CN101524554B - Composition used with contact lens for cleaning and disinfection and application thereof - Google Patents
Composition used with contact lens for cleaning and disinfection and application thereof Download PDFInfo
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- CN101524554B CN101524554B CN200910048952XA CN200910048952A CN101524554B CN 101524554 B CN101524554 B CN 101524554B CN 200910048952X A CN200910048952X A CN 200910048952XA CN 200910048952 A CN200910048952 A CN 200910048952A CN 101524554 B CN101524554 B CN 101524554B
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Abstract
The invention relates to a composition used with contact lens for cleaning and disinfection, sodium neo-houttuyfonate pre-solution for preparing the composition, as well as use of the composition and the sodium neo-houttuyfonate pre-solution for preparing a cleaning disinfectant, preservation solution, multi-functional solution and/or lubricating fluid used with the contact lens for cleaning and disinfection.
Description
Technical field
The present invention relates to a kind of compositions and application thereof that cooperates the contact lens cleaning-sterilizing to use, said composition cleaning-sterilizing effect obvious and don't damage glasses and/or eyes are applied to the contact lens care products field.
Background technology
Widely used now contact lens can be divided into two types by raw material, and one type is to be the hard lenses of primary raw material with the methyl methacrylate; Another kind of then is being the hydrogel or the soft lens of primary raw material such as hydroxyethyl methacrylate.The contact lens of being mentioned among the present invention refers in particular to hydrogel or soft lens.
Possess good deformation behavior, wear comfortable hydrogel or soft lens; Because eyeglass material and water content and wear environmental relation; Also adsorb all kinds of dirts all the more easily; If timely cleaning and sterilizing, all kinds of ocular disease of initiation easily then, serious in macropapillary conjunctivitis, cornea rebirth blood vessel, corneal infiltration, corneal ulcer etc.
Contact lens must be kept at when not wearing in the specific preservation system aqueous solution; Such system aqueous solution must guarantee that the breeding of each the bacterioid fungus on the eyeglass is suppressed under a certain particular range; This aqueous solution also is asked to not influence the comfortable wearing property of eyeglass simultaneously, promptly refers to indexs such as lens performance size.
The care product field that cooperates contact lens to use comprises disinfectant solution, preserves liquid, multifunctional solution and/or lubricating fluid (eye drop), and the most important effect of these care products is exactly the cleaning-sterilizing function.The cleaning-sterilizing system of early stage research employing is heating or the chemical preservative that uses hydrogen peroxide and so on, but the heating use is convenient inadequately, and hydrogen peroxide agent need neutralize otherwise stimulate eyes easily.The modern poly hexamethylene biguanide that uses usually is as antiseptic, like the poly hexamethylene biguanide concentration of mentioning use among the U.S. Pat P 6063745 between 0.1～1.0ppm.But along with the complicated day by day environment for use of wearing, also increasingly high to the requirement of cleaning-sterilizing, so this area research staff is at the up-to-date available antiseptic of research.As having mentioned the dual decontamination system that uses biguanide and ide polymers among the Chinese patent publication number CN1285866, but biguanide compound decomposition easily in long preservation.Mention in the and for example Chinese granted patent 97192736.7 and use epsilon-polylysine as antiseptic; But this material is effective to suppressing antibacterial under low concentration; Then must use high concentration to suppressing fungus and mycete yeast etc., bring the risk that stimulates eyes therefrom.
In seeking suitable antiseptic composition cleaning-sterilizing system, except that the Disinfection Effect of taking into account system itself, to consider also whether it can accumulation problems on eyeglass.The amount of antiseptic is not used in safety range can cause any problem, but contact lens is because originally as the moisture soft gel of porous, being prone to becomes the carrier that antiseptic is built up, so the antiseptic that use this area must have the characteristic that nothing is gathered on eyeglass.
Therefore, need seeking can the cleaning-sterilizing contact lens, the compositions non-stimulated to eye again, adds all kinds of materials with said composition as the basis and can extend different contact lens care products.
