CN104224890B - A kind of xanthophyll soft capsule and preparation method thereof - Google Patents

A kind of xanthophyll soft capsule and preparation method thereof Download PDF

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Publication number
CN104224890B
CN104224890B CN201410367651.4A CN201410367651A CN104224890B CN 104224890 B CN104224890 B CN 104224890B CN 201410367651 A CN201410367651 A CN 201410367651A CN 104224890 B CN104224890 B CN 104224890B
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capsule
content
soft capsule
weight
glue
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CN104224890A (en
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刘永刚
张正刚
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Zhonghong Biotechnology (Beijing) Co.,Ltd.
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ZHONGHONG BIOLOGICAL ENGINEERING Co Ltd
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Abstract

The present invention relates to a kind of xanthophyll soft capsule and preparation method thereof, xanthophyll soft capsule is made up of capsule skin and capsule 's content, wherein, the capsule 's content is made up of the raw material of following parts by weight:Bilberry fruit P.E 110 ~ 130, lutein 12 ~ 20, taurine 45 ~ 60, natural β ~ carrotene 7 ~ 11, phosphatidase 2 ~ 2.4, beeswax 24 ~ 29 and linseed oil 200 ~ 250;The capsule skin is made up of the raw material of following parts by weight:Gelatin 130 ~ 170, glycerine 62 ~ 72, purified water 110 ~ 130, light blue 0.029 ~ 0.032, temptation red 0.0275 ~ 0.0295, burnt sugar coloring 0.1428 ~ 0.1628 and titanium dioxide 0.2192 ~ 0.2392.Beneficial effect of the present invention:Compatibility rationally, with effective alleviates the symptoms such as visual fatigue, blurred vision, the eye dry and astringent, eye is swollen, ophthalmodynia, the photophobia that improve patient.

Description

A kind of xanthophyll soft capsule and preparation method thereof
Technical field
The present invention relates to field of health care products, more particularly to a kind of xanthophyll soft capsule and preparation method thereof.
Background technology
With the popularization of the electronic product such as Chinese society expanding economy and computer, TV and smart mobile phone, liquid crystal display Screen has been deep into daily life, and eyes cause heavy bear before the fluorescent screen of flicker to eyes for a long time Load, causes visual fatigue, promotes retinal ocular disease to be fallen ill with some chronic ocular diseases and is raised in advance with illness rate.Visual fatigue be it is a kind of with Subjective symptoms is the eye syndrome of main clinical manifestation, and the generation of visual fatigue is eye or whole body apparatus factors and psychiatric The result that factor is intertwined to form.Headache, dizziness, spasm of ocular muscles, induction stomach function barrier can be produced under visual fatigue serious conditions Hinder, the symptom such as whole body is uncomfortable.
Many alleviates the products such as tablet, hard shell capsules of visual fatigues by main component of lutein currently on the market, due to it Component compatibility is unreasonable, function approach is single can not meet people's alleviation visual fatigue, prevention macular degeneration and protect eyes The need for.
The content of the invention
It is an object of the invention to provide a kind of xanthophyll soft capsule and preparation method thereof, to overcome the upper of prior art presence State deficiency.
The purpose of the present invention is to be achieved through the following technical solutions:
A kind of xanthophyll soft capsule, is made up of capsule skin and capsule 's content, wherein, the capsule 's content is by following heavy The raw material of amount part is made:Bilberry fruit P.E 110 ~ 130, lutein 12 ~ 20, taurine 45 ~ 60, natural β ~ carrotene 7 ~ 11, phosphorus Fat 2 ~ 2.4, beeswax 24 ~ 29 and linseed oil 200 ~ 250;The capsule skin is made up of the raw material of following parts by weight:Gelatin 130 ~ 170th, glycerine 62 ~ 72, purified water 110 ~ 130, light blue 0.029 ~ 0.032, lure red 0.0275 ~ 0.0295, burnt sugar coloring 0.1428 ~ 0.1628 and titanium dioxide 0.2192 ~ 0.2392.
