WO2012005311A1 - Composition for contact lens care - Google Patents

Composition for contact lens care Download PDF

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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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WO
WIPO (PCT)
Prior art keywords
contact lens
composition
group
component
care composition
Prior art date
Application number
PCT/JP2011/065517
Other languages
French (fr)
Japanese (ja)
Inventor
紗衣子 林
Original Assignee
ロート製薬株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45441288&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2012005311(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ロート製薬株式会社 filed Critical ロート製薬株式会社
Priority to CN201180029189.1A priority Critical patent/CN102959458B/en
Priority to JP2012523908A priority patent/JPWO2012005311A1/en
Publication of WO2012005311A1 publication Critical patent/WO2012005311A1/en
Priority to HK13109675.8A priority patent/HK1182458A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L12/00Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
    • A61L12/08Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
    • A61L12/14Organic compounds not covered by groups A61L12/10 or A61L12/12
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION 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
    • A01N47/00Biocides, 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
    • A01N47/40Biocides, 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
    • A01N47/42Biocides, 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
    • A01N47/44Guanidine; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/04Artificial tears; Irrigation solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local 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

Disclosed is a composition for contact lens care, which is capable of effectively exhibiting the bactericidal effect of a polihexanide and/or a salt thereof even after storage and is also capable of maintaining excellent appearance without suffering from white turbidity over time. Specifically disclosed is a composition for contact lens care, which is prepared by combining and blending (A) at least one substance selected from the group consisting of polihexanides and salts thereof, (B) a polyoxyethylene polyoxypropylene glycol, (C) at least one substance selected from the group consisting of hydroxypropyl methylcellulose and salts thereof and (D) 0.04-0.2 w/v% of at least one substance selected from the group consisting of ethylenediamine acetic acid, derivatives thereof, and salts of ethylenediamine acetic acid or the derivatives.

Description

コンタクトレンズケア用組成物Contact lens care composition
 本発明は、コンタクトレンズケア用組成物に関する。詳細には、本発明は、保存後でも、ポリヘキサニド及び/又はその塩の殺菌作用を有効に発揮でき、更には白濁が生じずに優れた外観性状を保持できるコンタクトレンズケア用組成物に関する。 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.
 コンタクトレンズ(以下、単にCL、または単にレンズと表記することもある)は、眼鏡に比べて、視野が広い、像の歪みが少ない、裸眼時と顔の印象が変わらない等の利点があり、今日では多くの人がコンタクトレンズを装用している。その反面、コンタクトレンズは、装用中又は保存中に微生物と接触し易い環境に晒され、微生物の温床になり易く、汚染され易いという欠点がある。例えば、装用中には、外界から眼に入った微生物や眼粘膜に存在する微生物、脱着時には手指上の微生物、保存時にはコンタクトレンズケース内で繁殖した微生物がコンタクトレンズに付着することもある。 Contact lenses (hereinafter simply referred to as “CL” or simply “lens”) 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. For example, during wearing, microorganisms that have entered the eye from the outside, microorganisms present in the ocular mucosa, microorganisms on the fingers during attachment / detachment, and microorganisms that have propagated in the contact lens case during storage may adhere to the contact lens.
 コンタクトレンズに付着した微生物は、コンタクトレンズの装用感を悪化させることがあり、更にはそれが病原性微生物である場合には、眼感染症の一因にもなりかねない。また、結膜常在微生物の多くは非病原性であるが、コンタクトレンズに過剰に微生物が付着すると、付着した微生物から分泌される菌体外物質によりコンタクトレンズ表面にバイオフィルムが形成され、病原性微生物の温床となる危険性があり、眼感染症のリスクを高めることになる。 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.
 そのため、コンタクトレンズは、洗浄や消毒等のレンズケアによって、微生物の付着がない清潔な状態を維持することが不可欠である。 Therefore, it is indispensable to maintain the contact lens in a clean state free from microorganisms by lens care such as cleaning and disinfection.
 従来、コンタクトレンズの洗浄や消毒をするために、殺菌剤を配合したコンタクトレンズケア用組成物が使用されている。コンタクトレンズケア用組成物の中でも、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)は、コンタクトレンズを介して角膜に直接接触する製剤であることから、配合される殺菌剤は高い安全性を備えていることが肝要とされている。 Conventionally, a contact lens care composition containing a bactericide is used to clean and disinfect contact lenses. Among contact lens care compositions, contact lens disinfectant / cleaning / preserving 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.
 一方、ポリヘキサニド及び/又はその塩は、殺菌作用に加えて、高い生体適合性を有しており、コンタクトレンズケア用組成物(とりわけ、コンタクトレンズ消毒・洗浄・保存液)への配合に適した殺菌剤と考えられている。従来、ポリヘキサニド及び/又はその塩を配合したコンタクトレンズケア用組成物の処方も報告されている(特許文献1-2参照)。しかしながら、ポリヘキサニド及び/又はその塩を配合したコンタクトレンズケア用組成物において、保存後でも殺菌作用を損なうことなく有効に発揮させるための技術や製剤的な安定性を備えさせるための技術については、十分に検討がなされていないのが現状である。 On the other hand, 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. Conventionally, a formulation for a contact lens care composition containing polyhexanide and / or a salt thereof has also been reported (see Patent Document 1-2). However, in 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.
特表2007-532544号公報Special table 2007-532544 gazette 特表2001-504245号公報JP-T-2001-504245
 本発明者は、ポリヘキサニド及び/又はその塩を含むコンタクトレンズケア用組成物の開発を目的として種々の検討を重ねたところ、他の配合成分の種類や含有量によっては、保存後に、ポリヘキサニド及び/又はその塩による殺菌作用が減弱して、所期の消毒効果を有効に発揮できず、更には経時的に白濁が生じる場合があることを見出した。コンタクトレンズケア用組成物は、製造から流通の段階のみならず、消費者の手元での保管、使用開始、使用終了に至るまでに、長期間保存される。そのため、製造直後のみならず経時的にも殺菌作用が安定に保持され、白濁等の変化が生じないことが当然に望まれる。このような背景の下、ポリヘキサニド及び/又はその塩を含むコンタクトレンズケア用組成物を製剤設計する上で、保存後でも、ポリヘキサニド及び/又はその塩による殺菌作用を損なうことなく有効に発揮させ、且つ白濁等が生じることのない優れた製剤を提供する技術の開発が必要とされる。 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 | damps, it discovered that the desired disinfection effect was not able to be exhibited effectively, and also white turbidity may arise with time. 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. Under such a background, when designing a contact lens care composition containing polyhexanide and / or a salt thereof, even after storage, the composition is effectively exhibited without impairing the bactericidal action of polyhexanide and / or a salt thereof, In addition, it is necessary to develop a technique for providing an excellent preparation that does not cause white turbidity.
 そこで、本発明は、保存後でも、ポリヘキサニド及び/又はその塩による殺菌作用を有効に発揮でき、且つ経時的に白濁等の外観性状の変化が生じないコンタクトレンズケア用組成物を提供することを目的とする。 Therefore, 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.
