CN105412227A - Unsaturated fatty acid dietary supplement and preparing method thereof - Google Patents
Unsaturated fatty acid dietary supplement and preparing method thereof Download PDFInfo
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- CN105412227A CN105412227A CN201510873194.0A CN201510873194A CN105412227A CN 105412227 A CN105412227 A CN 105412227A CN 201510873194 A CN201510873194 A CN 201510873194A CN 105412227 A CN105412227 A CN 105412227A
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- fatty acid
- unsaturated fatty
- dietary supplement
- soft capsule
- oil
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- 238000004062 sedimentation Methods 0.000 description 1
- 208000017520 skin disease Diseases 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 201000000596 systemic lupus erythematosus Diseases 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 208000029257 vision disease Diseases 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
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Classifications
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- 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
- A61K35/612—Crustaceans, e.g. crabs, lobsters, shrimps, krill or crayfish; Barnacles
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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Abstract
The embodiment of the invention discloses an unsaturated fatty acid dietary supplement. The unsaturated fatty acid dietary supplement is mainly prepared from 5-30 parts of krill oil, 30-100 parts of fish oil and 5-20 parts of chia oil. The invention provides a preparing method for the unsaturated fatty acid dietary supplement. The preparing method comprises the steps of glue liquor preparing, pill pressing, setting, drying and final product obtaining in sequence. According to the unsaturated fatty acid dietary supplement, the three effective ingredients supplement one another, the effect of unsaturated fatty acid is given into full play, the unsaturated fatty acid is well absorbed by the human body, and the efficacy is improved. The preparing method is easy to operate, convenient, safe, efficient and suitable for industrialized popularization, and saves energy.
Description
Technical field
The present invention relates to field of health care products, particularly relate to a kind of unsaturated fatty acid dietary supplement and preparation method thereof.
Background technology
Fatty acid is the important composition of composition fat, and its chemical constitution is with the long-chain main body of carbon composition.The structure connected between carbon and carbon claims key, is connected the title satisfied fatty acid being a key in fatty acid between carbon with carbon.All satisfied fatty acid, can naturally synthesize in human body, do not need from food supplementary especially.If be doubly linked between carbon and carbon, then claim unsaturated fatty acid.The condition of synthesis unsaturated fatty acid is not possessed in human body, should by food supply, therefore unsaturated fatty acid is also referred to as essential fatty acid.
Unsaturated fatty acid is a kind of fatty acid forming body fat, the indispensable fatty acid of human body.Unsaturated fatty acid, according to the difference of double bond number, is divided into monounsaturated fatty acid and polyunsaturated fatty acid two kinds.In food fat, monounsaturated fatty acid has oleic acid etc., and polyunsaturated fatty acid has linoleic acid, linolenic acid, arachidonic acid etc.Human body can not synthesize linoleic acid plus linolenic acid, must supplement from meals.Again polyunsaturated fatty acid is divided into ω-6 series and ω-3 series according to the position of double bond and function, linoleic acid and arachidonic acid belong to ω-6 series, and linolenic acid, that DHA, EPA belong to ω-3 is serial.
After deliberation, unsaturated fatty acid has good effect to various diseases, as it can adjusting blood lipid, cleaning thrombosis, immunomodulating, safeguard that retina improves vision, supplementing the brain brain-strengthening, improves arthritic symptom, eases the pain.Although also there are the nutrient and healthcare products being much rich in unsaturated fatty acid in the market, these products have plenty of nutritional labeling and arrange in pairs or groups unreasonable, and some drug effects are difficult to give full play to, and general effect is bad.
Summary of the invention
Embodiments provide a kind of unsaturated fatty acid dietary supplement, to solve the problem that unreasonable, the drug effect of unsaturated fatty acids nutrient and healthcare products nutritional labeling collocation existed in the market is difficult to give full play to.
In order to solve the problem, the embodiment of the invention discloses a kind of unsaturated fatty acid dietary supplement, being prepared from primarily of following raw material: krill oil 5 ~ 30 parts, 30 ~ 100 parts, fish oil, Salvia Hispanica L. seed oil 5 ~ 20 parts.
Alternatively, described dietary supplement dosage form is soft capsule.
Alternatively, also comprise gelatin 20-25 and divide, glycerol 8-12 divides, and water 20-25 divides.。
Above-mentioned krill oil can adopt a commercially available krill oil, can be also raw material by krill section krill, and through washing, fragmentation, extraction, concentrated, filtration step is obtained.
