WO2023013628A1 - Eyewash composition - Google Patents
Eyewash composition Download PDFInfo
- Publication number
- WO2023013628A1 WO2023013628A1 PCT/JP2022/029621 JP2022029621W WO2023013628A1 WO 2023013628 A1 WO2023013628 A1 WO 2023013628A1 JP 2022029621 W JP2022029621 W JP 2022029621W WO 2023013628 A1 WO2023013628 A1 WO 2023013628A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- salts
- composition
- present disclosure
- acid
- eye wash
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims abstract description 83
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- 150000003839 salts Chemical class 0.000 claims abstract description 36
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims abstract description 12
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 9
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- 230000001387 anti-histamine Effects 0.000 description 1
- 229960005261 aspartic acid Drugs 0.000 description 1
- 150000001545 azulenes Chemical class 0.000 description 1
- 229960001950 benzethonium chloride Drugs 0.000 description 1
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 1
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 description 1
- 229940116229 borneol Drugs 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- ZTQSAGDEMFDKMZ-UHFFFAOYSA-N butyric aldehyde Natural products CCCC=O ZTQSAGDEMFDKMZ-UHFFFAOYSA-N 0.000 description 1
- 229930008380 camphor Natural products 0.000 description 1
- 229960000846 camphor Drugs 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229960003291 chlorphenamine Drugs 0.000 description 1
- SOYKEARSMXGVTM-UHFFFAOYSA-N chlorphenamine Chemical compound C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 SOYKEARSMXGVTM-UHFFFAOYSA-N 0.000 description 1
- 229940046978 chlorpheniramine maleate Drugs 0.000 description 1
- 238000012258 culturing Methods 0.000 description 1
- 229960002104 cyanocobalamin Drugs 0.000 description 1
- 235000000639 cyanocobalamin Nutrition 0.000 description 1
- 239000011666 cyanocobalamin Substances 0.000 description 1
- 229940099418 d- alpha-tocopherol succinate Drugs 0.000 description 1
- 229960000520 diphenhydramine Drugs 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 229960000525 diphenhydramine hydrochloride Drugs 0.000 description 1
- KCIDZIIHRGYJAE-YGFYJFDDSA-L dipotassium;[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl] phosphate Chemical compound [K+].[K+].OC[C@H]1O[C@H](OP([O-])([O-])=O)[C@H](O)[C@@H](O)[C@H]1O KCIDZIIHRGYJAE-YGFYJFDDSA-L 0.000 description 1
- 150000002016 disaccharides Chemical class 0.000 description 1
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 description 1
- VWWQXMAJTJZDQX-UYBVJOGSSA-N flavin adenine dinucleotide Chemical compound C1=NC2=C(N)N=CN=C2N1[C@@H]([C@H](O)[C@@H]1O)O[C@@H]1CO[P@](O)(=O)O[P@@](O)(=O)OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C2=NC(=O)NC(=O)C2=NC2=C1C=C(C)C(C)=C2 VWWQXMAJTJZDQX-UYBVJOGSSA-N 0.000 description 1
- 235000019162 flavin adenine dinucleotide Nutrition 0.000 description 1
- 239000011714 flavin adenine dinucleotide Substances 0.000 description 1
- 229940093632 flavin-adenine dinucleotide Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 1
- 238000001641 gel filtration chromatography Methods 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 150000004677 hydrates Chemical class 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 229940040452 linolenate Drugs 0.000 description 1
- DTOSIQBPPRVQHS-PDBXOOCHSA-M linolenate Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC([O-])=O DTOSIQBPPRVQHS-PDBXOOCHSA-M 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229940041616 menthol Drugs 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 1
- 229960002216 methylparaben Drugs 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 229940113124 polysorbate 60 Drugs 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 125000001453 quaternary ammonium group Chemical group 0.000 description 1
- 235000020945 retinal Nutrition 0.000 description 1
- 239000011604 retinal Substances 0.000 description 1
- 230000002207 retinal effect Effects 0.000 description 1
- NCYCYZXNIZJOKI-OVSJKPMPSA-N retinal group Chemical group C\C(=C/C=O)\C=C\C=C(\C=C\C1=C(CCCC1(C)C)C)/C NCYCYZXNIZJOKI-OVSJKPMPSA-N 0.000 description 1
- 229930002330 retinoic acid Natural products 0.000 description 1
