CN1197397A - Disinfection and cleaning of contact lenses - Google Patents
Disinfection and cleaning of contact lenses Download PDFInfo
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- CN1197397A CN1197397A CN 96197197 CN96197197A CN1197397A CN 1197397 A CN1197397 A CN 1197397A CN 96197197 CN96197197 CN 96197197 CN 96197197 A CN96197197 A CN 96197197A CN 1197397 A CN1197397 A CN 1197397A
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- tablet
- protease
- antiseptic solution
- catalase
- hydrogen peroxide
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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
- A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
- A61L12/124—Hydrogen peroxide; Peroxy compounds
- A61L12/126—Hydrogen peroxide; Peroxy compounds neutralised with catalase or peroxidase
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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
- A61L12/12—Non-macromolecular oxygen-containing compounds, e.g. hydrogen peroxide or ozone
- A61L12/124—Hydrogen peroxide; Peroxy compounds
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- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
本发明涉及一种利用过氧化氢作为消毒剂和一种蛋白酶作为清洁剂的这种类型的隐形眼镜消毒和清洁的一步法,其包括下述步骤:a)在一含有从1wt%到5wt%过氧化氢的眼睛不能接受的pH值下的消毒水溶液中对隐形眼镜消毒,b)通过用一种在眼睛不能接受pH水平下一段时间内可被灭活的蛋白酶处理隐形眼镜来清洁隐形眼镜,c)用一在pH3.0到7.0有基本活性的微生物过氧化氢酶对消毒水溶液中过氧化氢中和,d)调节消毒水溶液中的pH至眼睛可接受的pH水平。而且,本发明涉及一种适于一步消毒和清洁的药片或胶囊、一个一步消毒和清洁系统以及进而一个用于隐性眼镜消毒和清洁的一步法。The present invention relates to a one-step process for disinfecting and cleaning contact lenses of this type using hydrogen peroxide as a disinfectant and a protease as a cleaning agent, comprising the following steps: a) in a disinfection of contact lenses in an aqueous solution of hydrogen peroxide at an ocularly unacceptable pH, b) cleaning of contact lenses by treating the contact lenses with a protease that is inactivated over a period of time at ocularly unacceptable pH levels, c) neutralize the hydrogen peroxide in the disinfecting aqueous solution with a microbial catalase having basic activity at pH 3.0 to 7.0, d) adjust the pH in the disinfecting aqueous solution to an eye-acceptable pH level. Furthermore, the present invention relates to a tablet or capsule suitable for one-step disinfection and cleaning, a one-step disinfection and cleaning system and further a one-step method for contact lens disinfection and cleaning.
Description
The present invention relates to a kind of utilize hydrogen peroxide come as cleaning agent and a kind of catalase as disinfectant, a kind of protease in and the such one-step method that contact lens is carried out disinfection and cleans of hydrogen peroxide in the disinfectant solution.
And, the present invention relates to a kind of tablet that is suitable for a step sterilization and cleaning or capsule, a step sterilization and cleaning systems and further a kind of one-step method that is used to sterilize and cleans contact lens.
Present many people like wearing contact lens and do not wear glasses.Some are owing to the reason of aesthetics is used contact lens, because they think that glasses make them seem inconvenient.Other people value the freedom of the motion that contact lens provides, and this is as playing soccer or being favourable when participating in a HI high impact fitness exercise class.In addition, some inconvenience of greasy glasses of just disliking polishing.
Though contact lens has carried out improving in the past ten years and compare with glasses and to have many advantages, contact lens still needs periodically to sterilize and clean, and in most of the cases is every day, with infection and the discomfort of avoiding the wearer.
The product that is used for contact lens disinfection and cleaning has made that " task of every day " is easier.Yet the task that most of contact lens users still will sterilize and clean is regarded the task of a trouble as.
No matter contact lens is hard or soft, the optician advise usually every day to its sterilization and weekly the cleaning.
Sterilization stops the growth may cause eye infection and to make antibacterial on the contact lens surface that can not wear contact lens in several days.
Usually clean by a kind of enzyme that is accumulated in fragment on the contact lens surface and/or dirt of can degrading.These deposits reduce can see through the oxygen that contact lens arrives eyes, and increases friction between eyes and contact lens, thereby has reduced the comfort level of wearing.
once clean and/or sterilize after need the thorough rinsing of contact lens removing all enzymatic activitys and/or disinfectant, as by using a kind of normal saline solution.
In disinfectant is under the situation of hydrogen peroxide, and known many catalases are used as nertralizer.
Catalase E.C.1.11.1.6 (" enzyme nomenclature " (Enzyme Nomenclature), and academic publishing company (Academic Press, Inc), 1992) be catalyzing hydrogen peroxide (H
2O
2) be converted into water (H
2O) and oxygen (O
2) enzyme.
Known many methods that is used to sterilize and cleans contact lens.As at United States Patent (USP) 3,910, described in No. 296 (Allergan), protease is normally used for cleaning contact lens.
CA 1,146, and 881 (Bedding) relate to a kind of method of utilizing enzyme cleaning contact lens, wherein are the rinsing glasses behind cleaning, for example use saline, to remove activated enzyme from glasses.
United States Patent (USP) 4,670, No. 178 (Allergan) announced one in hydrogen peroxide with a kind of protease method of cleaning and disinfection contact lens simultaneously.Existence by proteinase activity realizes cleaning and shows it is very effective.After the cleaning and disinfection step, before usefulness, need to remove the activity of disinfectant and cleaning agent from glasses.
EP patent application 147, No. 100 (Ciba Geigy) relates in the presence of a kind of solid sustained-release composition of slow release one peroxide inactivator, with the cleaning and disinfection of a kind of hydrogenperoxide steam generator to contact lens.Can be with a wetting agent or comfortable dose of processing glasses before glasses are put into eyes.Yet, from the surface of contact lens, do not remove protein deposit effectively with the hydrogen peroxide cleaning and disinfection.
