CN110448678A - A kind of fusion factor containing PHPV is used to alleviate the component and Preparing Use of the eye drops of visual fatigue - Google Patents
A kind of fusion factor containing PHPV is used to alleviate the component and Preparing Use of the eye drops of visual fatigue Download PDFInfo
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Abstract
The present invention relates to eye drops and its pharmaceutical applications that a kind of fusion factor containing PHPV is used to alleviate visual fatigue.The eye drops includes following mass concentration ingredient: PHPV fusion factor 0.00005%---0.05%;Osmotic balance liquid 0.1%---1%;Sodium Hyaluronate 0.01%-0.2%;Ethyl hydroxy benzoate 0.01%-1%;Surplus is deionized water.Eye drops of the present invention has definite ingredients, and no sensitization, nonirritant, quality controllable advantage can be widely used for the treatment of various eye diseases and extenuates.
Description
Technical field
The present invention relates to a kind of medical instrument, specially a kind of fusion factor containing PHPV is used to alleviate the eye drip of visual fatigue
Liquid component and Preparing Use.
Background technique
Eyes are most important organs in human sensory.It is made of the accessory organ of eyeball and eye, major part is eye
Ball.Eyeball includes the tissue such as wall of eyeball, intraocular chamber and content, nerve, blood vessel.Wall of eyeball be broadly divided into it is outer, in, it is three layers interior.
Outer layer forms also known as fibrous layer film layer by cornea, sclera.Preceding 1/6 be transparent cornea, remaining 5/6 for white sclera, custom
Claim " white of the eye ".Eyeball outer layer plays a part of to maintain eyeball shape and protects eye inner tissue.Cornea is that the most outpost of reception information enters
Mouthful.Cornea is the transparent part of eyeball front, and it is transparence chip that light, which injects eyeball energy transmitted ray through this,.Cornea is slightly in
Ellipse is slightly dashed forward forward.Transverse diameter is 11.5~12mm, vertical diameter about 10.5~11mm.Periphery thickness about 1mm, center are 0.50-
0.57mm.Precorneal one layer of tear film prevents bitot's patches, keeps cornea smooth and optical characteristics.Cornea contains
Nerve abundant, hyperesthesia.Therefore cornea is in addition to being other than light enters the intraocular and primary structure of dioptric imaging, also to play guarantor
Shield effect, and be the significant points for measuring human body consciousness.Cornea is divided into five layers, from the front to the back successively are as follows: epithelium layer, preceding
Elastic layer, hypothallus, descemet's membrane, endothelial layer.Descemet's membrane is firm, to the resistance of chemical substance and pathological lesion
By force.Due to cornea be it is transparent, there is no blood vessel above.Therefore, cornea mainly obtains nutrition from tear, if eye
Nutritional ingredient contained by tear is not enough, and cornea just becomes drying, and transparency will reduce.Cornea can also be obtained from air
Oxygen is obtained, so many people can feel some dryings of eyes after waking up from a sleep, generates visual fatigue.The reason of leading to visual fatigue, has
It is several below:
One, accommodative asthenopia: Chang Fasheng adjust weak, paralysis accommodation, presbyopia, ametropia (long sight, astigmatism) with
And when wearing inappropriate glasses.Since farsightedness is often more excessive than emmetropia using adjusting near work, in addition influx and tune
Save disequilibrium relationship, therefore often have feeling of fatigue near work or study, may occur in which ophthalmodynia, forehead distending pain, it is drowsiness,
The symptoms such as absent minded.It is still normal to read anomalistic distance when starting, then distance gradually becomes remote and tired with eye later
Labor, slightly row rest symptom can reduce again.Also it is often associated with constitutional symptom, such as shoulder aches, has a sleepless night, failure of memory.Face or
If slight farsightedness reading time is too long or the near work time too long, can be because excessively using adjusting, ciliary muscle occurs
Spasmodic contraction and cause so-called pseudo-myopia (spasm of accommodation), be common in teenager.This pseudo-myopia often has apparent eyes
Fatigue symptom.Some myopia or astigmatism patient wear the biggish glasses of degree and asthenopia also easily occur.It declines adjusting insufficient or adjusting
When weak, anomalistic distance Xiang Yuanyi is such as unwilling to do closely again, then inevitable excessively to cause asthenopia using adjusting.Some offices
Portion or systemic disease such as glaucoma, Eye injuries, anaemia, dysendocrinism, acute infectious disease etc., can all have adjust it is weak and
Caused asthenopia symptom.
