CN106036882A - A lutein soft capsule and a preparing method thereof - Google Patents
A lutein soft capsule and a preparing method thereof Download PDFInfo
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- CN106036882A CN106036882A CN201610273346.8A CN201610273346A CN106036882A CN 106036882 A CN106036882 A CN 106036882A CN 201610273346 A CN201610273346 A CN 201610273346A CN 106036882 A CN106036882 A CN 106036882A
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- soft capsule
- content
- xanthophyll
- gelatin
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- 229960005375 lutein Drugs 0.000 title claims abstract description 44
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- KBPHJBAIARWVSC-RGZFRNHPSA-N lutein Chemical compound C([C@H](O)CC=1C)C(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\[C@H]1C(C)=C[C@H](O)CC1(C)C KBPHJBAIARWVSC-RGZFRNHPSA-N 0.000 title claims abstract description 39
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to a lutein soft capsule and a preparing method thereof. The soft capsule comprises a soft capsule wall material and contents sealed in the soft capsule wall material. The contents comprise 12-16 parts by weight of lutein, 6-10 parts by weight of a suspension, 75-80 parts by weight of a matrix and 0.15-0.25 part by weight of an antioxidant. During preparation, the contents are prepared by fully mixing raw materials of the contents, grinding and vacuumizing. The soft capsule wall material is prepared by fully mixing raw materials of the soft capsule wall material, vacuumizing and filtering. The soft capsule is prepared by subjecting the contents and the soft capsule wall material to pelleting, shaping, pill washing, drying, pill selecting, packaging, and the like. Compared with the prior art, the soft capsule has advantages of good effects for relieving asthenopia, rapid production of desired effects, good storage stability, good taste, easy deglutition, and the like. A production process is simple and suitable for large-scale production.
Description
Technical field
The present invention relates to a kind of health-related capsule, especially relate to a kind of phylloxanthin flexible glue having and alleviating asthenopia function
Capsule and preparation method thereof.
Background technology
Advanced information society, healthy eyes are more and more important for people, because most of information will lean on eye
Eyeball obtains, but meanwhile, watches computer, TV for a long time attentively, ignores the bad habits such as eye hygiene, is easily caused asthenopia
And visual deterioration, make the number of myopia constantly increase, the presbyopic generation age is rejuvenation trend.Asthenopic common manifestation
Tired for eye, occur that eyes are scorching hot, itch, be dried, the discomfort such as distending pain, blurred vision.If asthenopic situation is frequent, meeting
Make vision decline, eyes premature aging.For the maintenance of eye health, aside from care to eye protection, as taked light regulating, emphasis
Eyes are had a rest, are done outside the protective measures such as eye exercises, should also be noted that eye-candy, are eyes and supplement sufficient nutrition.It is true that as
It is the same that bone health requires supplementation with the nutrition such as calcium, magnesium, vitamin D, the nutrition needed for reasonable supplement eyes, to protection eyes, subtracts
Few vision injury, to improve vision etc. extremely important.All eye problems such as asthenopia, visual deterioration, for the good life of people
Cover with one layer of be shaded or hidden for foliage.
The eyes are the windows of the mind, and protection eye health is significant.Develop the new and effective asthenopic health care of alleviation
Food, the most significant to students in middle and primary schools, office building white-collar job person, middle-aged and elderly people etc., market development potential is huge.For
For noting the consumer of health, the vision kept fit is one " golden standard ".There are condensed food and the beverage of 83%
Consumer claims, and they are concerned about vision health very much or to a certain extent.For the health food of visual problems be the fourth-largest soon
The market that speed increases, comprehensive annual rate of growth is 9.32%.The consumer having 1/3 currently makes great efforts self-contr ol and treatment vision
Problem.The adult having more than 1/3 worries to go out in the future visual problems, and the people of 42% worries to suffer from cataract, people's load of 29%
Heart maculopathy.American contributes to the understanding of eye health to phylloxanthin, has risen to 2000 from 2% in 1999
27%, and doctor recommends phylloxanthin the most energetically.The domestic exploitation to phylloxanthin is applied seldom, and China is teen-age in addition regards
Power declines and increases severely, and old people's vision decline is numerous, is badly in need of the exploitation health food with phylloxanthin as main composition and supplies society
Meeting.Improve the exploitation of the health food of vision, there is huge market, have a extensive future.
