Summary of the invention
The objective of the invention is at above-mentioned deficiency, a kind of health food that is used for alleviating asthenopia is provided.
Health food of the present invention is that the pure natural raw material blueberry that filters out from motherland medicine treasure-house, grape seed extract, fish oil etc. are raw material, with reference to the modern pharmacological research achievement, strengthen its synergy by the theory of traditional Chinese medical science scientific composition, and behind the special process effective component extracting refining forming, reach the purpose of alleviating asthenopia preferably.
Blueberry derives from the Ericaceae genus vaccinium, is a kind of plant of dietotherapeutic, contains rich organic acid, amino acid and mineral element.The anthocyanidin of blueberry is its most important bioactive ingredients, and multiple ophthalmology disease is had good result of treatment, and has multiple pharmacologically active.
Aspect alleviating asthenopia, blueberry can activate the retina enzyme, promotes the synthetic of rhodopsin, improves the eyesight under the half-light.Can improve the eyeball blood circulation, strengthen eyesight, and to vision protection, delaying old hypopsia have sure effect.The applicant is divided into treatment group and control group at random with 326 near-sighted teenagers in the development process.Treatment group oral cranberry extract 200mg every day, control group oral starch 200mg every day.Observe the variation of eye symptom, eyesight and refraction of eye degree after one month, data is carried out statistical analysis and is shown: compare with control group, cranberry extract-anthocyanidin treatment group eye symptom obviously improves, and proves that cranberry extract-anthocyanidin can effectively improve the visual fatigue symptom.
Grape seed extract mainly contains the multiple compositions that belong to polyphenol compound such as OPC, anthocyanin.OPC is the poly-Polyphenols mixture that occurring in nature extensively exists, and has multiple biologically active, and, low toxicity efficient with it, high bioavilability and be celebrated are a kind of extremely strong activity in vivo function factors of constantly researching and developing in recent years.OPC belongs to the wholefood extract, and security is good, proves through pharmacological testing, as healthy food material effect is preferably arranged.
Aspect alleviating asthenopia, show by human trial: give 75 asthenopes of example because of working for a long time before display screen, take grape seed extract OPC 300mg every day, after 2 months, its relative sensitivity and nbjective symptom all have clear improvement.In the clinical testing to A nearsighted person's visual process, the patient who changes for 200 myopia retina non-inflammatories takes the grape seed extract OPC, and 150mg 2 totally months, compared experimenter's eyesight and was significantly improved before and after the test every day.
1988, Boissin and Corbe etc. studied the influence of grape pip procyanidin to vision respectively.They have selected the experimenter of 100 no serious retinal diseases or other ophthalmology disease from two therapeutic communities, and be divided into 2 groups, one winding is subjected to 5 weeks of 200mg/d OPC, and another group is control group, detects eyeball medicine role under high light with 3 kinds of different technologies.Experimental result shows that the visual performance of clothes OPC person's eyeball behind strong illumination has clear improvement than control group, shows that OPC can make retinal structure obtain better nutrition.
Nineteen ninety, Fusi etc. have studied 75 catatonic effects of eyes that the compositor causes because of job specification of OPC treatment.The patient accepts the treatment of 300mg/d OPC, and after 60 days, the contrast sensitiveness of eyes has clear improvement than control group.
Grape seed extract also has good antioxygenic property except that having preferably asthenopia releasing function, can guarantee the stability of product.
Fish oil extracts from seafood fish head, eye socket portion and fat and forms through refining, contains abundant EPA and DHA, plays a very important role on the physiological function of human body.Contain special ω-3 high unsaturated fatty acid EPA and DHA in the fish oil, can improve the functions such as vision relevant with brain.Especially its DHA composition that contains is amphiblestroid important composition composition, can strengthen amphiblestroid function.If meals lack n-3PUFAs such as DHA, retina DHA content reduces, and can be affected to the visual sensitivity of light.So, improve the intake of DHA and can avoid DHA to lack, recover DHA level in the retina.
Health food of the present invention, it is to be made by the raw material of following weight parts:
Blueberry 20-70 part, grape seed extract 5-40 part, fish oil 5-50 part.
