CN105595323A - Phosphatide-unsaturated fatty acid compound health product and preparation method thereof - Google Patents

Abstract

Embodiments of the invention disclose a phosphatide-unsaturated fatty acid compound health product. The compound health product is mainly prepared from the following raw materials: 280 to 600 parts of concentrated phosphatide, 280 to 400 parts of fish oil and 20 to 200 parts of chia seed oil. The invention also provides a preparation method for the phosphatide-unsaturated fatty acid compound health product. The preparation method comprises the following successive steps: preparation of colloidal solution, pill pressing, shaping, drying and preparation of the finished product, the compound health product. The three components of the compound health product complement each other, cooperate with each other, and exert respective effect, which enables the efficacy of effective ingredients in the three components to be given to full play and the effective ingredients to be perfectly absorbed by the human body, so drug effect is improved. The preparation method provided by the invention is simple to operate, convenient, safe, highly efficient, energy-saving and suitable for industrial promotion.

Description

A kind of phosphatide, unrighted acid complex health care product and preparation method thereof

Technical field

The present invention relates to health product technology field, relate in particular to a kind of phosphatide, unrighted acid complex health care product and preparation method thereof.

Background technology

Phosphatide is made up of lecithin, lipositol, cephalin etc. These phosphatide respectively each position to human body and each organ play corresponding function. In human body all cells, all contain phosphatide. It is the basic substance of the activity of sustaining life. Phosphatide to activating cell, maintain metabolism, basic metabolism and hormonal balanced secretion, the immunity and the regeneration power etc. that strengthen human body can bring into play great effect. Summarize the basic training of phosphatide with being: strengthen mental, stable nerve, balance endocrine, improve immunity and regeneration power, removing toxic substances diuresis, blood clean, vigorous and graceful skin, keep young, delay senility.

Unrighted acid is a kind of aliphatic acid that forms body fat, the indispensable aliphatic acid of human body. Unrighted acid, according to the difference of two key numbers, is divided into two kinds of monounsaturated fatty acids and polyunsaturated fatty acids. In food fat, monounsaturated fatty acids has oleic acid etc., and polyunsaturated fatty acid has linoleic acid, leukotrienes, arachidonic acid etc. Human body can not synthesize linoleic acid plus linolenic acid, must from meals, supplement. Again polyunsaturated fatty acid is divided into ω-6 series and ω-3 series according to the position of two keys and function, linoleic acid and arachidonic acid belong to ω-6 series, and leukotrienes, DHA, EPA belong to ω-3 series. After deliberation, unrighted acid has good effect to various diseases, as it can regulate blood fat, cleaning thrombus, immunological regulation, safeguard that retina improves eyesight, mends brain brain tonic, improves arthritic symptom, eases the pain etc.

Phosphatide and unrighted acid are all the main components that is conducive to the health products of health, but health products in the market, all there is many defects, such as active ingredient is single, effect is single, drug effect can not finely be brought into play, utilization rate is low etc., cannot meet consumer demand.

Summary of the invention

The embodiment of the present invention provides a kind of phosphatide, unrighted acid complex health care product, and to solve, current health products active ingredient is single, effect is single and drug effect is brought into play halfway problem.

In order to address the above problem, the embodiment of the invention discloses a kind of phosphatide, unrighted acid complex health care product, be mainly prepared from by following raw material by weight: concentrated phosphatide 280-600 part, fish oil 280-400 part, strange sub-seed oil 20-200 part.

Alternatively, described concentrated phosphatide is concentrating soya lecithin.

Alternatively, described complex health care product formulation is soft capsule.

Alternatively, also comprise following raw material: gelatin 180-300 part, glycerine: 72-150 part, water: 180-300 part.

Raw material is introduced:

Phosphatide is Life Base material. Cell membrane is just made up of the lipid (phosphatide is main) of 40% left and right protein and 50% left and right. Phosphatide is mainly made up of lecithin, lipositol, cephalin etc. These phosphatide respectively each position to human body and each organ play corresponding function. Phosphatide, to activating cell, maintains metabolism, basic metabolism and hormonal balanced secretion, and immunity and the regeneration power of enhancing human body, can bring into play great effect. In addition, phosphatide also has promotion fat metabolism, prevents fatty liver, reduces serum cholesterol, improves the effect of blood circulation, angiocardiopathy preventing.

Phosphatide also has following effect:

(1) emulsification

Phosphatide can decompose too high blood fat and too high cholesterol, and cleaning blood vessel makes blood vessel circulation smooth and easy, is acknowledged as " blood vessel street cleaner ". It is harmless particulate that phosphatide can also make the cholesterol emulsification depositing in neutral fat and blood vessel, soluble in water and excrete, and stops superabundant fats to deposit at vascular wall simultaneously, alleviates the pressure of cardiovascular and cerebrovascular wall. Why phosphatide can prevent and treat modern civilization diseases, and one of basic reason is to have powerful emulsification. As cardiovascular and cerebrovascular disease, in diet, meat picked-up too much, causes cholesterol, lipid deposition in vascular wall, causes blood vessel access narrow, causes hypertension. Blood fat piece in blood and the cholesterol piece coming off run into the narrow position of blood vessel, are stuck and can't pass, and have just caused obstruction, form embolism. And the powerful emulsification of phosphatide can be deposited on cholesterol and the lipid on vascular wall in emulsification blood vessel, form milky white liquid, excrete. Coronary heart disease, calculus are all equal reasons.