Summary of the invention
Defect that the purpose of the present invention is contemplated to overcome above-mentioned prior art to exist and provide a kind of and alleviate asthenopia effect
Xanthophyll soft capsule that the best, instant effect, storage stability are good, in good taste, easily swallow and preparation method thereof.
The purpose of the present invention can be achieved through the following technical solutions:
A kind of xanthophyll soft capsule, this soft capsule is made up of the content in soft capsule material and inclosure soft capsule material, described
Content be made up of the component of following weight portion content:
Preferably, described content is made up of the component of following weight portion content:
Described suspensoid is Cera Flava, and described substrate is soybean oil, and described antioxidant is natural Vitamin E.
Described soft capsule material includes the component of following weight portion content:
The mass ratio of described gelatin, plasticizer and pure water is 100:35:100.
Described plasticizer is glycerol, and described opacifier is titanium dioxide, and described coloring agent is lemon yellow.
The preparation method of a kind of xanthophyll soft capsule, comprises the following steps:
(1) preparation of content:
(1-1) by proportioning, outstanding mixture and substrate are mixed at a temperature of 60～65 DEG C, make outstanding mixture all be dissolved in base
In matter, it is subsequently cooled to 45～50 DEG C,
(1-2) phylloxanthin and antioxidant are added by proportioning, mix and blend 20～40 minutes at a temperature of 55～50 DEG C,
Make content each material mix homogeneously,
(1-3) colloid mill is used to grind 2～3 times,
(1-4) evacuation, takes off bubble, obtains content；
(2) preparation of soft capsule material glue:
(2-1) pure water and plasticizer are stirred at a temperature of 70～80 DEG C, add gelatin, maintain the temperature at 70
～80 DEG C, make gelatin be completely dissolved, put into opacifier and coloring agent and stir, wherein gelatin, plasticizer, pure water, screening
The mass ratio of photo etching and coloring agent is 100:(30～50): 100:(3～5): (0.005～0.015),
(2-2) evacuation, takes off bubble,
(2-3) use 100 mesh sock filtration, then at a temperature of 45～55 DEG C, stand 2～5 hours, obtain soft capsule
Material glue；
(3) content and soft capsule material glue are pressed into soft gelatin capsule in pellet processing machine, be then passed through sizing, wash ball, be dried,
Obtain xanthophyll soft capsule.
The described mix and blend time in step (1-2) is 30 minutes.
When determining the mix and blend time, we have done following test, by incorporation time set 20 minutes, 30 minutes, 40
Minute, separately sampled 5 times, each 100g, measure the content's index of functional component phylloxanthin, the mix and blend time is to functional component
The impact being evenly distributed is shown in Table 1.
Table 1
In terms of above-mentioned experimental result, mixing 30min, the RSD value of mixing 40min phylloxanthin change little, illustrate to mix
Uniformly, but in order to save the energy, selecting incorporation time is that 30min can reach raw material mix homogeneously.
Sizing in described step (3) processes the method for 2 hours in using sizing rotating cage.
During soft capsule pelleting, need the soft gelatin capsule pressed to be shaped, to ensure the face shaping of soft gelatin capsule.In sizing
During affect the time that the principal element of soft gelatin capsule fixed effect is sizing.When determining sizing parameter, its time is tested
Screening, shaping time is shown in Table 2 to the impact of molding situation.
Table 2
| Shaping time | Molding situation |
| 1 hour | Soft gelatin capsule is the softest, has adhesion, and molding is bad |
| 2 hours | Soft gelatin capsule good hand touch, forming |
| 3 hours | Soft gelatin capsule good hand touch, forming |
In terms of shaping time with soft gelatin capsule situation, shaping time ＜ 2 hours, soft gelatin capsule is the softest, has adhesion, and molding is bad, sizing
Time >=2 hour, soft gelatin capsule good hand touch, molding situation is intact, from the point of view of saving the energy, selects shaping time 2 hours.
The thickness of described soft capsule material is 0.75～0.85mm, and the loading amount of the content of each soft capsule is 500mg.
The present invention uses the form of soft capsule, and soft capsule is popular health food shape on current domestic and international market
State, soft capsule is in good taste, easily swallows, the most false proof, safe to carry, easy to use, and has hidden the uncomfortable taste of raw material, is suitable to day
Often while residential use, it is more suitable for people and is away on a vacation, uses when travelling.
