CN1628759A - Chinese medicinal formulation for treating asthenopia syndrome and its preparation method - Google Patents
Chinese medicinal formulation for treating asthenopia syndrome and its preparation method Download PDFInfo
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Abstract
The invention provides a Chinese medicinal formulation for treating asthenopia syndrome and its preparation method, wherein the formulation is prepared from butterflybush flower, wild chrysanthemum flower, cassia seed 20-30%, boneol, sodium hyaluronate.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, especially treat preparation of asthenopia syndrome and preparation method thereof, its dosage form comprises that eye drop, collyrium, eye ointment, gel for eye use, eye with dosage forms such as micropills, belong to field of traditional Chinese.
Background technology:
The asthenopia syndrome is an ophthalmology common disease disease, it is after vision is done under long-time over loading and a kind of lasting weak state that occurs, be substantial connection to be arranged with the local small factor of eyes, overall health of patients, psychological diathesis, and outstanding behaviours belongs to a kind of psychosomatic disorder disease at one group of symptom grouping of eye.Clinical manifestation is discomfort or the pain around the lighter's eyeball and the eye socket, weight person's eye and geisoma portion distending pain, blurred vision, eye is dry and astringent, hyperemia, photophobia, shed tears etc., when serious in addition occur feeling sick, General Symptoms such as vomiting, dizzy, night sweat, pale complexion, bradycardia, musculi colli anxiety, shoulder are ached, and mental symptoms such as normal spiritedness is dispirited, drowsy, hypomnesis, insomnia have a strong impact on patient's study, work and life.In recent years because the variation of social environment, the quickening of work rhythm, the popularizing of video terminal, closely meticulous with increasing gradually that eye is worked, this disease sickness rate is the trend that increases day by day.Therefore actively develop and strengthen that the control and the research of this disease are had crucial meaning.
In recent years, Chinese medicine asthenopia syndrome is obtained certain effect, and better action has been brought into play in the organic conception of the traditional Chinese medical science and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs in this respect, as the research to etiology and pathogenesis, except the argumentation of traditional medicine document, also incorporated the theory and the viewpoint of modern medicine; In treatment, except that using traditional differentiation of symptoms and signs for classification of syndrome and specially square treatment, also use dosage forms such as Chinese medicine eye drop, collyrium, outstanding its convenient, fast, economic and practical advantage.Therefore,, seek and develop effective prescription of treatment asthenopia syndrome, have important theoretical meaning and use value in conjunction with the modern study achievement.
Traditional Chinese medical theory is thought excess eye-using, with the bad or deficiency of the liver and kindey of eye, can not be and cause the five internal organs three internal organs by blood vessels fortune through in order, thus show as binocular dryness, swell and ache symptoms such as fuzzy viewing, the asthenopia of modern medicine meaning.The present invention establishes at asthenopia just, has heat-clearing and toxic substances removing, the effect that antiinflammatory tomorrow, yin nourishing are calmed the nerves, be applicable to that the eyeball that various asthenopias cause swells and ache, dry and astringent hyperemia, photophobia is shed tears, blurred vision, the bloated hyperemia of eye acid etc., Flos Buddlejae, the sweet cold of Flos Chrysanthemi in the prescription, wind and heat dispersing, suppressing the hyperactive liver are supported order; The Semen Cassiae nourishing the liver to improve visual acuity; The hot temperature of Radix Cynanchi Paniculati, wind-expelling pain-stopping, promoting blood circulation and detoxication; Margarita sweet-salty cold in nature, tool heat clearing away, the nebula that makes eye bright, dispels are protected the power of order, and are contained several amino acids; Borneolum Syntheticum nature and flavor bitter cold, materials for improving vision are gone conjunctival congestion skin nebula; Hyaluronic acid sodium can significantly improve bioavailability of medicament, makes medicine attach to the eye table for a long time, continues to play a role; Hyaluronic acid sodium has good lubricated and moisture retention in addition, can alleviate eye dry and astringent, itch, painful symptom, and reduce the stimulation of medicine to eye, increase the comfortableness of medicine.Play altogether with the effect that reaches heat-clearing and toxic substances removing, the antiinflammatory that makes eye bright, yin nourishing are calmed the nerves full side.Reach 85% through the clinical trial total effective rate, improving traditional Chinese medical science individual event symptom aspect does, looks thing and can not wait the primary symptom aspect all to be better than matched group lastingly ophthalmic bloated, eye acid, ophthalmalgia, hyperemia, eye, especially made eye drop, collyrium, eye ointment, gel for eye use, eye with dosage forms such as micropills, clinical effectiveness is satisfied.
