CN109619587A - A kind of Black Box Tracing preparation and preparation method thereof with efficacy of relieving visual fatigue - Google Patents
A kind of Black Box Tracing preparation and preparation method thereof with efficacy of relieving visual fatigue Download PDFInfo
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- CN109619587A CN109619587A CN201910068464.9A CN201910068464A CN109619587A CN 109619587 A CN109619587 A CN 109619587A CN 201910068464 A CN201910068464 A CN 201910068464A CN 109619587 A CN109619587 A CN 109619587A
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- black box
- preparation
- extract
- box tracing
- visual fatigue
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- 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
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Botany (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention provides a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue, comprising: 120-180g Black Box Tracing extract, 10-150g plant extracts, 10-50g lutein, 340-425g vegetable oil, 20g beeswax.The plant extracts is selected from grape seed extract, blueberry extract, fructus lycii and lifts object, chrysanthemum extract, mulberries extract, olive extract；The vegetable oil is selected from peony seed oil, soybean oil, Seabuckthorm Seed Oil.The present invention also provides the preparation methods of the Black Box Tracing.Raw material of the present invention, simple process can cover bad mouthfeel, alleviate visual fatigue significant effect and be suitable for proprietary soft capsule and preparation method thereof, can effectively solve the problems, such as asthenopia person.
Description
Technical field
The present invention relates to technical field of health care food, and in particular to a kind of black fruit gland rib flower with efficacy of relieving visual fatigue
Chinese catalpa preparation and preparation method thereof.
Background technique
As social environment changes, video terminal is universal and work rhythm is accelerated, and vision is using remote excess load, increasingly
More people starts to complain that visual fatigues symptom, the ranges of visual fatigue crowd such as dry and astringent eyes, distending pain and blurred vision constantly expand
Greatly.It is shown according to the data of China Internet Network Information Center, Chinese netizen's scale alreadys exceed 600,000,000；The U.S. at least 14%~
23% computer user suffers from computer vision syndrome in various degree, in Japan, India and Norway, this data difference
Reach 19.6%, 46.3% and 62.5%.The implementation of especially current 3D game, is easier to cause visual fatigue, some researches show that swimming
When the player that plays plays 3D game, 72% people has just felt fatigue in 15min, and after 45min, the people to feel fatigue reaches 100%.It is high
There are visual fatigue related symptoms researches show that 57% college student is surveyed certainly by scientific and technological industry field correlation practitioner.The whole world 90%
Computer user has the visual fatigues symptom such as dry and astringent eyes, ghost image, headache.It can thus be seen that the health care of visual fatigue can be alleviated
Product scope has huge crowd demand and the market space.
The product of visual fatigue is treated on domestic market mainly to improve ocular accommodation drug, artificial tears, ciliary
Flesh is newly benumbed based on drug, Chinese medicine etc., there are also the eye drops containing calf blood protein-removed extraction, the eye drops containing vitamins
Etc..
There are many patent for alleviating visual fatigue, but the product of Sorbus alnifloria is also fewer in the black fruit gland in relation to alleviating visual fatigue.
Aronia melanocarpa is a kind of emerging berry that China is introduced from foreign countries in recent years, is rich in anthocyanidin, flavones, polyphenol in fresh fruit
Substance, content are 80 to 180 times of grape, and 20 to 40 times of Cranberry, be 5 times of blueberry；Research shows that being rich in cyanine
Plain substance has the function of alleviating visual fatigue.It is all rich in that grape seed extract, blueberry extract, fructus lycii lift object etc.
Anthocyan substance.As grape seed extract be cannot be synthesized in a kind of human body extracted from grape seeds it is new and effective natural
Substance is one of big best selling variety of U.S.'s natural plants ten.In foreign countries, it is added in beverage and wine and various general extensively
In logical food such as cake, cheese, meets the requirement of people's back to nature, improve the safety of food.Lutein main source
It is not only safe in the natural plants such as marigold, but also there is excellent physiological function, it is easily absorbed by the body.Peony seed oil,
Unsaturated fatty acid rich in, linolenic acid, nutritive value are very high in the greases such as soybean oil, Seabuckthorm Seed Oil.