- 229960003471 retinol Drugs 0.000 description 1
- 235000020944 retinol Nutrition 0.000 description 1
- 239000011607 retinol Substances 0.000 description 1
- 229960000342 retinol acetate Drugs 0.000 description 1
- 235000019173 retinyl acetate Nutrition 0.000 description 1
- 239000011770 retinyl acetate Substances 0.000 description 1
- QGNJRVVDBSJHIZ-QHLGVNSISA-N retinyl acetate Chemical compound CC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C QGNJRVVDBSJHIZ-QHLGVNSISA-N 0.000 description 1
- 229940108325 retinyl palmitate Drugs 0.000 description 1
- 235000019172 retinyl palmitate Nutrition 0.000 description 1
- 239000011769 retinyl palmitate Substances 0.000 description 1
- HLWRUJAIJJEZDL-UHFFFAOYSA-M sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC([O-])=O HLWRUJAIJJEZDL-UHFFFAOYSA-M 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000021 stimulant Substances 0.000 description 1
- 229960003080 taurine Drugs 0.000 description 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 1
- 229950009883 tocopheryl nicotinate Drugs 0.000 description 1
- 239000012929 tonicity agent Substances 0.000 description 1
- 229960001727 tretinoin Drugs 0.000 description 1
- 229960005066 trisodium edetate Drugs 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
Definitions
- the present inventor aims to provide an eye wash composition that has excellent antiseptic properties while containing propylene glycol.
- the present inventors have conducted intensive studies in view of the above problems, and have found that by using a combination of 0.01 w/v% or more of hyaluronic acid with propylene glycol in an eye wash composition, the antiseptic agent is not added. Nevertheless, the present inventors have found that antiseptic properties can be imparted to eye wash compositions despite the fact that propylene glycol is incorporated.
- the present invention has been completed as a result of further studies based on this knowledge, and is described below. Section 1.
- An eye wash composition excellent in antiseptic properties can be provided even if it does not contain an antiseptic selected from chlorobutanol and sorbic acids.
- the present disclosure contains 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof, and propylene glycol, quaternary ammonium salt preservatives, paraoxybenzoic acid esters, It includes preservative-free eye wash compositions selected from chlorobutanol and sorbic acids.
- At least one selected from the group consisting of hyaluronic acid and salts thereof is a conventionally known substance, and as a salt of hyaluronic acid, preferably an alkali metal salt such as sodium salt. etc. are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- component (A) is not limited as long as it is 0.01 w/v% or more in the eye wash composition of the present disclosure, preferably 0.01 to 0.08 w/v%, more preferably 0.01. ⁇ 0.02 w/v%, more preferably 0.015 to 0.02 w/v% is exemplified.
- Propylene glycol (sometimes referred to as component (B)) is conventionally known.
- the content of propylene glycol is not limited as long as the effects of the present disclosure can be obtained, but it is preferably 0.01 to 2 w/v%, more preferably 0.05 to 1.5 w/v% in the eye wash composition. , and more preferably 0.1 to 1 w/v%.
- the content of propylene glycol is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 100 parts by mass, more preferably 10 to 100 parts by mass, per 1 part by mass of component (A) in the eye wash composition. 55 parts by mass, more preferably 20 to 50 parts by mass is exemplified.
- the eye wash composition of the present disclosure does not contain a preservative selected from quaternary ammonium salt preservatives, paraoxybenzoic acid esters, chlorobutanol and sorbic acids.
- the antiseptic is a conventionally known antiseptic in the fields of eye drops and eye washes.
- quaternary ammonium preservatives include benzalkonium chloride and benzethonium chloride.
- paraoxybenzoic acid esters include paraoxybenzoic acid esters such as methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butyl parahydroxybenzoate, and salts of paraoxybenzoic acid esters (alkali metal salts such as sodium salts, etc.).
- sorbic acids include sorbic acid, salts of sorbic acid (alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as calcium salts and magnesium salts, etc.), and the like.
