WO2012005311A1 - Composition for contact lens care - Google Patents
Composition for contact lens care Download PDFInfo
- Publication number
- WO2012005311A1 WO2012005311A1 PCT/JP2011/065517 JP2011065517W WO2012005311A1 WO 2012005311 A1 WO2012005311 A1 WO 2012005311A1 JP 2011065517 W JP2011065517 W JP 2011065517W WO 2012005311 A1 WO2012005311 A1 WO 2012005311A1
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- WIPO (PCT)
- Prior art keywords
- contact lens
- composition
- group
- component
- care composition
- Prior art date
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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
- A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
- A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
- A01N47/42—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —N=CX2 groups, e.g. isothiourea
- A01N47/44—Guanidine; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/04—Artificial tears; Irrigation solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
Definitions
- the present invention relates to a composition for contact lens care. Specifically, the present invention relates to a composition for contact lens care that can effectively exhibit the bactericidal action of polyhexanide and / or a salt thereof even after storage, and can maintain excellent appearance properties without causing cloudiness.
- Contact lenses have advantages such as a wider field of view, less distortion of images, and the same impression of the face as with the naked eye, compared to glasses. Many people wear contact lenses today. On the other hand, the contact lens is exposed to an environment in which it is easy to come into contact with microorganisms during wearing or storage, and thus has a drawback that it easily becomes a hotbed of microorganisms and is easily contaminated.
- microorganisms that have entered the eye from the outside may adhere to the contact lens.
- microorganisms that have entered the eye from the outside may adhere to the contact lens.
- the microorganisms adhering to the contact lens may worsen the wearing feeling of the contact lens, and if it is a pathogenic microorganism, it may contribute to an eye infection.
- Many of the conjunctival microorganisms are non-pathogenic, but if excessive microorganisms adhere to the contact lens, a biofilm is formed on the surface of the contact lens by extraneous substances secreted from the attached microorganism, causing pathogenicity. There is a danger of becoming a hotbed of microorganisms, which increases the risk of eye infections.
- contact lens care composition containing a bactericide is used to clean and disinfect contact lenses.
- contact lens disinfectant / cleaning / preserving solution multi-purpose solution
- multi-purpose solution is a preparation that directly contacts the cornea via contact lenses, so the disinfectant formulated is highly safe. It is important to have it.
- polyhexanide and / or its salt has high biocompatibility in addition to bactericidal action and is suitable for blending into contact lens care compositions (especially contact lens disinfecting / cleaning / preserving solutions). It is considered a disinfectant.
- a formulation for a contact lens care composition containing polyhexanide and / or a salt thereof has also been reported (see Patent Document 1-2).
- Patent Document 1-2 a formulation for a contact lens care composition containing polyhexanide and / or a salt thereof, for the technology for effectively exerting the bactericidal action without impairing the bactericidal action even after storage and the technology for providing formulation stability, The current situation has not been fully studied.
- the inventor has conducted various studies for the purpose of developing a contact lens care composition containing polyhexanide and / or a salt thereof. Depending on the type and content of other compounding components, Or the bactericidal action by the salt attenuate
- the composition for contact lens care is stored for a long period of time not only from the stage of manufacture to distribution but also from storage to the consumer, start of use, and end of use. Therefore, it is naturally desirable that the bactericidal action is stably maintained not only immediately after production but also over time, and no change such as white turbidity occurs.
- the present invention provides a composition for contact lens care that can effectively exhibit the bactericidal action due to polyhexanide and / or its salt even after storage, and does not change in appearance properties such as cloudiness over time. Objective.
- the present inventor has intensively studied to solve the above problems, and surprisingly, in the contact lens care composition, together with polyhexanide and / or a salt thereof, polyoxyethylene polyoxypropylene glycol, hydroxypropyl Bactericidal action by polyhexanide and / or its salt is effective even after storage by blending methylcellulose and / or its salt and 0.04-0.2w / v% ethylenediaminetetraacetic acid and / or its salt in combination In addition, the present inventors have found that excellent appearance properties can be maintained without causing white turbidity over time.
- the present inventor has also found that polyoxyethylene polyoxypropylene glycol is difficult to be reduced in molecular weight and stable in a contact lens care composition containing a combination of the above-described blending components. Further, the present inventor found that a contact lens care composition containing a combination of the above-described blended components is easy to scrub the contact lens, and when the contact lens is treated with the composition, the contact lens feels good. And found that it has an excellent feeling of use. Furthermore, when the present inventor treats a contact lens with a composition for contact lens care containing a combination of the above ingredients, the increase in the hardness of the contact lens due to drying can be suppressed. It has also been found that the flexibility of the lens can be maintained. The present invention has been completed by further studies based on these findings.
- this invention provides the composition for contact lens care of the following aspect, the contact lens care article using the same, and the processing method of a contact lens.
- Item 1-1 (A) at least one selected from the group consisting of polyhexanide and its salt, (B) at least one selected from the group consisting of (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and its salt, and (D) A composition for contact lens care, comprising 0.04 to 0.2 w / v% of at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof.
- Item 1-2 Item 10.
- the contact lens care composition according to Item 1-1 comprising as component (A) at least one selected from the group consisting of a compound represented by the following general formula (1) and a salt thereof.
- R 1 and R 2 are the same or different and are a group or an amino group represented by the following General Formula (2), and n represents an integer of 1 to 500. ]
- Item 1-3 Item 1.
- Item 4. The contact lens care composition according to any one of Items 1-1 to 1-3, which contains polyhexanide hydrochloride as the component (A).
- Item 5. The contact lens care composition according to any one of Items 1-1 to 1-4, wherein the content of component (A) is 0.00005 to 0.00012 w / v%.
- Item 1-6 Item 6.
- Item 11 The contact lens care composition according to any one of Items 1-1 to 1-10, further comprising (E) a borate buffer. Item 1-12.
- Item 13 The contact lens care composition according to any one of Items 1-1 to 1-12, which satisfies a ratio of 100 parts by weight or more in total. Item 1-14. Item 14.
- Item 18 The composition for contact lens care according to Item 1-17, wherein the soft contact lens is a lens belonging to soft contact lens classification group IV based on FDA standards.
- Item 15. A contact lens care product comprising a container filled with the contact lens care composition according to any one of Items 1-1 to 1-18. Item 1-20.
- Item 20. The contact lens care product according to Item 1-19, wherein the container is a plastic container comprising a polyester resin as a constituent resin.
- Item 20. The contact lens care product according to any one of Items 1-19 and 1-20, wherein the container is a plastic container comprising polyethylene terephthalate as a constituent resin.
- Item 20. A method for treating a contact lens, comprising immersing the contact lens in the contact lens care composition according to any one of items 1-1 to 1-18 for 1 minute or more.
- this invention provides the effect
- a method Item 2-1.
- a composition for contact lens care containing at least one selected from the group consisting of polyhexanide and a salt thereof, and (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and a salt thereof At least one selected from the group, and (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, 0.04-0.2 w / v%, polyhexanide characterized in that And / or a method of imparting to the composition for contact lens care an action of suppressing a decrease in the bactericidal action of a salt thereof.
- this invention provides the method of providing the effect
- Item 3-1 In the contact lens care composition, (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof And at least one selected from the group consisting of (D) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% in combination, A method for preventing white turbidity in a care composition. Item 3-2.
- a composition for contact lens care containing at least one selected from the group consisting of polyhexanide and a salt thereof, and (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and a salt thereof At least one selected from the group, and (D) 0.04 to 0.2 w / v% selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, A method for imparting an effect to prevent contact to the composition for contact lens care. Item 3-3.
- the cloudy contact lens care composition contains (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof in an amount of 0.04 to 0.2 w / v%.
- the present invention provides the following method for suppressing the reduction in molecular weight of polyoxyethylene polyoxypropylene glycol, and the composition for contact lens care, which suppresses the reduction in molecular weight of polyoxyethylene polyoxypropylene glycol.
- a method Item 4-1.
- the contact lens care composition (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof And at least one selected from the group consisting of (D) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% in combination.
- a method for suppressing a decrease in molecular weight of polyoxyethylene polyoxypropylene glycol in a care composition Item 4-2.
- the present invention provides the following methods for suppressing the increase in contact lens hardness due to drying, and methods for imparting the contact lens care composition with the effect of suppressing the increase in contact lens hardness due to drying.
- Item 5-1 (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof, and (D) treating the contact lens with a contact lens care composition containing 0.04 to 0.2 w / v% selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof.
- the composition for contact lens care includes at least one selected from the group consisting of (A) polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) a group consisting of hydroxypropylmethylcellulose and a salt thereof.
- Contact by drying characterized in that it comprises at least one selected from the group consisting of (D) ethylenediamineacetic acid, its derivatives, and salts thereof, and 0.04 to 0.2 w / v%
- the contact lens care composition of the present invention can effectively exhibit the bactericidal action due to polyhexanide and / or its salt even after storage, and can maintain excellent appearance properties without causing cloudiness over time. Therefore, even if it is stored for a long time from the production to distribution stage and until the end of use by the consumer, the bactericidal action and appearance properties can be maintained, and the actual use can be fully endured for a long time. Moreover, in the composition for contact lens care of this invention, the molecular weight reduction of polyoxyethylene polyoxypropylene glycol is suppressed. Therefore, the composition for contact lens care excellent in formulation stability can be provided.
- the contact lens care composition of the present invention is easy to scrub contact lenses, and when a contact lens is treated with the composition, the contact lens is also comfortable to wear. The feeling of use can be fully satisfied.
- contact lenses are easily affected by drying.
- the surface of the contact lens tends to be easily dried due to drying due to environmental factors such as an air conditioner and a decrease in blinking due to staring on a personal computer screen.
- the softness of the contact lens is impaired, which may lead to deterioration in wearing feeling and poor visibility.
- the contact lens care composition of the present invention can suppress an increase in the hardness of the contact lens due to drying, and can maintain the flexibility of the contact lens even when exposed to a dry atmosphere. The adverse effects on can also be wiped out.
- the contact lens care composition of the present invention (hereinafter sometimes referred to as CL care composition) is at least one selected from the group consisting of polyhexanide and salts thereof (hereinafter, ( A) (sometimes referred to as component).
