CN111820409A - Composition for relieving visual fatigue and preparation method thereof - Google Patents

Composition for relieving visual fatigue and preparation method thereof Download PDF

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CN111820409A
CN111820409A CN201910316791.1A CN201910316791A CN111820409A CN 111820409 A CN111820409 A CN 111820409A CN 201910316791 A CN201910316791 A CN 201910316791A CN 111820409 A CN111820409 A CN 111820409A
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astaxanthin
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张晓娟
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Zhengzhou City Xin Shiming Technology Engineering Co ltd
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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Abstract

The invention provides a composition for relieving visual fatigue, which consists of astaxanthin and olive oil in a weight ratio of 1: 0.4-40. The composition can effectively improve symptoms of eye ache, eye swelling, photophobia, blurred vision, dry and wet eyes, foreign body sensation, lacrimation and the like, obviously improves photopic vision persistence, and has a total effective rate of 70.2%.

Description

Composition for relieving visual fatigue and preparation method thereof
Technical Field
The invention relates to a composition for relieving visual fatigue and a preparation method thereof, belonging to the field of medicine and health care.
Background
Astaxanthin is a carotenoid, and is the highest-grade product of carotenoid synthesis, is widely present in the living world, particularly in feathers of shrimps, crabs, fish, algal bodies, yeasts and birds, and is one of the main carotenoids in marine organisms. Astaxanthin is one of the strongest antioxidants in the world, and is capable of effectively eliminating oxygen radicals in cells, enhancing the cell regeneration capacity, maintaining the balance of the organism and reducing the accumulation of aging cells, thereby protecting the health of skin, promoting the growth of hair, resisting aging, enhancing the immunity and relieving asthenopia.
Disclosure of Invention
The invention aims to provide a composition for relieving visual fatigue and a preparation method thereof.
As one aspect of the present invention, the present invention provides a composition for relieving asthenopia, which comprises astaxanthin and olive oil in a weight ratio of 1: (0.4-40).
Preferably, the composition is prepared from astaxanthin and olive oil in a weight ratio of 1: (0.4-4).
Further preferably, the composition is prepared from astaxanthin and olive oil in a weight ratio of 1: 0.4 or 1: 4.
The composition can be added with conventional auxiliary materials and prepared into oral dosage forms according to the conventional preparation process, such as granules, tablets, soft capsules, dripping pills, oral liquid, suspension, emulsion and the like.
The conventional auxiliary materials comprise: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the adhesive comprises: starch slurry, polyvinylpyrrolidone, hydroxypropylmethylcellulose, and the like; the sweetener comprises: saccharin sodium, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, and the like; the flavoring agent comprises: sweeteners and various essences; the preservative comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroacetidine acetate, eucalyptus oil, etc.; the matrix comprises: PEG6000, PEG4000, insect wax, etc.
As another aspect of the invention, the invention provides application of the composition in preparing a medicine or health-care product for relieving visual fatigue or dry eye.
In a third aspect of the present invention, there is provided a soft capsule for relieving asthenopia, the content of the soft capsule comprises astaxanthin and olive oil, the weight ratio of astaxanthin to olive oil is 1: (0.4-40).
Preferably, the weight ratio of the astaxanthin to the olive oil is 1: (0.4-4).
Further preferably, the content of the soft capsule consists of the following raw materials: 80-130 parts of astaxanthin and 430 parts of olive oil; the capsule shell is composed of the following raw materials: 470 and 540 parts of gelatin, 220 and 280 parts of glycerol and 470 and 540 parts of purified water.
Still more preferably, the content of the soft capsule consists of the following raw materials: 90-120 parts of astaxanthin and 420 parts of olive oil 370-; the capsule skin comprises the following raw materials: 480 parts of gelatin, 270 parts of glycerol, and 480 parts of purified water;
or the content of the soft capsule consists of the following raw materials: 95-110 parts of astaxanthin and 410 parts of olive oil; the capsule skin comprises the following raw materials: 510 parts of gelatin 490-containing material, 260 parts of glycerol 240-containing material and 510 parts of purified water 490-containing material.
Most preferably, the soft capsule contents consist of the following raw materials: 100 parts of astaxanthin and 400 parts of olive oil; the capsule skin comprises the following raw materials: 500 parts by weight of gelatin, 250 parts by weight of glycerol and 500 parts by weight of purified water.
As a fourth aspect of the present invention, the present invention provides a method for preparing a soft capsule of the composition, the method comprising the steps of:
step a, preparation of contents: mixing astaxanthin and olive oil to obtain a content material liquid for later use;
step b, sol: weighing according to a certain proportion, firstly adding purified water and glycerol, heating and stirring, then adding gelatin until the gelatin is completely dissolved for later use;
step c, pelleting: and c, pelleting and shaping the content prepared in the step a and the glue solution prepared in the step b to prepare the soft capsule.