Health food of the present invention can add various conventional auxiliary material required when preparing different dosage form, adopts the conventional method of Chinese medicine preparation to be prepared into any conventional oral formulations, as soft capsule, hard soft capsule, granule, tablet, oral liquid etc.
Another object of the present invention provides the preparation method of this health food.
Above-mentioned each component raw material is made the preparation method of health food of the present invention, comprise the following steps:
(1) with the blueberry of described weight portion, the water that adds 7-9 times of weight, heating is extracted 1-3 time under normal pressure, the each extraction 1-3 hour merges extract, filters 1-2 time with 300 mesh sieves, be concentrated into relative density and be 1.33 thick paste, under 70 ℃, 0.07Mpa vacuum, after the drying, be ground into 120 order fine powders, must withered more extract;
(2) grape seed extract of cranberry extract, described weight portion and the fish oil of described weight portion are mixed, promptly.
Health food of the present invention shows through effect experiment, toxicological experiment and stability experiment, remarkable, nontoxic, the good stability of its effect, and take confirmation through majority and can obviously improve visual fatigue, and safety non-toxic, easily be absorbed by the body, can take for a long time.Have prescription uniqueness, reasonable recipe, characteristics such as function is remarkable, taking dose is little.
The specific embodiment
Below in conjunction with embodiments of the invention and test example the present invention is further described, but the present invention is not limited to embodiment, those of ordinary skills do some modification with technical solution of the present invention, still in protection domain of the present invention.
Embodiment 1-5: health food preparation of soft capsule of the present invention
The weight proportion of each raw material sees Table 1 among each embodiment.
Table 1
Embodiment number |
Blueberry (Kg) |
Grape seed extract (Kg) |
Fish oil (Kg) |
Beeswax (Kg) |
1 |
70 |
40 |
50 |
2 |
2 |
50 |
35 |
10 |
0.7 |
3 |
40 |
25 |
8 |
0.5 |
4 |
30 |
20 |
6 |
0.3 |
5 |
20 |
5 |
5 |
0.05 |
Prepare the used auxiliary material of health food soft capsule of the present invention (suspending agent) and can select the raw material of following weight parts for use: beeswax 0.05-2 part.
The weight proportion for preparing the used capsule material of health food soft capsule of the present invention raw material can be:
1 part in gelatin; Glycerine 0.2-0.6 part; 1 part in water.
Its preparation method is (with embodiment 2 is example, and other embodiment is except that raw material consumption difference, and the preparation method is substantially the same manner as Example 2):
(1) choose blueberry, grape seed extract and the fish oil that meets specification requirement, standby.
(2) with the 50Kg blueberry, the water that adds 8 times of weight 400Kg, being heated to 100 ℃ under normal pressure extracts 2 times, each heating was extracted 2 hours, merged extract, filtered 2 times with 300 mesh sieves, be concentrated into relative density and be 1.33 thick paste, under 70 ℃, 0.07Mpa vacuum, after the drying, be ground into 120 order fine powders, cranberry extract.
(3) 10Kg fish oil, 0.7Kg beeswax are placed material-compound tank, after 35 ℃ of mixing of constant temperature are stirred, 35Kg grape seed extract and (2) gained cranberry extract are added wherein, continue stirring 20-30 minute, make mixing of materials even, 100 orders filter.Material after the filtration is squeezed in the degassing tank, under 35 ℃ of constant temperature, pressure 60-70mmHg vacuum, stirs 30-45 minute at a slow speed with the degassing, and the material after the degassing is squeezed in the heat-preserving container, gets soft capsule content.Be incubated in 35 ℃, in order to pelleting.
(4) get the soft capsule material batching, and make the soft capsule packaging material.Earlier glycerine and water are put into glue pot and be warming up to 70-80 ℃, the back that stirs adds gelatin, and it is even until color to continue stirring 2-3 hour under this temperature.Stir degassing 20-30 minute when being evacuated down to 60-70mmHg in the jar, squeeze into after the degassing and be incubated in the heat-preserving container, left standstill 2-3 hour, in order to giving vent to anger in 60 ℃.