The preparation method of above-mentioned xanthophyll soft capsule, comprises the following steps:
1)The preparation of capsule skin is prepared, is comprised the following steps:The titanium dioxide and glycerine of equivalent is taken to be sufficiently mixed, grind The titanium dioxide suspension crossed afterwards after 300 mesh sieves, and mixed with burnt sugar coloring, the red, light blue of temptation, obtain pigment solution;By above-mentioned steps In the purified water of remaining glycerine and formula ratio be heated to 70 ~ 80 degree, put into gelatin and stir to gelatin and be completely dissolved;By container Interior air is evacuated to ~ 0.07 ~ 0.10Mpa, and is kept for 10 ~ 20 minutes to capsule bubble-free, and capsule liquid then is crossed into 150 mesh sieves and put Go out glue, be placed in glue-storing barrel, add pigment solution and stir, stand more than 3 hours, but cannot be greater than or be equal to 24 hours, and 60 degree or so of glue is kept, it is standby;
2)Capsule 's content is prepared, is comprised the following steps:The linseed oil and beeswax of half parts by weight in formula are added Heat is to 65 ~ 75 DEG C, and stirring is completely dissolved to beeswax and by 300 mesh screens, adds the parts by weight of remaining half in formula Linseed oil in stir, cross colloid mill obtain oily wax liquor, it is stand-by;Again by natural β ~ carrotene, lutein, phosphatide, cowberry Extract and taurine are added in oily wax liquor and stirred, and obtain mixed material;Mixed material is crossed into colloid mill grinding, then put Stirred 20 minutes in vacuum emulsifying machine, cross 100 mesh sieves after observation bubble-free and release, obtain capsule 's content in capsule;
3)Pelleting, sizing
Capsule 's content, glue in capsule are pressed into soft capsule in encapsulating machine, it is 1.5 ~ 3.0 revs/min to keep rotating speed Clock, sprinkler body temperature is kept for 35 ~ 50 DEG C, and rubber thickness is 0.78 ~ 0.85mm, and loading amount is 0.45g/;The soft capsule pressed is put In rotating cage, shaped 1.0 ~ 2.5 hours under conditions of 18 ~ 26 DEG C of temperature, relative humidity 20 ~ 40%;
4)Dry
Obtained soft capsule is put in dry pallet, under conditions of 15 ~ 30 DEG C of temperature, relative humidity 15 ~ 30%, dried Soft capsule can be obtained by being less than 11% with the up to capsule severe edema due to hypofunction of the spleen point within 24 hours.
Beneficial effects of the present invention are:Present invention aims at existing for prior art, component compatibility is unreasonable, function Action pathway is single, bioavailability is low, effect is poor etc. it is not enough there is provided it is a kind of safely and effectively, compatibility rationally, with effective alleviation Symptom, prevention macular degeneration and the protect eyes such as visual fatigue, blurred vision, eye dry and astringent, eye is swollen, ophthalmodynia, the photophobia for improving patient Xanthophyll soft capsule and preparation method thereof.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to institute in embodiment The accompanying drawing needed to use is briefly described, it should be apparent that, drawings in the following description are only some implementations of the present invention Example, for those of ordinary skill in the art, on the premise of not paying creative work, can also be obtained according to these accompanying drawings Obtain other accompanying drawings.
Fig. 1 is the three-dimensional block diagram of triangle disposition on inspection table described according to embodiments of the present invention.
Embodiment
Embodiment 1
A kind of xanthophyll soft capsule described in the embodiment of the present invention 1, is made up of capsule skin and capsule 's content, in the capsule It is tolerant by following weight(kg)Raw material be made:Bilberry fruit P.E 115, lutein 15.2, taurine 56, natural β ~ carrotene 10th, phosphatidase 2 .2, beeswax 29 and linseed oil 223;The capsule skin is by following weight(kg)Raw material be made:Gelatin 153.2, Glycerine 67.86, purified water 122.56, light blue 0.0308, temptation red 0.0287, burnt sugar coloring 0.1528 and titanium dioxide 0.2292.