Raw material is introduced:
Krill is the biology the highest containing protein that people have been found that today, protein content reaches more than 50 percent, but also containing the very abundant necessary aminoacid of tissue and vitamin A, that the Nature is presented to the natural health food of the mankind, containing the irreplaceable effect of other food.Krill oil contains ω-3 essential fatty acid eicosapentaenoic acid (EPA) and docosahexenoic acid (DHA).ω-3 essential fatty acid has a lot of sanatory benefit, comprises cardiovascular, neural, skeleton and joint, vision, skin care etc.
Krill oil can reduce cholesterol, prevention cerebral hemorrhage, cerebral thrombosis, reduction blood viscosity, blood circulation promoting, prophylaxis of hypertension, nourishing the brain and improving intelligence, active thinking, prevention senile dementia.U.S. clinical confirms, krill oil has effect of superpower blood fat reducing, blood sugar lowering and blood pressure lowering, and can pass through blood brain barrier, and nutrition and activation brain cell and nerve, play the effect of prevention and therapy cerebrovascular disease; Meanwhile, prevention and therapy coronary atherosclerosis, coronary heart disease, there is the cardiovascular disease such as heart infarction in prevention; Certainly, krill oil can also play anti-inflammation, the developing of prophylaxis of cancer, the multi-efficiency such as slow down aging, endocrine regulation.
In addition, krill oil also has good effect to following disease:
(1) coronary heart diseases and angina pectoris, heart infarction, arteriosclerosis
Omega-3 unsaturated fatty acid abundant in krill oil effectively can be removed blood fat, vessel softening wall, significantly reduce LDL " bad " cholesterol in blood and triglyceride mass, promote HDL " optimum " cholesterol amount simultaneously, make blood vessel become more unblocked, more healthy and more flexible, this will lower the risk of heart attack or apoplexy significantly.Astaxanthin contained by it and animal-type flavonoid, can alleviate the oxidation of apolipoprotein, and to vascularization anti-oxidation protection, anti-hemostatic tube becomes fragile, hardens, and keeps blood vessel elasticity, can available protecting heart, prevention of arterial sclerosis and ischemic brain injury.Especially to medicated porridge sample arteriosclerosis and coronary heart disease, krill oil can obviously reduce c reactive protein level, greatly reduces sickness rate.
(2) hyperlipidemia, hyperlipidemia, thrombosis, apoplexy, cerebral infarction
Krill oil can reduce low density lipoprotein, LDL, triglyceride and cholesterol level in blood fast, promote that neutral or acid cholesterol is discharged automatically, suppress liver inner lipid and lipoprotein synthesis, adjusting blood lipid level, keep the quick flowing of blood, prevent hyperlipidemia and thrombosis from producing.Meanwhile, the omega-fatty acid in krill oil can also reduce the platelet of being crowded with cholesterol, and prevents the grumeleuse of energy occluding vascular from being formed.Unobstructed to maintenance cerebrovascular, prevent cerebrovascular from narrowing because of hyperlipidemia or blocking, minimizing apoplexy and cerebral infarction disease are sent out and are played an important role.
(3) hypertension
Krill oil focuses on the platelet in blood obvious resistancing action, and the expression of vascular adhesion molecule can be stoped, stimulate blood vessel endothelial cell activity, allow blood vessel be in relaxed state, thus can effectively improve because of vasospasm, distortion, the narrow hypertension caused.
Fish oil is the general designation of the whole oily substances in fish body, it comprises body oil, liver oil and cerebrol, main fish oil is a kind of oils and fats extracted from greasiness Fish, be rich in polyunsaturated fatty acid (DHA and EPA), there is the health benefits such as antiinflammatory, adjusting blood lipid, can prevention of arterial sclerosis and thrombosis.
Fish oil mainly has following effect:
(1) adjusting blood lipid, prevents blood coagulation, prevention cerebral thrombosis, cerebral hemorrhage and apoplexy;
(2) reduce blood fat, cleaning thrombosis, improve memory.
EPA and DHA obtained from meals based on every day in the coastal resident of edible marine organisms comparatively inland resident for height.In general inland crowd, in body, unsaturated fatty acid content is lower.
Salvia Hispanica L. seed oil: Salvia Hispanica L. (ChiaSeed) has another name called strange refined son, Salvia Hispanica L. seed, formal name used at school salvia hispanica L (SalviaHispanicaL.), pennyroyal, original producton location is the area, North America such as Mexico south and Guatemala, the area desert band height above sea level less than 4000 feet can be grown, the Salvia Hispanica L. of the usual indication of people is the seed of this plant in fact---Salvia Hispanica L. seed.
It is rich in the abundantest food of fatty acid, and containing the Natural antioxidant.The edible history of Salvia Hispanica L. seed can trace back to B.C. 3500, is the safety food of U.S. FDA certification now, the bread adding ingredient of Ye Shi European Union legislative confirmation.
