CN105341946A

CN105341946A - Dunaliella salina, lutein and huckleberry composition, soft capsule containing composition and preparation method of soft capsule

Info

Publication number: CN105341946A
Application number: CN201510930849.3A
Authority: CN
Inventors: 曹珍艳
Original assignee: Beijing Competitor Sports Technology Co Ltd
Current assignee: Beijing Competitor Sports Technology Co Ltd
Priority date: 2015-12-14
Filing date: 2015-12-14
Publication date: 2016-02-24

Abstract

The invention relates to a dunaliella salina, lutein and huckleberry composition and a preparation method thereof. The composition is prepared from dunaliella salina extractive, lutein, huckleberry extractive, beewax and the balance of grape seed oil, and has remarkable antioxidation and the function of relieving visual fatigue. The invention also provides a soft capsule preparation containing the dunaliella salina, lutein and huckleberry composition and a preparation method of the soft capsule preparation.

Description

A kind of salt algae lutein cowberry composition, soft capsule comprising said composition and preparation method thereof

Technical field

The present invention relates to the technical field of health product, especially a kind of salt algae lutein cowberry composition, comprises soft capsule preparation and the preparation method of said composition.

Background technology

Along with the quickening of modern people's life, study, work rhythm, universal and the application of TV, computer, and the impact that natural environment goes from bad to worse, asthenopia has become one of common eye disease, have and report in the experimenter carrying out conventional ophthalmic inspection, to have the people of 10%-to 15% owing to producing headache and visual fatigue because working before computer, and this phenomenon there is the trend of growth.Cause white elephant to eyes before the fluorescent screen that eyes are exposed to flicker for a long time, cause visual fatigue, impel retinal ocular disease and some chronic ocular disease to fall ill to shift to an earlier date and illness rate raises.The eye syndrome of visual fatigue to be a kind of with subjective symptoms be main clinical manifestation, asthenopic generation is the result that eye or whole body apparatus factors and psychologic factors are intertwined to form.Headache, dizzy, spasm of ocular muscles can be produced under visual fatigue serious conditions, bring out stomach dysfunction, the symptom such as whole body is uncomfortable.

The product of alleviating asthenopia is mostly exterior-applied article in the market, can not fundamentally prevent and improve asthenopia.So need to develop a kind of health food having protective effect for eyesight.

Summary of the invention

According to an aspect of the present invention, an object of the present invention is to provide a kind of salt algae lutein cowberry composition, said composition has remarkable non-oxidizability and asthenopia releasing function.

In order to achieve the above object, the invention provides following technical scheme: a kind of salt algae lutein cowberry composition, described composition comprises according to weight ratio: the grape-kernel oil of algae extrats 4%-10%, lutein 1.5%-4%, Bilberry fruit P.E 4-10%, beeswax 3%-5% and surplus.

Preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: the grape-kernel oil of algae extrats 4%-6%, lutein 1.5%-3%, Bilberry fruit P.E 4-6%, beeswax 4%-5% and surplus.

More preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: 4%, the algae extrats of 5% or 6%, 1.5%, the lutein of 2%, 2.5% or 3%, the Bilberry fruit P.E of 4%, 5% or 6%, the beeswax of 4%-5% and the grape-kernel oil of surplus.

Further preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: algae extrats 6%, and lutein 3%, Bilberry fruit P.E is 6%, beeswax 4% and grape-kernel oil 81%.

Further preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: algae extrats 4%, and lutein 1.5%, Bilberry fruit P.E is 4%, beeswax 4% and grape-kernel oil 86.5%.

Further preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: algae extrats 5%, and lutein 2%, Bilberry fruit P.E is 4%, beeswax 5% and grape-kernel oil 84%.

Further preferably, salt algae lutein cowberry composition according to the present invention comprises according to weight ratio: algae extrats 6%, and lutein 2.5%, Bilberry fruit P.E is 6%, beeswax 4.5% and grape-kernel oil 81%.

