CN109200061A - A kind of blood-fat reducing composition of high-purity fish oil and phytosterin ester - Google Patents
A kind of blood-fat reducing composition of high-purity fish oil and phytosterin ester Download PDFInfo
- Publication number
- CN109200061A CN109200061A CN201710513171.8A CN201710513171A CN109200061A CN 109200061 A CN109200061 A CN 109200061A CN 201710513171 A CN201710513171 A CN 201710513171A CN 109200061 A CN109200061 A CN 109200061A
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- Prior art keywords
- fish oil
- epa
- dha
- ester
- composition
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/60—Fish, e.g. seahorses; Fish eggs
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
- A23L33/11—Plant sterols or derivatives thereof, e.g. phytosterols
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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Abstract
The present invention relates to the blood-fat reducing composition of a kind of high-purity fish oil and phytosterin ester, the weight ratio of fish oil and phytosterin ester is 0.8:1 ~ 1.5:1 in the composition, and fish oil purity is not less than 75%.Fish oil and phytosterin ester composition of the invention has the function of that TC, TG, LDL-C index is effectively reduced.Fish oil is rich in EPA and DHA in composition of the invention, when the weight ratio of EPA and DHA is 1:1 ~ 1.5:1, moreover it is possible to effectively increase HDL-C index, reach synergistic synthesis hypolipemic function.Composition of the invention can be prepared into health care product or drug with hypolipemic function plus pharmaceutically acceptable auxiliary material.
Description
Technical field
The present invention relates to the compositions of a kind of fish oil and phytosterin ester, and in particular to a kind of high-purity fish oil and plant steroid
Alcohol ester matches the blood-fat reducing composition formed with specific.
Background technique
The illness rate and the death rate of the hyperlipemia in China increase year by year, focus mostly in, the elderly, and tend to be young
Change, brings huge body & mind pain to patient, also increase the financial burden of family and society.Blood lipid inspection clinically
Looking into most basic concern index is total cholesterol (TC), triglycerides (TG), low density lipoprotein cholesterol (LDL-C) and height
Density lipoprotein-cholesterol (HDL-C), and for any required progress cardiovascular danger evaluation and give lipid lowering drug treatment
Individual, should all carry out this four lipids detections.The wherein major lipids that LDL-C, which increases, to be atherosclerosis generation, develop
Risk factor, Clinical significance of MG are better than TC;HDL-C is considered as the lipoprotein in human body with antiatherosclerosis,
Blood plasma level is negatively correlated with incidence of coronary heart disease, is commonly called as " blood vessel scavenger ", is the protective factors of coronary heart disease, also referred to as " good "
Cholesterol, so the raising of HDL-C level advantageously reduces blood lipid level;TG increases the then knot by influencing LDL-C and HDL-C
Structure leads to Atherosclerosis, and the horizontal mild to moderate raising of TG just can increase the risk for suffering from coronary heart disease.
All exploring a kind of significant effect, green safe and small toxic side effect natural blood lipid-lowering composite both at home and abroad at present
Object, wherein fish oil and phytosterin ester cause industry to be paid close attention to.Contain eicosapentaenoic acid (EPA) and 22 carbon in deep sea fish oil
Acid (DHA) is the highly desirable fatty acid of human body.Clinic display: EPA and DHA, which has, promotes internal saturated fatty acid generation
The effect thanked, thus prevent fat from depositing in vascular wall, the formation and development of prevention of arterial atherosis.But fish oil is especially
The high fish oil of DHA content has the risk for increasing LDL-C, such as lists fish oil product Lovaza;Even if the fish oil of high EPA content
Product such as VascepaDo not have the effect for reducing LDL-C yet.Phytosterin ester is generally passed through by phytosterol and fatty acid
Esterification or transesterification are made, the preparation method as disclosed in CN104262444B, CN102603845B.Phytosterol
The hypolipemic function of ester is significant, and the bulletin of the Ministry of Public Health of China in 2010 " 2010 No. 3 " approval phytosterin ester is as new resources
Food adds in food, and essential information, the life of phytosterin ester standard are defined in " attachment: 7 kinds of new resource food catalogues "
Production. art brief introduction and quality requirement etc..Wherein the source of phytosterin ester have soybean oil, rapeseed oil, corn oil, sunflower oil with
And Tall oil etc..Production technology summary are as follows: using the plants oil distillate such as soybean oil or Tall oil be raw material, by saponification, extraction,
The techniques such as crystallization obtain phytosterol, and phytosterol and sunflower seed oil fatty acids are then carried out esterification production and obtain phytosterol
Ester.Quality requirement of the new resource food to phytosterin ester are as follows: 90% or more the content of phytosterin ester, phytosterin ester and plant
Object sterol adds up to 97% or more content, wherein free content of phytosterol is not higher than 6%.
Hypolipemic function based on fish oil and phytosterin ester has researcher to prepare the health care product containing the two, to
Have the function that tetra- blood lipids index of structure adjusting TC, TG, LDL-C and HDL-C.Applicant have discovered that the combination of these reports
In object, in addition to EPA, DHA and phytosterol (ester), universal also other effective components containing high-content, composition components are very
It is complicated.