Phylloxanthin non-toxic and safe, has the physiological function of excellence, meets food additive " natural ", " nutrition ", " many merits
Can " developing direction, nineteen ninety-five FDA (FDA) approval phylloxanthin be used for eating as food supplement
Product, beverage.In China, phylloxanthin can use as nutrition enhancer.Modern study shows, it is asthenopic that phylloxanthin has alleviation
Effect.
Phylloxanthin is a kind of flavochrome belonging to carotenoid, is widely present at nature, but its existence form has difference
Not.One important difference of phylloxanthin and other carotenoid be phylloxanthin be not provitamin A, human body self can not
Synthesis, is completely dependent on diet regimen.In human body, phylloxanthin is present in the macular area of blood plasma and eyes, is present in human eye
One of two kinds of carotene.Phylloxanthin can prevent eyes photic damage, prevents from, because phylloxanthin lacks the visual deterioration caused, preventing
The physiological structure of eyes and function variation, be eye retina, macula lutea can not lack mainly comprise material.The master of phylloxanthin
Wanting the mechanism of action is antioxidation, secondly as light protective ingredient, it is possible to effective filter out the indigo plant causing retina injury in sunlight
Light.Supplementary phylloxanthin can improve visual performance, effectively alleviates asthenopia.Phylloxanthin is intervened long-term fluorescent screen light resurrectionist's tear film
Rupture time, duration of photopic vision and simple reaction time are significantly improved.
Cera Flava: as suspensoid, can make raw material uniformly be suspended in soybean oil, it is ensured that during pelleting, soft capsule content is equal
Even property, stability.The present invention use phylloxanthin be powder, natural Vitamin E is grease, soybean oil as substrate with above-mentioned
Raw material mixes.Exist with suspension after above-mentioned raw materials mix homogeneously, it may happen that settle when this mixture is deposited, for protecting
During card pelleting, the uniformity of supplementary material and stability, therefore with the addition of suspensoid Cera Flava.Drawn by the experiment of numbered 1～3
The selection of Cera Flava consumption.
Weighed phylloxanthin 70g, natural Vitamin E 1g by formula proportion, added soybean oil, Cera Flava the most according to the following ratio, press
Technological requirement carries out dispensing.After dispensing is placed 48 hours after completing, compare total mixture state, observe its mobility, surely simultaneously
Qualitative
(1) phylloxanthin 70g+ natural Vitamin E 1g+ soybean oil 399g+ Cera Flava 30g
(2) phylloxanthin 70g+ natural Vitamin E 1g+ soybean oil 389g+ Cera Flava 40g
(3) phylloxanthin 70g+ natural Vitamin E 1g+ soybean oil 379g+ Cera Flava 50g,
Experimental result:
Numbering (1) total mixture good fluidity, stability is general, is layered after placing 48 hours.
Numbering (2) total mixture good stability, good fluidity, it is not layered after placing 48 hours.
Numbering (3) total mixture good stability, but mobility is slightly worse.
Experiment shows, suspending agent consumption is the biggest, and the stability of total mixture is the best.When Cera Flava consumption is 40g, can be effectively
Total mixture before pelleting of avoiding be layered, and the good fluidity of total mixture, as continued to increase the consumption of Cera Flava,
The mobility of total mixture is deteriorated, therefore selects the proportioning of numbering Cera Flava used by (2), and the consumption of Cera Flava is 40g, and gained always mixes
The good fluidity of thing, good stability.Now be equivalent to the content quality according to phylloxanthin, suspensoid, substrate and antioxidant
Ratio carries out dispensing for 14:8:77.8:0.2.
Soybean oil: as stromatolysis Cera Flava.
Natural Vitamin E: antioxidant, prevents the oxidation of phylloxanthin so that the stability of phylloxanthin strengthens.
Gelatin, glycerol, pure water are the raw material producing soft capsule material.Cyst wall has plasticity, and by force and elasticity is soft capsule
Feature, be also the basis of soft capsule molding, it is made up of gelatin, glycerol (plasticizer) and pure water three, if with sweet
Oil (plasticizer) measure too low (or too high), then cyst wall can (or the softest) really up to the mark, due in the preparation of soft capsule and placement
During be only moisture content loss, therefore, preparation and the quality of soft capsule are had by gelatin with the ratio of glycerol (plasticizer)
Highly important impact, by the screening experiment of numbered 1～5, investigate the optimal proportion of gelatin and glycerol, gelatin, glycerol
With the mass ratio of pure water, the impact of cyst wall soft durometer is shown in Table 3.