(5) with (4) gained soft capsule packaging material and (3) gained soft capsule content, respectively in two hoppers of suction pelleting, debugging machine is after the capacity of thickness, the uniformity and every seed lac ball of capsule skin meets the requirements, and compacting is produced continuously, gets health food soft capsule of the present invention.
Raw materials used source and technical indicator among each embodiment:
Blueberry: provided by Daxing'an Mountainrange Lin Gebei company, its technical indicator meets the requirement of blueberry in " Chinese medicine voluminous dictionary ".
Grape seed extract: spike natural products Co., Ltd provides by Tianjin, accord with Q/12BJ4963-2002 specification requirement, procyanidin content 95%.
Fish oil: foreign refreshing group provides by the Shandong letter, meets SC/T3502-2000 secondary refined fish oil regulation.
Every net content 0.5g of soft capsule that makes by embodiment 1-5 after testing, every contains OPC and is no less than 77mg, and all other indexs all meet the related standards regulation of country about health food.
Eating method: oral, every day 2 times, each 2.
The test example:
For examining or check the asthenopia releasing function of health food of the present invention, send Disease Prevention Control Center, Hubei Prov with embodiment 2 gained 0.5g/ grain * 40/bottle * 180 bottles health food soft capsule of the present invention (hereinafter to be referred as " soft capsule "), according to " health food check and assessment technique standard " (version in 2003), make the asthenopia releasing function human feeding trial, it is as follows to get No. 07097 examining report of Hubei Province disease control (2005) searching:
1 sample and method
1.1 sample provides " soft capsule " by the present patent application people; External packing, sensory properties and the similar placebo of health food soft capsule of the present invention are provided simultaneously.
1.2 it is subjects that this human feeding trial of subjects is selected 108 people of age in the crowd in 15-18 year, get rid of eye disease patients such as suffering from infectious eye part disease, nebula and cone angle film, take in a short time and tried the relevant article of function, influence judgement person as a result, take the medicine of other relevant treatment eyesight for a long time or use other methods of treatment to fail termination person, and do not take in accordance with regulations, or data is not congruent influences effect or security judgement person.During off-test, obtain 101 parts of efficiency test data altogether.
1.3 double-blind study is adopted in test grouping and this test of amount, at random the experimenter is divided into two groups, gets rid of and ends the experimenter midway for some reason, actual tests group 50 examples, control group 51 examples.Test group is taken " soft capsule ", and control group is taken placebo.Every day 2 times, each 2.Each experimenter takes 30 days cycles.
2 test methods and observation index
2.1 overview index
Physical examination, diet, sleep, mental status.
2.2 security is observed:
Blood, urine, stool routine examination inspection: red blood cell (RBC) counting, leucocyte (WBC) counting, hemoglobin (HB), blood platelet (PLT) etc. and routine urinalysis and stool routine inspection; Biochemical indicator is measured: glutamic-pyruvic transaminase ALT, glutamic-oxalacetic transaminease AST, total protein TP, seralbumin ALB, urea nitrogen BUN, creatinine CRE; Chest X-rays, electrocardiogram, Abdominal B type ultrasonography, pretest inspection are once.
2.3 eye subjective symptoms index
Ophthalmodynia, eye expand, photophobia, blurred vision, symptom such as dry and astringent, calculate the eye symptom total mark, see Table 2.
2.4 improve eyesight characteristic index
2.4.1 vision criteria: examination of distant vision
2.4.2 duration of photopic vision
Table 2 visual fatigue symptom decision method (sxemiquantitative integration method)
Project/rank |
0 |
1 minute |
2 minutes |
3 minutes |
Eye expands |
There is not 0 fen |
The random thoughts eye is done 1 fen |
The time have eye to expand, the back of having a rest takes a turn for the better 2 fens |
Often eye expands, and the back of having a rest is improved 3 fens |
Ophthalmodynia |
There is not 0 fen |
Random thoughts secret anguish, 1 minute |
The time ophthalmodynia is arranged, 2 minutes |
Frequent ophthalmodynia, 3 minutes |
Photophobia |
There is not 0 fen |
Idol has photophobia, 1 minute |
The time photophobia is arranged, 2 minutes |
Frequent photophobia, 3 minutes |
Blurred vision |
There is not 0 fen |
Idol has fuzzy, 1 minute |
In the time, have fuzzyly, and the back of having a rest is alleviated 2 fens |
Often fuzzy, the back of having a rest is improved 3 fens |
Eye is dry and astringent |
There is not 0 fen |
Idol has dry and astringent, 1 minute |
The time have dry and astringent, 2 minutes |
Often dry and astringent, 3 minutes |
In the table 2: " random thoughts " are meant 1-2 time/2 days, and " time have " is meant 1-3 time/day, " often " be meant>and 3 times/day.