(2) proliferation function

Human neuronal cell line and brain cell are the cell film coateds being made up of phosphatide, and phosphatide deficiency can cause film impaired, causes hypophrenia, stress. And contained acetyl group enters space between cells and choline binding in phosphatide, form acetylcholine. Acetylcholine is the signaling molecule of transmission of information between various nerve cells and brain cell, can accelerate the speed that between nerve cell and brain cell, information is transmitted, and strengthens memory, prevention senile dementia.

(3) activating cell

Phosphatide is the important component part of cell membrane, is bearing the important task of the inside and outside mass exchange of cell. If the phosphatide that people consumes every day can not get supplementing, cell will, in nutritional deficiency state, lose vigor. People's liver can synthesize some phosphatide, but major part absorbs from diet, particularly after thirty or forty year. But the activity of phosphatide is the most effective with 25 degree left and right, and temperature exceedes after 50 DEG C of degree, phosphatide is active can major part be lost. Therefore the people who advises healthy people's inferior health all edible phospholipid as the road of health care.

Soybean lecithin is the product extracting the oil foot from producing soybean oil, and the ester being made up of glycerine, aliphatic acid, choline or cholamine, can be dissolved in grease and non-polar solven. The constituent complexity of soybean lecithin, mainly contains lecithin (approximately 34.2%), cephalin (approximately 19.7%), lipositol (approximately 16.0%), phosphatidylserine (approximately 15.8%), phosphatidic acid (approximately 3.6%) and other phosphatide (approximately 10.7%). For thick liquid or the white pressed powder to light brown of shallow yellow to brown. Soybean lecithin not only has stronger emulsification, wetting, peptizaiton, also promoting in body fat metabolism, muscle growth, nervous system development and body the very important effects of aspect performance such as anti-oxidative damage.

Soybean lecithin has following physiological hygiene effect:

(1) phosphatide is the main composition composition of all life cells, and to promoting the metabolism of cell tissue, the normal configuration and the function that maintain cell membrane have important physiological action. Lecithin can make cytoactive, is the power resources that form human body.

(2) lecithin can effectively improve brain function, and lecithin can be strengthened information transmission between cerebral neuron, accelerates memory, makes thinking ability and IQ maintain higher level.

(3) lecithin can reduce serum cholesterol level, and can dissolve the cholesterol remaining on vascular wall, thereby plays prevention cardiovascular and cerebrovascular disease effect.

In soybean lecithin; its main component is soybean lecithin; and soybean lecithin is described as " the 3rd nutrient " arranged side by side with protein, vitamin; can effectively reduce low-density lipoprotein; maintain or elevating blood in HDL; effectively reduce T-CHOL amount in blood; recover normal blood fat and blood viscosity; improve blood vessel elasticity; prevent vascular sclerosis, protection cardiovascular and cerebrovascular, prevention of arterial sclerosis; protection liver, prevents and improves cirrhosis, fatty liver and by poisonous substance, foreign matter, drug-induced hepatic injury. Soybean lecithin or natural Choline Sources, ensure fetus and the normal development of infant's brain, improves memory, prevents middle-aged and old cerebral function declines; . The repairing cell membrane of soybean lecithin, the ability of activating cell can improve metabolism power, raising immunity of organisms, vis medicatrix naturae and the power of regeneration of cell, thereby play Promote immunity organ dysfunction, improve the effect of Abwehrkraft des Koepers.

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 grease extracting from greasiness fish, being rich in ω-3 is polyunsaturated fatty acid (DHA and EPA), there is anti-inflammatory, regulate the health advantages such as blood fat, can prevention of arterial sclerosis and thrombosis.

Fish oil mainly has following effect:

(1) regulate blood fat, prevent blood clotting, prevention cerebral thrombus, cerebral hemorrhage and apoplexy;

(2) reduce blood fat, cleaning thrombus, improve memory.

Taking eat the marine organisms EPA that obtain every day from meals in main coastal resident and DHA compared with inland resident as high. In general inland crowd, in body, unsaturated fatty acid content is lower.

Strange sub-seed oil: strange sub-(ChiaSeed) has another name called strange refined son, strange sub-seed, formal name used at school chia (SalviaHispanicaL.), pennyroyal, original producton location is the areas, North America such as Mexico south and Guatemala, can be grown in 4000 feet of following areas of desert band height above sea level, the strange Asia of the common indication of people is the seed of this plant in fact---strange sub-seed.

It is to be rich in the abundantest food of omega-fatty acid, and contains natural. The edible history of strange sub-seed can be traced 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.

In fish oil and Qi Ya seed oil component, all contain the effect of a large amount of unrighted acids, and unrighted acid has many benefits to health, specific as follows:

(1) regulate blood fat

High fat of blood causes the main cause of the diseases such as hypertension, artery sclerosis, heart disease, cerebral thrombus, apoplexy, and the main component EPA in fish oil and DHA, can reduce cholesterol and triglyceride harmful in blood; Can effectively control the concentration of human body blood fat; And the raising HDL ground content useful to human body. Maintain low concentration blood lipid level to keeping fit, angiocardiopathy preventing, improve endocrine and all play a part crucial.