Table 3
| Numbering | The mass ratio of gelatin, glycerol and pure water | Cyst wall soft durometer |
| 1 | 1:0.3:1 | The hardest |
| 2 | 1:0.35:1 | Tangible, neither too hard, nor too soft |
| 3 | 1:0.4:1 | Tangible, neither too hard, nor too soft |
| 4 | 1:0.5:1 | Soft, rubber is adhered, |
| 5 | 1:0.6:1 | Soft, rubber is adhered, has a little deformation |
The soft durometer of cyst wall is relevant with the consumption of glycerol (plasticizer), when the mass ratio of gelatin, glycerol and pure water is 1:
During 0.35:1, while saving glycerol consumption, cyst wall is neither too hard, nor too soft, and processability is good.
Titanium dioxide: as opacifier, it is to avoid the nutrient substance in soft capsule is irradiated by light, and make product quality unstable
Fixed
Lemon yellow: coloring agent, improves product appearance, avoids the nutrient substance in soft capsule to be produced by light irradiation simultaneously
Quality wild effect.
Compared with prior art, it is effective that the present invention has alleviation asthenopia, instant effect, storage stability be good, in good taste,
The advantage such as easily swallow, and production technology is simple, be suitable for large-scale industrial production.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described in detail.
Embodiment 1
A kind of xanthophyll soft capsule, this soft capsule is made up of the content in soft capsule material and inclosure soft capsule material, content
Thing is made up of phylloxanthin, Cera Flava, soybean oil, natural Vitamin E, soft capsule material by gelatin, glycerol, pure water, titanium dioxide and
Lemon yellow forms, and according to raw material, produces three batches of products, and the raw material composition of three batches of products and lot number are as shown in table 4.
Table 4
This Product Process highway route design meets the soft capsule pressing that Pharmacopoeia of People's Republic of China version in 2010 specifies.Tool
Body comprises the following steps:
1, the preparation of supplementary material
1.1 each supplementary materials are tested by respective quality standard, can use after the assay was approved；
1.2 weigh: weigh each supplementary material respectively by formula ratio；
2, the preparation of content
2.1 dissolve: put in material-compound tank by the soybean oil of formula ratio, be heated to 60～65 DEG C, add the honeybee of formula ratio
Wax mix and blend makes Cera Flava all dissolve, and is cooled to 45～50 DEG C；
2.2 mixing: phylloxanthin and the natural Vitamin E of formula ratio are joined mix and blend 30 points in above-mentioned solute
Clock, makes each material dispersion uniform, and temperature keeps 45～50 DEG C；
2.3 grind: foregoing thing is crossed 2～3 times colloid mills；
2.4 evacuation: material is poured in material-compound tank, evacuation, vacuum is-0.06～-0.08MPa, takes off bubble,
Obtain content；
3, the preparation of soft capsule material
3.1, by the pure water of formula ratio and glycerol putting into glue tank, are heated up to 70～80 DEG C and stir, and input is joined
The gelatin of side's amount, continues heating making glue tank temperature and is maintained at 70～80 DEG C, treat that gelatin is completely dissolved, put into titanium dioxide, lemon
Lemon Huang stirs；
3.2 evacuation, vacuum is-0.06～-0.08MPa, until glue bubble-free, obtains glue；
100 mesh filter bags crossed by glue by 3.3；
3.4 will filter after glue put into (or being pressed into) temperature control type rustless steel plane glue supply heat-preserving container insulation, holding temperature
50±5℃.Stand 3 hours, stand-by；
4, pelleting
Capsule 's content, glue are suppressed in soft capsule pellet processing machine soft gelatin capsule, and rubber thickness is 0.80mm ± 0.05mm, dress
Amount is about 500mg/ grain.Ambient temperature 18～26 DEG C, relative humidity 40%～50%；
5, sizing
Deliver to the soft gelatin capsule pressed shape in rotating cage, shape, time 2 h.Ambient temperature 18～26 DEG C are the wettest
Degree 40%～50%；
6, ball is washed
Clean soft gelatin capsule with 95% edible ethanol, make soft capsule clean surface oil stains-less.Edible ethanol should meet GB10343-
The regulation of 2008 " edible ethanols "；
7, it is dried
Dry environment temperature 20～28 DEG C, relative humidity 15～30%, drying time 10～15 hours, rubber (soft capsule
Material) moisture Control is 10%～14%；
8, ball is selected
Soft gelatin capsule is laid on lamp inspection desk, abnormity ball, seepage ball, bubble ball, content band impurity ball, big ball, piller
Pick out etc. whole defective soft gelatin capsules；
9, inner packing
Inner packaging material meets YBB00122002 oral stable medicinal polythene bottle with high density, 60 every bottle；
10, outer package: label, mounted box；
11, product inspection；
12, warehouse-in.
