CN1334097A - Health-care product for improving visual function - Google Patents

Health-care product for improving visual function Download PDF

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CN1334097A
CN1334097A CN 00119465 CN00119465A CN1334097A CN 1334097 A CN1334097 A CN 1334097A CN 00119465 CN00119465 CN 00119465 CN 00119465 A CN00119465 A CN 00119465A CN 1334097 A CN1334097 A CN 1334097A
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group
test
sample
vitamin
weight
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CN1141115C (en
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范小兵
李慈娟
韩超
沙大年
张迪
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ONLY CO Ltd SHANGHAI JIANTONG UNIV
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ONLY CO Ltd SHANGHAI JIANTONG UNIV
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Abstract

A health-care capsule for improving vision, relaxing visual fatigue, resisting radiation and preventing cataract is prepared from the extracts of wolfberry fruit, chrysanthemum flower and gingko leaf, taurine, beta-carotin, VB1, VB2, VC and zinc gluconate. Its preparing process is also disclosed.

Description

A kind of health product that improve visual performance
The present invention relates to health product, be specifically related to a kind of health product that can improve visual performance.
Along with science and technology development, office conditions is improved, and the work of people's daily life all be unable to do without TV, computer every day, and generation harm is to a certain degree known from experience to the people in TV, computer terminal, mainly show eyes, skeleton skin and nervous system etc., wherein outstanding with influence to eyes.Eyestrain's phenomenon does not occur over just among the students, and often takes place in the young and the middle aged even elderly population yet.Glass curtain wall uses in a large number in addition, and local light intensity is too high might damage retina.Increase with the age simultaneously, worn with age, deficiency of both the liver and kidney, QI and blood freely do not reach in the body a large amount of free radical surpluses etc., cause chronic cataract to form, and cause old visual disorder.The effectively eye protection product of exploitation food has extensive market prospect for this reason.
The objective of the invention is in conjunction with Chinese and western medicine theory, prepare a kind of health product that can improve visual performance.
The invention provides a kind of health product (Onlly photopic vision capsule) that improve visual performance; these health product are by 5~15 parts of Fructus Lyciis, 5~15 parts of Flos Chrysanthemis, 2~5 parts of Folium Ginkgo extract powders, 5~15 parts of taurines, 1~3 part of vitamin C by weight, 2~5 parts of zinc gluconate, vitamin B 10.01~0.1 part, vitamin B 20.01 any proportioning that~0.1 part and beta-carotene are 0.01~0.1 part is formed.
Above-mentioned Folium Ginkgo extract powder is commercially available obtaining.
A kind of anti-cataract result of the test following (through the Jiangsu Province Medicine Primary Institute test) of improving the health product of visual performance of the present invention:
1, medicine:
The photopic vision capsule is provided by Only Co., Ltd., Shanghai Jiantong Univ., lot number 980618; ZHANGYANMING PIAN is produced by Huizhou City, the Guangdong Province pharmaceutical factory of traditional Chinese medicine, lot number 950905; The D-galactose is that reagent two factories in Shanghai produce lot number 970722; MDA and protein determination test kit build up bio-engineering research institute available from Nanjing, and lot number is respectively 980620 and 980714.
2, animal:
50 of SD rats, body weight 80-100g, male and female half and half, by the Animal House supply of this institute, the quality certification: Soviet Union's kinoplaszm 97007.Soviet Union's rotating ring 97007.
3, experimental technique:
3.1 the grouping rat is no abnormal through the slit lamp examination eye, is divided into 5 groups at random by sex, body weight, 10 every group.Be respectively normal control group, cataract model group, ZHANGYANMING group and photopic vision capsule high and low dose group.
Be dissolved in distilled water and be made into 50% solution 3.2 the cataract model prepares galactose, after sterilization, lumbar injection, dosage are 10g/kg, once a day, and continuous 11 days.In drinking-water, add 5% galactose in addition, connect and give 5 days.
3.3 give the object space method of being tried: in beginning to being tried thing for sugared the last week, the photopic vision capsule 's content is made into suspension with 1%CMC, also is made into suspension with 1%CMC behind the ZHANGYANMING PIAN porphyrize, gastric infusion.Dosage is respectively high dose group 1g/kg, low dose group 0.25g/kg, and ZHANGYANMING group 1.65g/kg, once a day.Normal group and model group are irritated equivalent 1%CMC (1ml/100g body weight).Successive administration 36 days.After one week of administration, except that normal group, all the other each groups are brought out cataract by 3.2 described methods to galactose.
3.4 therapeutic evaluation:
3.4.1 the observation of crystal turbidity is observed weekly 2 times after beginning with the scoring modeling.Earlier with 1% atropine eye drip platycoria, then with the handheld slit lamp inspection and press that table 1 is marked, record.Under photoslit-lamp, check in case of necessity and take a picture.
The normal crystal of table 1 rat crystal turbidity standards of grading stage rank crystal turbidity score value is clarified 01 A crystal periphery and tiny cavity 0.1 occurred
There is cavity faciola 0.4 the B ambitus
The C cavity accounts for 1/3 0.7 of crystal frontal cortex area
The D cavity accounts for the 2/3 1.0 2 cavitys liquefaction of crystal frontal cortex area or opalescence occurs or minute quantity occurs
Point-like, muddy 2.0 3 crystal of strip white are dispersed in lamellar white precipitate 3.0 4 crystal nuclears and begin muddy 4.0 5 crystal nuclears whole muddy 5.0
3.4.2 crystal fibre Ultrastructural observation and biochemical indicator are measured
After the drug withdrawal 1 day, draw neck to put to death rat, dissect and take out two eye lenss.The right eye crystal at random every group get 8 preparation electron microscopic observation specimen, after the homogenate of left eye crystal, measure MDA, insoluble protein and high-molecular-weight protein content.
3.4.2.1 crystal fibre Ultrastructural observation and quantitative analysis
Crystal is through 4% glutaraldehyde fixing a couple of days, and fixing behind 4% osmic acid, the dehydration of acetone gradient is along antero posterior axis fracture sample, isoamyl acetate displacement, liquid CO 2Critical point drying behind the IB-3 type ion sputtering instrument plated film, is observed and photography with SX-40 type scanning mirror.Observe the ultrastructure of preceding shallow cortex of crystal and preceding dark cortical layer fiber, and calculate the phalangeal process number (n) on long 4 fibers of each crystal 8um, the width of 5 fibers (Tum), and the crystal fibre number is fibre density (D) in the 10um width.
3.4.2.2 lipid peroxidation product malonaldehyde (MDA) assay in the crystal
Take out a large amount of left eye crystal, blot the surface moisture weighing, respectively insert and in vitro add the 1.2ml normal saline, homogenate in the ice bath.Each is managed homogenate and draws 0.2ml, presses MDA and measures the mensuration of method (TBA method) shown in test kit MDA content.
3.4.2.3 the every pipe of insoluble protein and high-molecular-weight protein assay residue crystal homogenate adds the 1ml normal saline again in the crystal, with 9544 * g4 ℃ centrifugal 30 minutes (BeckmanCS-15R type centrifuge), is precipitated as insoluble protein.Take out supernatant, with 57300 * g4 ℃ centrifugal 15 minutes (Beckman Optima 9708LE-8K centrifuge), be precipitated as high-molecular-weight protein again.Dissolubility albumen and high-molecular-weight protein are dissolved with 7mol/L carbamide respectively, measure protein content respectively by method shown in the protein determination kit (biuret method)
4, result
When finishing to galactose, the scoring of model group rat crystal turbidity has reached more than 1 minute, stops to the follow-up supervention exhibition of sugar, divides equally to reach more than 3 minutes when experiment finishes, and shows cataract modeling success.
4.1. rat crystal turbidity appraisal result sees Table 2 under the slit lamp observation:
Table 2 photopic vision Capsule in Rats lens opacity score value affect after the administration of group number of crystals 36 days Normal group 20 00 model group 20 1.260 ± 0.985 3.350 ± 0.745 photopic vision high dose 20 0.560 ± bright group of 20 0.710 ± 0.506 1.950 ± 0.999** of 0.284 1.755 ± 1.244** capsule low dosage, 20 0.625 ± 0.215 1.970 ± 1.063** barrier eye after the administration in 18 days
Compare * P<0.05**P<0.01 (down together) with model group
The result shows, (finishing the same day for sugar) the photopic vision capsule that tried thing 18 days is respectively organized the scoring of crystal turbidity and all is lower than model group, shows that the photopic vision capsule has the trend that delays rat crystal development of cataracts, but the statistical test nonsignificance.Administration 36 days, photopic vision capsule are respectively organized the scoring of crystal turbidity and all significantly are lower than model group, have shown the effect of the anti-sugared cataract of photopic vision capsule.