Summary of the invention
The present invention provides a kind of compositions and application thereof that cooperates the contact lens cleaning-sterilizing to use.Said composition comprise neo-houttuyninum disinfecting system, or comprise with neo-houttuyninum and the synergistic disinfecting system of poly hexamethylene biguanide; Contain the surfactant that increases disinfecting system dissolubility, stability and comfortableness simultaneously, with general cleaning-sterilizing liquid or preserve liquid phase and can directly contact the also advantage of not damaged etc. of eyes than having.
Cleaning and disinfecting compositions of the present invention, composition and content are:
Neo-houttuyninum dissolves thing 0.001～0.01wt% in advance
Acid-base buffer system 0.1～2.0wt%
Osmotic pressure regulator makes the compositions osmotic pressure be adjusted to 220～380mOsm/kgH
2The amount of O
The pure water surplus
The pH value of said compositions is 6.5-7.8.
Herba Houttuyniae has antibacterial functions, and its main component is decanoylacetaldehyde, i.e. houttuynine sodium bisulfite.Its free state is easy to polymerization and lost efficacy, must be just stable with addition product character.China's synthetic in 1971 the sodium sulfite addition product hydroxyl sulfonate sodium of decanoylacetaldehyde, be called Sodium Houttuyfonate, synthetic lauroyl acetaldehyde sodium sulfite addition product is called neo-houttuyninum.
Neo-houttuyninum English name Sodium New Houttuyfonate, molecular formula is C
14H
27NaO
5S, white flakey or needle-like or crystalline powder be prone to dissolve in hot water, slightly soluble in water, ethanol, its raw material standard number is WS-10001-(HD-0484)-2002.Neo-houttuyninum is that each bacterioid, fungus, mycete and yeast etc. all have significantly bacteriostasis to gram positive bacteria and negative bacterium, and its biological activity is higher, and is antibacterial lasting and safe in utilization, also is usually used in treating ophthalmic diseases clinically.This described bioactive ingredients also comprises its homologue and derivant, the noval chemical compound of forming like the length that increases and reduce alkyl acyl carbochain etc.Among the present invention neo-houttuyninum dissolve in advance the content of thing be 0.001～0.01% (weight, wt); The actual content that is neo-houttuyninum be 0.00001～0.004% (weight, wt).
Dissolve thing in advance at neo-houttuyninum and can contain another antiseptic poly hexamethylene biguanide (PHMB); The poly hexamethylene biguanide of in U.S. Pat P4758595, mentioning has broad-spectrum sterilization property with its water soluble salt; Even in aqueous solution, have only the concentration of ppm level; Also all very effective to kill bacteria and fungus, and the damage of pair cell is used for the antiseptic minimum of eye compositions, the real safety non-toxic material that belongs to for all are known.But find that in the present invention's research temperature just possibly cause the Disinfection Effect of biguanide to descend in long storage time more than 45 ℃, this will increase the risk that consumer uses this series products.The poly hexamethylene biguanide that uses among the present invention content in preparatory solution be 0～0.4% (weight, wt).
Composition and content that neo-houttuyninum among the present invention dissolves thing in advance are:
Neo-houttuyninum 0.001～0.4wt%
Poly hexamethylene biguanide 0～0.4wt%
Polyhydric alcohol 0.1～2.0wt%
Inclusion agents 5～60wt%
The pure water surplus
Neo-houttuyninum of the present invention dissolves thing in advance can become a kind of product separately, and adding just becomes cleaning and disinfecting compositions of the present invention according to above-mentioned acid-base buffer, osmotic pressure regulator and water.