Document 1(Ciro L, Daniele N.P, Marina M etc. Study of the effects of a Diet supplemented with active components on lipid and glycemic pro les. [J] Nutrition, 2015(31):180-186) disclose one group and contain three kinds of omega-fatty acid, vitamin E and phytosterol work
The composition of property ingredient, can reduce TC(8% compared to control group), TG (12%), LDL-C (16%), and increase HDL-C
(12%), do not specify whether index change level has significant difference;And the document clearly states vitamin E with anti-artery
Atherosis effect, therefore effect of the vitamin E to drug effect cannot be ignored.In addition, the document does not do into one omega-fatty acid
Step explanation, wider range.
Chinese patent CN104187627A also discloses that one kind contains fish oil, phytosterin ester (or phytosterol) and flax
The composition of seed three kinds of active constituents of oil, high dose fish oil product group (embodiment 6 ~ 8) can be effectively reduced compared to model group
Serum TC, TG, LDL-C simultaneously increase HDL-C level, and difference has conspicuousness.But the patent specification describe activity at
/ mono- linseed oil is neccessary composition, " α-linolenic acid is rich in the linseed oil of plant origin, α-linolenic acid is in body
It is interior to be converted into EPA, DHA, meanwhile, α-linolenic acid can reduce low density lipoprotein cholesterol in serum (LDL-C) ".
In addition, Chinese patent CN105769919A is disclosed containing three kinds of fish oil, phytosterin ester and n-octacosanol etc.
The reducing blood lipid fish oil composition of active constituent, embodiment 2 specifically describe the group of a kind of fish oil (50%EPA) and phytosterin ester
Object is closed, it is horizontal that serum TC, TG and LDL-C can be effectively reduced compared to model group;But the purity of EPA is only 50% in above-mentioned fish oil,
And composition can reduce HDL-C level.In addition, the present inventor carries out zoopery, discovery according to the formula of the patent Example 2
It is only capable of that TG index effect is effectively reduced, and influences on other indexs without conspicuousness.
Document 2(Michelle A.M , Manohar L.G. The Lipid-Lowering Effects of Phytosterols and (n-3) Polyunsaturated Fatty Acids are Synergistic and Complementary in Hyperlipidemic Men and Women. [J]The Journal of Nutrition, 2008, 138: 1086-1090. ) scheme of combination drug therapy of fish oil and phytosterol is disclosed, it can effectively be dropped compared to baseline
Low TC, TG, LDL-C and raising HDL-C, difference have conspicuousness.It is found by the applicant that in addition to EPA, DHA and three kinds of work of phytosterol
Property ingredient outside, the constituent phytosterols table of table 1 is shown there are also considerable amount of alpha-linolenic acid in the document, and dosage reaches 1.2g, with EPA
Quite with the total amount (1.4g) of DHA, also containing the up to polyunsaturated fatty acid of 4g and in phytosterol.The present inventor tests hair
These existing ingredients are remarkably improved its lipid-lowering effect, by alpha-linolenic acid, polyunsaturated fatty acid etc. in addition to phytosterin ester
After ingredient removal, the composition for mainly containing EPA, DHA and phytosterin ester is only capable of that TC and TG index is effectively reduced.
Document 3(Rouyanne T.R, Isabelle. D, Yvonne E.M. etc. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. [J] The Journal of Nutrition, 2014, (10):1564-70) also disclose the composition of phytosterin ester and fish oil, compared to control group, only high dose fish oil group (is planted
Object sterol ester 3.75g and fish oil 6.6g) TC, TG, LDL-C can be effectively reduced and increase HDL-C index.Plant steroid in the composition
Alcohol ester dosage is big, and the purity of fish oil is low, EPA the and DHA gross weight although the total amount of EPA and DHA reaches 1.8g, in fish oil
Ratio is measured less than 30%.In addition, the component list of table 1 is shown in document, there are also a large amount of single unsaturated in addition to EPA and DHA for the composition
Fatty acid (2.4g), polyunsaturated fatty acid (4.1g) and n-6 polyunsaturated fatty acid (1.4g) etc..And according to this field public affairs
Know common sense, these unsaturated fatty acids also have effect for reducing blood fat, and its dosage is not allowed compared to above-mentioned main active
Ignore.In addition, the present inventor only retains EPA, DHA and three kinds of activity of phytosterin ester according to high dose group formula in the document
Then ingredient carries out animal experiment, it is found that it is only capable of that TC and TG index is effectively reduced, and influences on other indexs without conspicuousness.Always
It, the not only complicated component of formula described in the document, and also dosage is big, and single dose is up to 30g;It is not only at high cost, but also produce
On be difficult to monitor, while also bringing immense pressure to edible people.
In conclusion prior art disclosure can effectively adjust TC, TG, LDL-C containing fish oil and phytosterin ester simultaneously
And the most of complicated components of blood-fat reducing composition of tetra- blood lipids index of HDL-C, in addition to EPA, DHA and phytosterol (ester),
Also containing a large amount of polyunsaturated fatty acid, monounsaturated fatty acids etc., and in fish oil EPA and DHA purity it is lower, cause
Formulation dosage is big, is unfavorable for patient and takes, and dosage also makes greatly that increased production cost, is unfavorable for large-scale industrial production.It is existing
Technology fails to provide only containing phytosterin ester and fish oil two kinds of active components, and EPA and the high composition of DHA content in fish oil
It can synergic adjustment tetra- blood lipids index of TC, TG, LDL-C, HDL-C.