Preferably, after mixing the purified water and glycerol of step b, adding gelatin at 70-80 ℃;
preferably, the preparation method further comprises a step d of drying, wherein the drying temperature is 22-28 ℃, the humidity is 20-30%, and the drying time is 24-48 hours.
The research of the invention shows that the composition can effectively improve the symptoms of eye ache, eye swelling, photophobia, blurred vision, dry and wet eyes, foreign body sensation, lacrimation and the like, obviously improve the photopic vision persistence, has the total effective rate of 70.2 percent, and is obviously higher than that of a control group.
Detailed Description
Example 1
The formula is as follows:
Figure RE-GDA0002135661830000031
the preparation method comprises the following steps:
step a, preparation of contents: mixing astaxanthin and olive oil, stirring uniformly, vacuumizing (vacuum degree of-0.06 to-0.08 Mpa), removing bubbles, and filtering with a 100-mesh sieve. Obtaining content material liquid, and placing the content material liquid in a container for later use;
step b, sol: weighing according to a certain proportion, firstly adding purified water and glycerol, heating and stirring, adding gelatin at 70-80 deg.C until the gelatin is completely dissolved. Stirring for about 1 hour, vacuumizing (vacuum degree of-0.06 to-0.08 Mpa), removing bubbles, filtering with a 100-mesh sieve, and keeping the temperature at 60 +/-5 ℃ for later use;
step c, pelleting: c, pelleting and shaping the content prepared in the step a and the glue solution prepared in the step b to prepare soft capsules;
step d, drying: placing the shaped soft capsule in a drying room, controlling the indoor temperature at 22-28 deg.C, controlling the humidity at 20-30%, and drying for about 24 hr.
Example 2
The formula is as follows:
Figure RE-GDA0002135661830000032
Figure RE-GDA0002135661830000041
the preparation method is the same as example 1.
Example 3
The formula is as follows:
Figure RE-GDA0002135661830000042
the preparation method is the same as example 1.
Example 4
The formula is as follows:
Figure RE-GDA0002135661830000043
the preparation method is the same as example 1.
Example 5
The formula is as follows:
Figure RE-GDA0002135661830000044
Figure RE-GDA0002135661830000051
the preparation method is the same as example 1.
EXAMPLE 6 screening of oils
The edible oil has good solubility to fat-soluble components, has the characteristics of high vapor pressure, low volatility, edible safety and the like, and is suitable for serving as a soft capsule matrix component. Soft capsules were prepared according to the method and formulation of example 1 using soybean oil, olive oil and PEG400 as solvents, respectively, and the solubility of astaxanthin in soybean oil, olive oil and PEG400 was examined.
Preparation and linear relationship examination of control solutions: accurately weighing 2mg astaxanthin reference substance, dissolving with anhydrous ethanol and fixing volume to 20mL measuring flask, respectively accurately transferring to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.2mL, diluting with anhydrous ethanol and fixing volume to 10mL measuring flask, measuring light absorption at 478nmValues were plotted on the ordinate and concentration on the abscissa to obtain a standard curve, and the regression equation Y was 83.64X +0.0054, R2When the concentration of the astaxanthin control sample is 0.9985, the linear relation is good in the range of 1-12 mug/mL.
Accurately weighing appropriate amount of astaxanthin, respectively adding into equal amount of soybean oil, oleum Olivarum and PEG400, dissolving, performing ultrasonic treatment at room temperature for 30min, centrifuging to separate supernatant and precipitate, and measuring and calculating astaxanthin extraction rate. The results are shown in Table 1.
TABLE 1 measurement results of astaxanthin extraction rates in different solvents
Soybean oil Olive oil PEG400
Astaxanthin extraction yield (%) 69.65 75.42 48.33
Compared with the solubility of the three solvents to the astaxanthin, the dissolution effect of the soybean oil and the olive oil as the solvents to the astaxanthin is determined to be better, the solubility of the solvent with the same amount is higher, the astaxanthin ingredients are mixed more uniformly in the capsule, the precipitation risk is lower, the olive oil is rich in nutrition and higher in functional value, and the olive oil is selected as the solvent of the astaxanthin.
Example 7 verification of the ratio of olive oil to astaxanthin
Particularly, olive oil contains a large amount of polyunsaturated fatty acids (PUFA) and is more susceptible to oxygen, so that the astaxanthin can be used to inhibit the oxidative rancidity of the fatty acids in olive oil, and the optimal addition ratio of the astaxanthin can be determined by measuring the peroxide value of the olive oil at different times, thereby ensuring the optimal antioxidant activity.