And above-mentioned three kinds of raw material phosphor shrimp sauces, fish oil, Salvia Hispanica L. seed are oily, the effect all containing a large amount of unsaturated fatty acids in its composition, and unsaturated fatty acid has many benefits to health, specific as follows:
(1) adjusting blood lipid
Hyperlipidemia causes the main cause of the diseases such as hypertension, arteriosclerosis, heart disease, cerebral thrombosis, apoplexy, and the main component EPA in fish oil and DHA, can reduce cholesterol harmful in blood and triglyceride; Effectively can control the concentration of human body blood fat; And the content improved the useful high density lipoprotein of human body.Maintaining low concentration blood lipid level to keeping fit, angiocardiopathy preventing, improving endocrine and all play a part key.
(2) thrombosis is cleared up
The bathypelagic fish oil of supplementing with diet can promote the metabolism of satisfied fatty acid in body, alleviate and eliminate Animal fat in food (mainly from fat meat, milk product etc.) to the harm of human body, prevent the sedimentation of fat in blood vessel wall, suppress atherosclerotic formation and development, strengthen elasticity and the toughness of blood vessel, reduce blood viscosity, promote the ability that erythrocyte takes oxygen.EPA in fish oil, prevents the function of PA, cohesion in addition, and therefore it can the formation of effectively anti-tampon, prevention of stroke.
(3) immunomodulating
Supplement EPA, DHA, can enhancing human body immunity power, improve the ability that self immune system defeats cancerous cell.The research of Japan finds that the DHA in fish oil can inducing cancer cell " suicide ".According to another interrelated data report, fish oil is very remarkable to effects such as prevention and prohibition breast carcinoma.The serial unsaturated fatty acid of ω-3 can in order to landman's body self immune system, and in Britain, the U.S. and some developed countries, bathypelagic fish oil is also used to adjuvant therapy of diabetes, psoriasis, rheumatoid arthritis and systemic lupus erythematosus (sle) disease.Bathypelagic fish oil also suffers from special efficacy to anaphylactic disease, limitation gastroenteritis and skin disease.
(4) safeguard that retina improves vision
DHA is amphiblestroid important component part, accounts for 40 ~ 50%.Supplement the retina cell of enough DHA to activation decline helpful, have therapeutical effect to the disease such as tired, senile dim eyesight, blurred vision, glaucoma, cataract that excess eye-using causes.DHA also can provide optic nerve desired nutritional composition, and prevents visual disorder.
(5) supplementing the brain brain-strengthening
DHA is that brain cell forms growth and the indispensable material base that moves.People has memory, function and thinking to depend on DHA to maintain and improves.Supplementary DHA can promote that brain cell reaches full growth, and delays intelligence and declines, forgetful and prevention Alzheimer (senile dementia) etc.
(6) improve arthritic symptom to ease the pain
The serial unsaturated fatty acid of ω-3 can be assisted and be formed lubricating fluid in articular cavity, and improve the ability of leukocytic anti-inflammation and sterilization in body, ameliorate osteoarthritis symptom, lubricating joint, eases the pain.
The present invention adopts krill oil, fish oil and Salvia Hispanica L. seed oil cooperatively interact, complement each other, wherein, ω-3 essential fatty acid eicosapentaenoic acid (EPA) and docosahexenoic acid (DHA) is all rich in krill oil and fish oil, and Salvia Hispanica L. seed oil generally acknowledges to be rich in the abundantest food of omega-fatty acid, and containing the Natural antioxidant, unsaturated fatty acid in three kinds of raw materials can help human body adjusting blood lipid, cleaning thrombosis, prevent blood coagulation, prevention cerebral thrombosis, cerebral hemorrhage and apoplexy, improve memory, body immunity can also be improved, safeguard retina, improve vision, simultaneously, also containing the Natural antioxidant in Salvia Hispanica L. seed oil, contribute to slow down aging, maintain the young state of body, thus further improve human immunity mechanism, maintain health.Above-mentioned three kinds of components complement each other, and mutually coordinate, and have given play to its respective effect separately, have also enable effect of the unsaturated fatty acid in three kinds of components give full play to and absorbed well by human body, improve drug effect.