- Polyhexanide is a known disinfectant called polyhexamethylene biguanide or PHMB.
- the polyhexanide used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- the compound shown in (1) is exemplified.
- R 1 and R 2 are the same or different and represent a group or an amino group represented by the following general formula (2).
- R 1 is an amino group
- R 2 is a group or an amino group represented by the general formula (2), more preferably R 1 is an amino group, and R 2 is represented by the general formula (2).
- n represents an integer of 1 to 500. Preferably, it represents an integer of 2 to 200, more preferably an integer of 4 to 100, and particularly preferably an integer of 8 to 20.
- the salt of polyhexanide is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- Specific examples of polyhexanide salts include inorganic acid salts such as hydrochloric acid, hydrogen bromide, sulfuric acid, and boric acid; and organic acid salts such as acetic acid, gluconic acid, maleic acid, ascorbic acid, stearic acid, tartaric acid, and citric acid. Illustrated.
- inorganic acid salts are preferable, and hydrochlorides are more preferable.
- These polyhexanide salts may be used alone or in any combination of two or more.
- the component (A) one kind of polyhexanide and a salt thereof may be used alone, or two or more kinds may be used in any combination. Also good.
- the polyhexanide represented by the general formula (1) or an inorganic acid thereof is preferably used from the viewpoint of maintaining the bactericidal action more stably and further maintaining the appearance properties by preventing white turbidity and the like.
- a salt more preferably a polyhexanide represented by the general formula (1) or a hydrochloride thereof, particularly preferably a hydrochloride of polyhexanide represented by the general formula (1).
- the component (A) exemplified here suppresses the lowering of the molecular weight of the component (B), further improves the feeling of use of the composition for CL care, or further increases the inhibitory effect on the increase in hardness of the contact lens due to drying. It is also suitable from the viewpoint.
- the content ratio of the component (A) is appropriately set according to the type of the component (A), the type of other compounding components, and the like.
- the total amount of the component (A) is 0.00005 to 0.00012 w / v%, preferably 0.00006 to 0.00012 w / v%, more preferably 0.00007 to 0.00012 w / v%, based on the total amount of the composition for use. If the component (A) is within the above content ratio, the bactericidal action and appearance properties can be more stably maintained while having high safety.
- the above content ratio of the component (A) is also suitable for more effectively achieving the other effects of the present invention.
- the CL care composition of the present invention further contains polyoxyethylene polyoxypropylene glycol (hereinafter sometimes referred to as component (B)).
- component (B) polyoxyethylene polyoxypropylene glycol
- POE polyoxyethylene
- POP polyoxypropylene
- the numbers in parentheses indicate the number of moles added.
- POEPOP glycol is a compound obtained by addition polymerization of ethylene oxide to polypropylene glycol obtained by addition polymerization of propylene oxide, and is represented by the following general formula.
- the POPPOE glycol used in the present invention is not particularly limited in terms of its molecular weight and the average degree of polymerization of propylene oxide and ethylene oxide, but the average molecular weight is preferably 1000 to 30000, more preferably 1500 to 20000, and more preferably 2000 to 15000. Is particularly preferred.
- the average degree of polymerization of propylene oxide represented by y in the above general formula is preferably 5 to 100, more preferably 20 to 80, still more preferably 30 to 70, and particularly preferably 60 to 70.
- the average degree of polymerization of ethylene oxide represented by x and z in the above general formula is preferably 3 to 250, more preferably 20 to 220, still more preferably 50 to 200, and particularly preferably 150 to 200.
- POP POE glycols include POE (196) POP (67) glycol (poloxamer 407, average molecular weight 11500), POE (24) POP (20) glycol (poloxamer 124, average molecular weight 2200), POE (160) POP (30 ) Glycol (poloxamer 188, average molecular weight 8350), POE (54) POP (39) glycol (poloxamer 235, average molecular weight 4600), POE (200) POP (70) glycol and the like.
- poloxamer 407 is exemplified from the viewpoint of more stably maintaining the bactericidal action of the CL care composition and more effectively suppressing the lowering of the molecular weight of POPPOE glycol.
- the component (B) exemplified here is also suitable from the viewpoint of further improving the feeling of use of the CL care composition or further enhancing the inhibitory effect on the hardness increase of the contact lens due to drying.
- the content ratio of the component (B) is appropriately set according to the type of the component (B), the type of other compounding components, and the like.
- the total amount of the component (B) is 0.01 to 0.5 w / v%, preferably 0.01 to 0.3 w / v%, more preferably 0.05 to 0.2 w / v% with respect to the total amount of the composition for use. If the component (B) is within the above range, the bactericidal action and appearance properties can be more stably maintained.
- the above-described content ratio of the component (B) is suitable for more effectively achieving the other effects of the present invention.
- the ratio of the component (B) to the component (A) is not particularly limited, but the bactericidal action of the composition for CL care is more stably maintained, and further From the viewpoint of preventing appearance of white turbidity and maintaining better appearance properties, the total amount of the component (B) is 80 to 10,000 parts by weight, preferably 80 to 6000 parts by weight per 1 part by weight of the total amount of the component (A). More preferably, the range is 400 to 4000 parts by weight.
- the ratio exemplified here is from the viewpoint of further suppressing the low molecular weight of the component (B), further improving the feeling of use of the composition for CL care, or further increasing the inhibitory action against the increase in hardness of the contact lens due to drying. Is also suitable.
- the CL care composition of the present invention further contains at least one selected from the group consisting of hydroxypropylmethylcellulose and salts thereof (hereinafter sometimes referred to as component (C)).
- the hydroxypropylmethylcellulose used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Further, the content of methoxy group and hydroxypropoxy group in hydroxypropylmethylcellulose is not particularly limited.
- the molecule (100% by weight) contains 19 to 31.5% by weight of methoxy group and 4% of hydroxypropoxy group. Examples are those containing ⁇ 12% by weight.
- the salt of hydroxypropylmethylcellulose is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- These hydroxypropylmethylcellulose salts may be used alone or in any combination of two or more.
- the molecular weight of hydroxypropylmethylcellulose and a salt thereof varies depending on the type of substituent and the degree of substitution, but is usually from 10,000 to 1,500,000, preferably from 50,000 to 1,300,000, more preferably from a weight average molecular weight. About 10,000 to 1,000,000 can be used.
- the component (C) one of hydroxypropylmethylcellulose and a salt thereof may be used alone, or two or more of them may be used in any combination. May be.
- hydroxypropylmethylcellulose is preferably used from the viewpoint of keeping the bactericidal action of the CL care composition more stable and further preventing appearance of white turbidity and keeping the appearance properties better.
- the component (C) exemplified here further suppresses the lowering of the molecular weight of the component (B), further improves the feeling of use of the CL care composition, or further enhances the inhibitory effect on the increase in contact lens hardness due to drying. From this point of view, it is preferable.
- the content ratio of the component (C) is appropriately set according to the type of the component (C), the type of other compounding components, and the like.
- the total amount of the component (C) is 0.01 to 0.5 w / v%, preferably 0.01 to 0.3 w / v%, more preferably 0.01 to 0.1 w / v%, based on the total amount of the composition for use.
- the component (C) is within the above range, the bactericidal action and appearance properties can be maintained more stably.
- the above-described content ratio of the component (C) is suitable for more effectively achieving the other effects of the present invention.
- the ratio of the component (C) to the component (A) is not particularly limited, but the bactericidal action of the CL care composition is more stably maintained, and further From the viewpoint of preventing appearance of white turbidity and maintaining better appearance properties, the total amount of component (C) is 80 to 10000 parts by weight, preferably 80 to 6000 parts by weight per part by weight of component (A). More preferably, the range is 80 to 2000 parts by weight.
- the ratio exemplified here is from the viewpoint of further suppressing the low molecular weight of the component (B), further improving the feeling of use of the composition for CL care, or further increasing the inhibitory action against the increase in hardness of the contact lens due to drying. Is also suitable.
- the CL care composition of the present invention comprises at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof in addition to the components (A) to (C) (hereinafter referred to as (D )) (Sometimes referred to as “component”) at a content of 0.04 to 0.2 w / v%.
- component ethylenediamineacetic acid, derivatives thereof, and salts thereof in addition to the components (A) to (C) (hereinafter referred to as “component”) at a content of 0.04 to 0.2 w / v%.
- the molecular weight of the component (B) is suppressed and the feeling of use of the composition for CL care is improved. Further, it is possible to suppress an increase in the hardness of the contact lens due to drying.
- the ethylenediamineacetic acid used in the present invention is a compound in which 1 to 4 carboxymethyl groups are bonded to the two amino groups of ethylenediamine.
- ethylenediamineacetic acid used as the component (D) in the present invention There is no particular limitation as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- Specific examples of ethylenediamineacetic acid used in the present invention include ethylenediaminediacetic acid (EDDA), ethylenediaminetriacetic acid, ethylenediaminetetraacetic acid (edetic acid, EDTA), and the like.
- ethylenediamineacetic acid derivative examples include N- (2-hydroxyethyl) ethylenediaminetriacetic acid (HEDTA) and diethylenetriaminepentaacetic acid (DTPA).
- HEDTA N- (2-hydroxyethyl) ethylenediaminetriacetic acid
- DTPA diethylenetriaminepentaacetic acid
- ethylenediamineacetic acids and derivatives thereof ethylenediaminetetraacetic acid is preferable.
- These ethylenediamineacetic acids and / or their derivatives may be used alone or in any combination of two or more.
- the salt of ethylenediamineacetic acid and / or a derivative thereof is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- an inorganic base and [For example, ammonium salts; alkali metals (sodium, potassium, etc.), alkaline earth metals (calcium, magnesium, etc.), salts with metals such as aluminum, etc.] and the like.
- alkali metal salts more preferred are sodium salts and potassium salts, and particularly preferred are sodium salts. These salts may be used alone or in any combination of two or more.
- the ethylenediamineacetic acid, its derivative and / or salt used as the component (D) may be in the form of a hydrate.
- ethylenediamineacetic acid, derivatives thereof, and salts thereof may be used alone or in combination of two or more. May be used in combination.