(2) cleaning thrombus

Can promote the metabolism of saturated fatty acid in body with the supplementary deep sea fish oil of diet, alleviate and eliminate the harm of animal tallow (mainly from fat meat, dairy produce etc.) to human body in food, prevent the sedimentation of fat in vascular wall, suppress atherosclerotic formation and development, strengthen elasticity and the toughness of blood vessel, reduce blood viscosity, enhancement red blood cell is taken the ability of oxygen. EPA in fish oil, prevents the function of PA, cohesion in addition, the formation that therefore it can effectively anti-tampon, prevention of stroke.

(3) immunological regulation

Supplement EPA, DHA, can strengthen immunity of organisms, improve autoimmunity system and defeat the ability of cancer 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 inhibition breast cancer. The serial unrighted acid in ω-3 can be in order to landman's body autoimmunity system, and in Britain, the U.S. and some developed countries, deep sea fish oil is also used to adjuvant therapy of diabetes, psoriasis, rheumatoid arthritis and systemic loupus erythematosus disease. Deep sea fish oil also suffers from special efficacy to anaphylactia, limitation enterogastritis and skin disease.

(4) safeguard that retina improves eyesight

DHA is amphiblestroid important component part, accounts for 40～50%. Supplement enough DHA helpful to the retina cell of activation decline, the diseases such as tired, senile dim eyesight that excess eye-using is caused, eye-blurred, glaucoma, cataract have therapeutic action. DHA also can provide optic nerve desired nutritional composition, and prevents vision disorder.

(5) mend brain brain tonic

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 improve. Supplementary DHA can promote that brain cell reaches full growth, and delays intelligence and declines, forgetful and prevention Alzheimer disease (senile dementia) etc.

(6) improving arthritic symptom eases the pain

The serial unrighted acid in ω-3 can be assisted and be formed lubricating fluid in articular cavity, improves the ability of leukocytic anti-inflammation and sterilization in body, ameliorate osteoarthritis symptom, and lubricated joint, eases the pain.

The present invention adopts concentrated phosphatide, fish oil and Qi Ya seed oil to cooperatively interact, and complements each other, and wherein, concentrated phosphatide is by lecithin, lipositol, the compositions such as cephalin. these phosphatide respectively each position to human body and each organ play corresponding function. phosphatide, to activating cell, maintains metabolism, basic metabolism and hormonal balanced secretion, and immunity and the regeneration power of enhancing human body, can bring into play great effect. in addition, phosphatide also has promotion fat metabolism, prevents fatty liver, reduces serum cholesterol, improves the effect of blood circulation, angiocardiopathy preventing. in fish oil, be rich in ω-3 essential fatty acid eicosapentaenoic acids (EPA) and DHA (DHA), and strange sub-seed oil is to generally acknowledge to be rich in the abundantest food of omega-fatty acid, and contain natural, unrighted acid can help human body to regulate blood fat, cleaning thrombus, prevent blood clotting, prevention cerebral thrombus, cerebral hemorrhage and apoplexy, improve memory, can also improve body immunity, safeguard retina, improve eyesight, simultaneously, in strange sub-seed oil, also contain natural, contribute to delay senility, maintain the young state of body, thereby further improve human immunity mechanism, maintain health. above-mentioned three kinds of components complement each other, and mutually coordinate, and have given play to separately its effect separately, also make effect of three kinds of active ingredients in component give full play to and to be absorbed well by human body, have improved drug effect.

In order to address the above problem, the embodiment of the invention also discloses the preparation method of a kind of above-mentioned phosphatide, unrighted acid complex health care product, comprise the following steps:

(1) glue preparation: gelatin is made to its imbibition with part water soaking, obtain expansion gelatin, then expansion gelatin, glycerine and remaining water are mixed and be heated to 70-80 DEG C, stir it is dissolved, obtain glue;

(2) pelleting: concentrated phosphatide, fish oil, strange sub-seed oil are mixed, obtain mixed material, then mixed material and step (1) gained glue are carried out to pelleting, make soft capsule, in described pelleting process, temperature is 22-24 DEG C, and relative humidity is 40-45%;

(3) sizing: the soft capsule that step (2) is made is shaped, described in to be fixed in temperature be dry 3-5 hour under 22-24 DEG C, the relative humidity environment that is 40-45%;

(4) dry: it is 26-28 DEG C that the soft capsule after step (3) sizing is placed in to temperature, and relative humidity is to be dried under 30-40% environment, and be 22-26h drying time.

Optionally, step also comprises glue is kept to 70-80 DEG C in (1), leaves standstill 1-2h, removes offscum, then vacuumizing and defoaming.

Optionally, in step (1), after vacuumizing and defoaming, then glue is filtered, then stand for standby use under 55-65 DEG C of condition, described filtration adopts 80-120 mesh sieve.

Optionally, before step (4) is dry, adopt ethanol to clean to remove the oil stain on soft capsule shell the soft capsule after step (3) sizing.

Optionally, described concentrated phosphatide is concentrating soya lecithin.

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 describe the present invention in detail in connection with embodiment. It should be noted that, in the situation that not conflicting, the feature in embodiment and embodiment in the present invention can combine mutually.