Summary of the invention
In order to overcome the prior art to fail to provide only containing phytosterin ester and fish oil two kinds of active components, and in fish oil
EPA and DHA content are high, and ingredient is simple, and the blood lipid-lowering composite of energy synergic adjustment tetra- blood lipids index of TC, TG, LDL-C, HDL-C
Object.The present invention now provides the following technical solutions:
The object of the present invention is to provide a kind of composition containing fish oil and phytosterin ester, it is characterised in that fish oil and plant steroid
The weight ratio of alcohol ester is 0.8:1 ~ 1.5:1, and the total weight percent of EPA and DHA is not less than 75% in fish oil.
The weight ratio of fish oil and phytosterin ester is 0.9 ~ 1.4,1:1 ~ 1.3:1,1:1 ~ 1.2:1 or 1 in the composition:
1。
The total weight percent of EPA and DHA is 75% ~ 95%, 80% ~ 95%, 85% ~ 95%, 87% ~ 92%, 75% in the fish oil
~90%、75%~85%、75%~80%。
EPA and DHA weight ratio is 1:1 ~ 1.5:1, preferably 1.1:1 ~ 1.3:1, most preferably 1.2:1 in the fish oil.
In the preferred technical solution of the present invention, EPA and DHA in the composition are free acid, glycerol ester type, ethyl ester type
And one of phosphatide type, preferably ethyl ester type.
In the further preferred technical solution of the present invention, 430 ~ 495mg/g of EPA ethyl ester in the fish oil, DHA ethyl ester 347 ~
403mg/g, EPA ethyl ester add 800 ~ 880mg/g of DHA ethyl ester.
The purity of phytosterin ester is 97% or more, 98% or more, 99% or more in composition of the present invention.
In the further preferred technical solution of the present invention, polyunsaturated fatty acid in the fish oil in addition to EPA and DHA it is total
Weight is no more than 15%.
Composition provided by the invention has the application in hypolipemic function health care product or drug in preparation.
The composition further includes pharmaceutically acceptable auxiliary material.
The composition is one of soft capsule or hard capsule, preferably soft capsule.
It prepares the present invention further provides a kind of containing pharmaceutically acceptable auxiliary material and a effective amount of present composition
Method, this method includes mixing the present composition with pharmaceutically acceptable auxiliary material.
Percentage (" % ") of the present invention is all weight percent, and " content " is weight percentage, described " pure
Degree " is also weight percentage.
" the fish oil purity " that the present invention narrates is total with the content of EPA and DHA.
The inspection method of EPA and DHA content is carried out referring to " United States Pharmacopeia " general rule in fish oil, such as "<401>Fats and
Detection method in Fixed Oils " under " OMEGA-3 FATTY ACIDS DETERMINATION AND PROFILE " item.
Phytosterin ester of the present invention meets the Ministry of Public Health in 2010 recorded in background technique and announces " 2010 the 3rd
Number " standard added in food as new resource food of phytosterin ester of approval, i.e. " attachment: 7 kinds of new resource food mesh
Requirement in record " to phytosterin ester.Specifically: phytosterin ester and phytosterol add up to content 97% or more, phytosterol
The content of 90% or more the content of ester, the phytosterol that dissociates is not higher than 6%.
" phytosterol purity " of the present invention is subject to total content of phytosterin ester and phytosterol.
By health care product or compsn. consisting of influenza virus surface of the invention, pharmaceutically acceptable auxiliary material is added, is routinely made according to preparation
Standby technique, can be made pharmaceutically acceptable various dosage forms, such as soft capsule, hard capsule, pulvis, pill, pellet, emulsion, coagulate
Jelly etc., preferably soft capsule, hard capsule, most preferably soft capsule.
Preparation conventional fabrication process of the present invention, such as: active compound and pharmaceutically acceptable auxiliary material are mixed, filled out
It is filled in hollow hard capsules, then hard capsule is made through processes such as fitting, Mi Kou, packagings.Or by compsn. consisting of influenza virus surface and
Pharmaceutically acceptable auxiliary material mixing is placed between two blocks of rubber, with steel mold pressing at soft capsule etc..
Common auxiliary material of the present invention includes suspending agent, film forming agent, plasticizer, emulsifier, lubricant, colorant, seasoning
Agent, opacifier, antioxidant can also only include Suspension stabilisers, film forming agent, plasticizer.The preparation oral administration.
Inventive compound composition is used for reducing blood lipid, all and treatment or prevention and the raising of TG level, TC level liter
High, LDL-C level increases and HDL-C level reduces relevant illness within the scope of the present invention, and the example of this illness includes
But it is not limited to atherosclerosis, dyslipidemia, hypertriglyceridemia, hypertension, heart failure, arrhythmia cordis, low HDL
Horizontal, high LDL level, stable angina cordis, coronary heart disease, acute myocardial infarction, the secondary prevention of myocardial infarction, cardiomyopathy, the heart
Intimitis, diabetes B, insulin resistance, glucose tolerance, hypercholesterolemia, apoplexy, hyperlipidemia, egg high in fat
White mass formed by blood stasis, chronic kidney disease, intermittent claudication, hyperphospheremia, carotid atherosclerosis, peripheral arterial disease, diabetic keratopathy
Nephrosis, the hypercholesterolemia in HIV infection, acute coronary syndrome (ACS), alcoholic fatty liver, non-alcoholic rouge
Fat liver disease, arterial occlusive disease, cerebral atherosclerosis, artery sclerosis, cerebrovascular condition, myocardial ischemia and diabetic keratopathy
Autonomic neuropathy.The present composition can be used as drug or health care product, when as health care product, meet the related state of health care product
Family's regulation.