WO 86/07264 (Kellway Pharm.Ltd.) has described one with disinfectant with hydrogen peroxide and cleaning contact lens and utilize a kind of catalase that is fixed in the container to come the method for neutralization of hydrogen peroxide.This method need not washed just with unnecessary hydrogen peroxide decomposes.
WO 93/17721 (Genencor Int.Inc.) has described improved comprising and has used the method that is used for the contact lens cleaning and disinfection that makes remaining peroxide breakdown from the catalase (CatR) of filamentous fungi aspergillus niger with disinfectant with hydrogen peroxide with in solution.
WO 95/02044 (Novo Nordisk A/S) relate to two kinds concentration up to the hydrogen peroxide of 5wt% in the presence of activated acid protease.The embodiment 5 of said application described utilize a kind of in the acid protease of mentioning as cleaning agent and hydrogen peroxide as the cleaning and disinfection of disinfectant to contact lens.In addition, also mention the neutralization that catalase can be used for hydrogen peroxide.
The cleaning and disinfection of contact lens is taken as be a kind of task every day of trouble by most of contact lens wear person.And, so the method that was used for contact lens disinfection and cleaning in the past owing to carrying out two discontinuous steps at least because as the risk of often forgetting a step be not as safe as a house and easily.
Thereby, need safer and sterilization easily and clean method and system.A kind of step sterilization and cleaning systems of contact lens can increase safety and convenience.
The objective of the invention is the task facility that makes the sterilization of trouble every day and clean contact lens and these tasks got up safer.
In first aspect, the present invention relates to a kind of one-step method that is used for contact lens disinfection and cleaning, it comprises step:
A) the aqueous antiseptic solution under contains from 1wt% to the unacceptable pH value of the eyes of 5wt% hydrogen peroxide to contact lens disinfection,
B) by can not accepting the Protease Treatment contact lens that pH can be inactivated in following a period of time of level at eyes and clean contact lens with a kind of,
C) there is the microorganism catalase of primary activity that the hydrogen peroxide in the aqueous antiseptic solution is neutralized with one at pH3.0 to 7.0,
D) pH in the adjusting aqueous antiseptic solution is to the acceptable level of eyes.
The invention still further relates to a kind of tablet or capsule that is used for contact lens disinfection and cleaning, its Chinese medicine tablet is a kind of multilamellar tablet, comprises
I) in a kind of aqueous antiseptic solution under the unacceptable pH level of eyes in a period of time can by the protease of irreversible deactivation and
Ii) a kind of have the microorganism catalase of primary activity at pH3.0 to 7.0,
Iii) a kind ofly can regulate disinfectant solution can be accepted pH to eyes reagent.
The present invention also at a kind of be used for contact lens disinfection and cleaning one the step system, comprise
A) a kind of contain 1wt% to the aqueous antiseptic solution of 5wt% hydrogen peroxide and
B) a kind of tablet or capsule, it contains
I) in a kind of aqueous antiseptic solution under the unacceptable pH level of eyes in a period of time can by the protease of irreversible deactivation and
Ii) a kind of have the microorganism catalase of primary activity at pH3.0 to 7.0,
Iii) a kind ofly can regulate aqueous antiseptic solution can be accepted pH to eyes reagent.
At last, the present invention relates to a kind of one-step method that is used for contact lens disinfection and cleaning, comprise
1) 1wt% that contains in a fixed amount soaks contact lens in the aqueous antiseptic solution of 5wt% hydrogen peroxide, and
2) add a tablet of the present invention, then
3) in aqueous antiseptic solution, contact lens is stored a period of time.
The objective of the invention is to make the cumbersome task facility of sterilization every day and cleaning contact lens and it is more safely carried out.
The sterilization of contact lens and cleaning are the types that comprises the steps in the context of the present invention:
A) one contain in the hydrogen peroxide of 1wt% to 5wt%, the particularly aqueous solution of 3wt% hydrogen peroxide to contact lens disinfection and
B) with protease cleaning contact lens removing fragment and/or spot, and
C) with the hydrogen peroxide neutralization of a catalase to aqueous antiseptic solution.
Inventors of the present invention have solved some problems in former sterilization and the cleaning systems by a kind of safer system easily is provided.
A kind ofly saferly mean and utilize the system of above-mentioned same principle to compare accordingly in the past to have in the following advantage at least with cleaning systems with sterilization easily:
-reduce or eliminated the risk (promptly this system uses safer) of this system of incorrect use;
-made things convenient for the task (it is easier promptly to use) of sterilization and cleaning for contact lens user;
-reduced the number of steps of being undertaken by contact lens user (promptly carry out disinfection and clean up task need do still less work and the shorter time).
The present invention can be used to sterilization and the cleaning that all kinds contact lens comprises hard, soft, inflexible breathability glasses and polysiloxanes glasses etc.
Ultimate principle of the present invention is to utilize a kind of suitable protease that can be inactivated in aqueous antiseptic solution owing to influence, Temperature Influence or the similar influence of for example pH in cleaning course.Before by complete inactivation, protease must have the competent time and competent enzymatic activity cleans contact lens.
Need be clear that and utilize sterilization of the present invention and cleaning principle to be used for comprising accordingly that the sterilization separately and the sterilization and the clean method (being two-step method) of cleaning are within the scope of the invention.
In first aspect, the present invention relates to a kind of one-step method that is used for contact lens disinfection and cleaning, it comprises step:
A) the aqueous antiseptic solution under contains from 1wt% to the unacceptable pH value of the eyes of 5wt% hydrogen peroxide to contact lens disinfection,
B) by can not accepting the Protease Treatment contact lens that pH can be inactivated in following a period of time of level at eyes and clean contact lens with a kind of,
C) there is the microorganism catalase of primary activity that the hydrogen peroxide in the aqueous antiseptic solution is neutralized with one at pH3.0 to 7.0,
D) pH in the adjusting aqueous antiseptic solution is to the acceptable level of eyes.