Table 3 photopic vision capsule influences shallow cortex depth cortex before the group number of crystals to the rat crystal is Ultrastructural
Phalangeal process number (n) width (T) density (D) phalangeal process number (n) width (T) density (D) normal control group 8 93.4 ± 9.9 5.92 ± 0.55 7.2 ± 0.7 89.1 ± 9.8 6.30 ± 0.67 6.7 ± 0.7 model group 8 28.9 ± bright group of 8 81.3 ± 18.2**, 6.04 ± 0.81*, 7.1 ± 0.9*, 81.9 ± 9.0**, 6.04 ± 0.45**, 6.9 ± 0.5** of 22.4 8.26 ± 2.16 5.4 ± 1.7 41.5 ± 27.2 7.16 ± 0.67 5.8 ± 0.6 photopic vision high dose 8 82.0 ± 11.8**, 5.19 ± 0.56*, 7.0 ± 0.8*, 79.8 ± 7.1**, 6.29 ± 0.73*, 6.8 ± 0.7* capsule low dosage, 8 85.4 ± 10.6**, 6.08 ± 0.53*, 7.0 ± 0.9*, 80.9 ± 12.2**, 6.45 ± 0.66 6.5 ± 0.9* barrier eye
The result of electron microscopic observation and quantitative analysis shows, normal crystal fibre marshalling, and phalangeal process is more clear; The obvious swelling of cataract membranous type group crystal, width increases, density decline, arrangement disorder, the phalangeal process number obviously reduces even disappears, and it is outstanding that shallow cortex was more obvious in the past; The pathological change that the photopic vision capsule is respectively organized crystal fibre significantly is lighter than model group: fiber alignment is all more neat, and the more clear and number of phalangeal process is significantly more than model group.The pathological changes that shows rat crystal fibre when the photopic vision capsule can alleviate the cataract modeling.
4.2 the measurement result of rat crystal MDA; Insoluble protein and high-molecular-weight protein sees Table 4, group number of crystals insoluble protein (ug/mg) macromolecule protein (ug/mg) normal control group 10 41.01 ± 11.49 11.96 ± 3.73 model group 10 80.83 ± 39.10 33.69 ± 5.56 photopic vision high doses, 10 44.24 ± 29.43**, the 12.84 ± 8.03** capsule low dosage 10 69.84 ± 31.92 31.21 ± 3.15 that affects that affects bright group of 10 0.373 ± 0.186* table 5 photopic vision Capsule in Rats crystalline protein content of group number of crystals MDA content (umol/mg) normal control group 10 0.359 ± 0.060 model group 10 0.634 ± 0.232 photopic vision high dose 10 0.368 ± 0.147** capsule low dosage 10 0.414 ± 0.158* barrier eye of table 5. table 4 photopic vision Capsule in Rats crystal MDA content hinders bright group of 10 52.83 ± 12.76*, 23.78 ± 2.44** of eye
The result shows that photopic vision capsule and ZHANGYANMING all can significantly suppress the increase of MDA content in the crystal, show lipoid peroxidization resistant.Photopic vision capsule in high dose group and ZHANGYANMING group still can reduce the content of interior insoluble protein of crystal and high-molecular-weight protein.
5, conclusion (of pressure testing):
Comprehensive slit lamp observation scoring, scanning electron microscope think that to the result of crystal fibre Ultrastructural observation and quantitative analysis and MDA, insoluble protein and high-molecular-weight protein biochemical measurement the photopic vision capsule has remarkable prevention effect to rat galactose cataract.
A kind of protective effect result of study following (through the research of East China biology department of Normal University) of improving the health product of visual performance to rat and rabbit retina elder generation chemical damage of the present invention:
One, experimental technique:
1, experiment material:
Laboratory animal SD rat available from Shanghai family planning institute, belongs to clean level
Illuminance 251.17 ± 127.69Lx during normal the raising
Beginning to the sample body weight after buying is 75.52 grams, 300 ± 14.32 grams during experiment
2, the filling of capsule sample is fed
Divide high dose group and low dose group to sample group rat, the high dose group rat feeds Onlly photopic vision capsule-like part 137mgkg body weight/day, and low dose group is fed the 68.5mg/kg body weight/day, continuous irrigation is fed to experiment get eyeball before, totally 30 days.
3, the foundation of illumination damage model
Rat feeding is in normal illumination, among illuminance 251.17 ± 127.69Lx, before illumination, in the darkroom, closed earlier 36 hours, be positioned over after closing in the steel wire illumination cage, ad lib and drinking-water, around the cage and end face place 12 of 60W white fluorescent lamps (illuminance 2986.67 ± 1236.96Lx), illumination cage keep ventilating, and control temperature and do not rise.Continuous light 48 hours, illumination finish the back puts to death, and gets eyeball and surveys rhodopsin, SOD and MDA.
4, the mensuration of rhodopsin
Acute execution rat is won eyeball rapidly in the darkroom, with PBS (0.1mol/L, pH7.0) flushing cuts off epibulbar blood vessel and connective tissue, inhales on filter paper and removes PBS, in homogenizer, shred, add the PBS2ml that contains 15%Trtonx-100, homogenate in ice bath is with centrifugal (4 ℃ of homogenate low-temperature and high-speed, 1500RPM, 15min), get supernatant, survey absorbance A in the 500nm place with spectrophotometer 1, supernatant places irradiation 10min under the 100W electric filament lamp then, and spectrophotometer 500nm place surveys absorbance A 2, rhodopsin content is by absorbance A=A 1-A 2Calculate, it is expressed as the nmol number of every eyeball by the rhodopsin molar absorptivity.
5, the mensuration of retina, crystalline lens SOD and MDA
Win eyeball, in ice PBS, cut off epibulbar blood vessel and connective tissue, on filter paper, inhale and remove PBS, cut off eyeball along limbus of corneae, obtain retina choroid and crystalline lens cornea respectively, be sub-packed in two Eppendorf pipes, claim weight in wet base, press weight in wet base: volume=usefulness PBS diluted in 1: 9, ground to form 10 homogenate with homogenizer.Centrifugal on freezing high speed centrifuge (3000RPM, 4 ℃, 10min) gets supernatant.Measure SOD, the MDA content of supernatant respectively with SOD, MDA test kit.
6, the mensuration of rabbit electroretinogram
The animal grouping
New Zealand white rabbit, available from biological supplies station, Shanghai, body weight 2.770 ± 0.378kg is divided into normal group at random and to the sample group, 3 every group, freely gets food drinking-water.
The filling of capsule sample is fed
Onlly photopic vision capsule-like powder is dissolved as suspension (45mg/ml) with distilled water, directly irritates with filling hello device insertion esophagus and feeds.Rabbit filling every day to the sample group is fed once, and the sample amount is the 45mg/kg body weight/day.Continuous irrigation was fed 12 days.
The foundation of photic damage model
Rabbit is twilight-sleep with urethanes, and animal is fixed, and draws back eyelid, and with the pupil irradiation of cold light lamp over against rabbit, illuminance is 3500Lx, and the continuous light time is 4 hours.
The mensuration of electroretinogram
Animal is twilight-sleep, fixing, place on the cornea as recording electrode with the suspension radius tip electrode, it is preceding subcutaneous that indifferent electrode is put the rabbit volume, and recording electrode and indifferent electrode connect with MASTER-A bio signal processing system (development of department of biology of East China Normal University) amplifier, uses flash stimulation, the thorn laser point is over against pupil, after the dark adaptation 15 minutes, the stimulation of glittering is with electroretinogram input MASTER-A bio signal processing system record, date processing and the preservation that is directed to.
Write down normal group respectively and to the electroretinogram before and after the photic damage of sample group.Measure the b ripple incubation period of electroretinogram and the amplitude of b ripple.
