rats were used as experimental animals, and after the adaptation period, a mixed hyperlipidemia animal model was established and randomly grouped according to the TC level.

[0034] Three dose groups, two positive control groups, a blank control group, and a model control group were set up. The test sample was set up at 5 times the recommended human dose (166.77 mg / kg) as one of the dose groups, and two other dose groups were set up at 10 times the recommended human dose (333.33 mg / kg) and 25 times the recommended human dose (833.33 mg / kg). The positive control group dose was 5 times the recommended human dose (fish oil: 150 mg / kg; atorvastatin calcium: 0.83 mg / kg). The blank control group and the model control group were given the corresponding volume of distilled water by gavage. The body weight of each group was measured regularly. After 30 days of test sample administration, blood was collected without fasting to separate serum, and the serum levels of TC (total serum cholesterol), TG (serum triglyceride), HDL-C (serum high-density lipoprotein cholesterol), and apo-A1 (serum apolipoprotein A1) were measured. The specific method is as follows:

[0035] 1. Adaptation period

[0036] Adaptation period: The rats were fed with maintenance feed under the barrier system for 5-7 days.

[0037] 2. Modeling period:

[0038] Rats were randomly divided into 22 groups of 6 rats each, based on their body weight. One group of rats was given a maintenance diet as a blank control group, while the other 21 groups were given a high-fat diet as a model control group. Rats were weighed once a week.

[0039] After the model control group was fed a high-fat diet for 20 days, blood was collected from rats in both the blank control group and the model control group without fasting (1-1.5 mL of blood was collected from the tail vein). Serum was quickly separated into new centrifuge tubes and stored at -20°C for later testing. Serum levels of TC, TG, LDL-C, and HDL-C were measured using an ELISA kit to detect total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol in rats. Based on TC levels, the model control group was randomly divided into a model group, a fish oil control group, an atorvastatin calcium control group, and six sample groups. Each sample group had three dose groups.

[0040] 3. Administration of test samples: After grouping, the three dosage groups were administered the test samples orally daily, while the two positive control groups were administered diluted positive control fish oil and diluted atorvastatin calcium solutions orally daily. The blank control group and the model control group were simultaneously given the corresponding volume of distilled water. The blank control group continued to be given a maintenance diet, while the positive control group, the model control group, and the three dosage groups continued to be given a high-fat diet. Body weight was measured regularly. At the end of the experiment, blood was collected by enucleation without fasting. Serum was separated as soon as possible after blood collection, and serum TC, TG, HDL-C, and apo-A1 levels were measured.

[0041] 4. Data Processing and Result Judgment: Data can be processed using analysis of variance (ANOVA), but a homogeneity of variance test must be performed first according to the ANOVA procedure. If the variances are homogeneous, calculate the F-value. If the F-value < F... 0.05 Conclusion: There was no significant difference between the means of each group: F-value ≥ F 0.05 If P ≤ 0.05, statistical analysis is performed using pairwise comparisons of the means among multiple experimental groups and one control group. Appropriate variable transformations are applied to non-normal or unequal variance data. Once the data meets the requirements for normality or homogeneity of variance, statistical analysis is performed using the transformed data. If the transformation still does not achieve normality or homogeneity of variance, the rank-sum test is used for statistical analysis.

[0042] 5. Referring to the "Technical Specifications for Inspection and Evaluation of Health Foods" (2012 updated version), the following criteria were used to determine the results of the auxiliary function of lowering blood lipids: Compared with the blank control group, the model control group showed significant differences in serum triglycerides, serum total cholesterol or low-density lipoprotein cholesterol.

[0043] (1) Compared with the model control group, the serum total cholesterol or low-density lipoprotein cholesterol in each dose group decreased and the serum triglycerides in each dose group decreased significantly. At the same time, the serum high-density lipoprotein cholesterol in each dose group was not significantly lower than that in the model control group. Therefore, the animal experiment results of the test sample's function of assisting in lowering blood lipids were positive.

[0044] (2) Compared with the model control group, the serum total cholesterol or low-density lipoprotein cholesterol in each dose group decreased significantly. At the same time, the serum triglycerides in each dose group were not significantly higher than those in the model control group, and the serum high-density lipoprotein cholesterol in each dose group was not significantly lower than those in the model control group. Therefore, the animal experiment results of the test sample's function of assisting in lowering cholesterol were positive.

[0045] (3) Compared with the model control group, serum triglycerides decreased in each dose group and the difference was significant. At the same time, serum total cholesterol and low-density lipoprotein cholesterol in each dose group were not significantly higher than those in the model control group, and serum high-density lipoprotein cholesterol was not significantly lower than those in the model control group. Therefore, the animal experiment results of the test sample in assisting to reduce triglycerides were positive.