The dosage of its active ingredient compositions is effective, non-toxic.The adult general 0.5 ~ 6g active constituent of daily dosage,
It is preferred that 2 ~ 4g active constituent.
In pharmacological testing of the present invention between animals and human beings body equivalent dose conversion bibliography (Huang Jihan, Huang Xiao Sunshine, Chen Zhi raise the equivalent dose in pharmacological evaluation between animal between animals and human beings body conversion [J] Chinese Clinical pharmacology with Acology, 2004:1069-1072.) in method calculate.
The present invention narrates " conspicuousness reduction/raising " or " significant decrease/raising " refers to P < 0.05 or lower, i.e. difference has
It is statistically significant.
The preparation method of high-purity fish oil of the present invention is known technology, such as the preparation of high-purity EPA fish oil (97%)
Method: referring to the method disclosed in US4377526A or US5840944A, natural fish oil is carried out transesterification to obtain ethyl ester type fish
Purifying obtains EPA after oil.High-purity DHA fish oil and high-purity EPA and DHA fish oil can be used document (Tao Liancheng, Xie Hong Force, Liu Hui sesame silver nitrate-water law purifying high content DHA and EPA experimental study [J] Chinese Journal of Marine Drugs, 2004 (3): 28-30) in silver nitrate-water law purifying EPA, DHA;Or according to document (Wang Xian is prepared up to supercritical fluid chromatography EPA-EE and the Zhejiang DHA-EE [D]: Zhejiang University's material and chemical engineering institute, 2003:1-82) described in supercritical fluid
Chromatography purity EPA and DHA.
Compared with prior art, high-purity fish oil of the invention and phytosterin ester composition are imitated with following Advantageous
Fruit:
1, the present invention is the composition of high-purity fish oil (75% or more EPA and DHA total content) and phytosterin ester, meets fish oil
When weight ratio with phytosterin ester is 0.8:1 ~ 1.5:1, there is synergistic hypolipemic function, can specially be effectively reduced
TC, TG and LDL-C are horizontal, and significant effect overcomes in the prior art the group of only fish oil and phytosterin ester two kinds of active components
Close the problem of cannot this three indexs be significantly effectively reduced simultaneously in object.
2, the present composition is also full while the weight ratio of high-purity fish oil and phytosterin ester is 0.8:1 ~ 1.5:1
When the weight ratio of EPA and DHA is 1:1 ~ 1.5:1 in sufficient fish oil, TC, TG, LDL-C level can not only significantly be effectively reduced, also
HDL-C level significantly can be effectively increased, overcoming the prior art cannot be while significantly reducing tri- indexs of TC, TG, LDL-C
The significant problem for effectively increasing HDL-C index, to truly realize the comprehensive beneficial skill for effectively adjusting blood fat function
Art effect.
Comparative example
Comparative example 1
Formula: being formulated according to described in document 2, retains main active: triglyceride type fish oil (EPA+DHA=36%) 4.0g,
Phytosterol 2.0g, alpha-linolenic acid 1.2g, n-3 fatty acid 1.2g, polyunsaturated fatty acid 4.0g in addition to EPA and DHA.
It mixes the above components evenly in 70 DEG C of conditions, is then dispensed while hot in glove box, nitrogen protection lower cover.
Comparative example 2
Formula: being formulated according to described in document 3, retains main active: triglyceride type fish oil (EPA+DHA=27%) 6.6g,
Phytosterin ester 3.75g, polyunsaturated fatty acid 4.1g, the n-6 polyunsaturated fatty acid 1.4g in addition to EPA and DHA.
Above-mentioned active component is uniformly mixed in 70 DEG C of conditions, is then dispensed while hot in glove box, under nitrogen protection
Gland.
Comparative example 3
Formula: triglyceride type fish oil (EPA+DHA=36%) 4.0g, phytosterol 2.0g.Other are the same as comparative example 1.
Comparative example 4
Formula: triglyceride type fish oil (EPA+DHA=27%) 6.6g, phytosterin ester 3.75g.Other are the same as comparative example 2.
Comparative example 5
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 0.5g, 98% phytosterin ester 1.5g(fish oil: phytosterin ester=1:3).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 6
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 0.9g, 98% phytosterin ester 1.1g(fish oil: phytosterin ester=0.8:
1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 7
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 1.2g, 98% phytosterin ester 0.8g(fish oil: phytosterin ester=1.5:
1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 8
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 1.4g, 98% phytosterin ester 0.6g(fish oil: phytosterin ester=2:1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 9
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 1.5g, 98% phytosterin ester 0.5g(fish oil: phytosterin ester=3:1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 10
Formula: ethyl ester type fish oil (EPA+DHA=50%) 1.0g, 98% phytosterin ester 1.0g(fish oil: phytosterin ester=1:1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 11
Formula: ethyl ester type fish oil (EPA+DHA=75%) 1.0g, 98% phytosterin ester 1.0g(fish oil: phytosterin ester=1:1).
