CN107372861B

CN107372861B - Composition and application thereof in preparation of product for improving hyperlipidemia

Info

Publication number: CN107372861B
Application number: CN201710736049.7A
Authority: CN
Inventors: 牟媛; 易斌; 罗丽莲; 王曙宾; 肖艳皎; 郭珊珊
Original assignee: Beijing Silian Pharmaceutical Industry Co ltd
Current assignee: Beijing Silian Pharmaceutical Industry Co ltd
Priority date: 2017-08-24
Filing date: 2017-08-24
Publication date: 2021-04-13
Anticipated expiration: 2037-08-24
Also published as: CN107372861A

Abstract

The invention relates to the technical field of health care products, in particular to a composition and application thereof in preparing a product for improving hyperlipidemia. The composition provided by the invention consists of krill oil, a fish oil extract and plukenetia volubilis oil, has the effect of improving hyperlipidemia, the three components are matched with each other to play a remarkable synergistic effect, the effect of improving hyperlipidemia of the composition is remarkably superior to the effect of combining the two components or only using a single component under the same dosage, and p is less than 0.05. In addition, the arsenic content of the composition provided by the invention is low, and the composition can meet the standard of national standard health food for food safety on the arsenic content of health products.

Description

Composition and application thereof in preparation of product for improving hyperlipidemia

Technical Field

The invention relates to the technical field of health care products, in particular to a composition and application thereof in preparing a product for improving hyperlipidemia.

Background

Hyperlipidemia refers to a condition in which the level of one or more lipids in the plasma is higher than normal due to abnormal metabolism or movement of body fat. Lipids are insoluble or sparingly soluble in water and must be bound to proteins in the form of lipoproteins, and thus, hyperlipidemia is often hyperlipoproteinemia (hyperlipidemia), manifested by hypercholesterolemia, hypertriglyceridemia or both. Besides statins, fibrates, nicotinic acids, resins, ezetimibe and probucol, Omega-3 fatty acid preparations are also commonly used for assisting in reducing blood fat at present. Omega-3 fatty acid can promote neutral or acidic cholesterol to be discharged from feces, inhibit lipid and lipoprotein synthesis in liver, reduce cholesterol, triglyceride, Low Density Lipoprotein (LDL) and Very Low Density Lipoprotein (VLDL) in blood plasma, increase High Density Lipoprotein (HDL), participate in arachidonic acid metabolism, has effects of relaxing blood vessel, resisting blood platelet aggregation and resisting thrombi, and can be used for cardiovascular diseases such as hyperlipoproteinemia, atherosclerosis and coronary heart disease. Important Omega-3 essential fatty acids include alpha-linolenic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), all polyunsaturated fatty acids. Although Omega-3 fatty acids are essential nutrients for humans, humans cannot synthesize them by themselves and must obtain them from food.

Krill is the highest protein-containing organism found to date, has a protein content of more than fifty percent, and is extremely rich in amino acids and vitamins necessary for human tissues. Krill oil extracted from krill is widely used in the field of health products for the auxiliary reduction of blood lipid due to the content of certain amounts of Omega-3 fatty acids, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and the natural antioxidant astaxanthin.

Fish oil is a general term for all oily substances in fish bodies and comprises body oil, liver oil and naphtha. The fish oil extract is mainly composed of polyunsaturated fatty acids, especially EPA and DHA. These substances can reduce LDL cholesterol and triglyceride in human blood, increase HDL cholesterol, prevent atheromatous plaque formation, and prevent thrombosis by inhibiting platelet aggregation by affecting metabolism of other substances in vivo. DHA can also pass through the blood brain barrier, has important effect on nerve conduction, and is a good brain-strengthening substance.

The seeds of the Plukenetia volubilis (Plukenetia volubilis) are rich in high-quality protein, the oil is rich in Omega-3, Omega-6, Omega-9 polyunsaturated fatty acid, vitamin A, vitamin E and other trace elements, the unsaturated fatty acid content of the oil reaches more than 90 percent, and the Plukenetia volubilis has good nutrition effect on human bodies, and has the effects of preventing cardiovascular diseases and caring skin.