- the components (D) from the viewpoint of keeping the bactericidal action of the CL care composition more stable, further suppressing the white turbidity and keeping the appearance properties better, preferably ethylenediaminetetraacetic acid and its salt, More preferably, an alkali metal salt of ethylenediaminetetraacetic acid, particularly preferably a sodium salt of ethylenediaminetetraacetic acid, and still more preferably disodium ethylenediaminetetraacetic acid.
- disodium ethylenediaminetetraacetate means sodium edetate hydrate (dihydrate) of the 15th revision Japanese Pharmacopoeia.
- the component (D) exemplified here further suppresses the lowering of the molecular weight of the component (B), further improves the feeling of use of the CL care composition, or further enhances the inhibitory action against the increase in contact lens hardness due to drying. From this point of view, it is preferable.
- the content ratio of the component (D) satisfies 0.04 to 0.2 w / v% of the total amount of the component (D) with respect to the total amount of the CL care composition. However, it is preferably 0.04 to 0.15 w / v%, more preferably 0.04 from the viewpoint of maintaining the bactericidal action of the CL care composition more stably and further maintaining the appearance properties. -0.1 w / v% is exemplified. If the component (D) is within the above range, the bactericidal action and appearance can be maintained more stably while providing a good feeling of use with low irritation. In addition, the content ratio of the component (D) is also suitable for more effectively achieving the other effects of the present invention.
- the ratio of the component (D) to the component (A) is not particularly limited, but the bactericidal action of the CL care composition is more stably maintained, and further From the viewpoint of suppressing the white turbidity and keeping the appearance property better, the total amount of the component (D) is 300 to 4000 parts by weight, preferably 300 to 3000 parts by weight per 1 part by weight of the total amount of the component (A). A range of 300 to 2000 parts by weight is more preferable.
- the ratio exemplified here is from the viewpoint of further suppressing the low molecular weight of the component (B), further improving the feeling of use of the composition for CL care, or further increasing the inhibitory action against the increase in hardness of the contact lens due to drying. Is also suitable.
- the ratio of the (D) component to the (C) component is not particularly limited, but the bactericidal action of the CL care composition is more stably maintained. Furthermore, from the viewpoint of further improving the appearance properties by suppressing white turbidity, the total amount of the component (D) is 0.08 to 20 parts by weight, preferably 0.1 to 15 parts by weight per 1 part by weight of the total amount of the component (C). Part, more preferably in the range of 0.4 to 10 parts by weight.
- the ratio exemplified here is from the viewpoint of further suppressing the low molecular weight of the component (B), further improving the feeling of use of the composition for CL care, or further increasing the inhibitory action against the increase in hardness of the contact lens due to drying. Is also suitable.
- the CL care composition of the present invention preferably contains a borate buffer (hereinafter sometimes referred to as the component (E)).
- borate buffer used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- boric acid (orthoboric acid), metaboric acid examples thereof include boric acid, tetraboric acid and salts thereof.
- these salts include alkali metal salts, alkaline earth metal salts, ammonium salts, and the like.
- Specific examples of boric acid buffers used as component (E) include boric acid, metaboric acid, hypoboric acid, sodium borate, potassium tetraborate, sodium tetraborate, potassium metaborate, ammonium borate, boron Examples include sand. These may be hydrates.
- boric acid buffers may be used alone or in combination of two or more.
- component (E) a combination (combination) of boric acid and borax is preferably exemplified.
- boric acid and borax Japanese Pharmacopoeia conformity goods are used suitably and these can use a commercially available thing.
- the borax is generally 0.
- the amount is 1 to 200 parts by weight, preferably 1 to 100 parts by weight, and more preferably 5 to 50 parts by weight.
- the content ratio of the component (E) is appropriately set according to the type of the component (E), the type of other compounding components, etc.
- the total amount of the component (E) is 0.1 to 2.0 w / v%, preferably 0.2 to 1.5 w / v%, more preferably 0.4 to 1.0 w / v% with respect to the total amount of the composition for use.
- the CL care composition of the present invention preferably contains at least one selected from the group consisting of sodium chloride and potassium chloride (hereinafter sometimes referred to as component (F)).
- the component (F) one of sodium chloride and potassium chloride may be used alone, or both may be used in combination.
- a combination (combination) of sodium chloride and potassium chloride is preferably exemplified.
- component (F) When sodium chloride and potassium chloride are used in combination as component (F), the ratio of these is not particularly limited, but the total amount of potassium chloride is usually 1 to 100 per 100 parts by weight of sodium chloride. Part by weight, preferably 1 to 50 parts by weight, more preferably 5 to 20 parts by weight.
- the content ratio of the component (F) is appropriately set according to the type of the component (F), the type of other compounding components, etc.
- the total amount of the component (F) is 0.01 to 2 w / v%, preferably 0.02 to 1 w / v%, more preferably 0.03 to 0.5 w / v%, based on the total amount of the composition for use.
- the above (E) component and (F) component are combined. It is preferable to contain.
- the total amount of the component (E) is 100 parts by weight or more, preferably 100 to 300 parts by weight, more preferably 100 to 200 parts by weight, and particularly preferably 100 to 150 parts by weight per 100 parts by weight of the total amount of the component (F).
- the combined use of the above components (E) and (F) and the above ratios thereof further suppress the reduction in the molecular weight of the component (B), further improve the feeling of use of the composition for CL care, or dry the components. It is also suitable from the viewpoint of further enhancing the inhibitory action against the hardness increase of the contact lens.
- the CL care composition of the present invention preferably contains a monoterpene (hereinafter sometimes referred to as component (G)).
- component (G) a monoterpene
- the component (G) can contribute to further improvement in the feeling of use of the composition for CL care, which further suppresses the low molecular weight of the component (B).
- Monoterpene is a known compound that has a structure having an isoprene unit as a structural unit and is widely used as a cooling agent.
- the monoterpene used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- Specific examples of monoterpenes include menthol, menthone, camphor, borneol, geraniol, cineol, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, and derivatives thereof. These compounds may be d-form, l-form or dl-form.
- an essential oil containing the above compound may be used as the monoterpene.
- Such essential oils include eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, rose oil, camphor oil and the like. These monoterpenes may be used individually by 1 type, and may be used in combination of 2 or more types arbitrarily.
- menthol menthone, camphor, borneol, geraniol, more preferably l-menthol, dl-menthol, d-camphor and dl-camphor, and the essential oil containing these is cool mint.
- examples include oil, peppermint oil, mint oil, camphor oil and the like.
- the content ratio of the component (G) is appropriately set according to the type of the component (G), the type of other compounding components, and the like.
- the total amount of the component (G) is 0.0001 to 0.02 w / v%, preferably 0.0002 to 0.01 w / v%, more preferably 0.0005 to 0.005 w / v%, based on the total amount of the composition for use.
- the essential oil containing a monoterpene as (G) component it sets so that the monoterpene content in the essential oil mix
- the CL care composition of the present invention may contain a buffering agent other than the component (E).
- the buffer that can be incorporated into the CL care composition of the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Examples of such a buffer include a phosphate buffer, a carbonate buffer, a citrate buffer, an acetate buffer, a Tris buffer, and the like. These buffering agents may be used in combination.
- the CL care composition of the present invention may contain a surfactant other than the component (B).
- the surfactant that can be blended in the CL care composition of the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable, and is a nonionic surfactant. Any of an agent, an amphoteric surfactant, an anionic surfactant, and a cationic surfactant may be used.
- the CL care composition of the present invention may further contain an isotonic agent other than the component (F).
- the isotonic agent that can be incorporated into the CL care composition of the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.
- the pH of the CL care composition of the present invention is not particularly limited as long as it is within a pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable range.
- the pH of the CL care composition of the present invention in order to keep the bactericidal action more stable and to further suppress the white turbidity and keep the appearance of properties better.
- the above pH is from the viewpoint of further suppressing the low molecular weight of the component (B), further improving the feeling of use of the composition for CL care, or further enhancing the inhibitory effect on the hardness increase of the contact lens due to drying. Is also suitable.
- the osmotic pressure of the CL care composition of the present invention is not particularly limited as long as it is within a range acceptable for a living body.
- the osmotic pressure ratio is the ratio of the osmotic pressure of the sample to the osmotic pressure of 0.9w / v% sodium chloride aqueous solution based on the 15th revised Japanese Pharmacopoeia.
- the osmotic pressure is the osmotic pressure measurement method described in the Japanese Pharmacopoeia (freezing point depression method) Measure with reference to.
- the standard solution for osmotic pressure ratio measurement is sodium chloride (Japanese Pharmacopoeia standard reagent) dried at 500-650 ° C for 40-50 minutes, then allowed to cool in a desiccator (silica gel), accurately weigh 0.900 g and purify. Dissolve in water to prepare exactly 100 mL, or use a commercially available standard solution for osmotic pressure ratio measurement (0.9 w / v% sodium chloride aqueous solution).
- an active ingredient (pharmacologically active ingredient, physiologically active ingredient, etc.) can be blended in addition to the above ingredients.
- the type of such component is not particularly limited, and examples thereof include a decongestant component, an eye muscle modulator component, an anti-inflammatory component or an astringent component, an antihistamine component or an antiallergic component, vitamins, amino acids, antibacterial agents.
- examples thereof include drug components or bactericidal components, saccharides, polymer compounds or derivatives thereof, cellulose or derivatives thereof, and local anesthetic components.
- various components and additives are appropriately selected according to conventional methods according to the use and form as long as the effects of the invention are not impaired.
- the above can be used in combination.
- carriers aqueous solvents, aqueous or oily bases, etc.
- aqueous or oily bases etc.
- Various additives such as an agent can be mentioned.
- Carrier For example, water, aqueous solvent such as water-containing ethanol.
- PH adjuster For example, hydrochloric acid, sodium hydroxide, etc.
- the CL care composition of the present invention is prepared by adding a desired amount of the above components (A) to (D) and, if necessary, other components to a desired concentration.
- the CL care composition of the present invention is not particularly limited as long as it can be used for cleaning, disinfecting, storing, etc. of contact lenses, but is preferably in liquid form.
- liquid (aqueous composition) pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable water may be used as an aqueous carrier.