In order to solve the problem, the embodiment of the invention also discloses a kind of preparation method of above-mentioned unsaturated fatty acid dietary supplement, comprising the following steps:
(1) glue preparation: gelatin part water soaking is made its imbibition, obtains expansion gelatin, is then heated to 70-80 DEG C by glycerol, expansion gelatin and remaining water mix homogeneously, stirs and makes it dissolve, obtain glue;
(2) pelleting: by krill oil, fish oil, the mixing of Salvia Hispanica L. seed oil, obtain mixed material, then mixed material and step (1) gained glue are carried out pelleting, obtained soft capsule, in described pelleting process, temperature is 22-24 DEG C, and relative humidity is 40-45%;
(3) shape: soft capsule obtained for step (2) is shaped, described in be fixed to temperature be 22-24 DEG C, relative humidity be the environment of 40-45% under dry 3-5 hour;
(4) dry: it is 26-28 DEG C that the soft capsule after step (3) being shaped is placed in temperature, and relative humidity is carry out drying under 30-40% environment, and drying time is 22-26h.
Optionally, also comprise in step (1) and glue is kept 70-80 DEG C, leave standstill 1-2h, removing offscum, then vacuumizing and defoaming.
Optionally, in step (1), after vacuumizing and defoaming, then filtered by glue, then stand for standby use under 55-65 DEG C of condition, described filtration adopts 80-120 mesh sieve.
Optionally, the soft capsule after step (3) being shaped adopts ethanol to carry out cleaning to remove the oil stain on soft capsule shell before step (4) is dry.
Optionally, step (4) dried soft capsule is selected, rejects underproof soft capsule, retain qualified soft capsule.
Preparation method provided by the present invention, it is simple to operate, convenient, safe, efficient, energy-conservation, be suitable for industrialization promotion.
Detailed description of the invention
Hereinafter will describe the present invention in detail in conjunction with the embodiments.It should be noted that, when not conflicting, the embodiment in the present invention and the feature in embodiment can combine mutually.
Embodiment 1
Present embodiments provide a kind of unsaturated fatty acid dietary supplement, be prepared from by following raw material by weight: krill oil 15 parts, 55 parts, fish oil, Salvia Hispanica L. seed oil 10 parts, 20 parts, gelatin, glycerol 8 parts, purified water 20 parts, described dietary supplement dosage form is soft capsule.
The preparation method of above-mentioned unsaturated fatty acid dietary supplement is specific as follows:
(1) glue preparation: gelatin partial purification water soaking is made its imbibition, must be expanded gelatin, then glycerol, expansion gelatin and remaining purified water mix homogeneously are heated to 75 DEG C, stir and make it dissolve, after expansion gelatin and glycerol dissolve completely, keep 75 DEG C of constant temperature, leave standstill 1.5h, removing offscum, then vacuumizing and defoaming, glue is obtained, stand for standby use under gained glue 60 DEG C of conditions after 100 mesh sieves filter;
(2) pelleting: by krill oil, fish oil, the mixing of Salvia Hispanica L. seed oil, obtain mixed material, then mixed material and step (1) gained glue are carried out pelleting, obtained soft capsule, in described pelleting process, temperature is 22 DEG C, and relative humidity is 42%;
(3) shape: by soft capsule obtained for step (2) temperature be 22 DEG C, relative humidity is dry under being the condition of 42% within 4 hours, shapes;
(4) ball is washed: the ethanol being 95% by the soft capsule employing mass fraction after step (3) sizing carries out cleaning to remove the oil stain on soft capsule shell;
(5) dry: it is 27 DEG C that the soft capsule after step (4) being cleaned is placed in temperature, and relative humidity is carry out drying under 35% environment, and drying time is 24h;
(6) step (5) dried soft capsule is selected, reject underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.
Embodiment 2
Present embodiments provide a kind of unsaturated fatty acid dietary supplement, be prepared from by following raw material by weight: krill oil 5 parts, 100 parts, fish oil, Salvia Hispanica L. seed oil 5 parts, 25 parts, gelatin, glycerol 10 parts, purified water 25 parts, described dietary supplement dosage form is soft capsule.
The preparation method of above-mentioned unsaturated fatty acid dietary supplement is specific as follows:
(1) glue preparation: gelatin partial purification water soaking is made its imbibition, must be expanded gelatin, then glycerol, expansion gelatin and remaining purified water mix homogeneously are heated to 80 DEG C, stir and make it dissolve, after expansion gelatin and glycerol dissolve completely, keep 80 DEG C of constant temperature, leave standstill 1h, removing offscum, then vacuumizing and defoaming, glue is obtained, stand for standby use under gained glue 65 DEG C of conditions after 80 mesh sieves filter;
(2) pelleting: by krill oil, fish oil, the mixing of Salvia Hispanica L. seed oil, obtain mixed material, then mixed material and step (1) gained glue are carried out pelleting, obtained soft capsule, in described pelleting process, temperature is 23 DEG C, and relative humidity is 45%;
(3) shape: soft capsule step (2) obtained is 23 DEG C in temperature, relative humidity is dry under 45% condition sizing for 5 hours;
(4) ball is washed: the ethanol being 95% by the soft capsule employing mass fraction after step (3) sizing carries out cleaning to remove the oil stain on soft capsule shell;
(5) dry: it is 28 DEG C that the soft capsule after step (4) being cleaned is placed in temperature, and relative humidity is carry out drying under 30% environment, and drying time is 26h;
(6) step (5) dried soft capsule is selected, reject underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.