Two, convergence visual fatigue: ametropic people is often betided.Such as near-sighted or presbyopia, heterophoria, influx function
It is not congruent.In near work or study, in order to keep binocular single vision, two internus need co-contraction.Object is closer,
Required influx function is bigger, and the contraction of internal rectus muscle is also bigger.If eye fatigue can occur for influx function deficiency.Myopia
When eye is not worn glasses, since anomalistic distance is close, it is not required to or is rarely employed adjusting force, thus influx is destroyed with adjustment, spoke
More than adjusting eye fatigue can also occur for concentrate around one point, as spokes on acis.Work or reading cannot be lasting, easily slip a line, and have flash of light to feel, cannot be engaged in solid
Feel work, in addition still there is conjunctival congestion.Once putting on suitable glasses, symptom can reduce or disappear.Used rectify is worn for a long time
Spectacles for long sight, can also often cause influx function insufficient, exotropia gradually occurs.In addition, influx functional development is not complete, disease
Failure, dysendocrinism, neurasthenia, amblyopia, presbyopia etc. can also cause eye fatigue afterwards.
Three, muscular asthenopia: extraocular muscle balance of power person, two eyeballs no matter it is static or movement when, be look at object or
All fall in image in the corresponding points in two eyes retinas center naturally in symmetric position when not watching object attentively, will not eyes it is tired
Labor.Extraocular muscle strength imbalance person (such as heterophoria) may occur in which deflection when not watching object attentively for two.If watching object attentively,
Part extraocular muscle will be especially nervous, to make great efforts to overcome this non-equilibrium state.It is this nervimuscular overstretched, it can be with
Cause eye fatigue.There is significant squinter, eyeball direction can not be made consistent though watching object attentively, neuromuscular also need not be excessive
Anxiety is unlikely to cause eye fatigue to maintain two balances.
Four, Environmental visual fatigue: with the continuous development of cause of science, the daily locating environment of people, including life with
Working environment is sufficiently complex.Due to the abnormal stimulation (the especially video equipments such as computer) lived with working environment, can also draw
Play eye fatigue.If light source is too light or too dark, light flash is unstable, and indoor wall color is improper, and tables and chairs height difference is too
Greatly, intense noise, room temperature supercooling or overheat, read on car and boat etc..Since everyone is to environmental abnormality stimulation (part
Or whole body) tolerance degree it is different, the symptom sent out also has notable difference.This may be similar with nerve eye fatigue, be by
In the neurosis that life or working environment influence and occur.Such as with ametropia, eye fatigue exacerbation of symptoms can be made.
The core component PHPV fusion factor contained in the present invention is to be sent out by cell-penetrating peptide and oligopeptides -1 by genetic engineering
A kind of high-new fusion factor of ferment technological expression purifying, has multiple biological function.The cell-penetrating peptide that PHPV fusion factor contains
The small peptide with cell-penetrating function being made of less than 30 amino acid, 1. which has characteristics that has only
Positive charge and amphipathic;2. it is high to wear film transfer efficiency;3. nearly all cell can be imported;4. a variety of work can be carried
Property substance enters cell;5. penetrating cell film can be targeted, reach a variety of viruses of inactivation, bacterium and do not cause cellular damage.It is few
Peptide -1 (that is: recombinant human epidermal growth factor) be United States Biochemical scholar Stanley doctor Cohen in 1962 at first in mouse
It is found in the extracting solution of lower jaw gland, and proposes that the factor has the growth for directly facilitating mucocutaneous reparation and epidermal cell, and
It can make the cell of aging is inverse to be divided into young cell.The EGF growth factor of Stanley doctor Cohen discovery was obtained in 1986
International Nobel Prize in Physiology or Medicine.Oligopeptides -1 (EGF) is a kind of intracorporal active material of people, and the work being made of 53 amino is thin
Born of the same parents reach the effect of repairing hyperplasia cornea by the tyrosine phosphorylation of stimulation one 1 receptor of oligopeptides.PHPV fusion factor
Preparation method has carried out detailed record in the earlier application ZL CN201610728673.8 of the applicant, and the application is complete
Text introduces above content.The applicant has found that corneal stroma can be improved again in PHPV fusion factor in long-term scientific research
Raw ability, though endothelium heals, area can enhance the activity of endothelial cell, to corneal abrasion, the dotted cornea of shallow-layer without influence
Inflammation, contusion of cornea, xerophthalmia have positive effect, can promote the regeneration of corneal epithelial cell, so as to shorten being cured for damaged corneal
Close the time.