In the context of the present invention unacceptable pH level of eyes mean one from about pH8.0 in 13.0 scopes and at the about pH1.0 pH in 6.0 scopes.The acceptable pH level of eyes means one at the pH in scope between about pH6.0 to 8.0.
Said method of the present invention can carry out according to any of following sequence of steps:
I) a)-b)-c)-d), or
Ii) a)-c)-b)-d), or
Iii) a)-b)-d)-c), or
Iv) a)-b)/c)-d), wherein step b) and step c) are carried out simultaneously.
In an embodiment preferred of the inventive method, aqueous antiseptic solution is the commercialization disinfectant solution (for example Oxysept 1 of Allegan) of a kind of traditional pH3.5 that contains about 3wt % hydrogen peroxide.
At least in the context of the present invention " one step " sterilization and cleaning mean that the task of contact lens user only is made up of a successive step, and it can carry out and need not any additional step before contact lens is fit to wear in several seconds.
Sterilization every day of associating and cleaning make that the cleaning weekly of suggestion is unnecessary, because fragment of piling up on contact lens surface and/or spot reduce widely.The comfort level that the sterilization of every day and cleaning cause wearing is improved.
According to the present invention, all proteinase activities must have in the set time to be determined by irreversibly deactivation at one.
For example, if this protease will be by irreversibly deactivation in the time of lacking very much, the amount of protease must be big relatively to guarantee the cleaning of contact lens before the protease complete inactivation.Opposite with it, if this protease will then only need very a spot of protease by deactivation very lentamente after the time of growing.
Can be for the inactivation time of protease from about 1 to 10 minute to 1,2,3 be no more than 4 hours.
Every day cleaning reduces than the enzyme amount that needs with cleansing phase weekly.Can determine at an easy rate by those skilled in the art for before all proteinase activities are inactivated by the pH deactivation, cleaning the Sq that contact lens need be added to the active protease in the aqueous antiseptic solution effectively.
The amount of the protease of being considered is in the scope from 0.5ug to 50ug, and preferred 1ug is to 25ug, and particularly 2ug is to 10ug pheron/ml.
The protease that is utilized according to the present invention can be that (on seeing) can be by any neutrality, acidity or the alkaline protease of irreversible deactivation in a period of time in a kind of disinfectant solution under a unacceptable pH of eyes.
For example, if protease is a kind of alkalescence (or neutral) protease, the pH of aqueous antiseptic solution should be acid so that inactivated proteases irreversibly.
Can from the group that comprises serine protease, aspartic protease, cysteine proteinase and metalloproteases, select suitable protease.
Listed group that block, that modify or misfolded proteins enzyme is also considered to suit in addition.
The example of preferred serine protease is trypsin, Chymotrypsin and has a liking for the alkali subtilisin.
Most preferably, block body, modify body and variant as subtilopeptidase A, subtilisin BPN ', subtilisin Carlsberg, subtilisin PB92, subtilisin 309, subtilisin 147, subtilisin 168, subtilisin DY, aqualysin or thermitase and its from the alkaline serine protease of bacillus.
The example of cysteine proteinase comprises papain and bromelain.
As for suitable metalloproteases group as being Neutrase and collagenase.
The example of aspartic protease is as pepsin A, pepsin B, pepsin C, Chymosin, cathepsin B and feritin.
Usually select the cattle liver catalase to be used for the hydrogenperoxide steam generator neutralization used to contact lens disinfection.Yet, may propagate owing to worry a kind of slow virus infection (mad cow disease (BSE), it identifies) in European neatherd, so there are the needs of a kind of cattle liver catalase of exploration discovery substitute to the people.
Propagating the sick people's of giving of slow virus risk can avoid by using the microorganism catalase, as can be from antibacterial, filamentous fungi or zymic catalase.
Compare with " standard " cattle liver catalase, catalatic stability of microorganism such as microorganism catalase cited below are better under acid pH.Thereby the neutralization that utilizes the microorganism catalase to carry out hydrogen peroxide in the contact lens disinfecting solutions of acid pH is favourable.
Some so suitable microorganism catalases have been proposed to be used in contact lens.From the catalase of filamentous fungi aspergillus niger even be proved to be and have than the better character of cattle liver catalase.
Aspergillus niger produces two kinds of catalases that are called as catalase A (CatA) and catalase R (CatR).CatR is 4 times of " standard " cattle liver catalase efficient in needs and in the application of strong hydrogen peroxide solution.In other words, CatR (is 3wt % H in traditional disinfectant solution
2O
2, pH3.5) neutralization of hydrogen peroxide is more faster than the cattle liver catalase of standard.In addition, CatR for Proteolytic enzyme, extreme pH, temperature, hydrogen peroxide and by the deactivation of glutaraldehyde, SDS etc. than cattle liver catalase more stable (seeing WO93/17721) from Genencor.
In addition, CatR is having primary activity in the presence of the 3wt % hydrogen peroxide under the pH of pH3.0 at least and 7.0, and traditional cattle liver catalase activity sharply descends in pH3.0 at pH7.0.
According to the present invention, having been found that a kind ofly has the microorganism catalase of primary activity can not accept can be advantageously used in together by the protease of irreversible deactivation in a period of time in the disinfectant solution of pH the neutralization of hydrogen peroxide in the used aqueous antiseptic solution of contact lens at eyes with a kind of at the preferred pH3.0 to 4.5 of pH3.0 to 7.0.Embodiment 1 shows that subtilopeptidase A is a kind of so suitable protease.
PH3.0 to 7.0 preferred 3.0 to 4.5 times " a kind of catalase that primary activity is arranged " be defined as a kind of in said pH scope (pH dependency optimum is decided to be 100%) have and be higher than 60%, better 70%, even be higher than 80% as 90%, and under best situation up to about 100% relative activity.