Embodiment 3
Present embodiments provide a kind of unsaturated fatty acid dietary supplement, be prepared from by following raw material by weight: krill oil 30 parts, 30 parts, fish oil, Salvia Hispanica L. seed oil 20 parts, 23 parts, gelatin, glycerol 12 parts, purified water 23 parts, described dietary supplement dosage form is soft capsule.
The preparation method of above-mentioned unsaturated fatty acid dietary supplement is specific as follows:
(1) glue preparation: gelatin partial purification water soaking is made its imbibition, must be expanded gelatin, then glycerol, expansion gelatin and remaining purified water mix homogeneously are heated to 70 DEG C, stir and make it dissolve, after expansion gelatin and glycerol dissolve completely, keep 70 DEG C of constant temperature, leave standstill 2h, removing offscum, then vacuumizing and defoaming, glue is obtained, stand for standby use under gained glue 55 DEG C of conditions after 120 mesh sieves filter;
(2) pelleting: by krill oil, fish oil, the mixing of Salvia Hispanica L. seed oil, obtain mixed material, then mixed material and step (1) gained glue are carried out pelleting, obtained soft capsule, in described pelleting process, temperature is 24 DEG C, and relative humidity is 40%;
(3) shape: soft capsule step (2) obtained is 24 DEG C in temperature, relative humidity is dry under the condition of 40% sizing for 3 hours;
(4) ball is washed: the ethanol being 95% by the soft capsule employing mass fraction after step (3) sizing carries out cleaning to remove the oil stain on soft capsule shell;
(5) dry: it is 26 DEG C that the soft capsule after step (4) being cleaned is placed in temperature, and relative humidity is carry out drying under 40% environment, and drying time is 22h;
(6) step (5) dried soft capsule is selected, reject underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.
Testing inspection is carried out to embodiment of the present invention gained sample below
1, safety experiment:
Materials and methods
Sample: adopt the embodiment of the present invention 1 gained sample, specification 1.0g/ grain.The oral recommendation consumption of people is everyone (adult) every day 2, and adult's body weight is pressed 60kg and calculated, and amounting to dosage is 33.3mg/kg.BW.
Experimental animal and environment: the healthy Kunming mouse of SPF level, bred by Sichuan University's West China Experimental Animal Center.Animal Lab. is barrier system, laboratory animal room temperature: 21 ~ 23 DEG C, relative humidity: 65 ~ 75%.
Chmice acute Oral toxicity is tested: adopt maximum resistance test method, select the Kunming mouse 20 of body weight 18 ~ 22g, male and female half and half.Before test, animal fasting 16 hours, does not limit drinking-water.Take 50.0g sample, add pure water to 100mL, mix, be made into 500mg/mL strength solution, then give animal gavage 2 times (interval 6h), each gavage amount is 0.4mL/20g.BW, and total dosage is 20000mg/kg.BW.Observe, record the poisoning manifestations of animal after gavage.Weigh weekly once, observe two time-of-weeks, off-test is dissected animal and is carried out gross examination of skeletal muscle.By the acute toxicity of toxicity grading standard evaluation tested material.
Table 1. sample is to the acute toxicity tests of mice
Result: as seen from Table 1, after giving mouse stomach with the sample of 20000mg/kg.BW dosage, growth of animal is good, has no body weight and receives impact.Test mice has been showed no poisoning symptom, observes 14 days without animal dead.Animal, gross examination of skeletal muscle are dissected in off-test, and the main organs such as liver,kidney,spleen, the heart, lung, stomach, intestinal are showed no obvious abnormalities change.Result shows, the acute oral toxicity dosage of this sample to mice is greater than 20000mg/kg.BW, and acute oral toxicity belongs to nontoxic.Its result of the test of other embodiments of the invention gained sample is identical with embodiment 1.
2, functional experiment:
Materials and methods
Sample: adopt the embodiment of the present invention 1 gained sample, specification 1.0g/ grain.The oral recommendation consumption of people is everyone (adult) every day 2, and adult's body weight is pressed 60kg and calculated, and amounting to dosage is 33.3mg/kg.BW.
Experimental animal and raising
SPF level male SD rat 36, body weight 150-200g, is provided by Sichuan Academy of Medical Sciences's Animal Experimental Study center.Animal feeding is in barrier level (IVC) Animal House.In whole experimentation, animal freely ingests and drinks water, room temperature 19-22 DEG C, relative humidity 50%-70%.