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 12
Formula: ethyl ester type fish oil (EPA+DHA > 80%) 2.0g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 13
Formula: 98% phytosterin ester 2.0g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Present invention applicant carries out pharmacological experiment study, experimental method and experiment knot according to the formula of above-mentioned 13 comparative examples
Fruit is as follows:
1, influence of the ratio of fish oil and phytosterin ester to drug effect
1.1 experimental material
1.1.1 animal
SD rat, ♂, 200 ± 20g of weight, test Company of Animals Ltd. up to rich fruit purchased from Chengdu, production licence by totally 160:
The river SCXK() 2013-24.
1.1.2 feed
The feed that " auxiliary lipid-lowering function evaluation method " requires in health care product state food medicine prison [2012] No. 107 texts of guarantorization is matched
Side: it maintains to add 20.0% sucrose, 15.0% lard, 1.2% cholesterol, 0.2% sodium taurocholate, whole milk protein in feed
1.0%, medelling animal basestocks 62.6%.The formula forage is tested Company of Animals Ltd.'s production up to rich fruit by Chengdu and is provided.
1.1.3 by test product
Phytosterin ester used in this pharmacological evaluation is bought from BASF (BASF);Fish oil used in comparative example 1 ~ 12 is all purchased
It buys from Sichuan Xin Meijia biological medicine Co., Ltd, wherein the fish oil purity of comparative example 1 is 36%, EPA about 320mg, and DHA is about
1120mg;The fish oil purity of comparative example 2 is 27%, EPA about 1188mg, DHA about 594mg;The fish oil of comparative example 3 is the same as comparative example 1;
The fish oil of comparative example 4 is the same as comparative example 2;The fish oil purity about 84% of comparative example 5 ~ 9 and 12, EPA ethyl ester 430 ~ 495mg/g, DHA second
347 ~ 403mg/g of ester, EPA ethyl ester add 800 ~ 880mg/g of DHA ethyl ester;The fish oil purity of comparative example 10 be 50%, EPA about
300mg, DHA about 200mg;The fish oil purity of comparative example 11 is 75%, EPA about 450mg, DHA about 300mg.
It keeps 1 ~ 13 formula rate of comparative example and preparation process constant, expands each comparative example sample amount respectively to 40g, packing
It is placed on refrigerator cold-storage, is directly taken when using every time and is configured to stomach-filling solution with solvent in right amount.
1.2 experimental method
SD rat adaptive feeding is randomly divided into 2 groups after 5 days, by weight, and 10 animals, which are given, maintains feed as blank control
Group, 150 are only given model feed, establish SD hyperlipemia model of rats after two weeks.
In addition to blank control group, remaining 150 are horizontally divided into 15 groups according to TC: model control group, positive controls and
13 by test product group.At this point, model control group and 13 are compared by test product group, four blood lipids index answer that there was no significant difference;Mould
Type control group and blank control group compare, TC(or LDL) and TG should increase, and have significant difference.After grouping, blank control group
Excipient is given once daily with model control group;Positive controls give Simvastatin, and dosage drafts dosage by clinic
10mg/d conversion is the equivalent dose of rat;Comparative example 1-11 gives corresponding drug, and 1 dosage of comparative example is drafted by clinic
Dosage 13g/d conversion is the equivalent dose of rat, and 2 dosage of comparative example is drafted dosage 16g/d by clinic and converted
For the equivalent dose of rat, 3 dosage of comparative example is drafted the equivalent dose that dosage 6g/d conversion is rat by clinic, right
4 dosage of ratio is drafted the equivalent dose that dosage 10g/d conversion is rat by clinic, and 5 ~ 11 dosage of comparative example is pressed
Clinic drafts the equivalent dose that dosage 2g/d conversion is rat;The dosage of comparative example 12 recommends dosage according to clinic
The conversion of 2g/d fish oil is the equivalent dose of rat, and the dosage of comparative example 13 recommends dosage 2g/d phytosterin ester according to clinic
Conversion is the equivalent dose of rat.Successive administration 30 days, during administration, each group feed was constant.Animal takes blood examination after administration 30 days
Survey four items of blood lipid tests index.
1.3, experimental result
1.3.1 overview
Each group SD activities in rats is normal during experiment, and physical appearance, excrement etc. are without exception.It was administered by 30 days, each administration group phase
Than model group body weight no difference of science of statistics.Details as Follows:
1 each group SD rat body weight of table changes (X ± SD, g)
1.3.2 influence of each test drug to hyperlipidemia SD Serum Lipids in Experimental HypercholesterolemicRats
Experimental result data is shown after administration 30 days: model group is compared with Normal group, TC, TG, LDL-C, HDL-C in serum
Significantly raised, difference is statistically significant;Compared with model group, TC, TG, LDL-C are decreased obviously in positive controls serum,
HDL-C is significantly raised, and difference is statistically significant.Comparative example 1 ~ 7,10,11,13 has obviously serum TC compared to model group
Decline effect, difference are statistically significant;Comparative example 1 ~ 4,6 ~ 9,11,12 decreased significantly serum TG compared to model group
Effect, difference are statistically significant;Comparative example 1,2,6,7,11 decreased significantly work for serum LDL-C compared to model group
With difference is statistically significant;Comparative example 1,2,6,7,11 is increased significantly effect for Serum HDL-C compared to model group,
Difference is statistically significant.Details as Follows:
Each group SD Serum Lipids in Experimental HypercholesterolemicRats (X ± SD, mmol/L) after table 2 is administered 30 days
Compared with normal group, P < 0.001 * P < 0.05, * * P < 0.01, * * *;Compared with model group,▲P < 0.05,▲▲P<
0.01,▲▲▲P<0.001
Above-mentioned experimental data is shown: administration 30 days after, positive control Simvastatin group compared to model group to serum TC, TG,
LDL-C decreased significantly effect, be increased significantly effect to HDL-C, difference is statistically significant, and model is good.