The present invention is by my doctor Wei research team, joint Harvard University, company, Shandong Agricultural University doctor Yu research
Team, Chinese biological medicine research institute, Guangdong medical insurance pharmaceutcal corporation, Ltd, Hong Kong Pharmaceuticals Ltd research and develop jointly, are
A kind of highly-safe, for alleviating visual fatigue eye drops.It is tired suitable for accommodative asthenopia, convergence visual fatigue, flesh view
Labor, Environmental visual fatigue;Have the effects that refrigerant antipruritic, alleviation asthenopia, promotes eye nutrition, keeps eyes wet.It is aobvious
Write advantage be can alleviate eyes it is dry, it is puckery, itch, the discomforts such as pain, swollen and foreign body sensation;To corneal abrasion, superficial punctate keratitis,
Contusion of cornea, xerophthalmia have positive effect, can promote the regeneration of corneal epithelial cell, so as to shorten the healing of damaged corneal
Time.
Summary of the invention
The present invention is suitable for accommodative asthenopia, convergence visual fatigue, muscular asthenopia, Environmental visual fatigue;With clear
The effects of cool antipruritic, alleviation asthenopia, promotion eye nutrition, wet holding eyes.Remarkable advantage is can to alleviate eyes
It is dry, puckery, itch, the discomforts such as pain, swollen and foreign body sensation;Have to corneal abrasion, superficial punctate keratitis, contusion of cornea, xerophthalmia bright
Effective fruit provides a kind of for alleviating the eye drops component and Preparing Use of visual fatigue.
The present invention is achieved by the following technical scheme: a kind of for alleviating the eye drops of visual fatigue, it is characterised in that
Include following mass concentration ingredient;
Wherein, PHPV albumen is that cell-penetrating peptide ELP and oligopeptides -1 pass through fusion egg constructed by recombinant expression mode
It is white;
Wherein, the sequence of cell-penetrating peptide ELP is Val-Pro-Gly-Xaa-Gly, and Xaa is preferably Ala;
Wherein, the NaCl aqueous solution that osmotic balance liquid is 0.1%.
Wherein, the pH value of eye drops is 6.5.
And the purposes for alleviating visual fatigue drug is being prepared using component eye drops of the present invention.
The concrete component of eye drops of the present invention is described below:
1, osmotic balance liquid: it is a kind of osmotic pressure regulator that biology maintains internal salinity and ocular fluid to balance, can maintains
Eyes normal osmotic pressure environment provides clean environment for eyeball, and can improve the biological utilisation of other products ingredient in product
Degree.
2, Sodium Hyaluronate: it is one of the constituent of human body tear, there is good viscoplasticity and rheology shape, energy
Enough play to eyes keeps the skin wet, wet ocular surface, generates mucus solution and be covered in eye surface, thus protect eyes and
Improve eyes it is dry and astringent, do not accommodate foreign body sensation.
3, PHPV fusion factor is the one kind for passing through genetic engineering fermentation technique expression and purification by cell-penetrating peptide and oligopeptides -1
Fusion protein has multiple biological function.The power of regeneration of corneal stroma can be improved, though endothelium heals, area is without influence,
The activity that endothelial cell can be enhanced has positive effect to corneal abrasion, superficial punctate keratitis, contusion of cornea, xerophthalmia,
It can promote the regeneration of corneal epithelial cell, so as to shorten the healing time of damaged corneal.