Two, experimental result;
1, rhodopsin content table 1 Onlly as shown in table 1 below photopic vision capsule causes the influence of rhodopsin changes of contents to retinal photic injury in rats
Group Sample number Rhodopsin contains reason nmol/eye
Normal group ????8 ??????1.648±0.842
The photic damage matched group ????7 ??????0.902±0.197
The photic damage high dose is to the sample group ????8 ??????1.633±0.837
The photic damage low dosage is to the sample group ????8 ??????1.195±1.572
After the high light damage, photic damage group rhodopsin content obviously reduces than normal group, significant difference (P<0.05).After giving sample, low dose group and high dose group rhodopsin content rise, significant difference (P<0.05) between high dose group and the photic damage matched group wherein, and its content almost reaches normal level.Difference is not remarkable between low dose group and the photic damage matched group.
2, retina, crystalline lens MDA content are as shown in table 2
Table 2 Onlly photopic vision capsule to retinal photic injury in rats cause retina,
The influence of crystalline lens MDA changes of contents
Group Sample number Retina MDA content nmol/mg weight in wet base Crystalline lens MDA content nmol/mg weight in wet base
Normal group ????7 ????1.886±0.347 ????1.067±0.160
The photic damage matched group ????8 ????2.701±0.856 ????1.120±0.201
The photic damage high dose is to the sample group ????8 ????2.171±0.391 ????1.085±0.116
The photic damage low dosage is to the sample group ????7 ????2.600±0.534 ????1.375±0.531
MDA content in the retina, high light damage back matched group MDA content rises, diversity is (P<0.05) significantly, give sample after MDA content descend but difference not significantly (P>0.05).
MDA content in crystalline lens and the cornea, whole no significant difference.
3, retina, crystalline lens SOD content are as shown in table 3
Table 3 Onlly photopic vision capsule to retinal photic injury in rats cause retina,
The influence of crystalline lens SOD changes of contents
Group Sample number Retina SOD content NU/mg weight in wet base Crystalline lens SOD content NU/mg weight in wet base
Normal group ????7 ????38.18±7.27 ????47.75±22.76
The photic damage matched group ????8 ????44.30±7.65 ????63.94±26.46
The photic damage high dose is to the sample group ????8 ????55.75±16.32 ????39.52±14.68
The photic damage low dosage is to the sample group ????6 ????65.68±6.23 ????25.56±17.55
Annotate: according to the definition of enzyme: to reach 50% o'clock pairing SOD amount be a nitrous acid unit to the SOD suppression ratio in every ml reactant liquor.(NU/ml)
For amphiblestroid SOD content, occur the increase of compensatory during photic damage, obviously rise to SOD content behind the sample, wherein low dose group is compared effect extremely significantly (P<0.01) with the photic damage matched group, high dose group SOD content also has rising, but difference not significantly (P>0.05).In crystalline lens and cornea, SOD does not have rising trend to the sample group.
4, rabbit electroretinogram rabbit electroretinogram Fig. 1-4 that sees Appendix.
Experimental record to electroretinogram b ripple, is carried out incubation period and amplitude measurement, calculate its meansigma methods and standard error.With the significance of difference of each group of t inspection, the result is as shown in table 4.
Table 4 Onlly photopic vision capsule is to the rabbit retina photodamage
Cause the influence that electroretinogram b ripple incubation period and amplitude change
The animal grouping Incubation period (meansigma methods ± standard error) ms Amplitude (meansigma methods ± standard error) mv
Normal group ??????8.619±0.971 ??????0.334±0.042
The normal group photic damage ??????10.304±1.211 ??????0.181±0.031
To the sample group ??????7.842±2.364 ??????0.355±0.054
To the photic damage of sample group ??????7.773±1.697 ??????0.210±0.061
The result shows, the amplitude of normal group rabbit electroretinogram b ripple has significantly after photic damage and reduces, mutual difference is (P<0.001) extremely significantly, be slightly larger than normal group to electroretinogram b wave amplitude before the photic damage of sample group rabbit, but difference is remarkable (P<0.05) not, to sample group rabbit electroretinogram b wave amplitude significantly minimizing is arranged after photic damage, difference is (P<0.001) extremely significantly, and than the b wave amplitude height after the photic damage of normal group rabbit, significant difference (P<0.05), but Shang Weijian returns to the b ripple level before the normal group photic damage, b ripple after the photic damage of normal group rabbit obviously prolongs (P<0.05) incubation period, difference not significantly (P>0.05) between b ripple incubation period and the normal group to the sample group and after giving the sample photic damage.
Three, conclusion
From experimental result, Onlly photopic vision capsule has the certain protection effect to photochemical damage.Its model of action show following some:
1, do not strengthen retinal rod, looks the protection of vertebra cell by increasing intraocular rhodopsin content.
2, by in the inhibition body, especially intraretinal lipid oxidation process reduces lipid peroxide to amphiblestroid damage.
3, by increasing eyeball, especially intraretinal SOD content strengthens the ability of removing oxygen-derived free radicals in the retina.
In this experiment, high dose group effect on increase rat retina rhodopsin is obvious, significant difference.Low dose group is obvious to the enhance SOD activity effect, and difference is extremely remarkable.Though all the other effects have the difference on the meansigma methods, t-check difference is not remarkable.
4, electroretinogram b ripple reflection retina is the excitatoty useful index of retina to the activity of light type bipolar cell.Feed with Onlly photopic vision capsule to rabbit, compare with the photic damage group, the amplitude of its electroretinogram b ripple increases, significant difference (P<0.05), and prompting Onlly photopic vision capsule can improve the retina irritability.
A kind of health product that improve visual performance of the present invention are to antifatigue effect assay following (through Shanghai Disease Prevention and Control Centre's check):
One, antifatigue effect:
1, sample character and processing: yellow powder is modulated into each concentration with distilled water, for examination.
2, dosage design: this product human body recommended dose is 1.2g/60kg every day.Basic, normal, high three agent groups are established in this experiment, are respectively 0.1,0.2,0.68g/kg, and other establishes blank group (distilled water).
3, laboratory animal: Kunming kind white mice, male, 20-22 gram, by the cleaning level animal (raising of our station SPF Animal House) that Shanghai Medical Univ's Animal House provides, the quality certification number: 02-22-1.
4, give the sample approach: irritate stomach.
5, experimental technique and result:
5.1 swimming with a load attached to the body test: get 40 of Kunming kind white mice, be divided into four groups at random, every group 10, design was according to dosage fed 28 days continuously, after last is irritated stomach 30 minutes, mice is put into water swim, depth of water 30cm, 25 ± 0.5 ℃ of water temperatures, the load sheet lead of 5% body weight of Mus root of the tail portion, the record mice from the swimming beginning to the dead time.
((through variance analysis) compared with the blank group in dosage 10 511.7 ± 210.2 high doses 10 786.7 ± 296.4**P<0.05 to sample in group number of animals (only) swimming with a load attached to the body time (second) blank 10 419.1 ± 247.5 low dosages 10 487.9 ± 220.3 of X ± SD) to the influence of mice swimming with a load attached to the body time
As seen from the above table, the sample high dose group is compared with the blank group, and there were significant differences.
5.2 liver glycogen is measured: get 40 of Kunming kind white mice, be divided into four groups at random, 10 every group, design is according to dosage fed continuously and was cultivated 28 days, after last is irritated stomach 30 minutes, mice is put into 30 ℃ of water swimming 90 minutes, and take out, it is dirty to get Hepar Mus at once, surveys liver glycogen.
Sample to the mice animal after the influence of liver glycogen ((through variance analysis) compared with the blank group in dosage 10 801.5 ± 95.3 high doses 10 995.9 ± 101.2**P<0.05 in group number of animals (only) liver glycogen (second) blank 10 503.7 ± 76.4 low dosages 10 694.4 ± 99.8 of X ± SD)
As seen from the above table, the sample high dose group is compared with the blank group, and there were significant differences.
5.3 lactic acid is measured: 40 of Kunming kind white mice, be divided into four groups at random, every group 10, design is according to dosage fed continuously and is surveyed blood lactic acid after 28 days and after last is given sample 30 minutes, and 2% (body weight) of bearing a heavy burden swim 60 minutes in temperature 25-30 ℃ water, taking-up, survey blood lactic acid, hot-air seasoning after quiet 60 minutes, is surveyed blood lactic acid again.