In algae extrats described in described composition, the weight percentage of beta carotene is 8%.

In Bilberry fruit P.E described in described composition, anthocyanidin weight percentage is 25%.

According to another aspect of the present invention, an object of the present invention is to provide the soft capsule preparation comprising described salt algae lutein cowberry composition, described soft capsule preparation is made up of content and soft capsule shell, described content is above-mentioned salt algae lutein cowberry composition, and described soft capsule comprises the purified water of gelatin 25%-40%, glycerine 10%-17%, D-sorbite 5%-8%, titanium dioxide 1.5%-3%, Cacao pigment 1.5%-3% and surplus according to weight ratio.

Preferably, each raw material of described soft capsule shell according to weight ratio is: gelatin 40%, glycerine 12%, D-sorbite 5%, titanium dioxide 0.5%, Cacao pigment 2.5% and purified water 40%.

According to another aspect of the present invention, another object of the present invention is to provide the preparation method of described salt algae lutein cowberry soft capsule preparation, said method comprising the steps of:

1) salt algae lutein cowberry composition feed liquid (content feed liquid) is prepared:

Weigh algae extrats, Bilberry fruit P.E, lutein, beeswax, grape-kernel oil respectively, for subsequent use; After grape-kernel oil and beeswax heating for dissolving, obtain oily wax liquid; When oily wax liquid is cooled to room temperature, algae extrats, Bilberry fruit P.E, lutein are joined in oily wax liquid, limit edged stirs, mix, then be placed in colloid mill and grind 3-5 time, vacuumize, vacuum remains on-0.06 ~-0.08Mpa with de-bubble to the greatest extent, cross 120 mesh sieves, obtain content feed liquid, stand-by.

2) glue is prepared: weigh gelatin, glycerine, titanium dioxide, D-sorbite, cacao pigment, purified water respectively, for subsequent use; By in glycerine, titanium dioxide, cacao pigment, D-sorbite and putting into of purified water glue tank, stir, when being heated to 70 ~ 80 DEG C, add gelatin, stir and boil 1h, vacuumize, de-bubble to the greatest extent, crosses 80 mesh sieves, make glue, put into glue bucket insulation (60 DEG C ~ 65 DEG C), for subsequent use.

3) capsule is pressed into: the tolerant feed liquid of Inner, glue, by pellet press, make soft capsule.In pelleting process, check a ball weight, guarantee that content uniformity is in acceptability limit, checks capsule appearance at any time every about 30min, whether ball shape is normal, has ne-leakage.In production process, keep a close eye on the working order of equipment, temperature remains on 18 ~ 26 DEG C, and relative humidity is 40% ± 5%.

4) shape: the soft capsule be pressed into is placed in sizing rotating cage and shapes about 1 ~ 2.5 hour, and temperature remains on 18 ~ 26 DEG C, relative humidity 40% ± 5%.

5) dry: the soft capsule after heat treatment 18 ~ 26 DEG C temperature and 30% ± 5% relative humidity under carry out preliminarily dried about 16 hours.

6) ball is washed: dried soft capsule is put in ultrasonic wave soft capsule cleaner with the 95% edible alcohol cleaning meeting GB10343 quality requirement, the grease on removing surface, the temperature of 18 ~ 26 DEG C and 30% ± 5% relative humidity under, the soft capsule after cleaning is divided in screen tray, for subsequent use.

7) dry in the air ball: the soft capsule after cleaning is divided in drying cart screen tray, and send into drying room and carry out drying, temperature remains on 18 ~ 26 DEG C, relative humidity 30% ± 5%.

Preferably, the preparation method of described salt algae lutein cowberry soft capsule preparation also comprises 8) packaging:

By step 7) in the salt algae lutein cowberry soft capsule that obtains screen, remove the defective soft capsule such as large piller, special-shaped ball, flat ball, the ball that breaks, thin-walled ball, significantly wire mark ball, bubble ball, adhesion ball, the capsule meeting finished product requirement is wrapped inside dress, be encapsulated in medicinal high density ethylene bottle, then after check problem, be divided into marketing packing namely become the finished product that can dispatch from the factory.