A kind of protease that can be inactivated in a period of time under the unacceptable pH level of eyes and a kind of microorganism catalase are united and are used for contact lens disinfection and cleaning and produce the as safe as a house and system easily of a kind of very fast one-step method and.
In addition, because protease is removed the spot substrate that has antibacterial (will be killed by hydrogen peroxide), so said the associating guarantee that one-step method of the present invention is fast and effeciently sterilized contact lens.Thereby hydrogen peroxide is very good to the accessibility of antibacterial for this reason.Because the microorganism catalase is activated in the pH of broad scope,, reduces and carry out whole sterilization and required time of cleaning so neutralization can take place immediately.
The microorganism catalase can advantageously be any in the catalase above-mentioned, as aspergillus niger catalase, particularly CatR.
The microorganism catalase also can be by Novo Nordisk A/S nineteen ninety announce be used for neutral aspergillus niger catalase at the used aqueous antiseptic solution hydrogen peroxide of contact lens.
It is believed that at present best mode of the present invention is by uniting serine protease subtilopeptidase A as protease (can be available from Novo Nordisk with Cleanlens Pro) and obtaining as the aspergillus niger catalase of describing that is called as CatR of microorganism in WO 93/17721.Protease will be by irreversibly deactivation in one suitable period under the pH level in one 1.0 to 4.5 scope in this specific embodiment.
The reagent that can regulate pH in aqueous antiseptic solution can be the acceptable suitable reagent of any eyes.For example the pH regulator agent can be a kind of buffer agent, a kind of acid or a kind of alkali.
The purpose of pH regulator is that the assurance contact lens can directly be put into eyes safely from aqueous antiseptic solution, without any the danger of infringement eyes.
A kind of suitable buffer agent can be from comprising alkali metal salt, as potassium carbonate or sodium salt, acetate, borate, and sodium phosphate or potassium salt, citrate and hydroxide, and select in the group of weak acid such as acetic acid and boric acid.
In second aspect, the present invention relates to a kind of tablet, capsule or analog that utilizes the principle of the inventive method.
Even it is believed that the best approach that aqueous antiseptic solution is introduced in protease, catalase and pH regulator agent is the form with a kind of tablet or analog, but need know that other embodiment also considered by inventors, and should regard included as by scope of the present invention.For example, protease, catalase and the pH regulator agent form with liquid and solid bond can be joined in the aqueous antiseptic solution.
For going on foot sterilization and clean constructed a kind of multilamellar tablet, one of contact lens comprises
I) a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by the protease of irreversible deactivation and
Ii) one has the microorganism catalase of primary activity at pH3.0 to 7.0,
Iii) a kind ofly can regulate aqueous antiseptic solution can be accepted pH to eyes reagent.
The definition of " the unacceptable pH level of eyes " and " the acceptable pH level of eyes " has been described above.
Tablet may have any suitable embodiment.To 4 suitable embodiments be described as embodiment below.Also to be described in the effect of 4 embodiments (A, B, C and D) of tablet when being used for step sterilization and cleaning below.
In first embodiment, multilamellar tablet A comprises
A) one contain said pH3.0 to 7.0 have the catalatic skin of microorganism of primary activity or coating and
B) in said skin contain a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by one deck of the protease of irreversible deactivation and
C) a kind ofly can regulate disinfectant solution can be accepted pH to eyes reagent.
In second embodiment, multilamellar tablet B comprises
A) one contain a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by the skin of the protease of irreversible deactivation or coating and
B) in said skin contain said pH3.0 to 7.0 have primary activity the catalatic one deck of microorganism and
C) a kind ofly can regulate disinfectant solution can be accepted pH to eyes reagent.
In the 3rd embodiment, multilamellar tablet C comprises
A) one contain a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by the skin of the protease of irreversible deactivation or coating and
B) in said skin contain a kind of can regulate disinfectant solution can accept to eyes pH reagent one deck and
C) one contains a kind of catalatic core of microorganism that primary activity is arranged at pH3.0 to 7.0.
In the 4th embodiment, multilamellar tablet D comprises
A) one contain a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by the protease of irreversible deactivation and a kind of pH3.0 to 7.0 have the catalatic skin of microorganism of primary activity or coating and
B) one contains and a kind ofly can regulate aqueous antiseptic solution can be accepted the reagent of pH to eyes core.
Protease and microorganism catalase can be any in protease above-mentioned and the catalase.
Microorganism catalase pH field of activity widely is favourable, because this makes that regulating the accurate pH of aqueous antiseptic solution to becomes so not crucial, this strictness and control in time that catalase layer is discharged becomes so unimportant.
Said pH regulator agent can be any suitable reagent, as can regulate a kind of buffer agent or a kind of acid or a kind of alkali of pH to the eyes acceptable level in an aqueous antiseptic solution.
Can be with each layer of core and multilamellar tablet separately by a kind of barrier or a kind of film.In one embodiment of the invention, said barrier can be made up of the preferred water-soluble film of a kind of water miscible polymeric layer.
The example of said water-soluble film is included in polymer soluble in a kind of acid medium, as the polymer of dimethylamino methyl acrylate and neutral methacrylic acid esters.
In addition, thin film contains the neutral soluble polymer of a kind of pH.Suitable polymer blend is for example soluble cellulose ether such as methylcellulose, hydroxy methocel, the hydroxymethyl ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, sodium carboxymethyl cellulose, cellulose acetate phthalate, Hydroxypropyl Methylcellulose Phathalate, the polymer of methacrylic acid and methacrylate, the copolymer of methacrylic acid and methacrylate, the copolymer of ethylene methacrylic ether and maleic anhydride and polyvinyl alcohol.
In another embodiment, tablet contains a microsolubility core and one or two skin that makes active component disperse or distribute.
Add suitable polyhydroxy-alcohol plasticizer and water in the above in the soluble film polymer that can be listed and control diffusion rate.For this purpose, preferred plasticizer is 1,2-propylene glycol, Polyethylene Glycol and citrate.