Specific embodiment
It below in conjunction with specific embodiment, elaborates to technical solution of the present invention, it should be understood that these embodiments are only
For illustrating the present invention rather than limiting the scope of the invention, after the present invention has been read, those skilled in the art are to this
The modification of the various equivalent forms of invention is each fallen in the application range as defined in the appended claims.
Embodiment 1: the specific of eye drops of the present invention matches when preparing process
It is a kind of for alleviating the eye drops of visual fatigue, calculate by weight, PHPV fusion factor: 0.0004%;Osmotic pressure
Equilibrium liquid: 0.9%;Sodium Hyaluronate: 0.05%;Ethyl hydroxy benzoate: 0.5%.In mentioned component, it is to prepare 100kg eye drops
Example, i.e., the 0.0004kg of fusion factor containing PHPV, Sodium Hyaluronate 0.05kg in 100kg eye drops;Osmotic balance liquid 0.9kg;
Ethyl hydroxy benzoate: 0.5kg;The specific process is as follows: material-compound tank is added in deionized water, lead to steam, is heated to 85 DEG C of water temperature, heat preservation
30min sterilizing;Sodium Hyaluronate, osmotic balance liquid is added by above-mentioned dosage, closes cover, opens vacuum pump, while stirring
Interval homogeneous 10min, until being uniformly dispersed;Logical condensed water is cooled to 30 DEG C of feed liquid temperature, closes condensed water, adds by above-mentioned dosage
Enter PHPV fusion factor, while stirring interval homogeneous 3min, until being uniformly dispersed;The stirring of ethyl hydroxy benzoate side is added by above-mentioned dosage
Side interval homogeneous 3min, until being uniformly dispersed;PH is surveyed in semi-finished product sampling, adjusts PH to 6.5.
Embodiment 2: the specific of eye drops of the present invention matches when preparing process
It is a kind of for alleviating the eye drops of visual fatigue, calculate by weight, PHPV fusion factor: 0.0002%;Osmotic pressure
Equilibrium liquid: 0.5%;Sodium Hyaluronate: 0.08%;Ethyl hydroxy benzoate: 0.3%.In mentioned component, it is to prepare 100kg eye drops
Example, i.e., the 0.0002kg of fusion factor containing PHPV, Sodium Hyaluronate 0.08kg in 100kg eye drops;Osmotic balance liquid 0.5kg;
Ethyl hydroxy benzoate: 0.3kg;The specific process is as follows: material-compound tank is added in deionized water, lead to steam, is heated to 85 DEG C of water temperature, heat preservation
30min sterilizing;Sodium Hyaluronate, osmotic balance liquid is added by above-mentioned dosage, closes cover, opens vacuum pump, while stirring
Interval homogeneous 10min, until being uniformly dispersed;Logical condensed water is cooled to 30 DEG C of feed liquid temperature, closes condensed water, adds by above-mentioned dosage
Enter PHPV fusion factor, while stirring interval homogeneous 3min, until being uniformly dispersed;The stirring of ethyl hydroxy benzoate side is added by above-mentioned dosage
Side interval homogeneous 3min, until being uniformly dispersed;PH is surveyed in semi-finished product sampling, adjusts PH to 6.5.
Embodiment 3: the specific of eye drops of the present invention matches when preparing process
It is a kind of for alleviating the eye drops of visual fatigue, calculate by weight, PHPV fusion factor: 0.0006%;Osmotic pressure
Equilibrium liquid: 0.3%;Sodium Hyaluronate: 0.02%;Ethyl hydroxy benzoate: 0.2%.In mentioned component, it is to prepare 100kg eye drops
Example, i.e., the 0.0006kg of fusion factor containing PHPV, Sodium Hyaluronate 0.02kg in 100kg eye drops;Osmotic balance liquid 0.3kg;
Ethyl hydroxy benzoate: 0.2kg;The specific process is as follows: material-compound tank is added in deionized water, lead to steam, is heated to 85 DEG C of water temperature, heat preservation
30min sterilizing;Sodium Hyaluronate, osmotic balance liquid is added by above-mentioned dosage, closes cover, opens vacuum pump, while stirring
Interval homogeneous 10min, until being uniformly dispersed;Logical condensed water is cooled to 30 DEG C of feed liquid temperature, closes condensed water, adds by above-mentioned dosage
Enter PHPV fusion factor, while stirring interval homogeneous 3min, until being uniformly dispersed;The stirring of ethyl hydroxy benzoate side is added by above-mentioned dosage
Side interval homogeneous 3min, until being uniformly dispersed;PH is surveyed in semi-finished product sampling, adjusts PH to 6.5.
Embodiment 4: the safety pharmacology experiment of eye drops of the present invention
The experiment of 4.1 high temperature:
It according to eye drops sample prepared by embodiment 1, is placed under the conditions of high temperature (60 DEG C), places 10 days, in the 5th day, the
It is measured by sampling respectively within 10 days, and compared with 0 day data, as a result, it has been found that the appearance of this product, pH value, PHPV fusion factor under high temperature
Content has no significant change, the results showed that this eye drops has good stability at high temperature.As a result as follows:
Table 1, PHPV fusion factor eye drops high temperature experimental result
Appearance | PH value | PHPV fusion factor | |
0 day | Colourless transparent liquid | 6.50 | 0.0004% |
5 days | Colourless transparent liquid | 6.48 | 0.0004% |
10 days | Colourless transparent liquid | 6.47 | 0.0004% |
4.2 stability experiments:
The eye drops sample prepared according to embodiment 1 is taken, being placed in temperature is 40 DEG C, in the environment that relative humidity is 75%
It places 180 days, respectively in 30,60,180 days sample detections, observes appearance, pH value, PHPV fusion factor content.Pass through experiment
Statistics indicate that having no significant change before indices and experiment.
Table 2, PHPV fusion factor eye drops stability experiment result
Appearance | PH value | PHPV fusion factor | |
0 day | Colourless transparent liquid | 6.50 | 0.0004% |
30 days | Colourless transparent liquid | 6.51 | 0.0004% |
60 days | Colourless transparent liquid | 6.46 | 0.0004% |
180 days | Colourless transparent liquid | 6.47 | 0.0004% |
The experiment of 4.3 safety pharmacologies:
Healthy rabbits 6 of 2 kilograms of weight of selection, half male and half female, what every rabbit right eye instillation was prepared according to embodiment 1
Eye drops 1 drips, and left eye instills 1 drop physiological saline as control, and every 4 hours are primary, continuous 10 days, upon administration eight hours and
1,3,5,7,9 days when, with lens examination rabbit eyes, as a result two are showed no exception.
Table 3, PHPV fusion factor eye drops integrate (n=6) to the reaction of rabbit Eye irritation
After administration | 8 hours | 1 day | 3 days | 5 days | 7 days | 9 days |
Integral | 0±0 | 0±0 | 0±0 | 0±0 | 0±0 | 0±0 |
Note: integral 0--5 indicates non-stimulated
Embodiment 5: clinical application effect verifying
The present invention has carried out experimental study to clinical application effect, those selected is with a degree of visual fatigue symptom
Volunteer, between 20-45 years old age, the clinical symptoms with apparent visual fatigue: eyes are dry, it is puckery, itch, bitterly, swollen and foreign matter
Sense etc., is selected in 120 volunteers, this test completes 115 altogether.Wherein eyes are dry, volunteer 40 puckery, and eyes are itched, pain is volunteered
Person 38, eyes are swollen and foreign body sensation volunteer 37.
Table 4, test front and back eyes are done, puckery volunteer's symptom improves situation analysis
Number of days | It is dry, puckery | It moistens comfortable | It is efficient |
0 | 40 | 0 | 0 |
1 | 15 | 25 | 62.5% |
3 | 5 | 35 | 87.5% |
6 | 2 | 38 | 95% |
It can be seen from Table 4 that thering is the 62.5% dry and astringent symptom of volunteer's eyes on probation to obtain obviously after using 1 day
Improve, dry and astringent symptom disappears, and eyes are felt to moisten comfortable;After using 6 days, there is the dry and astringent symptom of 95% volunteer on probation
It disappears, eyes are felt to moisten comfortable.The eye drops of the fusion factor containing PHPV has positive effect for alleviating dry, puckery visual fatigue.
Table 5, test front and back eyes are itched, pain volunteer's symptom improves situation analysis
Number of days | Itch, pain | It moistens comfortable | It is efficient |
0 | 38 | 0 | 0 |
1 | 17 | 21 | 55.3% |
3 | 6 | 32 | 84.2% |
6 | 3 | 35 | 92.1% |
It can be seen from Table 5 that using having after 1 day, 55.3% volunteer's eyes on probation are itched, pain symptom obtains obviously
Improve, itch, pain symptom disappearance, eyes are felt to moisten comfortable;After using 6 days, there is itching, bitterly for 92.1% volunteer on probation
Symptom disappears, and eyes are felt to moisten comfortable.The eye drops of the fusion factor containing PHPV itches for alleviating eyes, has obvious effect bitterly
Fruit.
Table 6, test front and back eyes are swollen, foreign body sensation volunteer's symptom improves situation analysis
Number of days | Swollen, foreign body sensation | It moistens comfortable | It is efficient |
0 | 37 | 0 | 0 |
1 | 7 | 30 | 81.1% |
3 | 5 | 32 | 86.5% |
6 | 2 | 35 | 94.6% |
It can be seen from Table 6 that using having after 1 day, 81.1% volunteer's eyes on probation are swollen, foreign body sensation symptom obtains
It is obviously improved, swollen, foreign body sensation symptom disappears, and eyes are felt to moisten comfortable;After using 6 days, there is 94.6% volunteer on probation
Swollen, foreign body sensation symptom disappear, eyes are felt to moisten comfortable.The eye drops of the fusion factor containing PHPV is swollen, different for alleviating eyes
Object sense has positive effect.
It should be pointed out that the mode of specific implementation described above can be such that those skilled in the art are more fully understood
The contents of the present invention, but do not limit the invention in any way.Therefore, although this specification and embodiment to the present invention
Be described in detail, but it should be appreciated by those skilled in the art that still can modify to the present invention or
Equivalent replacement, and all do not depart from the technical solution and its improvement of the spirit and scope of the present invention, should all cover in the present invention
In the protection scope of patent.
Claims (7)
1. a kind of for alleviating the eye drops of visual fatigue, it is characterised in that include following mass concentration ingredient:
2. eye drops according to claim 2, it is characterised in that the PHPV fusion factor is cell-penetrating peptide ELP and widow
Peptide -1 passes through fusion protein constructed by recombinant expression mode.
3. eye drops according to claim 2, it is characterised in that the sequence of the cell-penetrating peptide ELP is Val-Pro-
Gly-Xaa-Gly。
4. eye drops according to claim 3, it is characterised in that the Xaa in the sequence of the cell-penetrating peptide ELP is preferred
For Ala.
5. eye drops described in -4 according to claim 1, it is characterised in that the NaCl that the osmotic balance liquid is 0.1% is water-soluble
Liquid.
6. eye drops described in -5 according to claim 1, it is characterised in that the pH value of the eye drops is 6.5.
7. any one of the claim 1-6 component eye drops is preparing the purposes for alleviating visual fatigue drug.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110664742A (en) * | 2019-10-29 | 2020-01-10 | 易金阳 | Eye drops for relieving asthenopia and preparation method and application thereof |
CN116693697A (en) * | 2023-06-02 | 2023-09-05 | 深圳市瑞鑫医药开发有限公司 | Eye drop for relieving asthenopia |
Citations (1)
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CN106279439A (en) * | 2016-08-26 | 2017-01-04 | 易金阳 | A kind of oligopeptide 1 fusion protein containing cell-penetrating peptide and preparation method thereof |
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2018
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CN106279439A (en) * | 2016-08-26 | 2017-01-04 | 易金阳 | A kind of oligopeptide 1 fusion protein containing cell-penetrating peptide and preparation method thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110664742A (en) * | 2019-10-29 | 2020-01-10 | 易金阳 | Eye drops for relieving asthenopia and preparation method and application thereof |
CN116693697A (en) * | 2023-06-02 | 2023-09-05 | 深圳市瑞鑫医药开发有限公司 | Eye drop for relieving asthenopia |
CN116693697B (en) * | 2023-06-02 | 2024-03-19 | 深圳市瑞鑫医药开发有限公司 | Eye drop for relieving asthenopia |
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