Summary of the invention
Country's Aronia melanocarpa correlative study at present is more external few very much, and the product of correlation processing is also seldom.It enriches black
Fruit gland rib flower, which seizes product category, can promote the development of Aronia melanocarpa related industry, and Aronia melanocarpa extract can be with
The utilization rate of Aronia melanocarpa is improved, production cost is reduced.Aronia melanocarpa soft capsule, that is, instant edible can be alleviated again
Visual fatigue is one good direction of Aronia melanocarpa product development.Therefore, for the needs of eyesight fatiguability crowd, choosing
It is raw material with Black Box Tracing extract, plant extracts, lutein, vegetable oil, has developed to have and alleviate visual fatigue function
A kind of Black Box Tracing preparation with efficacy of relieving visual fatigue of energy facilitates the life matter for improving eyesight fatiguability crowd
Amount.
Technical problem to be solved by the present invention lies in overcoming, existing alleviation visual fatigue product effect is significant, complex process
The shortcomings that, a kind of raw material, simple process are provided, bad mouthfeel can be covered, alleviate visual fatigue significant effect and be suitable for institute
Soft capsule of someone and preparation method thereof can effectively solve the problems, such as asthenopia person.
Black Box Tracing soft capsule used by above-mentioned technical problem is solved by the raw material system of following percent mass proportionings
At:
Medical fluid:
Black Box Tracing extract 120-180g
Plant extracts 10-150g
Lutein 10-50g
Vegetable oil 340-425g
Beeswax 20g
Softgel shell:
Gelatin 180g
Glycerol 72g
Purified water 180g
Pigment 4.5g
1000 (0.6g/) are made altogether
Black Box Tracing soft capsule of the invention is preferably made of the raw material of following percent mass proportionings:
Medical fluid:
Black Box Tracing extract 150-160g
Plant extracts 50-100g
Lutein 15-18g
Vegetable oil 375-385g
Beeswax 20g
Softgel shell:
Gelatin 180g
Glycerol 72g
Purified water 180g
Pigment 4.5g
1000 (0.6g/) are made altogether
Above-mentioned plant extracts be grape seed extract, blueberry extract, fructus lycii lift object, chrysanthemum extract, mulberries extract,
One of olive extract is a variety of.
Above-mentioned lutein is one of xanthophyll-oil suspension or lutein powder or a variety of.
Above-mentioned vegetable oil is one of peony seed oil, soybean oil, Seabuckthorm Seed Oil or a variety of.
Above-mentioned pigment is one of burnt sugar coloring, red ferric oxide or a variety of.
The preparation method of Black Box Tracing soft capsule of the present invention is made of following step:
1. matching glue
Gelatin, glycerol, purified water are weighed by formula rate, 65 DEG C~75 DEG C are heated in being placed in glue tank, is melted completely to gelatin
Change, stir evenly, be added pigment continue to stir, stir evenly, 100 mesh nylon screens filtering, filtrate vacuumize (- 0.07~-
It 0.08Mpa) deaerates, 50~55 DEG C of heat preservations are spare.
2. ingredient
It takes vegetable oil, beeswax to be added in material-compound tank, is heated to 70 DEG C, beeswax is made to melt and stir evenly, 35 are down to temperature~
Black Box Tracing extract, plant extracts, lutein are added at 40 DEG C, stirs 20~30min, stirs evenly, crosses colloid
Mill grinding 2 times, 120 mesh screens vacuumize (- 0.07~-0.08Mpa) degassing, and 35~40 DEG C of heat preservations are spare.
3. pelleting
Medical fluid and glue are placed in soft capsule pellet press batch can respectively, 20~24 DEG C of room temperature of control, relative humidity 30%~
40%, 8~12 DEG C of head supply air temperature, 50~55 DEG C of glue box temperature, 40~47 DEG C of nozzle temperature, rubber 0.7~0.9mm of thickness,
The soft capsule of every 0.5g is made.
4. sizing
Molding soft capsule be formed in rolling cage 8~12 hours (22~25 DEG C of temperature, relative humidity 30%~40%) sizing.
5. washing ball
Ball is washed with 95% ethyl alcohol after sizing.
6. dry
Set the drying 12~24 hours of (25~28 DEG C of temperature, relative humidity 20%~30%) of drying room；
7. selecting ball
Soft capsule after drying is selected ball, removes the failures such as special-shaped ball, leakage ball, especially big ball, special piller.