2.5 effect criterion
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.
Invalid: as not reach effective standard.
Eyesight improving: test-meal test back is improved 2 behaviors before than the test-meal test and is improved, with the eyesight improving rate as the reference index.
2.6 data are handled and statistical analysis
Measurement data adopts the t check to analyze.Own control adopts paired t-test.Two groups of means relatively adopt t check in groups.Comparing difference does not have under the prerequisite of conspicuousness between group before test, can test between the group of back and compare.
The improvement rate is an enumeration data, adopts 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 frequency occurs and be equal to or less than at 1 o'clock, should use definite probabilistic method instead.
3 results
3.1 take " soft capsule " general index situation of change, experimenter's edible " soft capsule " is after 30 days, there is certain improvement subjective symptom aspects such as diet, sleep, mental status, do not find bad reaction.Physical examination is also carried out no abnormal variation respectively before and after test-meal.
3.2 blood safety index observing: the results are shown in Table 3, by table 3 as seen, before and after two groups of test-meals, blood biochemical detects every index all in normal range (NR).
3.3 Chest X-rays, electrocardiogram, ultrasound diagnosis:
The experimenter is normally.
Safety indexs such as table 3 test-meal front and back blood change relatively (mean+SD)
Project |
Test group (n=50) |
Control group (n=51) |
Before the test-meal |
After the test-meal |
Before the test-meal |
After the test-meal |
RBC(×10
12/L)
|
4.27±0.47 |
4.36±0.40 |
4.33±0.52 |
4.37±0.49 |
WBC(×10
9/L)
|
7.02±1.27 |
7.25±1.35 |
6.53±1.40 |
6.75±1.40 |
HB(g/L) |
124.6±10.63 |
126.3±11.26 |
122.3±12.23 |
123.0±12.17 |
PLT(×10
9/L)
|
180.5±34.81 |
188.1±34.92 |
180.9±34.49 |
189.3±39.71 |
TP(g/L) |
71.7±4.47 |
72.9±4.16 |
71.6±4.43 |
72.6±3.98 |
ALB(g/L) |
42.1±4.67 |
42.6±4.23 |
41.3±4.50 |
41.8±4.26 |
ALT(u/L) |
23.3±4.72 |
23.5±4.19 |
23.6±4.20 |
24.3±3.20 |
AST(u/L) |
32.2±4.83 |
33.2±4.19 |
32.2±5.93 |
33.1±4.12 |
BUN(mmol/L) |
4.7±1.14 |
4.7±1.08 |
4.51±1.10 |
4.52±1.04 |
CRE(umol/L) |
85.3±14.70 |
86.2±14.38 |
86.4±11.74 |
87.2±11.46 |
Routine urinalysis |
Normally |
Normally |
Normally |
Normally |
Stool routine examination |
Normally |
Normally |
Normally |
Normally |
3.4 take " soft capsule " eye subjective symptoms situation of change:
The results are shown in Table 4, by table 4 as seen, expand at the ophthalmodynia of taking " soft capsule " back test group, eye, photophobia, blurred vision, symptom such as dry and astringent obviously improve, during off-test, comparing difference has utmost point conspicuousness (P<0.01) before and after the eye symptom total mark test-meal of test group; Eye symptom total mark and control group comparing difference have conspicuousness (P<0.05) after the test group test-meal; Eye symptom total mark difference and control group comparing difference have utmost point conspicuousness (P<0.01) before and after the test-meal of test-meal group.
3.5 take the situation of change of " soft capsule " back eyesight, the results are shown in Table 5, by table 5 as seen, take " soft capsule " eyesight is not had obvious improvement effect.
