CN102960738A - Bilberry and lutein soft capsule and preparation method thereof - Google Patents
Bilberry and lutein soft capsule and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a bilberry and lutein soft capsule, which aims to overcome the defects that a number of oral medicaments and eye drops taking lutein as a main ingredient for easing visual fatigue on the market are difficult to bring the efficacy of the lutein into full play due to unreasonable compatibility and can not fulfill the effect of easing the visual fatigue. The bilberry and lutein soft capsule comprises contents and glue liquor, wherein the contents are prepared from the following auxiliary materials in parts by weight: 70-88 parts of bilberry extracts, 36-45 parts of lutein ester, 8-12 parts of natural beta-carotene oil, 0.9-1.2 part(s) of natural vitamin E, 23-28 parts of beeswax and 320-380 parts of soybean oil. The invention further relates to a preparation method of the bilberry and lutein soft capsule. The bilberry and lutein soft capsule disclosed by the invention can bring the effects of the lutein into full play, becomes effective at a high speed, does not bounce in effect, has the advantages of being capable of consolidating curative effects, lasting in action and the like, and is widely suitable for treatment on functional visual fatigue and symptomatic visual fatigue, and in particular suitable for patients with the visual fatigue caused by long-term overuse of the eyes.
Description
Technical field
The present invention relates to a kind of compound functional health product of effectively alleviating asthenopia, particularly a kind of cowberry xanthophyll soft capsule and preparation method thereof.
Background technology
Along with social competition is day by day fierce, the pressure of entering a higher school and obtaining employment is usually so that people's excess eye-using, increasing people because of excess load with causing visual fatigue.Visual fatigue is divided into functional visual fatigue and symptomatic visual fatigue, and wherein functional visual fatigue is without organic disease, refers to the long-term overstretched activity of the organs of vision and surpasses its compensatory capacity, a kind of pathology of the eye that causes and whole body; Symptomatic visual fatigue refers to the eye organ pathology that caused by other diseases.The symptoms such as eyes are dry and astringent, acid is swollen, pain can appear in the visual fatigue initial stage, and then dim eyesight, drowsiness, the dimness of vision, visual impairment appear, severe patient can be felt numb limb, has a pain in the back, katzeniammer, the tired whole body chronic disease such as weak, visual fatigue also can cause early ageing and immunity degradation simultaneously, has had a strong impact on normal working and learning.
Many medicinal preparation for oral administration and eye drops take lutein as the main component alleviating asthenopia occurred on the market now, yet because its component compatibility is unreasonable, made it be difficult to bring into play the due effect of lutein, fundamentally alleviating asthenopia.
Summary of the invention
The technical problem to be solved in the present invention is the defects that how to overcome prior art, a kind of effectively alleviating asthenopia is provided, and the old and feeble long sight presbyopic that causes of degenerating of the organs of vision is had cowberry xanthophyll soft capsule of certain result for the treatment of and preparation method thereof.
Solve the problems of the technologies described above, this cowberry xanthophyll soft capsule comprises content and glue, the preparation of weight portion shown in wherein content is pressed by following supplementary material:
Whortle extract-70-88 lutein ester-36-45
Natural beta-carotin oil-8-12 natural VE-0.9-1.2
Beeswax-23-28 soybean oil-320-380.
So design, cooperate lutein ester, natural beta-carotin oil as active ingredient take the whortle extract, be equipped with natural VE, beeswax, soybean oil, the effect of lutein is given full play to, and the stability of raising pharmacy effect, it is easily absorbed by body, thereby at utmost bring into play drug effect.
As optimization, the preparation of weight portion shown in the glue of described capsule is pressed by following supplementary material:
Gelatin-170-220 glycerine-78-93
Pure water-156-190 caramel colorant-10-13.