Sample is to the influence of mouse movement bleeding from anus lactic acid (the group number of animals blood lactic acid (mmol/l) of X ± SD)
(only)
Test in rear 60 minutes blank 10 4.32 ± 0.69 11.59 ± 1.54 7.72 ± 1.09 low dosage 10 4.43 ± 0.40 11.51 ± 2.01 5.65 ± 1.81 of rear 0 minute of front experiment experiment dosage 10 4.28 ± 0.44 11.89 ± 3.18 5.57 ± 4.02 high dose 10 4.26 ± 0.53 12.00 ± 3.46 4.50 ± 2.03**P<0.05 and compare (Analysis of variance) with the blank group
As seen from the above table, the sample high dose group is tested back 60 minutes animal blood lactic acid contents and is compared with the blank group, and significant difference is arranged.
Determination of urea nitrogen: get 40 of Kunming kind white mice, being divided at random is four groups, and 10 every group, design was according to dosage fed 28 days continuously, after last is irritated stomach 30 minutes, mice is put into 30 ℃ of water swimming 90 minutes, take out hot-air seasoning, make peace and quiet, get Mus blood, centrifugal, get serum and survey blood urea nitrogen.
Sample to mouse movement after the influence of serum urea nitrogen ((through variance analysis) compared with the blank group in dosage 10 6.01 ± 1.68 high doses 10 5.17 ± 1.98**P<0.05 in group number of animals (only) blood urea nitrogen (mmol/l) blank 10 7.71 ± 0.86 low dosage 10 6.76 ± 2.07 of X ± SD)
As seen from the above table, the sample high dose group is compared with the blank group, and significant difference is arranged.
A kind of health product that improve visual performance of the present invention are to improving vision effect human trial result following (through Shanghai Sanitation Control and Inspection Station for Foodstuff's check): 1. materials and methods 1.1 diagnostic criterias: it is clear that (according to Ministry of Public Health new Chinese medicine clinical research guideline) 1.1.1 tcm diagnosis standard 1.1.1.1 looks nearly thing, look thing far away cover, look the thing slur, often must foreign body in the eye and look.1.1.1.2 eyestrain, the ophthalmic bloated headache.1.1.2 Chinese medical discrimination standard
Syndrome of yin deficiency of liver and kidney: except that having above-mentioned symptom, have the dry and astringent discomfort of eye concurrently, can not watching for a long time, eyelid is tired to be desired to close, dry mouth and throat or blurred vision, or have a dizzy spell, or tinnitus is forgetful, red tongue with a little fluid, few tongue or no fur, thready pulse or count accurately.1.1.3 Western medicine diagnose standard 1.1.3.1 definition:
Pseudomyopia: school age population distant vision under normality is regulated reduce<1.0, near vision is normal 〉=1.0, microcoria inspection shadow is the myopia ametropia, use multiple spherical lens can improve the near-sighted state of distant vision, but after using the atropine platycoria, myopia disappears, and is rendered as and faces or hypermetropia.1.1.3.2 clinical manifestation: blurred vision is unclear, eyes tire easily, and looking thing when serious has slur,
Or ophthalmic bloated, forehead headache etc.1.2 including standard 1.2.1 in, the experimenter meets diagnostic criteria and Chinese medical discrimination person; 1.2.2 age 6-15 year student; 1.2.3 bore hole distant vision 〉=0.1,<1.0 bore hole near vision 〉=1.0; 1.2.4 platycoria inspection shadow, diopter is 0.1.3 exclusion standard 1.3.1 does not meet the patient who includes age criterion in, to this product allergy sufferers; 1.3.2 suffer from infectious eye part disease person, corneal nebula, circle Phasiana cornea; 1.3.3 suffer from fundus oculi disease or be associated with cardiovascular, cerebrovascular, liver, kidney, hemopoietic system
Etc. serious primary disease, the psychotic.1.3.4 take other relevant medicine for a long time or use other Therapeutic Method, fail to stop
The person; 1.3.5 do not meet the standard of including in, do not use this product in accordance with regulations, can't judge result of the test,
Or the not congruent impact effect of data is judged or safety judgement person.2. observation index 2.1 visions are observed: the 2.1.1 distant vision is observed: check with the international standard distant vision test chart; 2.1.2 near vision is observed: check with the international standard near vision test type; 2.1.3 near-sighted diopter: microcoria is the inspection shadow down, uses negativity spherical lens myopia correction, Ah
Examine shadow (refractive diopter 0) behind the tropine platycoria.2.1.4 the eye subjective symptoms is observed and classification
A, ophthalmic bloated: no ophthalmic bloated 0 minute
Accidental ophthalmic bloated 1 minute
Frequent ophthalmic bloated, but do not influence study, life 2 minutes
Continue ophthalmic bloated, influence study, life 3 minutes
B, ophthalmalgia: no ophthalmalgia 0 minute
Accidental ophthalmalgia 1 minute
Frequent ophthalmalgia, but do not influence study, life 2 minutes
Continue ophthalmalgia, influence study, life 3 minutes
C, the eye puckery: dry and astringent 0 minute of anophthalmia
Eye is dry and astringent not well, and tear soaked filter paper>5mm<10mm 1 minute
The dry and astringent pain of eye, tear soaked filter paper 1mm~5mm 2 minutes
The dried causalgia of eye, tear soaked filter paper<1mm 3 minutes
D, xerostomia: no xerostomia 0 minute
Slight 1 minute of dry mouth and throat
Dry mouth and throat can tolerate 2 fens
Dry mouth and throat 3 minutes unbearably
E, have a dizzy spell: do not have dizzy 0 minute
Accidental dizzy 1 minute
Often dizzy, do not influence study, life 2 minutes
Continue dizziness, influence study, life 3 minutes
F, tinnitus: no tinnitus 0 minute
Tinnitus there is 1 minute accidentally
Often tinnitus does not influence study, life 2 minutes
Continue tinnitus, influence study, 3 minutes 2.2 eyesight improving effect criterion 2.2.1 visions of life
Clinical cure: distant vision recovers normal 〉=1.0, and diopter disappears under the microcoria, transference cure.
Produce effects: naked vision improves more than four rows, and symptom is obviously improved.
Effectively: naked vision improves more than two rows, and clinical symptoms is improved.
Invalid: naked vision does not have raising or descends, and clinical symptoms does not have improvement.2.2.2 diopter
Effectively: diopter attenuating 〉=-0.50 under the microcoria.
Invalid: diopter lowers not enough-0.50 under the microcoria.2.3 respectively look into routine blood test one time before and after safety observation 2.3.1 takes; 2.3.2 respectively carry out once conventional physical examination before and after taking.3. test method and test period
Test group and matched group are set up in this test, according at random, double blinding, contrast method, 70 official holiday myopes are divided into two groups, every group is 35 people.
Test group: oral Onlly photopic vision capsule (limited company provides by the Shanghai Communications University Onlly), every 300mg, 12 of every plates, every bag 2 plate, lot number: 990113.Every day 2 times, each 2,30 days is an observation cycle, and per two weeks follow up a case by regular visits to once.
Matched group: oral be subjected to the on all four blank starch capsule of examination group outward appearance, every day 2 times, each 2,30 days is an observation cycle, per two weeks follow up a case by regular visits to once.4. result's 4.1 physical data
This organizes 70 official holiday myopes, male's 28 examples, women's 42 examples; Minimum 6 years old of age, maximum 15 years old, average 11.2 ± 2.26 years old.Table one test group and matched group grouping situation (symptom integral test group 35 13 22 11.31 ± 2.43 0.43 ± 0.19-1.17 ± 0.46 2.34 ± 1.45 matched group 35 15 20 11.11 ± 2.11 0.40 ± 0.17-1.31 ± 0.45 2.66 ± 1.00 before X ± SD) the routine number men and women age distant vision myopia of grouping diopter is tested
Learn check by statistics, two groups aspect sex, age, distant vision, near-sighted diopter and clinical subjective symptoms, no difference of science of statistics between P>0.05, two group has comparability.4.2 improve vision effect situation
Before and after the test-meal, the eyesight improving situation of test group and matched group sees table two table two test group and the matched group eyesight improving situation routine number produce effects enabledisable obvious effective rate effective percentage test group 35 47 15 9 31.43% 74.29% ※ matched groups 35 128 24 8.57% 31.43% of fully recovering that relatively divide into groups for details
※ tests through X2, and there were significant differences between X2=13.54 P<0.05, two group.Show that test group eyesight improving situation obviously is better than matched group.4.3 30 days difference test group 70 0.43 ± 0.19 0.56 ± 0.23 0.66 ± 0.30 ※ △, 0.23 matched group 70 0.40 ± 0.17 0.47 ± 0.19 0.51 ± 0.20 0.11 after the test-meal in 14 days after the distant vision test-meal before comparison (X+SD) the grouping eye number test-meal that distant vision changes before and after the test-meal of three liang of vision change lists group
※ represents: through t check, P<0.05
Table three as seen, test-meal is after 30 days, with before the test-meal relatively, the test group distant vision has significant difference.