3.6 duration of photopic vision: the results are shown in Table 6, by table 6 as seen, duration of photopic vision is significantly improved after the test group test-meal, with the control group comparing difference utmost point conspicuousness (P<0.01) is arranged, duration of photopic vision relatively before and after the test group test-meal, difference has utmost point conspicuousness (P<0.01), and difference and control group relatively have utmost point conspicuousness (P<0.01) before and after the test-meal of test group duration of photopic vision, and the average improvement value of duration of photopic vision is 0.116.
Table 4 is taken " soft capsule " back eye symptom total mark relatively (mean+SD)
Group |
Number |
The symptom total mark |
Before the test-meal |
After the test-meal |
The P value |
Difference (back-preceding) |
Test group |
50 |
4.3±1.72 |
3.2±1.62 |
0.000 |
-1.04±0.81 |
Control group |
51 |
4.2±1.92 |
4.1±1.86 |
0.348 |
-0.12±0.89 |
P value (comparing between group) |
0.946 |
0.011 |
- |
0.000 |
Table 5 is taken the front and back of " soft capsule " left eye distant vision and is compared (mean+SD)
Group |
The eye number |
Before the test-meal |
After the test-meal |
P value (front and back relatively) |
Test group |
50 |
4.6±0.29 |
4.6±0.28 |
0.135 |
Control group |
51 |
4.7±0.31 |
4.7±0.30 |
0.420 |
P value (comparing between group) |
0.178 |
0.216 |
- |
Continuous table 5 is taken the front and back of " soft capsule " right eye distant vision and is compared (mean+SD)
Group |
The eye number |
Before the test-meal |
After the test-meal |
P value (front and back relatively) |
Test group |
50 |
4.6±0.29 |
4.6±0.30 |
0.133 |
Control group |
51 |
4.7±0.33 |
4.7±0.33 |
0.182 |
P value (comparing between group) |
0.139 |
0.158 |
- |
Duration of photopic vision compared (mean+SD) before and after table 6 was taken " soft capsule "
Group |
Number |
Before the test-meal |
After the test-meal |
P value (front and back relatively) |
Difference |
Test group |
50 |
0.564±0.125 |
0.680±0.122 |
0.000 |
0.116±0.056 |
Control group |
51 |
0.567±0.132 |
0.595±0.124 |
0.081 |
0.028±0.113 |
P value (comparing between group) |
0.900 |
0.001 |
- |
0.000 |
3.7 total effective rate:
The results are shown in Table 7, by table 7 as seen, the total effective rate of the remitting vision fatigue of test group is apparently higher than control group after taking " soft capsule ", and difference has utmost point conspicuousness (P<0.01).
Table 7 is taken " soft capsule " total effective rate situation relatively
Group |
Number |
Effective number |
Total effective rate (%) |
P value (comparing between group) |
Test group |
50 |
32 |
64.0 |
P<0.01 |
Control group |
51 |
4 |
7.8 |
- |
4 conclusions
The experimenter takes " soft capsule " after 30 days continuously, and the ophthalmodynia of test group, eye expand, photophobia, blurred vision, symptom such as dry and astringent are obviously improved, and during off-test, comparing difference has utmost point conspicuousness (P<0.01) before and after the eye symptom total mark test-meal of test group; Eye symptom total mark and control group comparing difference have conspicuousness (P<0.05) after the test group test-meal; Eye symptom total mark difference and control group comparing difference have utmost point conspicuousness (P<0.01) before and after the test group test-meal; Duration of photopic vision after the test group test-meal is significantly improved, with before the test-meal and the control group comparing difference utmost point conspicuousness (P<0.01) is all arranged; The average improvement value of test group duration of photopic vision is 0.116 (greater than 0.1), and difference and control group comparing difference have utmost point conspicuousness (P<0.01) before and after the test-meal; Test group remitting vision fatigue total effective rate reaches 64.0%, and apparently higher than control group, difference has utmost point conspicuousness (P<0.01).In the test-meal, blood parameters and clinical health check-up index there is no ANOMALOUS VARIATIONS, have not observed bad reaction.According to criterion, verify that health food of the present invention has the effect of tangible alleviating asthenopia.