A kind of traditional Chinese medicine composition for relieving asthenopia and preparation thereof and preparation method
Technical field
The invention belongs to field of pharmaceutical preparations, alleviate asthenopic Chinese medicine composition particularly to one
Thing and preparation thereof and preparation method.
Background technology
Asthenopia is a kind of disease that current ophthalmology is common, and the symptom of patient is varied, often
See have pain around eye and eye socket, blurred vision, eyes are dry and astringent, shed tears, severe patient
Headache, feel sick, dizziness, lethargy, hypomnesis, the mental symptom such as insomnia, sternly
Ghost image rings the study of patient, live and work.Asthenopia is not independent disease, but by
In one group of fatigue syndrome that a variety of causes causes, its occurrence cause is varied, common
Have: the reason of (l) eyes itself, such as ametropia, regulations such as myopia, hypermetropia, astigmatism
Factor, eye muscle factor, conjunctivitis, keratitis, worn glasses improper etc.;(2) whole body
Factor, such as neurasthenia, health overwork, hysteria or involutional women;(3) environment because of
Element, as not enough in illumination or too strong, distribution of light sources is uneven or glimpses, the target watched attentively
Too small, meticulous or unstable etc..The quickening of modern life rhythm, the change of environment, with eye
The increase of work, all makes asthenopic sickness rate have the trend increased, therefore researchs and develops
A kind of medicine with alleviation asthenopia function or health food all have highly important meaning
Justice.
It is currently used for alleviating asthenopic medicine common for collyrium, but collyrium can only be temporary transient
Alleviate the tired symptom of vision, asthenopia can not be effected a radical cure, cure the symptoms, not the disease;And current 90%
Collyrium in all contain preservative, these materials can produce infringement to the cell of ocular surface.
At present, increasing people use Chinese medicine composition to effect a radical cure the ophthalmic diseasess such as asthenopia, example
It is as a kind of for alleviating asthenopic medicine in Chinese patent application CN102949523 discloses
Compositions, this pharmaceutical composition is mainly by Semen Cassiae, Flos Chrysanthemi, Fructus Lycii, Fructus Corni, former flower
Blue or green element and taurine are prepared from according to certain weight proportion, can reach alleviation asthenopic
Effect;Chinese patent CN103431390B discloses a kind of health food, Lycium ruthenicum Murr. carries
Take thing, Radix Ginseng extract, Radix Rehmanniae Preparata extract, Semen Cuscutae extract, Fructus Ligustri Lucidi extract,
Rhizoma Atractylodis Macrocephalae extract, Fructus Hippophae extract, Flos Chrysanthemi extract, phylloxanthin, astaxanthin, β-Hu Luo
Bu Su, vitamin C, vitamin E, zinc and selenium are prepared from, and have preventing and treating maculopathy,
Effect of the ophthalmics such as cataract, presbyopia, asthenopia.
Summary of the invention
A kind of traditional Chinese medicine composition for relieving asthenopia of offer, Yi Jiqi are provided
Preparation and the method for preparation said composition.According to the compatibility of science, utilize multiple Chinese herbal medicine
The mutual synergism of active component, makes compositions provided by the present invention can effectively alleviate regarding tired
Labor and have improving eyesight, clear purpose effect, and without any side effects to human body.
For achieving the above object, the concrete technical scheme of the present invention is as follows:
A kind of traditional Chinese medicine composition for relieving asthenopia, mainly the raw material by following weight portion is processed
It is prepared from:
Lycium ruthenicum Murr. 10-20 Herba Euphrasiae Regelii 5-18 taurine 2-10
Radix Puerariae 18-32 Flos Chrysanthemi 10-30 salt alga 80-200
Perilla oil 120-350 vitamin C 2-10.
The method have the benefit that invention uses multiple pure natural medical material meticulously to develop,
Integration of edible and medicinal herbs, safe green, proportioning equalize, without any side effects to health;Each component phase
The most collaborative, effectively alleviate asthenopia, and improving eyesight, clear mesh effect can be played, it is possible to strengthen patient
Anti-asthenopia ability, fundamentally solve asthenopia problem.
Preferably, preparing the raw materials used parts by weight of described compositions is:
Lycium ruthenicum Murr. 15 Herba Euphrasiae Regelii 10 taurine 5
Radix Puerariae 25 Flos Chrysanthemi 20 salt alga 150
Perilla oil 250 vitamin C 5.