Summary of the invention:
The invention belongs to a kind of Chinese medicine preparation for the treatment of the asthenopia syndrome, it is characterized in that forming, comprise Flos Buddlejae (10～50%), Flos Chrysanthemi (10～30%), Semen Cassiae (15～40%), Radix Cynanchi Paniculati (16～30%), Borneolum Syntheticum (0.5～3%), Margarita hydrolyzed solution (2～20%), hyaluronic acid (0.05～5%) by the Chinese prescription that heat-clearing and toxic substances removing, the antiinflammatory that makes eye bright, yin nourishing are calmed the nerves.
Prescription of the present invention can also add that other heat-clearing and toxic substances removing, eyesight-strengthening and inflammation-resisting, yin nourishing are calmed the nerves and other increase the Chinese medicine of our curative effect.For example: Spica Prunellae (5～30%), Rhizoma Coptidis (3～10%), Radix Angelicae Sinensis (1～15%), allantoin flavour of a drug such as (0.1～5%), but above-mentioned flavour of a drug single as required add, the whole adding or wherein any two flavors of adding, and make preparation by extraction process of the present invention.
Technical scheme of the present invention is: to the Chinese medicine elder generation volatile matter distillation composition of respectively distinguishing the flavor of among the present invention, and extract, concentrate concentrated solution precipitate with ethanol (2～2 ℃); Reclaim ethanol to most, or continue to be condensed into the extraction concentrated solution; Or add suitable quantity of water water precipitating (2～2 ℃), filter; Must extract medicinal liquid; Extract concentrated solution and extract in the medicinal liquid and add volatile ingredient, Margarita hydrolyzed solution, Borneolum Syntheticum, hyaluronic acid sodium and adjuvant respectively, make eye drop, collyrium, eye ointment, gel for eye use and eye with micropill etc.
The different auxiliary material that adds in the different dosage form of the present invention does not influence clinical effectiveness of the present invention, and these adjuvants comprise the pH value regulator: as phosphate buffer, and borate buffer solution etc.; Antibacterial: as benzalkonium chloride, benzalkonium bromide, chlorobutanol, ethyl hydroxybenzoate, sorbic acid etc.; Cosolvent: tween 80, propylene glycol, glycerol etc.Thickening agent: as methylcellulose, polyvidone, polyvinyl alcohol, Ka Baimu, vaseline etc.Therefore the present invention can satisfy the requirement of asthenopia syndrome patient to different dosage form.
The purpose of this invention is to provide a kind of Chinese medicine preparation that the asthenopia syndrome has obvious curative effects for the treatment of.The said preparation Pharmacodynamic test of active extract is the result show: (1) this preparation can obviously suppress rabbit and cause scorching back 2～24 hours eye inflammation reaction (P＜0.001); (2) the rabbit conjunctive bulbi microcirculation disturbance that macromolecule right rotary glycoside is caused has clear improvement, and capillary blood flow is speeded up, and the site intersects increases, and side Zhi Xunhuan is open, and it is granular that the erythrocyte fluidised form is recovered line.The result sees Table 1 respectively, table 2.