At present, most of products for regulating blood fat take krill oil as main components, so that the nutritional ingredients are single, and the risk of massive accumulation of arsenic elements in vivo is caused after long-term administration, therefore, the products for regulating blood fat with multiple components are found, the nutritional ingredients are enriched, and the effect of further improving the blood fat regulation effect is still the key point of current research.

Disclosure of Invention

In view of the above, the technical problem to be solved by the present invention is to provide a composition and its application in preparing a product for improving hyperlipidemia, wherein the composition has a significantly better effect of regulating blood lipid than a single component.

The composition provided by the invention comprises krill oil, a fish oil extract and embelia oil.

The krill oil, the fish oil extract and the plukenetia volubilis linneo oil are compounded, and the result proves that the compounding of the krill oil, the fish oil extract and the plukenetia volubilis linneo oil can generate obvious synergistic effect, the effect of the composition is obviously superior to that of the composition of the krill oil and the fish oil or a single component under the same dosage, and p is less than 0.05. In addition, through detection, the arsenic content of the composition provided by the invention is low, and the composition can meet the standard of national standard health food for food safety on the arsenic content of health products.

The krill oil, fish oil extract or meadowfoam oil according to the present invention may be obtained by self-production or may be obtained by legal commercial means, and the present invention is not limited thereto. In the embodiment of the invention, the krill oil is from ocean biology Limited, Akkery, Norway, and the mass fractions of DHA, EPA and phospholipid are 3%, 6% and 38% in sequence; the fish oil extract is from Pasteur (China) GmbH, and the DHA and EPA have mass fractions of 20% and 50% in sequence; the plukenetia volubilis linneo oil is from Puer allied biological resource development limited company, and the mass fraction of linolenic acid is 35%.

In the embodiment of the invention, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): (20-30): (40-60).

The mass ratio of the materials is (20-30): (20-30): (40-60), the krill oil, the fish oil extract and the embelia nasuta oil can generate obvious synergistic effect, and have good regulation effect on the blood fat content of a human body.

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (25-30): (25-30): (40-50).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-25): (20-25): (50-60).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (25-30): (20-25): 50.

in some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-25): (25-30): 50.

in some embodiments, the krill oil, fish oil extract, plukenetia volubilis oil are in a weight ratio of 30: (20-30): (40-50).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): 30: (40-50).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): 20: (50-60).

In some embodiments, the krill oil, the fish oil extract, and the meadow nut oil are in a mass ratio of 20: (20-30): (50-60).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (25-30): (20-30): 50.

in some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): (20-25): (50-60).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (25-30): (20-25): (50-60).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-25): (20-30): (50-60).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): (20-30): (40-50).

In some embodiments, the mass ratio of the krill oil, the fish oil extract and the calamus macrocarpa oil is (20-30): (20-30): (50-60).

In some embodiments, the krill oil, the fish oil extract, and the meadow nut oil are in a mass ratio of 25:25: 50.

In some embodiments, the mass ratio of the krill oil, the fish oil extract, and the meadow nut oil is 30:30: 40.

In some embodiments, the krill oil, the fish oil extract, and the meadow nut oil are in a mass ratio of 20:20: 60.

In some embodiments, the krill oil, the fish oil extract, and the meadow nut oil are in a mass ratio of 30:20: 50.

In some embodiments, the ratio of the krill oil, the fish oil extract, and the meadow nut oil is 20:30:50 by mass.

The composition provided by the invention is prepared by mixing krill oil, fish oil extract and embelia nasuta oil.

Hyperlipidemia is mainly manifested by elevated blood cholesterol levels, triglyceride levels (above the standard range), and reduced high density lipoprotein cholesterol levels (below the standard range). The test food experiment is carried out on the non-hospitalized essential hyperlipidemia patients, and the result shows that the composition provided by the invention can reduce the serum Total Cholesterol (TC) level and the Triglyceride (TG) level, and increase the high density protein cholesterol (HDL-C) level. And the reduction rate of TC level is more than 10 percent, the reduction rate of TG level is more than 15 percent, and the increase of HDL-C level is more than 0.104 mmol/L.

The composition provided by the invention is applied to preparing a product for improving hyperlipidemia.