 本発明者は、上記課題を解決すべく鋭意検討を行ったところ、驚くべきことに、コンタクトレンズケア用組成物中に、ポリヘキサニド及び/又はその塩と共に、ポリオキシエチレンポリオキシプロピレングリコール、ヒドロキシプロピルメチルセルロース及び/又はその塩、並びに0.04~0.2w/v%のエチレンジアミン四酢酸及び/又はその塩を組み合わせて配合することによって、保存後でも、ポリヘキサニド及び/又はその塩による殺菌作用を有効に発揮させることができ、しかも経時的に白濁を生じさせることなく優れた外観性状を保ち得ることを見出した。更に、本発明者は、上記配合成分を組み合わせて含有するコンタクトレンズケア用組成物では、ポリオキシエチレンポリオキシプロピレングリコールが低分子化し難く、安定であることをも見出した。また、本発明者は、上記配合成分を組み合わせて含有するコンタクトレンズケア用組成物は、コンタクトレンズを擦り洗いし易く、また、当該組成物でコンタクトレンズを処理すると、コンタクトレンズの装着感も良好であり、優れた使用感を備えていることを見出した。また更に、本発明者は、上記配合成分を組み合わせて含有するコンタクトレンズケア用組成物でコンタクトレンズを処理すると、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できることをも見出した。本発明は、これらの知見に基づいて、更に検討を重ねることにより完成したものである。 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. Furthermore, 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.
 即ち、本発明は、下記態様のコンタクトレンズケア用組成物、これを用いたコンタクトレンズケア用品、及びコンタクトレンズの処理方法を提供する。
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.
Figure JPOXMLDOC01-appb-C000001
Figure JPOXMLDOC01-appb-C000001
[式(1)中、R1及びR2は、同一又は異なって、下記一般式(2)に示される基又はアミノ基であり、nは1~500の整数を示す。] [In Formula (1), 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. ]
Figure JPOXMLDOC01-appb-C000002
Figure JPOXMLDOC01-appb-C000002
項1-3. 式(1)中、R1はアミノ基であり、且つR2は一般式(2)に示される基である、項1-2に記載のコンタクトレンズケア用組成物。
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.
 また、本発明は、下記に掲げる、ポリヘキサニド及び/又はその塩の殺菌作用の低下抑制方法、及びコンタクトレンズケア用組成物に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付与する方法を提供する。
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.
 また、本発明は、下記に掲げる、コンタクトレンズケア用組成物の白濁防止方法、及びコンタクトレンズケア用組成物に白濁を防止する作用を付与する方法を提供する。
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.
 また、本発明は、下記に掲げる、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抑制方法、及びコンタクトレンズケア用組成物に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作用を付与する方法を提供する。
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.
 更に、本発明は、下記に掲げる、乾燥によるコンタクトレンズの硬度の上昇の抑制方法、及びコンタクトレンズケア用組成物に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付与する方法を提供する。
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は、保存後でも、ポリヘキサニド及び/又はその塩による殺菌作用を有効に発揮でき、且つ経時的な白濁が生じずに優れた外観性状を保つことができる。そのため、製造から流通の段階、及び消費者によって使用が終了するまでの長期間保存されても、殺菌作用、外観性状を維持でき、長期に亘り十分に実使用に耐えることができる。また、本発明のコンタクトレンズケア用組成物においては、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が抑制されている。そのため、製剤安定性に優れたコンタクトレンズケア用組成物を提供することができる。 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.
 更に、本発明のコンタクトレンズケア用組成物は、コンタクトレンズの擦り洗いをし易く、また、当該組成物でコンタクトレンズを処理すると、更にはコンタクトレンズの装着感も良好であるので、消費者の使用感を十分に満足させることもできる。 Furthermore, 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.
 また、コンタクトレンズは、乾燥によって悪影響を受けやすい。例えば、コンタクトレンズ装用中には、エアコン等の環境要因による乾燥や、パソコン画面の凝視等による瞬きの減少等から、コンタクトレンズ表面が乾燥し易い傾向にある。そして、その結果、コンタクトレンズの柔らかさが損なわれ、装用感の悪化や視界不良等に繋がる畏れがある。また、一旦乾燥により硬くなってしまったコンタクトレンズは、本来の柔軟性を取り戻すことが困難である。これに対して、本発明のコンタクトレンズケア用組成物は、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できるので、乾燥によるコンタクトレンズへの悪影響も払拭することができる。 Also, contact lenses are easily affected by drying. For example, when a contact lens is worn, 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. As a result, the softness of the contact lens is impaired, which may lead to deterioration in wearing feeling and poor visibility. Moreover, it is difficult to regain the original flexibility of contact lenses that have become hard once dried. In contrast, 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.
1.コンタクトレンズケア用組成物
 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).
 ポリヘキサニドは、ポリヘキサメチレンビグアニド又はPHMBと称される公知の殺菌剤である。本発明で使用されるポリヘキサニドについては、医薬上、薬理学的に(製薬上)又は生理学的に許容されることを限度として、特に制限されるものではないが、具体的には、下記一般式(1)に示される化合物が例示される。 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.
Figure JPOXMLDOC01-appb-C000003
Figure JPOXMLDOC01-appb-C000003
 一般式(1)中、R1及びR2は、同一又は異なって、下記一般式(2)で示される基又はアミノ基を示す。好ましくはR1がアミノ基であり、且つR2が一般式(2)で示される基又はアミノ基であり、更に好ましくはR1がアミノ基であり、R2が一般式(2)で示される基である。 In the general formula (1), 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). Preferably, R 1 is an amino group, and 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). Group.
Figure JPOXMLDOC01-appb-C000004
Figure JPOXMLDOC01-appb-C000004
 また、一般式(1)中、nは、1~500の整数を示す。好ましくは、2~200の整数、更に好ましくは4~100の整数、特に好ましくは8~20の整数を示す。 In general formula (1), 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.
 ポリヘキサニドの塩としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものである限り、特に制限されない。ポリヘキサニドの塩として、具体的には、塩酸、臭化水素、硫酸、ホウ酸等の無機酸塩;酢酸、グルコン酸、マレイン酸、アスコルビン酸、ステアリン酸、酒石酸、クエン酸等の有機酸塩が例示される。これらのポリヘキサニドの塩の中でも、好ましくは無機酸塩であり、更に好ましくは塩酸塩である。これらのポリヘキサニドの塩は、1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。 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. Among these polyhexanide salts, 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.
 本発明のCLケア用組成物において、(A)成分は、ポリヘキサニド及びその塩の中から1種のものを単独で使用してもよく、また2種以上のものを任意に組み合わせて使用してもよい。(A)成分の中でも、殺菌作用を一層安定に保持させ、更には白濁等を防止して外観性状を一層良好に保つという観点から、好ましくは一般式(1)で示されるポリヘキサニド又はその無機酸塩、更に好ましくは一般式(1)で示されるポリヘキサニド又はその塩酸塩、特に好ましくは一般式(1)で示されるポリヘキサニドの塩酸塩が挙げられる。ここで例示する(A)成分は、(B)成分の低分子化を抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the CL care composition of the present invention, as 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. Among the components (A), 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.
 本発明のCLケア用組成物において、上記(A)成分の含有割合は、該(A)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(A)成分が総量で0.00005~0.00012w/v%、好ましくは0.00006~0.00012w/v%、更に好ましくは0.00007~0.00012w/v%が例示される。(A)成分が上記含有割合の範囲内にあれば、高い安全性を有しつつ、殺菌作用及び外観性状を一層安定に維持することができる。また、(A)成分の上記含有割合は、本発明の他の効果をより有効に奏させる上でも好適である。 In the CL care composition of the present invention, 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. In addition, the above content ratio of the component (A) is also suitable for more effectively achieving the other effects of the present invention.
 本発明のCLケア用組成物は、更にポリオキシエチレンポリオキシプロピレングリコール(以下、(B)成分と表記することもある)を含有する。また、以下、POEはポリオキシエチレン、POPはポリオキシプロピレン、括弧内の数字は付加モル数を表す。 The CL care composition of the present invention further contains polyoxyethylene polyoxypropylene glycol (hereinafter sometimes referred to as component (B)). Hereinafter, POE is polyoxyethylene, POP is polyoxypropylene, and the numbers in parentheses indicate the number of moles added.