Table 1 is respectively organized the comparison (X ± s) of rabbit eye conjunctivitis disease different time reaction score value
| Group | n | Cause time after the inflammation (hour) | ||||||||
| 0.5 | ??1 | ??2 | ??4 | ??6 | ??8 | ??24 | ??48 | ??72 | ||
| Model group | 6 | 13.5 ± 1.0 | ??13.0 ??±1.0 | ??10.5 ??±1.5 | ??8.8± ????1.9 | ??5.8± ????2.0 | ??3.2± ????0.8 | ??1.7± ????0.6 | ??0.7 ??± ????0.6 | ??0.3 ??± ????0.5 |
| The normal saline group | 6 | 13.5 ± 0.8 | ??12.8 ??±0.7 | ??9.7± ????1.8 | ??7.6± ????2.2 | ??4.7± ????1.1 | ??2.8± ????1.1 | ??1.9± ????0.5 | ??0.3 ??± ????0.6 | ??0.3 ??± ????0.4 |
| Pearl eyesight | 6 | 13.5 | ??11.8 | ??7.3± | ??4.5± | ??2.4± | ??1.3± | ??0.7± | ??0.2 | ??0 |
| The eye drop matched group | ??± ????0.5 | ??±1.1 | 1.3 (2) | 1.3 (2) | 1.0 (2) | 0.8 (2) | 0.4 (1) | ± 0.4 | ||
| Eye drop group of the present invention | ??6 | ??13.5 ??± ????1.1 | ??11.7 ??±1.8 | 7.2± 1.6 (2) | 4.9± 1.7 (2) | 2.9± 1.1 (2) | 0.9± 0.6 (2) | 0.4± 0.7 (1) | 0.2 ± 0.2 | ?0 |
Annotate: compare with model group: 1) P＜0.05; 2) P＜0.01; 3) P＜0.001
Table 2 eye drop of the present invention is to the microcirculatory influence of tame lagophthalmos conjunctiva
| Group | ????n | Microvascular blood flow velocity (μ m/s) | Blood capillary intersection site is (individual/1.67mm 2) | ||
| Before the treatment | After the treatment | Before the treatment | After the treatment | ||
| The normal saline matched group | ????6 | ??73.3±9.2 | ??72.1±7.5 | ??2.66± ????0.87 | ????2.78± ????????0.74 |
| Eye drop group of the present invention | ????6 | ??76.9±12.4 | ??145.2± ????19.8 (1) | ??3.05± ????0.82 | ????6.25± ????????1.17 (1) |
Annotate: compare before and after the medication: 1) P＜0.001
Characteristics of the present invention and effect are: clinical observation 40 routine asthenopia syndrome patients, test group 20 examples wherein, matched group (ZHENZHU MINGMU DIYANYE) 20 examples, the result shows that said preparation is treated 20 routine asthenopia syndrome patients, cures 11 examples, produce effects 5 examples, 1 example that takes a turn for the better, total effective rate 85.0%; Eye acid, ophthalmic bloated, ophthalmalgia, eye are done, congested, look thing and can not wait lastingly and all be better than matched group aspect the primary symptom.Clinical observation confirms that said preparation is the safe and effective medicine of treatment asthenopia syndrome.
Below further confirm by the effect of clinical trial said preparation treatment asthenopia syndrome.
Random experiment is adopted in this research, by patient's sequence number of going to a doctor, meets and includes standard person in, all includes observation in, observes 40 examples altogether.
Therapeutic Method: this preparation, usage: every day 4～6 times, each 1～2.30 days is a course of treatment.Observe two courses of treatment altogether.Matched group: ZHENZHU MINGMU DIYANYE usage: every day 4～6 times, each 1～2.20 days is a course of treatment.
One, total effects sees Table 1.
Table 1 curative effect of disease
| Group | The example number | Clinic control | Produce effects | Take a turn for the better | Invalid | Effectively total |
| Example % number | Example % number | Example % number | Example % number | Example % number | ||
| Test group | 20 | 11????55 | 5????25 | 1????5 | 3?????15 | 17????85 |
| Matched group | 20 | 8?????40 | 2????10 | 2????10 | 8?????40 | 12????60 |
Analyze through Ridit, test group and matched group compare, P＜0.05, and curative effect obviously is better than matched group.
Two, each primary symptom is treated forward and backward comparison, sees Table 2.