Capital equipment used by production is detailed as shown in table 5.
Table 5
| Device name | Specifications and models |
| Material-compound tank | 20030249 |
| Change glue tank | YA04-596 |
| Soft capsule pellet processing machine | RJWJ-11 |
| Colloid mill | RJWJ-84 |
| Temperature control type rustless steel plane glue supply heat-preserving container | 200L |
| Sizing rotating cage | YGJ-11 |
| Soft capsule washing machine | YY0222-1995 |
| Vacuum machine | The bipolar water-circulating pump of 2S-230 |
By workshop thorough disinfection before producing, by thorough for operator's articles for use such as standby working clothing, clothes, mask, glove, boots
Sterilize in the end, by various apparatus, the thorough sterilizing of drum
According to " health food Good Manufacture Practice " and " health food factory formula optimization design and new technology, new technique,
New standard eats handbook " in administration of health related request, relevant in strict accordance with health food GMP of the production environment of this product
Regulation design, for ensureing product quality, key link in strict control production process.Clean area rank is 100,000 grades of purifications, can
To ensure product quality.
The alleviation asthenopia function of the xanthophyll soft capsule preparing the present embodiment detects
I material and method
1.1 samples and placebo: xanthophyll soft capsule 1, No. 2, the two is basic in packaging, outward appearance, color and luster and mouthfeel
Unanimously, one of them is xanthophyll soft capsule, and another is placebo, and people is administered orally every day 2 times, each 1.
1.2 experimenters select
1.2.1 experimenter's mass selection is selected: select long-term eye, the fatigable adult of vision.All meet above-mentioned condition and voluntary
Participate in and ensure that cooperation person all can include test in.
1.2.2 exclusion standard:.
1.2.2.1 do not meet the experimenter including age criterion in；To health food allergy sufferers.
1.2.2.2 favour infectious ocular disease person, eye disease patient inside and outside corneal nebula, circle Phasiana cornea etc..
1.2.2.3 suffer from fundus oculi disease or be associated with the diseases such as cardiovascular, cerebrovascular, liver, kidney, hemopoietic system.
Take the article relevant with tested function the most in a short time, have influence on the judgement person to result.
1.2.2.5 long-term taking other about the treatment medicine of vision or use other Therapeutic Method, fail terminator.
1.2.2.6 do not meet inclusive criteria, take by regulation, or data is congruent affects effect or safety and judge
Person.
1.3 test methods: use two kinds of control design between self and group. according to random, the requirement of double blinding, will meet and include in
Standard also ensures the volunteer of compatibility test, according to symptom, examination of visual acuity situation, considers the factor such as age, sex simultaneously
It is divided into test-meal group and matched group.Test-meal group and matched group take sample or placebo by recommended dose, continuous 45 days.During test
Do not change original dietary habit, normal diet.
2. observation index:
2.1 safety indexes
2.1.1 general physical examination: inquiry experimenter's health condition in detail before test, understand the spirit of experimenter, sleep,
The situation such as diet, defecation, and measure body weight, blood pressure, changes in heart rate, all experimenters are carried out conventional physical examination and necessity
Lab testing.
2.1.2 routine blood test: red blood cell count(RBC), numeration of leukocyte, content of hemoglobin mensuration etc..
2.1.3 routine urinalysis: pH value, leukocyte, glucose in urine etc..
2.1.4 stool for routine: worm's ovum inspection etc..