 POEPOPグリコールは、プロピレンオキシドを付加重合させて得られるポリプロピレングリコールにエチレンオキシドを付加重合した化合物であり、下記の一般式で示される。 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.
Figure JPOXMLDOC01-appb-C000005
Figure JPOXMLDOC01-appb-C000005
 本発明で使用されるPOPPOEグリコールについては、その分子量、プロピレンオキサイドとエチレンオキサイドの平均重合度等については特に制限されないが、平均分子量は1000~30000が好ましく、1500~20000がより好ましく、2000~15000が特に好ましい。また、上記一般式中yで表されるプロピレンオキサイドの平均重合度は5~100が好ましく、20~80がより好ましく、30~70がさらに好ましく、60~70が特に好ましい。また、上記一般式中xおよびzで表されるエチレンオキサイドの平均重合度は、併せて3~250が好ましく、20~220がより好ましく、50~200がさらに好ましく、150~200が特に好ましい。これらのPOPPOEグリコールとしては、POE(196)POP(67)グリコール(ポロクサマー407、平均分子量11500)、POE(24)POP(20)グリコール(ポロクサマー124、平均分子量2200)、POE(160)POP(30)グリコール(ポロクサマー188、平均分子量8350)、POE(54)POP(39)グリコール(ポロクサマー235、平均分子量4600)、POE(200)POP(70)グリコール等が挙げられる。これらの中でも、CLケア用組成物の殺菌作用をより一層安定に保持させ、POPPOEグリコールの低分子化をより有効に抑制させるという観点から、好ましくは、ポロクサマー407が例示される。ここで例示する(B)成分は、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 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. In addition, 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. In addition, 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. These 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. Among these, preferably, 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.
 本発明のCLケア用組成物において、上記(B)成分の含有割合は、該(B)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(B)成分が総量で0.01~0.5w/v%、好ましくは0.01~0.3w/v%、更に好ましくは0.05~0.2w/v%が例示される。(B)成分が上記含有割合の範囲内にあれば、殺菌作用及び外観性状を一層安定に維持することができる。また、(B)成分の上記含有割合は、本発明の他の効果をより有効に奏させる上でも好適である。 In the CL care composition of the present invention, 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. In addition, the above-described content ratio of the component (B) is suitable for more effectively achieving the other effects of the present invention.
 本発明のCLケア用組成物において、(A)成分に対する(B)成分の比率については、特に制限されるものではないが、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁等を防止して外観性状を一層良好に保つという観点から、(A)成分の総量1重量部当たり、上記(B)成分の総量が80~10000重量部、好ましくは80~6000重量部、更に好ましくは400~4000重量部となる範囲が例示される。ここで例示する比率は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the composition for CL care 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.
 また、本発明のCLケア用組成物は、更にヒドロキシプロピルメチルセルロース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、(C)成分と表記することもある)を含有する。 In addition, 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)).
 本発明に使用されるヒドロキシプロピルメチルセルロースは、医薬上、薬理学的に(製薬上)又は生理学的に許容される限り、特に制限されるものではない。また、ヒドロキシプロピルメチルセルロースにおけるメトキシ基とヒドロキシプロポキシ基の含有量についても、特に制限されないが、例えば、分子(100重量%)内に、メトキシ基が19~31.5重量%及びヒドロキシプロポキシ基が4~12重量%含まれるものが例示される。本発明に使用されるヒドロキシプロピルメチルセルロースとして、具体的には、ヒドロキシプロピルメチルセルロース(置換度タイプ2208)、ヒドロキシプロピルメチルセルロース(置換度タイプ2906)、ヒドロキシプロピルメチルセルロース(置換度タイプ2910)、ヒドロキシプロピルメチルセルロース(置換度タイプ1828)等が挙げられる。 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. For example, 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. Specific examples of hydroxypropylmethylcellulose used in the present invention include hydroxypropylmethylcellulose (substitution degree type 2208), hydroxypropylmethylcellulose (substitution degree type 2906), hydroxypropylmethylcellulose (substitution degree type 2910), hydroxypropylmethylcellulose ( Substitution degree type 1828) and the like.
 また、ヒドロキシプロピルメチルセルロースの塩としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されることを限度として、特に制限されるものではない。塩の形態の中でも、好ましくは無機塩基との塩、より好ましくはアルカリ金属塩、更に好ましくはナトリウム塩及びカリウム塩、特に好ましくはナトリウム塩が挙げられる。これらのヒドロキシプロピルメチルセルロースの塩は、1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。 Further, the salt of hydroxypropylmethylcellulose is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Among the salt forms, preferred are salts with inorganic bases, more preferred are alkali metal salts, still more preferred are sodium salts and potassium salts, and most preferred are sodium salts. These hydroxypropylmethylcellulose salts may be used alone or in any combination of two or more.
 ヒドロキシプロピルメチルセルロース及びその塩の分子量については、置換基の種類や置換度等によって異なるが、通常、重量平均分子量で0.1万~150万、好ましくは0.5万~130万、更に好ましくは1万~100万程度のものを使用することができる。 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.
 本発明のCLケア用組成物において、(C)成分は、ヒドロキシプロピルメチルセルロース及びその塩の中から1種のものを単独で使用してもよく、また2種以上のものを任意に組み合わせて使用してもよい。(C)成分の中でも、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁等を防止して外観性状を一層良好に保つという観点から、好ましくはヒドロキシプロピルメチルセルロースが挙げられる。ここで例示する(C)成分は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the CL care composition of the present invention, as 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. Among the components (C), 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.
 本発明のCLケア用組成物において、上記(C)成分の含有割合は、該(C)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(C)成分が総量で0.01~0.5w/v%、好ましくは0.01~0.3w/v%、更に好ましくは0.01~0.1w/v%が例示される。(C)成分が上記含有割合の範囲内にあれば、殺菌作用及び外観性状を一層安定に維持することができる。また、(C)成分の上記含有割合は、本発明の他の効果をより有効に奏させる上でも好適である。 In the CL care composition of the present invention, 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. When the component (C) is within the above range, the bactericidal action and appearance properties can be maintained more stably. In addition, the above-described content ratio of the component (C) is suitable for more effectively achieving the other effects of the present invention.
 本発明のCLケア用組成物において、(A)成分に対する(C)成分の比率については、特に制限されるものではないが、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁等を防止して外観性状を一層良好に保つという観点から、(A)成分の総量1重量部当たり、上記(C)成分の総量が80~10000重量部、好ましくは80~6000重量部、更に好ましくは80~2000重量部となる範囲が例示される。ここで例示する比率は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the composition for CL care 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.
 更に、本発明のCLケア用組成物は、上記(A)~(C)成分に加えて、エチレンジアミン酢酸、その誘導体、及びそれらの塩からなる群より選択される少なくとも1種(以下、(D)成分と表記することもある)を0.04~0.2w/v%の含有割合で含む。このように、上記(A)~(C)成分と共に、特定の割合の(D)成分を含有することによって、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、外観性状を良好に保つことが可能になる。また、上記(A)~(C)成分と特定の割合の(D)成分を一体として含むことによって、(B)成分の低分子化を抑制し、CLケア用組成物の使用感を向上させ、乾燥によるコンタクトレンズの硬度上昇を抑制することも可能になる。 Further, 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%. As described above, by containing the component (D) in a specific ratio together with the components (A) to (C), the bactericidal action of the CL care composition can be stably maintained, and further the cloudiness with time can be maintained. It is possible to maintain good appearance properties without being generated. In addition, by containing the above components (A) to (C) and a specific proportion of the component (D) as a whole, 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.