Feedstuff:
A) normal feedstuff: Sichuan University's Experimental Animal Center provides;
B) high lipid food (%): normal feedstuff 78.8, Adeps Sus domestica 10, yolk powder 10, cholesterol 1, cholate 0.2.
Key instrument and reagent
Olympus400 type automatic clinical chemistry analyzer (Japan), Australian Olympus company clinical biochemical reagent.
Experimental technique
Rat is with normal feedstuff adaptability feed after seven days, get tail hematometry basis TC, TG and HDL-C level, according to TC level, following four groups are divided into: 166.5mg/kg.BW, 333mg/kg.BW, 666mg/kg.BW (being equivalent to 5,10,20 times of human intaking amount 33.3mg/kg.BW) and matched group by random packet principle, every treated animal 9, four treated animals all use high lipid food feed.Experimental group is with the sample gavage of corresponding dosage, and matched group is with same volume edible vegetable oil gavage, and gavage amount is 10ml/kg.BW, and once a day, continuous gavage 30 days, weighs weekly and adjust gavage amount by body weight.Experiment terminates fasting 16 hours, gets blood measure TC, TG and HDL-C from rat femoral.
Experimental result
(1) sample is on the impact of rat body weight
As shown in table 2, the body weight of sample three dosage group rats and weightening finish compared with matched group, difference that there are no significant (P > 0.05).Show that tested material has no adverse effects to rat body weight.
Table 2. sample must affect rat body weight
(2) sample is on the impact of rat fat
As shown in table 3, before TC, TG of matched group is significantly higher than test during off-test, show hyperlipidemia model success.At the end of experiment, the TC of the basic, normal, high dosage group of sample is significantly lower than matched group (P < 0.05); The TG of basic, normal, high dosage group is significantly lower than matched group (P < 0.05).
Table 3. sample is on the impact of Serum TC, TG, HDL-C
# compares with before test, P < 0.01; * compare with matched group, P < 0.05
Conclusion: auxiliary lipid-lowering function animal test results shows, this tested material has no adverse effects to rat body weight; Before TC, TG of matched group is significantly higher than test at the end of experiment, show hyperlipidemia model success; During off-test, the basic, normal, high dosage group of tested material obtains TC significantly lower than matched group (P < 0.05); The TG of basic, normal, high dosage group is significantly lower than matched group (P < 0.05).By evaluation criterion, the embodiment of the present invention 1 has auxiliary lipid-lowering function.Coming to the same thing of its experimental result of other embodiments of the invention gained sample and embodiment 1.
3, human experiment report:
(1) experimenter selects
Study subject: by the principle of voluntariness select 18-65 year, hyperlipidemia person.
The person's of including in standard: simple dyslipidemia crowd, usual diet.Blood sampling 2 times in half a year, twice serum total cholesterol (TC) all >=5.2mmol/L and serum triglycerides (TG) >=1.65mmol/L, can test-meal observation be carried out.
Eliminator's standard:
A, age under-18s or over-65s person, gestation or women breast-feeding their children, those who are allergic to the health care products;
B, be associated with the serious diseases such as heart kidney and hemopoietic system, psychotic;
C, take the article relevant with tested function in a short time, have influence on the judgement person to result;
D, do not meet inclusive criteria, not by regulation tested material, cannot judge effect or data not umbra ring effect or safety judgement person;
(2) EXPERIMENTAL DESIGN and grouping require: 120 routine experimenters are divided into test-meal group and blank group at random, adopt before and after self and contrast form with between group.Tested period keeps life on ordinary days and dietary habit.Get the every biochemical indicator of hematometry on an empty stomach.
(3) taking dose and the time: test-meal group dose, each 1, every day 2 times, continuous 90 days, the embodiment of the present invention 1 gained sample is adopted.
(4) instrument and reagent: F-820 type blood counting instrument, (Japan produces) MIDIRON layer ten analyser (Germany produces), RA1000 automatic clinical chemistry analyzer (U.S.'s product), biochemical reagents box is all provided by Zhong Sheng company.
(5) observation index
Safety observations
Ordinary circumstance:
Detailed medical history-taking, understands the situations such as experimenter's spirit, diet, sleep, defecation, heart rate, blood pressure, observes main clinic symptoms: tired, uncomfortable in chest, dizzy, irritated etc.Before and after test-meal, add up integrated value by symptom weight (serious symptom 3 points, moderate 2 points, mild 1 point), and with regard to its cardinal symptom improve (each symptom improve 2 points effective, improve 1 point effectively), calculate improvement rate.