Accompanying drawing explanation

In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, be briefly described to the accompanying drawing used required in embodiment or description of the prior art below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skill in the art, under the prerequisite not paying creative work, other accompanying drawing can also be obtained according to these accompanying drawings.

Fig. 1 is the flow chart of preparation method of the present invention.

Detailed description of the invention

Below in conjunction with accompanying drawing of the present invention, be clearly and completely described technical scheme of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.

Salt algae is a kind of single celled eukaryotic algae, it is one of eucaryote of the most salt tolerant found up to now, salt algae is throughout the year not only high temperature resistant but also resist cold, containing protein up to about 50% (dry powder extracted after carrotene reaches more than 70%), and be rich in the beta carotene with unique health care and medical effect.Content beta-carotene contained by it is higher than carrot to 60-160 times.The same with other natural materials, algae carrotene has the broad-spectrum action of carrotene, the medical health care function of salt algae beta carotene is affirmed: anti-oxidant, binding activities oxygen, catch free radical, radioresistance and photosensitization damage, raising immunity, anti-sudden change, antitumor and can change into the effects such as vitamin A, preventing and treating the cancer of more than belly, yctalopia and cataract, cardiovascular disease, oral cavity, esophagus and gastric ulcer, chemotherapy patients, old age and valetudinarian have good therapeutic effect.Beta carotene is the ideal medicament of anti-curing cancers, cardiovascular disease, chemotherapy patients, vitamine A deficiency.It is degraded by body metabolism, use safety, and this is that other cancer therapy drugs institute can not be than.With the functional health care product that salt algae produces, there is extra-nutritions, remove oxyradical, delay senility, raising immunity and to functions such as the resistivities of disease.

Experiment shows: algae extrats obviously can reduce LPO content in blood and liver, improves SOD and GSH-Px active, have anti-oxidant, delay senility left and right.Epidemiological study shows: in body, the incidence of beta carotene and vitamin a level and tumour is negative correlation.And have research surface: relevant with cancer metastasis under the anti-oxidation function of tumor patient.Long-term taking salt algae will improve the anti-oxidation function of body, thus suppresses recurrence and the transfer of cancer, and anti-oxidation function and the immunologic function of body are closely related, because free radical causes immunosupress.And beta carotene has enhancing immunity of organism and oxidation resistant effect.Therefore, can promote body killing and wounding tumour cell, its effect is extensive, nontoxic, and abundance, has positive effect to the prevention and therapy of malignant tumour.

Salt algae beta carotene has the non-specific humoral and cellular immune response function of promotion, particularly evident to the effect of T lymphopoiesis and t lymphocyte subgroup.Beta carotene facedown lipid peroxidation of erythrocyte membrane is damaged, and alleviates the destruction of C3b receptor, improves its activity, adds the immune adherence to tumour cell and lethal effect.

Salt algae beta carotene, as antioxidant, has anti peroxidation of lipid lesion capability, and reduce Serum MDA, (MDA) reduces the content of Arterial Cholesterol (TC) cholesteryl ester (CE) and MDA.There is protective effect to endarterium and stop its foamed, the generation of effective prevention of arterial sclerosis pathology and development, and in dose-dependence.To be that clinical practice antioxidant prevention of arterial is atherosis provide theoretical foundation in this research.There are some researches show: lipid-metabolism wadding disorderly, on the basis of radical damage and artery sclerosis correlation, for the sclerosis generation of pathology of beta carotene prevention of arterial and development provide test basis, prove the oral effect with prevention of arterial sclerosis of beta carotene, support the neodoxy of antioxidant prevention coronary heart disease.Atherosclerotic is the pathologic basis of cardiovascular and cerebrovascular disease.It occurs, develop and fat metabolism is wadded a quilt with cotton disorderly in close relations, particularly closely related with the deposition of oxidized low density lipoprotein, beta carotene is fat-soluble antioxidant in human body, mainly act on MDA, suppress the peroxidating of unrighted acid on membranous structure.