Placing 30mL of oleum Olivarum in 50mL conical flask, numbers 1, 2, 3, 4, 5, and 6, wherein number 1 is control, and numbers 2-6 are added with 0.0075, 0.075, 0.75, 7.5, and 75g astaxanthin oil respectively. Each sample was placed in an oven at 60 ℃ and the peroxide value was measured daily (24 h). The results are shown in Table 2.
TABLE 2 verification of the olive oil to astaxanthin ratio
Figure RE-GDA0002135661830000061
The experimental result shows that the group 5 (adding 7.5 g of astaxanthin oil in 30ml of olive oil) can achieve the best antioxidation result, the antioxidation effect is not obviously increased when the group 5 is continuously added, the cost is increased, and the significance is small. And (3) fixing natural astaxanthin: the ratio of olive oil is 1: 4.
EXAMPLE 8 Effect test
1 materials and methods
1.1 sample: composition softgels (prepared as in example 1). It is administered orally 2 times a day, 1 granule each time.
1.2 subjects: selecting the subjects with asthenopia symptoms of 18-65 years old according to the self-induction principle.
1.2.1 Inclusion criteria: adults 18-65 years old, and people with long-term eye use and easy fatigue of vision.
1.2.2 exclusionary criteria
1.2.2.1 patients with infectious, traumatic eye disease. Eye surgery is performed for less than 3 months.
1.2.2.2 patients with internal and external eye diseases such as cornea, vitreous body, eyeground pathological changes, and the like.
1.2.2.3 patients with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic system diseases.
1.2.2.4 pregnant or lactating women, allergic constitution patients.
1.2.2.5 taking the article related to the tested function in a short time affects the judger of the result.
1.2.2.6 it can be used for treating vision diseases by long-term administration of medicine, health product, or other treatment method.
1.2.2.7 not meeting the inclusion criteria, not eating the test substance as specified, or the data is not complete and affects the efficacy or safety judgment.
1.3 Experimental design and grouping
Two control designs, self and group, were used. Grouping according to random and double-blind requirements, and balancing the symptoms and vision level of the trial group and the control group according to the symptoms and vision examination conditions during grouping. Meanwhile, factors such as age, sex and the like are considered, so that the two groups have comparability. The number of the test subjects in each group is not less than 50 at the end of the feeding trial.
1.4 dosage and time
The test group took the soft capsules prepared in example 12 times a day, 1 capsule each time, and took orally. The control group received placebo. The subject is administered for 60 consecutive days. The subject stopped taking medications or other health care products related to improving vision during the feeding period.
1.5 instruments and reagents
Hitachi 7180 full-automatic biochemical analyzer (CENTRONIC, Germany); DIRUIH-300 urine eight item Analyzer (Changdui corporation); Sysmex-K21 three-class blood analyzer (Sysmex corporation); sysmex hemocyte analysis diluent (Sysmex corporation); DIRUI urinalysis reagent strips (vinddi); ridman biochemical kit (beijing ridman biochemical corporation), japan cooperative biochemical kit (japan cooperative medical corporation), and japan biochemical kit (japan chemical corporation).
2 observation index
2.1 efficacy index
2.1.1 questionnaire: symptom inquiry, eye (computer, television, book and newspaper) condition.
2.1.2 ophthalmic examinations: including fundus examination, vision examination (myopia, hyperopia, astigmatism, etc.).
2.1.3 photopic Vision persistence detection
The photopic vision persistence measuring method comprises drawing a 'pin' -shaped three-dimensional block diagram on a check table, wherein each side of each block is a centimeter, and the local illumination is 100-150LX (a specially manufactured lamp box can be used). The distance between the checklist and the eyes should be kept at a proper distance according to the visual habit of the subject, and the subject is defined to see the character "Pin" as photopic vision, and to be not photopic vision when the character "Pin" is inverted, and the measurement time is 3 minutes.
Photopic vision duration ═ 100% (photopic vision time/total fixation time)%
2.2 safety indices
2.2.1 routine examination of blood, urine and feces
Erythrocyte count, hemoglobin, leukocyte count, urine ten-item test and stool microscopic examination.
2.2.2 Biochemical index determination
Serum albumin (AIb), Total Protein (TP), liver and kidney functions (aspartate Aminotransferase (AST), alanine Aminotransferase (ALT), Urea (Urea), creatinine (Cre), blood glucose (GIu), blood lipids (total cholesterol (TC), and Triglycerides (TG).