The invention has the benefit that
1, the present invention uses Black Box Tracing extract, plant extracts, lutein, vegetable oil to have for raw material exploitation and alleviates
The soft capsule of visual fatigue.
2, product of the present invention has significant alleviation visual fatigue effect, and in good taste, there is no safety problems for long-term consumption.
Specific embodiment
Below with reference to embodiment, the present invention is described in more detail, but protection scope of the present invention is not limited only to these realities
Apply example.
Embodiment 1
1. matching glue
Gelatin, glycerol, purified water are weighed by formula rate, 65 DEG C is heated in being placed in glue tank, melts completely to gelatin, is stirred
Uniformly, red ferric oxide 4.5g is added to continue to stir, stirs evenly, the filtering of 100 mesh nylon screens, it is de- that filtrate vacuumizes -0.07Mpa
Gas, 50 DEG C of heat preservations are spare.
2. ingredient
It takes peony seed oil 385g, beeswax 20g to be added in material-compound tank, is heated to 70 DEG C, so that beeswax is melted and is stirred evenly, to temperature
Black Box Tracing extract 160g, grape seed extract 50g, xanthophyll-oil suspension 15g, stirring are added when being down to 35 DEG C
30min is stirred evenly, and is crossed colloid mill and is ground 2 times, 120 mesh screens, vacuumizes -0.07Mpa degassing, and 35 DEG C of heat preservations are spare.
3. pelleting
Medical fluid and glue are placed in soft capsule pellet press batch can respectively, 20 DEG C of room temperature of control, relative humidity 30%, head
8 DEG C of supply air temperature, glue box temperature 50 C, 40 DEG C of nozzle temperature, the soft capsule of every 0.5g is made in rubber thickness 0.7mm.
4. sizing
Molding soft capsule be formed in rolling cage 8 hours (22 DEG C of temperature, relative humidity 30%) sizing.
5. washing ball
Ball is washed with 95% ethyl alcohol after sizing.
6. dry
Set the drying 12~24 hours of (25 DEG C of temperature, relative humidity 20%) of drying room；
7. selecting ball
Soft capsule after drying is selected ball, removes the failures such as special-shaped ball, leakage ball, especially big ball, special piller.
Embodiment 2
1. matching glue
Gelatin, glycerol, purified water are weighed by formula rate, 75 DEG C is heated in being placed in glue tank, melts completely to gelatin, is stirred
Uniformly, burnt sugar coloring 4.5g is added to continue to stir, stirs evenly, 100 mesh nylon screens filtering, filtrate vacuumizes (- 0.075Mpa)
Degassing, 52 DEG C of heat preservations are spare.
2. ingredient
It takes Seabuckthorm Seed Oil and the total 375g of soybean oil, beeswax 20g to be added in material-compound tank, is heated to 70 DEG C, beeswax is made to melt and stir
Uniformly, Black Box Tracing extract 150g, blueberry extract 50g, grape seed extract are added when temperature is down to 37 DEG C
50g, lutein powder 18g stir 30min, stir evenly, and cross colloid mill and grind 2 times, 120 mesh screens, vacuumize (-
It 0.075Mpa) deaerates, 37 DEG C of heat preservations are spare.
3. pelleting
Medical fluid and glue are placed in soft capsule pellet press batch can respectively, control 22 DEG C of room temperature, relative humidity 35, head is sent
10 DEG C of air temperature, 52 DEG C of glue box temperature, 44 DEG C of nozzle temperature, the soft capsule of every 0.5g is made in rubber thickness 0.8mm.
4. sizing
Molding soft capsule be formed in rolling cage 10 hours (23 DEG C of temperature, relative humidity 35) sizing.
5. washing ball
Ball is washed with 95% ethyl alcohol after sizing.
6. dry
Set the drying 18 hours of (26 DEG C of temperature, relative humidity 25) of drying room；
7. selecting ball
Soft capsule after drying is selected ball, removes the failures such as special-shaped ball, leakage ball, especially big ball, special piller.