In a preferred embodiment, tablet is that the composition that a kind of composition that at first discharges in the skin then discharges in the second layer over time also finishes such sustained release tablet with the release of nucleus over time.Wherein the composition of one deck or two-layer or core can be discharged lentamente.
The release time of pH regulator agent should long enough so that protease has adequate time degrades at the heavy collection thing on recessive glasse surface.
Because catalase has primary activity in the pH scope widely at one, so catalatic neutralising capacity and do not rely on the effect of pH regulator agent.
In another embodiment of the invention, composition in the second layer and/or nucleus are delayed and are discharged in the aqueous antiseptic solution.
The active supplementary element of not serious reduction active component can be added or is incorporated in tablet or the capsule.
Example is as effervescent, stabilizing agent, chelating agen and/or chelating agen, coloring agent, tension regulator, surfactant and similar composition.In addition, also can mix binding agent, lubricant, carrier and other excipient that is normally used for making tablet.
When enzyme provides with solid form, typically use effervescent.The example of suitable effervescent comprises the tartaric acid or the citric acid of uniting use with suitable alkali metal salt such as sodium carbonate.
Because tablet of the present invention will use in a kind of aqueous antiseptic solution, it can contain one or more suitable chelating agen and/or sequestering agent, tension regulator and surfactants.
Suitable tension regulator comprises the chloride of chloride, glucose, calcium and the magnesium of sodium and potassium.
Suitable surfactant can be cationic, anionic, non-ionic or amphoteric.Preferred surfactants is neutral or non-ionic.
Specific example comprises the polyglycol ether of fatty acid, the polyethenoxy ether of C12-C18 alkane and polyoxyethylene, the polyoxypropylene block copolymers (being poloxamine) of ethylenediamine.
The example of preferred chelating agen comprises ethylenediaminetetraacetic acid (EDTA) and its salt (disodium) and some polyvinyl alcohol.
Tablet of the present invention has been formed the step sterilization and the cleaning systems of recessive glasse together to the aqueous antiseptic solution of 5wt% hydrogen peroxide with a kind of 1wt% of containing.
Ideal easily sterilization of a kind of user and cleaning procedure are to carry out with successive step that makes recessive glasse directly can wear from hold-up vessel without any need for other work in the next morning only.
According to the present invention, the recessive glasse user only needs recessive glasse is put into an aqueous antiseptic solution that contains the fixed amount of hydrogen peroxide, and adds a slice tablet of the present invention.Said tablet is carried out the cleaning and disinfection task and and then with a kind of safe mode neutralization of hydrogen peroxide.
Thereby, of the present invention one the step system reduced the recessive glasse user in the work that carries out disinfection and will do during clean up task; Make sterilization and clean up task facility because only need carry out a successive step; Owing to this step can in seconds carry out eliminating continuously incorrect use decontamination system risk (for example forget the sterilization and/or the cleaning after before wearing in and recessive glasse).
Of the present invention one the step system comprise
A) a kind of contain 1wt% to the aqueous antiseptic solution of 5wt% hydrogen peroxide and
B) a kind of tablet or capsule, it contains
I) in a kind of aqueous antiseptic solution under the unacceptable pH of eyes in a period of time can by the protease of irreversible deactivation and
Ii) a kind of microorganism catalase that primary activity is arranged between pH3.0 to 7.0 that is used for neutralization of hydrogen peroxide and
The iii) a kind of reagent that can regulate the acceptable pH level of pH to eyes of aqueous antiseptic solution.
In an embodiment preferred of the present invention, hydrogen peroxide is present in (pH3.5) in the aqueous antiseptic solution with 3wt%.
Tablet of the present invention or capsule can be advantageously used for a component in the present invention one step system.
Below rough recessive glasse one step sterilization and the cleaning of using tablet A, B, C and D of describing.
Utilize step sterilization and the cleaning of tablet A
Recessive glasse is immersed in a kind of traditional 3wt% disinfectant with hydrogen peroxide liquid (pH3.5) together with multilamellar tablet A.Initial disinfectant with hydrogen peroxide recessive glasse.Microorganism catalase (being included in the skin) is released the neutralization that causes hydrogen peroxide in the aqueous antiseptic solution.Protease (being included in the one deck under the skin) is released in the disinfectant solution and cleans recessive glasse over time.In a period of time, protease is by irreversibly deactivation.Final buffer agent (being included in the core of tablet) is released and causes pH to rise to an acceptable pH of eyes.Recessive glasse is suitable for directly wearing from aqueous antiseptic solution.
Utilize step sterilization and the cleaning of tablet B
Recessive glasse is immersed in a kind of traditional 3wt% disinfectant with hydrogen peroxide liquid (pH3.5) together with multilamellar tablet B.Initial disinfectant with hydrogen peroxide recessive glasse.Protease (being included in the skin) is released in the disinfectant solution and cleans recessive glasse.In a period of time, protease is by irreversibly deactivation.Microorganism catalase (being included in the one deck under the skin) is released the neutralization that causes hydrogen peroxide in the disinfectant solution over time.Final buffer agent (being included in the core of tablet) is released and causes pH to rise to an acceptable level of eyes.Recessive glasse is suitable for directly wearing from aqueous antiseptic solution.
Utilize step sterilization and the cleaning of tablet C
Recessive glasse is immersed in a kind of traditional 3wt% disinfectant with hydrogen peroxide liquid (pH3.5) together with multilamellar tablet C.Initial disinfectant with hydrogen peroxide recessive glasse.Protease (being included in the skin) is released in the disinfectant solution and cleans recessive glasse.In a period of time, protease is by irreversibly deactivation.Buffer agent (being included in the one deck under the skin) is released and causes pH to rise to an acceptable level of eyes over time.Catalase (being included in the core of tablet) is released the neutralization that causes hydrogen peroxide in the aqueous antiseptic solution.Recessive glasse is suitable for directly wearing from aqueous antiseptic solution.