2.2.3 Abdominal ultrasonography B, electrocardiogram, X-ray chest fluoroscopy (one examination before taking test).
2.3 efficacy determination
2.3.1 effective rate for improving symptoms
The symptoms of the eye are 3 improved in 8 symptoms of eye ache, eye swelling, photophobia, blurred vision, dry and wet eyes, foreign body sensation, lacrimation and general discomfort, and the symptoms are judged to be improved if other symptoms are not worsened. Two groups of symptom improvement cases and two groups of symptom improvement effective rates are calculated. The effective rate (%) for symptom improvement was calculated as 100 test food examples of symptom improvement. The two groups of symptoms are tested for improving the effective rate statistically.
2.3.2 mean integral of symptoms
And calculating symptom integrals of each test taker before and after the test eating, respectively calculating average integral values of the two groups, and performing statistical test. The scoring criteria are shown in table 3.
TABLE 3 asthenopia symptom determination method
Figure RE-GDA0002135661830000081
Figure RE-GDA0002135661830000091
Note: "occasionally" means 1-2 times per day; "occasionally" means 1-3 times per day; "often" means > 3 times per day
2.3.3 photopic Vision persistence
Compared with the test group or the test group and the control group, the photopic vision persistence difference is significant (P is less than 0.05), and the improvement of the average photopic vision persistence is more than or equal to 10 percent, which is effective.
2.4 statistical analysis of data
The metrology data can be analyzed using a t-test. Paired t-tests were used for self-control and grouped t-tests were used for two-panel mean comparisons. And (3) carrying out appropriate variable conversion on the data with abnormal distribution or variance, carrying out t test on the converted data after the converted data meets the normal variance, and carrying out t test or rank sum test on the converted data if the converted data still can not meet the normal variance requirement. On the premise that the comparison difference between groups before test feeding is not significant, comparison between groups after test can be carried out.
X for counting data2And (6) checking. And when the total case number of the four-table is less than 40 or the total case number is equal to or more than 40 but the theoretical frequency is equal to or less than 1, the exact probability method is applied.
2.5 determination of results
2.5.1 compared with the test group or the test group and the control group, the effective rate of improving symptoms or the difference of total score of symptoms is significant (P < 0.05).
2.5.2 compared with the test group or the test group and the control group, the photopic vision persistence difference is significant (P is less than 0.05), and the average photopic vision persistence is improved by more than or equal to 10%.
2.5.1 and 2.5.2, and the rate of improvement of vision is not significantly reduced, and it can be judged that the test substance has the function of contributing to the alleviation of asthenopia.
3 results of the experiment
3.1 Observation of efficacy
3.1.1 general conditions
118 subjects were included and randomized into a test diet group and a control group. The subjects who are deprived of test are 2 in each of the diet group and the control group, 114 effective subjects, 57 test diet groups and 57 control groups, the examinations of blood routine, urine routine, stool routine, liver and kidney functions, chest X-ray, electrocardiogram, B-ultrasound and the like of the subjects before the test are in a normal range, and the ages, sexes, photopic persistence, vision, total integral of symptoms and eye time of the subjects in the two groups before the test are not obviously different (P is more than 0.05), so that the subjects have comparability. The predator has no obvious changes in spirit, sleep, diet, defecation and the like before and after the predator takes the test.
3.1.2 Change in Total integral of symptoms
The results are shown in Table 4.
TABLE 4 Total integral Change in symptoms before and after eating trial
Figure RE-GDA0002135661830000101
Group of Number of examples Before tasting After eating trial
Test food group 57 16.19±2.16 12.93±2.90***###
Control group 57 16.04±2.16 15.81±2.29
Self comparison of P <0.001, between # groups of P <0.001
The results show that the total symptom score is obviously improved (P is less than 0.001) by comparing the test food group with the control group before and after the test food group tests the food and comparing the test food group with the control group.
3.1.3 improvement of the Primary symptoms
The results are shown in Table 5.
TABLE 5 improvement of the chief complaints
Figure RE-GDA0002135661830000102
3.1.4 photopic Vision persistence Change
The results are shown in Table 6.
TABLE 6 Change in photopic vision persistence before and after eating trial
Figure RE-GDA0002135661830000103
Figure RE-GDA0002135661830000104
Figure RE-GDA0002135661830000111
Self comparison of P <0.001, between # groups of P <0.001
The photopic vision persistence is improved by comparing the test group with the control group before and after the test, and the differences are obvious (P is less than 0.001); after the test diet, the average photopic vision persistence is improved by 10.1 percent, and is obviously different (P is less than 0.001) compared with that of a control group.
3.1.5 effective rate for improving symptoms
The results are shown in Table 7.