△: expression is through t test P<0.05.
After showing test-meal, test group and matched group compare, and distant vision has significant difference.Effectively invalid number effective percentage (%) test group of the eye number 70 49 21 70% ※ matched groups 70 7 63 10% of a number 4.4 four liang of groups of diopter improvement situation comparison sheet test-meal front and back diopter situation of change is relatively divided into groups
※ tests P<0.05 through X2, and table four shows test group and matched group, and relatively there were significant differences.4.5 (difference test group 70-1.17 ± 0.46-0.73 ± 0.57 ※ △ 0.44 matched group 70-1.31 ± 0.45-1.20 ± 0.53 0.11, test back before X ± SD) grouping eye number is tested of the comparison of refraction of eye degree before and after the test-meal of five liang of groups of near-sighted diopter change list
※: expression: before and after the test group test-meal, near-sighted diopter self relatively has significant difference in P<0.05.
△: expression: near-sighted diopter before and after the test-meal, test group and matched group relatively have significant difference in P<0.05.(symptom integral difference test group 35 2.34 ± 1.45 0.71 ± 1.07 ※ △ 1.63 matched groups 35 2.66 ± 1.00 2.06 ± 1.55 0.60 after the preceding symptom integral test-meal of routine number test-meal are observed in the grouping of X ± SD) 4.6 the eye subjective symptoms changes 4.6.1 eye symptom integration comparison sheet six test group and matched group symptom integral statistics
※: expression: through t check P (0.05, show that the test group own control has significant difference before and after the test-meal.
△: expression:, show between test group and the matched group and compare that significant difference is arranged through t check P<0.05.4.6.2 the eye subjective symptoms relatively
(the symptom test group matched group of X ± SD) of symptom variation before and after table seven test group and the matched group test-meal
0.26 ± 0.44 0.11 ± 0.32 0.14 ± 0.36 0.11 ± 0.32 tinnitus 0.11 ± 0.32 0.03 ± 0.17 0.09 ± 0.28 0.03 ± 0.17 of having a dizzy spell, swollen 0.37 ± 0.55 0.09 ± 0.28 ※ 0.54 of eye ± dry and astringent 0.40 ± 0.50 0.03 ± 0.17 ※ 0.71 ± 0.62 0.49 ± 0.51 dry 0.94 ± 0.73 0.34 ± 0.48 ※ 0.89 ± 0.68 0.71 ± 0.79,0.65 0.37 ± 0.65 ophthalmodynia 0.29 ± 0.46 0.09 ± 0.28 ※ 0.37 ± 0.55 0.26 ± 0.56 after the front test-meal of test-meal after the front test-meal of test-meal
※: expression has significant difference through t check P<0.05.
Table seven as seen, ophthalmic bloated after the test group test-meal, eye are dry and astringent, the xerostomia symptom promptly has clear improvement.The ophthalmalgia symptom will have clear improvement from testing the day after tomorrow.Have a dizzy spell, integration descends to some extent after the tinnitus test-meal, but no difference of science of statistics.4.7 safety relatively before and after the test
Test group and matched group test anteroposterior diameter have a blood test conventional and conventional physical examination, every inspection index is all in normal range.5. 5.1 Onlly photopic vision capsules are discussed are had the health-care effect that improves vision.Compare test with matched group
The sense of group asthenopia obviously alleviates, and distant vision on average improves 0.23, and effective percentage is 74.39%,
The near-sighted diopter of eye on average reduces by 0.44, and effective percentage is 70.00%, place by statistics
Reason difference has significance.5.2 compare with matched group, Onlly photopic vision capsule is for blurred vision, the eye of people with visual impairment
Expand, asthenopia symptom tools such as ophthalmalgia, eye are dry and astringent, xerostomia have a better role.5.3 test-meal group and matched group are relatively, physiochemical indice and physical examination index are all no abnormal,
Do not observe allergy and other untoward reaction in the test-meal process, the trencherman is healthy to examination
There is not obviously influence.
A kind of acute toxicity that improves the health product of visual performance of the present invention, micronucleus, sperm deformity, Ames and 30 days feeding trial results following (through Shanghai Disease Prevention and Control Centre's test): 1. acute toxicity (per os LD 50) test: 1.1 sample character: the buff powder is partially soluble in water.1.2 the processing of sample and preparation: sample thief 20000mg adding distil water supplies to 20ml
Examination.1.3 laboratory animal: 1.3.1 source: laboratory animal portion of Shanghai Medical Univ, the quality certification number: 02-22-1.1.3.2 kind and strain: Kunming mouse 1.3.3 sex: before female and male 1.3.4 body weight: 18-22 restrains 1.4 experimental technique 1.4.1 test, laboratory animal fasting 16 hours.1.4.2 with the animal random packet, each one group of male and female, 10 every group, weigh, press 0.4ml/20g
Body weight adopts administration by gavage to carry out once giving sample.1.4.3 observe in two weeks behind the sample poisoning manifestations of laboratory animal and death condition.1.4.4 calculate LD 50And 95% credibility interval.1.5 result: table male and female chmice acute per os toxicity test result
Animal sex dosage number of animals death toll mortality rate
(mg/kg) (only) (only) (%)
Female mice 20,000 10 00
The performance of male mice 20,000 10 0 01.5.1 cardinal symptoms: each treated animal of experimental session is movable normal, and the hair color glossiness is good,
Do not find any symptom.1.5.2 median lethal dose(LD 50), female mice: LD 50>20000mg/kg.