Utilize step sterilization and the cleaning of tablet D
Recessive glasse is immersed in a kind of traditional 3wt% disinfectant with hydrogen peroxide liquid (pH3.5) together with multilamellar tablet D.Initial disinfectant with hydrogen peroxide recessive glasse.Protease and microorganism catalase (being included in the skin) are released in the disinfectant solution.By protease cleaning recessive glasse by the catalase neutralization of hydrogen peroxide.In a period of time, protease is by irreversibly deactivation.Buffer agent (being included in the core of tablet) is released and causes pH to rise to an acceptable level of eyes over time.Recessive glasse is suitable for directly wearing from aqueous antiseptic solution.
Example page certification unification kind of the protease and the catalatic favourable use of a kind of microorganism of above-mentioned step sterilization and cleaning.
Because microorganism catalase (opposite with the cattle liver catalase) is great-hearted under pH3.5, thus catalase can be when protease cleans recessive glasse neutralization of hydrogen peroxide.
At last, the present invention relates to a kind of one-step method that is used for recessive glasse sterilization and cleaning, comprise step
1) contain in the aqueous antiseptic solution of 1wt% fixed amount of preferred 3wt% hydrogen peroxide one and soak recessive glasse to 5wt%, and
2) add a slice tablet of the present invention,
3) in aqueous antiseptic solution, recessive glasse is stored a period of time.
Aqueous antiseptic solution must constitute one usually at 1ml to the about fixed amount of 5ml particularly between the 10ml.
Required period of storage depends on its composition in step 3).Substantially, the preparation tablet is so that recessive glasse must be by storage 10 minutes to 12 hours, preferred 15 minutes to 4 hours, particularly 20 minutes to 2 hours.
Material and method
Subtilopeptidase A (can be available from Novo Nordisk) with Cleanlens Pro.
Proteolytic activity
Can determine proteolytic activity as substrate with the hemoglobin of degeneration.In the Anson-hemoglobin method that is used for determining proteolytic activity, the hemoglobin of degeneration is digested, and precipitates the hemoglobin that is not digested with trichloroacetic acid (TCA).With producing the amount that blue phenol reagent is determined the TCA soluble product with tyrosine and tryptophan.
An Anson unit (AU) is defined as such enzyme amount, and its under standard conditions (promptly 25 ℃, pH7.5,10 minutes response time) discharge with phenol reagent per minute with an initial rate digestion hemoglobin and produce TCA soluble product with the amount of 1 milliequivalent tyrosine same color.
Can demand the file AF4/5 of this analytical method of more detailed description to Novo Nordisk A/S (Denmark), incorporate it into this paper as a reference herein.
Embodiment 1
Have/stability of subtilopeptidase A during no 3wt% hydrogen peroxide
The pH stability of subtilopeptidase A (can be available from Novo Nordisk with Cleanlens Pro) is by allowing an enzymatic solution (0.0003AU/ml) continue 0 to 240 minute at 25 ℃ down with different pH value (from pH2 to 7), and detects proteolytic activity before and afterwards.
Listed the test result of representing with relative activity in table 1 below and the table 2.
For each pH the activity of 0 time is made as 100%.
Table 1
No H
2O
2There is the pH stability of subtilopeptidase A down
N.d.: do not determine
| Minute | pH2 | pH3 | pH4 | pH5 | pH7 |
| 0 | 100 | 100 | 100 | 100 | 100 |
| 15 | 0 | 21 | 79 | n.d. | n.d. |
| 30 | 0 | 22 | 49 | n.d. | n.d. |
| 60 | 0 | 8 | 14 | 88 | 95 |
| 120 | n.d. | n.d. | n.d. | 77 | 94 |
| 240 | n.d. | n.d. | n.d. | 67 | 106 |
Table 2
At 3% H
2O
2There is the pH stability of subtilopeptidase A down
N.d.: do not determine
| Minute | pH3 | pH4 | pH5 | pH7 |
| 0 | 100 | 100 | 100 | 100 |
| 15 | 0 | 6 | 18 | 13 |
| 30 | 0 | 0 | 5 | 13 |
| 60 | 0 | 0 | 0 | 15 |
| 120 | n.d. | n.d. | 0 | 14 |
| 240 | n.d. | n.d. | n.d. | 12 |
As seeing from table 1, subtilopeptidase A is lacking H
2O
2Be stable under pH7.Table 2 shows that it is very unsettled that subtilopeptidase A is lower than below 7 at pH.
Claims (44)
1, a kind of one-step method that is used for recessive glasse sterilization and cleaning, it may further comprise the steps
A) the aqueous antiseptic solution under contains from 1wt% to the unacceptable pH value of the eyes of 5wt% hydrogen peroxide with contact lens disinfection,
B) by can not accepting the Protease Treatment contact lens that pH can be inactivated in following a period of time of level at eyes and clean contact lens with a kind of,
C) there is the microorganism catalase of primary activity that the hydrogen peroxide in the aqueous antiseptic solution is neutralized with one at pH3.0 to 7.0,
D) pH in the adjusting aqueous antiseptic solution is to the acceptable level of eyes.
2, according to the one-step method of claim 1, it is according to a)-b)-c)-d) sequence of steps.
3, according to the one-step method of claim 1, it is according to a)-c)-b)-d) sequence of steps.
4, according to the one-step method of claim 2 or 3, wherein step b) and step c) are carried out simultaneously.
5, according to the one-step method of claim 1, it is according to a)-b)-d)-c) sequence of steps.
6, according to the one-step method of claim 1, wherein aqueous antiseptic solution contains about 3wt% hydrogen peroxide, and pH is approximately 3.0 to 4.5, particularly about pH3.5.
7, according to any one one-step method in the claim 1 to 6, wherein with a kind of protease cleaning recessive glasse that is selected from acid asparagine pepsin, cysteine proteinase, serine protease or metalloproteases.