- the eyewash composition of the present disclosure may further contain at least one selected from the group consisting of edetic acid and salts thereof (sometimes referred to as component (C)).
- Edetic acid is also known as ethylenediaminetetraacetic acid (EDTA).
- Edetate salts include monosodium edetate, disodium edetate, trisodium edetate, tetrasodium edetate, dipotassium edetate, tripotassium edetate, and tetrapotassium edetate (including hydrates). be done. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- component (C) in the eyewash composition is 0.02 w/ v % or more, preferably 0.05 w/v % or more, more preferably 0.05 to 0.1 w/v %, still more preferably 0.05 to 0.08 w/v %.
- the content of component (C) is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 8 parts by mass, more preferably 1 to 8 parts by mass per 1 part by mass of component (A) in the eye wash composition. Examples are 2 to 6 parts by mass, more preferably 2.5 to 5 parts by mass.
- the eyewash composition of the present disclosure may further contain at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof (sometimes referred to as component (D)).
- Pyridoxine and its salts are known substances and are not limited, but examples of salts of pyridoxine include hydrochloride (pyridoxine hydrochloride) and inorganic acid salts such as phosphate.
- Chondroitin sulfate is a mucopolysaccharide that has a structure in which sulfuric acid is ester-bonded to a sugar chain of repeating disaccharides of D-glucuronic acid and N-acetylgalactosamine.
- chondroitin sulfate salts include, but are not limited to, alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as magnesium salts and calcium salts, and the like.
- Examples of chondroitin sulfate salts which are not intended to limit the scope of the present invention, include sodium chondroitin sulfate and the like.
- the chondroitin sulfate and salts thereof used in the present disclosure are not limited in this respect, but the molecular weight thereof is preferably exemplified by a weight-average molecular weight of about 05,000 to 45,000, more preferably 10,000 to 4,000. About 10,000, more preferably about 15,000 to 30,000 are exemplified. Weight average molecular weight is measured by gel filtration chromatography. Chondroitin sulfate and salts thereof are commercially available, for example, under the trade name of sodium chondroitin sulfate (manufactured by Seikagaku Corporation, weight average molecular weight: 20,000).
- chondroitin sulfate and its salts may be used singly or in combination of two or more.
- component (D) in the eye wash composition is preferably 0.5. 001 to 0.1 w/v%, more preferably 0.01 to 0.07 w/v%, and still more preferably 0.04 to 0.06 w/v%.
- the content of component (D) is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 10 parts by mass, more preferably 2 parts by mass per 1 part by mass of component (A) in the eye wash composition. Up to 6 parts by mass, more preferably 2 to 4 parts by mass are exemplified.
- At least one selected from the group consisting of pyridoxine and its salts is 0.008 to 0.01 w/v% in the eye wash composition, More preferably 0.001 to 0.01 w/v%, particularly preferably 0.005 to 0.01 w/v%.
- At least one selected from the group consisting of chondroitin sulfate and salts thereof is 0.0055 to 0.05 w/v% in the eye wash composition. , more preferably 0.01 to 0.05 w/v%, particularly preferably 0.025 to 0.05 w/v%.
- the eye wash composition of the present disclosure may further contain any other component acceptable for use in eye drops or eye wash.
- Other ingredients include, but are not limited to, buffers, stabilizers, tonicity agents, solvents (such as water), pH adjusters, medicinal ingredients, cooling agents, stimulants, and thickeners. etc. are exemplified.
- the other components may be appropriately selected according to the purpose, etc., as long as they do not interfere with the effects of the present disclosure, and may be used singly or in combination of two or more. , and the blending amount thereof may be appropriately determined.
- the components (A) to (D) are also known as, for example, medicinal ingredients, stabilizers, thickeners, etc., depending on the component, but in the present disclosure, the components (A) to (D) are It is not included in any other component.
- buffering agents such as boric acid and borax.
- a buffering agent may be used individually by 1 type, and may be used in combination of 2 or more type.
- boric acid the content of boric acid is not limited as long as it does not interfere with the effects of the present disclosure. exemplified, more preferably 0.5 to 2 w/v%.