It has been found that the fish oil (comparative example 12) of the one pack system of daily dose (2g/d) of the present invention is only right compared to model group
TG has significant decrease to act on (P < 0.001), influences on other indexs without conspicuousness;
The phytosterin ester (comparative example 13) of the one pack system of daily dose (2g/d) of the present invention only can significantly reduce compared to model group
TC level (P < 0.01) influences other indexs without conspicuousness;
Comparative example 1 ~ 4: the clinical test results of document 2 and 3 described in the animal test results and background technique of comparative example 1 and 2
Trend is consistent, significant effective to four indices, illustrates that our model almost can normal reaction human test results.And it compares
Example 3 and 4 eliminates other unsaturated fats in comparative example 1 and 2 in addition to EPA, DHA and three kinds of active constituents of phytosterol (ester)
The influence of acid, test result, which is shown, is only capable of being effectively reduced TC and TG index, can also reduce LDL-C, but it is poor not have conspicuousness
It is different;The experimental result of Comprehensive Correlation example 1 ~ 4 illustrates other more in addition to EPA, DHA and phytosterol (ester) in comparative example 1 and 2
Unsaturated fatty acid can not be ignored the contribution of drug effect.
Applicant studies the composition mainly containing EPA, DHA and phytosterin ester, the most of combination of experiment discovery
Object proportion is only capable of reducing plasma tg, when the composition of only fish oil and phytosterin ester meets specific proportion, in reducing blood lipid
Just there is synergistic effect in curative effect.High-purity fish oil and phytosterin ester, can be within the scope of the weight proportion of 0.8:1 ~ 1.5:1
Serum TC, TG, LDL-C level are significantly reduced, and it is horizontal (comparative example 6 and 7) significantly to increase HDL-C, and lower than the proportion (comparison
Example 5) or be higher than the proportion (comparative example 8 and 9) said effect is not achieved, this is the discovery that unexpected.In addition, applicant
It has also been found that the fish oil that reach above-mentioned technical effect must be high-purity fish oil, as comparative example 10 low-purity fish oil (50%) only
It can conspicuousness reduction TG level.It is found by the applicant that the total content of EPA and DHA need to be in 75% or more (comparative example 11), ability in fish oil
The synergy of phytosterin ester and fish oil is played, i.e., increases HDL-C water while conspicuousness reduces TC, TG, LDL-C
It is flat.
Applicant has found in a series of pharmacological evaluation, only the fish oil (75% or more) and phytosterin ester of high-purity
With specific 0.8:1 ~ 1.5:1 weight ratio proportion, TC, TG, LDL-C are can be only achieved while be effectively reduced, and effectively increase
The curative effect of HDL-C plays the synergy of phytosterin ester and fish oil.
2, influence of the ratio of EPA and DHA to drug effect in fish oil
It is known in the art that main active is EPA and DHA in fish oil, but the prior art did not report fish oil and plant steroid
When alcohol ester forms blood-fat reducing composition, whether the different ratio of EPA and DHA have shadow to the collaboration Hypolipidemic efficacy of composition
It rings.Based on this, the present invention has carried out following pionerring research: on the basis of aforementioned comparison's example 6 is formulated, i.e., comparative example 14 ~ 18 is
When the weight proportion of fish oil and phytosterin ester is 0.8:1, the present inventor adjusts the ratio of EPA and DHA in fish oil
It is whole, and carry out animal experiment according to the identical test method of aforementioned comparison's example 1 ~ 13.Wherein, phytosterin ester is bought from BASF
(BASF), fish oil is bought from Sichuan Xin Meijia biological medicine Co., Ltd.
Comparative example 14
Formula: ethyl ester type fish oil (EPA+ DHA=84%, EPA:DHA=0.5:1) 0.9g, 98% phytosterin ester 1.1g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 15
Formula: ethyl ester type fish oil (EPA+ DHA=84%, EPA:DHA=1:1) 0.9g, 98% phytosterin ester 1.1g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 16
Formula: ethyl ester type fish oil (EPA+ DHA=84%, EPA:DHA=1.5:1) 0.9g, 98% phytosterin ester 1.1g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 17
Formula: ethyl ester type fish oil (EPA+ DHA=84%, EPA:DHA=2:1) 0.9g, 98% phytosterin ester 1.1g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Comparative example 18
Formula: ethyl ester type fish oil (EPA=97%, DHA < 3%) 0.9g, 98% phytosterin ester 1.1g.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
2.1 experimental result
It is carried out according to the experimental method of aforementioned comparison's example 1 ~ 13.
Each group SD activities in rats is normal during experiment, and physical appearance, excrement etc. are without exception.It was administered by 30 days, it is each to be administered
Group compares model group body weight no difference of science of statistics.