Embodiment 3
1. matching glue
Gelatin, glycerol, purified water are weighed by formula rate, 65 DEG C is heated in being placed in glue tank, melts completely to gelatin, is stirred
Uniformly, red ferric oxide 4.5g is added to continue to stir, stirs evenly, the filtering of 100 mesh nylon screens, it is de- that filtrate vacuumizes -0.08Mp
Gas, 55 DEG C of heat preservations are spare.
2. ingredient
It takes peony seed oil and soybean oil 395g, beeswax 20g to be added in material-compound tank, is heated to 70 DEG C, melt beeswax and stir
It is even, when temperature is down to 40 DEG C be added Black Box Tracing extract 150g, grape seed extract 15g, wolfberry fruit extract 25g,
Xanthophyll-oil suspension 15g stirs 20min, stirs evenly, and crosses colloid mill and grinds 2 times, 120 mesh screens vacuumize -0.08Mpa
Degassing, 40 DEG C of heat preservations are spare.
3. pelleting
Medical fluid and glue are placed in soft capsule pellet press batch can respectively, 24 DEG C of room temperature of control, relative humidity 40%, head
12 DEG C of supply air temperature, 55 DEG C of glue box temperature, 47 DEG C of nozzle temperature, the soft capsule of every 0.5g is made in rubber thickness 0.9mm.
4. sizing
Molding soft capsule be formed in rolling cage 12 hours (25 DEG C of temperature, relative humidity 40%) sizing.
5. washing ball
Ball is washed with 95% ethyl alcohol after sizing.
6. dry
Set the drying 24 hours of (28 DEG C of temperature, relative humidity 30%) of drying room；
7. selecting ball
Soft capsule after drying is selected ball, removes the failures such as special-shaped ball, leakage ball, especially big ball, special piller.
Embodiment 4
Preparation process is the same as embodiment 1, peony seed oil 340g, beeswax 20g, Black Box Tracing extract 120g, mulberries extract
20g, chrysanthemum extract 20g, xanthophyll-oil suspension 10g.
Embodiment 5
Preparation process is the same as embodiment 1, peony seed oil 425g, beeswax 20g, Black Box Tracing extract 180g, olive extract
8g, chrysanthemum extract 2g, xanthophyll-oil suspension 50g.
Evaluate example 1
Experimental animal: healthy SD rat, 200 ± 20g of weight, male and female dual-purpose, slit-lamp microscope, funduscopy anterior ocular segment and
Eyeground is without exception can be used to test.With age in days rat, the experiment condition in animal house environment is fed 2 weeks for selection before rat test,
20 DEG C ~ 25 DEG C of temperature, relative humidity 40% ~ 80%.
Xerophthalmia rat modeling: 0.6mg/0.1mL scopolamine hydrobromide alternately is injected in rat double lower limb, 4 times a day
(respectively morning 8:00 and 11:00, afternoon 2:00 and 5:00, each 0.5ml), and rat is placed in homemade ventilation device
In, convective wind 12h is continuously blown daily, continuous 14 days, xerophthalmia model is prepared with completion, rat is placed in two wind by ventilation device
Free convection wind is blown between fan.
Grouping and administration: choosing 8 week old rat 80, and half male and half female is divided into 8 groups at random: blank group, model group, implementation
1 group of example, 2 groups of embodiment, 3 groups of embodiment, 4 groups of embodiment, 5 groups of embodiment, positive controls.In daily fixed time period with medicine
Liquid ingredient stomach-filling medicine feed, stomach-filling amount 2ml/200g weight, blank group, model group are filled with isometric physiological saline, positive controls
Using commercially available lutein multidimensional soft capsule medicinal liquid ingredient (lutein content 8%), continuous gavage 30 days.
Lacrimal secretion measurement: animal subject left/right eye is randomly selected, every group or so fifty-fifty.It is 35mm × 2mm by length and width
The experiment of size filter paper item is placed on the inside of palpebra inferior in conjunctival sac, filter paper is immersed in record 5 minutes away from bending at the 3mm of one end
Wet length.
Breakup time of tear film measurement: eyes not tested in animal subject lacrimal secretion measurement experiment, every eye are chosen
Eyeball instills 2% Fluress one drop, is closed eyelid, fluorescein is allowed to be uniformly distributed in anterior corneal surface, then opens eye up and down
Eyelid, sufficiently exposes cornea, while timing, with slit-lamp bore blue light observe and record first breakdown point occurred in tear film when
Between.