A kind of preparation method of xanthophyll soft capsule described in embodiment 1 comprises the following steps:
1)Prepare capsule skin
Take the titanium dioxide and glycerine of equivalent 0.2292 to be sufficiently mixed, grind after cross 300 mesh sieves after titanium dioxide be suspended Liquid, and mixed with burnt sugar coloring, the red, light blue of temptation, obtain pigment solution;By the purified water of remaining glycerine and formula ratio in above-mentioned steps 70 ~ 80 degree are heated to, gelatin is put into and stirring to gelatin is completely dissolved;Air in container is evacuated to ~ 0.07 ~ 0.10Mpa, and Kept for 10 ~ 20 minutes to capsule bubble-free, capsule liquid is then crossed into 150 mesh sieves and releases glue, is placed in glue-storing barrel, adds color Plain solution & stir is uniform, stands more than 3 hours, but cannot be greater than or equal to 24 hours, and keeps 60 degree or so of glue, standby With;
2)Prepare capsule 's content
Linseed oil and beeswax are heated to 65 ~ 75 DEG C, stirring is completely dissolved to beeswax and by 300 mesh screens, plus Enter in formula and stirred in remaining linseed oil, cross colloid mill and obtain oily wax liquor, it is stand-by;It is again that natural β ~ carrotene, leaf is yellow Element, phosphatide, Bilberry fruit P.E and taurine are added in oily wax liquor and stirred, and obtain mixed material;Mixed material is crossed into colloid Mill grinding, is subsequently placed in vacuum emulsifying machine and stirs 20 minutes, crosses 100 mesh sieves after observation bubble-free and releases, obtains capsule in capsule Content;
3)Pelleting, sizing
Capsule 's content, glue in capsule are pressed into soft capsule in encapsulating machine, it is 1.5 ~ 3.0 revs/min to keep rotating speed Clock, sprinkler body temperature is kept for 35 ~ 50 DEG C, and rubber thickness is 0.78 ~ 0.85mm, and loading amount is 0.45g/;The soft capsule pressed is put In rotating cage, shaped 1.0 ~ 2.5 hours under conditions of 18 ~ 26 DEG C of temperature, relative humidity 20 ~ 40%;
4)Dry
Obtained soft capsule is put in dry pallet, under conditions of 15 ~ 30 DEG C of temperature, relative humidity 15 ~ 30%, dried Soft capsule can be obtained by being less than 11% with the up to capsule severe edema due to hypofunction of the spleen point within 24 hours.
Embodiment 2
A kind of xanthophyll soft capsule described in the embodiment of the present invention 2, including capsule skin and capsule 's content, the capsule contents Thing is by following weight(kg)Raw material be made:Bilberry fruit P.E 110, lutein 15.6, taurine 60, natural β ~ carrotene 9, Phosphatidase 2, beeswax 29 and linseed oil 220;The capsule skin is by following weight(kg)Raw material be made:Gelatin 130, glycerine 72, Purified water 120, light blue 0.029, temptation red 0.0295, burnt sugar coloring 0.01428 and titanium dioxide 0.2392.
A kind of preparation method of xanthophyll soft capsule is consistent with the preparation method in embodiment 1 described in embodiment 2.
Embodiment 3
A kind of xanthophyll soft capsule described in the embodiment of the present invention 3, including capsule skin and capsule 's content, the capsule contents Thing is by following weight(kg)Raw material be made:Bilberry fruit P.E 130, lutein 20, taurine 45, natural β ~ carrotene 11, phosphorus Fat 2.4, beeswax 24 and linseed oil 200;The capsule skin is by following weight(kg)Raw material be made:Gelatin 170, glycerine 62, Purified water 130, light blue 0.032, temptation red 0.0275, burnt sugar coloring 0.1628 and titanium dioxide 0.2192.
A kind of preparation method of xanthophyll soft capsule is consistent with the preparation method in embodiment 1 described in embodiment 3.
Embodiment 4
A kind of xanthophyll soft capsule described in the embodiment of the present invention 4, including capsule skin and capsule 's content, the capsule contents Thing is by following weight(kg)Raw material be made:Bilberry fruit P.E 120, lutein 12, taurine 50, natural β ~ carrotene 7, phosphorus Fat 2.1, beeswax 26 and linseed oil 250;The capsule skin is by following weight(kg)Raw material be made:Gelatin 149, glycerine 69.8th, purified water 110, light blue 0.031, temptation red 0.0281, burnt sugar coloring 0.1518 and titanium dioxide 0.2392.
A kind of preparation method of xanthophyll soft capsule is consistent with the preparation method in embodiment 1 described in embodiment 4.
The test-meal response situation of the xanthophyll soft capsule:
1st, subject chooses the adult of 18 ~ 65 one full year of life and uses eye vision fatigue person for a long time.
2nd, the exclusion standard of subject:
(1)With infectious, traumatic eye part disease person.Carry out less than 3 months persons of operated eye.
(2)With eye disease patient inside and outside cornea, crystal, vitreum, eyeground pathological changes etc..
(3)With the disease patient such as angiocarpy, the cerebrovascular, liver, kidney, hemopoietic system.