The preparation method of this cowberry xanthophyll soft capsule may further comprise the steps:
1) preparation of glue:
Formula ratio by the glue of aforementioned capsule takes by weighing gelatin, glycerine, purified water and burnt sugar coloring; With glycerine, purified water inputization glue tank, be heated to 70～80 ℃ first, drop into again gelatin, insulated and stirred 40～70 minutes, add burnt sugar coloring, stirred 5-15 minute, vacuumize 10 ~ 40 minutes, detect the glue viscosity at 2.0～2.5 ten thousand mPa.s, filter the filtrate stand for standby use with 100 eye mesh screens;
2) preparation of content:
Formula ratio by aforementioned content takes by weighing whortle extract, lutein ester, natural beta-carotin oil, natural VE, beeswax, soybean oil; 50% soybean oil is added in the material-compound tank, stir, heat and after 70-80 ℃, add the beeswax dissolving, after beeswax all dissolved, the soybean oil that adds whortle extract, lutein ester, natural beta-carotin oil, natural VE and residue recipe quantity stirred stir about 20-35 minute, be cooled to about 45-55 ℃, enable grinder and grind, remove the content bubble with the filtration of 80-100 eye mesh screen and with vacuum machine, get content;
3) pelleting, typing:
Content, glue are pressed into soft capsule in pellet press, rubber thickness is 0.66～0.72mm, and loading amount is the 500mg/ grain; The soft capsule that presses was finalized the design 2.5～3.5 hours under the condition of 18～25 ℃ of temperature, relative humidity≤35%;
4) drying:
The soft capsule of typing evenly is laid in the drying tray, and 18～25 ℃ of temperature, under the condition of relative humidity≤30%, dried ball moisture 10.0～14.0% is controlled in aeration-drying more than 22 hours.
Cowberry xanthophyll soft capsule of the present invention is by the reasonable compatibility of each component, make the performance of lutein, Bilberry fruit P.E should be powerful, and make cowberry xanthophyll soft capsule onset speed fast, effect does not rebound, has simultaneously efficacy consolidation, act on the advantages such as lasting, be widely used in treating functional visual fatigue and symptomatic visual fatigue, be particularly useful for using because of the visual fatigue patient that long-term excess eye-using causes.
The specific embodiment
Embodiment 1: the preparation of this cowberry xanthophyll soft capsule may further comprise the steps:
1) preparation of glue:
Take by weighing respectively 170kg gelatin, 93kg glycerine, 190kg purified water and 11.75kg caramel colorant; With glycerine, purified water inputization glue tank, be heated to 70～80 ℃ first, drop into again gelatin, insulated and stirred 40～70 minutes, add burnt sugar coloring, stirred 5-15 minute, vacuumize 10 ~ 40 minutes, detect the glue viscosity at 2.0～2.5 ten thousand mPa.s, filter the filtrate stand for standby use with 100 eye mesh screens;
2) preparation of content:
Take by weighing respectively 70kg whortle extract, 40kg lutein ester, 10kg natural beta-carotin oil, 0.9kg natural VE, 28kg beeswax, 344kg soybean oil; The 172kg soybean oil is added in the material-compound tank, stir, heat and after 70-80 ℃, add the beeswax dissolving, after beeswax all dissolves, add whortle extract, lutein ester, natural beta-carotin oil, natural VE and remaining 172kg soybean oil and stir stir about 20-35 minute, be cooled to about 45-55 ℃, enable grinder and grind, remove the content bubble with the filtration of 80-100 eye mesh screen and with vacuum machine, get content;
3) pelleting, typing:
Content, glue are pressed into soft capsule in pellet press, rubber thickness is 0.66～0.72mm, and loading amount is the 500mg/ grain; The soft capsule that presses was finalized the design 2.5～3.5 hours under the condition of 18～25 ℃ of temperature, relative humidity≤35%;
4) drying:
The soft capsule of typing evenly is laid in the drying tray, and 18～25 ℃ of temperature, under the condition of relative humidity≤30%, dried ball moisture 10.0～14.0% is controlled in aeration-drying more than 22 hours.Obtain cowberry xanthophyll soft capsule finished product A.