 本発明に使用されるエチレンジアミン酢酸は、エチレンジアミンの2つのアミノ基に対して1~4個のカルボキシメチル基が結合した化合物であり、本発明において上記(D)成分として使用されるエチレンジアミン酢酸については、医薬上、薬理学的に(製薬上)又は生理学的に許容される限り、特に制限されない。本発明に使用されるエチレンジアミン酢酸としては、具体的には、エチレンジアミン二酢酸(EDDA)、エチレンジアミン三酢酸、エチレンジアミン四酢酸(エデト酸、EDTA)等が例示される。また、エチレンジアミン酢酸の誘導体としては、N-(2-ヒドロキシエチル)エチレンジアミン三酢酸(HEDTA)、ジエチレントリアミン五酢酸(DTPA)等が例示される。これらのエチレンジアミン酢酸及びその誘導体の中でも、エチレンジアミン四酢酸が好ましい。これらのエチレンジアミン酢酸及び/又はその誘導体は、1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。 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. Regarding the 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. Examples of the ethylenediamineacetic acid derivative include N- (2-hydroxyethyl) ethylenediaminetriacetic acid (HEDTA) and diethylenetriaminepentaacetic acid (DTPA). Among these 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.
 また、エチレンジアミン酢酸及び/又はその誘導体の塩としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されないが、具体的には、無機塩基との塩[例えば、アンモニウム塩;アルカリ金属(ナトリウム、カリウム等)、アルカリ土類金属(カルシウム、マグネシウム等)、アルミニウム等の金属との塩等]等が挙げられる。これらの塩の中でも、好ましくはアルカリ金属塩、更に好ましくはナトリウム塩及びカリウム塩、特に好ましくはナトリウム塩が挙げられる。これらの塩は、1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。 Further, 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. Specifically, 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. Among these salts, preferred are 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.
 なお、(D)成分として使用されるエチレンジアミン酢酸、その誘導体及び/又はそれらの塩は、水和物の形態であってもよい。 The ethylenediamineacetic acid, its derivative and / or salt used as the component (D) may be in the form of a hydrate.
 本発明のCLケア用組成物において、(D)成分は、エチレンジアミン酢酸、その誘導体、及びそれらの塩の中から1種のものを単独で使用してもよく、また2種以上のものを任意に組み合わせて使用してもよい。(D)成分の中でも、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁を抑制して外観性状を一層良好に保つという観点から、好ましくはエチレンジアミン四酢酸及びその塩、更に好ましくはエチレンジアミン四酢酸のアルカリ金属塩、特に好ましくはエチレンジアミン四酢酸のナトリウム塩、更に特に好ましくはエチレンジアミン四酢酸二ナトリウムが挙げられる。なお、エチレンジアミン四酢酸二ナトリウムとは、第十五改正日本薬局方のエデト酸ナトリウム水和物(二水和物)を意味する。ここで例示する(D)成分は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the CL care composition of the present invention, as the component (D), ethylenediamineacetic acid, derivatives thereof, and salts thereof may be used alone or in combination of two or more. May be used in combination. Among 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. Here, 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.
 本発明のCLケア用組成物において、上記(D)成分の含有割合は、該CLケア用組成物の総量に対して、該(D)成分が総量で0.04~0.2w/v%を充足する範囲であればよいが、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には外観性状を一層良好に保つという観点から、好ましくは0.04~0.15w/v%、更に好ましくは0.04~0.1w/v%が例示される。(D)成分が上記含有割合の範囲内にあれば、低刺激性で良好な使用感を備えさせつつ、殺菌作用及び外観性状を一層安定に維持することができる。また、(D)成分の上記含有割合は、本発明の他の効果をより有効に奏させる上でも好適である。 In the CL care composition of the present invention, 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.
 本発明のCLケア用組成物において、(A)成分に対する(D)成分の比率については、特に制限されるものではないが、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁を抑制して外観性状を一層良好に保つという観点から、(A)成分の総量1重量部当たり、上記(D)成分の総量が300~4000重量部、好ましくは300~3000重量部、更に好ましくは300~2000重量部となる範囲が例示される。ここで例示する比率は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the composition for CL care 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.
 また、本発明のCLケア用組成物において、(C)成分に対する(D)成分の比率については、特に制限されるものではないが、CLケア用組成物の殺菌作用をより一層安定に保持させ、更には白濁を抑制して外観性状を一層良好に保つという観点から、(C)成分の総量1重量部当たり、上記(D)成分の総量が0.08~20重量部、好ましくは0.1~15重量部、更に好ましくは0.4~10重量部となる範囲が例示される。ここで例示する比率は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the CL care composition of the present invention, 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.
 更に、本発明のCLケア用組成物は、ホウ酸緩衝剤(以下、(E)成分と表記することもある)を含有することが好ましい。 Furthermore, the CL care composition of the present invention preferably contains a borate buffer (hereinafter sometimes referred to as the component (E)).
 本発明で使用されるホウ酸緩衝剤は、医薬上、薬理学的に(製薬上)又は生理学的に許容される限り、特に制限されないが、例えば、ホウ酸(オルトホウ酸)、メタホウ酸、次ホウ酸、四ホウ酸及びこれらの塩等が挙げられる。これらの塩としては、例えば、アルカリ金属塩、アルカリ土類金属塩、アンモニウム塩等が例示される。(E)成分として使用されるホウ酸緩衝剤として、具体的には、ホウ酸、メタホウ酸、次ホウ酸、ホウ酸ナトリウム、テトラホウ酸カリウム、テトラホウ酸ナトリウム、メタホウ酸カリウム、ホウ酸アンモニウム、ホウ砂等が例示される。これらは、水和物であってもよい。これらのホウ酸緩衝剤は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。(E)成分として、好ましくはホウ酸とホウ砂の組合せ(併用)が例示される。尚、ホウ酸、ホウ砂は、日本薬局方適合品が好適に用いられ、これらは市販のものを用いることができる。 The borate buffer used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. For example, boric acid (orthoboric acid), metaboric acid, Examples thereof include boric acid, tetraboric acid and salts thereof. Examples of 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. These boric acid buffers may be used alone or in combination of two or more. As the component (E), a combination (combination) of boric acid and borax is preferably exemplified. In addition, as for boric acid and borax, Japanese Pharmacopoeia conformity goods are used suitably and these can use a commercially available thing.
 (E)成分として、例えばホウ酸とホウ砂を組み合わせて使用する場合、これらの比率については、特に制限されるものではないが、ホウ酸100重量部当たり、ホウ砂が総量で、通常0.1~200重量部、好ましくは1~100重量部、更に好ましくは5~50重量部が挙げられる。 As the component (E), for example, when boric acid and borax are used in combination, these ratios are not particularly limited. However, 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.
 本発明のCLケア用組成物において、上記(E)成分の含有割合は、該(E)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(E)成分が総量で0.1~2.0w/v%、好ましくは0.2~1.5w/v%、更に好ましくは0.4~1.0w/v%が例示される。 In the composition for CL care of the present invention, 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.
 また、本発明のCLケア用組成物は、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(以下、(F)成分と表記することもある)を含有することが好ましい。 Further, 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)).
 本発明のCLケア用組成物において、(F)成分は、塩化ナトリウム及び塩化カリウムの中から一方を単独で使用してもよく、また双方を組み合わせて使用してもよい。(F)成分として、好ましくは塩化ナトリウムと塩化カリウムの組み合わせ(併用)が例示される。 In the CL care composition of the present invention, as the component (F), one of sodium chloride and potassium chloride may be used alone, or both may be used in combination. As the component (F), a combination (combination) of sodium chloride and potassium chloride is preferably exemplified.
 (F)成分として、塩化ナトリウムと塩化カリウムを組み合わせて使用する場合、これらの比率については、特に制限されるものではないが、塩化ナトリウム100重量部当たり、塩化カリウムが総量で、通常1~100重量部、好ましくは1~50重量部、更に好ましくは5~20重量部が挙げられる。 (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.