2.1.5 blood biochemistry index inspection: total serum protein (TP), albumin (ALB), glutamate pyruvate transaminase (ALT), each grass turn
Ammonia enzyme (AST), cholesterol (CHOL), triglyceride (TG), blood urea nitrogen (BUN), creatinine (Cr), blood uric acid (UA), blood glucose (GLU)
Deng mensuration.
2.1.6 electrocardiogram, Abdominal B type ultrasonography, Chest X-rays etc. check.
2.1.7 untoward reaction is observed.
2.2 efficiency index
2.2.1 observation of symptoms: in detail inquiry asthenopia situation, observe ophthalmalgia, with swollen, photophobia, blurred vision, eye dry and astringent etc.
Symptom, adds up integrated value before and after test-meal by mild symptoms multiple integral (serious symptom 3 points, middle disease 2 points, mild 1 point), and changes with regard to its symptom
Kind (arbitrary symptom improves 1 point and above for improving) situation, observe the symptoms improvement rate.
2.2.2 visuognosis persistence test.
2.2.3 distant vision measures.
3. experimental data statistics: data results mean ± standard deviation represents, self pair data uses paired t-test,
Between observation group and matched group on the premise of variance is neat, mean compares employing independent samples t-test, full after otherwise carrying out variables transformations
Foot variance uses t to check the most afterwards, if variance is the most uneven, uses rank test.Improvement rate is enumeration data, can use card side
Inspection, the total number of cases of four fold table is less than 40, or total number of cases equal to or more than 40 but occurs when theoretical value equals to or less than I, uses instead really
Cut probabilistic method.
4. result criterion:
4.1 symptoms are improved: the dry and astringent arbitrary symptom of ophthalmalgia, ophthalmic bloated, photophobia, blurred vision, eye improves 1 point and more than 1 point i.e.
For improving, without deteriorating, 5 kinds of arbitrary improvement of symptom and other symptoms i.e. judge that symptom is improved.
4.2 is effective: symptom is improved and differs by more than equal to 0.l before and after duration of photopic vision, and has aobvious through statistical difference
Work property.
4.3 is invalid: not up to effective standard.
4.4 reference indexs: eyesight improving rate.Improve two behaviors before relatively test after testing with test-meal to improve, add up two groups of clothes
The most effectively sentence not as to alleviation asthenopia function as reference index, reference index by the eyesight improving rate after tested material
Calibration standard.
5. result
Double-blind method is observed end and is made known: taking l person for receiving because of board xanthophyll soft capsule, taking No. 2 persons is placebo
5.1 ordinary circumstances: initial trial crowd's test-meal group 55 example, matched group 55 falls, matched group: male/female is 21/34, year
Age is 46.04 ± 10.57 years old；Test-meal group: male/female is 20/35, the age is 46.13 ± 10:70 year.Experimenter's essence during test-meal
God, sleep, diet, defecation are the most normal.
5.2 safety observations
5.2.1 body weight, blood pressure, heart rate, routine urinalysis, stool normal phase, routine blood test and changes of biochemical indexes situation are shown in Table 1,2.
Edible tested material is after 45 days, and test-meal group and matched group body weight, blood pressure, heart rate are showed no obvious abnormalities change, and routine urinalysis, stool are often
Rule, routine blood test and biochemical indicator all within normal range, prompting receive xanthophyll soft capsule to body health without obvious damage.
Body weight, blood pressure, heart rate, routine urinalysis, stool routine examination, routine blood indexes change before and after table 6 xanthophyll soft capsule test-meal
Situation
Changes of biochemical indexes situation before and after table 7 xanthophyll soft capsule test-meal
5.2.2 electrocardiogram, Abdominal B type ultrasonography, Chest X-rays inspection, all within normal range.
5.2.3 during test-meal, experimenter has no obvious adverse reaction.
53 functional observations
5 31 observation of symptoms:
It is shown in Table 8,9,.Test-meal group ophthalmalgia after test-meal, ophthalmic bloated, photophobia, blurred vision, eye have in the clinical symptoms such as puckery and substantially change
Kind, obvious reduction before its symptom integral and test-meal, difference has significance (P < 0.05), compares with matched group, and difference also has
Significance (P < 0.05).
Symptom integral statistics before and after table 8 xanthophyll soft capsule test-meal
* comparing with matched group, P < 0.05, # compares P < 0.05 with self.