[0046] 6. Results

[0047] (1) Establishment of a mixed hyperlipidemia SD rat model

[0048] The serum TC level in the blank control group was 936.46 μmol / L, while the TC level in the model control group was 1148.96 μmol / L, showing a significant difference compared to the blank control group (P = 0.004, < 0.01). The serum TG level in the blank control group was 146.20 μmol / L, while the TG level in the model control group was 190.62 μmol / L, showing a significant difference compared to the blank control group (P = 0.005, < 0.01). The serum HDL-C level in the blank control group was 727.84 μmol / L, while the level in the model control group was 734.67 μmol / L, showing no significant difference compared to the blank control group (P = 0.902, > 0.05). The serum LDL-C level in the blank control group was 810.07 μmol / L, while the level in the model control group was 947.36 μmol / L, showing a significant difference compared to the blank control group (P = 0.013, < 0.05). Compared with the control group, the serum TG level, serum TC and LDL-C levels of this animal experimental model were significantly increased, indicating that the mixed hyperlipidemia SD rat model was successfully established.

[0049] (2) Effect on body weight of SD rats

[0050] Figure 1The results showed that the weight gain rate of the high-fat diet groups in Example 1 and the model control group was significantly higher than that of the maintenance diet group, but there was no significant difference in weight between the high-fat diet groups and the model control group. These results indicate that the composition of this invention has no significant effect on the weight of SD rats.

[0051] (3) Effect on serum total cholesterol (TC) levels in SD rats

[0052] Table 1

[0053]

[0054]

[0055] Note: * indicates the difference between the blank group and the high-fat model group, where ** indicates P < 0.01; * indicates P < 0.05; # indicates the difference between each dose group of the sample and the high-fat model group, where ## indicates P < 0.01; # indicates P < 0.05.

[0056] Table 1 shows that the serum TC content in the high-dose group of the composition in Example 1 of this invention was 977.98 μmol / L, which was significantly different from the model control group (1148.96 μmol / L) (P < 0.05); the serum TC content in the medium and low-dose groups was 1053.20 μmol / L and 1077.21 μmol / L, respectively, which were not significantly different from the model control group (P > 0.05); the serum TC content in the high and medium-dose groups of Example 2 was 966.57 μmol / L and 1051.72 μmol / L, respectively, which were significantly different from the model control group (1148.96 μmol / L) (P < 0.01, P < 0.05); the serum TC content in the low-dose group was 1076.76 μmol / L, which was not significantly different from the model control group (P > 0.05). Meanwhile, there was no significant difference between the two positive control groups and the model control group. The results of this experiment show that the composition of Example 1 of the present invention can significantly reduce the serum TC content of SD rats, and the effect is better than that of fish oil and atorvastatin calcium.

[0057] (4) Effect on serum triglyceride (TG) levels in SD rats

[0058] Table 2

[0059]

[0060]

[0061] Note: * indicates the difference between the blank group and the high-fat model group, where ** indicates P < 0.01; * indicates P < 0.05; # indicates the difference between each dose group of the sample and the high-fat model group, where ## indicates P < 0.01; # indicates P < 0.05;

[0062] Table 2 shows that the serum TG content in the high-dose group of the composition in Example 1 was 159.03 μmol / L, which was significantly different from that in the model control group (190.62 μmol / L) (P < 0.05); the TG content in the medium-dose group was 155.19 μmol / L, which was significantly different from that in the model control group (P < 0.05); and the TG content in the low-dose group was 176.96 μmol / L, which was not significantly different from that in the model control group (P > 0.05).

[0063] In Example 2, the serum TG content in the high-dose group was 151.01 μmol / L, which was significantly different from that in the model control group (190.62 μmol / L) (P < 0.05); the serum TG content in the medium- and low-dose groups was 175.07 μmol / L and 178.85 μmol / L, respectively, which were not significantly different from those in the model control group (P > 0.05).

[0064] In Example 3, the serum TG content in the high-dose group was 154.94 μmol / L, which was significantly different from that in the model control group (190.62 μmol / L) (P < 0.05). In Example 4, the serum TG content in the high-dose group was 151.03 μmol / L, which was also significantly different from that in the model control group (190.62 μmol / L) (P < 0.05).

[0065] The serum TG levels in the high, medium, and low dose groups of the single-dose group were 180.92 μmol / L, 179.32 μmol / L, and 187.50 μmol / L, respectively, which were not significantly different from those in the model control group (190.62 μmol / L) (P > 0.05).