Embodiment 1

The present embodiment provides a kind of phosphatide, unrighted acid complex health care product, be prepared from by following raw material by weight: 450 parts of concentrating soya lecithins, 340 parts, fish oil, 120 parts of strange sub-seed oil, 180 parts, gelatin, 72 parts of glycerine, 180 parts of purified water, described dietary supplements formulation is soft capsule.

Above-mentioned phosphatide, the preparation method of unrighted acid complex health care product, comprise the following steps:

(1) glue preparation: gelatin is made to its imbibition with partial purification water soaking, gelatin must expand, then glycerine, expansion gelatin and remaining purified water are mixed and be heated to 75 DEG C, stir it is dissolved, after expand gelatin and glycerine dissolve completely, keep 75 DEG C of constant temperature, leave standstill 1.5h, remove offscum, then vacuumizing and defoaming, after filtering, 100 mesh sieves obtain glue, stand for standby use under 60 DEG C of conditions of gained glue;

(2) pelleting: concentrating soya lecithin, fish oil, strange sub-seed oil are mixed, obtain mixed material, then mixed material and step (1) gained glue are carried out to pelleting, make soft capsule, in described pelleting process, temperature is 22 DEG C, and relative humidity is 42%;

(3) sizing: the soft capsule that step (2) is made is dry sizing for 4 hours under 22 DEG C, the relative humidity condition that is 42% in temperature;

(4) wash ball: adopt the ethanol that mass fraction is 95% to clean to remove the oil stain on soft capsule shell the soft capsule after step (3) sizing;

(5) dry: it is 27 DEG C that the soft capsule after step (4) is cleaned is placed in temperature, and relative humidity is to be dried under 35% environment, and be 24h drying time;

(6) the dried soft capsule of step (5) is selected, rejected underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.

Embodiment 2

The present embodiment provides a kind of phosphatide, unrighted acid complex health care product, be prepared from by following raw material by weight: 280 parts of concentrating soya lecithins, 400 parts, fish oil, 20 parts of strange sub-seed oil, 300 parts, gelatin, 150 parts of glycerine, 300 parts of purified water, described dietary supplements formulation is soft capsule.

The above-mentioned preparation method who prepares phosphatide, unrighted acid complex health care product comprises the following steps:

(1) glue preparation: gelatin is made to its imbibition with partial purification water soaking, gelatin must expand, then glycerine, expansion gelatin and remaining purified water are mixed and be heated to 80 DEG C, stir it is dissolved, after expand gelatin and glycerine dissolve completely, keep 80 DEG C of constant temperature, leave standstill 1h, remove offscum, then vacuumizing and defoaming, after filtering, 80 mesh sieves obtain glue, stand for standby use under 65 DEG C of conditions of gained glue;

(2) pelleting: concentrating soya lecithin, fish oil, strange sub-seed oil are mixed, obtain mixed material, then mixed material and step (1) gained glue are carried out to pelleting, make soft capsule, in described pelleting process, temperature is 23 DEG C, and relative humidity is 45%;

(3) sizing: the soft capsule that step (2) is made is 23 DEG C in temperature, relative humidity is dry sizing for 5 hours under 45% condition;

(4) wash ball: adopt the ethanol that mass fraction is 95% to clean to remove the oil stain on soft capsule shell the soft capsule after step (3) sizing;

(5) dry: it is 28 DEG C that the soft capsule after step (4) is cleaned is placed in temperature, and relative humidity is to be dried under 30% environment, and be 26h drying time;

(6) the dried soft capsule of step (5) is selected, rejected underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.

Embodiment 3

The present embodiment provides a kind of phosphatide, unrighted acid complex health care product, be prepared from by following raw material by weight: 600 parts of concentrating soya lecithins, 280 parts, fish oil, 200 parts of strange sub-seed oil, 240 parts, gelatin, 120 parts of glycerine, 240 parts of purified water, described dietary supplements formulation is soft capsule.

The above-mentioned preparation method who prepares phosphatide, unrighted acid complex health care product comprises the following steps:

(1) glue preparation: gelatin is made to its imbibition with partial purification water soaking, gelatin must expand, then glycerine, expansion gelatin and remaining purified water are mixed and be heated to 70 DEG C, stir it is dissolved, after expand gelatin and glycerine dissolve completely, keep 70 DEG C of constant temperature, leave standstill 2h, remove offscum, then vacuumizing and defoaming, after filtering, 120 mesh sieves obtain glue, stand for standby use under 55 DEG C of conditions of gained glue;

(2) pelleting: concentrating soya lecithin, fish oil, strange sub-seed oil are mixed, obtain mixed material, then mixed material and step (1) gained glue are carried out to pelleting, make soft capsule, in described pelleting process, temperature is 24 DEG C, and relative humidity is 40%;

(3) sizing: the soft capsule that step (2) is made is 24 DEG C in temperature, dry sizing for 3 hours under the condition that relative humidity is 40%;

(4) wash ball: adopt the ethanol that mass fraction is 95% to clean to remove the oil stain on soft capsule shell the soft capsule after step (3) sizing;

(5) dry: it is 26 DEG C that the soft capsule after step (4) is cleaned is placed in temperature, and relative humidity is to be dried under 40% environment, and be 22h drying time;

(6) the dried soft capsule of step (5) is selected, rejected underproof soft capsule, retain qualified soft capsule, then qualified soft capsule is packed, checks, put in storage.