Lutein has another name called " Lutein ", is a kind of natural colouring matter be extensively present in the plants such as banana, Kiwi berry, corn and marigold.Lutein belongs to the one of carotenoid.This natural colouring matter has the advantages such as lovely luster, strong coloring force, safety non-toxic, oxidation resistance be strong.

Lutein is the precursor of vitamin A, and it can change into vitamin A in human body.The main Physiological Function of lutein to eyes is as antioxidant and photoprotection.Optic nerve is unrenewable, and what be vulnerable to oxidative damage most is bar, the cone cell that on retina, content of polyunsaturated fatty acid is higher, by the formation suppressing oxygen radical to suppress harmful free radicals.The a large amount of blue light of lutein Absorbable rod, wavelength and the ultraviolet light of blue visible light are close, are to reach the maximum a kind of light of potential hazard in amphiblestroid visible ray.Before arriving cell responsive on retina, light first through the highest accumulation regions of lutein, if at this moment just this injury can be reduced to minimum depending on the lutein content at macula lutea place is abundant.

Bilberry fruit P.E demonstrates the obvious help of eye by improving oxygen and blood-transmitted to the ability of eye.The source that many eye diseases comprise Cataractogenesis and macular degeneration finally ascribes the injury of radical pair eye to.Bilberry fruit P.E, as strong antioxidant, can protect eyes from free radical injury.Scientific research display Healthy People uses Bilberry fruit P.E can cause the improvement of night vision acuity, the raising of the quickening of blackout governing speed and the rear eyesight resume speed of flash of light.

Grape-kernel oil is the natural product refined by grape pip expression separation and obtain.In various animal and plant oil known at present, essential fatty acid contained in grape-kernel oil is the highest (>90%), and wherein linoleic content reaches more than 75%.Also containing liposoluble vitamin and various trace elements such as abundant vitamin E and a certain amount of vitamin A, D in grape-kernel oil.Therefore, grape-kernel oil is a kind of rare natural product.Grape pip crude oil is light green color, is colourless or oyster after refining, smell without exception, and not containing cholesterol and sodium, its Heat stability is good, smoke point is high.Its nutritive value and medical function all obtain the abundant affirmation of domestic and international medical circle and nutrition man; there is reduction blood fat, softening blood vessel, prevention vascular sclerosis, reduce blood pressure, reduce blood viscosity and prevent the various biological effectiveness such as thrombosis; also can produce, maintain the function of epithelium and nerve cell normal configuration and anti-oxidant, anti-ageing, the various physiological action such as vision protection, promotion upgrowth and development of children; grape-kernel oil is suitable for various different crowd, is particularly suitable for the elderly edible.

The present invention is the mode adopting oral soft capsule preparation, fundamentally increases eye nutrition, reaches the object alleviated and repair.Its algae extrats Wheat Protein, can nutrition human body cell, effectively alleviates or eliminates visual fatigue; Lutein is enrichment on the retina, can improve GJIC function, maintains amphiblestroid normal vision, and protection retina damages from blue light, suppression, cancellation free radical; Bilberry fruit P.E, as strong antioxidant, can protect eyes from free radical injury.Algae extrats, lutein and Bilberry fruit P.E all belong to integration of drinking and medicinal herbs, take safe and reliable, and three's Synergistic has very strong antioxidation activity, and is easily absorbed by the body, and energy is scavenging free radicals in time, keep eye vigor.For mid-aged population with through conventional eye, the crowd of visual fatigue has the function of good alleviation visual fatigue.

Various compositions in salt algae lutein cowberry composition according to the present invention are commercially, such as described algae extrats, lutein, Bilberry fruit P.E can be not gloomy purchased from Shaanxi, described beeswax can purchased from Beijing Procaine Preparations, and described grape-kernel oil can purchased from Hebei Xin Qi Dian Biotechnology Co., Ltd..