- borax the content of borax is not limited as long as it does not interfere with the effects of the present disclosure. exemplified, more preferably 0.005 to 0.05 w/v%.
- the composition may or may not contain buffering agents other than boric acid and borax. Also, the composition may contain only one of boric acid and borax.
- stabilizers include stabilizers such as polysorbate (polysorbate 80, polysorbate 60, etc.), polyoxyethylene (POE) hydrogenated castor oil (POE (80) hydrogenated castor oil, POE (60) hydrogenated castor oil,
- POE polyoxypropylene glycol
- the number in parentheses means the average number of added moles of ethylene oxide), POE polyoxypropylene glycol, trometamol and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- the composition contains a stabilizer, its content is not limited as long as it does not interfere with the effects of the present disclosure, preferably 0.01 to 1 w / v% in the composition, more preferably 0.05 to 0.1 w/v% is exemplified.
- composition when the composition contains a stabilizer, it may contain only one or only two selected from, for example, polysorbate, POE hydrogenated castor oil, POE polyoxypropylene glycol and trometamol. , polysorbate, it can also be prepared without POE hydrogenated castor oil, POE polyoxypropylene glycol and/or trometamol.
- ingredients examples include amino acids, anti-inflammatory agents, vitamins, antihistamines, and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- amino acids include amino acids such as glutamic acid and salts thereof and salts thereof; amino acid analogues such as taurine. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- the eyewash composition of the present disclosure can also be prepared without the amino acid and/or salt thereof.
- amino acid as used herein means an amino acid having both an amino group and a carboxyl group and capable of becoming a structural unit of a protein, and includes, for example, L-aspartic acid.
- the eyewash composition of the present disclosure can also be prepared without the amino acid analogue.
- Non-limiting examples of anti-inflammatory agents include zinc sulfate, zinc lactate, epsilon-aminocaproic acid, allantoin, glycyrrhizic acid and its salts, azulenes (azulene, dimethylisopropylazulene, dimethylethylazulene, these salt etc.) and the like are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type. While not limiting the disclosure, the composition preferably does not contain zinc sulfate and/or zinc lactate. The composition can also be prepared without epsilon-aminocaproic acid, allantoin, glycyrrhizic acid and salts thereof.
- vitamins examples include vitamin A (retinol palmitate, retinol acetate, retinol, retinal, retinoic acid, etc.), vitamin B (flavin adenine dinucleotide, cyanocobalamin, etc.), vitamin E (acetic acid tocopherol, tocopherol succinate, tocopherol nicotinate, tocopherol linolenate, etc.). These may be used individually by 1 type, and may be used in combination of 2 or more type. While not limiting the disclosure, the composition may be prepared without at least one of the vitamins.
- vitamin A retinol palmitate, retinol acetate, retinol, retinal, retinoic acid, etc.
- vitamin B flavin adenine dinucleotide, cyanocobalamin, etc.
- vitamin E acetic acid tocopherol, tocopherol succinate, tocopherol nicotinate, tocopherol linol
- antihistamines include chlorpheniramine and its salts (chlorpheniramine maleate, etc.), diphenhydramine and its salts (diphenhydramine hydrochloride, etc.), and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type. Compositions of the present disclosure may also be prepared without an antihistamine.
- the content of the medicinal ingredient is not limited as long as it does not interfere with the effects of the present disclosure, and the content of the medicinal ingredient in the composition is preferably 0.05 to 0. .3 w/v%, more preferably 0.1 to 0.3 w/v%, and even more preferably 0.2 to 0.27 w/v%.
- cooling agents such as menthol, camphor, and borneol.
- a cooling agent may be used individually by 1 type, and may be used in combination of 2 or more types.
- the compositions of the present disclosure may contain cooling agents or may be prepared without cooling agents.
- compositions of the present disclosure may contain a stimulant or may be prepared without a stimulant.
- Examples of other components include thickeners, such as alginic acid and salts thereof, hydroxyethylcellulose, methylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, carboxyvinyl polymer, and these. Salt, glycerin and the like are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type.
- the eyewash composition of the present disclosure can also be prepared without these thickening agents.