The water solublity of poly hexamethylene biguanide own is little, uses its hydrochloride form to be mixed with aqueous solution more.Neo-houttuyninum is insoluble in water, in all kinds of uses, adds inclusion agents such as 2-hydroxypropyl beta-Cyclodextrin (mentioning among the CN1449834A) or poloxamer (mentioning among the CN1689562A) and increases its dissolubility in water.The inventor if only use Cyclodextrin class or poloxamer class enclose neo-houttuyninum, still needs heating enclose for a long time through discovering, if contain also in the solution that biguanide has and in body series solution, can't guarantee effective sterilization time limit of biguanide.The present invention disperses neo-houttuyninum and biguanide in propylene glycol, glycerin or Polyethylene Glycol; Only use any or two kinds of enclose in β-Cyclodextrin, hydroxy propyl-Beta-Cyclodextrin or the poloxamer (Poloxamer) to get final product then; So do not need the long-time heating reaction; And the sterilization timeliness that this method makes biguanide is identical with neo-houttuyninum, in the effect duration of this area product, can both guarantee the cleaning-sterilizing effect.The use of neo-houttuyninum and biguanide among the present invention is as long as in effective scope of restraining fungi separately; There is not any optimal proportion relation; Even do not contain biguanide; Only contain neo-houttuyninum also can, but also have the risk that causes the solution zest to increase because of the content that improves neo-houttuyninum, need the content of careful control neo-houttuyninum.Through the antiseptic of enclose, its composition only remains on the eyeglass, and can not be embedded in eyeglass inside, does not therefore have antiseptic accumulation concentration basically and causes all kinds of eye stimulations etc.
In the present composition; Its buffer system should maintain the PH of compositions 6.5～7.8 for excellent, and buffer agent can be selected one or more mixture such as borate, phosphate, acetate, citrate, carbonate, polyhydric alcohol, Bis-Tris for use.Be preferably borate, it possesses the system of powerful buffer capacity in a wide temperature range, and Disinfection Effect is had synergistic function.Generally, the content of buffer agent is 0.001～5.0% (wt).
Osmotic pressure regulator can be regulated the osmotic pressure of compositions of the present invention near natural tear, promptly is equivalent to the osmotic pressure of 0.9%NaCl solution.Because of hypotonic and highly ooze the variation that all can cause the contact lens optical parametric, cause eye twinge and stimulation.The general tension regulator commonly used such as NaCl, KCl or mannitol that uses.The preferred NaCl of the present invention, its content is 260～340mOsm/kgH for the osmotic pressure of the whole compositions of adjusting system
2O.
Compositions of the present invention can be used with various contact lenss, and such eyeglass kind much comprises: wear type eyeglass, long type eyeglass, periodic replacement type eyeglass and the disposal type eyeglass worn day.
The remarkable advantage of the present composition is to have good cleaning-sterilizing eyeglass function; And can be in the lens surface deposition build-up; The said composition long storage time also possesses same Disinfection Effect simultaneously; Improved the safety of wearing eyeglass, and preserved liquid phase than obviously lubricating eyeglass, can increase wearing comfort with general cleaning-sterilizing.
Through add other like chelating agen, tackify wetting agent, freshener, nutrient etc.; Present composition solution can also be as the ophthalmic solution that obtains other functions, but noticeable for the composition that adds must be with eyeglass biocompatible and can not deposit or accumulate in lens surface.Should be appreciated that the present invention is not limited to this, the adding of some other materials and change are conspicuous for a person skilled in the art.
The specific embodiment
The present composition, preparation and result of use will be further helped to understand through following embodiment, but scope of the present invention can not be limited.
Embodiment 1:
The preparatory solution of neo-houttuyninum
Earlier neo-houttuyninum and poly hexamethylene biguanide are disperseed in propylene glycol or Polyethylene Glycol according to prescription, stirring at normal temperature 2～4 hours, and then will stir in the aqueous solutions such as liquid input Cyclodextrin or poloxamer and stir 2～4 hours, for use.
Above-mentioned preparatory solution formula is carried out water solublity test, and the result shows that the preparatory solution of numbering 1-10 can both dissolve each other with water with any ratio, and in solution stable existence.
Embodiment 2
The compositions that cooperates the contact lens cleaning-sterilizing to use
Osmotic pressure regulator and acid-base buffer system component are dissolved in pure water earlier, dissolve the thing consumption in advance according to neo-houttuyninum in the formula table then and add.Room temperature stirred 1～2 hour down, measured the pH-value and the osmotic pressure value of solution, preserved in the aseptic bottle of after absolute aseptic filtration, packing at last.