Embodiment 1

To make 1000 salt algae lutein cowberry soft capsule preparations for sample.

Formulation selection:

Capsule 's content: take formula material according to weight, gets the algae extrats 30 grams that purity is 8%, and purity is 15 grams, the lutein of 75%, and purity is the Bilberry fruit P.E 30 grams of 25%, 20 grams, beeswax, grape-kernel oil 405 grams.

Soft capsule shell: take formula material according to weight, gets 200 grams, gelatin, glycerine 57 grams, D-sorbite 23 grams, titanium dioxide 0.6 gram, Cacao pigment 2 grams, purified water 200 grams.

The salt algae lutein cowberry soft capsule preparation made according to above-mentioned formula, the tolerant content of every intragranular is 0.5 gram, experimentally proves, according to adult body weight 60KG meter, adult daily once, each one can reach anti-oxidant, alleviates the effect of visual fatigue.

According to Fig. 1, salt algae lutein cowberry soft capsule preparation can be prepared by the method comprising following key step:

1) content feed liquid is prepared:

Weigh algae extrats, Bilberry fruit P.E, lutein, grape-kernel oil, beeswax respectively, for subsequent use; After grape-kernel oil and beeswax heating for dissolving, obtain oily wax liquid; When oily wax liquid is cooled to room temperature, join in oily wax liquid by algae extrats, Bilberry fruit P.E, lutein, limit edged stirs, and mixes, put in colloid mill again and grind 4 times, vacuumize, vacuum remains on-0.06Mpa with de-bubble to the greatest extent, cross 120 mesh sieves, obtain content feed liquid, stand-by.

2) glue is prepared:

Weigh gelatin, glycerine, titanium dioxide, D-sorbite, cacao pigment, purified water respectively, for subsequent use; By in glycerine, titanium dioxide, cacao pigment, D-sorbite and putting into of purified water glue tank, stir, when being heated to 80 DEG C, add gelatin, stir and boil 1h, vacuumize, de-bubble to the greatest extent, crosses 80 mesh sieves, make glue, put into glue bucket insulation (60 DEG C ~ 65 DEG C), for subsequent use.

3) capsule is pressed into:

The tolerant feed liquid of Inner, glue, by pellet press, make soft capsule.In pelleting process, check a ball weight, guarantee that content uniformity is in acceptability limit, checks capsule appearance at any time every about 30min, whether ball shape is normal, has ne-leakage.In production process, keep a close eye on the working order of equipment.Temperature remains on 18 ~ 26 DEG C, and relative humidity is 40% ± 5%.

4) shape:

The soft capsule be pressed into is put in sizing rotating cage and is shaped 1 hour, and temperature remains on 18 ~ 26 DEG C, and relative humidity is 40% ± 5%.

5) dry:

Soft capsule after heat treatment 18 ~ 26 DEG C temperature and 30% ± 5% relative humidity under carry out preliminarily dried about 16 hours.

6) ball is washed:

Dried soft capsule is put in ultrasonic wave soft capsule cleaner with the 95% edible alcohol cleaning meeting GB10343 quality requirement, the grease on removing surface, the temperature of 18 ~ 26 DEG C and 30% ± 5% relative humidity under, the soft capsule after cleaning is divided in screen tray, for subsequent use.

7) dry in the air ball:

Soft capsule after cleaning is divided in drying cart screen tray, sends into drying room and carries out drying, temperature (18 ~ 26) DEG C, relative humidity 30% ± 5%.

8) pack:

By step 7) in the salt algae lutein cowberry soft capsule preparation that obtains screen, remove the defective soft capsule such as large piller, special-shaped ball, flat ball, the ball that breaks, thin-walled ball, significantly wire mark ball, bubble ball, adhesion ball, the capsule meeting finished product requirement is wrapped inside dress, be encapsulated in medicinal high density ethylene bottle, then after check problem, be divided into marketing packing namely become the finished product that can dispatch from the factory.