Embodiment of the present invention gained sample is tested to detection below

1, toxicity safety test

Materials and methods:

Sample: adopt the embodiment of the present invention 1 gained sample, 1.0g/ grain, the oral RD of people is every day 2 times, each 2, become body weight for humans press 60kg calculating, amount to dosage 66.6mg/kg.BW.

Animal used as test and environment: clean level Kunming mouse and SD rat are provided by Changsha Kaifu District Dong Chuan Animal Science service department. Feed is provided by same unit. Experimental situation is barrier system. 23 DEG C～24 DEG C of experimental session experimental situation temperature, humidity 52%～58%.

(1) acute toxicity test in mice: adopt mtd test. If dosage is 21.5g/kg.BW. Selecting body weight is 20 of the clean level Kunming mouses of 18～22g, male and female half and half. Sample thief capsule 's content 86.0g to 160ml, gets in this liquid one day interval 4 hours to its mouse oral gavage 2 times with edible vegetable oil, and each gavage volume is 0.2ml/10g.BW. The front fasting of gavage first 16 hours. After gavage, Continuous Observation two weeks, records poisoning manifestations and death condition.

(2) Salmonella reversion test: employing is tested through identifying satisfactory salmonella typhimurium histidine defect type TA97, TA98, TA100, TA102 tetra-strain bacterial strains. Adopt the rat liver microsomes enzyme (S-9) of Polychlorinated biphenyls (PCB) induction as Metabolic Activation of Cyclophosphamide. In top agar, add 0.1ml experimental strain enrichment liquid, 0.1ml tested material solution and 0.5mlS-9 mixed liquor (in the time of needs metabolism activation), after mixing, pour on bottom culture medium flat plate. Five test doses are respectively 5000 μ g/ wares, 1000 μ g, ware, 200 μ g/ wares, 40 μ g/ wares, 8 μ g/ wares, under aseptic technique, sample thief capsule 's content 1.25g adds sterilizing dimethyl sulfoxide (DMSO) to 25ml, be 5000 μ g/ ware dosage, get this liquid 5ml and add sterilizing dimethyl sulfoxide (DMSO) and be made into 1000 μ g/ wares to 25ml, below three dosage so analogize preparation. Establish from beaming back change, solvent control and the contrast of positive mutagens simultaneously. Cultivate 48 hours, count every ware clump count for 37 DEG C. If the change clump count that returns of tested material exceedes from beaming back change the more than 2 times of clump count, and person is decided to be the positive dose-response relationship. A whole set of test repeats once under same test conditions.

(3) PCEMNR micronucleus test: adopt 24 hours twice, interval per os administration by gavage to test. 50 of clean level Kunming mouses getting body weight and be 25～30g, are divided into 5 groups at random, and 10 every group, male and female half and half. With the positive contrast of endoxan of 40mg/kg.BW dosage, the negative contrast of edible vegetable oil. 3 dosage of experimental group are respectively 10.0g/kg.BW, 5.0g/kg.BW, 2.5g/kg.BW, sample thief content 50.0g, 25.0g and 12.5g are with food vegetable oil to 100ml respectively, and what be made into corresponding dosage is subject to test solution to mouse stomach (0.20ml/10g.BW). Last to sample after the dislocation of 6 hours cervical vertebras put to death animal, get bone marrow of sternum calf serum and dilute smear, methyl alcohol is fixed, Giemsa dyeing. Under light microscope, every animal 1000 polychromatic erythrocytes of counting (PCE), microkernel incidence, in the PCE permillage containing micronucleus, carries out statistical analysis. Count 200 polychromatic erythrocytes, the ratio (PCE/NCE) of counting polychromatic erythrocyte and mature erythrocyte.

(4) mouse sperm deformity test: get 25 of the male mice in kunming of body weight 25～35g, be divided at random 5 groups, 5 every group. With the positive contrast of endoxan of 40mg/kg.BW dosage, the negative contrast of edible vegetable oil. 3 dosage of test group are respectively 10.0g/kg.BW, 5.0g/kg.BW, 2.5g/kg.BW, sample thief soft capsule content 50.0g, 25.0g and 12.5g are with edible vegetable oil to 100ml respectively, and what be made into corresponding dosage is subject to test solution to mouse stomach (0.20ml/10g.BW). Every day gavage once, continuous 5 days, after last gavage the 30th day put to death animal, get epididymis smear, Yihong dyeing, the sperm of 1000 structural integrities of every animal counting, calculates defective sperm incidence.

(5) 30 days feeding trials:

Dosage group selection and tested material give mode: get 80 of SD rats, and male and female half and half, male mouse body weight is 72.48 ± 6.00g, female mouse body weight 73.26 ± 6.43g. Animal used as test is divided into four groups at random, i.e. control group and three tested material groups, 20 every group, male and female half and half. If basic, normal, high dosage is 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW respectively, be equivalent to respectively 25,50,100 times of human body RD. When basic, normal, high dosage is subject to test solution preparation, sample thief content 33.4g, 66.6g, 133.2g are settled to 100ml with edible vegetable oil respectively, control group gives equal-volume edible vegetable oil, every day gavage once, gavage volume is 0.5ml/100g.BW, continuously gavage 30 days.