[0066] Meanwhile, there were no significant differences between the two positive control groups and the model control group. These experimental results indicate that the composition of this invention can significantly reduce serum TG levels in SD rats, with better effects than fish oil, atorvastatin calcium, and single-dose groups.

[0067] (5) Effect on serum high-density lipoprotein cholesterol (HDL-C) levels in SD rats

[0068] Table 3

[0069]

[0070]

[0071] Note: * indicates the high-fat model group compared with the blank group, where ** indicates P < 0.01; * indicates P < 0.05; # indicates the difference between each dose group of the sample and the high-fat model group, where ## indicates P < 0.01; # indicates P < 0.05;

[0072] Table 3 shows that the HDL-C levels in the serum of the high, medium, and low dose groups of the composition in Example 1 were 895.00 μmol / L, 997.48 μmol / L, and 839.52 μmol / L, respectively. Compared with the model control group (734.86 μmol / L), the medium dose group showed a highly significant difference (P < 0.01), and the high dose group showed a significant difference (P < 0.05).

[0073] In Example 2, the serum HDL-C levels in the sample groups were higher in all three dosage groups compared to the model group. The high-dose serum HDL-C level was 876.72 μmol / L, which was not significantly different from the model control group (734.86 μmol / L) (P > 0.05). The serum HDL-C levels in the medium- and low-dose groups were 895.46 μmol / L and 881.95 μmol / L, respectively. Compared with the model control group, the medium-dose group showed a significant difference (P < 0.05).

[0074] In Example 3, the HDL-C levels in the high, medium, and low dose groups were not significantly different from those in the model control group (734.86 μmol / L). In Example 4, the HDL-C levels in the serum of the high and medium dose groups were 898.88 μmol / L and 973.12 μmol / L, respectively, which were significantly different from those in the model control group (P < 0.05, P < 0.01). These results indicate that the composition of the present invention can significantly increase the serum HDL-C level in SD rats.

[0075] The serum HDL-C levels in the high, medium, and low dose groups of the single-dose group were 874.57 μmol / L, 881.54 μmol / L, and 887.16 μmol / L, respectively. Compared with the model control group (734.86 μmol / L), the serum HDL-C levels were slightly higher, but the difference was not statistically significant.

[0076] In the positive control group, only atorvastatin calcium showed a significant difference from the model group (P < 0.05). Compared with the single-dose group and the positive control group, the composition of the present invention is superior to both experimental groups overall.

[0077] (6) Effects on serum low-density lipoprotein cholesterol (LDL-C) levels in SD rats

[0078] Table 4

[0079] Group Mean ± SD M-control 947.36±89.26 Control 810.07±60.36 Fish oil 945.27±139.98 Atorvastatin calcium 853.24±236.19 Example 1H 907.27±243.42 Example 1M 920.78±90.08 Example 1L 983.71±183.33 Example 2H 810.92±80.28# Example 2M 868.11±109.04 Example 2L 807.88±148.94

[0080] Note: * indicates the difference between the blank group and the high-fat model group, where ** indicates P < 0.01; * indicates P < 0.05; # indicates the difference between each dose group of the sample and the high-fat model group, where ## indicates P < 0.01; # indicates P < 0.05;

[0081] Table 4 shows that the serum LDL-C content in the high, medium, and low dose groups of the composition in Example 1 was lower than that in the model group, but the difference was not statistically significant.

[0082] In Example 2, the serum LDL-C content in the high-dose group was 810.92 μmol / L, which was significantly different from that in the model control group (947.36 μmol / L) (P < 0.05). The serum LDL-C content in the medium- and low-dose groups was 868.11 μmol / L and 807.88 μmol / L, respectively. Compared with the model control group, the medium-dose group showed a significant difference (P < 0.05).

[0083] The positive control group showed no significant difference from the model group, especially the fish oil, which was even equivalent to the model group. This indicates that the composition of the present invention is superior to the positive control group.

[0084] (7) Effect on serum apolipoprotein A1 (apo-A1) levels in SD rats

[0085] Table 5

[0086] Group Mean ± SD M-control 2260.49±201.25 Control 2271.27±237.59 Fish oil 2645.26±626.25 Atorvastatin calcium 2693.76±435.48 Single dose group H 3057.53±389.92## Single dose group M 2715.42±324.11# Single dose group L 2325.71±540.44 Example 1H 2609.00±373.79 Example 1M 2675.43±496.39 Example 1L 2933.80±389.24## Example 2H 2725.43±357.92# Example 2M 2545.46±489.45 Example 2L 2717.48±401.72#

[0087] Note: * indicates the difference between the blank group and the high-fat model group, where ** indicates P < 0.01; * indicates P < 0.05; # indicates the difference between each experimental group and the high-fat model group, where ## indicates P < 0.01; # indicates P < 0.05.