Embodiment 2: the supplementary material formulation by weight of the glue of capsule is changed into:
Gelatin-193.15kg glycerine-78kg
Pure water-172.46kg caramel colorant-13kg.
The supplementary material formulation by weight of content is changed into:
Whortle extract-88kg lutein ester-36kg
Natural beta-carotin oil-8kg natural VE-1kg
Beeswax-25kg soybean oil-380kg.
Then according to embodiment 1 described method, make cowberry xanthophyll soft capsule finished product B
Embodiment 3
The supplementary material formulation by weight of the glue of capsule is changed into:
Gelatin-220kg glycerine-85.1kg
Pure water-156kg caramel colorant-10kg.
The supplementary material formulation by weight of content is changed into:
Whortle extract-88kg lutein ester-45kg
Natural beta-carotin oil-12kg natural VE-1.2kg
Beeswax-23kg soybean oil-320kg.
Then according to embodiment 1 described method, make cowberry xanthophyll soft capsule finished product C
Human feeding trial:
1.1 sample and placebo: the placebo of cowberry xanthophyll soft capsule finished product A and same package, outward appearance, color and luster and mouthfeel, oral 1 time of everyone every day, each 1.
1.2 the experimenter selects
1.2.1 experimenter's mass selection is selected: select long-term with eye, the fatigable adult of eyesight.Allly meet above-mentioned condition and voluntary participation and guarantee that cooperation person all can include test in.
1.2.2 exclusion standard:
1.2.2.1 do not meet the experimenter who includes age criterion in; To the health food allergy sufferers.
1.2.2.3 suffer from infectious eye disease person, the inside and outside eye disease patients such as nebula, circle pheasant cornea.
1.2.2.4 take in a short time the article relevant with tested function, have influence on the judgement person to the result.
1.2.2.5 other has long-term taking the medicine for the treatment of eyesight or uses other methods for the treatment of, fails the terminator.
1.2.2.6 do not meet inclusive criteria, do not take in accordance with regulations, or data is not congruent affects power or security judgement person.
1.3 test method: adopt two kinds of control design between self and group, according at random, the requirement of double blinding, to meet inclusive criteria and guarantee the volunteer of compatibility test, according to symptom, eye test situation, consider that simultaneously the factors such as age, sex are divided into tested group and control group.Tested group with control group take sample or placebo by RD, continuous 45 days.Duration of test does not change original eating habit, normal diet.
2. observation index:
2.1 safety indexes:
2.1.1 general physical examination: inquire in detail experimenter's health condition before the test, understand experimenter's spirit, the situations such as sleep, diet, stool and urine, and measure body weight, blood pressure, changes in heart rate, all experimenters are carried out conventional physical examination and necessary laboratory examination.
2.1.2 routine blood test: red blood cell count(RBC), white blood cell count(WBC), content of hemoglobin mensuration etc.
2.1.3 routine urinalysis: pH value, leucocyte, glucose in urine etc.
2.14 stool for routine: worm's ovum inspection etc.
2.1.5 blood biochemistry index inspection: the mensuration of total serum protein (TP), albumin (ALB), glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminease (AST), cholesterol (CHOL), triglycerides (TG), urea nitrogen (BUN), creatinine (Cr), blood uric acid (UA), blood sugar (GLU) etc.
2.1.7 bad reaction is observed.
2.2 efficiency index
2.2.1 Symptom Observation: inquire in detail the visual fatigue situation, the symptom such as observe ophthalmodynia, eye is swollen, photophobia, blurred vision, eye are dry and astringent, by mild symptoms multiple integral (severe 3 minutes, middle disease 2 minutes, light disease 1 minute) statistics integrated value before and after test-meal, and with regard to its doing well,improving (arbitrary doing well,improving 1 minute and above for improving) situation, the improvement rate observes the symptoms.
2.2.2 visuognosis persistence test.
2.2.3 distant vision is measured.