Key instrument and reagent: key instrument: the full-automatic blood counting instrument of the CD3700 of Abbott Laboratories, OLYMPUSAU400 automatic clinical chemistry analyzer, LD5-10B centrifuge etc. Main agents: total protein (TP), albumin (ALB), urea nitrogen (BUN), blood sugar (GLU), glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminease (AST), cholesterol (CHOL), triglycerides (TG) and creatinine (Cr) kit.

Experimental technique: all animals of duration of test give normal diet, single cage is raised, the drinking-water of freely ingesting, observe activity and the growing state of animal every day, add weekly food 2 times, record, to appetite and surplus appetite, claims weekly body weight one time, calculate weekly food-intake and food utilization, total food utilization is calculated at experiment end. Test latter stage, fasting is plucked eyeball and is adopted 2 parts of blood after 16 hours, the full-automatic blood counting instrument Measuring hemoglobin of the CD3700 of Abbott Laboratories (Hb), packed cell volume (HCT) for anticoagulation, carry out red blood cell (RBC), leucocyte (WBC), blood platelet (PLT) counting and WBC classification. Non-anticoagulation separation of serum, with OLYMPUSAU400 automatic clinical chemistry analyzer mensuration TP, ALB, ALT, Cr, BUN, AST, CHOL, TG and GLU. After blood sampling, cervical vertebra dislocation is put to death animal and is done gross anatomy, claims liver,kidney,spleen, testicular weight, calculates dirty/body ratio, gets liver,kidney,spleen, Stomach duodenum, testis, ovary and makes check pathological section. In the time each dosage treated animal made to gross examination not finding obvious pathology and Biochemical index change, only carry out the histopathological examination of maximum dose level group and control animals main organs, as found, pathology is to checking compared with low dose group corresponding organ and tissue.

2, result

(1) formulation Oral toxicity test

The acute toxicity of table 1 sample to mouse

From table 1, have no star's poisoning symptom with the sample contents of 21.5g/kg.BW dosage to after the Kunming mouse gavage of two kinds of sexes, observe 14 days without dead. Within the 15th day, animal subject is put to death and dissected the major organs such as inspection, liver,spleen,kidney, stomach and intestine, the heart, lung, show no obvious abnormalities change. Sample is greater than 21.5g/kg.BW to maximum tolerated dose (MTD) female, male Kunming mouse. According to the acute toxicity grading criteria in " health food inspection and assessment technique specification " (version in 2003), belong to nontoxic level.

(2) Salmonella reversion test

Table 2 sample Salmonella reversion test result (for the first time)

Note: above result is the means standard deviation of 3 plates.

Positive control: TA97+S9, TA98+S9, TA100+S9 adopt 2-AF (dosage: 10.0 μ g/ wares); TA97-S9, TA98-S9 adopt 9-Fluorenone (dosage: 0.2 μ g/ ware); TA100-S9 adopts NaN3 (dosage: 1.5 μ g/ wares); TA102+S9 adopts 1,8-dihydroxy anthraquinone (dosage: 50 μ g/ wares); TA102-S9 adopts MMC (dosage: 0.5 μ g/ ware).

Table 3 is with table 2.

Table 3 sample Salmonella reversion test result (for the second time)

Note: above result is the means standard deviation of 3 plates.

From table 2,3, to TA97, TA98, TA100, TA102 tetra-strain test strains, add and do not add S-9, the each dosage group of sample is returned change clump count and is not all exceeded from 2 times that beam back change clump count, also without dose-response relationship, illustrates that changing tested material is mutagenesis feminine gender.

(3) PCEMNR micronucleus test

The impact of table 4 sample on Micronuclei In The Mouse Bone Marrow incidence

From table 4, sample each dosage group micronuclear rates and negative control group comparing difference are without conspicuousness, and endoxan group and negative control group comparing difference have conspicuousness (P < 0.05). Sample has no damaging action to bone marrow cells in mice.

(4) mouse sperm deformity test:

The impact of table 5 sample on Sperm Abnormalities of Mice

From table 5, sample does not produce obvious change to Sperm Abnormalities of Mice, the each dosage group of sample and negative control group comparing difference are without conspicuousness (P > 0.05), and endoxan positive controls and negative control group comparing difference have conspicuousness (P < 0.05). Sample does not produce distortion effect to mouse sperm.

(5) 30 days feeding trials

During within 30 days, feeding, each treated animal grows well, without abnormal behaviour and poisoning symptom, without dead.

A, the impact of sample on rat body weight and food utilization

With the sample contents of 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW dosage to rat oral gavage 30 days, during nursing, the heavy and weightening finish of the each time point body weight of each dosage group male and female mouse, end, average food-intake, weekly and total foodstuff utilization rate and control group comparing difference without conspicuousness (P > 0.05).

Table 6 sample must affect rat body weight

The impact of table 7 sample on rat food utilization (the 4th week)

The impact of table 8 sample on rat total foodstuff utilization rate

B, the impact of sample on rat serum conventional index

With the sample contents of 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW dosage to rat oral gavage 30 days, hemoglobin, red blood cell sum, packed cell volume, platelet count, total white blood cells and classification and the control group comparison of each dosage group male and female rat, no significant difference (P > 0.05).