Test result is shown in Table 1:
Note: it is compared with model group, P < 0.01 * P < 0.05, * *；#P < 0.05, ##P < 0.01 are compared with positive controls
Model group and blank group contrast difference highly significant (P < 0.01), rat lacrimal secretion reduces, breakup time of tear film increases
Add, illustrates modeling success.With the progress of experiment, model group rats lacrimal secretion and breakup time of tear film are restored,
But it is compared with blank group, difference still highly significant (P < 0.01).1 ~ 5 group of embodiment and positive controls contrast model group difference
Highly significant (P < 0.01) illustrates secretory volume and breakup time of tear film that tear is increased after rat medication, is conducive to alleviate eye
Portion's fatigue.1 ~ 4 group of embodiment has differences compared with positive controls, has statistical significance (P < 0.05), illustrates the present invention
Good product effect is in commercially available lutein multidimensional soft capsule.Example 1 group, 2 groups of embodiment and positive controls difference highly significant
(P < 0.01).
Evaluate example 2
After tear film rupture test, continues to feed rat 6 days, take 36 days rats of stomach-filling, after last dose 16h, 0.3ml/
10% chloraldurate solution intraperitoneal injection of anesthesia of 100g, the blood sampling of abdominal cavity abdominal aorta are put to death, and take out Binocular vison in ice environment rapidly
Nethike embrane, with filter paper suck dry moisture, precise weighing.Be added pH=7.3 PBS buffer solution be made 3% retina homogenate, 2500rpm from
The heart (4 DEG C) 15min, takes supernatant to be homogenized, strictly by superoxide dismutase in ELISA kit specification instruction measurement retina
The content of enzyme (SOD), malonaldehyde (MDA).
Test result is shown in Table 2:
Note: it is compared with model group, P < 0.01 * P < 0.05, * *；#P < 0.05, ##P < 0.01 are compared with positive controls
Blank group rat is normal rat, is contained with the decline of SOD content, MDA in rat retina after model group comparison display modeling
Amount rises, result difference highly significant (P < 0.01).1 ~ 5 group of embodiment and positive controls are compared with model group, retina
Middle SOD content is increased, MDA content declines, and as a result has otherness (P < 0.05).1 ~ 5 group of embodiment and positive control
Group compares, and 1 ~ 4 group of result of embodiment has otherness (P < 0.05), illustrates that effect is better than positive controls；5 groups of embodiment and sun
Property control group result do not have otherness.
Evaluate example 3
Experimental animal: healthy SD rat, 200 ± 20g of weight, male and female dual-purpose, slit-lamp microscope, funduscopy anterior ocular segment and
Eyeground is without exception can be used to test.With age in days rat, the experiment condition in animal house environment is fed 2 weeks for selection before rat test,
20 DEG C ~ 25 DEG C of temperature, relative humidity 40% ~ 80%.
Intraocular hypertension rat modeling: it irons and closes 3 episcleral veins of rat right eye.1.5ml/kg weight is pressed with 3% yellow Jackets
Left lower extremity intraperitoneal injection of anesthesia, while the cacaine angle conjunctival surface for giving 1% to right eye is anaesthetized, fixed rat.In right upper lid midpoint away from
Forward line is drawn at 1 ~ 2mm of margo palpebrae, and along top, corneoscleral junction cuts off bulbar conjunctiva, and blunt separation fascia exposes episcleral vein, gently
It by vein separation and burns to iron and closes, reduce the influence to sclera to the greatest extent.It examines: nearly corneosclera rim segment blood vessel anger, remote corneosclera
Rim segment blood flow disappears, while not having bleeding, illustrates to iron and closes success.Post surgery treatment: with the not damaged medical forward line interrupted suture knot of 8-0
Film, art eye apply aureomycin eye cream, put back in cage after rat revival, hereafter with 0.25% Chloroptic eye drip, 2 times/day, connect
Continuous medication 6 days, measure rat intraocular pressure.Left eye compares group and is not processed.