Each test drug is to the following table 3 of the influence result of hyperlipidemia SD Serum Lipids in Experimental HypercholesterolemicRats: testing knot after administration 30 days
Fruit data are shown: model group is compared with Normal group, and TC, TG, LDL-C, HDL-C are significantly raised in serum, and difference has system
Meter learns meaning;Compared with model group, TC, TG, LDL-C are decreased obviously in positive controls serum, and HDL-C is significantly raised, difference
It is statistically significant.Comparative example 14 ~ 18 decreased significantly effect for serum TC compared to model group, and difference has statistics meaning
Justice;Comparative example 14 ~ 18 decreased significantly effect for serum TG compared to model group, and difference is statistically significant;Comparative example 14 ~
18 decreased significantly effect for serum LDL-C compared to model group, and difference is statistically significant;Comparative example 15,16 compared to
Model group is increased significantly effect for Serum HDL-C, and difference is statistically significant.Details as Follows:
Each group SD Serum Lipids in Experimental HypercholesterolemicRats (X ± SD, mmol/L) after table 3 is administered 30 days
Compared with normal group, P < 0.001 * P < 0.05, * * P < 0.01, * * *;Compared with model group,▲P < 0.05,▲▲P<
0.01,▲▲▲P<0.001
Above-mentioned experimental data is shown: administration 30 days after, positive control Simvastatin group compared to model group to serum TC, TG,
LDL-C decreased significantly effect, be increased significantly effect to HDL-C, difference is statistically significant, and model is good.
The applicant by above-mentioned pharmacological evaluation surprisingly it has been found that high-purity fish oil (75% or more EPA and DHA total weight) and
In the composition of phytosterin ester, the ratio in fish oil between EPA and DHA has larger impact to blood lipids index HDL-C.Work as EPA
Weight ratio between DHA can significantly reduce serum TC, TG, LDL- in the proportional region of 1:1 ~ 1.5:1, relative to model group
C and the effect for increasing HDL-C level, difference have conspicuousness (comparative example 15 and 16).Without the ratio model in the EPA and DHA
(comparative example 14,17 and 18) is enclosed, either raising EPA ratio still improves DHA ratio, all cannot effectively increase HDL-C index.
The present inventor has found that the ratio of EPA and DHA is cooperateing with raising with the composition of phytosterin ester to high-purity fish oil in a creative way
HDL-C level plays key effect.
In addition, the applicant is surprisingly it has been found that the ratio of EPA and DHA has an effect on the reduction degree of LDL-C index.Although right
LDL-C level is effectively reduced in ratio 14 ~ 18, but reduces degree and have nothing in common with each other.When the weight ratio between EPA and DHA is in 1:1
When the proportional region of ~ 1.5:1, the composition can reduce LDL-C level about 38%(comparative example 16 and 17) compared to model group;And
Out of this range, the composition is only capable of reducing LDL-C level about 16%(comparative example 14,15 and 18) compared to model group.As back
Described in scape technology, those skilled in the art have been generally acknowledged that fish oil (such as Vascepa of high EPA content) LDL-C is not risen not yet
Drop, and fish oil (such as Lovaza that DHA content is higher) then there is elevated risk to LDL-C.Therefore, those skilled in the art are general
It will be considered that the effect for cooperateing with reduction LDL-C of the former and phytosterin ester should be able to be better than the latter;But the present inventor is unexpected
It is anti-that ground finds that the collaboration of the fish oil (1:1 ~ 1.5:1) and phytosterin ester of certain EPA and DHA proportional region reduces LDL-C effect
And it is more preferable than the collaboration reducing effect of the fish oil of high EPA content and phytosterin ester.I.e. this synergistic effect is not simple to be embodied
For the addition of the respective effect of fish oil and phytosterin ester.
Present invention applicant also found, using different types of phytosterin ester, such as cupreol ester commonly used in the art,
When campesterol ester and stigmasterol ester, either one pack system still press different proportion mixing, the fish oil system with 75% or more purity
After composition, in the improvement of TC, TG, LDL-C and HDL-C index of reducing blood lipid and no significant difference, illustrate phytosterol
The different type and the pairs of high-purity fish oil of group of ester and the Hypolipidemic efficacy of phytosterin ester composition influence little.
The experimental result that comprehensive present invention applicant carries out, applicant creatively have found only to contain fish oil and phytosterol
The total content of the blood-fat reducing composition of ester two kinds of active components, only EPA and DHA is in 75% or more high-purity fish oil and plant
Composition composed by weight ratio of the sterol ester with 0.8:1 ~ 1.5:1 just has optimal synergistic effect, can be effectively reduced TC,
TG, LDL-C index, and in further satisfaction fish oil EPA and DHA ratio be 1:1 ~ 1.5:1 when can also effectively increase HDL-C
Index, and reinforce obtaining the beneficial effect of effective structure adjusting blood lipid to the reducing effect of LDL-C.
Specific embodiment
In order to make the objectives, technical solutions and advantages of the present invention clearer, below with reference to specific embodiment pair
The present invention is further described.It should be understood that these descriptions are merely illustrative, and it is not intended to limit the scope of the invention.
The present invention is illustrated with reference to embodiments, and the embodiment of the present invention is merely to illustrate technical side of the invention
Case, and non-limiting essence of the invention.
Embodiment 1
Formula: triglyceride type fish oil (EPA+DHA=75%, EPA:DHA=0.1:2) 1.2g, 99% phytosterin ester 0.8g.(fish
Oil: phytosterin ester=1.5:1)
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, under nitrogen protection
Gland.