- specific examples of water include distilled water, normal water, purified water, sterilized purified water, water for injection, and distilled water for injection. These definitions are based on the 15th revision Japanese Pharmacopoeia.
- the total amount of water is usually 50 w / v% or more with respect to the total amount of the CL care composition, more preferably 80 w / v% or more, more preferably 90 w / v% or more, particularly preferably 95 w / v% or more.
- the CL care composition of the present invention is used for contact lens care such as cleaning, disinfection and storage of contact lenses.
- contact lens disinfectant and storage for contact lenses Agents, contact lens cleaning agents, contact lens cleaning preservatives, contact lens disinfecting / cleaning / preserving agents (multipurpose solutions), and the like.
- a contact lens disinfectant and a contact lens disinfectant / cleaning / preserving agent (multipurpose solution) are preferable.
- a contact lens disinfecting / cleaning / preserving agent (multipurpose solution) is a preparation that directly contacts the cornea via a contact lens in order to disinfect, clean, and store the contact lens as a single agent. Therefore, it is particularly suitable as a preparation form of the CL care composition of the present invention from the viewpoint of effectiveness, safety and the like.
- the contact lens includes any of a soft contact lens, a hard contact lens, and an oxygen permeable hard contact lens.
- Soft contact lenses include both ionic and non-ionic, and include both silicone hydrogel contact lenses and non-silicone hydrogel contact lenses (soft contact lenses that are not silicone hydrogel lenses).
- the CL care composition of the present invention is preferably a soft contact lens care composition (that is, a CL care composition in which the target lens is a soft contact lens).
- the moisture content of the soft contact lens to be applied is not particularly limited.
- the moisture content is 20% or more, preferably 30% or more. More preferably, it is 50 to 90%.
- the moisture content of the soft contact lens indicates the ratio of water in the soft contact lens, and is specifically obtained by the following formula.
- Moisture content (%) (weight of water contained / weight of soft contact lens in water content) x 100 Such moisture content can be measured by a gravimetric method according to the description of ISO18369-4: 2006.
- a lens having a water content of 50% or more is called a high water content soft contact lens, and since there is a lot of moisture contained in the material, microorganisms are easy to propagate and higher sterilization power is required.
- the soft contact lens classification group IV lens according to the FDA standard is susceptible to the contact lens hardness increase due to drying in addition to the characteristics of the soft contact lens and the high water content soft contact lens. Therefore, suppression of the increase in hardness is strongly demanded.
- the physical properties of high water content soft contact lenses, particularly lenses of soft contact lens classification group IV are easily affected by the CL care composition whose uniformity has been impaired due to white turbidity, etc.
- the CL care composition of the present invention it is possible to effectively suppress an increase in the hardness of the contact lens due to drying, as well as excellent bactericidal action, and further to maintain the uniformity of the composition without causing cloudiness. Therefore, the above-mentioned drawbacks of high water content soft contact lenses, particularly soft contact lens classification group IV lenses can be eliminated.
- examples of contact lenses suitable for application of the CL care composition of the present invention include high water content soft contact lenses, particularly soft contact lens classification group IV lenses.
- a method for performing treatment such as cleaning, disinfection and storage of the contact lens using the CL care composition of the present invention is not particularly limited, but the following embodiment is exemplified as a preferred example.
- cleaning a contact lens 1 to 10 drops, preferably 2 to 4 drops of the CL care composition of the present invention is dropped onto the contact lens and rubbed with fingers about 20 to 30 times on each side, and then 1 to Rinse with 20 mL, preferably about 1 to 5 mL of the CL care composition of the present invention.
- 1 contact lens is immersed in 0.5 to 5 mL, preferably 1 to 3 mL of the CL care composition of the present invention for 1 minute or more, preferably 10 minutes or more, more preferably Store for more than 4 hours.
- the type of lens case used when the contact lens is immersed in the CL care composition of the present invention is not particularly limited, but a plastic lens case is preferable.
- a thermoplastic resin is preferable.
- thermoplastic resin examples include olefin resins such as polyethylene and polypropylene, and styrene resins such as acrylonitrile-styrene copolymer (AS resin) such as acrylonitrile butadiene styrene copolymer (ABS resin).
- AS resin acrylonitrile-styrene copolymer
- ABS resin acrylonitrile butadiene styrene copolymer
- the CL care composition of the present invention is a contact lens disinfecting / cleaning / preserving agent (multipurpose solution)
- the above-described cleaning, disinfecting / preserving may be performed in series.
- the CL care composition of the present invention is housed in a container and provided as a contact lens care product.
- the type of container for containing the CL care composition of the present invention is not particularly limited, and may be either plastic or glass, but the plastic container is lightweight and has good squeeze properties, and is repetitive. Since it has durability against pressing, it is suitable for containing a CL care composition.
- thermoplastic resin As the resin constituting the plastic container used for housing the CL care composition of the present invention, a thermoplastic resin is preferable.
- thermoplastic resins include polyester resins such as polyethylene terephthalate (PET), polyethylene naphthalate, and polyarylate; olefin resins such as polyethylene and polypropylene; polystyrene, acrylonitrile-styrene copolymer (AS resin) Examples thereof include styrene resins such as polyphenylene ether resins, polycarbonate resins, polysulfone resins, polyamide resins, and hard vinyl chloride resins.
- thermoplastic resins described above a container comprising a polyester resin, particularly PET, tends to attenuate the bactericidal action of polyhexanide and / or its salt over time, and further, polyhexanide and / or its salt is used.
- the contact lens care composition containing the composition tends to cause white turbidity over time, and also tends to cause a low molecular weight polyoxyethylene polyoxypropylene glycol.
- the CL care composition of the present invention even if it is accommodated in a container having a polyester resin, particularly PET as a constituent resin, such concerns are eliminated, and the CL care composition
- the bactericidal action can be stably maintained, and furthermore, the appearance can be stably maintained without causing white turbidity over time.
- a polyester resin container preferably a PET container
- the PET container may contain PET in an amount of 50% by weight or more, preferably 70% by weight or more, more preferably 90% by weight or more of the total resin.
- the filling amount of the CL care composition of the present invention into the container is not particularly limited, but usually 50 to Examples are 1000 mL, preferably 80 to 600 mL.
- the present invention is at least one selected from the group consisting of (A) polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropyl methylcellulose and salts thereof And at least one selected from the group consisting of (E) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% in combination.
- the present invention provides a method for suppressing a decrease in the bactericidal action of polyhexanide and / or a salt thereof.
- the present invention also provides (C) a composition for CL care containing at least one selected from the group consisting of (A) polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropyl methylcellulose. And (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, and 0.04 to 0.2 w / v%. Also provided is a method for imparting to the CL care composition an action that suppresses the temporal deterioration of the bactericidal action of polyhexanide and / or a salt thereof.
- the types and content ratios of the components (A) to (D) to be used, the types and content ratios of other components, the formulation form of the composition, the container, the type of contact lens to be applied, And the like are the same as those in “1. Contact lens care composition”.
- the present invention from yet another viewpoint, in the CL care composition, (A) at least one selected from the group consisting of polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C 0.04 to 0.2 w / v% selected from the group consisting of at least one selected from the group consisting of :) hydroxypropylmethylcellulose and salts thereof; and (D) ethylenediamineacetic acid, derivatives thereof, and salts thereof.
- a method for preventing or suppressing white turbidity in the CL care composition which is used in combination.
- the present invention also provides (C) a composition for CL care containing at least one selected from the group consisting of (A) polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropyl methylcellulose. And 0.04 to 0.2 w / v% of (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof. Also provided is a method for imparting to the CL care composition the feature of preventing or suppressing white turbidity.
- the present invention provides at least one selected from the group consisting of (A) polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, and (C) a group consisting of hydroxypropylmethylcellulose and a salt thereof.
- the CL care composition containing at least one selected from the group consisting of (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, 0.04 to 0.2 w / v%. Also provided is a method for imparting to the CL care composition the feature of preventing or suppressing white turbidity.
- the types and content ratios of the components (A) to (D) used the types and content ratios of other components, the formulation form of the composition, the types of contact lenses to be applied, etc. And “1. Composition for contact lens care”.
- the present invention from yet another viewpoint, in the composition for CL, (A) at least one selected from the group consisting of polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) Combined use of at least one selected from the group consisting of hydroxypropylmethylcellulose and salts thereof, and (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof and salts thereof in an amount of 0.04 to 0.2 w / v%
- the present invention provides a method for suppressing a decrease in molecular weight of polyoxyethylene polyoxypropylene glycol in the composition for contact lens care.
- the present invention provides a contact lens care composition containing (B) polyoxyethylene polyoxypropylene glycol, (A) at least one selected from the group consisting of polyhexanide and a salt thereof, (C) hydroxypropyl At least one selected from the group consisting of methylcellulose and its salts, and (D) at least one selected from the group consisting of ethylenediamineacetic acid, its derivatives and their salts, 0.04 to 0.2 w / v%. Also provided is a method for imparting the contact lens care composition with the effect of preventing polyoxyethylene polyoxypropylene glycol from lowering the molecular weight.
- the types and content ratios of the components (A) to (D) used the types and content ratios of other components, the formulation form of the composition, the types of contact lenses to be applied, etc. And “1. Composition for contact lens care”.
- Method for suppressing increase in hardness of contact lens due to drying Method for imparting an effect of suppressing increase in hardness of contact lens due to drying to a composition for CL care As described above, together with the components (A) to (C), By treating the contact lens with a CL care composition containing a specific component (D) as a single component, the contact lens can be prevented from increasing in hardness due to drying, and even when exposed to a dry atmosphere, the contact lens It becomes possible to maintain the flexibility of the.
- the present invention is at least one selected from the group consisting of (A) polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropyl methylcellulose and salts thereof And at least one selected from the group consisting of (D) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% of a composition for contact lens care
- a method for suppressing an increase in hardness of a contact lens due to drying which comprises treating the contact lens with an object.
- the present invention provides a CL care composition
- a CL care composition comprising (A) at least one selected from the group consisting of polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropyl methylcellulose and And at least one selected from the group consisting of salts and 0.04 to 0.2 w / v% selected from the group consisting of (D) ethylenediamineacetic acid, derivatives thereof, and salts thereof,
- a method for imparting the CL care composition with an action of suppressing the increase in hardness of a contact lens due to drying.
- Test Example 1 Evaluation of bactericidal power before and after storage, appearance properties, etc.
- a CL care composition having the composition shown in Table 1 was prepared, and according to the following method, bactericidal power before and after storage, appearance of properties of the preparation, polyoxyethylene poly The stability of oxypropylene glycol was evaluated.
- bacterial species Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC9027, Serratia marcescens ATCC13880, Escherichia coli ATCC 8739
- 2 fungal species Candida albicans ATCC10231
- TSA trypsoy agar
- SDA Sabouraud dextrose agar
- Cultured cells are aseptically collected with a platinum loop and an appropriate amount of sterile Dulbecco's phosphate buffered saline (CaCl 2 , MgCl 2 free, DPBS) or Dulbecco's phosphate buffered saline containing 0.05 wt% Tween80 Suspended in (CaCl 2 , MgCl 2 free, DPBST) to prepare a bacterial suspension containing about 1 ⁇ 10 7 colony forming units (CFU) / mL of live bacteria. An appropriate amount of each CL care composition was added to the bacterial suspension to adjust the initial concentration to the concentration shown in Table 2, and then stored at 23 ⁇ 1 ° C.
- ⁇ The log value decrease of bacterial count after storage is 1 log or more and less than 2 log relative to the log value of the number of bacteria before storage. ⁇ : There is one or more bacterial species whose log number decrease after storage is less than 1 log relative to the log value of the bacterial number before storage ⁇ : Not evaluated
- Each CL care composition is filled into a PET container (PET content 90% or more, volume 100 mL) 100 mL each and stored under light-shielded conditions for 2 weeks at 60 ° C and 1.5 months at 40 ° C. did. After storage, the presence or absence of cloudiness of the preparation was observed with the naked eye using a black background.
- Polyoxyethylene polyoxypropylene glycol stability measurement method CL care composition (Example 2-3 and Comparative Example 4-5) is filled into a PET container (PET content 90% or more, capacity 100 mL) in 100 mL portions. And stored at 60 ° C. for 2 weeks under light-shielded conditions. After storage, a chromatogram of polyoxyethylene polyoxypropylene glycol was obtained using high performance liquid chromatography, and the change in molecular weight distribution of polyoxyethylene polyoxypropylene glycol was evaluated by comparison with the chromatogram before storage.
- Results Table 3 shows the results of measurement of sterilizing power and appearance properties.
- any of the CL care compositions of Examples 1 to 3 and Comparative Examples 1 to 6 were clear and had no problem in appearance properties immediately after the preparation. Clear cloudiness was observed in the CL care composition. In contrast, the CL care compositions of Examples 1 to 3 maintained a clear appearance without causing cloudiness even after storage.
- the appearance properties after storage at 60 ° C. for 2 weeks were the same as those after storage at 40 ° C. for 1.5 months. That is, from this test result, when the concentration of disodium edetate is 0.02 w / v% or less, even if it contains polyhexanide hydrochloride, poloxamer 407, and hydroxypropyl methylcellulose in combination, white turbidity cannot be prevented. It was confirmed.
- the CL care compositions of Examples 1 to 3 and Comparative Examples 1 to 6 were stored at 60 ° C. for 1 month, even though there was no judgment result immediately after preparation. Later, in the CL care compositions of Comparative Examples 1 to 3 and 6, the bactericidal activity was greatly reduced, the determination result was x, and the bactericidal action was reduced by storage.
- the CL care compositions of Comparative Examples 1 to 3 and 6 are It cannot be put to practical use.
- the CL care compositions of Examples 1 to 3 were able to retain excellent bactericidal power even after storage. In Comparative Examples 4 and 5, since cloudiness occurred after storage, it was not necessary to evaluate the bactericidal power after storage.
- Test Example 2 Evaluation of feeling of use
- ease of rubbing and feeling of wearing The test regarding was conducted by five panelists. Specifically, drop 2 drops of each CL care composition onto the contact lens, rub 20-20 times on both sides of the finger, and lightly contact with 1 to 3 mL of each CL care composition. After rinsing the lens, a contact lens was attached to the eye. In this case, the ease of rubbing and the feeling of wearing were evaluated by the VAS method (visual analogue scale method).
- the evaluation axis of the VAS method is that “Ease of scrubbing” is 0 points (0 cm) at the left end on the 10 cm scale, which is the most difficult to scrub. The most easily rubbed state was 10 points (10 cm). On that basis, the “ease of scrubbing”, which seems to be equivalent for each test solution, was evaluated by a method of freely writing on the scale. Similarly, with regard to “wearing feeling”, 0 points (0 cm) for “the worst wearing feeling expected” at the left end on the 10 cm scale, “the best wearing feeling expected” was 10 points (10 cm). On that basis, the points of “wearing feeling” considered to be equivalent for each test solution were evaluated by a method of freely writing on the scale.
- Test Example 3 Evaluation of Contact Lens Hardness Change due to Drying
- a contact lens (group IV water content 58%, material: Etafilcon A) was immersed in a physiological saline solution and the CL care composition of Example 2 or 3 for 15 hours. Thereafter, the contact lens was taken out, wiped off excess water, and allowed to stand at room temperature for 30 minutes.
- the hardness of the contact lens was measured using a Bubble Tester T-1T (manufactured by TECHNO HASHIMOTO Co., Ltd) under the following conditions.
- Example 4-31 A contact lens disinfectant / cleaning / preserving agent (multipurpose solution) (Example 4-31) was prepared according to the formulations shown in Tables 6-9.
- Example 4-17 Immediately after preparation, the contact lens disinfection / cleaning / preservative of Example 4-17 was filled into a PET container (PET content 90% or more, capacity 500 mL) in a volume of 500 mL, and a cap was applied. Stored for a week. After storage, under the same conditions as in Test Examples 1 and 2, the bactericidal power, appearance properties, polyoxyethylene polyoxypropylene glycol stability, and usability were evaluated. Immediately after the preparation, the change in the contact lens due to drying was evaluated under the same conditions as in Test Example 3.
- PET container PET content 90% or more, capacity 500 mL
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Abstract
Description
項1-1. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を含有することを特徴とする、コンタクトレンズケア用組成物。
項1-2. (A)成分として、下記一般式(1)で示される化合物及びその塩からなる群より選択される少なくとも1種を含む、項1-1に記載のコンタクトレンズケア用組成物。 That is, this invention provides the composition for contact lens care of the following aspect, the contact lens care article using the same, and the processing method of a contact lens.
Item 1-1. (A) at least one selected from the group consisting of polyhexanide and its salt, (B) at least one selected from the group consisting of (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and its salt, and (D) A composition for contact lens care, comprising 0.04 to 0.2 w / v% of at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof.
Item 1-2. Item 10. The contact lens care composition according to Item 1-1, comprising as component (A) at least one selected from the group consisting of a compound represented by the following general formula (1) and a salt thereof.
項1-4. (A)成分として、ポリヘキサニドの塩酸塩を含む、項1-1乃至1-3のいずれかに記載のコンタクトレンズケア用組成物。
項1-5. (A)成分の含有割合が、0.00005~0.00012w/v%である、項1-1乃至1-4のいずれかに記載のコンタクトレンズケア用組成物。
項1-6. (B)成分として、ポロクサマー407を含む、項1-1乃至1-5のいずれかに記載のコンタクトレンズケア用組成物。
項1-7. (B)成分の含有割合が、0.01~0.5w/v%である、項1-1乃至1-6のいずれかに記載のコンタクトレンズケア用組成物。
項1-8. (C)成分として、ヒドロキシプロピルメチルセルロースを含む、項1-1乃至1-7のいずれかに記載のコンタクトレンズケア用組成物。
項1-9. (C)成分の含有割合が、0.01~0.5w/v%である、項1-1乃至1-8のいずれかに記載のコンタクトレンズケア用組成物。
項1-10. (D)成分として、エチレンジアミン四酢酸及びその塩よりなる群から選択される少なくとも1種を含む、項1-1乃至1-9のいずれかに記載のコンタクトレンズケア用組成物。
項1-11. 更に、(E)ホウ酸緩衝剤を含有する、項1-1乃至1-10のいずれかに記載のコンタクトレンズケア用組成物。
項1-12. 更に、(F)塩化ナトリウム及び塩化カリウムよりなる群から選択される少なくとも1種を含有する、項1-1乃至1-11のいずれかに記載のコンタクトレンズケア用組成物
項1-13. 更に、(E)ホウ酸緩衝剤、並びに(F)塩化ナトリウム及び塩化カリウムよりなる群から選択される少なくとも1種を含有し、(F)成分の総量100重量部に対して(E)成分が総量で100重量部以上の比率を充足する、項1-1乃至1-12のいずれかに記載のコンタクトレンズケア用組成物。
項1-14. 更に、(G)モノテルペンを含有する、項1-1乃至1-13のいずれかに記載のコンタクトレンズケア用組成物。
項1-15. pHが6.0~8.0である、項1-1乃至1-14のいずれかに記載のコンタクトレンズケア用組成物。
項1-16. コンタクトレンズ消毒・洗浄・保存液(マルチパーパスソリューション)である、項1-1乃至1-15のいずれかに記載のコンタクトレンズケア用組成物。
項1-17. ソフトコンタクトレンズに適用される、項1-1乃至1-16のいずれかに記載のコンタクトレンズケア用組成物。
項1-18. ソフトコンタクトレンズが、FDAの基準によるソフトコンタクトレンズ分類グループIVに属するレンズである、項1-17に記載のコンタクトレンズケア用組成物。
項1-19. 項1-1乃至1-18のいずれかに記載のコンタクトレンズケア用組成物が、容器に充填されてなる、コンタクトレンズケア用品。
項1-20. 容器が、ポリエステル系樹脂を構成樹脂とするプラスチック製容器である、項1-19に記載のコンタクトレンズケア用品。
項1-21. 容器がポリエチレンテレフタレートを構成樹脂とするプラスチック製容器である、項1-19又は1-20のいずれかに記載のコンタクトレンズケア用品。
項1-22. 項1-1乃至1-18のいずれかに記載のコンタクトレンズケア用組成物に、コンタクトレンズを1分間以上浸漬することを特徴とする、コンタクトレンズの処理方法。 Item 1-3. Item 1. The contact lens care composition according to Item 1-2, wherein in Formula (1), R 1 is an amino group, and R 2 is a group represented by Formula (2).
Item 1-4. Item 4. The contact lens care composition according to any one of Items 1-1 to 1-3, which contains polyhexanide hydrochloride as the component (A).
Item 1-5. Item 5. The contact lens care composition according to any one of Items 1-1 to 1-4, wherein the content of component (A) is 0.00005 to 0.00012 w / v%.
Item 1-6. Item 6. The contact lens care composition according to any one of Items 1-1 to 1-5, which comprises Poloxamer 407 as a component (B).
Item 1-7. Item 7. The contact lens care composition according to any one of Items 1-1 to 1-6, wherein the content of component (B) is 0.01 to 0.5 w / v%.
Item 1-8. Item 8. The contact lens care composition according to any one of Items 1-1 to 1-7, which comprises hydroxypropylmethylcellulose as component (C).
Item 1-9. Item 9. The contact lens care composition according to any one of Items 1-1 to 1-8, wherein the content of component (C) is 0.01 to 0.5 w / v%.
Item 1-10. Item 10. The contact lens care composition according to any one of Items 1-1 to 1-9, wherein the component (D) comprises at least one selected from the group consisting of ethylenediaminetetraacetic acid and salts thereof.
Item 1-11. Item 11. The contact lens care composition according to any one of Items 1-1 to 1-10, further comprising (E) a borate buffer.
Item 1-12. The contact lens care composition according to any one of Items 1-1 to 1-11, further comprising (F) at least one selected from the group consisting of sodium chloride and potassium chloride. Furthermore, it contains at least one selected from the group consisting of (E) borate buffer and (F) sodium chloride and potassium chloride, and (E) component is contained in 100 parts by weight of the total amount of (F) component. Item 13. The contact lens care composition according to any one of Items 1-1 to 1-12, which satisfies a ratio of 100 parts by weight or more in total.
Item 1-14. Item 14. The contact lens care composition according to any one of Items 1-1 to 1-13, further comprising (G) a monoterpene.
Item 1-15. Item 15. The contact lens care composition according to any one of Items 1-1 to 1-14, which has a pH of 6.0 to 8.0.
Item 1-16. Item 15. The contact lens care composition according to any one of Items 1-1 to 1-15, which is a contact lens disinfecting / cleaning / preserving solution (multipurpose solution).
Item 1-17. The contact lens care composition according to any one of Items 1-1 to 1-16, which is applied to a soft contact lens.
Item 1-18. Item 18. The composition for contact lens care according to Item 1-17, wherein the soft contact lens is a lens belonging to soft contact lens classification group IV based on FDA standards.
Item 1-19. Item 15. A contact lens care product comprising a container filled with the contact lens care composition according to any one of Items 1-1 to 1-18.
Item 1-20. Item 20. The contact lens care product according to Item 1-19, wherein the container is a plastic container comprising a polyester resin as a constituent resin.
Item 1-21. Item 20. The contact lens care product according to any one of Items 1-19 and 1-20, wherein the container is a plastic container comprising polyethylene terephthalate as a constituent resin.
Item 1-22. Item 20. A method for treating a contact lens, comprising immersing the contact lens in the contact lens care composition according to any one of items 1-1 to 1-18 for 1 minute or more.
項2-1. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を併用することを特徴とする、ポリヘキサニド及び/又はその塩の殺菌作用の低下を抑制する方法。
項2-2. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種を含有するコンタクトレンズケア用組成物に、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を配合することを特徴とする、ポリヘキサニド及び/又はその塩の殺菌作用の低下を抑制する作用を該コンタクトレンズケア用組成物に付与する方法。 Moreover, this invention provides the effect | action which suppresses the fall of the bactericidal action of polyhexanide and / or its salt hung up below and the bactericidal action of polyhexanide and / or its salt to the composition for contact lens care listed below. Provide a method.
Item 2-1. (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof, and (D) Decreasing the bactericidal action of polyhexanide and / or its salt, characterized by using 0.04 to 0.2 w / v% of at least one selected from the group consisting of ethylenediamineacetic acid, its derivatives, and salts thereof How to suppress.
Item 2-2. (A) A composition for contact lens care containing at least one selected from the group consisting of polyhexanide and a salt thereof, and (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and a salt thereof At least one selected from the group, and (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, 0.04-0.2 w / v%, polyhexanide characterized in that And / or a method of imparting to the composition for contact lens care an action of suppressing a decrease in the bactericidal action of a salt thereof.
項3-1. コンタクトレンズケア用組成物において、(A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を併用することを特徴とする、該コンタクトレンズケア用組成物における白濁を防止する方法。
項3-2. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種を含有するコンタクトレンズケア用組成物に、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を配合することを特徴とする、白濁を防止する作用を該コンタクトレンズケア用組成物に付与する方法。
項3-3. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、並びに(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種を含有するコンタクトレンズケア用組成物に、(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を配合することを特徴とする、白濁を防止する作用を該コンタクトレンズケア用組成物に付与する方法。 Moreover, this invention provides the method of providing the effect | action which prevents the cloudiness to the composition for contact lens care, and the composition for contact lens care which are hung up below.
Item 3-1. In the contact lens care composition, (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof And at least one selected from the group consisting of (D) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% in combination, A method for preventing white turbidity in a care composition.
Item 3-2. (A) A composition for contact lens care containing at least one selected from the group consisting of polyhexanide and a salt thereof, and (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and a salt thereof At least one selected from the group, and (D) 0.04 to 0.2 w / v% selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof, A method for imparting an effect to prevent contact to the composition for contact lens care.
Item 3-3. (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycol and (C) hydroxypropylmethylcellulose and salts thereof The cloudy contact lens care composition contains (D) at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof in an amount of 0.04 to 0.2 w / v%. A method for imparting an effect to prevent contact to the composition for contact lens care.
項4-1. コンタクトレンズケア用組成物において、(A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を併用することを特徴とする、該コンタクトレンズケア用組成物におけるポリオキシエチレンポリオキシプロピレングリコールの低分子化を抑制する方法。
項4-2. (B)ポリオキシエチレンポリオキシプロピレングリコールを含有するコンタクトレンズケア用組成物に、(A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を配合することを特徴とする、ポリオキシエチレンポリオキシプロピレングリコールの低分子化を防止する作用を該コンタクトレンズケア用組成物に付与する方法。 In addition, the present invention provides the following method for suppressing the reduction in molecular weight of polyoxyethylene polyoxypropylene glycol, and the composition for contact lens care, which suppresses the reduction in molecular weight of polyoxyethylene polyoxypropylene glycol. Provide a method.
Item 4-1. In the contact lens care composition, (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof And at least one selected from the group consisting of (D) ethylenediamineacetic acid, a derivative thereof, and a salt thereof, and 0.04 to 0.2 w / v% in combination. A method for suppressing a decrease in molecular weight of polyoxyethylene polyoxypropylene glycol in a care composition.
Item 4-2. (B) a composition for contact lens care containing polyoxyethylene polyoxypropylene glycol, comprising (A) at least one selected from the group consisting of polyhexanide and its salt, and (C) hydroxypropylmethylcellulose and its salt Characterized by blending at least one selected from the group and 0.04 to 0.2 w / v% selected from the group consisting of (D) ethylenediamineacetic acid, derivatives thereof, and salts thereof, A method of imparting an effect of preventing molecular weight reduction of oxyethylene polyoxypropylene glycol to the composition for contact lens care.
項5-1. (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を含有するコンタクトレンズケア用組成物を用いて、コンタクトレンズを処理することを特徴とする、乾燥によるコンタクトレンズの硬度の上昇を抑制する方法。
項5-2. コンタクトレンズケア用組成物に、(A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を配合することを特徴とする、乾燥によるコンタクトレンズの硬度の上昇を抑制する作用を該コンタクトレンズケア用組成物に付与する方法。 Furthermore, the present invention provides the following methods for suppressing the increase in contact lens hardness due to drying, and methods for imparting the contact lens care composition with the effect of suppressing the increase in contact lens hardness due to drying.
Item 5-1. (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof, and (D) treating the contact lens with a contact lens care composition containing 0.04 to 0.2 w / v% selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof. A method for suppressing an increase in hardness of a contact lens due to drying.
Item 5-2. The composition for contact lens care includes at least one selected from the group consisting of (A) polyhexanide and a salt thereof, (B) polyoxyethylene polyoxypropylene glycol, (C) a group consisting of hydroxypropylmethylcellulose and a salt thereof. Contact by drying, characterized in that it comprises at least one selected from the group consisting of (D) ethylenediamineacetic acid, its derivatives, and salts thereof, and 0.04 to 0.2 w / v% A method for imparting an effect of suppressing an increase in lens hardness to the contact lens care composition.
本発明のコンタクトレンズケア用組成物(以下、CLケア用組成物と表記することもある)は、ポリヘキサニド及びその塩からなる群より選択される少なくとも1種(以下、(A)成分と表記することもある)を含有する。 1. Contact Lens Care Composition The contact lens care composition of the present invention (hereinafter sometimes referred to as CL care composition) is at least one selected from the group consisting of polyhexanide and salts thereof (hereinafter, ( A) (sometimes referred to as component).
かかる含水率はISO18369-4:2006の記載に従って、重量測定方法により測定され得る。 Moisture content (%) = (weight of water contained / weight of soft contact lens in water content) x 100
Such moisture content can be measured by a gravimetric method according to the description of ISO18369-4: 2006.
コンタクトレンズを洗浄する場合:コンタクトレンズに1~10滴、好ましくは2~4滴の本発明のCLケア用組成物を滴下し、両面各々20~30回程度指でこすり洗いした後に、1~20mL、好ましくは1~5mL程度の本発明のCLケア用組成物ですすぎを行う。
コンタクトレンズを消毒・保存する場合:コンタクトレンズ1枚を、0.5~5mL、好ましくは1~3mLの本発明のCLケア用組成物に浸漬して、1分以上、好ましくは10分以上、更に好ましくは4時間以上保存する。コンタクトレンズを本発明のCLケア用組成物に浸漬する際に用いるレンズケースの種類については特に制限されないが、プラスチック製レンズケースが好適である。このようなレンズケースを構成する樹脂としては、熱可塑性樹脂が好ましい。熱可塑性樹脂としては、ポリエチレン、ポリプロピレン等のオレフィン系樹脂、アクリロニトリルブタジエンスチレン共重合体(ABS樹脂)のようなアクリロニトリル-スチレン共重合体(AS樹脂)等のスチレン系樹脂等が挙げられる。 A method for performing treatment such as cleaning, disinfection and storage of the contact lens using the CL care composition of the present invention is not particularly limited, but the following embodiment is exemplified as a preferred example.
When cleaning a contact lens : 1 to 10 drops, preferably 2 to 4 drops of the CL care composition of the present invention is dropped onto the contact lens and rubbed with fingers about 20 to 30 times on each side, and then 1 to Rinse with 20 mL, preferably about 1 to 5 mL of the CL care composition of the present invention.
When disinfecting and preserving contact lenses : 1 contact lens is immersed in 0.5 to 5 mL, preferably 1 to 3 mL of the CL care composition of the present invention for 1 minute or more, preferably 10 minutes or more, more preferably Store for more than 4 hours. The type of lens case used when the contact lens is immersed in the CL care composition of the present invention is not particularly limited, but a plastic lens case is preferable. As the resin constituting such a lens case, a thermoplastic resin is preferable. Examples of the thermoplastic resin include olefin resins such as polyethylene and polypropylene, and styrene resins such as acrylonitrile-styrene copolymer (AS resin) such as acrylonitrile butadiene styrene copolymer (ABS resin).
これに対して、本発明のCLケア用組成物によれば、ポリエステル系樹脂、特にPETを構成樹脂とする容器に収容しても、このような懸念を払拭して、CLケア用組成物の殺菌作用を安定に保持させ、更には経時的に白濁が生じることなく外観性状を安定に保持することができる。かかる観点に鑑みれば、本発明のCLケア用組成物を収容する容器の好適な一例として、ポリエステル系樹脂製容器、好ましくはPET製容器を挙げることができる。PET製容器としては、PETを樹脂全体の50重量%以上、好ましくは70重量%以上、より好ましくは90重量%以上含有していればよい。 Among the thermoplastic resins described above, a container comprising a polyester resin, particularly PET, tends to attenuate the bactericidal action of polyhexanide and / or its salt over time, and further, polyhexanide and / or its salt is used. The contact lens care composition containing the composition tends to cause white turbidity over time, and also tends to cause a low molecular weight polyoxyethylene polyoxypropylene glycol.
On the other hand, according to the CL care composition of the present invention, even if it is accommodated in a container having a polyester resin, particularly PET as a constituent resin, such concerns are eliminated, and the CL care composition The bactericidal action can be stably maintained, and furthermore, the appearance can be stably maintained without causing white turbidity over time. In view of this viewpoint, a polyester resin container, preferably a PET container, can be mentioned as a suitable example of a container for housing the CL care composition of the present invention. The PET container may contain PET in an amount of 50% by weight or more, preferably 70% by weight or more, more preferably 90% by weight or more of the total resin.
前述するように、上記(A)~(C)成分と共に、特定の含有割合の(D)成分を一体として含有することによって、CLケア用組成物において、ポリヘキサニド及び/又はその塩の殺菌作用を経時的に低減させることなく、安定に保持させることができる。 2. Method for suppressing the decrease in the bactericidal action of polyhexanide and / or its salt; Method for imparting the action for suppressing the decrease in the bactericidal action of polyhexanide and / or its salt to the CL care composition As described above, (A) to (A) By containing the component (D) in a specific content ratio together with the component (C), the CL care composition can be stably maintained without reducing the bactericidal action of polyhexanide and / or its salt over time. Can be made.
前述するように、上記(A)~(C)成分と共に、特定の含有割合の(D)成分を一体として含有することによって、CLケア用組成物において、経時的な白濁の発生を防止又は抑制して、外観性状を良好に保つことができる。 3. Method for preventing white turbidity of CL care composition; Method for imparting action to prevent white turbidity in CL care composition As described above, together with the above components (A) to (C), component (D) having a specific content ratio In the composition for CL care, the appearance properties can be kept good by preventing or suppressing the occurrence of white turbidity over time.
前述するように、上記(A)~(C)成分と共に、特定の含有割合の(D)成分を一体として含有することによって、(B)成分が経時的に低分子化するのを抑制することができる。 4). Method for inhibiting polyoxyethylene polyoxypropylene glycol molecular weight reduction; Method for imparting an action of inhibiting molecular weight reduction of polyoxyethylene polyoxypropylene glycol to a composition for CL care As described above, (A) to (A By containing the component (D) with a specific content ratio together with the component (C), it is possible to suppress the component (B) from decreasing in molecular weight over time.
前述するように、上記(A)~(C)成分と共に、特定の含有割合の(D)成分を一体として含有するCLケア用組成物でコンタクトレンズを処理することによって、乾燥によるコンタクトレンズの硬度の上昇を抑制でき、乾燥した雰囲気に晒されてもコンタクトレンズの柔軟性を保持させることが可能になる。 5. Method for suppressing increase in hardness of contact lens due to drying; Method for imparting an effect of suppressing increase in hardness of contact lens due to drying to a composition for CL care As described above, together with the components (A) to (C), By treating the contact lens with a CL care composition containing a specific component (D) as a single component, the contact lens can be prevented from increasing in hardness due to drying, and even when exposed to a dry atmosphere, the contact lens It becomes possible to maintain the flexibility of the.
表1に示す組成のCLケア用組成物を調製し、下記の方法に従って、保存前後の殺菌力、製剤の性状外観、ポリオキシエチレンポリオキシプロピレングリコールの安定性を評価した。 Test Example 1: Evaluation of bactericidal power before and after storage, appearance properties, etc. A CL care composition having the composition shown in Table 1 was prepared, and according to the following method, bactericidal power before and after storage, appearance of properties of the preparation, polyoxyethylene poly The stability of oxypropylene glycol was evaluated.
各CLケア用組成物をPET製容器(PET含有量90%以上、容量100mL)に100mLずつ充填し、キャップを施した上で60℃にて1ヶ月間保存した。これら60℃1ヶ月保存後及び保存前(調製直後)のCLケア用組成物を用いて、ISO14729の試験方法に従い、殺菌力試験を実施した。具体的にはISO14729で定められる細菌3菌種に1菌種を加えた4菌種(Staphylococcus aureus ATCC 6538、Pseudomonas aeruginosa ATCC9027、 Serratia marcescens ATCC13880、Escherichia coli ATCC 8739)及び真菌2菌種(Candida albicans ATCC10231, Fusarium solani ATCC36031)を用いて実施した。具体的には、細菌をトリプトソイ寒天(TSA)培地で、真菌をサブロー・デキストロース寒天(SDA)培地で混釈し、寒天が固化した後、細菌は32.5℃で48時間、真菌は22.5℃で72時間培養して発育する集落を計数した。培養菌体を白金耳で無菌的に採取し、適量の滅菌ダルベッコのリン酸緩衝生理食塩液(CaCl2,MgCl2不含有,DPBS)または0.05重量%Tween80を含むダルベッコのリン酸緩衝生理食塩液(CaCl2,MgCl2不含有,DPBST)に浮遊させて、約1×107コロニー形成単位(CFU)/mLの生菌を含む菌浮遊液を調製した。この菌浮遊液に対して、各CLケア用組成物を適量添加して、初期濃度が表2の濃度となるように調整した後に23±1℃で保存した。 1. Method of measuring bactericidal power before and after storage Each CL care composition was filled into a PET container (PET content 90% or more, volume 100 mL) 100 mL each, and the cap was capped and stored at 60 ° C. for 1 month. . Using these CL care compositions after 1 month storage at 60 ° C. and before storage (immediately after preparation), a bactericidal activity test was performed according to the test method of ISO14729. Specifically, 4 bacterial species (Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC9027, Serratia marcescens ATCC13880, Escherichia coli ATCC 8739) and 2 fungal species (Candida albicans ATCC10231) , Fusarium solani ATCC36031). Specifically, the bacteria were mixed with trypsoy agar (TSA) medium and the fungus with Sabouraud dextrose agar (SDA) medium. After the agar solidified, the bacteria were 48 hours at 32.5 ° C, and the fungi were 72 ° C at 22.5 ° C. The colonies that grew in time culture were counted. Cultured cells are aseptically collected with a platinum loop and an appropriate amount of sterile Dulbecco's phosphate buffered saline (CaCl 2 , MgCl 2 free, DPBS) or Dulbecco's phosphate buffered saline containing 0.05 wt% Tween80 Suspended in (CaCl 2 , MgCl 2 free, DPBST) to prepare a bacterial suspension containing about 1 × 10 7 colony forming units (CFU) / mL of live bacteria. An appropriate amount of each CL care composition was added to the bacterial suspension to adjust the initial concentration to the concentration shown in Table 2, and then stored at 23 ± 1 ° C.
<判定基準>
細菌に対する殺菌力の判定基準
○:保存前の菌数のlog値に対して保存後の菌数のlog値減少が全ての菌種で4log以上である
△:保存前の菌数のlog値に対して保存後の菌数のlog値減少が3log以上4log未満の菌種が1以上ある
×:保存前の菌数のlog値に対して保存後の菌数のlog値減少が3log未満の菌種が1以上ある
-:評価せず
真菌に対する殺菌力の判定基準
◎:保存前の菌数のlog値に対して保存後の菌数のlog値減少が全ての菌種で3log以上である
○:保存前の菌数のlog値に対して保存後の菌数のlog値減少が2log以上3log未満の菌種が1以上ある
△:保存前の菌数のlog値に対して保存後の菌数のlog値減少が1log以上2log未満の菌種が1以上ある
×:保存前の菌数のlog値に対して保存後の菌数のlog値減少が1log未満の菌種が1以上ある
-:評価せず For each CL care composition, the number of viable bacteria per mL after 4 hours of storage was measured. The bactericidal power against each bacterium was evaluated from the measured viable count according to the following criteria.