8, according to the one-step method of claim 7, wherein protease is a kind of asparagine pepsin, as pepsin A, B or C or cathepsin D.
9, according to the one-step method of claim 7, wherein protease is a kind of cysteine proteinase, as papain.
10, according to the one-step method of claim 7, wherein protease is a kind of metalloproteases, as Neutrase .
11, according to the one-step method of claim 6, wherein protease is a kind of serine protease, is preferably the subtilisin type, comprises having a liking for alkali subtilisin, particularly subtilopeptidase A.
12, according to any one one-step method in the claim 1 to 11, wherein protease is between 1.0 to 4.5 in a pH level, particularly is inactivated in 3.5 o'clock.
13, according to any one one-step method in the claim 1 to 12, wherein the microorganism catalase is from a kind of antibacterial, a kind of filamentous fungi or a primary yeast.
14, according to the one-step method of claim 13, wherein the microorganism catalase can be from aspergillus, particularly aspergillus niger.
15, according to the one-step method of claim 14, wherein catalase is CatA or CatR.
16, a kind of tablet or capsule that is used to sterilize and cleans recessive glasse, its Chinese medicine tablet is a kind of multilamellar tablet, contains
I) a kind of eyes can not accept in the aqueous antiseptic solution under the pH level in a period of time can by the protease of irreversible deactivation and
Ii) one has the microorganism catalase of primary activity at pH3.0 to 7.0,
Iii) a kind ofly can regulate aqueous antiseptic solution can be accepted pH to eyes reagent.
17, according to the tablet of claim 16, wherein the multilamellar tablet comprises
A) one contain the catalatic skin of said microorganism or coating and
B) contain one deck of said protease at said skin, and
C) core that contains said pH regulator agent.
18, according to the tablet of claim 16, wherein the multilamellar tablet comprises
A) skin that contains said protease or coating and
B) in said skin, contain the catalatic one deck of said microorganism, and
C) core that contains said pH regulator agent.
19, according to the tablet of claim 16, wherein the multilamellar tablet comprises
A) one contain said protease and the catalatic skin of said microorganism or coating and
B) core that contains said pH regulator agent.
20, according to any one tablet in the claim 16 to 19, wherein protease be one according to any one protease in the claim 7 to 11.
21, according to any one tablet in the claim 17 to 21, wherein catalase be one according to any one microorganism catalase in the claim 13 to 15.
22, according to any one tablet in the claim 16 to 21, wherein the pH regulator agent is a kind of buffer agent or a kind of acid or a kind of alkali.
23, according to any one tablet in the claim 16 to 22, at least one is separated by a kind of barrier or a kind of film in wherein said tablet or the capsular layer.
24, according to the tablet of claim 23, wherein said barrier is a kind of water-soluble polymer layer, preferred a kind of aqueous solution thin film.
25, according to the tablet of claim 24, wherein said soluble polymer layer contains the polymer that is selected from the dimethylamino methyl acrylate, soluble cellulose ether such as methylcellulose, hydroxy methocel, the hydroxymethyl ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl-cellulose, sodium carboxymethyl cellulose, cellulose acetate phthalate, Hydroxypropyl Methylcellulose Phathalate, the polymer of methacrylic acid and methacrylate, the copolymer of methacrylic acid and methacrylate, the copolymer of ethylene methacrylic ether and maleic anhydride and the chemical compound of polyvinyl alcohol.
26, according to any one tablet in the claim 16 to 25, it contains a kind of plasticizer, and is preferred 1 as polyhydroxy-alcohol, 2-propylene glycol, Polyethylene Glycol and citrate.
27, according to any one tablet in the claim 16 to 26, it has a microsolubility core.
28, according to any one tablet in the claim 16 to 27, it is a kind of tablet or capsule of sustained release.
29, according to any one tablet in the claim 16 to 28, it belongs to the type of sustained release, wherein
-at first discharge outer field composition, then
-secondly discharge the said composition of the second layer over time, then
-discharge nucleus at last over time.
30. according to the tablet of claim 29, wherein said pH regulator agent is slowly discharged.
31. according to any one tablet among the claim 16-30, wherein the inclusions of the second layer and/or core is slowly discharged.
32. one kind with the disinfectant with hydrogen peroxide in the aqueous antiseptic solution, with protease remove surface contaminants and/or fragment and with catalase neutralization of hydrogen peroxide solution be used for contact lens disinfection and cleaning one the step system, comprise
A) a kind of contain 1wt% to the aqueous antiseptic solution of 5wt% hydrogen peroxide and
B) a kind of tablet or capsule, it contains
I) in a kind of aqueous antiseptic solution under the unacceptable pH level of eyes in a period of time can by the protease of irreversible deactivation and
Ii) a kind of have the microorganism catalase of primary activity at pH3.0 to 7.0,
Iii) a kind ofly can regulate aqueous antiseptic solution can be accepted pH to eyes reagent.
33. according to claim 32 one the step system, wherein in the aqueous antiseptic solution amount of hydrogen peroxide be 1wt% to 5wt%, particularly about 3wt%, pH value are 3.0 to 4.5, particularly about pH3.5.
34. according to claim 32 or 33 one the step system, its Chinese medicine tablet and capsule are according to each tablet or capsule of claim 16-31.
35. according to claim 32-34 each one the step system, wherein protease is according to each protease of claim 7-11.
36. according to claim 32-35 each one the step system, wherein the microorganism catalase is according to each catalase of claim 13-15.
37. according to claim 32-36 each one the step system, wherein the pH regulator agent is a kind of buffer agent, or acid or alkali.
38. according to claim 37 one the step system, wherein the pH regulator agent be can regulate the pH of aqueous antiseptic solution to enzyme can be by the buffer agent of the pH value of irreversible deactivation.
39. according to claim 38 one the step system, wherein buffer agent is regulated the pH of aqueous antiseptic solution to the acceptable pH of eyes.