(4)Gestation or women breast-feeding their children, allergic constitution patient.
(5)The article relevant with tested function is taken in a short time, has influence on the judgement person to result.
(6)Long-term taking health products or fails terminator about treating the medicine of eyesight using other treatment method.
3rd, experimental design and packet are required:Using itself between group two kinds of control designs.Entered according to random, double blinding requirement Row packet, according to symptom and eye test situation during packet, makes test-meal group and the symptom and eyesight horizontal equalization of control group.Simultaneously Consider the factors such as age, sex, make two groups there is comparativity.Every group of number of subjects is no less than 50 during test-meal off-test Example.
4th, the dosage and application method of tested material:Test-meal group takes tested material, control group clothes by recommendation method and recommended amounts With placebo, subject's Time of Administration is continuous 60 days.
5th, observation index:
(1)Safety indexes before and after test-meal:Blood, routine urianlysis, physical examination;Liver and kidney function is checked;Chest X-rays or X Mating plate, electrocardiogram, abdominal B-scan ultrasonography inspection.
(2)Efficiency index:In test-meal start and at the end of check, survey:Symptom inquires, uses eye situation;Ophthalmology Check:Including funduscopy, eye test(Myopia, long sight, astigmatism etc.);The assay method of duration of photopic vision sees below described.
6th, effect criterion
(1)Symptom improves efficient:Eye ache, eye is swollen, photophobia, blurred vision, dry and astringent eye, foreign body sensation, shed tears, whole body not Fitting has 3 kinds of improvement in 8 kinds of symptoms, and other symptoms improve without i.e. judgement symptom is deteriorated.Calculating two groups of symptoms improves number of cases and two Group symptom improves efficient.Symptom improves efficient(%)Computational methods are that symptom improves number of cases/test-meal number of cases × 100.By two groups Symptom improves efficient progress statistical test.
(2)Symptom average integral:The symptom integral before and after every examination trencherman's test-meal is calculated, two groups of average product is calculated respectively Score value, and statistical test is carried out, following chart 1 show visual fatigue symptom decision method(Sxemiquantitative integration method).
Table 1
Note:" random thoughts " refer to 1-2 times/2 days in table;" when have " refers to 1-3 times/day;" frequent " refers to>3 times/day
7th, vision improvement rate:So that, compared with two behaviors improvement is improved before test-meal, what two groups of statistics was taken after tested material regards after test-meal Power improvement rate is used as reference index.
8th, duration of photopic vision:Test-meal group itself compare or test-meal group and control group group between compared, duration of photopic vision difference has Conspicuousness(p<0.05), and it is effective that average duration of photopic vision, which is improved more than or equal to 10%,.
9th, result of the test:Subject in the safe performance indexes before and after experiment in normal range (NR), 8 kinds of diseases after experiment Shape has more than 3 kinds of improvement rate more than 98%;According to the reference standard in table 1, compared with the probability that two rows are improved before test-meal after test-meal For 99.7%;Test-meal group itself compare or test-meal group and control group group between compared, duration of photopic vision difference has conspicuousness(p< 0.05), and average duration of photopic vision raising is more than or equal to 10%.
Show that the xanthophyll soft capsule tested material helps to alleviate the effect of visual fatigue function according to above-mentioned experiment, And effect is obvious.
The assay method of duration of photopic vision:
As shown in Figure 1:The three-dimensional block diagram of triangle disposition is drawn on table is checked, square is per length of side 1cm, local lighting 100 LX-150 LX(The lamp box specially made can be used).During measure, checking the distance of table and eyes should practise according to subject regarding thing Used to be maintained at that suitable distance is motionless, regulation subject sees that " product " word image is considered as photopic vision, fall " product " word when be not photopic vision.Determine Time is 3min.
Allowed during inspection subject it is hand-held can interrupted timing stopwatch, examiner sent after the password of beginning, and subject is immediately The pattern watched attentively in square(Or open lamp box switch), while starting the manual time-keeping in hand.See down during being look at The pause switch of stopwatch is pressed during " product " word immediately;See and start stopwatch again when being in " product " word image, be so repeated.Survey Subject hears that the password of examiner stops stopwatch immediately at the end of determining to stipulated time 3min, and stopwatch is passed by this period Reading is exactly the total time that subject regards " product " word image as, i.e. the photopic vision time.
Duration of photopic vision=(The photopic vision time/watch total time attentively)×100%
Place and illumination are should be noted that during measure, the also use eye degree with subject before tested is relevant, should be noted that before experiment.