Male mice: LD 50>20000mg/kg.1.6 conclusion:
With acute toxicity median lethal dose(LD 50) toxicity grading, true border nontoxic level material.2. micronucleus test: 2.1 sample character: the buff powder is partially soluble in water.2.2 the processing of sample and preparation: sample thief 10000mg, 5000mg, 2500mg add respectively
Distilled water is to 20ml, and each becomes concentration is 500mg/ml, 250mg/ml, 125mg/ml
Suspension, for the examination.2.3 laboratory animal: 2.3.1 source: laboratory animal portion of the Shanghai Medical Univ, (quality certification number: 02-22-1).2.3.2 kind and strain: Kunming mouse 2.3.3 sex: female and male 2.3.4 body weight: 25-30 restrains 2.4 experimental techniques: 2.4.1 animal is divided into 5 groups at random, and 10 every group, male and female half and half are respectively as sample
Three dosage groups and distilled water negative control group and cyclophosphamide positive controls.2.4.2 adopt administration by gavage 30 hours twice, animal is weighed, with the variable concentrations sample of preparation
Press the 0.4ml/20g body weight, respectively each treated animal is irritated stomach.2.4.3 after for the second time irritating stomach 6 hours, animal was put to death in the cervical vertebra dislocation, gets femur bone marrow and adds
The calf serum mixing, routine smear, fixing Giemsa stained preparation.2.4.4 microscopy is observed, the micronucleus number of 1000 polychromatic erythrocytes of every Mus counting calculates little
The nuclear incidence rate, and carry out statistical analysis.2.5 result:
Table animal bone marrow polychromatic erythrocyte microkernel incidence
Dosage sex number of animals is examined male 5 5,000 122 24.4<0.01 (the distilled water 40mg/kg) female 5 5,000 124 24.8<0.01 of cell number micronucleus cell micronuclear rates statistics (mg/kg) (only) (individual) number (individual) (‰) check * female 5 5,000 7 1.4 positive controls of male 5 5,000 8 1.6 (the distilled water 20000mg/kg) of 10000 male 5 5,000 8 1.6>0.05 10000 female 5 5,000 7 1.4>0.05 5000 male 5 5,000 7 1.4>0.05 5000 female 5 5,000 7 1.4>0.05 2500 male 5 5,000 8 1.6>0.05 2500 female 5 5,000 8 1.6>0.05 negative controls
* compare (through X 2 test) 2.6 conclusions with negative control group:
Credit is analysed by statistics, and the result is negative for sample bone marrow polychromatic erythrocyte micronucleus test.3. be skillful in the deformity test: 3.1 sample character: the buff powder is partially soluble in water.3.2 the processing of sample and preparation: sample thief 10000mg, 5000mg, 2500mg add respectively
Distilled water is to 20ml, and each becomes concentration is 500mg/ml, 250mg/ml, 125mg/ml
Suspension, for the examination.3.3 laboratory animal: 3.3.1 source: laboratory animal portion of the Shanghai Medical Univ, (quality certification number: 02-22-1).3.3.2 kind and strain: Kunming mouse 3.3.3 sex: male 3.3.4 body weight: 25-35 restrains 3.4 experimental techniques: 3.4.1 animal is divided into 5 groups at random, 5 every group, and respectively as three dosage groups of sample
And distilled water negative control group and cyclophosphamide positive controls.3.4.2 after animal is weighed, the variable concentrations sample of preparation is pressed the 0.4ml/20g body weight, divides
Other to each treated animal filling stomach.Once a day, continuous 5 days.3.4.3 after giving sample first the 35th day, animal was put to death in the cervical vertebra dislocation, gets two side epididymis and puts into
In the normal saline, shred, the filtrate smear is got in four layers of filtration, and is fixing, 2% Yihong
Stained preparation.3.4.4 microscopy is observed, the lopsided number of 1000 sperms of every Mus counting calculates sperm deformity and sends out
The rate of giving birth to, and carry out statistical analysis.3.5 result:
Table animal sperm birth prevalence dosage number of animals is examined sperm count distortion sperm distortion rate statistics, (mg/kg), (only), (individual) number, (individual), (‰) check * 10,000 5 5,000 71 14.2>0.05 5,000 5 5,000 70 14.0>0.05 2,500 5 5,000 69 13.8>0.05 negative controls 5 5,000 74 14.8, (distilled water 20000mg/kg) positive control 5 5,000 320 64.0<0.01, (distilled water 40mg/kg)
* compare (through X 2 test) 3.6 conclusions with negative control group:
Credit is analysed by statistics, and the result is negative in the sample sperm malformation test.4.Ames test: 4.1 sample character: buff powder.
Solvent: sterile distilled water 4.2 sample treatment and preparation: sample is modulated into each concentration with sterile distilled water, for examination.4.3 proof load: 0.1mg/ ware, 0.5mg/ ware, 1mg/ ware, 2.5mg/ ware, 5mg/ ware.4.3.1 test strain: TA97, TA98, TA100, TA102.By California, USA
Department of biochemistry of university provides, and biological character meets the bacterial strain requirement.Bacterium is used in test
Liquid concentration 1-2 * 10 9/ ml.4.3.2 metabolism activation: Polychlorinated biphenyls is induced SD rats'liver S9 component, protein content 33
mg/ml。
The metabolism activation S9 mixed liquor of the S9 component that contains 8% (v/v).4.3.3 solvent control: sterile distilled water 4.3.4 positive control :-S9:TA97 atabrine (500 μ g/ ware), TA98 are to the nitro quinoline
Quinoline (200 μ g/ ware) TA100, TA102 MMS.
+ S9:TA97, TA98, TA100 2-aminofluorene (20 μ g/ ware),
TA102 1.8-dihydroxy is feared quinone (501 μ g/ ware).4.4. method of testing: mix method: tried thing, bacterium liquid by the pre-culture plate of GB15193-94
With 0.5mlS9 mixed liquor or PBS in 30 ℃ of cultivations of 100 * 15mm sterile test tube
30min adds 2ml top agar, pour plate.4.5 test result:
Dosage mg/ ware Reply clump count (individual/ware) X ± SD
?????????TA97 ?????????TA98 ?????????TA100 ?????????TA102
??-S9 ??+S9 ??-S9 ??+S9 ??-S9 ??+S9 ??-S9 ??+S9
????0.1 ?137±8 ?139±9 ?28±5 ?33±6 ?141±12 ?141±14 ?264±12 ?267±10
????0.5 ?145±6 ?146±8 ?29±3 ?36±2 ?143±6 ?146±3 ?269±6 ?271±6
????1 ?126±8 ?129±7 ?25±1 ?28±1 ?132±2 ?133±7 ?251±6 ?255±8
????2.5 ?135±4 ?136±6 ?26±5 ?30±10 ?134±13 ?137±4 ?261±12 ?257±14
????5 ?123±7 ?125±6 ?24±2 ?27±6 ?128±3 ?138±4 ?243±6 ?260±14
Blank ?147±17 ?155±19 ?27±3 ?29±1 ?134±6 ?149±5 ?256±14 ?260±14
Solvent control ?145±17 ?153±19 ?25±2 ?28±2 ?132±6 ?147±5 ?251±16 ?256±14
Positive control ?>1500 ?>1500 ?819±6 ?>3000 ?>2000 ?>1500 ?>3000 ?919±11
4.6 conclusion: the result is negative for the sample Salmonella reversion test.5.30 it feeding trial, the design of 5.1 dosage, the human body recommended dose of sample is 1.2g/60kg every day.This experiment is established
Basic, normal, high three dosage promptly 1.5,3,6g/kg, are equivalent to human body and recommend agent
The amount 75 times, 150 times, 300 times, other establishes the blank group.5.2 the processing of sample and preparation:
According to the designing requirement of this test dose, sample is mixed in the feedstuff respectively by different proportionings
Mix thoroughly, for examination.5.3 laboratory animal: 5.3.1 source: the 02-22-45.3.2 of laboratory animal portion of Shanghai Medical Univ kind: rat 5.3.3 strain; The Wistar5.3.4 sex; Female and male 5.3.5 body weight: 58-65 restrains 5.4 experimental techniques: 5.4.1 animal is divided into 4 groups at random, and 20 every group, male and female half and half.Respectively as sample
Three dosage groups and blank group, single cage is fed, and free diet is fed continuously
30 days.5.4.2 according to dosage designing, the feedstuff that sample size is different feeds for respectively each treated animal.5.4.3 experiment begins and tests the weekly animal in back and weigh, record feedstuff intake (is picked
Remove loss 10%), calculate food utilization, draw growth curve.5.4.4 after feeding 30 days continuously, get Mus blood and carry out hematology, biochemical analysis, put to death,
Dissection is got liver,kidney,spleen etc. and is weighed.Calculate dirty body ratio, and main organs is carried out