 本発明のCLケア用組成物において、上記(F)成分の含有割合は、該(F)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(F)成分が総量で0.01~2w/v%、好ましくは0.02~1w/v%、更に好ましくは0.03~0.5w/v%が例示される。 In the CL care composition of the present invention, 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.
 本発明のCLケア用組成物において、殺菌作用をより一層安定に保持させ、更には白濁を抑制して外観性状を一層良好に保つために、上記(E)成分と(F)成分を組み合わせて含有することが好ましい。とりわけ、上記(F)成分の総量100重量部あたり、上記(E)成分が総量で100重量部以上、好ましくは100~300重量部、更に好ましくは100~200重量部、特に好ましくは100~150重量部の比率を充足することによって、殺菌作用の安定保持効果及び白濁抑制効果を格段顕著に向上させることが可能になる。また、上記の(E)成分と(F)成分の併用及びそれらの上記比率は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 In the composition for CL care of the present invention, in order to keep the bactericidal action more stably, and further to suppress the white turbidity and keep the appearance properties better, the above (E) component and (F) component are combined. It is preferable to contain. In particular, 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). By satisfying the ratio of parts by weight, it is possible to remarkably improve the effect of stably maintaining the bactericidal action and the effect of suppressing white turbidity. Further, 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.
 更に、本発明のCLケア用組成物は、モノテルペン(以下、(G)成分と表記することもある)を含有することが好ましい。本発明のCLケア用組成物において、更に(G)成分を含有することによって、殺菌作用をより一層安定に保持させ、更には白濁を抑制して性状外観を一層良好に保つことが可能になる。また、(G)成分は、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感のより一層の向上にも寄与しうる。 Furthermore, the CL care composition of the present invention preferably contains a monoterpene (hereinafter sometimes referred to as component (G)). In the composition for CL care of the present invention, by further containing the component (G), it is possible to maintain the bactericidal action more stably, and further to suppress the white turbidity and keep the appearance of properties better. . In addition, 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).
 モノテルペンは、イソプレンユニットを構成単位とする構造を有し、清涼化剤として汎用されている公知の化合物である。 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.
 本発明に使用されるモノテルペンとしては、医薬上、薬理学的に(製薬上)又は生理学的に許容される限り、特に制限されない。モノテルペンとして、具体的には、メントール、メントン、カンフル、ボルネオール、ゲラニオール、シネオール、シトロネロール、カルボン、アネトール、オイゲノール、リモネン、リナロール、酢酸リナリル、これらの誘導体等が挙げられる。これらの化合物はd体、l体又はdl体のいずれでもよい。また、本発明において、モノテルペンとして、上記化合物を含有する精油を使用してもよい。このような精油としては、例えば、ユーカリ油、ベルガモット油、ペパーミント油、クールミント油、スペアミント油、ハッカ油、ウイキョウ油、ケイヒ油、ローズ油、樟脳油等が挙げられる。これらのモノテルペンは、1種単独で使用してもよく、また2種以上を任意に組み合わせて使用してもよい。 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. In the present invention, an essential oil containing the above compound may be used as the monoterpene. Examples of 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.
 これらのモノテルペンの中でも、好ましくは、メントール、メントン、カンフル、ボルネオール、ゲラニオール、更に好ましくはl-メントール、dl-メントール、d-カンフル及びdl-カンフルが挙げられ、これらを含有する精油としてクールミント油、ペパーミント油、ハッカ油、樟脳油等が例示される。 Among these monoterpenes, preferred are 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.
 本発明のCLケア用組成物において、上記(G)成分の含有割合は、該(G)成分の種類、他の配合成分の種類等に応じて適宜設定されるが、一例として、該CLケア用組成物の総量に対して、該(G)成分が総量で0.0001~0.02w/v%、好ましくは0.0002~0.01w/v%、更に好ましくは0.0005~0.005w/v%が例示される。なお、(G)成分として、モノテルペンを含む精油を使用する場合は、配合される精油中のモノテルペン含有量が上記含有割合を満たすように設定される。 In the CL care composition of the present invention, 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. In addition, when using the essential oil containing a monoterpene as (G) component, it sets so that the monoterpene content in the essential oil mix | blended may satisfy | fill the said content rate.
 本発明のCLケア用組成物は、上記(E)成分以外の緩衝剤を含有してもよい。本発明のCLケア用組成物に配合できる緩衝剤としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。かかる緩衝剤の一例として、リン酸緩衝剤、炭酸緩衝剤、クエン酸緩衝剤、酢酸緩衝剤、トリス緩衝剤等が挙げられる。これらの緩衝剤は組み合わせて使用しても良い。 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.
 また、本発明のCLケア用組成物は、上記(B)成分以外の界面活性剤を含有してもよい。本発明のCLケア用組成物に配合可能な界面活性剤としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されることを限度として特に制限されず、非イオン性界面活性剤、両性界面活性剤、陰イオン性界面活性剤、陽イオン性界面活性剤のいずれであってもよい。 Further, 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.
 本発明のCLケア用組成物は、更に上記(F)成分以外の等張化剤を含有してもよい。本発明のCLケア用組成物に配合できる等張化剤としては、医薬上、薬理学的に(製薬上)又は生理学的に許容されるものであれば、特に制限されない。 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.
 本発明のCLケア用組成物のpHについては、医薬上、薬理学的に(製薬上)又は生理学的に許容される範囲内であれば特に限定されるものではない。本発明のCLケア用組成物において、殺菌作用をより一層安定に保持させ、更には白濁を抑制して性状外観を一層良好に保つために、本発明のCLケア用組成物のpHの一例として、6.0~8.0、好ましくは6.2~8.0、更に好ましくは6.5~7.8となる範囲が挙げられる。また、上記のpHは、(B)成分の低分子化を一層抑制する、CLケア用組成物の使用感を一層向上させる、又は乾燥によるコンタクトレンズの硬度上昇に対する抑制作用を一層高めるという観点からも好適である。 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. In the CL care composition of the present invention, as an example of 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. 6.0 to 8.0, preferably 6.2 to 8.0, more preferably 6.5 to 7.8. In addition, 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.
 また、本発明のCLケア用組成物の浸透圧については、生体に許容される範囲内であれば、特に制限されない。本発明のCLケア用組成物の浸透圧比の一例として、好ましくは0.7~5.0、更に好ましくは0.9~3.0、特に好ましくは1.0~2.0となる範囲が挙げられる。浸透圧比は、第十五改正日本薬局方に基づき0.9w/v%塩化ナトリウム水溶液の浸透圧に対する試料の浸透圧の比とし、浸透圧は日本薬局方記載の浸透圧測定法(氷点降下法)を参考にして測定する。浸透圧比測定用標準液は、塩化ナトリウム(日本薬局方標準試薬)を500~650℃で40~50分間乾燥した後、デシケーター(シリカゲル)中で放冷し、その0.900gを正確に量り、精製水に溶かし正確に100mLとして調製するか、市販の浸透圧比測定用標準液(0.9w/v%塩化ナトリウム水溶液)を用いる。 In addition, 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. As an example of the osmotic pressure ratio of the CL care composition of the present invention, a range of preferably 0.7 to 5.0, more preferably 0.9 to 3.0, and particularly preferably 1.0 to 2.0. Can be mentioned. 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).
 本発明のCLケア用組成物には、上記の成分に加えて、有効成分(薬理活性成分や生理活性成分等)を配合することができる。このような成分の種類は特に制限されず、例えば、充血除去成分、眼筋調節薬成分、抗炎症薬成分又は収斂薬成分、抗ヒスタミン薬成分又は抗アレルギー薬成分、ビタミン類、アミノ酸類、抗菌薬成分又は殺菌薬成分、糖類、高分子化合物又はその誘導体、セルロース又はその誘導体、局所麻酔薬成分等が例示できる。 In the CL care composition of the present invention, 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.
 また、本発明のCLケア用組成物には、発明の効果を損なわない範囲であれば、その用途や形態に応じて、常法に従い、様々な成分や添加物を適宜選択し、一種またはそれ以上を併用して含有させることができる。それらの成分または添加物として、例えば、液剤の調製に一般的に使用される担体(水性溶媒、水性又は油性基剤など)、防腐剤、殺菌剤又は抗菌剤、pH調節剤、キレート剤、安定化剤等の各種添加剤を挙げることができる。 In addition, in the CL care composition of the present invention, 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. As those components or additives, for example, carriers (aqueous solvents, aqueous or oily bases, etc.) commonly used in the preparation of solutions, antiseptics, bactericides or antibacterial agents, pH adjusters, chelating agents, stable agents Various additives such as an agent can be mentioned.
 以下に本発明のCLケア用組成物に使用される代表的な他の成分を例示するが、これらに限定されない。 Hereinafter, typical other components used in the composition for CL care of the present invention are exemplified, but not limited thereto.
 担体:例えば、水、含水エタノール等の水性溶媒など。 Carrier: For example, water, aqueous solvent such as water-containing ethanol.
 pH調節剤:例えば、塩酸、水酸化ナトリウムなど。 PH adjuster: For example, hydrochloric acid, sodium hydroxide, etc.
 本発明のCLケア用組成物は、所望量の上記(A)~(D)成分、及び必要に応じて他の成分を所望の濃度となるように添加することにより調製される。 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.
 本発明のCLケア用組成物は、コンタクトレンズの洗浄、消毒、保存等に利用できる限り、その剤型については特に制限されないが、液状が好ましい。本発明のCLケア用組成物を液状(水性組成物)にする場合、医薬上、薬理学的に(製薬上)又は生理学的に許容される水を水性担体として使用すればよく、このような水として、具体的には、蒸留水、常水、精製水、滅菌精製水、注射用水、注射用蒸留水等が例示される。これらの定義は第十五改正日本薬局方に基づく。尚、本発明のCLケア用組成物を水性組成物とする場合の水の含有割合については、通常、CLケア用組成物の全量に対し、水を総量で50w/v%以上、より好ましくは80w/v%以上、更に好ましくは90w/v%以上、特に好ましくは95w/v%以上とすればよい。 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. When the CL care composition of the present invention is 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. As for the content ratio of water when the CL care composition of the present invention is an aqueous composition, 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.
 本発明のCLケア用組成物は、コンタクトレンズの洗浄、消毒、保存等のコンタクトレンズケアに使用されるものであり、その製剤形態として、具体的には、コンタクトレンズ消毒剤、コンタクトレンズ用保存剤、コンタクトレンズ用洗浄剤、コンタクトレンズ用洗浄保存剤、コンタクトレンズ用消毒・洗浄・保存剤(マルチパーパスソリューション)等が挙げられる。これらの製剤形態の中でも、コンタクトレンズ消毒剤、コンタクトレンズ用消毒・洗浄・保存剤(マルチパーパスソリューション)が好適である。また、コンタクトレンズ消毒・洗浄・保存剤(マルチパーパスソリューション)は、コンタクトレンズの消毒・洗浄・保存を一剤で行うため、コンタクトレンズを介して角膜に直接接触する製剤である。従って、有効性、安全性等の面から、本発明のCLケア用組成物の製剤形態として特に好適である。 The CL care composition of the present invention is used for contact lens care such as cleaning, disinfection and storage of contact lenses. Specifically, as a preparation form thereof, specifically, 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. Among these preparation forms, 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.
 なお、本発明において、コンタクトレンズとは、ソフトコンタクトレンズ、ハードコンタクトレンズ、及び酸素透過性ハードコンタクトレンズのいずれをも包含する。また、ソフトコンタクトレンズとは、イオン性及び非イオン性の双方を包含し、シリコーンハイドロゲルコンタクトレンズ及び非シリコーンハイドロゲルコンタクトレンズ(シリコーンハイドロゲルレンズでは無いソフトコンタクトレンズ)の双方を包含する。 In the present invention, 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).
 コンタクトレンズの中でも、ソフトコンタクトレンズは、微生物が付着しやすく、CLケア用組成物による微生物の殺菌が強く要求される。更に、ソフトコンタクトレンズは、白濁等により均一性が損なわれたCLケア用組成物で処理すると、物性変化を受け易いレンズでもある。また、乾燥によるレンズ硬度の上昇が起こりやすく、柔らかさの保持が強く求められる。かかる観点から、本発明のCLケア用組成物は、ソフトコンタクトレンズケア用組成物(即ち、適用対象レンズがソフトコンタクトレンズであるCLケア用組成物)が好適である。 Among contact lenses, soft contact lenses tend to adhere to microorganisms, and sterilization of microorganisms with a CL care composition is strongly required. Furthermore, soft contact lenses are lenses that are susceptible to changes in physical properties when treated with a CL care composition whose uniformity has been impaired by cloudiness or the like. Further, the lens hardness is likely to increase due to drying, and it is strongly required to maintain softness. From this point of view, 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).
 また、本発明のCLケア用組成物をソフトコンタクトレンズに適用する場合、適用対象となるソフトコンタクトレンズの含水率については特に制限されないが、例えば、含水率が20%以上、好ましくは30%以上、より好ましくは50~90%である。 In addition, when the CL care composition of the present invention is applied to a soft contact lens, the moisture content of the soft contact lens to be applied is not particularly limited. For example, the moisture content is 20% or more, preferably 30% or more. More preferably, it is 50 to 90%.
 ここでソフトコンタクトレンズの含水率とは、ソフトコンタクトレンズ中の水の割合を示し、具体的には以下の計算式により求められる。 Here, 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.
 含水率(%)=(含水した水の重量/含水状態のソフトコンタクトレンズの重量)×100
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.
 また、ソフトコンタクトレンズの中でも、含水率が50%以上であるレンズは高含水ソフトコンタクトレンズと呼ばれ、素材中に含まれる水分が多いため微生物が繁殖しやすく、より高い殺菌力が求められる。また、高含水ソフトコンタクトレンズの中でも、特に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のレンズは、上記ソフトコンタクトレンズ、高含水ソフトコンタクトレンズの特性に加え、乾燥によるコンタクトレンズの硬度上昇を受け易く、当該硬度上昇の抑制が強く求められる。更に、ソフトコンタクトレンズの中でも、高含水ソフトコンタクトレンズ、特にソフトコンタクトレンズ分類グループIVのレンズの物性は、白濁等により均一性が損なわれたCLケア用組成物によって悪影響を受け易く、白濁等がなく均一性の高いCLケア用組成物での処理が強く求められる。これに対して、本発明のCLケア用組成物によれば、優れた殺菌作用と共に、乾燥によるコンタクトレンズの硬度上昇を有効に抑制でき、更には白濁が生じることなく組成の均一性を保持できるので、高含水ソフトコンタクトレンズ、特にソフトコンタクトレンズ分類グループIVのレンズの上記欠点を解消することができる。かかる利点を鑑みれば、本発明のCLケア用組成物の好適な適用対象のコンタクトレンズの一例として、高含水ソフトコンタクトレンズ、特にソフトコンタクトレンズ分類グループIVのレンズが挙げられる。 Further, among soft contact lenses, 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. Among the high water content soft contact lenses, in particular, 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. Furthermore, among soft contact lenses, 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. Treatment with a highly uniform CL care composition is strongly demanded. On the other hand, according to 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. In view of such advantages, 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.
 本発明のCLケア用組成物を用いて、コンタクトレンズの洗浄、消毒、保存等の処理を行う方法については特に制限されないが、好適な一例として下記態様が例示される。
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).
 なお、本発明のCLケア用組成物がコンタクトレンズ用消毒・洗浄・保存剤(マルチパーパスソリューション)である場合には、上記の洗浄と消毒・保存を一連に行えばよい。 When 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.
 本発明のCLケア用組成物は、容器に収容して、コンタクトレンズケア用品として提供される。本発明のCLケア用組成物を収容する容器の種類については特に制限されず、プラスチック製及びガラス製のいずれであってもよいが、プラスチック製容器は、軽量でスクイズ性が良好で、繰り返しの押圧に対する耐久性を有しているので、CLケア用組成物の収容に好適である。 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.
 本発明のCLケア用組成物の収容に使用されるプラスチック製容器を構成する樹脂としては、熱可塑性樹脂が好ましい。このような熱可塑性樹脂としては、例えば、ポリエチレンテレフタレート(PET)、ポリエチレンナフタレート、ポリアリレート等のポリエステル系樹脂;ポリエチレン、ポリプロピレン等のオレフィン系樹脂;ポリスチレン、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;ポリフェニレンエーテル系樹脂;ポリカーボネート系樹脂;ポリスルホン系樹脂;ポリアミド系樹脂;硬質塩化ビニル樹脂等が例示される。 As the resin constituting the plastic container used for housing the CL care composition of the present invention, a thermoplastic resin is preferable. Examples of such 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.
 上記熱可塑性樹脂の中でも、ポリエステル系樹脂、特にPETを構成樹脂とする容器は、ポリヘキサニド及び/又はその塩の殺菌作用を経時的に減弱させ易い傾向にあり、更にはポリヘキサニド及び/又はその塩を含むコンタクトレンズケア用組成物の経時的な白濁を招き易く、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も招きやすい特性がある。
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.
 また、本発明のCLケア用組成物を容器に収容してコンタクトレンズケア用品として提供する場合、本発明のCLケア用組成物の容器への充填量については、特に制限されないが、通常50~1000mL、好ましくは80~600mLが例示される。 Further, when the CL care composition of the present invention is contained in a container and provided as a contact lens care product, 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.
 2.ポリヘキサニド及び/又はその塩の殺菌作用の低下抑制方法;CLケア用組成物に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付与する方法
 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.
 従って、本発明は、更に別の観点から、(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(E)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を提供する。また、本発明は、(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CL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経時的な低下を抑制する作用を該CLケア用組成物に付与する方法をも提供する。 Accordingly, the present invention, from yet another point of view, 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.
 これらの方法において、使用する(A)~(D)成分の種類や含有割合、その他に配合される成分の種類や含有割合、組成物の製剤形態、容器、適用対象となるコンタクトレンズの種類、等については、前記「1.コンタクトレンズケア用組成物」と同様である。 In these methods, 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”.
 3.CLケア用組成物の白濁防止方法;CLケア用組成物に白濁を防止する作用を付与する方法
 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.
 従って、本発明は、更に別の観点から、CL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CLケア用組成物における白濁を防止又は抑制する方法を提供する。また、本発明は、(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CL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種を0.04~0.2w/v%配合することを特徴とする、白濁を防止又は抑制する作用を該CLケア用組成物に付与する方法をも提供する。更に、本発明は、(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CL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、白濁を防止又は抑制する作用を該CLケア用組成物に付与する方法をも提供する。 Accordingly, 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. Further, 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.
 これらの方法において、使用する(A)~(D)成分の種類や含有割合、その他に配合される成分の種類や含有割合、組成物の製剤形態、適用対象となるコンタクトレンズの種類等については、前記「1.コンタクトレンズケア用組成物」と同様である。 In these methods, 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”.
 4.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抑制方法;CLケア用組成物に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作用を付与する方法
 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.
 従って、本発明は、更に別の観点から、CL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を提供する。また、本発明は、(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をも提供する。 Accordingly, 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. In addition, 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.
 これらの方法において、使用する(A)~(D)成分の種類や含有割合、その他に配合される成分の種類や含有割合、組成物の製剤形態、適用対象となるコンタクトレンズの種類等については、前記「1.コンタクトレンズケア用組成物」と同様である。 In these methods, 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”.
 5.乾燥によるコンタクトレンズの硬度の上昇の抑制方法;CLケア用組成物に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付与する方法
 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.
 従って、本発明は、更に別の観点から、(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を提供する。また、本発明は、CL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CLケア用組成物に付与する方法をも提供する。 Accordingly, the present invention, from yet another point of view, 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 Provided is a method for suppressing an increase in hardness of a contact lens due to drying, which comprises treating the contact lens with an object. Further, the present invention provides 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, Also provided is a method for imparting the CL care composition with an action of suppressing the increase in hardness of a contact lens due to drying.
 これらの方法において、使用する(A)~(D)成分の種類や含有割合、その他に配合される成分の種類や含有割合、組成物の製剤形態、適用対象となるコンタクトレンズの種類、CLケア用組成物でコンタクトレンズを処理する方法等については、前記「1.コンタクトレンズケア用組成物」と同様である。 In these methods, the types and content ratios of the components (A) to (D) used, the types and content ratios of other components, the formulation of the composition, the types of contact lenses to be applied, and CL care About the method etc. which treat a contact lens with the composition for cosmetics, it is the same as that of the said "1. composition for contact lens care".
 以下に、実施例に基づいて本発明を詳細に説明するが、本発明はこれらの実施例によって限定されるものではない。 Hereinafter, the present invention will be described in detail based on examples, but the present invention is not limited to these examples.
 試験例1:保存前後の殺菌力、外観性状等の評価
 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.
Figure JPOXMLDOC01-appb-T000006
Figure JPOXMLDOC01-appb-T000006
1.保存前後の殺菌力の測定方法
 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.
Figure JPOXMLDOC01-appb-T000007
Figure JPOXMLDOC01-appb-T000007
 各CLケア用組成物について、保存4時間後の1mL当たりの生菌数を測定した。測定した生菌数から下記の判定基準に従って、各菌に対する殺菌力を評価した。
<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
 2.外観性状の測定方法
 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.
 3.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測定方法
 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.
 3.結果
 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.
 性状外観については、実施例1~3及び比較例1~6のいずれのCLケア用組成物でも、調製直後は澄明で外観性状に問題はなかったが、保存後では、比較例4及び5のCLケア用組成物において、明らかな白濁が認められた。これに対して、実施例1~3のCLケア用組成物では、保存後でも白濁を生じることなく、澄明な外観性状を維持できていた。なお、いずれのCLケア用組成物でも、60℃2週間保存後の外観性状は、40℃1.5ヶ月間保存後の場合と同じ結果であった。即ち、この試験結果からは、エデト酸2ナトリウムの濃度が0.02w/v%以下の場合には、たとえポリヘキサニド塩酸塩、ポロクサマー407、及びヒドロキシプロピルメチルセルロースを組み合わせて含有しても、白濁を防止できないことが確認された。 As for the appearance of the 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. In any CL care composition, 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.
 殺菌力については、実施例1~3及び比較例1~6のいずれのCLケア用組成物でも、調製直後には判定結果が×となるものが無かったにも拘らず、60℃1ヶ月保存後には、比較例1~3及び6のCLケア用組成物において、殺菌力が大きく低下し、判定結果が×になっており、保存により殺菌作用の低下を招いていた。尚、ISO14729の規定によれば、上記判定基準において、判定結果が「×」のものは、規格に適合していないとされており、比較例1~3及び6のCLケア用組成物は、実用に供することができないものである。これに対して、実施例1~3のCLケア用組成物では、保存後でも優れた殺菌力を保持できていた。尚、比較例4、5については、保存後に白濁が生じていたことから、保存後の殺菌力を評価するまでもなかった。 Regarding the bactericidal activity, 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. In addition, according to the provisions of ISO14729, in the above judgment criteria, those with a judgment result of “×” are considered not to conform to the standard, and the CL care compositions of Comparative Examples 1 to 3 and 6 are It cannot be put to practical use. In contrast, 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.
 以上の結果から明らかなように、比較例1~7のCLケア用組成物には、保存後の殺菌力の維持と白濁の抑制された優れた外観性状を兼ね備えるものは無かったが、実施例1~3のCLケア用組成物のいずれでも、保存後に殺菌力が安定に保持されており、更に保存によって白濁が生じることなく澄明な外観性状を維持できていた。 As is apparent from the above results, none of the CL care compositions of Comparative Examples 1 to 7 had both excellent sterilizing power after storage and excellent appearance properties with suppressed white turbidity. In any of the 1 to 3 CL care compositions, the bactericidal power was stably maintained after storage, and a clear appearance property could be maintained without causing cloudiness by storage.
 また、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保存後のクロマトグラムを確認した結果、比較例4及び5のCLケア用組成物では明らかに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が進んでいたのに対し、実施例2及び3のCLケア用組成物の処方では、殆ど低分子化していなかった。 In addition, as a result of confirming the chromatogram after storage of polyoxyethylene polyoxypropylene glycol, the molecular weight of polyoxyethylene polyoxypropylene glycol was clearly advanced in the CL care compositions of Comparative Examples 4 and 5. In contrast, the CL care compositions of Examples 2 and 3 were hardly reduced in molecular weight.
 従って、本試験結果から、ポリヘキサニド塩酸塩、ポロクサマー407、ヒドロキシプロピルメチルセルロース、エデト酸2ナトリウム0.04~0.2 w/v%を一体として含有することによって、保存後でも、ポリヘキサニド及び/又はその塩による殺菌作用を安定に保持し、且つ澄明な優れた外観性状を維持できることが明らかとなった。 Therefore, from the results of this test, by containing polyhexanide hydrochloride, poloxamer 407, hydroxypropylmethylcellulose, and 0.04 to 0.2% w / v% of edetate as a whole, bactericidal action by polyhexanide and / or its salt even after storage. It was clarified that it was possible to maintain a stable and clear appearance characteristic.
Figure JPOXMLDOC01-appb-T000008
Figure JPOXMLDOC01-appb-T000008
試験例2:使用感の評価
 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).
 VAS法の評価軸は、「こすり洗いのし易さ」については、10cmのスケール上の左端に「予想される中で最もこすり洗いし難い状態」を0点(0cm)、「予想される中で最もこすり洗いし易い状態」を10点(10cm)とした。その上で、各試験液について相当すると思われる「こすり洗いのし易さ」の点をスケール上に自由に記す方法で評価した。同様に、「装着感」については、10cmのスケール上の左端に「予想される中で最も装着感が悪い状態」を0点(0cm)、「予想される中で最も装着感が良い状態」を10点(10cm)とした。その上で、各試験液について相当すると思われる「装着感」の点をスケール上に自由に記す方法で評価した。 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.
 結果を表4に併せて示す。この結果から、実施例2のCLケア用組成物は、こすり洗いのし易さ、及び装着感が共に顕著に優れており、使用感が極めて良好であることが明らかとなった。尚、実施例2のCLケア用組成物をPET容器に充填し、40℃1.5ヶ月保存した後に同様の試験を実施したところ、こすり洗いのし易さ及び装着感共に、製造直後の場合と同様の良好な結果であった。 The results are also shown in Table 4. From this result, it was revealed that the CL care composition of Example 2 was remarkably excellent in both ease of rubbing and wearing feeling, and the feeling in use was extremely good. In addition, when the CL care composition of Example 2 was filled in a PET container and stored at 40 ° C. for 1.5 months, the same test was conducted. Both the ease of rubbing and the feeling of wearing were the same as those immediately after production. It was a good result.
Figure JPOXMLDOC01-appb-T000009
Figure JPOXMLDOC01-appb-T000009
試験例3:乾燥によるコンタクトレンズの硬度変化の評価
 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.
 測定した各コンタクトレンズの硬度を元に、生理食塩液で処理した場合の硬度を100とした場合の、各CLケア用組成物で処理した場合の硬度の比率(硬度比:%)を算出した。なお、硬度が小さいほどコンタクトレンズが柔らかさを保っていると考えられる。 Based on the measured hardness of each contact lens, the ratio of hardness when treated with each CL care composition (hardness ratio:%) when the hardness when treated with physiological saline was set to 100 was calculated. . In addition, it is thought that a contact lens is maintaining softness, so that hardness is small.
 結果を表5に示す。この結果から、実施例2及び3のCLケア用組成物に浸漬処理したコンタクトレンズは、乾燥条件下に置いて柔らかさが保持できていることが確認された。尚、実施例2のCLケア用組成物をPET容器に充填し、40℃1.5ヶ月保存した後に同様の試験を実施したところ、製造直後の場合と同様の良好な結果であった。 The results are shown in Table 5. From this result, it was confirmed that the contact lenses immersed in the CL care compositions of Examples 2 and 3 were kept soft under dry conditions. A similar test was conducted after filling the CL care composition of Example 2 in a PET container and storing it at 40 ° C. for 1.5 months. The result was the same as that obtained immediately after the production.
Figure JPOXMLDOC01-appb-T000010
Figure JPOXMLDOC01-appb-T000010
製剤例 表6~9に記載の処方で、コンタクトレンズ用消毒・洗浄・保存剤(マルチパーパスソリューション)(実施例4-31)を調製した。 Formulation Examples A contact lens disinfectant / cleaning / preserving agent (multipurpose solution) (Example 4-31) was prepared according to the formulations shown in Tables 6-9.
 実施例4-17のコンタクトレンズ用消毒・洗浄・保存剤を調製直後にPET製容器(PET含有量90%以上、容量500mL)に500mLずつ充填し、キャップを施した上で60℃にて2週間保存した。保存後に、上記試験例1及び2と同条件で、殺菌力、外観性状、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、使用感について評価を行った。また、調製直後に上記試験例3と同条件で、乾燥によるコンタクトレンズの変化について評価を行った。この結果、実施例4-17のコンタクトレンズ用消毒・洗浄・保存剤のいずれでも、殺菌力、外観性状、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の抑制効果、使用感、及び乾燥によるコンタクトレンズの変化の抑制効果は、良好であった。 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. As a result, any of the disinfecting / cleaning / preserving agents for contact lenses of Example 4-17, bactericidal power, appearance properties, the effect of suppressing the low molecular weight of polyoxyethylene polyoxypropylene glycol, feeling of use, and contact by drying The effect of suppressing the lens change was good.
Figure JPOXMLDOC01-appb-T000011
Figure JPOXMLDOC01-appb-T000011
Figure JPOXMLDOC01-appb-T000012
Figure JPOXMLDOC01-appb-T000012
Figure JPOXMLDOC01-appb-T000013
Figure JPOXMLDOC01-appb-T000013
Figure JPOXMLDOC01-appb-T000014
Figure JPOXMLDOC01-appb-T000014

Claims (8)

  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。 (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.
  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、(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.
  3.  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.
  4.  (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%.
  5.  (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%.
  6.  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.
  7.  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.
  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.
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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
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JPWO2012005311A1 (en) 2013-09-05
CN102959458A (en) 2013-03-06

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