Grouping and administration: choosing 8 week old rat 70, and half male and half female is divided into 7 groups at random: model group, example 1 group,
2 groups of embodiment, 3 groups of embodiment, 4 groups of embodiment, 5 groups of embodiment, positive controls.In daily fixed time period with medicine liquid ingredient
Stomach-filling medicine feed, stomach-filling amount 2ml/200g weight, model group are filled with isometric physiological saline, and positive controls use commercially available lutein
Multidimensional soft capsule medicinal liquid ingredient (lutein content 8%), continuous gavage 3 months.
Intraocular pressure determination: after 1% cacaine angle conjunctival surface anesthesia, with pen type tonometer again daily same time (morning 9:
00, afternoon 2:00,5:00) measure, every time measurement 3 times, be averaged the measurement intraocular pressure as the same day.
Test result is shown in Table 3, table 4, table 5:
Note: it is compared with model group, P < 0.01 * P < 0.05, * *；#P < 0.05, ##P < 0.01 are compared with positive controls
Note: it is compared with model group, P < 0.01 * P < 0.05, * *；#P < 0.05, ##P < 0.01 are compared with positive controls
The results show that compared with model group, 1 ~ 5 group of embodiment and positive controls to rat intraocular pressure have reduction effect (P <
0.05), wherein 1 ~ 3 group of difference highly significant (P < 0.01) of embodiment.Compare rat right and left eyes pressure difference, 1 ~ 5 group of difference of embodiment
Property highly significant (P < 0.01), illustrates the high intraocular pressure for effectively reducing operated rats.1 ~ 3 group of comparison positive controls of embodiment
Effect highly significant (P < 0.01) illustrates the effect of improving lutein after dosage contents compatibility.
Evaluate example 4
In order to prove safe and effective effect of the invention, inventor has carried out safety toxicology test and human feeding trial.
Specific test result is as follows:
One, Safety and toxicology is tested:
1. rat acute toxicity test: " Black Box Tracing soft capsule " is with maximum tolerated dose (MTD) 20.0g/kg.BW's
After (500 times that are equivalent to human body recommended amounts) dosage gives rat oral gavage, have no that animal has obvious poisoning symptom, no animal is dead
It dies, animal is dissected in off-test, and gross examination of skeletal muscle is shown no obvious abnormalities, according to acute toxicity grading criteria, rat acute toxicity category
Nontoxic grade.
2. three genetic toxicity tests: " Black Box Tracing soft capsule " Salmonella reversion test, mouse marrow cell micro nuclear test,
Mouse inbred strain, result are feminine gender.
3.30 days feeding trials: " Black Box Tracing soft capsule " is set into 4.0,2.0, tri- dosage groups of 1.0g/kg.BW (difference
It is equivalent to human body and recommends 100,50,25 times of dosage), separately set solvent control group.Rat continuous gavage 30 days, animal was raw during test
Length physically well develops, the weight of animals of each dosage group, food-intake, food utilization, hematological indices, blood biochemical analysis index, dirty
Device weight in wet base and internal organs/weight ratio are compared with solvent control group, and there are no significant for difference (P > 0.05)；Gross anatomy observation and group
It knits pathological examination and has no abnormal change related with given the test agent.Have no the given the test agent to rat within the scope of study dosage
Every observation index generates toxic side effect.
Two, human trial:
Meet asthenopia crowd 114 that this tests tested inclusion criteria (test-meal group 57, male 22, female 35, control group
57, male 23, female 34), wherein test-meal group continuously takes Black Box Tracing soft capsule 60 days, and control group, which is given, comforts
Agent, under the premise of between at the moment without significant change, the duration of photopic vision of test-meal group subject averagely increases 11.02% after test-meal,
Itself compare before and after test-meal, difference has conspicuousness (P < 0.01)；The duration of photopic vision of subject compares between two groups after test-meal, test-meal
Group is apparently higher than control group (P < 0.01), and the duration of photopic vision before and after control group subject's test-meal is without significant change；After test-meal
Test-meal group subject's eye is swollen, eye is ached, blurred vision, foreign body sensation, shed tears, the symptom of general malaise relevant to visual fatigue improves
Effective percentage is apparently higher than control group, and test-meal group subject symptom, which improves efficient difference compared with the control group, after test-meal conspicuousness
(P < 0.01)；Symptom total mark before and after test-meal group test-meal itself compares, and difference has conspicuousness (P < 0.01), and control group test-meal
The symptom total mark of front and back is without significant change；Two groups of symptom total mark compares after test-meal, test-meal group significantly lower than control group (P <
0.01)；Compared with the control group, no conspicuousness is poor for test-meal group subject left vision improvement rate and right vision improvement rate after test-meal
Different (P > 0.05).Before and after test-meal, the white egg of red blood cell, leucocyte, hemoglobin, blood platelet, total serum protein, serum of subject
White, glutamic-oxalacetic transaminease, glutamic-pyruvic transaminase, creatinine, urea nitrogen, total cholesterol, triglycerides, blood glucose and routine urinalysis, stool routine examination,
Electrocardiogram, fluoroscopy of chest and abdominal B-scan ultrasonography etc. are every to be checked in normal range (NR), illustrates this product to subject's health without bad
It influences.Allergy and other adverse reactions are not observed during test-meal.Medicine prison guarantorization [2012] 107-is eaten according to state to alleviate
Visual fatigue function evaluation methods can determine that Black Box Tracing soft capsule has the function of alleviating visual fatigue.