Further preferably, described compositions also includes the raw material of following parts by weight:
Herba Pteridis Multifidae 10-30 Radix Trichosanthis 5-15 Herba Ixeritis chinensis 20-35.
After increasing above-mentioned raw materials, with main mutually synergism, improve treatment asthenopia further
Curative effect, and simultaneously auxiliary improve spirit, improve memory.
In order to strengthen bioavailability and improve ease of use, described alleviation is regarded tired by the present invention
The Chinese medicine composition of labor is made according to the ratio of weight and number of 1:2-5 with pharmaceutically acceptable adjuvant
Preparation, described preparation one in capsule, tablet, powder or pill.
Preferably, described preparation is capsule, and described adjuvant includes filler, disintegrating agent and glues
Mixture, the weight part ratio of described filler, disintegrating agent and binding agent is 3-5:2-3:1-2.
Preferably, described filler be ratio of weight and number be the beta-schardinger dextrin-of 1:3 and glycerol mixing
Thing;Described disintegrating agent be ratio of weight and number be micropowder silica gel and the mixing of Cyclomethicone of 1:2
Thing;Described binding agent be ratio of weight and number be chitose and the mixture of docusate sodium of 1:1.
The capsule described traditional Chinese medicine composition for relieving asthenopia made with above-mentioned adjuvant, extends
The use time, carry and use more convenient;Meanwhile, three kinds of accessory formula collocation rationally, make
The disintegration of medicine accelerates, and in 10min, in compositions, all compositions are all releasable out;Surely
Qualitative height, and have preferable mobility, make medicament contg uniform.
Further, described adjuvant also includes polyvinylpyrrolidone and the fibre that mass ratio is 5:1
The mixture of Fibronectin, the parts by weight of described mixture are 1-2 part.
After increasing above-mentioned adjuvant, medicine and adjuvant are made microcapsule, then makes capsule, enter
One step improves medicine stability and dissolubility, makes medicine be absorbed by the body to greatest extent, enters
And improve the bioavailability of capsule;And the adjuvant safety height selected by the present invention, internal
Absorbable, biodegradable, stability is high.
On the other hand the invention provides the preparation side of described traditional Chinese medicine composition for relieving asthenopia
Method, the method comprises the steps:
1) weigh the Radix Puerariae of recipe quantity and pulverize, adding 4-6 times of clear water of raw material weight and decoct 1-2h,
Being repeated twice, collecting decoction also filters, and collects filtrate, concentrating under reduced pressure, vacuum drying, obtains
To Radix Puerariae extract;
2) Flos Chrysanthemi weighing recipe quantity is cleaned, and adds 2-3 times of water pulping, filtering and collecting filter liquid,
Concentrating under reduced pressure, is spray-dried, obtains Flos Chrysanthemi extract;
3) Lycium ruthenicum Murr. weighing recipe quantity is pulverized, the alcohol reflux of addition 75-95% 3 times,
Adding ethanol weight every time and be 3-5 times of raw material, return time is 1-2h, merges back into flow liquid,
Drying under reduced pressure after concentrating under reduced pressure, obtains Lycium ruthenicum Murr. extract;
4) weight water such as the Herba Euphrasiae Regelii weighing recipe quantity is cleaned, addition soak 4-6h, are collected by filtration
Filtrate, adds the 85%-90% ethanol of raw material weight 2-3 times, after backflow 2-3h in filter cake
Collect backflow, merging filtrate and backflow, concentrating under reduced pressure, lyophilization, obtain Semen setariae
Grass extract.
5) Lycium ruthenicum Murr. extract, Herba Euphrasiae Regelii extract, Radix Puerariae extract and Flos Chrysanthemi extract are mixed
Uniformly, extract mixtures is obtained stand-by;
6) weighing the salt alga of recipe quantity, vitamin C and taurine, pulverize pulverization, mixing is all
Even stand-by;
7) by step 5) extract mixtures of gained and step 6) mixture of gained joins
In perilla oil, mix homogeneously, obtain described Chinese medicine composition.
Above-mentioned production technology is reasonable, retains the effective ingredient in raw material very well.
On the other hand, the present invention also provides for described traditional Chinese medicine composition for relieving asthenopia and preparation thereof
Purposes, its in preparation for alleviating the application in asthenopia, improving eyesight, clear purpose medicine.