[0088] Table 5 shows that the serum Apo-A1 content in the high, medium, and low dose groups of the composition of Example 1 of the present invention was 2609.00 μg / mL, 2675.43 μg / mL, and 2933.80 μg / mL, respectively. Compared with the model control group (2260.49 μg / mL), the low dose group showed a highly significant difference (P < 0.01).

[0089] In Example 2, the serum Apo-A1 levels in the high, medium, and low dose groups of the composition were 2725.43 μg / mL, 2545.46 μg / mL, and 2717.48 μg / mL, respectively. Compared with the model group, the high and low dose groups showed significant differences (P < 0.05).

[0090] The serum Apo-A1 levels in the high, medium, and low dose groups of the single-dose group were 3057.53 μg / mL, 2715.42 μg / mL, and 2325.71 μg / mL, respectively. Compared with the model group, the high and medium dose groups showed significant differences (P < 0.01, P < 0.05).

[0091] Meanwhile, there was no significant difference between the two positive control groups and the model control group. These experimental results indicate that the composition described in this invention can significantly increase the serum Apo-A1 level in SD rats, with better effects than fish oil and atorvastatin calcium.

[0092] Apo-A1 is a major component of HDL and is involved in the formation of HDL protein particles. It is also the main activator of LCAT (lecithin-cholesterol acyltransferase), which plays a key role in the reverse transport of cholesterol. The reverse transport of cholesterol catalyzes the conversion of non-esterified cholesterol scattered and deposited in the surrounding tissues into cholesterol, which enters HDL and is transported to the liver, where it is metabolized and excreted into the gallbladder.

[0093] Example 6: Comparison of disintegration time of soft capsules prepared with different excipients

[0094] Using the composition of Example 2 as the content of soft capsules, soft capsules were prepared by encapsulating the content with the following excipients, and the effects of different soft capsule excipients on the disintegration time of the same content were compared (mainly reflected in the fact that the differences in the excipient ratio for different types of content were not significant):

[0095] Capsule 1: Carrageenan, oxidized starch, glycerin, water;

[0096] Capsule 2: Gelatin, glycerin, water;

[0097] The contents of the two capsules are exactly the same, and the same ingredients in the excipients are exactly the same. The amount of carrageenan + oxidized starch in the different ingredients is equal to the amount of gelatin.

[0098] The instrument is generally equipped with 6 sets of measuring devices connected to the motor via basket shafts. Measurement method: Before measurement, the instrument should be adjusted so that the bottom of the rotating basket is 25mm ± 2mm from the inner bottom of the dissolution vessel. Measure the degassed dissolution medium separately and place it in each dissolution vessel. The actual measured volume should deviate from the specified volume by no more than ± 1%. After the temperature of the dissolution medium has stabilized at 37℃ ± 0.5℃, take 6 capsules of the test sample and place them separately into 6 dry rotating baskets. Lower the baskets into the dissolution vessels, ensuring there are no air bubbles on the surface of the test sample. Start the instrument at the speed specified for each product, observe for complete capsule disintegration, and record the time. The results are shown in the table below.

[0099] Table 6

[0100]

[0101] As can be clearly seen from the results in the table above, soft capsules prepared using the excipients of the present invention have a shorter disintegration time, making them easier to disintegrate in the gastrointestinal tract.

[0102] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. The use of a composition in the preparation of lipid-lowering drugs, characterized in that, The drug increases the level of high-density lipoprotein cholesterol in serum. The composition consists of blue thistle seed oil, shepherd's purse seed oil and safflower seed oil, wherein the mass ratio of blue thistle seed oil, shepherd's purse seed oil and safflower seed oil is 9:1:

1.

2. The application as described in claim 1, characterized in that, The composition is prepared by the following method: Blue thistle seeds, shepherd's purse seeds, and safflower seeds are crushed, pressed, and filtered to obtain blue thistle seed oil, shepherd's purse seed oil, and safflower seed oil, which are then mixed to obtain the composition.

3. The application as described in claim 1, characterized in that, The medicine is a soft capsule.

4. The application as described in claim 3, characterized in that, The soft capsule is prepared from the composition of claim 1, carrageenan, oxidized starch, glycerin and water.

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