The improvement of hyperlipidemia according to the present invention includes lowering cholesterol levels, lowering triglyceride levels, and/or increasing high density protein cholesterol levels.

The invention also provides a product for improving hyperlipidemia, which comprises the composition.

The product for improving hyperlipidemia is food, medicine or health product.

The food for improving hyperlipidemia comprises the composition and the ingredients acceptable in the food.

The health care for improving hyperlipidemia comprises the composition and auxiliary materials acceptable in health care products.

The medicine for improving hyperlipidemia comprises the composition and acceptable auxiliary materials in the medicine.

The dosage form of the product for improving hyperlipidemia is soft capsules.

The soft capsule is prepared by encapsulating the composition provided by the invention by a soft capsule shell.

The invention also provides a method for improving hyperlipidemia, and the product for improving hyperlipidemia is provided by the invention. The dose administered was 3 times daily, 1.2g each time. Administration was continued for 45 days.

The composition has the effect of improving hyperlipidemia, the three components are matched with each other to play a remarkable synergistic effect, the improvement effect of the composition on hyperlipidemia is remarkably superior to the combination of the two components or only a single component is used under the same dosage, and p is less than 0.05. In addition, the arsenic content in the composition provided by the invention is low, and the composition can meet the standard of national standard health food for food safety on the arsenic content of health products.

Detailed Description

The invention provides a composition and application thereof in preparing a product for improving hyperlipidemia, hyperlipemia, and a person skilled in the art can use the content for reference and appropriately improve process parameters to realize the purpose. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations and modifications in the methods and applications described herein, as well as other suitable variations and combinations, may be made to implement and use the techniques of this invention without departing from the spirit and scope of the invention.

The materials adopted by the invention are all common commercial products and can be purchased in the market.

The invention is further illustrated by the following examples:

examples

Soft capsules were prepared according to the formulation of the active ingredients reported in table 1:

TABLE 1 formulation of effective ingredients of soft capsules (composition of the present invention)

Mixing the effective components, and making into soft capsule by conventional method, wherein each capsule contains 0.6g of effective components.

Quality detection

And measuring the arsenic content in each group of samples according to the national food safety standard (GB 5009.11-2014 for measuring the total arsenic and the inorganic arsenic in the food). Measurement results table 2:

TABLE 2 arsenic content of the samples of each group

Group of	Arsenic content
		1	0.52mg/kg
2	0.61mg/kg
		3	0.41mg/kg
4	0.62mg/kg
		5	0.42mg/kg
6	1.06mg/kg
		7	1.05mg/kg
8	Not detected out
		9	2.1mg/kg
10	Not detected out
		11	Not detected out
12	Not detected out

The results show that the compositions of groups 1-5 have low arsenic content and can meet the national standards. While other compositions with krill oil added have arsenic levels exceeding national standards.

Effect detection

The following conditions were selected for the trial: the disease condition of a non-hospitalized primary hyperlipidemia patient is stable in 45-55 years, under the normal diet condition, the blood lipid level after fasting for 12-14 hours is detected, at least two blood lipid detections are carried out within half a year, the total serum cholesterol (TC) is 5.18-6.21 mmol/L, and the serum Triglyceride (TG) is 1.70-2.25 mmol/L.

Selecting 600 subjects, randomly dividing into 12 groups according to blood lipid level, taking 50 capsules in each group, respectively taking the soft capsules in 1-12 groups, taking 2 capsules each time 3 times a day, and continuously taking for 45 days. The daily life and dietary habits are kept during the test period, and various indexes are measured by taking blood on an empty stomach.

Efficacy determination criteria:

the method has the following advantages: TC reduction > 10%; TG reduction > 15%; HDL-C increase > 0.104 mmol/L.