Table 7 results of total effective rate improvement of symptoms before and after test eating
Group of Number of examples Effective number of cases Number of invalid cases Effective rate (%)
Test food group 57 40 17 70.2###
Control group 57 1 56 1.8
Comparison between # group P <0.001
The total symptoms after the test eating are 40 cases, the total effective rate is 70.2 percent, and the obvious difference is compared with a control group (P is less than 0.001).
3.2 safety observations
The blood routine, the urine routine, the stool routine, the blood biochemical index and the electrocardiogram are normal before and after the test, and the chest fluoroscopy by x-ray is normal, and no adverse reaction is seen in the two groups.
4 small knot
4.1118 visual fatigue test subjects meeting the requirements are randomly divided into a test food group and a control group, 114 effective test subjects, 57 test food groups and 57 control groups. The control group received placebo. After the test group orally takes the composition soft capsules prepared in example 1 as required for 60 days, the total integral of symptoms is obviously improved (P is less than 0.001) by comparing the test group with the control group before and after test eating. The total symptoms after the test eating are 40 cases, the total effective rate is 70.2 percent, and the obvious difference is compared with a control group (P is less than 0.001). The photopic vision persistence is improved by comparing the test group with the control group before and after the test, and the differences are obvious (P is less than 0.001); after the test diet, the average photopic vision persistence is improved by 10.1 percent, and is obviously different (P is less than 0.001) compared with that of a control group. According to the judgment standard of the function of relieving the asthenopia in the national food and drug administration of food and drug supervision and protection No. 2012/107 annex 4, the result shows that the composition soft capsule prepared by the invention has the function of relieving the asthenopia.
4.2 the chest X-ray, abdomen B-ultrasonic, electrocardiogram, blood routine, urine routine, stool routine and blood biochemical indexes of the person who eats the test food have no obvious change, which indicates that the product has no adverse effect on the physical health of the subject.
4.3 No allergy or other adverse reactions are observed in the process of eating the composition soft capsule.

Claims (10)

1. The composition for relieving the visual fatigue is characterized by comprising astaxanthin and olive oil in a weight ratio of 1: 0.4-40.
2. The composition of claim 1, wherein the composition comprises astaxanthin and olive oil in a weight ratio of 1: 0.4 to 4.
3. The composition of claim 2, wherein the composition consists of astaxanthin and olive oil in a weight ratio of 1: 0.4 or 1: 4.
4. The composition according to any one of claims 1 to 3, wherein the composition is a granule, a tablet, a soft capsule, a drop pill, an oral liquid, a suspension or an emulsion; preferably a soft capsule.
5. Use of a composition according to any one of claims 1 to 3 for the preparation of a medicament or health product for relieving asthenopia or dry eye.
6. The soft capsule for relieving the visual fatigue is characterized in that the content of the soft capsule consists of astaxanthin and olive oil, wherein the weight ratio of the astaxanthin to the olive oil is 1: 0.4-40.
7. The soft capsule according to claim 6, wherein the weight ratio of astaxanthin to olive oil is 1: (0.4-4).
8. The soft capsule according to claim 7, wherein the contents of the soft capsule consist of: 80-130 parts of astaxanthin and 430 parts of olive oil; the capsule shell is composed of the following raw materials: 470 and 540 parts of gelatin, 220 and 280 parts of glycerol and 470 and 540 parts of purified water.
Preferably, the content of the soft capsule consists of the following raw materials: 90-120 parts of astaxanthin and 420 parts of olive oil 370-; the capsule skin comprises the following raw materials: 480 parts of gelatin, 270 parts of glycerol, and 480 parts of purified water;
or the content of the soft capsule consists of the following raw materials: 95-110 parts of astaxanthin and 410 parts of olive oil; the capsule skin comprises the following raw materials: 510 parts of gelatin 490-containing material, 260 parts of glycerol 240-containing material and 510 parts of purified water 490-containing material.
9. The soft capsule of claim 8, wherein the soft capsule contents consist of: 100 parts of astaxanthin and 400 parts of olive oil; the capsule skin comprises the following raw materials: 500 parts by weight of gelatin, 250 parts by weight of glycerol and 500 parts by weight of purified water.
10. The process for the preparation of the soft capsules according to any one of claims 6 to 9, comprising the steps of:
step a, preparation of contents: mixing astaxanthin and olive oil to obtain a content material liquid for later use;
step b, sol: weighing according to a certain proportion, firstly adding purified water and glycerol, heating and stirring, then adding gelatin until the gelatin is completely dissolved for later use;
step c, pelleting: and c, pelleting and shaping the content prepared in the step a and the glue solution prepared in the step b to prepare the soft capsule.
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