3. experimental data is added up: data result represents with mean ± standard deviation, self paired data adopts paired t-test, between observation group and the control group under the neat prerequisite of variance, mean relatively adopts in groups t check, otherwise carry out satisfying after variable transforms the neat rear t of the employing check of variance, if variance is still uneven, adopt rank test.The improvement rate is enumeration data, can use x
2Check, the total routine number of four fold table is less than 40, or total routine number is equal to or greater than 40 but theoretical value occurs and be equal to or less than at 1 o'clock, uses definite probabilistic method instead.
4. as a result criterion:
4.1 doing well,improving: ophthalmodynia, eye is swollen, photophobia, blurred vision, the dry and astringent arbitrary doing well,improving of eye are improvement more than 1 minute and 1 minute, and 5 kinds of arbitrary improvement of symptom and other symptoms are namely judged doing well,improving without worsening.
4.2 effectively: doing well,improving and duration of photopic vision front and back differ by more than and equal 0.1, and comparing difference has conspicuousness by statistics.
4.3 invalid: as not reach effective standard.
4.4 reference index: eyesight improving rate.Improve to improve two behaviors before the test after the test-meal test, add up two groups and take eyesight improving rate after the tested material as the reference index, reference index is not as to whether effectively criterion of asthenopia releasing function.
5. result
Double-blind study is observed and finished to make known: taking No. 1 person is cowberry xanthophyll soft capsule finished product A, takes No. 2 persons and is placebo
5.1 ordinary circumstance: initial trial crowd's test group 52 examples, control group 52 examples, control group: male/female is 4/48, the age is 20.71 ± 4.27 years old; The test-meal group: male/female is 4/48, and the age is 20.79 ± 4.23 years old.Experimenter's spirit during the test-meal, sleep, diet, stool and urine are all normal.
5.2 security is observed
5.2.1 body weight, blood pressure, heart rate, routine urinalysis, stool routine examination, routine blood test and changes of biochemical indexes situation see Table 1,2.Edible tested material is after 45 days, test-meal group and control group body weight, blood pressure, heart rate are showed no obvious abnormalities, routine urinalysis, stool routine examination, routine blood test and biochemical indicator all in normal range (NR), point out cowberry xanthophyll soft capsule finished product A of the present invention to body health without obvious damage.
Body weight, blood pressure, heart rate, routine urinalysis, stool routine examination, routine blood test index situation of change before and after the table 1 cowberry xanthophyll soft capsule finished product A test-meal
Changes of biochemical indexes situation before and after the table 2 cowberry xanthophyll soft capsule finished product A test-meal
5.2.2 electrocardiogram, Abdominal B type ultrasonography, Chest X-rays inspection are all in normal range (NR).
5.2.3 the experimenter has no obvious adverse reaction during the test-meal.
5.3 functional observation
5.3.1 Symptom Observation
See Table 3,4.The clinical symptoms such as test-meal group ophthalmodynia after the test-meal, eye is swollen, photophobia, blurred vision, eye are dry and astringent have clear improvement, apparent in view reduction before its symptom integral and the test-meal, difference has conspicuousness (P＜0.05), compares with control group, and difference also has conspicuousness (P＜0.05).
Symptom integral statistics before and after the table 3 cowberry xanthophyll soft capsule finished product A test-meal
| Group | Before the test-meal | After the test-meal |
| Control group | 7.83±2.63 | 7.52±2.65 |
| The test-meal group | 7.85±2.77 | 6.44±2.68 *# |
* compare with control group, P＜0.05, P＜0.05 is compared in # and self.
Doing well,improving situation before and after the table 4 cowberry xanthophyll soft capsule finished product A test-meal
5.3.2 observation of curative effect:
By as seen from Table 5, take tested material after 45 days, test-meal group clinical observation total effective rate is 80.77%, with control group (23.08%) comparing difference conspicuousness (P＜0.05) is arranged.