Traditional Chinese medicine composition for relieving asthenopia of the present invention uses multiple pure natural medical material to carry out
Meticulously develop, integration of edible and medicinal herbs, safe green, reasonable mixture ratio, health is had no side effect;
Each component is the most collaborative, effectively alleviates asthenopia, and can play improving eyesight, clear purpose effect, energy
Enough strengthen the anti-asthenopia ability of patient, fundamentally solve asthenopia problem.By of the present invention
Chinese medicine composition and suitable adjuvant make external preparation, extend the use time, carry and make
With more convenient, and the bioavailability of active component can be improved greatly.
Detailed description of the invention
Embodiment 1
A kind of traditional Chinese medicine composition for relieving asthenopia, said composition by the raw material of following parts by weight through adding
Work is prepared from:
Lycium ruthenicum Murr. 15 Herba Euphrasiae Regelii 10 taurine 5
Radix Puerariae 25 Flos Chrysanthemi 20 salt alga 150
Perilla oil 250 vitamin C 5.
Embodiment 2
A kind of traditional Chinese medicine composition for relieving asthenopia, said composition by the raw material of following parts by weight through adding
Work is prepared from:
Embodiment 3
A kind of traditional Chinese medicine composition for relieving asthenopia, said composition by the raw material of following parts by weight through adding
Work is prepared from:
Lycium ruthenicum Murr. 20 Herba Euphrasiae Regelii 18 taurine 10
Radix Puerariae 32 Flos Chrysanthemi 30 salt alga 200
Perilla oil 350 vitamin C 10
Preparation method:
1) Radix Puerariae is pulverized, add 5 times of clear water of raw material weight and decoct 2h, be repeated twice, merge
Decocting liquid also filters, and collects filtrate, concentrating under reduced pressure, vacuum drying, obtains Radix Puerariae extract;
2) Flos Chrysanthemi is cleaned, add 2 times of water pulping, filtering and collecting filter liquid, concentrating under reduced pressure,
It is spray-dried, obtains Flos Chrysanthemi extract;
3) Lycium ruthenicum Murr. is pulverized, the alcohol reflux of addition 85% 3 times, add ethanol weight every time
Amount is 4 times of raw material, and return time is 1.5h, merges back into flow liquid, concentrating under reduced pressure, decompression
It is dried, obtains Lycium ruthenicum Murr. extract;
4) being cleaned by Herba Euphrasiae Regelii, the weight water such as addition soaks 5h, filtrate is collected by filtration, to filter cake
85% ethanol of middle addition raw material weight 3 times, collects backflow, merging filtrate after backflow 2h
And backflow, concentrating under reduced pressure, lyophilization, obtain Herba Euphrasiae Regelii extract;
5) Lycium ruthenicum Murr. extract, Herba Euphrasiae Regelii extract, Radix Puerariae extract and Flos Chrysanthemi extract are mixed
Uniformly, extract mixtures is obtained stand-by;
6) weighing the salt alga of recipe quantity, vitamin C and taurine, pulverize pulverization, mixing is all
Even stand-by;
7) by step 5) extract mixtures of gained and step 6) mixture of gained joins
In perilla oil, mix homogeneously, obtain described Chinese medicine composition.
Embodiment 4
Traditional Chinese medicine composition for relieving asthenopia, said composition is by the processed system of raw material of following parts by weight
For forming:
Preparation method:
1) Radix Puerariae is pulverized, add 4 times of clear water of raw material weight and decoct 2h, be repeated twice, merge
Decocting liquid also filters, and collects filtrate, concentrating under reduced pressure, vacuum drying, obtains Radix Puerariae extract;
2) Flos Chrysanthemi is cleaned, add 3 times of water pulping, filtering and collecting filter liquid, concentrating under reduced pressure,
It is spray-dried, obtains Flos Chrysanthemi extract;
3) Lycium ruthenicum Murr. is pulverized, the alcohol reflux of addition 75% 3 times, add ethanol weight every time
Amount is 5 times of raw material, and return time is 2h, merges back into flow liquid, concentrating under reduced pressure, and decompression is dry
Dry, obtain Lycium ruthenicum Murr. extract;
4) being cleaned by Herba Euphrasiae Regelii, the weight water such as addition soaks 6h, filtrate is collected by filtration, to filter cake
90% ethanol of middle addition raw material weight 2 times, collects backflow, merging filtrate after backflow 3h
And backflow, concentrating under reduced pressure, lyophilization, obtain Herba Euphrasiae Regelii extract;
5) Lycium ruthenicum Murr. extract, Herba Euphrasiae Regelii extract, Radix Puerariae extract and the Flos Chrysanthemi of recipe quantity are weighed
Extract mix homogeneously, obtains extract mixtures stand-by;
6) weighing the salt alga of recipe quantity, vitamin C and taurine, pulverize pulverization, mixing is all
Even stand-by;
7) by step 5) extract mixtures of gained and step 6) mixture of gained joins
In perilla oil, mix homogeneously, obtain described Chinese medicine composition.