Histological examination.5.5 result: 5.5.1 growing state and food utilization:
Each experimental group the weight of animals growth pattern (unit: g of X ± SD)
Dosage 60 ± 6 71 ± 8 92 ± 14 107 ± 17 127 ± 26 high dose 62 ± 6 71 ± 9 92 ± 13 109 ± 19 127 ± 25 among dosage 63 ± 7 80 ± 9 103 ± 12 131 ± 18 148 ± 29 high dose 62 ± 6 82 ± 8 103 ± 14 129 ± 21 149 ± 33 contrast 61 ± 6 71 ± 8 91 ± 12 107 ± 15 128 ± 27 low dosage 62 ± 7 72 ± 9 89 ± 13 108 ± 16 126 ± 26 ♀ among 0 week, 1 week, 2 week, 3 week, 4 week contrast, 62 ± 5 81 ± 9 102 ± 11 128 ± 17 147 ± 28 low dosage 60 ± 7 79 ± 7 101 ± 12 128 ± 19 149 ± 30 ♂
Each experimental group animal food utilization rate (X ± SD)
Test is the whole growth food intake food use of test just
Body weight, (g) body weight, (g), (g) amount, (g) rate, (g) dosage 60 ± 6 127 ± 26 67 344 19 high dose 62 ± 6 127 ± 25 65 320 20 among dosage 63 ± 7 148 ± 29 85 417 20 high dose 62 ± 6 149 among contrast 62 ± 5 147 ± 28 85 421 20 low dosage 60 ± 7 149 ± 30 89 459 19 ♂ ± 33 87 462 19 contrast 61 ± 6 128 ± 27 67 332 20 low dosage 62 ± 7 126 ± 26 64 299 21 ♀
By above two tables as seen, each experimental group rat growing state of sample is good substantially.5.5.2 hematological examination:
Routine blood test measurement result (the group numeration of leukocyte red blood cell count(RBC) hematochrome lymphocyte neutrophilic granulocyte of X ± SD)
(10 9Individual/L) (10 12Individual/L) (%) dosage 9.4 ± 2.8 5.5 ± 0.4 152 ± 6.1 72 ± 5.1 28 ± 5.1 high dose 9.1 ± 1.1 5.5 ± 0.3 150 ± 8.1 74 ± 3.5 26 ± 3.5 among dosage 9.6 ± 2.2 5.5 ± 0.3 150 ± 10.5 73 ± 5.2 27 ± 5.2 high dose 9.9 ± 1.4 5.3 ± 0.3 149 ± 6.2 73 ± 3.0 27 ± 3.0 contrast 8.8 ± 1.0 5.3 ± 0.3 149 ± 7.8 73 ± 3.4 27 ± 3.4 low dosage 8.9 ± 2.0 5.3 ± 0.3 147 ± 10.8 72 ± 4.3 28 ± 4.3 ♀ among (%) contrast 8.9 ± 1.4 5.3 ± 0.3 148 ± 12.6 75 ± 5.0 25 ± 5.0 low dosage 9.0 ± 0.8 5.4 ± 0.2 147 ± 9.3 74 ± 4.9 26 ± 4.9 ♂ of Hb (g/L)
Above result as seen, the check result of the hematochrome of each experimental group and control rats, erythrocyte, numeration of leukocyte and classification thereof is all in normal range.5.5.3 biochemical analysis
Biochemistry detection result's (group dextrose albumin cholesterol carbamide ammonia glutamate pyruvate transaminase of X ± SD)
(mmol/L) (g/dL) (mmol/L) (mmol/L) dosage 4.9 ± 0.2 3.8 ± 0.2 1.9 ± 0.2 6.2 ± 0.8 33 ± 4.1 high dose 4.8 ± 0.2 3.8 ± 0.2 2.0 ± 0.2 6.0 ± 0.3 32 ± 11.7 among dosage 5.0 ± 0.2 3.8 ± 0.2 1.8 ± 0.2 6.3 ± 0.3 35 ± 6.5 high dose 5.0 ± 0.3 3.8 ± 0.2 1.9 ± 0.1 6.0 ± 0.3 36 ± 4.6 contrast 5.0 ± 0.2 3.8 ± 0.2 2.0 ± 0.2 6.4 ± 0.5 32 ± 3.9 low dosage 4.8 ± 0.3 3.7 ± 0.2 1.9 ± 0.2 6.1 ± 0.3 32 ± 5.2 ♀ among (IU/L) contrast 5.0 ± 0.5 3.8 ± 0.7 1.9 ± 2.0 6.1 ± 0.5 35 ± 3.4 low dosage 5.1 ± 0.2 3.8 ± 0.2 2.0 ± 0.2 6.1 ± 0.3 33 ± 2.4 ♂
Above result shows that biochemical analysis results such as the serum glucose of each experimental group and control rats, albumin, cholesterol, blood urea nitrogen, glutamate pyruvate transaminase are all in normal range.5.5.4 organ weights is the dirty body ratio of each dosage group rat group liver/body kidney/body spleen/body as a result
(%), (%), (%) dosage 3.88 ± 0.27 1.02 ± 0.05 0.49 ± 0.04 high dose 3.88 ± 0.19 1.02 ± 0.05 0.49+0.05 among dosage 3.82 ± 0.27 1.01 ± 0.05 0.49 ± 0.05 high dose 3.88 among contrast 3.85 ± 0.15 1.03 ± 0.11 0.51 ± 0.04 low dosages 3.88 ± 0.18 1.06 ± 0.10 0.50 ± 0.04 ♂ ± 0.17 1.01 ± 0.05 0.49 ± 0.05 contrast 3.90 ± 0.17 1.03 ± 0.05 0.50 ± 0.04 low dosages 3.88 ± 0.26 1.07 ± 0.22 0.50 ± 0.04 ♀
Last table as seen, the main dirty body of each experimental group rat is compared than with matched group, all no significant difference.5.5.5 histological examination result:
By following table as seen, each treated animal is checked all no abnormal substantially, the histological examination of main organs such as liver, kidney, and the result does not find and tests relevant pathological changes.Liver group sample high dose group * control animals number (only) 20 20 is by membrane change (example) 00
Downright bad (example) 00 hepatorrhagia (example) 00
Cavity becomes (example) 01 granule degeneration (example) 00
Hepatic cords fracture (example) 00 leaf swelling of liver cell (example) 25
Inflammatory cell infiltration (example) 14
Downright bad (example) 00 of other (example) 00 remittances
Hemorrhage (example) 00 pipe bile duct proliferations (example) 00
Other (example) 00 of inflammatory cell infiltration (example) 01 districts
* check substantially and do not find obvious pathological changes, therefore only select high dose group to make histological examination kidney group sample high dose group * blank treated animal number (only) 20 20
By membrane change (example) 00
Renal necrosis (example) 00 skins are little
Pipe swelling (example) 12
On
The skin cavity becomes (water sample
The thin change with fat becomes) (example) 00
Kytoplasm becomes cast (example) 00
The property
Inflammatory cell infiltration (example) 14
Glomerule degeneration (example) 00
Between pathological changes (inflammation portion cellular infiltration) (example) 00 in the matter
Other (example) 00
Bent downright bad (example) 00 spinal canals
Last swelling (example) 00
The thin cavity of cortex becomes (example) 00
Born of the same parents
Become 00 property of cast (example)
Inflammatory cell infiltration (example) 47
Between matter inflammatory cell infiltration (example) 12
Renal pelvis portion nipple changes (example) 00
Move the shape epithelial cell and change (example) 00
* check substantially and do not find obvious pathological changes, therefore only select high dose group to do histological examination
Another object of the present invention has provided a kind of preparation method of improving the health product of visual performance, it is characterized in that this method comprises the following steps: (1) preparation wolfberry fruit extract:
The hydroecium warm macerating of Fructus Lycii with 8 times of amounts steeped 2 hours, divide secondary respectively to steep 1 hour again with 6 times of weight hydroecium warm macerating, extracting solution ultracentrifugation, supernatant are carried out the ultrafiltration of 100~300K ultrafilter membrane to dam, ultrafilter membrane with 5~10K molecular weight is dialysed, and obtains the extract of molecular weight for 5~300K; (2) preparation Flos Chrysanthemi extract;
Flos Chrysanthemi carries twice with 60 ℃ in the water of 10 times of weight, 8 times of weight each 2 hours, 1 little intermittent fever respectively, and last 400 macroporous absorption posts adsorb behind the ultracentrifugation, carry out eluting with 70% ethanol then, recovery ethanol, and vacuum drying obtains Flos Chrysanthemi extract; (3) preparation finished product:
Press recipe quantity, with Flos Chrysanthemi, wolfberry fruit extract, taurine, Folium Ginkgo extract vitamin C, zinc gluconate, vitamin B 1And vitamin B 2Carry out compositely, filled capsules gets product.
Preparation of product intermediate of the present invention has adopted membrane separation technique and industry chromatography technique, and extraction effect is good, and preparation method is simple, is suitable for large-scale production.
Example 1, wolfberry fruit extract 20 grams
Prescription: Flos Chrysanthemi extract 20 grams
Folium Ginkgo extract powder 8 grams
Taurine 20 grams
Vitamin C 5 grams
Zinc gluconate 8 grams
Beta-carotene 0.14 gram
Vitamin B 10.08 gram
Vitamin B 20.08 gram
Preparation method:
The kilogram Fructus Lycii was soaked 2 hours with 8 times of weight hydroecium temperature, steeped each 1 hour with 6 times of weight hydroecium warm macerating respectively again, with the extracting solution ultracentrifugation, supernatant carries out the ultrafiltration of 300k ultrafilter membrane and dams, the ultrafilter membrane of 10k molecular weight is dialysed, and obtains extract 20 grams of molecular weight for 10-300k.