Functional observation relatively before and after the table 5 cowberry xanthophyll soft capsule finished product A test-meal
| Group | Effectively | Invalid | Total effective rate (%) |
| Control group | 12 | 40 | 23.08 |
| The test-meal group | 42 | 10 | 80.77 * |
* compare P＜0.05 with control group
5.3.3 the impact on duration of photopic vision
As seen from Table 6, test-meal group duration of photopic vision is tested front raising 0.11 after the test, with comparing difference before self test-meal and after the control group test conspicuousness (P＜0.05) is arranged all.
Duration of photopic vision situation before and after the table 6 cowberry xanthophyll soft capsule finished product A test-meal
| Group | Before the test-meal | After the test-meal | Increase rate |
| Control group | 0.59±0.08 | 0.61±0.07 | 0.02±0.03 |
| The test-meal group | 0.58±0.07 | 0.69±0.08 *# | 0.11±0.03 # |
* compare with control group, P＜0.05, P＜0.05 is compared in # and self.
5.3.4 the impact on eyesight
By as seen from Table 7, before test-meal group test-meal backsight force level and the test-meal and compare, difference five conspicuousnesses (P〉0.05).
Eyesight situation before and after the table 7 cowberry xanthophyll soft capsule finished product A test-meal
5.4 take off the mistake rate
After test in 45 days, control group has 0 routine experimenter to take because of interruption to be subjected to test product or can't to be screened out by determine effect; The test-meal group has 0 routine experimenter to take because of interruption to be subjected to test product or can't to be screened out by determine effect.Last efficiency test crowd control group 52 examples, test-meal group 52 examples.See Table 8.
The mistake rate is taken off in table 8 test
| Group | Control group (example) | Test-meal group (example) |
| Before the test-meal | 52 | 52 |
| Take off the mistake number | 0 | 0 |
| Take off the mistake rate | 0.00% | 0.00% |
Use respectively cowberry xanthophyll soft capsule finished product B, cowberry xanthophyll soft capsule finished product C, replace cowberry xanthophyll soft capsule finished product A, repeat above-mentioned human feeding trial, the result is without substantive difference.
6 brief summaries
Result of the test shows: the cowberry xanthophyll soft capsule to ophthalmodynia, eye is swollen, photophobia, blurred vision, eye are dry and astringent etc., and clinical symptoms are improved, reaching the control group comparing difference before test-meal group symptom integral and the test-meal after the test has conspicuousness (P＜0.05); Test-meal group clinical observation total effective rate is 80.77%, with control group (23.08%) comparing difference conspicuousness (P＜0.05) is arranged; Test-meal group duration of photopic vision is tested front raising 0.11 after the test, with comparing difference before self test-meal and after the control group test conspicuousness (P＜0.05) is arranged all; Reach control group relatively before test-meal group test backsight force level and the test-meal, no significant difference (P〉0.05).According to the judgment criteria of regulation in " health food check and assessment technique standard " (version in 2003), point out this cowberry xanthophyll soft capsule to have the effect of asthenopia releasing function.
The present invention includes but be not limited to above-mentioned embodiment, anyly meet product, the method that these claims are described, all fall within protection scope of the present invention.
Claims (3)
1. a cowberry xanthophyll soft capsule comprises content and capsule, it is characterized in that: the preparation of weight portion shown in described content is pressed by following supplementary material:
Whortle extract-70-88 lutein ester-36-45
Natural beta-carotin oil-8-12 natural VE-0.9-1.2
Beeswax-23-28 soybean oil-320-380.
2. cowberry xanthophyll soft capsule according to claim 1 is characterized in that: the preparation of weight portion shown in the glue of described capsule is pressed by following supplementary material:
Gelatin-170-220 glycerine-78-93
Pure water-156-190 caramel colorant-10-13.