Claims (7)
1. a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue, which is characterized in that quality formula includes:
Black Box Tracing extract 120-180g
Plant extracts 10-150g
Lutein 10-50g
Vegetable oil 340-425g
Beeswax 20g.
2. a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue according to claim 1, which is characterized in that
The plant extracts is that grape seed extract, blueberry extract, fructus lycii lift object, chrysanthemum extract, mulberries extract, olive
One of extract is a variety of.
3. a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue according to claim 1, which is characterized in that
The lutein is one of xanthophyll-oil suspension or lutein powder or a variety of.
4. a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue according to claim 1, which is characterized in that
The vegetable oil is one of peony seed oil, soybean oil, Seabuckthorm Seed Oil or a variety of.
5. a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue according to claim 1, which is characterized in that
Preferably quality formula includes:
Black Box Tracing extract 150-160g
Plant extracts 50-100g
Lutein 15-18g
Vegetable oil 375-385g
Beeswax 20g.
6. a kind of preparation method of the Black Box Tracing preparation with efficacy of relieving visual fatigue, which is characterized in that including following
Step:
Vegetable oil, beeswax is taken to be added in material-compound tank, heating makes beeswax melt and stir evenly, and adds when temperature is down to 35~40 DEG C
Entering Black Box Tracing extract, plant extracts, lutein, stir evenly, crosses colloid mill grinding, filtering vacuumizes degassing,
It is spare, obtain a kind of Black Box Tracing preparation with efficacy of relieving visual fatigue.
7. a kind of preparation method of Black Box Tracing preparation with efficacy of relieving visual fatigue according to claim 6,
It is characterized in that, specific steps include:
1) gelatin, glycerol, purified water are taken, is heated to 65~75 DEG C in being placed in glue tank, melts completely to gelatin, stirs evenly,
Pigment is added to continue to stir, stirs evenly, filters, filtrate vacuumizes degassing, and 50~55 DEG C of heat preservations are spare；
2) it takes vegetable oil, beeswax to be added in material-compound tank, is heated to 70 DEG C, beeswax is made to melt and stir evenly, be down to 35 to temperature
Black Box Tracing extract, plant extracts, lutein are added at~40 DEG C, stirs 20~30min, stirs evenly, crosses glue
Body mill grinding 2 times, 120 mesh screens vacuumize degassing, and 35~40 DEG C of heat preservations are spare；
3) medical fluid and glue are placed in soft capsule pellet press batch can respectively, the soft capsule of every 0.5g is made, by being formed, wash
It is complete, dry, select ball, obtain a kind of Black Box Tracing soft capsule with efficacy of relieving visual fatigue.
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| WO2024115646A1 (en) * | 2022-12-01 | 2024-06-06 | Bioactor Bv | Non-therapeutic use of an aronia berry extract |
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| CN107951955A (en) * | 2017-12-29 | 2018-04-24 | 西安交通大学 | A kind of compound for alleviating asthenopia |
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| CN101856118A (en) * | 2010-03-23 | 2010-10-13 | 无锡市天赐康生物科技有限公司 | Health-care food for relieving asthenopia and preparation method thereof |
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