Blood and urine and stool routine examination:
Red blood cell count(RBC), hemoglobin, numeration of leukocyte, routine urinalysis, just routine examination.
Biochemical Indexes:
Serum albumin ALB, albumin TP, darling renal function (glutamic oxaloacetic transaminase, GOT AST, glutamate pyruvate transaminase ALT, carbamide UREA, inosine CRE), blood glucose GLU.
Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest.
Untoward reaction is observed.
(6) efficiency index:
Serum total cholesterol level and reduction percentage rate, triglyceride levels and reduction percentage rate, High-density Lipoprotein-cholesterol ascensional range.
(7) effect criterion:
A, effectively:
Cholesterol decline > 10%, triglyceride decline > 15%, HDL-C rising > 0.104mmol/L.Serum total cholesterol, triglyceride, test-meal group self compares and between matched group group, comparing difference has significance, and HDL-C is not significantly lower than matched group.
B, invalid:
Do not reach above standard person.
(8) experimental result:
General status:
Observe hyperlipidemia experimenter 120 example altogether, effective case 100 example, test-meal group male 12 example, women 38 example, maximum 65 years old, average 57.28 ± 6.78 years old, average course of disease 5.09 ± 4.00 years.Blank group male 17 example, women 33 example, minimum 38 years old of age, maximum 65 years old, average 57.44 ± 6.14 years old, average course of disease 5.17 ± 4.26 years.Before and after experimenter's test-meal, the symptom such as spirit, sleep, diet, defecation is without obvious change.
Table 4. is observed front ordinary circumstance and is compared (X ± SD)
Heart rate (beat/min), blood pressure (mmHg) change before and after table 5. test-meal
Cholesterol changes:
Cholesterol change unit before and after table 6. test-meal: (mmol/L)
| Number of cases | Before test-meal | After test-meal | Difference | Effective percentage % | |
| Test-meal group | 50 | 6.47±0.83 | 5.76±0.99 | 0.72±1.24** | 62 (31 examples) |
| Matched group | 50 | 6.61±1.10 | 6.54±1.31 | 0.06±0.99# | 20 (10 examples) |
Self compare between * * P < 0.01 group and compare #P < 0.05
The change of triglyceride:
Triglyceride change unit before and after table 7. test-meal: (mmol/L)
| Number of cases | Before test-meal | After test-meal | Difference | Effective percentage % | |
| Test-meal group | 50 | 2.93±0.99 | 2.18±0.98 | 0.75±0.98** | 74 (37 examples) |
| Matched group | 50 | 2.66±0.95 | 2.80±1.30 | -0.13±0.99# | 26 (13 examples) |
Self compare between * * P < 0.01 group and compare #P < 0.05
High density lipoprotein changes:
High density lipoprotein change unit before and after table 8. test-meal: (mmol/L)
| Number of cases | Before test-meal | After test-meal | Difference | Effective percentage % | |
| Test-meal group | 50 | 1.07±0.36 | 1.07±0.38 | 0.01±0.44 | 40 (20 examples) |
| Matched group | 50 | 1.16±0.46 | 1.11±0.42 | 0.06±0.40 | 28 (14 examples) |
Efficacy assessments:
Table 9. effect judges
| Number of cases | Effectively | Invalid | Total effective rate (%) |
| Test-meal group | 50 | 26 | 24 | 52.00％# |
| Matched group | 50 | 3 | 47 | 6.00％ |
#P < 0.05 is compared between group
Symptom improves situation:
Table 10. cardinal symptom improves situation
Symptom integral changes:
Table 11. symptom integral changes
| Group | Number of cases | Before test-meal | After test-meal |
| Test-meal group | 50 | 8.14±4.54 | 5.76±4.03** |
| Matched group | 50 | 7.32±4.90 | 5.82±4.42** |
**P＜0.01
Safety indexes detects:
Table 12. safety indexes detects
Before and after test-meal, indices is substantially in normal range.
Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest, substantially in normal range.
Case depigmentation rate: test-meal group and matched group are respectively 60 examples, has 3 examples not take tested material, 7 routine detection data by regulation incomplete at the end of the test-meal of wherein test-meal group, matched group has 7 routine detection data incomplete, and 3 examples are dropped by the wayside.Test-meal group and matched group respectively have 10 examples to meet Subject Exclusion Criteria, and effective case often organizes 50 examples, and case depigmentation rate is 16.67%.