Before and after table 9 xanthophyll soft capsule test-meal, symptom improves situation
5.3.2 curative effect is perceived:
From table 10, after taking tested material 45 days, test-meal group clinical observation total effective rate is 82.35%, with matched group
(19.61%) comparing difference has significance (P < 0.05).
Before and after table 10 xanthophyll soft capsule test-meal, functional observation compares
* compare with matched group, P < 0.05.
5.3.3 the impact on duration of photopic vision
As seen from Table 11, before test-meal group duration of photopic vision is relatively tested after test, improve 0.12, and before self test-meal and compare
After group test, comparing difference all has significance (P < 0.05).
Duration of photopic vision situation before and after table 11 xanthophyll soft capsule test-meal
* comparing with matched group, P < 0.05, # compares with self, P < 0.05.
5.3.4 the impact on vision
From table 12, test-meal group test-meal backsight force level with before test-meal and matched group compares, no significant difference (P ＞
0.05)
Vision condition before and after table 12 xanthophyll soft capsule test-meal
5.4 depigmentation rates
After 45 days test, matched group has 4 example experimenters cannot be judged that effect is screened out because being interrupted to take by test product；Examination
Food group has 4 example experimenters cannot be judged that effect is screened out because being interrupted to take by test product.Last efficiency test crowd's matched group 51 example,
Test-meal group 51 example.It is shown in Table 13.
Depigmentation rate tested by table 13
6 brief summaries
Result of the test shows: receive because board xanthophyll soft capsule is to the clinic such as ophthalmalgia, ophthalmic bloated, photophobia, blurred vision, eye be dry and astringent
Symptom has improvement, after test before test-meal group symptom integral and test-meal and matched group comparing difference has significance (P < 0.05)；Test-meal
Group clinical observation total effective rate is 82.35%, has significance (P < 0.05) with matched group (19.61%) comparing difference；After test
Test-meal group duration of photopic vision improves before 0.12, with self test-meal before relatively testing and after matched group test, comparing difference all has significance
(P<0.05)；Test-meal group test backsight force level with before test-meal and matched group compares, no significant difference (P > 0.05).According to
The judgment criteria of regulation in " health food inspection and assessment technique specification " (version in 2003), prompting xanthophyll soft capsule has slow
Solve the effect of asthenopia function.
Embodiment 2
The xanthophyll soft capsule of the present embodiment is made up of soft capsule material and the content enclosed in soft capsule material, content by
The component composition of following weight portion content:
Soft capsule material includes the component of following weight portion content:
The thickness of soft capsule material is 0.75～0.85mm, and the loading amount of the content of each soft capsule is 500mg.
The preparation method of this xanthophyll soft capsule is substantially the same manner as Example 1, and difference is, the step of the present embodiment
The mix and blend time of 2.2 is 20 minutes.
It is effective that this xanthophyll soft capsule alleviates asthenopia, instant effect, storage stability be good, in good taste, easily swallow and
Preparation method is simple, it is easy to industrialized production.
Embodiment 3
The xanthophyll soft capsule of the present embodiment is made up of soft capsule material and the content enclosed in soft capsule material, content by
The component composition of following weight portion content:
Soft capsule material includes the component of following weight portion content:
Wherein the thickness of soft capsule material is 0.75～0.85mm, and the loading amount of the content of each soft capsule is 500mg.
The preparation method of this xanthophyll soft capsule is substantially the same manner as Example 1, and difference is, the step of the present embodiment
The mix and blend time of 2.2 is 40 minutes.
It is effective that this xanthophyll soft capsule alleviates asthenopia, instant effect, storage stability be good, in good taste, easily swallow and
Preparation method is simple, it is easy to industrialized production.
Embodiment 4
The xanthophyll soft capsule of the present embodiment is made up of soft capsule material and the content enclosed in soft capsule material, content by
The component composition of following weight portion content:
The preparation method of the xanthophyll soft capsule of the present embodiment is substantially the same manner as Example 1, and difference is this enforcement
The proportioning of the content of example is described above.
Embodiment 5
The xanthophyll soft capsule of the present embodiment is made up of soft capsule material and the content enclosed in soft capsule material, content by
The component composition of following weight portion content:
The preparation method of the xanthophyll soft capsule of the present embodiment is substantially the same manner as Example 1, and difference is this enforcement
The proportioning of the content of example is described above.