Embodiment 2
Formula: sequestered fish oil (EPA+DHA=84%, EPA:DHA=5:1) 1.0g, 98% phytosterin ester 1.0g.It (fish oil: plants
Object sterol ester=1:1)
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, under nitrogen protection
Gland.
Embodiment 3
Formula: ethyl ester type fish oil (EPA+DHA=84%, EPA:DHA=1.2:1) 1.0g, 97% phytosterin ester 1.0g.It (fish oil: plants
Object sterol ester=1:1)
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, under nitrogen protection
Gland.
Embodiment 4
Formula: ethyl ester type fish oil (EPA+DHA >=95%, EPA:DHA=1:1) 1.1g, 98% phytosterin ester 0.9g.It (fish oil: plants
Object sterol ester=1:1)
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, under nitrogen protection
Gland.
Embodiment 5
Formula: glyceride type fish oil (EPA+DHA=90%, EPA:DHA=1.3:1) 1.0g, 98% phytosterin ester 1.0g.(fish
Oil: phytosterin ester=1:1)
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, under nitrogen protection
Gland.
Embodiment 6
Formula: ethyl ester type fish oil 1.0g, 99% phytosterin ester 1.0g.(fish oil: phytosterin ester=1:1).EPA second in fish oil
430 ~ 495mg/g of ester, 347 ~ 403mg/g of DHA ethyl ester, EPA ethyl ester add 800 ~ 880mg/g of DHA ethyl ester.
Fish oil and phytosterin ester are uniformly mixed in 70 DEG C of conditions, then dispensed while hot in glove box, nitrogen is protected
Protect lower cover.
Embodiment 7
Capsule composition
Content: ethyl ester type the fish oil 481mg, 99% phytosterin ester 481mg, beeswax 38mg of embodiment 6.
Rubber component: gelatin 264mg, glycerol 120mg, purified water 45.5mg.
It is prepared as follows into soft capsule:
With liquid: under the conditions of nitrogen protection, taking the phytosterin ester and beeswax of recipe quantity, carry out 65 DEG C or so heating water baths, stir
Mixing makes to be dissolved into clear solution, and recipe quantity fish oil is added, and stirs 10 ~ 30min, and 35 ~ 55 DEG C of water-bath heat preservations are spare.
Change glue: taking the glycerol of recipe quantity, in purified water being placed in glue tank, stir, heating water bath make mixture be warming up to 59 ~
75℃.Recipe quantity gelatin is added, stirring vacuumizes (vacuum degree be not less than -0.07MPa) 40min or more, to without obvious particle with
Bubble.
Pelleting, predry wash ball, do eventually, selecting ball, packaging.
Animal pharmacodynamic study is carried out to embodiment 1 ~ 6 according to aforementioned test methods, investigates four blood lipids index.Test knot
Fruit proves that embodiment 1 ~ 2 can significantly reduce TC, TG, LDL-C index, and embodiment 3 ~ 6 is gone back while significantly reducing TC, TG, LDL-C
It is significant to increase HDL-C index, and 3 ~ 6 composition of embodiment drop LDL-C significant effect is higher than 1 ~ 2 composition of embodiment.
Claims (11)
1. a kind of composition, active constituent are made of fish oil and phytosterin ester, it is characterised in that fish oil and phytosterin ester
Weight ratio is 0.8:1 ~ 1.5:1, and the total weight percent of EPA and DHA is not less than 75% in the fish oil.
2. composition according to claim 1, it is characterised in that the weight ratio of fish oil and phytosterin ester be selected from 1:1 ~
1.3:1, the total weight percent of EPA and DHA is 75%-95% in the fish oil.
3. according to claim 1 or 2 described in any item compositions, it is characterised in that the weight of EPA and DHA in the fish oil
Than for 1:1 ~ 1.5:1, preferably 1.1:1 ~ 1.3:1.
4. according to claim 1 or 2 described in any item compositions, it is characterised in that the EPA and DHA be selected from free acid,
One of glycerol ester type, ethyl ester type and phosphatide type, preferably ethyl ester type.
5. according to claim 1 or 2 described in any item compositions, it is characterised in that EPA ethyl ester 430 in the fish oil ~
495mg/g, 347 ~ 403mg/g of DHA ethyl ester, EPA ethyl ester add 800 ~ 880mg/g of DHA ethyl ester.
6. according to claim 1 or 2 described in any item compositions, it is characterised in that the phytosterin ester purity is 97%
More than.
7. according to claim 1 or 2 described in any item compositions, the polyunsaturated fat in the fish oil in addition to EPA and DHA
The total weight of acid is no more than 15%.
8. according to claim 1 or 2 described in any item compositions have in hypolipemic function health care product or drug in preparation
Using.
9. a kind of health care product or pharmaceutical composition, the composition includes the composition and pharmaceutically of any one of claims 1 or 2
Acceptable auxiliary material.
10. pharmaceutical composition according to claim 9, the composition is one of soft capsule or hard capsule, preferably
Soft capsule.
11. the side that preparation contains pharmaceutically acceptable auxiliary material and a effective amount of composition as defined in claims 1 or 2
Method, this method include mixing composition defined in claims 1 or 2 with pharmaceutically acceptable auxiliary material.
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