Conclusion:
On request, test-meal group takes sample, each 1 for a, 100 routine hyperlipidemia experimenters, every day 2 times, continuous 90 days.Matched group is blank group, and result test-meal group cholesterol on average declines 0.72 ± 1.24mmol/L, and triglyceride on average declines 0.75 ± 0.98mmol/L, high density lipoprotein on average raises 0.01 ± 0.44mmol/L, in 50 examples, effective 26 examples, total effective rate 52.00%.Blank group cholesterol on average declines 0.06 ± 0.99mmol/L, and triglyceride on average declines-0.13 ± 0.99mmol/L, and high density lipoprotein on average raises-0.06 ± 0.40mmol/L, in 50 examples, and effective 3 examples, total effective rate 6.00%.Test-meal group cholesterol and self compare and more all have significant difference between group.High density lipoprotein self compares and compares no significant difference between group.Interpret sample has the effect of auxiliary antilipemic.
B, sample are improved effect to the feeling of fatigue of hyperlipidemia experimenter, the symptom such as uncomfortable in chest, dizzy, irritated.
Before and after c, sample test-meal, the Testing index such as hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, inosine, carbamide, blood glucose, routine urinalysis, just routine, substantially in normal range, illustrate that this product has no adverse effects to experimenter is healthy.
Before and after d, examination trencherman test-meal, heart rate, blood pressure are in normal range.Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest, substantially in normal range.
After e, sample test-meal, have no irritated and other untoward reaction.
Adopt other embodiments of the invention to test, its acquired results is identical with embodiment 1.
It should be noted that, for aforesaid embodiment of the method, in order to simple description, therefore it is all expressed as a series of combination of actions, but those skilled in the art should know, the present invention is not by the restriction of described sequence of movement, because according to the present invention, some step can adopt other orders or carry out simultaneously.Secondly, those skilled in the art also should know, the embodiment described in description all belongs to preferred embodiment, and involved action might not be essential to the invention.
Last it is noted that above embodiment is only in order to illustrate technical scheme of the present invention, be not intended to limit; Although with reference to previous embodiment to invention has been detailed description, those of ordinary skill in the art is to be understood that: it still can be modified to the technical scheme described in foregoing embodiments, or carries out equivalent replacement to wherein portion of techniques feature; And these amendments or replacement, do not make the essence of appropriate technical solution depart from the spirit and scope of various embodiments of the present invention technical scheme.
Claims (7)
1. a unsaturated fatty acid dietary supplement, is characterized in that, is prepared from primarily of following raw material: krill oil 5 ~ 30 parts, 30 ~ 100 parts, fish oil, Salvia Hispanica L. seed oil 5 ~ 20 parts.
2. unsaturated fatty acid dietary supplement according to claim 1, is characterized in that, described dietary supplement dosage form is soft capsule.
3. unsaturated fatty acid dietary supplement according to claim 2, is characterized in that, also comprise gelatin 20-25 and divide, glycerol 8-12 divides, and water 20-25 divides.。
4. a preparation method for unsaturated fatty acid dietary supplement as claimed in claim 2 or claim 3, is characterized in that, comprise the following steps:
(1) glue preparation: gelatin part water soaking is made its imbibition, obtains expansion gelatin, is then heated to 70-80 DEG C by glycerol, expansion gelatin and remaining water mix homogeneously, stirs and makes it dissolve, obtain glue;
(2) pelleting: by krill oil, fish oil, the mixing of Salvia Hispanica L. seed oil, obtain mixed material, then mixed material and step (1) gained glue are carried out pelleting, obtained soft capsule, in described pelleting process, temperature is 22-24 DEG C, and relative humidity is 40-45%;
(3) shape: soft capsule obtained for step (2) is shaped, described in be fixed to temperature be 22-24 DEG C, relative humidity be the environment of 40-45% under dry 3-5 hour;
(4) dry: it is 26-28 DEG C that the soft capsule after step (3) being shaped is placed in temperature, and relative humidity is carry out drying under 30-40% environment, and drying time is 22-26h.
5. the preparation method of unsaturated fatty acid dietary supplement according to claim 4, is characterized in that, also comprises glue is kept 70-80 DEG C in step (1), leaves standstill 1-2h, removing offscum, then vacuumizing and defoaming.
6. the preparation method of unsaturated fatty acid dietary supplement according to claim 5, is characterized in that, in step (1), after vacuumizing and defoaming, filtered by glue, then stand for standby use under 55-65 DEG C of condition, described filtration adopts 80-120 mesh sieve again.
7. the preparation method of unsaturated fatty acid dietary supplement according to claim 4, it is characterized in that, the soft capsule after step (3) being shaped adopts ethanol to carry out cleaning to remove the oil stain on soft capsule shell before step (4) is dry.
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| CN108936632A (en) * | 2018-08-08 | 2018-12-07 | 深圳极醇健康产业股份有限公司 | A kind of krill fat capsule and preparation method thereof |
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