Claims (10)
1. an xanthophyll soft capsule, this soft capsule is made up of the content in soft capsule material and inclosure soft capsule material, its feature
Being, described content is made up of the component of following weight portion content:
A kind of xanthophyll soft capsule the most according to claim 1, it is characterised in that described content is by following weight portion
The component composition of content:
A kind of xanthophyll soft capsule the most according to claim 1, it is characterised in that described suspensoid is Cera Flava, described
Substrate be soybean oil, described antioxidant is natural Vitamin E.
A kind of xanthophyll soft capsule the most according to claim 1, it is characterised in that described soft capsule material includes following heavy
The component of amount part content:
A kind of xanthophyll soft capsule the most according to claim 4, it is characterised in that described gelatin, plasticizer and pure
The mass ratio of water is 100:35:100.
A kind of xanthophyll soft capsule the most according to claim 4, it is characterised in that described plasticizer is glycerol, described
Opacifier be titanium dioxide, described coloring agent is lemon yellow.
The preparation method of a kind of xanthophyll soft capsule the most according to claim 1, it is characterised in that comprise the following steps:
(1) preparation of content:
(1-1) by proportioning, outstanding mixture and substrate are mixed at a temperature of 60～65 DEG C, make outstanding mixture all be dissolved in substrate,
It is subsequently cooled to 45～50 DEG C,
(1-2) adding phylloxanthin and antioxidant by proportioning, mix and blend 20～40 minutes at a temperature of 55～50 DEG C, in making
Tolerant each material mix homogeneously,
(1-3) colloid mill is used to grind 2～3 times,
(1-4) evacuation, takes off bubble, obtains content；
(2) preparation of soft capsule material glue:
(2-1) pure water and plasticizer are stirred at a temperature of 70～80 DEG C, add gelatin, maintain the temperature at 70～80
DEG C, make gelatin be completely dissolved, put into opacifier and coloring agent and stir, wherein gelatin, plasticizer, pure water, opacifier
It is 100:(30～50 with the mass ratio of coloring agent): 100:(3～5): (0.005～0.015),
(2-2) evacuation, takes off bubble,
(2-3) use 100 mesh sock filtration, then at a temperature of 45～55 DEG C, stand 2～5 hours, obtain soft capsule material glue
Liquid；
(3) content and soft capsule material glue are pressed into soft gelatin capsule in pellet processing machine, be then passed through sizing, wash ball, be dried, obtain
Xanthophyll soft capsule.
The preparation method of a kind of xanthophyll soft capsule the most according to claim 7, it is characterised in that described step (1-
2) the mix and blend time in is 30 minutes.
The preparation method of a kind of xanthophyll soft capsule the most according to claim 7, it is characterised in that described step (3)
In sizing use sizing rotating cage in process the method for 2 hours.
A kind of xanthophyll soft capsule the most according to claim 1, it is characterised in that the thickness of described soft capsule material is
0.75～0.85mm, the loading amount of the content of each soft capsule is 500mg.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106723031A (en) * | 2016-12-12 | 2017-05-31 | 宁夏沃福百瑞枸杞产业股份有限公司 | Matrimony vine zeaxanthin, lutein, the preparation method of vitamin E soft capsule |
| CN108851063A (en) * | 2018-08-03 | 2018-11-23 | 汤臣倍健股份有限公司 | A kind of Co-Q10 natural vitamin E soft capsule and preparation method thereof |
| CN108991364A (en) * | 2018-08-29 | 2018-12-14 | 广州加原医药科技有限公司 | A kind of black pine novel foodstuff and preparation method thereof |
-
2016
- 2016-04-28 CN CN201610273346.8A patent/CN106036882A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106723031A (en) * | 2016-12-12 | 2017-05-31 | 宁夏沃福百瑞枸杞产业股份有限公司 | Matrimony vine zeaxanthin, lutein, the preparation method of vitamin E soft capsule |
| CN108851063A (en) * | 2018-08-03 | 2018-11-23 | 汤臣倍健股份有限公司 | A kind of Co-Q10 natural vitamin E soft capsule and preparation method thereof |
| CN108991364A (en) * | 2018-08-29 | 2018-12-14 | 广州加原医药科技有限公司 | A kind of black pine novel foodstuff and preparation method thereof |
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Application publication date: 20161026 |