40. according to claim 38 or 39 one the step system, wherein buffer agent is selected from the potassium salt or the sodium salt of alkali metal salt such as carbonic acid, acetic acid, boric acid, phosphoric acid, citric acid potassium salt and sodium salt, potassium hydroxide and sodium hydroxide, and weak acid such as acetic acid and boric acid.
41. an one-step method that is used for contact lens disinfection and cleaning may further comprise the steps:
1) 1wt% that contains in fixed amount soaks contact lens in the aqueous antiseptic solution of 5wt% hydrogen peroxide, and
2) add one according to each tablet of claim 16-31, and
3) in aqueous antiseptic solution, contact lens is stored a period of time.
42. according to the method for claim 41, wherein aqueous antiseptic solution contains 3% the hydrogen peroxide of having an appointment, pH is 3.0 to 4.5, particularly about pH3.5.
43. according to a method of claim 41 or 42, the fixed amount that wherein contains the aqueous antiseptic solution of peroxide people hydrogen be 1ml to 10ml, particularly about 5ml.
44. according to each method of claim 41-35, wherein contact lens was stored in aqueous antiseptic solution 5 minutes to 12 hours, and preferred 10 minutes to 2 hours, particularly 20 minutes to 1 hour.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK107095 | 1995-09-25 | ||
| DK1168/95 | 1995-10-16 | ||
| DK116895 | 1995-10-16 | ||
| DK1070/95 | 1995-10-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1197397A true CN1197397A (en) | 1998-10-28 |
Family
ID=26065170
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 96197197 Pending CN1197397A (en) | 1995-09-25 | 1996-09-24 | Disinfection and cleaning of contact lenses |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP0999857A1 (en) |
| JP (1) | JPH11512834A (en) |
| CN (1) | CN1197397A (en) |
| AU (1) | AU698356B2 (en) |
| CA (1) | CA2231845A1 (en) |
| WO (1) | WO1997011722A1 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101664043B (en) * | 2009-09-30 | 2012-05-30 | 孙泽 | Disinfecting liquid used for disinfecting and cleaning water channel of hemodialysis machine and preparation method thereof |
| CN102802677B (en) * | 2009-06-29 | 2014-12-24 | 美你康株式会社 | System for sterilizing contact lens |
| CN105579073A (en) * | 2013-09-27 | 2016-05-11 | 诺华股份有限公司 | Compositions and methods for disinfecting and cleaning contact lenses |
| CN115350306A (en) * | 2022-10-20 | 2022-11-18 | 北京安吉贝玛健康科技有限公司 | Variable buoyancy generating type oxygen mask disinfection device |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI970012L (en) * | 1997-01-03 | 1998-07-04 | Rinne Ari E | Use of cysteine proteinases and their inhibitors in oral hygiene products |
| WO1998037921A2 (en) * | 1997-02-28 | 1998-09-03 | Albert Sturm | Water-soluble contact lens care product |
| KR20160119881A (en) * | 2014-11-28 | 2016-10-17 | 주식회사 씨케이바이오텍 | Coating composition for disinfectant tablet, and preparation method of coated disinfectant tablet using the same |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4899914A (en) * | 1988-11-04 | 1990-02-13 | Ciba-Geigy Corporation | Method for producing a sterile preservative-free aerosol saline solution |
| ES2146610T3 (en) * | 1992-03-04 | 2000-08-16 | Genencor Int | USE OF ASPERGILLUS NIGER CATALASE R FOR HYDROGEN PEROXIDE NEUTRALIZATION. |
| US5494817A (en) * | 1993-12-06 | 1996-02-27 | Allergan, Inc. | Sugar-based protease composition for use with constant-PH borate buffers |
-
1996
- 1996-09-24 EP EP96931760A patent/EP0999857A1/en not_active Withdrawn
- 1996-09-24 AU AU70836/96A patent/AU698356B2/en not_active Ceased
- 1996-09-24 JP JP9513090A patent/JPH11512834A/en not_active Ceased
- 1996-09-24 WO PCT/DK1996/000404 patent/WO1997011722A1/en not_active Application Discontinuation
- 1996-09-24 CA CA002231845A patent/CA2231845A1/en not_active Abandoned
- 1996-09-24 CN CN 96197197 patent/CN1197397A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102802677B (en) * | 2009-06-29 | 2014-12-24 | 美你康株式会社 | System for sterilizing contact lens |
| US9427488B2 (en) | 2009-06-29 | 2016-08-30 | Menicon Co., Ltd. | Disinfection system of contact lens |
| US10137218B2 (en) | 2009-06-29 | 2018-11-27 | Menicon Co., Ltd. | Disinfection system of contact lens |
| US11331404B2 (en) | 2009-06-29 | 2022-05-17 | Menicon Co., Ltd. | Disinfection system of contact lens |
| US12042567B2 (en) | 2009-06-29 | 2024-07-23 | Menicon Co., Ltd. | Disinfection system of contact lens |
| CN101664043B (en) * | 2009-09-30 | 2012-05-30 | 孙泽 | Disinfecting liquid used for disinfecting and cleaning water channel of hemodialysis machine and preparation method thereof |
| CN105579073A (en) * | 2013-09-27 | 2016-05-11 | 诺华股份有限公司 | Compositions and methods for disinfecting and cleaning contact lenses |
| CN105579073B (en) * | 2013-09-27 | 2020-02-28 | 爱尔康公司 | Compositions and methods for disinfecting and cleaning contact lenses |
| CN115350306A (en) * | 2022-10-20 | 2022-11-18 | 北京安吉贝玛健康科技有限公司 | Variable buoyancy generating type oxygen mask disinfection device |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2231845A1 (en) | 1997-04-03 |
| AU7083696A (en) | 1997-04-17 |
| AU698356B2 (en) | 1998-10-29 |
| WO1997011722A1 (en) | 1997-04-03 |
| EP0999857A1 (en) | 2000-05-17 |
| JPH11512834A (en) | 1999-11-02 |
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