<Criteria>
Judgment criteria for bactericidal activity against bacteria ○: The log value of the number of bacteria after storage is 4 log or more in all bacterial species with respect to the log value of the number of bacteria before storage Δ: The log value of the number of bacteria before storage On the other hand, there is one or more bacterial species whose log value reduction after storage is 3 log or more and less than 4 log ×: Bacteria whose log value reduction after storage is less than 3 log relative to the log value of the number of bacteria before storage There is more than one species-: not evaluated
Judgment criteria for fungicidal activity against fungi ◎: The log value decrease in the number of bacteria after storage is more than 3 logs in all bacterial species compared to the log value of the number of bacteria before storage ○: The log value of the number of bacteria before storage On the other hand, there is one or more bacterial species whose log number decrease after storage is 2 log or more and less than 3 log. Δ: The log value decrease of bacterial count after storage is 1 log or more and less than 2 log relative to the log value of the number of bacteria before storage. ×: There is one or more bacterial species whose log number decrease after storage is less than 1 log relative to the log value of the bacterial number before storage −: Not evaluated
各CLケア用組成物をPET製容器(PET含有量90%以上、容量100mL)に100mLずつ充填し、60℃で2週間及び40℃で1.5ヶ月間、遮光条件下で保存した。保存後、製剤の白濁の有無について黒色背景を用いて肉眼で観察した。 2. Measuring method of appearance properties Each CL care composition is filled into a PET container (PET content 90% or more, volume 100 mL) 100 mL each and stored under light-shielded conditions for 2 weeks at 60 ° C and 1.5 months at 40 ° C. did. After storage, the presence or absence of cloudiness of the preparation was observed with the naked eye using a black background.
CLケア用組成物(実施例2-3及び比較例4-5)をPET製容器(PET含有量90%以上、容量100mL)に100mLずつ充填し、60℃で2週間、遮光条件下で保存した。保存後、高速液体クロマトグラフィーを用いて、ポリオキシエチレンポリオキシプロピレングリコールのクロマトグラムを得、保存前のクロマトグラムと比較し、ポリオキシエチレンポリオキシプロピレングリコールの分子量分布の変化を評価した。 3. Polyoxyethylene polyoxypropylene glycol stability measurement method CL care composition (Example 2-3 and Comparative Example 4-5) is filled into a PET container (PET content 90% or more, capacity 100 mL) in 100 mL portions. And stored at 60 ° C. for 2 weeks under light-shielded conditions. After storage, a chromatogram of polyoxyethylene polyoxypropylene glycol was obtained using high performance liquid chromatography, and the change in molecular weight distribution of polyoxyethylene polyoxypropylene glycol was evaluated by comparison with the chromatogram before storage.
殺菌力及び外観性状の測定結果を表3に示す。 3. Results Table 3 shows the results of measurement of sterilizing power and appearance properties.
表4に示す実施例2及び比較例7のCLケア用組成物(製造直後)を用いて、使用感を評価するために、こすり洗いのし易さ及び装着感に関する試験を5名のパネラーにて実施した。具体的には、コンタクトレンズに各CLケア用組成物2滴を滴下し、指の腹で両面各々20回~30回のこすり洗いを行い、軽く1~3mLの各CLケア用組成物でコンタクトレンズをすすいだ後に、コンタクトレンズを目に装着した。その際のこすり洗いのし易さ、及び装着感について、VAS法(visual analogue scale法)で評価した。 Test Example 2: Evaluation of feeling of use In order to evaluate the feeling of use using the compositions for CL care of Example 2 and Comparative Example 7 shown in Table 4 (immediately after production), ease of rubbing and feeling of wearing The test regarding was conducted by five panelists. Specifically, drop 2 drops of each CL care composition onto the contact lens, rub 20-20 times on both sides of the finger, and lightly contact with 1 to 3 mL of each CL care composition. After rinsing the lens, a contact lens was attached to the eye. In this case, the ease of rubbing and the feeling of wearing were evaluated by the VAS method (visual analogue scale method).
表1に示す実施例2及び3のCLケア用組成物(製造直後)を用いて、乾燥によるコンタクトレンズの硬度変化を評価するために、以下の試験を実施した。具体的には、コンタクトレンズ(グループIV 含水率58%、素材:Etafilcon A)を、生理食塩液、実施例2又は3のCLケア用組成物に15時間浸漬した。その後、コンタクトレンズを取り出し、余分な水分を拭き取った後に、30分間室温で放置した。次いで、コンタクトレンズの硬度を、Bubble Tester T-1T(TECHNO HASHIMOTO Co., Ltd製)を用いて下記の条件にて測定した。
<硬度の測定条件>
・サイクル試験(サイクル回数1)
・往復幅:10mm
・移動速度:10mm/s
・加速速度:0.1G
・開始位置:190mm。 Test Example 3: Evaluation of Contact Lens Hardness Change due to Drying In order to evaluate the contact lens hardness change due to drying using the CL care compositions of Examples 2 and 3 shown in Table 1 (immediately after production), The test was conducted. Specifically, a contact lens (group IV water content 58%, material: Etafilcon A) was immersed in a physiological saline solution and the CL care composition of Example 2 or 3 for 15 hours. Thereafter, the contact lens was taken out, wiped off excess water, and allowed to stand at room temperature for 30 minutes. Next, the hardness of the contact lens was measured using a Bubble Tester T-1T (manufactured by TECHNO HASHIMOTO Co., Ltd) under the following conditions.
<Measurement conditions for hardness>
・ Cycle test (cycle number 1)
-Round trip width: 10mm
・ Movement speed: 10mm / s
・ Acceleration speed: 0.1G
・ Start position: 190mm.
Claims (8)
- (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を含有することを特徴とする、コンタクトレンズケア用組成物。 (A) at least one selected from the group consisting of polyhexanide and its salt, (B) at least one selected from the group consisting of (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and its salt, and (D) A composition for contact lens care, comprising 0.04 to 0.2 w / v% of at least one selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof.
- (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を含有することを特徴とする、コンタクトレンズケア用水性組成物。 (A) at least one selected from the group consisting of polyhexanide and its salt, (B) at least one selected from the group consisting of (B) polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and its salt, and (D) An aqueous composition for contact lens care, comprising 0.04 to 0.2 w / v% selected from the group consisting of ethylenediamineacetic acid, derivatives thereof, and salts thereof.
- 更に、(E)ホウ酸緩衝剤、並びに(F)塩化ナトリウム及び塩化カリウムよりなる群から選択される少なくとも1種を含有し、(E)成分の総量100重量部に対して(F)成分が総量で100重量部以上の比率を充足する、請求項1又は2に記載のコンタクトレンズケア用組成物。 Furthermore, it contains at least one selected from the group consisting of (E) borate buffer, and (F) sodium chloride and potassium chloride, and (F) component is contained in 100 parts by weight of the total amount of (E) component. The composition for contact lens care according to claim 1 or 2, which satisfies a ratio of 100 parts by weight or more in total amount.
- (B)成分の含有割合が、0.01~0.5w/v%である、請求項1~3のいずれかに記載のコンタクトレンズケア用組成物。 The contact lens care composition according to any one of claims 1 to 3, wherein the content ratio of the component (B) is 0.01 to 0.5 w / v%.
- (A)成分の含有割合が、0.00005~0.00012w/v%である、請求項1~4のいずれかに記載のコンタクトレンズケア用組成物。 The composition for contact lens care according to any one of claims 1 to 4, wherein the content ratio of the component (A) is 0.00005 to 0.00012 w / v%.
- 更に、(G)モノテルペンを含有する、請求項1~5のいずれかに記載のコンタクトレンズケア用組成物。 The contact lens care composition according to any one of claims 1 to 5, further comprising (G) a monoterpene.
- 請求項1~6のいずれかに記載のコンタクトレンズケア用組成物が、ポリエステル系を構成樹脂とするプラスチック製容器に充填されてなる、コンタクトレンズケア用品。 A contact lens care product, wherein the contact lens care composition according to any one of claims 1 to 6 is filled in a plastic container comprising a polyester resin.
- (A)ポリヘキサニド及びその塩よりなる群から選択される少なくとも1種、(B)ポリオキシエチレンポリオキシプロピレングリコール、(C)ヒドロキシプロピルメチルセルロース及びその塩よりなる群から選択される少なくとも1種、並びに(D)エチレンジアミン酢酸、その誘導体、及びそれらの塩よりなる群から選択される少なくとも1種0.04~0.2w/v%を併用することを特徴とする、ポリヘキサニド及び/又はその塩の殺菌作用の低下を抑制する方法。 (A) at least one selected from the group consisting of polyhexanide and salts thereof, (B) at least one selected from the group consisting of polyoxyethylene polyoxypropylene glycol, (C) hydroxypropylmethylcellulose and salts thereof, and (D) Decreasing the bactericidal action of polyhexanide and / or its salt, characterized by using 0.04 to 0.2 w / v% of at least one selected from the group consisting of ethylenediamineacetic acid, its derivatives, and salts thereof How to suppress.
Priority Applications (3)
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CN201180029189.1A CN102959458B (en) | 2010-07-06 | 2011-07-06 | Composition for contact lens care |
JP2012523908A JPWO2012005311A1 (en) | 2010-07-06 | 2011-07-06 | Contact lens care composition |
HK13109675.8A HK1182458A1 (en) | 2010-07-06 | 2013-08-20 | Composition for contact lens care |
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CN (1) | CN102959458B (en) |
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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 |
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JP2021130007A (en) | 2021-09-09 |
CN102959458B (en) | 2014-10-08 |
HK1182458A1 (en) | 2013-11-29 |
JP2018022170A (en) | 2018-02-08 |
JP2019202164A (en) | 2019-11-28 |
JP2016194704A (en) | 2016-11-17 |
JP6232475B2 (en) | 2017-11-15 |
JPWO2012005311A1 (en) | 2013-09-05 |
CN102959458A (en) | 2013-03-06 |
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