3. the preparation method of a cowberry xanthophyll soft capsule, it is characterized in that: described preparation method may further comprise the steps:
1) preparation of glue:
Formula ratio by the glue of the described capsule of claim 2 takes by weighing gelatin, glycerine, purified water and burnt sugar coloring; With glycerine, purified water inputization glue tank, be heated to 70～80 ℃ first, drop into again gelatin, insulated and stirred 40～70 minutes, add burnt sugar coloring, stirred 5-15 minute, vacuumize 10 ~ 40 minutes, detect the glue viscosity at 2.0～2.5 ten thousand mPa.s, filter the filtrate stand for standby use with 100 eye mesh screens;
2) preparation of content:
Formula ratio by the described content of claim 1 takes by weighing whortle extract, lutein ester, natural beta-carotin oil, natural VE, beeswax, soybean oil; 50% soybean oil is added in the material-compound tank, stir, heat and after 70-80 ℃, add the beeswax dissolving, after beeswax all dissolved, the soybean oil that adds whortle extract, lutein ester, natural beta-carotin oil, natural VE and residue recipe quantity stirred stir about 20-35 minute, be cooled to about 45-55 ℃, enable grinder and grind, remove the content bubble with the filtration of 80-100 eye mesh screen and with vacuum machine, get content;
3) pelleting, typing:
Content, glue are pressed into soft capsule in the pelleting press, rubber thickness is 0.66～0.72mm, and loading amount is the 500mg/ grain; The soft capsule that presses was finalized the design 2.5～3.5 hours under the condition of 18～25 ℃ of temperature, relative humidity≤35%;
4) drying:
The soft capsule of typing evenly is laid in the drying tray, and 18～25 ℃ of temperature, under the condition of relative humidity≤30%, dried ball moisture 10.0～14.0% is controlled in aeration-drying more than 22 hours.
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| CN103190610A (en) * | 2013-03-18 | 2013-07-10 | 北京博远欣绿科技有限公司 | Double-pigment soft capsule preparation and preparation method |
| CN103190629A (en) * | 2013-04-10 | 2013-07-10 | 浙江蜂莓生物科技有限公司 | Blueberry and bee product composite capsules |
| CN103405630A (en) * | 2013-08-26 | 2013-11-27 | 费海荣 | Compound capsule for treating aplastic anemia and preparation method thereof |
| CN104147081A (en) * | 2014-08-20 | 2014-11-19 | 哈尔滨顺亿堂医药生物科技开发有限公司 | Blueberry lutein soft capsule for improving eyesight and manufacturing method thereof |
| CN104224890A (en) * | 2014-07-29 | 2014-12-24 | 中宏生物工程有限责任公司 | Lutein soft capsule and preparation method thereof |
| CN104824675A (en) * | 2015-05-13 | 2015-08-12 | 宁波北仑戌鸿农业科技有限公司 | Eyesight improving lutein capsule |
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| CN103405630A (en) * | 2013-08-26 | 2013-11-27 | 费海荣 | Compound capsule for treating aplastic anemia and preparation method thereof |
| CN104224890B (en) * | 2014-07-29 | 2017-09-19 | 中宏生物工程有限责任公司 | A kind of xanthophyll soft capsule and preparation method thereof |
| CN104224890A (en) * | 2014-07-29 | 2014-12-24 | 中宏生物工程有限责任公司 | Lutein soft capsule and preparation method thereof |
| CN104147081A (en) * | 2014-08-20 | 2014-11-19 | 哈尔滨顺亿堂医药生物科技开发有限公司 | Blueberry lutein soft capsule for improving eyesight and manufacturing method thereof |
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| CN105106291A (en) * | 2015-09-22 | 2015-12-02 | 哈尔滨宝德生物技术股份有限公司 | Lutein ester soft capsule capable of relieving asthenopia and manufacture method |
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| CN107616506A (en) * | 2017-09-12 | 2018-01-23 | 陈胤成 | Brain-invigorating walnut oil capsule based on phosphatidylserine and preparation method thereof |
| CN111991437A (en) * | 2020-10-10 | 2020-11-27 | 环贯绿佳利(珠海)科技发展有限公司 | Formula and preparation method of soft capsule for protecting eyesight |
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Application publication date: 20130313 |