1 kilogram of Flos Chrysanthemi is carried twice with 60 ℃ of heat of water of 10 times of weight, 8 times of weight respectively, and each is 2 hours, 1 hour.Go up the macroporous absorption post behind the ultracentrifugation and adsorb, carry out eluting with 70% ethanol then, reclaim ethanol, vacuum drying obtains Flos Chrysanthemi extract 60 grams.
With composite, filled capsules such as Flos Chrysanthemi, wolfberry fruit extract and cattle iodic acid, Folium Ginkgo extract, be Onlly photopic vision capsule, every capsules is 300 milligrams.
Example 2, prescription: wolfberry fruit extract 15 gram zinc gluconate 5 grams
Flos Chrysanthemi extract 8 gram beta-carotene 0.1 gram
Folium Ginkgo extract powder 5 gram vitamin Bs 10.1 gram
Taurine 15 gram vitamin Bs 20.1 gram
Vitamin C 3 is restrained Preparation Method with example 1.Example 3, prescription: wolfberry fruit extract 5 gram zinc gluconate 2 grams
Flos Chrysanthemi extract 5 gram beta-carotene 0.01 gram
Folium Ginkgo extract powder 2 gram vitamin Bs 10.01 gram
Taurine 5 gram vitamin Bs 20.01 gram
Vitamin C 1 is restrained Preparation Method with example 1.Example 4, prescription: wolfberry fruit extract 10 gram zinc gluconate 4 grams
Flos Chrysanthemi extract 6 gram beta-carotene 0.06 gram
Folium Ginkgo extract powder 4 gram vitamin Bs 10.04 gram
Taurine 10 gram vitamin Bs 20.05 gram
Vitamin C 2 is restrained Preparation Method with example 1.

Claims (2)

1, a kind of health product that improve visual performance is characterized in that these health product are by 5~15 parts of Fructus Lyciis, 5~15 parts of Flos Chrysanthemis, 2~5 parts of Folium Ginkgo extract powders, 5~15 parts of taurines, 1~3 part of vitamin C by weight, 2~5 parts of zinc gluconate, vitamin B 10.01~0.1 part, vitamin B 20.01 any proportioning that~0.1 part and beta-carotene are 0.01~0.1 part is formed.
2, a kind of preparation method of improving the health product of visual performance as claimed in claim 1, this method comprise the following steps: (1) preparation wolfberry fruit extract:
The hydroecium warm macerating of Fructus Lycii with 8 times of weight steeped 2 hours, divide secondary respectively to steep 1 hour again with 6 times of weight hydroecium warm macerating, extracting solution ultracentrifugation, supernatant are carried out the ultrafiltration of 100~300K ultrafilter membrane to dam, ultrafilter membrane with 5~10K molecular weight is dialysed, and obtains the extract of molecular weight for 5~300K; (2) preparation Flos Chrysanthemi extract;
Flos Chrysanthemi carries twice with 60 ℃ in the water of 10 times of weight, 8 times of weight each 2 hours, 1 little intermittent fever respectively, and last 400 macroporous absorption posts adsorb behind the ultracentrifugation, carry out eluting with 70% ethanol then, recovery ethanol, and vacuum drying obtains Flos Chrysanthemi extract; (3) preparation finished product: press recipe quantity, with Flos Chrysanthemi, wolfberry fruit extract, taurine, silver-colored t Folium Pruni extract, vitamin C, zinc gluconate, vitamin B 1And vitamin B 2Carry out compositely, filled capsules gets product.
CNB001194658A 2000-07-17 2000-07-17 Health-care product for improving visual function Expired - Lifetime CN1141115C (en)

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EP1537896A1 (en) * 2003-12-03 2005-06-08 Franz-Peter Dr. Liebel Compound mixtures based on sulphur containing amino acids, antioxidants, phospholipids and vitamins for the preparation of a medicament for treating L-diabetes and/or associated diseases.
CN100344240C (en) * 2005-09-07 2007-10-24 辽宁省农业科学院作物研究所 Nutrient food capable of preventing cataract and muscae volitantes and its making process
CN100462074C (en) * 2007-02-14 2009-02-18 北京东方兴企食品工业技术有限公司 Chewing tablet with vision fatigue relieving function
CN1823827B (en) * 2005-12-29 2010-09-29 颜怀伟 Medicine and food dual purpose nutritive product for preventing and treating xeroma and its manufacturing method
CN101912116A (en) * 2010-08-04 2010-12-15 安徽燕之坊食品有限公司 Nutritious rice for alleviating asthenopia and processing method thereof
CN1823838B (en) * 2005-12-29 2011-06-08 颜怀伟 Medicine and food dual purpose vitamin micro element mineral calcium nutritive product for preventing myopia and its manufacturing method
CN1823837B (en) * 2005-12-29 2011-06-08 颜怀伟 Use of composition in preparing nutritire product for preventing and treating myopia
CN104397101A (en) * 2014-10-13 2015-03-11 浙江奥奇食品有限公司 Eye protecting biscuit preparation method
CN104922296A (en) * 2015-05-23 2015-09-23 张家港市五湖新材料技术开发有限公司 Pharmaceutical composition for relieving eyestrain and preparation method for pharmaceutical composition
CN105395701A (en) * 2015-11-30 2016-03-16 黄宇 Health care product for relieving eyestrain
CN106420816A (en) * 2016-09-28 2017-02-22 北京瑞济善健康科技有限公司 Compound lutein solid preparation for relieving asthenopia and improving vision function and preparation method thereof
CN106491840A (en) * 2016-10-24 2017-03-15 广西圣保堂健康产业股份有限公司 A kind of composition for relieving asthenopia and preparation method thereof

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1537896A1 (en) * 2003-12-03 2005-06-08 Franz-Peter Dr. Liebel Compound mixtures based on sulphur containing amino acids, antioxidants, phospholipids and vitamins for the preparation of a medicament for treating L-diabetes and/or associated diseases.
CN100344240C (en) * 2005-09-07 2007-10-24 辽宁省农业科学院作物研究所 Nutrient food capable of preventing cataract and muscae volitantes and its making process
CN1823837B (en) * 2005-12-29 2011-06-08 颜怀伟 Use of composition in preparing nutritire product for preventing and treating myopia
CN1823827B (en) * 2005-12-29 2010-09-29 颜怀伟 Medicine and food dual purpose nutritive product for preventing and treating xeroma and its manufacturing method
CN1823838B (en) * 2005-12-29 2011-06-08 颜怀伟 Medicine and food dual purpose vitamin micro element mineral calcium nutritive product for preventing myopia and its manufacturing method
CN100462074C (en) * 2007-02-14 2009-02-18 北京东方兴企食品工业技术有限公司 Chewing tablet with vision fatigue relieving function
CN101912116A (en) * 2010-08-04 2010-12-15 安徽燕之坊食品有限公司 Nutritious rice for alleviating asthenopia and processing method thereof
CN101912116B (en) * 2010-08-04 2012-05-02 安徽燕之坊食品有限公司 Nutritious rice for alleviating asthenopia and processing method thereof
CN104397101A (en) * 2014-10-13 2015-03-11 浙江奥奇食品有限公司 Eye protecting biscuit preparation method
CN104922296A (en) * 2015-05-23 2015-09-23 张家港市五湖新材料技术开发有限公司 Pharmaceutical composition for relieving eyestrain and preparation method for pharmaceutical composition
CN105395701A (en) * 2015-11-30 2016-03-16 黄宇 Health care product for relieving eyestrain
CN106420816A (en) * 2016-09-28 2017-02-22 北京瑞济善健康科技有限公司 Compound lutein solid preparation for relieving asthenopia and improving vision function and preparation method thereof
CN106491840A (en) * 2016-10-24 2017-03-15 广西圣保堂健康产业股份有限公司 A kind of composition for relieving asthenopia and preparation method thereof
WO2018077311A1 (en) * 2016-10-24 2018-05-03 广西圣保堂健康产业股份有限公司 Composition for relieving eye strain and preparation method therefor

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