Embodiment 2

Except preparing except capsule 's content and glue respectively according to following proportioning, salt algae lutein cowberry soft capsule preparation is prepared according to the method that embodiment 1 is similar, wherein algae extrats 20 grams, 7.5 grams, lutein, Bilberry fruit P.E 20 grams, 20 grams, beeswax, grape-kernel oil 432.5 grams, described glue comprises 200 grams, gelatin, glycerine 57 grams, D-sorbite 23 grams, titanium dioxide 0.6 gram, Cacao pigment 2 grams, purified water 200 grams.

Embodiment 3

Except preparing except capsule 's content and glue respectively according to following proportioning, salt algae lutein cowberry soft capsule preparation is prepared according to the method that embodiment 1 is similar, algae extrats 25 grams, 10 grams, lutein, Bilberry fruit P.E 20 grams, 25 grams, beeswax, grape-kernel oil 420 grams, described glue comprises 200 grams, gelatin, glycerine 57 grams, D-sorbite 23 grams, titanium dioxide 0.6 gram, Cacao pigment 2 grams, purified water 200 grams.

Embodiment 4

Except preparing except capsule 's content and glue respectively according to following proportioning, salt algae lutein cowberry soft capsule preparation is prepared according to the method that embodiment 1 is similar, algae extrats 30 grams, 12.5 grams, lutein, Bilberry fruit P.E 30 grams, 22.5 grams, beeswax, grape-kernel oil 405 grams, described glue comprises 200 grams, gelatin, glycerine 57 grams, D-sorbite 23 grams, titanium dioxide 0.6 gram, Cacao pigment 2 grams, purified water 200 grams.

Test example 1

The salt algae lutein cowberry soft capsule preparation obtained with embodiment 1 and embodiment 2 below carries out human experimentation, further illustrates effect that the present invention has alleviating asthenopia.

1) object and method:

Tested material: the salt algae lutein cowberry soft capsule preparation obtained with embodiment 1 and embodiment 2 is for given the test agent.Reference substance soft capsule preparation is made up of content and soft capsule shell, the each raw material of content is lutein 4% according to weight ratio, beeswax 6% and grape-kernel oil 80%, the each raw material of soft capsule shell according to weight ratio is: gelatin 40%, glycerine 12%, D-sorbite 5%, titanium dioxide 0.5%, Cacao pigment 2.5% and purified water 40%.

Study subject: select the personnel participating in test from entering one's name voluntarily the age be 19-23 year, be experimenter with eye, eyesight fatiguability person for a long time, two test group 60 examples, control group 30 are routine.

Diagnostic criteria: use eye for a long time, has that ophthalmodynia, eye are dry, eye is puckery, eye is swollen, blurred vision symptom.

The person's of including in standard: all ages are 19-23 year, being volunteer for a long time, all can carrying out test-meal experiment through being up to the standards with eye, eyesight fatiguability person.

Eliminator's standard: age those who do not meet, gestation or women breast-feeding their children, to this health food allergy sufferers; Be associated with the severe primary diseases such as conscience kidney and hemopoietic system, mental patient; Do not meet inclusive criteria, not by regulation test food, effect or data not umbra sound effect or analysis person cannot be judged.

Contrast form: adopt self cross-reference form.

Taking dose and time: tested material and placebo are each 1, every day 2 times, continuous 30 days, experimenter cut out about the medicine of alleviating asthenopia or other health foods and eyedrops at experimental session.

Instrument and reagent: Olympus fully-automatic analyzer.

2) observation index: be divided into safety indexes and its functional attributes, indices in test-meal on-test and at the end of each to measure once.

2.1) both effectiveness observation: efficiency index criterion

Symptom is improved: ophthalmodynia, eye are dry, eye is puckery, eye is swollen, the arbitrary symptom of blurred vision is improved and other symptoms without deterioration;

Effective: symptom is improved and differed >=0.1 before and after duration of photopic vision, and has statistical significance through statistical comparison difference;

Invalid: not reach effective standard.