The employed reagent of said composition is commercially available reagent commonly used, and the osmotic pressure of solution A～I is at 235～370mOsm/kgH2O, and pH-value is 6.68～7.50.
Embodiment 3 present composition Performance Detection
For detecting the safety of solution, utilize the assay method of mentioning among the GB16886, measured the cytotoxicity of 7 solution in the foregoing description 2; The growth of finding cell in 7 solution all is superior to negative control (wait and ooze normal saline), and cell proliferation degree method measured value all is 0 grade, and (0 grade best, and the propagation degree is＞75%; 4 grades the poorest, and the propagation degree is 0 or negative, is 1 rank with 25%; General estimation is nonirritant liquid more than 1 grade), explain that promptly the safety of 7 solution is all relatively good, but these data have shown that also anticorrosion dosage is big more simultaneously; The probability that causes the eye stimulation is also big more; The cytotoxicity of solution D, F just reaches 1 grade, is worse than negative control, and when the debugging prescription, paying particular attention to 2 kinds of antiseptic contents can not be too high.Concrete outcome can be referring to table 3.
Each solution cytotoxicity testing result of table 3
| The prescription lot number | ?A | ?C | ?D | ?F | ?G | ?H | ?I | Negative control |
| Propagation degree % | ?89 | ?88 | ?69 | ?72 | ?89 | ?77 | ?79 | 78 |
| Judge | 0 grade | 0 grade | 1 grade | 1 grade | 0 grade | 0 grade | 0 grade | 0 grade |
Simultaneously to solution A, D, G, H, I effect detection (" disinfection technology standard " 2002 editions that carry out disinfection; 4 hours Disinfection Effect sterilizing rate of dissolved liquid effect); Select 3 kinds of antibacterials and a kind of fungus, to initial and 45 ℃ under deposit after 6 months the Disinfection Effect of (being equivalent to deposit under the room temperature 2 years) and estimate, this stability approach is with reference to ISO13212 and ISO14730 formulation; The result shows that each solution is the good sterile products of bactericidal effect, and stability is more than 2 years.
Each solution disinfection effect assessment contrast table of table 4
Generally speaking, with the standard that GB GB19192 formulates, the cleaning-sterilizing that cooperates contact lens to use is preserved the Disinfection Effect of liquid, and antibacterial should want >=99.90%, fungus >=90.00%, mycete >=90.00%.
Embodiment 5 present composition comfort levels detect
Solution A among the embodiment 2, E, G, I have been carried out experiment on probation.About 50 of random chooses continue to wear the volunteer of contact lens more than 2 years and are group two, and are that contrast is tried out with the normal saline.Its subjective sensation assessment item is the vision definition, dry sensation, excitement.Specifically referring to table 5.
Each solution result on trial of table 5
The above results shows, the too high levels of neo-houttuyninum and biguanide has excitement easily, then is difficult for having dry sensation but wear for a long time, possibly increase relevant with the content of Cyclodextrin in the solution or poloxamer, polyhydric alcohol.
The residual observation on eyeglass of embodiment 6 present compositions
Eyeglass is immersed in taking-up after 24 hours in each solution, under slit lamp, observes lens surface, observe the section of eyeglass gap at high power microscope (500 times) down; The result shows; The present invention's compositions, all less at lens surface and eyeglass gap residuals, specifically referring to table 6.
Each solution of table 6 is in the residual contrast of lens surface and gap
Annotate: "-" representative does not observe or does not find mutation, and "+" representative observes or mutation arranged.
Claims (5)
1. compositions that cooperates the contact lens cleaning-sterilizing to use is characterized in that said composition contains the preparatory solution of neo-houttuyninum of following composition and content:
2. compositions as claimed in claim 1 is characterized in that: said polyhydric alcohol is the nonionic surfactant of propylene glycol, glycerin or Polyethylene Glycol or their mixture; Said inclusion agents is β one Cyclodextrin, hydroxy propyl-Beta-Cyclodextrin or poloxamer or their mixture.