The forward and backward symptom total effective rate that relatively improves of each primary symptom treatment of table 2
| Syndrome | Before the treatment | After the treatment | ??X2 | ??P | |||||||
| ??N | ??0 | ??2 | ??4 | ??6 | ??0 | ??2 | ??4 | ??6 | |||
| Blurred vision | ??20 | ??0 | ??1 | ??16 | ??3 | ??5 | ??13 | ??2 | ??0 | ??4.81 | ??0.00 |
| Ophthalmic is dry and astringent | ??20 | ??0 | ??8 | ??11 | ??1 | ??6 | ??9 | ??5 | ??0 | ??2.64 | ??0.00 |
| Eyeball swells and ache | ??20 | ??0 | ??9 | ??9 | ??2 | ??8 | ??10 | ??2 | ??0 | ??3.51 | ??0.00 |
| Vertigo and tinnitus | ??0 | ??2 | ??0 | ??2 | |||||||
| Soreness of the waist and knees | ??20 | ??6 | ??14 | ??18 | ??2 | ??3.51 | ??0.00 | ||||
| Headache | ??20 | ??18 | ??2 | ??19 | ??1 | ??0.27 | ??0.39 | ||||
| Nauseating nausea | ??20 | ??14 | ??6 | ??17 | ??3 | ??0.82 | ??0.21 | ||||
Conclusion: learn by statistics and handle (P＜0.05), before and after the treatment of tcm syndrome integration significant difference is arranged.
Model case: in * *, woman, 30 years old, cadre, computerite, sensation blurred vision 2 days.Main suit's eye acid is expanded uncomfortable, and twinge is not sometimes desired to open eyes unbearably, and whole body is with agitation, sleeplessness, headache, bitter taste.Western medicine diagnose: on inspection, eye conjunctiva mild hyperaemia, margo palpebrae is red and swollen rotten to the corn, gets rid of other ophthalmic, is defined as asthenopia disease.Give this preparation eye drip, every day 4～6 times, each 1～2.After 1 month, conscious making eye bright, acid is expanded to feel and is alleviated, and symptom disappears substantially, clinical cure.
Above-mentioned clinical pre-test result shows: clinical treatment asthenopia syndrome, cure 11 examples, produce effects 5 examples, 1 example that takes a turn for the better, total effective rate 85.0%; Can not wait lastingly and all be better than matched group aspect the primary symptom eye acid, ophthalmic bloated, ophthalmalgia, eye being done, looked thing.Not seeing untoward reaction in clinical observation, is the safe and effective medicine of treatment asthenopia syndrome.
Using method of the present invention: eye drop: every day 4～6 times, each 1～2.Collyrium: every day 1～2 time, each 10ml.Eye ointment, gel for eye use: every day 1～2 time, each 1.Eye micropill: every day 1 time, each 1.
The specific embodiment:
Embodiment 1:
Get Flos Buddlejae 50g, Flos Chrysanthemi 60g, Radix Cynanchi Paniculati 80g, volatile matter distillation composition 4h, medicinal residues and Semen Cassiae 75g decoct with water 2 times, each 1 hour, collecting decoction filters, and filtrate concentrates, adding ethanol in the concentrated solution (relative density is 1.12～1.16) makes and contains the alcohol amount and reach 75%, precipitate with ethanol, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol is to there not being the alcohol flavor, add the 500ml distilled water, water precipitating (2～2 ℃) 24 hours filters, add Margarita hydrolyzed solution 100ml volatile ingredient Borneolum Syntheticum 2.5g, hyaluronic acid sodium 2g, be extraction concentrated solution of the present invention.
Embodiment 2:
Get Flos Buddlejae 80g, Flos Chrysanthemi 96g, Radix Cynanchi Paniculati 128g, volatile matter distillation composition 6h, medicinal residues and Semen Cassiae 120g decoct with water 2 times, each 1.5 hours, collecting decoction filtered, filtrate concentrates, adding ethanol in the concentrated solution (relative density is 1.16～1.18) makes and contains the alcohol amount and reach 85%, precipitate with ethanol, cold preservation (2～2 ℃) 48 hours, filter, filtrate recycling ethanol adds the 400ml distilled water, water precipitating (2～2 ℃) 48 hours to there not being the alcohol flavor, filter, add Margarita hydrolyzed solution 100ml, volatile ingredient Borneolum Syntheticum 4g, hyaluronic acid sodium 1g are extraction concentrated solution of the present invention.
Embodiment 3:
Get Flos Buddlejae 60g, Flos Chrysanthemi 70g, Radix Cynanchi Paniculati 60g, volatile matter distillation composition 4h, medicinal residues and Semen Cassiae 55g decoct with water 2 times, each 1 hour, collecting decoction filters, and filtrate concentrates, adding ethanol in the concentrated solution (relative density is 1.12～1.16) makes and contains the alcohol amount and reach 75%, precipitate with ethanol, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol is to there not being the alcohol flavor, get concentrated solution (relative density is 1.14～1.16), add Margarita hydrolyzed solution 100ml, volatile ingredient, Borneolum Syntheticum 2.5g and hyaluronic acid sodium 2g are extraction concentrated solution of the present invention.
Embodiment 4: eye drop
With adding Borax 2.8g, boric acid 10.5g heating for dissolving in arbitrary extraction medicinal liquid in the various embodiments described above, boiled 5～15 minutes, put coldly, filter with microporous filter membrane (0.22 μ m), add sterile purified water to 1000ml, be eye drop of the present invention.
Embodiment 5: collyrium
Sodium pyrosulfite 1g, disodiumedetate 0.3g will be added in arbitrary extraction medicinal liquid in the various embodiments described above, shake up, regulate pH6～7, filter with microporous filter membrane (0.22 μ m) with 0.1mol/L hydrochloric acid, add sterile purified water to 1000ml, be collyrium of the present invention.
Embodiment 6: eye ointment
Add vaseline 500g, ethyl hydroxybenzoate 1g in the concentrated solution with extracting in the foregoing description, stir evenly, sterilization is eye ointment of the present invention.
Embodiment 7: gel for eye use
With adding Ka Baimu 100g, benzalkonium bromide 1g in arbitrary extraction medicinal liquid in the foregoing description, stir evenly, sterilization is gel for eye use of the present invention.
According to prescription of the present invention, can also make eye with other ophthalmic preparations such as micropills.
Claims (4)
1. Chinese medicine preparation for the treatment of the asthenopia syndrome, it is characterized in that described Chinese medicine preparation is to be extracted by following flavour of a drug to be prepared from: Flos Buddlejae 10～50%, Flos Chrysanthemi 10～30%, Semen Cassiae 15～40%, Radix Cynanchi Paniculati 16～30%, Borneolum Syntheticum 0.5～3%, Margarita hydrolyzed solution 2～20%, and hyaluronic acid 0.05～5%.
2. the preparation method of the described Chinese medicine preparation of claim 1, the technological process that it is characterized in that described preparation is: get Flos Buddlejae, Flos Chrysanthemi, Radix Cynanchi Paniculati volatile matter distillation composition 4～6h, medicinal residues and Semen Cassiae decoct with water 2 times, each 1.5～2 hours, collecting decoction, filter, filtrate concentrates, and be concentrated solution l.10～1.20 during to 60 ℃ of relative densities, adds ethanol and makes and contain alcohol and measure and reach 50%～85%, precipitate with ethanol, cold preservation 24～48 hours filters, and filtrate recycling ethanol is to there not being the alcohol flavor, or continue to concentrate, relative density is 1.10～1.20 extraction concentrated solution; Or adding 200～500ml distilled water, water precipitating 24～48 hours filters, and must extract medicinal liquid; Add Margarita hydrolyzed solution 100ml and volatile ingredient respectively, Borneolum Syntheticum and hyaluronic acid sodium are extraction concentrated solution of the present invention and extraction medicinal liquid of the present invention.
3. the described a kind of Chinese medicine preparation for the treatment of the asthenopia syndrome of claim 1 is characterized in that by adding the pH value regulator: phosphate buffer, borate buffer solution etc.; Antibacterial: benzalkonium chloride, benzalkonium bromide, chlorobutanol, ethyl hydroxybenzoate, sorbic acid etc.; Cosolvent: propylene glycol, glycerol, tween.Thickening agent: methylcellulose, polyvidone, polyvinyl alcohol, Ka Baimu, vaseline can be made into eye drop, collyrium, eye ointment, gel for eye use, eye with dosage forms such as micropills.
4. the described a kind of Chinese medicine preparation for the treatment of the asthenopia syndrome of claim 1, it is characterized in that adding in the described prescription Spica Prunellae 5～30%, Rhizoma Coptidis 3～10%, Radix Angelicae Sinensis 1～15%, allantoin 0.1～5%, but above-mentioned flavour of a drug single as required add, the whole adding or wherein any two flavors of adding, and make preparation by extraction process of the present invention.
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102357196A (en) * | 2011-09-27 | 2012-02-22 | 金明 | External traditional Chinese medicine composition for treating xerophthalmia and preparation method thereof |
| CN102600235A (en) * | 2012-04-09 | 2012-07-25 | 龚建国 | Chinese medicinal eye drop for treating oculopathy |
| CN104288334A (en) * | 2014-09-17 | 2015-01-21 | 张道敬 | Traditional Chinese medicine eye drop for relieving eyestrain and preparation method thereof |
| CN104547621A (en) * | 2015-01-21 | 2015-04-29 | 訾庆彬 | Eye protection traditional Chinese medicine |
| CN104644941A (en) * | 2014-06-10 | 2015-05-27 | 陈莉芬 | Eye drop |
| CN107510715A (en) * | 2016-06-15 | 2017-12-26 | 江苏吉贝尔药业股份有限公司 | A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof |
| CN107510714A (en) * | 2016-06-15 | 2017-12-26 | 江苏吉贝尔药业股份有限公司 | A kind of pharmaceutical composition containing pranoprofen and preparation method thereof |
| CN109010375A (en) * | 2018-09-11 | 2018-12-18 | 厦门阿欧客健康科技有限公司 | A kind of collyrium |
| CN114042021A (en) * | 2021-10-28 | 2022-02-15 | 秦胜军 | Eye-moistening essence and preparation method thereof |
| CN116850245A (en) * | 2023-08-22 | 2023-10-10 | 陕西东健药业有限公司 | Deuterium-depleted water traditional Chinese medicine combined eye care solution and preparation method thereof |
| CN116889597A (en) * | 2023-08-23 | 2023-10-17 | 首曜(江苏)生物科技有限公司 | Composition for relieving asthenopia and improving eyesight and preparation method thereof |
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2004
- 2004-10-13 CN CNB2004100359186A patent/CN1285349C/en not_active Expired - Fee Related
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102357196A (en) * | 2011-09-27 | 2012-02-22 | 金明 | External traditional Chinese medicine composition for treating xerophthalmia and preparation method thereof |
| CN102600235A (en) * | 2012-04-09 | 2012-07-25 | 龚建国 | Chinese medicinal eye drop for treating oculopathy |
| CN104644941A (en) * | 2014-06-10 | 2015-05-27 | 陈莉芬 | Eye drop |
| CN104288334A (en) * | 2014-09-17 | 2015-01-21 | 张道敬 | Traditional Chinese medicine eye drop for relieving eyestrain and preparation method thereof |
| CN104547621A (en) * | 2015-01-21 | 2015-04-29 | 訾庆彬 | Eye protection traditional Chinese medicine |
| CN107510715A (en) * | 2016-06-15 | 2017-12-26 | 江苏吉贝尔药业股份有限公司 | A kind of Flos Buddlejae extract eye-drops preparations and preparation method thereof |
| CN107510714A (en) * | 2016-06-15 | 2017-12-26 | 江苏吉贝尔药业股份有限公司 | A kind of pharmaceutical composition containing pranoprofen and preparation method thereof |
| CN109010375A (en) * | 2018-09-11 | 2018-12-18 | 厦门阿欧客健康科技有限公司 | A kind of collyrium |
| CN109010375B (en) * | 2018-09-11 | 2022-04-15 | 厦门阿欧客健康科技有限公司 | Eye lotion |
| CN114042021A (en) * | 2021-10-28 | 2022-02-15 | 秦胜军 | Eye-moistening essence and preparation method thereof |
| CN116850245A (en) * | 2023-08-22 | 2023-10-10 | 陕西东健药业有限公司 | Deuterium-depleted water traditional Chinese medicine combined eye care solution and preparation method thereof |
| CN116889597A (en) * | 2023-08-23 | 2023-10-17 | 首曜(江苏)生物科技有限公司 | Composition for relieving asthenopia and improving eyesight and preparation method thereof |
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|---|---|
| CN1285349C (en) | 2006-11-22 |
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