3) experimental result:

3.1) general status:

Observe visual fatigue experimenter 90 example altogether, the test group male sex 27 example, women 33 example, minimum 19 years old of age, maximum 23 years old, the mean age (21 ± 1) year, the control group male sex 15 example, women 15 example, minimum 19 years old of age, maximum 23 years old, year mean age (21 ± 1).

3.2) safety indexes is observed:

Before and after test-meal to the eye symptom of test group and control group crowd and funduscopy all in normal range (NR).

3.3) distant vision improvement is compared

Test group right and left eyes distant vision all makes moderate progress than before test-meal, and difference has statistical significance (P < 0.05); After control group test-meal, right and left eyes distant vision is not improved with comparing before test-meal, no significant difference (P > 0.05).

Table 1: distant vision improvement is compared

3.4) duration of photopic vision change is compared

Test group 1 duration of photopic vision rises to 0.71 ± 0.08 after test-meal by 0.59 ± 0.07 before test-meal, improve 0.12 ± 0.03, difference has statistical significance (P < 0.05), test group 2 duration of photopic vision rises to 0.70 ± 0.07 after test-meal by 0.61 ± 0.06 before test-meal, improve 0.09 ± 0.03, difference has statistical significance (P < 0.05); After test-meal, test group 1 duration of photopic vision (0.71 ± 0.08) and test group 2 duration of photopic vision (0.61 ± 0.06) compare with (0.63 ± 0.07) after control group test-meal statistical significance (P < 0.05).

Table 2: before and after test-meal, duration of photopic vision change is compared

3.5) symptom improvement is compared

Table 3: before and after test-meal, symptom improvement is compared

As can be seen from Table 3, the eye symptom trying trencherman has clear improvement.

3.6) before and after test-meal, total effective rate compares

The total effectively number of cases of test group 1 is 19 examples, and total effective rate is 63.33%; The total effectively number of cases of test group 2 is 16 examples, and total effective rate is 53.33%; The total effectively number of cases of control group is 5 examples, and total effective rate is 16.67%, and comparing result total effective rate comparing difference has statistical significance (P < 0.05).

Table 4: before and after test-meal, functional observation compares

4) conclusion

According to human experiment result, can think that this health care soft capsule has asthenopia releasing function effect to human body.In whole test-meal process, tested safety indexes all, all in range of normal value, illustrates that taking the health of this product to examination trencherman has no adverse effects.

Claims

1. a salt algae lutein cowberry composition, described composition comprises according to weight ratio: the grape-kernel oil of algae extrats 4%-10%, lutein 1.5%-4%, Bilberry fruit P.E 4-10%, beeswax 3%-5% and surplus.

2. salt algae lutein cowberry composition according to claim 1, it is characterized in that, described salt algae lutein cowberry composition comprises according to weight ratio: the grape-kernel oil of algae extrats 4%-6%, lutein 1.5%-3%, Bilberry fruit P.E 4-6%, beeswax 4%-5% and surplus.

3. salt algae lutein cowberry composition according to claim 1, it is characterized in that, described salt algae lutein cowberry composition comprises according to weight ratio: 4%, the algae extrats of 5% or 6%, 1.5%, the lutein of 2%, 2.5% or 3%, 4%, the Bilberry fruit P.E of 5% or 6%, the beeswax of 4%-5% and the grape-kernel oil of surplus.

4. salt algae lutein cowberry composition according to claim 1, is characterized in that, preferably, described salt algae lutein cowberry composition comprises according to weight ratio: algae extrats 6%, lutein 3%, Bilberry fruit P.E is 6%, beeswax 4% and grape-kernel oil 81%; Or

Preferably, described salt algae lutein cowberry composition comprises according to weight ratio: algae extrats 4%, lutein 1.5%, and Bilberry fruit P.E is 4%, beeswax 4% and grape-kernel oil 86.5%; Or

Preferably, described salt algae lutein cowberry composition comprises according to weight ratio: algae extrats 5%, lutein 2%, and Bilberry fruit P.E is 4%, beeswax 5% and grape-kernel oil 84%; Or

Preferably, described salt algae lutein cowberry composition comprises according to weight ratio: algae extrats 6%, and lutein 2.5%, Bilberry fruit P.E is 6%, beeswax 4.5% and grape-kernel oil 81%.