The present invention is not limited to above-mentioned preferred forms, and anyone can show that other are various under the enlightenment of the present invention The product of form, however, make any change in its shape or structure, it is every that there is skill identical or similar to the present application Art scheme, is within the scope of the present invention.

Claims (2)

1. a kind of xanthophyll soft capsule, it is made up of capsule skin and capsule 's content, it is characterised in that
The capsule skin is made up of the raw material of following parts by weight:Gelatin 153.2, glycerine 67.86, purified water 122.56, light blue 0.0308th, red 0.0287, burnt sugar coloring 0.1528 and titanium dioxide 0.2292 are lured;And
The capsule 's content is made up of the raw material of following parts by weight:Bilberry fruit P.E 115, lutein 15.2, taurine 56, day So ~ bata-carotene 10, phosphatidase 2 .2, beeswax 29 and linseed oil 223.
2. the preparation method of the xanthophyll soft capsule described in claim 1, it is characterised in that comprise the following steps:
1)Capsule skin is prepared, is comprised the following steps:Take the titanium dioxide and glycerine of equivalent to be sufficiently mixed, grind after cross 300 mesh sieves Titanium dioxide suspension afterwards, and mixed with burnt sugar coloring, the red, light blue of temptation, obtain pigment solution;By remaining glycerine in above-mentioned steps 70 ~ 80 degree are heated to the purified water of formula ratio, gelatin is put into and stirring to gelatin is completely dissolved;Air in container is taken out To -0.07 ~ 0.1Mpa, and kept for 10-20 minutes to capsule bubble-free, capsule liquid is then crossed into 150 mesh sieves and releases glue, is placed in In glue-storing barrel, add pigment solution and stir, stand more than 3 hours, but cannot be greater than or equal to 24 hours, and protect 60 degree or so of glue is held, it is standby;
2)Capsule 's content is prepared, is comprised the following steps:The linseed oil and beeswax of half parts by weight are heated to 65 ~ 75 DEG C, stirring is completely dissolved to beeswax and by 300 mesh screens, adds the linseed oil of second half remaining parts by weight in formula In stir, cross colloid mill obtain oily wax liquor, it is stand-by;Again by natural β ~ carrotene, lutein, phosphatide, Bilberry fruit P.E and ox Sulfonic acid is added in oily wax liquor and stirred, and obtains mixed material;Mixed material is crossed into colloid mill grinding, vacuum emulsification is subsequently placed in Stirred 20 minutes in machine, cross 100 mesh sieves after observation bubble-free and release, obtain capsule 's content in capsule;
3)Pelleting, sizing:Capsule 's content, glue in capsule are pressed into soft capsule in encapsulating machine, keep rotating speed be 1.5 ~ 3.0 revs/min, sprinkler body temperature is kept for 35 ~ 50 DEG C, and rubber thickness is 0.78 ~ 0.85mm, and loading amount is 0.45g/;By what is pressed Soft capsule is placed in rotating cage, is shaped 1.0 ~ 2.5 hours under conditions of 18 ~ 26 DEG C of temperature, relative humidity 20 ~ 40%;And
4)Dry:Obtained soft capsule is put in dry pallet, under conditions of 15 ~ 30 DEG C of temperature, relative humidity 15 ~ 30%, done It is less than 11% with the up to capsule severe edema due to hypofunction of the spleen point within dry 24 hours.
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CN106236739B (en) 2016-07-27 2019-06-07 上海宣泰生物科技有限公司 Contain lutein/lutein ester composition and its application
CN106880046A (en) * 2017-02-10 2017-06-23 合肥师范学院 A kind of Blueberry pigment soft capsule and preparation method thereof
CN107307418B (en) * 2017-07-01 2020-11-20 山东健康源生物工程有限公司 Blueberry vitamin A soft capsule for relieving visual fatigue and preparation method thereof
CN107279976A (en) * 2017-07-01 2017-10-24 山东健康源生物工程有限公司 A kind of natural VE adds bata-carotene soft capsule and preparation method thereof
CN107375504A (en) * 2017-08-15 2017-11-24 庞会心 A kind of composition for preventing and treating visual fatigue and preparation method and application
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CN102960738A (en) * 2012-12-20 2013-03-13 汤臣倍健股份有限公司 Bilberry and lutein soft capsule and preparation method thereof

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