3.-plant the compositions that cooperates the contact lens cleaning-sterilizing to use, it is characterized in that the composition of said composition and content are:
The pH value of said compositions is 6.5～7.8.
4. compositions as claimed in claim 3 is characterized in that:
Said osmotic pressure regulator is selected from one or more the mixture in sodium chloride, potassium chloride or the mannitol;
Said acid-base buffer system is selected from one or more the mixture in borate, phosphate, citrate or the carbonate.
5. the application of compositions as claimed in claim 3 is characterized in that said preparation of compositions becomes to be used to cooperate to wear the cleaning-sterilizing liquid of contact lens use, preserves liquid and/or lubricating fluid.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910048952XA CN101524554B (en) | 2009-04-08 | 2009-04-08 | Composition used with contact lens for cleaning and disinfection and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910048952XA CN101524554B (en) | 2009-04-08 | 2009-04-08 | Composition used with contact lens for cleaning and disinfection and application thereof |
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| CN101524554A CN101524554A (en) | 2009-09-09 |
| CN101524554B true CN101524554B (en) | 2012-08-01 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105296213A (en) * | 2015-11-30 | 2016-02-03 | 谢松芬 | Contact lens cleaning solution |
| CN107281557A (en) * | 2017-06-21 | 2017-10-24 | 江苏天眼医药科技股份有限公司 | A kind of production technology of contact lenses lubricating fluid |
| CN107201277A (en) * | 2017-06-21 | 2017-09-26 | 江苏天眼医药科技股份有限公司 | A kind of contact lens care solution |
| CN107929790A (en) * | 2017-11-08 | 2018-04-20 | 常州武城服饰有限公司 | A kind of multi-functional contact lenses conditioning liquid |
| CN109929702A (en) * | 2018-12-26 | 2019-06-25 | 上海卫康光学眼镜有限公司 | A kind of pair of contact lenses have composition and its application of high-efficiency cleaning disinfection |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1432345A (en) * | 1972-04-13 | 1976-04-14 | Smith Enphew Research Ltd | Ophthalmic compositions and contact lens disinfecting compo sitions |
| CN1769411A (en) * | 1997-11-26 | 2006-05-10 | 先进医用光学公司 | Contact lens cleaning compositions |
| CN1853726A (en) * | 2005-04-18 | 2006-11-01 | 汕头大学医学院 | Polymer system for improving insoluble medicine water solubility and preparation thereof |
| CN1861063A (en) * | 2005-05-11 | 2006-11-15 | 胡才忠 | Ophthalmic gel contg. neo-decanoy acetaldehyde sodium |
-
2009
- 2009-04-08 CN CN200910048952XA patent/CN101524554B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1432345A (en) * | 1972-04-13 | 1976-04-14 | Smith Enphew Research Ltd | Ophthalmic compositions and contact lens disinfecting compo sitions |
| CN1769411A (en) * | 1997-11-26 | 2006-05-10 | 先进医用光学公司 | Contact lens cleaning compositions |
| CN1853726A (en) * | 2005-04-18 | 2006-11-01 | 汕头大学医学院 | Polymer system for improving insoluble medicine water solubility and preparation thereof |
| CN1861063A (en) * | 2005-05-11 | 2006-11-15 | 胡才忠 | Ophthalmic gel contg. neo-decanoy acetaldehyde sodium |
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Owner name: SHANGHAI WEICON OPTICAL SPECTACLE CO., LTD. Free format text: FORMER OWNER: SHANGHAI WEICON OPTICAL CO., LTD. Effective date: 20100108 |
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Effective date of registration: 20100108 Address after: Shanghai city Pudong New Area Yide Road No. 379 post encoding: 200124 Applicant after: Shanghai Weikang optical eye Co. Ltd. Address before: Shanghai city Pudong New Area Yide Road No. 379 post encoding: 200124 Applicant before: Weikang Optical Co., Ltd., Shanghai |
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