5. salt algae lutein cowberry composition as claimed in any of claims 1 to 4, it is characterized in that, in described algae extrats, the weight percentage of beta carotene is 8%, and in described Bilberry fruit P.E, anthocyanidin weight percentage is 25%.

6. one kind comprises the soft capsule preparation of salt algae lutein cowberry composition, it is characterized in that, described soft capsule preparation is made up of content and soft capsule shell, described content is salt algae lutein cowberry composition as claimed in any of claims 1 to 5, and described soft capsule comprises the purified water of gelatin 25%-40%, glycerine 10%-17%, D-sorbite 5%-8%, titanium dioxide 1.5%-3%, Cacao pigment 1.5%-3% and surplus according to weight ratio.

7. soft capsule preparation according to claim 6, is characterized in that, each raw material of described soft capsule shell according to weight ratio is: gelatin 40%, glycerine 12%, D-sorbite 5%, titanium dioxide 0.5%, Cacao pigment 2.5% and purified water 40%.

8. a preparation method for soft capsule preparation, said method comprising the steps of:

1) salt algae lutein cowberry composition feed liquid is prepared, i.e. content feed liquid:

Weigh algae extrats, Bilberry fruit P.E, lutein, beeswax, grape-kernel oil respectively, for subsequent use; After grape-kernel oil and beeswax heating for dissolving, obtain oily wax liquid; When oily wax liquid is cooled to room temperature, algae extrats, Bilberry fruit P.E, lutein are joined in oily wax liquid, limit edged stirs, mix, then be placed in colloid mill and grind 3-5 time, vacuumize, vacuum remains on-0.06 ~-0.08Mpa with de-bubble to the greatest extent, cross 120 mesh sieves, obtain content feed liquid, stand-by;

2) glue is prepared: weigh gelatin, glycerine, titanium dioxide, D-sorbite, cacao pigment, purified water respectively, for subsequent use; By in glycerine, titanium dioxide, cacao pigment, D-sorbite and putting into of purified water glue tank, stir, add gelatin when being heated to 70 ~ 80 DEG C, stirring boils, vacuumize, de-bubble to the greatest extent, crosses 80 mesh sieves, make glue, put into 60 DEG C ~ 65 DEG C glue bucket insulations, for subsequent use;

3) capsule is pressed into: the tolerant feed liquid of Inner, glue pass through pellet press, make soft capsule, in pelleting process, check a ball weight every about 30min, guarantee that content uniformity is in acceptability limit, check capsule appearance at any time, whether ball shape is normal, has ne-leakage, in production process, the working order of close attention equipment, temperature remains on 18 ~ 26 DEG C, and relative humidity is 40% ± 5%;

4) shape: the soft capsule be pressed into is placed in sizing rotating cage and shapes about 1 ~ 2.5 hour, and temperature remains on 18 ~ 26 DEG C, relative humidity 40% ± 5%;

5) dry: the soft capsule after heat treatment 18 ~ 26 DEG C temperature and 30% ± 5% relative humidity under carry out preliminarily dried about 16 hours;

6) ball is washed: dried soft capsule is put in ultrasonic wave soft capsule cleaner with the 95% edible alcohol cleaning meeting GB10343 quality requirement, the grease on removing surface, the temperature of 18 ~ 26 DEG C and 30% ± 5% relative humidity under, the soft capsule after cleaning is divided in screen tray, for subsequent use;

9. the preparation method of soft capsule preparation according to claim 8, is characterized in that, described preparation method also comprises step 8) packaging: