CN108310442A - Ophthalmic composition - Google Patents
Ophthalmic composition Download PDFInfo
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- CN108310442A CN108310442A CN201710041254.1A CN201710041254A CN108310442A CN 108310442 A CN108310442 A CN 108310442A CN 201710041254 A CN201710041254 A CN 201710041254A CN 108310442 A CN108310442 A CN 108310442A
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- ophthalmic composition
- contact lenses
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- pga
- clo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/10—Halogens or compounds thereof
- A61L12/102—Chlorine dioxide (ClO2)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
-
- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C13/00—Assembling; Repairing; Cleaning
- G02C13/008—Devices specially adapted for cleaning contact lenses
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Epidemiology (AREA)
- General Physics & Mathematics (AREA)
- Ophthalmology & Optometry (AREA)
- Optics & Photonics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Eyeglasses (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention discloses a kind of ophthalmic composition, and it includes the γ PGA and 0.1x 10 of 0.5 10% (w/v)‑4‑2.0x10‑4The ClO of % (v/v)2.The ophthalmic composition can be used as the use of contact lenses Precerving liquid.
Description
【Technical field】
The present invention relates to a kind of ophthalmic composition, more particularly to a kind of ophthalmic composition without preservative can
For contact lenses cleaning, wetting and/or disinfection.
【Background technology】
Modern science and technology constantly improves, it is many be particular about light, comfortable, timesaving products substitute gradually not when suitable object
Product create the diversification of article.Contact lenses are developing progressively soft eyeglass or even popular from the rigid eyeglass of early stage
Colored multi-configuration item eyeglass, solve the obstacle of frame and risk that weight, eyeglass may rupture, and be sportsman
And player, dancer, performer bring the convenience of bigger, being one has medical treatment that is beautiful and providing human body vision correction
Equipment.However, contact lenses are directly contacted with cornea for a long time, in order to avoid causing infection and discomfort, contact lenses
Cleaning maintenance Related product is even more important.Contact lenses are attached directly to eyeball surface, when cleaning or Precerving liquid contain stimulation at
When dividing or pollution condition occur, it is possible to the problems such as causing eye infection, inflammation.Find that contact lenses group is most according to statistics
The eye condition being susceptible to includes pinkeye, dry eyes and allergy, and it is because of contact lenses Precerving liquid or related preservation that this is mostly
Symptom caused by product.
It refers to product necessary to contact lenses are cleaned, sterilize, rinse and stored daily that contact lenses, which preserve articles for use, including hidden
Shape glasses conserving case, cleaning solution, flushing liquor, Multifunctional protective nutrient solution, normal saline solution, dioxygen system, deproteinized piece etc..It is general and
Speech, contact lenses Precerving liquid mainly have cleaning, sterilization, moistening and other effects, can divide into cleaning solution, soak/preservation liquid, rinse
Liquid, thimerosal, lubricating fluid etc. then have unicity, two-in-one (tool cleans and preserves function), three-in-one (tool cleaning, guarantor on the market
Deposit and sterilizing function) or multi-functional product, in response to different use demands.(1) cleaning solution：Cleaning mainly will remove attachment
In the dirty or foreign particle of contact lens surface, and removes and be adsorbed in eye discharge such as protein of contact lenses etc..
Common ingredient includes interfacial agent, ferment.Interfacial activity cleaning solution is cleaned using mechanical friction dissolved impurity, ferment
Plain (Fructus Chaenomelis ferment or pancreas ferment) cleaning solution is then to come cleaning efficacy using chemical bonded refractory.(2) thimerosal：Disinfection is mainly
Remove pathogenic and toxin factor, such as bacterium, virus, Amoeba, Pseudomonas aeruginosa etc..Common kills including chloride containing gram
The chemical agent of fourth or alcohols etc. and the thimerosal containing hydrogen peroxide.Chemical disinfection liquid is simply universal, is to impregnate contact lenses
A few hours can reach Disinfection Effect in liquid medicine, but be easy to cause the stimulation and allergic reaction of eyeball.Hydrogen peroxide itself has
Biocidal efficacies recycle platinum ring plate to be neutralized with normal saline solution, you can reach disinfection, but if neutralizing not exclusively
Injury may be generated to eyes.(3) fountain solution：It is that moisturizing layer is formed on contact lenses to soak major function, increases eyeglass
Moisturizing degree reduces the dry and astringent sense of discomfort of eyeball generated after contact lens wear.Common ingredient includes methylcellulose, sodium hyaluronate
Deng.(4) flushing liquor：Rinse the filths, generally normal saline solution such as impurity and the thalline that mainly rinse out on eyeglass.
(5) soak：It is to preserve liquid that soak, which can also be said, and major function is anti-corrosion, by the effectiveness for reaching sterilization preservation after immersion.Often
Contain certain preservative ingredients.(6) protein liquid removal：Major function is to remove the protein excretion accumulated on eyeglass.Due to eye
For eyeball meeting secretory protein to resist the invasion of bacterium or virus, secretion accumulation can reduce oxygen flow in the pore of contact lenses
Therefore degree can periodically extend the service life of contact lenses, and reduce the friction to eyeball using deproteinized enzyme film or enzyme liquid
Stimulation.
According to the survey, up to 6-7 easy tos produce some eye conditions, including eyes to root at the group of contact lens wear
The discomforts such as dry and astringent, red and swollen, allergy, and it is the symptom because caused by contact lenses Precerving liquid that this is mostly.For the benefit of in damp and hot ring
The preservation in border, and extend the use effect phase behind product Kaifeng, contact lenses Precerving liquid is in addition to containing cleaning, sterilization, moistening, remove egg
Outside white ingredient, preservative can be also added mostly, however, preservative mainly causes the arch-criminal of pinkeye and allergy.Early stage
Precerving liquid contains the ingredient of mercury, easily causes allergic reaction, though current commercial product mostly uses not mercurous and selects to add
The preservative that qualification uses can reduce the probability for inducing allergy, but still can be generated to cornea and injure or cause inflammation etc. no
Good reaction, gets off possibly even cause allergic conjunctivitis for a long time.
Consider the problems of that preservative easily causes allergy, derives the maintenance liquid product without preservative then, but also therefore
The overwhelming majority does not have the function that antibacterial preserves, and causes Precerving liquid to be easy to grow bacterium at any time or contamination phenomenon occurs, in turn
Cause the adverse reactions such as stimulation and the inflammation of eyes, or even causes the disease of eye such as ulcer of the cornea.Although contact lenses can impregnate
It is sterilized in 3% hydrogen peroxide, then to neutralize in platinum sheet and normal saline solution and hydrogen peroxide, advantage is that allergic reaction is less, saves
When, bleaching effect it is good, but there may be incomplete problem is neutralized, toxicity and injury are generated to eyeball and keratocyte.This
Outside, hydrogen peroxide can become water after neutralizing, and not have sterilizing function, if eyeglass impregnates after a week, non-re-disinfection is directly put on, and is equal to
It does not sterilize, can allow bacterial proliferation instead, influence eye health.
In addition, because contact lens can absorb tear and make eyes anoxic, cause eyes water shortage with it is dry and astringent, there is phase
To property xerophthalmia, cause tear matter or amount unbalance, severe patient may cause cornea to injure.Therefore, general recommendations is used containing big
The Precerving liquid of the moistening ingredients of Molecularly Imprinted Polymer allows eyes to maintain moistening.At present on the market, addition sodium hyaluronate or methyl are mostly used
The ingredients such as cellulose are to provide eyes wettability, though however, such fountain solution, which can be contact lens wearers, brings of short duration relax
Slow fruit and comfort, but still it is unable to reach the Probability for lockking moisture longer and effectively reducing xerophthalmia.In addition,
Preservative is often added in the composition of wetting solution as bacteriostatic agent, can be easy to cause the neurotoxic injury to cornea instead.
In view of above-mentioned, it is still necessary to be free of preservative, but the contact lenses Precerving liquid of antibacterial and wetting effect can be had both.
【Invention content】
It finds unintendedly in the present invention, contains specific quantity γ-PGA and specific quantity ClO2Ophthalmic composition,
With splendid antibacterial effect, (synergistic) that can be especially directed to fungi (for example, Candida albicans) offer collaboration is anti-
Bacterium effect.
The present invention provides a kind of ophthalmic composition, it includes γ-PGA and ClO2.Preferably, the content of γ-PGA is
0.5 to 10% (w/v), ClO2Content be 0.1x 10-4-2.0x 10-4% (v/v).
The content of some embodiments according to the present invention, γ-PGA is 1 to 8% (w/v), preferably 1 to 5% (w/
V), more preferably 1 to 2% (w/v).In the specific embodiment of the present invention, which includes about 1.5% (w/v)
γ-PGA.
Some embodiments according to the present invention, ClO2Content be 0.1x 10-4-1.8x 10-4% (v/v), preferably
For 0.5x 10-4-1.5x 10-4% (v/v), more preferably 1.0x 10-4-1.5x 10-4% (v/v).One in the present invention is specific real
It applies in example, which includes about 1.25x 10-4The ClO of % (v/v)2。
According to an of the invention certain specific embodiments, which includes the γ-PGA and about of about 1.5% (w/v)
1.25x 10-4The ClO of % (v/v)2。
The ophthalmic composition of the present invention preferably exists with liquid, can be used as contact lenses Precerving liquid.
It should be understood that foregoing general explanation and detailed description below are only to provide example and explain to be used, not for
The limitation present invention.
【Specific implementation mode】
The present invention provides a kind of ophthalmic composition, it includes γ-PGA and ClO2.Preferably, the content of γ-PGA is
0.5 to 10% (w/v), ClO2Content be 0.1x 10-4-2.0x 10-4% (v/v).
The content of some embodiments according to the present invention, γ-PGA is 1 to 8% (w/v), preferably 1 to 5% (w/
V), more preferably 1 to 2% (w/v).In the specific embodiment of the present invention, which includes 1.5% (w/v's)
γ-PGA。
The poly- Vetsins of γ-(γ-poly glutamic acid, γ-PGA) most found to be present in anthrax bar earlier than 1973
In the cell wall of bacterium (Bacillus anthracis), being one kind can be fermented by microorganism (such as the mutation of hay bacillus Bacillus natto)
The natural polymer of synthesis has many good characteristics, including nontoxic, high bio-compatibility and biodegradability ... etc..
Some embodiments according to the present invention, ClO2Content be 0.3x 10-4-1.8x 10-4% (v/v), preferably
For 0.5x 10-4-1.5x 10-4% (v/v), more preferably 1.0x 10-4-1.5x 10-4% (v/v).One in the present invention is specific real
It applies in example, which includes 1.25x 10-4The ClO of % (v/v)2。
According to an of the invention certain specific embodiments, the ophthalmic composition include about 1.5% (w/v) γ-PGA and
1.25x 10-4The ClO of % (v/v)2。
The ophthalmic composition of the present invention preferably exists with liquid, can be used as contact lenses Precerving liquid.
The ophthalmic composition of the present invention has splendid antibacterial effect, can especially be directed to fungi (for example, Candida albicans
Bacterium) (synergistic) antibacterial effect cooperateed with is provided.
Some embodiments according to the present invention, the ophthalmic composition further include sodium hyaluronate, to increase moistening effect.
Some embodiments according to the present invention, the ophthalmic composition further include known buffer components, for example,
CaCl2、KCl、NaCl、Na2HPO4... etc..
Some embodiments according to the present invention, the ophthalmic composition further include known nonionic interfacial activity
Agent, including but not limited to poloxamer (Poloxamer), for example, poloxamer -407.
Some embodiments according to the present invention, the ophthalmic composition further include EDTA-2Na.
Some embodiments according to the present invention, the ophthalmic composition further include tea polyphenols, including but not limited to
Theine (catechin), epicatechin (epicatechin, EC), epigallocatechin (epigallocatechin, EGC),
L-Epicatechin gallate (epicatechingallate, ECG) and epi-nutgall acid gallate
(epigallocatechin gallate, EGCG).In the specific embodiment of the present invention, which further includes
EGCG。
Specific implementation mode
The present invention is further illustrated by following Examples, is the purpose offer with illustration, and unrestricted purpose.
The cytotoxicity and antibiotic property of 1. ophthalmic composition of embodiment
Material and method
1. ophthalmic composition formula
It is as shown in table 1 below for the ophthalmic composition formula in this example.
The formula (100ml) of 1. ophthalmic composition of table
Separately contain buffer components：CaCl20.015g, KCl 0.15g, NaCl 0.45g, Na2HPO40.45-1.8g,
PH=6.5-7.5 and interfacial agent poloxamer -407,0.05-0.5g.
2. cytotoxicity test
Take 100 μ L, a concentration of 1 × 105L929 (mouse lung fibroblast strain, the juridical person's food industry of cell/mL
Institute of Development Studies, deposit number BCRC 60091) in cell suspending liquid 96 porose discs of addition, containing 5 ± 1% carbon dioxide, temperature
It is cultivated 24 ± 2 hours under 37 ± 1 DEG C of environment of degree.Culture solution is absorbed, 100 μ L are added and prepare the ophthalmic composition dilution completed
(intact cell culture solution is added as dilution using 0.2g ± 10%/mL ratios) after liquid, is containing 5 ± 1% carbon dioxide, temperature
It is cultivated 24 hours under 37 ± 1 DEG C of environment.Positive (10%DMSO), negative (intact cell culture solution) control group are combined with ophthalmic
Object dilution all carries out triple retrials and tests.The dimethyl mercaptan diphenyltetrazoliumbromide that cell culture fluid is replaced as to 50 μ l smells solution
(MTT, Sigma, Cat No.298931) (1mg/mL MTT are dissolved in the cell culture fluid of serum-free), is containing 5 ± 1% dioxies
Change and is cultivated ± 10 minutes 2 hours under 37 ± 1 DEG C of carbon, temperature environment.Removal dimethyl mercaptan diphenyltetrazoliumbromide smells solution, is added
10 minutes are stood after the DMSO of 100 μ l at room temperature, makes the first moon for the crystallization dissolving of (formazan) bluish violet.Exempted from disc type ferment
Epidemic disease analyzer detects the absorption value (reference wavelength 650nm) of 570nm wavelength.
3. antibacterial effect is tested
The antibacterial effect of 3 kinds of bacterial strains of ophthalmic composition pair of test formulations 1 and 2.3 kinds of bacterial strains thaw respectively draws disk, training
It supports 2 days.It respectively takes one to arrive bacterium solution pipe bacterium colony on disk, cultivates 2 days.It is (big that O.D. values are measured using the growth standard curve of bacterial strain
Enterobacteria, O.D.=1, bacterium number：1x109；Staphylococcus aureus, O.D.=1, bacterium number：2.5x108；Candida albicans, O.D.
=1, bacterium number：1.6x106), with water 10:1 serial dilution to bacterial concentration is adjusted to 106cfu/ml.It takes 0.1ml bacterium solutions to be added to match
In the ophthalmic composition of side 1 and 2, being sufficiently mixed makes bacterium be completely dispersed.Bacterium group (Escherichia coli, staphylococcus aureus) is set
In 25 DEG C of cultures, fungi group (Candida albicans) is placed in 35 DEG C of cultures.The 3-7 days, 1ml sample liquids are taken, dilute 10 successively3、102、
101Bacterium amount is counted again, to assess antibacterial effect.
As a result：
1. cytotoxicity
Compared to control group (untreated), with the cell of the ophthalmic composition processing of formula 1, survival rate average out to 89%
(result is not shown), to be formulated the cell of 2 ophthalmic compositions processing, survival rate average out to 77% (result is not shown).
2. antibacterial effect
The antibacterial effect of 3 kinds of bacterial strains of ophthalmic composition pair of formula 1 and 2 is as shown in table 2 below.
The bacterium amount (experimental group each group n=2) of 2. 3 kinds of bacterial strains of table
| Concentration (cfu/ml) | Control group | Formula 1 | Formula 2 | Formula 3 | Formula 4 | Formula 5 | Formula 6 |
| Escherichia coli | 105-106 | 0 | 0 | 0 | 0 | 0 | 5.06x106 |
| Staphylococcus aureus | 105-106 | 0 | 0 | 1.2x105 | 1x105 | 4.8x105 | 6.6x105 |
| Candida albicans | 105-106 | 2.54x104 | 0 | 6x106 | 6x106 | 6x106 | 8.4x105 |
The results show that γ-PGA and ClO2It is used alone, Candida albicans (is formulated by 1 and is matched without apparent antibacterial effect
Square 3-6), but be applied in combination, it may achieve unexpected cooperative effect, have splendid resist to the fungi Candida albicans of more difficult killing
Bacterium effect (formula 2), while can also kill Escherichia coli or staphylococcus aureus.
Those skilled in the art in the invention will be seen that, can be to upper in the case where not departing from the main concept of the invention of the present invention
The specific embodiment stated carries out a variety of modifications, replacement.It is understood, therefore, that the present invention is not limited to revealed specific
Specific embodiment, but it is intended to cover spirit of that invention defined in claim and any modification in range.
Claims (10)
1. a kind of ophthalmic composition, which is characterized in that include the γ-PGA and 0.1x10 of 0.5-10% (w/v)-4-2.0x10-4The ClO of % (v/v)2。
2. ophthalmic composition as described in claim 1, which is characterized in that include the γ-PGA of 1-5% (w/v).
3. ophthalmic composition as claimed in claim 2, which is characterized in that include the γ-PGA of 1-2% (w/v).
4. ophthalmic composition as claimed in claim 3, which is characterized in that include the γ-PGA of 1.5% (w/v).
5. ophthalmic composition as described in claim 1, which is characterized in that include 0.5x10-4-1.5x10-4% (v/v)
ClO2。
6. ophthalmic composition as claimed in claim 5, which is characterized in that include 1.0x10-4-1.5x10-4%'s (v/v)
ClO2。
7. ophthalmic composition as claimed in claim 6, which is characterized in that include 1.25x10-4The ClO of % (v/v)2。
8. ophthalmic composition as described in claim 1, which is characterized in that comprising 1.5% (w/v) γ-PGA and
1.25x10-4The ClO of % (v/v)2。
9. ophthalmic composition as described in claim 1, exists with liquid.
10. ophthalmic composition as claimed in claim 9 is contact lenses Precerving liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710041254.1A CN108310442B (en) | 2017-01-17 | 2017-01-17 | Ophthalmic composition |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710041254.1A CN108310442B (en) | 2017-01-17 | 2017-01-17 | Ophthalmic composition |
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| CN108310442A true CN108310442A (en) | 2018-07-24 |
| CN108310442B CN108310442B (en) | 2021-08-27 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112500528A (en) * | 2020-12-03 | 2021-03-16 | 山东省眼科研究所 | Drug-loaded contact lens with antibacterial effect and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN108310442B (en) | 2021-08-27 |
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