30 days feeding trial hematological examination results of table 9 sample

The impact of table 10 sample on rat WBC, lymph, neutrophil cell

The impact of table 11 sample on large mononuclear cell, eosinophil, basophilic granulocyte

C, the impact of sample on rat biochemical indicator

With the sample contents of 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW dosage to rat oral gavage 30 days, serum glutamic pyruvic transminase, cholesterol, urea nitrogen, creatinine, blood sugar, total protein, albumin, glutamic-oxalacetic transaminease and the triglycerides of each dosage group male and female rat and control group relatively there are no significant difference (P > 0.05).

30 days feeding trial biochemical investigation in latter stage results of table 12 sample

30 days feeding trial biochemical investigation in latter stage results of table 13 sample ()

D, the impact of sample on Rats Organs and Tissues weight and internal organs/body weight ratio

The impact of table 14 sample on Rats Organs and Tissues weight ()

The impact of table 15 sample on the dirty body ratio of rat

From table 14-15, with the sample contents of 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW dosage to rat oral gavage 30 days, liver,kidney,spleen, testicular weight and liver/body, spleen/body, kidney/body, male mouse testis/body ratio and the control group comparison of each dosage group rat, no significant difference (p > 0.05).

E, gross anatomy and histological examination result

In the time each dosage treated animal being done to gross anatomy inspection, do not find obvious pathology, only carry out the histopathological examination of high dose group and control animals main organs.

Tissue pathological slice check result shows, the accidental a small amount of inflammatory cell infiltration of the male No. 24 liver cell interstitials of mouse of high dose group, and liver cell form is normal, and other tissue shows no obvious abnormalities change.

Other male and female rat liver of control group and high dose group, spleen, kidney, Stomach duodenum, male mouse testis, female mouse ovary check pathological section show no obvious abnormalities change.

F, brief summary

Under this experiment condition, embodiment 1 gained sample is all greater than 21.5g/kg.BW to maximum tolerated dose (MTD) female, male Kunming mouse, belongs to nontoxic level. Three genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test) result is all negative. With the sample of 1.67g/kg.BW, 3.33g/kg.BW, 6.66g/kg.BW dosage to rat oral gavage 30 days, duration of test, animal growth is good, each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, organ weights and internal organs/body weight ratio and control group comparison, there was no significant difference (P > 0.05). Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking. Other embodiments of the invention gained sample of the present invention is tested, and its experimental result is identical with embodiment 1.

3, function assessment experiment:

(1) materials and methods

Sample: the embodiment of the present invention 1 gained sample, 1.0g/ grain, the oral RD of people is every day 2 times, each 2, become body weight for humans press 60kg calculating, amount to dosage 66.6mg/kg.BW. Getting capsule 's content tests.

Animal used as test and environmental condition: 40 of the clean level male SD rats that Changsha Kaifu District Dong Chuan Animal Science service department provides, body weight 165.0 ± 11.3g. Experimental session environment is 23 DEG C～24 DEG C, humidity 52%～58%.

Dosage is selected: establish basic, normal, high dosage and be respectively 0.333g/kg.BW, 0.666g/kg.BW, 1.998g/kg.BW (be equivalent to respectively human body recommended amounts 5,10,30 times), while being subject to test solution preparation, sample thief content 3.33g, 6.66g, 19.98g are assigned to 50ml with food vegetable oil respectively, control group gives equal-volume edible vegetable oil, give respectively animal subject gavage, once a day, gavage volume is 0.5ml/100g.BW, continuous 30 days.

Key instrument, equipment and reagent: OLYMPUSAU400 automatic clinical chemistry analyzer, LD5-10B centrifuge etc.; Cholesterol (TC) kit, triglycerides (TG) kit, HDL-C (HDL-C) kit.

High lipid food: 78.8% basal feed, 1% cholesterol, 10% yolk powder, 10% lard, 0.2% cholate.

Experimental technique: feed and raise rat and observe after one week with basal feed, fasting 16 hours, get tail blood, measure serum total cholesterol (TC), triglycerides (TG), HDL-C (HDL-C) with OLYMPUSAU400 automatic clinical chemistry analyzer, take into account TG according to TC level animal is divided into 4 groups at random: high fat control group and three tested material groups. From formal test, each treated animal is used high lipid food instead, and tested material gives the test solution that is subject to of variable concentrations by above-mentioned dosage design gavage simultaneously, and high fat control group gavage gives the edible vegetable oil of same volume, continuous 30 days, weighs weekly once. Finish fasting 16 hours in experiment, pull out eyeball blood sampling and measure serum TC, TG, HDL-C.

(2) result is judged

Auxiliary lipid-lowering function result is judged: in serum total cholesterol, triglycerides, HDL-C detect, serum total cholesterol, the triglycerides binomial index positive, can judge this given the test agent auxiliary lipid-lowering function results of animal positive.

The auxiliary triglycerides result that reduces is judged: 1, two dosage group result positives of triglycerides; 2, dosage group result positive of triglycerides, HDL-C is significantly higher than control group simultaneously, can judge the auxiliary triglycerides results of animal positive that reduces of this given the test agent.

4, result

(1) impact of sample on rat body weight

In table 17. Give and feed high lipid food rat oral gavage 30 days with the sample contents of 0.333g/kg.BW, 0.666g/kg.BW, 1.998g/kg.BW dosage, each dosage group experiment the weight of animals in latter stage and experimental session body weight and experimental session body weight gain and the comparison of high fat control group, no significant difference (P > 0.05).

The impact of table 17 sample on rat body weight

(2) impact on Serum TC, TG, HDL-C

In Table 18-21. After experiment, high fat control group serum TC, TG all obviously raise, and relatively front with experiment, difference has conspicuousness (P < 0.01), show modeling success. With the sample of 0.333g/kg.BW, 0.666g/kg.BW, 1.998g/kg.BW dosage, to rat oral gavage 30 days, high dose group serum TG level, serum TC level were significantly lower than high fat control group (P < 0.05). With the comparison of high fat control group, the serum TC decline percentage of basic, normal, high dosage group is respectively 9.6%, 10.55%, 16.07%; Serum TG decline percentage is respectively 8.00%, 13.15%, 22.17%. Sample is to Serum HDL-C level do not make significant difference (P > 0.05).

Each group serum TC level before and after table 18 experiment

Each group serum TG level before and after table 19 experiment

Each group Serum HDL-C level before and after table 20 experiment

The impact of table 21 tested material on Serum TC, TG, HDL-C level

Dosage group (g/kg.BW)	TC(％)	TG(％)	HDL-C(mmol/L)
				Control group	-------	-------	-------
Low dosage	-9.67	-8.00	+0.067
				Middle dosage group	-10.55	-13.15	+0.070
High dose group	-16.07	-22.17	+0.087

5, brief summary

With the sample contents of 0.333g/kg.BW, 0.666g/kg.BW, 1.998g/kg.BW dosage to rat oral gavage 30 days, with the comparison of high fat control group, 1.998g/kg.BW dosage can significantly reduce raises high lipid food rat blood serum triglyceride levels and rat blood serum total cholesterol level, P < 0.05, each dosage is to rat blood serum High-density Lipoprotein-cholesterol do not make significant difference (P > 0.05). The embodiment of the present invention 1 gained sample has auxiliary lipid-lowering function to animal, and other embodiments of the invention gained sample is identical with embodiment 1 performance.

It should be noted that, for aforesaid embodiment of the method, for simple description, therefore it is all expressed as to a series of combination of actions, but those skilled in the art should know, the present invention is not subject to 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 related action might not be essential to the invention.

Finally it should be noted that: above embodiment only, in order to technical scheme of the present invention to be described, is not intended to limit; Although the present invention is had been described in detail with reference to previous embodiment, those of ordinary skill in the art is to be understood that: its technical scheme that still can record aforementioned each embodiment is modified, or part technical characterictic is wherein equal to replacement; 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 (9)

1. phosphatide, a unrighted acid complex health care product, is characterized in that, by weight mainly by withLower raw material is prepared from: concentrated phosphatide 280-600 part, fish oil 280-400 part, strange sub-seed oil 20-200Part.

2. phosphatide according to claim 1, unrighted acid complex health care product, is characterized in that,Described concentrated phosphatide is concentrating soya lecithin.

3. phosphatide according to claim 1, unrighted acid complex health care product, is characterized in that,Described complex health care product formulation is soft capsule.

4. phosphatide according to claim 3, unrighted acid complex health care product, is characterized in that,Also comprise following raw material: gelatin 180-300 part, glycerine: 72-150 part, water: 180-300 part.

5. a preparation method for the phosphatide described in claim 3 or 4, unrighted acid complex health care product,It is characterized in that, comprise the following steps:

(1) glue preparation: gelatin is made to its imbibition with part water soaking, obtain expansion gelatin, then willExpansion gelatin, glycerine and remaining water mix and are heated to 70-80 DEG C, stir it is dissolved, and obtain glueLiquid;

(2) pelleting: concentrated phosphatide, fish oil, strange sub-seed oil are mixed, obtain mixed material, then will mixMaterial and step (1) gained glue carries out pelleting, makes soft capsule, and in described pelleting process, temperature is22-24 DEG C, relative humidity is 40-45%;

(3) sizing: the soft capsule that step (2) is made is shaped, described in be fixed in temperature and beDry 3-5 hour under the environment that 22-24 DEG C, relative humidity are 40-45%;

(4) dry: it is 26-28 DEG C that the soft capsule after step (3) sizing is placed in to temperature, relative humidityFor being dried under 30-40% environment, be 22-26h drying time.

6. the preparation method of phosphatide according to claim 5, unrighted acid complex health care product, itsBe characterised in that, step also comprises glue is kept to 70-80 DEG C in (1), leaves standstill 1-2h, removes offscum, soRear vacuumizing and defoaming.

7. the preparation method of phosphatide according to claim 5, unrighted acid complex health care product, itsBe characterised in that, in step (1), after vacuumizing and defoaming, then glue filtered, then 55-65 DEG C of barStand for standby use under part, described filtration adopts 80-120 mesh sieve.

8. the preparation method of phosphatide according to claim 4, unrighted acid complex health care product, itsBe characterised in that, before step (4) is dry, adopt ethanol to clean the soft capsule after step (3) sizingTo remove the oil stain on soft capsule shell.

9. the preparation method of phosphatide according to claim 5, unrighted acid complex health care product, itsBe characterised in that, described concentrated phosphatide is concentrating soya lecithin.