And (4) invalidation: and those not meeting the effective standard. The results are shown in tables 3 to 5:

TABLE 3 Effect on Cholesterol (TC) levels

Group of	Before tasting	After eating trial	Difference between front and rear	Rate of decline
					1	5.95	5.15**A	0.79	13.30％
2	5.93	5.16**A	0.77	13.02％
					3	5.93	5.16**A	0.77	12.96％
4	5.92	5.16**A	0.76	12.90％
					5	5.93	5.17**A	0.77	12.90％
6	5.94	5.48**B	0.46	7.71％
					7	5.94	5.51**C	0.43	7.26％
8	5.92	5.51**C	0.41	6.95％
					9	5.94	5.59**D	0.35	5.93％
10	5.93	5.60**D	0.33	5.56％
					11	5.93	5.63**E	0.31	5.14％
12	5.93	5.94F	0.00	+0.05％

Note that the significant difference P <0.01 existed between the TC levels before and after the self-test;

the same row of shoulder marks with different letters (A, B, C, D, E, F) shows that the TC level is very different among different groups, and P is less than 0.01

The result shows that the TC level can be reduced more remarkably by the composition of groups 1-5, and p is less than 0.01, so that the three components play a good synergistic and synergistic effect. Whereas groups given only a single component or both components were less effective.

TABLE 4 Effect of Triglyceride (TG) levels

Group of	Before tasting	After eating trial	Difference value	Rate of decline
					1	1.96	1.45**A	0.51	25.94％
2	1.96	1.46**A	0.51	25.87％
					3	1.95	1.46**A	0.50	25.38％
4	1.94	1.46**A	0.48	24.90％
					5	1.95	1.45**A	0.50	25.46％
6	1.94	1.62**B	0.32	16.67％
					7	1.95	1.63**B	0.33	16.79％
8	1.96	1.64**C	0.32	16.16％
					9	1.96	1.68**D	0.28	14.10％
10	1.96	1.69**D	0.27	13.88％
					11	1.95	1.69**D	0.26	13.32％
12	1.95	1.96E	0.00	+0.20％

Note that there was a very significant difference P <0.01 in TG levels before and after self-feeding;

the same row of shoulder marks with different letters (A, B, C, D, E, F) shows that there is a very significant difference in TG levels among different groups, P <0.01

The result shows that the composition of groups 1-5 can reduce the TG level more obviously, and p is less than 0.01, which shows that the three components play a good synergistic and synergistic effect. Whereas groups given only a single component or both components were less effective.

TABLE 5 Effect on high Density protein Cholesterol (HDL-C) levels

Note that there was a very significant difference P <0.01 in the levels of HDL-C before and after self-feeding;

the same column with different letters (A, B, C, D, E, F) shows that there is a very significant difference in HDL-C level between different groups, P <0.01

The results show that the compositions of groups 1-5 can more obviously improve the HDL-C level, and p is less than 0.01, which shows that the three components play a good synergistic and synergistic effect. Whereas groups given only a single component or both components were less effective.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that it is obvious to those skilled in the art that various modifications and improvements can be made without departing from the principle of the present invention, and these modifications and improvements should also be considered as the protection scope of the present invention.

Claims

1. A composition for improving hyperlipidemia is characterized by comprising krill oil, fish oil extract and Plukenetia volubilis oil; the mass ratio of the krill oil to the fish oil extract to the calamus macrocarpa oil is (20-30): (20-30): (40-60).

2. The composition as claimed in claim 1, wherein the ratio of krill oil, fish oil extract and meadow nut oil is 25:25:50 by weight.

3. The composition as claimed in claim 1, wherein the ratio of krill oil, fish oil extract and meadow nut oil is 30:30:40 by weight.

4. The composition as claimed in claim 1, wherein the ratio of krill oil, fish oil extract and meadow nut oil is 20:20:60 by weight.

5. The composition as claimed in claim 1, wherein the ratio of krill oil, fish oil extract and meadow nut oil is 30:20:50 by weight.

6. The composition as claimed in claim 1, wherein the ratio of krill oil, fish oil extract and meadow nut oil is 20:30: 50.

7. Use of the composition of any one of claims 1 to 6 for the preparation of a product for ameliorating hyperlipidemia.

8. The use of claim 7, wherein the amelioration of hyperlipidemia comprises lowering cholesterol levels, lowering triglyceride levels, and/or increasing high density protein cholesterol levels.

9. A product for ameliorating hyperlipidemia, comprising the composition according to any one of claims 1 to 6.