Embodiment 5
Traditional Chinese medicine composition for relieving asthenopia, said composition is by the processed system of raw material of following parts by weight
For forming:
Preparation method:
1) Radix Puerariae is pulverized, add 6 times of clear water of raw material weight and decoct 1h, be repeated twice, merge
Decocting liquid also filters, and collects filtrate, concentrating under reduced pressure, vacuum drying, obtains Radix Puerariae extract;
2) Flos Chrysanthemi is cleaned, add 2 times of water pulping, filtering and collecting filter liquid, concentrating under reduced pressure,
It is spray-dried, obtains Flos Chrysanthemi extract;
3) Lycium ruthenicum Murr. is pulverized, the alcohol reflux of addition 95% 3 times, add ethanol weight every time
Amount is 3 times of raw material, and return time is 1h, merges back into flow liquid, concentrating under reduced pressure, and decompression is dry
Dry, obtain Lycium ruthenicum Murr. extract;
4) being cleaned by Herba Euphrasiae Regelii, the weight water such as addition soaks 4h, filtrate is collected by filtration, to filter cake
85% ethanol of middle addition raw material weight 3 times, collects backflow, merging filtrate after backflow 2h
And backflow, concentrating under reduced pressure, lyophilization, obtain Herba Euphrasiae Regelii extract;
5) Herba Pteridis Multifidae, Herba Ixeritis chinensis are pulverized, the alcohol reflux of addition 95% 3 times, add every time
Enter that ethanol weight is raw material 3 times, return time is 1h, merges back into flow liquid, concentrating under reduced pressure,
Drying under reduced pressure, obtains mixed extract;
5) the Lycium ruthenicum Murr. extract of recipe quantity, Herba Euphrasiae Regelii extract, Radix Puerariae extract, Flos Chrysanthemi are weighed
Extract, Herba Pteridis Multifidae extract and Herba Ixeritis chinensis extract mix homogeneously, obtain extract mixing
Thing is stand-by;
6) weigh the salt alga of recipe quantity, vitamin C, Radix Trichosanthis and taurine, pulverize pulverization,
Mix homogeneously is stand-by;
7) by step 5) extract mixtures of gained and step 6) mixture of gained joins
In perilla oil, mix homogeneously, obtain described Chinese medicine composition.
Embodiment 6 capsule
Preparation method:
1) beta-schardinger dextrin-and glycerol are dissolved in 75% ethanol solution of weight 2 times, add embodiment 1
The compositions of gained and micropowder silica gel, Cyclomethicone, docusate sodium and chitose, stirring is mixed
After closing uniformly, cross the 80 wet grains of eye mesh screen system;
2) by step 1) the wet grain of gained is dried, and cross 40 eye mesh screens and obtain granulate, granulate is measured
In rear loading capsule, obtain described capsule.
Embodiment 7 capsule
Preparation method:
1) polyvinylpyrrolidone is joined in the water of weight 30 times, add docusate sodium, mixing
Uniformly obtain aqueous phase, by fibronectin, micropowder silica gel, the beta-schardinger dextrin-of 1/2,1/2 sweet
Oil, Cyclomethicone, chitose and the compositions prepared by embodiment 4 are dissolved in gross weight 5 times
95% ethanol in, formed oil phase;Oil phase is joined mix homogeneously in aqueous phase, at continuous ultrasound
After reason 25min, prepare colostrum;Colostrum is placed in emulsifying in high pressure homogenizer, prepares emulsion;
By emulsion micronizing, prepared particle size range is the pastille microcapsule of 10 μm;
2) by step 1) the pastille microcapsule that obtains mixs homogeneously with remaining beta-schardinger dextrin-and glycerol, system
Load in capsule after obtaining mixed powder, and metering, obtain described capsule.
Embodiment 8 capsule
Preparation method: prepared by the method as described in embodiment 7.
Embodiment 9 capsule
Preparation method: prepared by the method as described in embodiment 6.
Embodiment 10 tablet
Preparation method:
1) glucose is added in the water of 2.5 times amount, be fully ground to the pasty state being less than 8% to water quantities
Thing, grinds the lower compositions added prepared by embodiment 4, mix homogeneously, lyophilization, makes
Obtain clathrate;
2) clathrate is mixed homogeneously with Macrogol 4000 and polyethylene glycol 6000, prepares mixture,
Pelletize, add cross-linking sodium carboxymethyl cellulose, mix homogeneously, tabletting and get final product.
Clinical trial
1. test case
Trier is long-term eye, the fatigable adult of vision, and having in various degree is had in mind tired
Labor, eye are dry and astringent, foreign body sensation, eyelid sense of heaviness, blurred vision, photophobia, eye are congested and
Dizzy, have a headache, feel sick, lethargy and/or the symptom such as forgetful;It is and participates in clinic examination voluntarily
Test, altogether 123 example, all between age 18-51 year.
3. efficacy assessment standard
Recovery from illness: treatment transference cure, vision no longer fatiguability;
Effective: after treatment, symptom substantially alleviates, drug withdrawal does not increases the weight of;
Invalid: after treatment, symptom is without changing or more serious.
4. packet and administration
123 example experimenters are randomly divided into three groups, wherein, treat 1 group of 31 people, implement
Compositions described in example 1, is administered orally 3 every day, each 0.5-1g (crude drug);Treat 2 group 31
People, gives the compositions described in embodiment 2, is administered orally every day 3 times, each 0.5-1g (crude drug);
Compare 1 group of 30 people, give the Lycium ruthenicum Murr. disclosed in Chinese patent application CN103431390B bright
Mesh is clear, is administered orally every day 3 times, each 0.5-1g (crude drug);Compare 2 group of 31 people, give commercially available
" moistening " eye drop clean, three times a day, each 2-3 drips.
5. result
Four groups are all administered 30 days, and observe to 4 months, do not change during test with eye custom and
Between at the moment, comparing asthenopic therapeutic effect and be shown in Table 1, recovery from illness patient's vision resisting fatigue is lasting
Spend to compare and be shown in Table 2.
Asthenopic therapeutic effect is compared by table 1 treatment group and matched group
Treatment group is respectively provided with significant difference (Pa < 0.01) compared with matched group;
Table 2 treatment group and matched group recovery from illness vision resisting fatigue persistence compare
Treatment group is respectively provided with significant difference (Pa < 0.01) compared with matched group;
6. conclusion
From above-mentioned clinical examination, asthenopia is had extraordinary by compositions provided by the present invention
Remissive treatment effect, effective percentage may be up to 100%, and cure rate also can reach more than 87%, compares
Two groups of matched groups are respectively provided with significant difference;On the other hand, compositions provided by the present invention is to trouble
Person's asthenopia has radical cure effect, improves the resisting fatigue degree of patient, and relapse rate is low, treats 1
After organizing 4 months, relapse rate is just to 14.8%, treat 2 groups relatively treat 1 group better;And it is right
According to 1 group of relapse rate after 2 months to reach more than 36%, compare 2 groups and the most easily recur, typical case
Cure the symptoms, not the disease.
Model case
Man, 28 years old, IT worker, it is engaged in IT and works 7 years, be very easy to asthenopia,
Having headache and the symptom of eye socket pain concurrently, when staying up late or have a rest the best, one's eyes became bloodshot, with crossing a lot of dripping
Ocular fluid all can not effectively be alleviated, and has the trend increased the weight of, and takes alleviation of the present invention and regards tired
The Chinese medicine composition of labor 10 days, substantially lighten around eye socket pine, and headache is inconspicuous, continues to take
After 10 days, asthenopia sense disappears, and continuously work a couple of days does not feels asthenopia symptom yet.
Mrs Zhou, 63 years old, due to the growth at age, visual deterioration also suffered from slight cataract,
Used medicine and the Chinese medicine formula of a lot of improving eyesight, had little effect, took of the present invention slow
Solving asthenopic Chinese medicine composition after 37 days, cataract disease is fully recovered, and vision is obviously improved.