- the eye wash composition of the present disclosure can be produced by mixing the components (A) and (B), and optionally the components (C) and (D), and the other components.
- the mixing is not limited as long as these components can be mixed, and may be mixed according to a normal procedure.
- the pH of the eye wash composition of the present disclosure is not limited as long as it can be used as an eye drop or an eye wash. is pH 5.5 to 6, more preferably pH 5.5 to 5.8.
- the form of the eye wash composition of the present disclosure is liquid at room temperature, and the method of use is not limited as long as the eye can be washed in the same manner as in conventionally known methods. used or used to wash the eyes with eye drops.
- the eye wash composition of the present disclosure may be used with or without contact lenses.
- Contact lenses may be either hard contact lenses or soft contact lenses.
- the eye wash composition of the present disclosure is not limited as long as it can be used as described above. (including the cap).
- the volume of the container is not limited, the volume is preferably 450 to 550 mL from the viewpoint of ease of use.
- Eyewashing using an eyewash cup may follow a normal procedure.
- an appropriate amount of the eyewash composition of the present disclosure is poured from the container into the eyewash cup, for example, 4 to 6 mL per eye at a time, and then the cup is poured. is pressed around the eye on one side to bring the eye wash composition in the cup into contact with the eye, and the eye is blinked several times.
- the eyewash composition of the present disclosure when used for eyewash by eyedrops, it is usually housed in an eyedropper container for use.
- the eye drop container is not limited as long as the composition can be accommodated and applied to the eye. and at least two of the caps are integrated) is exemplified.
- the volume of the container is not limited, a volume of 8 to 20 mL is exemplified from the viewpoint of ease of use.
- the eye wash by instillation may follow the usual method of use, and the eye wash composition of the present disclosure is used by instilling 4 to 6 drops per eye at a time.
- the amount to be dropped per drop is also not limited, but preferably 35 to 40 ⁇ L is exemplified per drop.
- the eye wash composition of the present disclosure hyaluronic acid and By using 0.01 w/v% or more of at least one selected from the group consisting of salts thereof in combination with propylene glycol, excellent antiseptic properties can be imparted to the eye wash composition. Further, by blending at least one selected from the group consisting of edetic acid and salts thereof, or blending at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof, As shown in the examples, the eyewash composition can be provided with even better antiseptic properties, although no antiseptic is added. In addition, when the composition further contains the above-mentioned active ingredients and the like, useful effects based on the active ingredients and the like can also be obtained.
- Test example 1 Preparation of eyewash composition
- Each component was mixed according to the mixing ratio shown in Table 1 below, and the resulting mixture was passed through a sterilizing filter (Examples 1 to 5, Reference Examples, Comparative Examples 1 to 3).
- the pH of each composition immediately after preparation was measured.
- the pH was measured at room temperature (25° C.) using a desktop pH meter F-52 (manufactured by Horiba, Ltd.).
- sodium chondroitin sulfate ester in the table a pharmacologically approved sodium chondroitin sulfate (weight average molecular weight: 20,000) was used.
- a bacterial solution (1 ⁇ 10 8 cfu/mL) was prepared by suspending Candida albicans in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1 ⁇ 10 6 cfu/mL and stored at 30° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Candida was applied to a commercially available GPLP agar medium (GPLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick and cultured at 30 ° C. for 48 hours.
- GPLP agar medium "Daigo" manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.
- the antiseptic power of the eye wash composition was evaluated according to the following criteria. [Evaluation criteria] ⁇ : Survival rate decreased to 0.1% or less of the inoculated dose ⁇ : Survival rate decreased to 1% or less of the inoculated dose ⁇ : Survival rate decreased to 10% or less of the inoculated dose ⁇ : Does not meet the above ⁇ criteria
- ⁇ Staphylococcus aureus> A bacterial solution (1 ⁇ 10 8 cfu/mL) was prepared by suspending Staphylococcus aureus in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1 ⁇ 10 6 cfu/mL, and stored at 35° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Staphylococcus aureus was applied to a commercially available SCDLP agar medium (SCDLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick, and kept at 35 ° C. for 48 hours.
- SCDLP agar medium "Daigo manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.
- the antiseptic power of the eye wash composition was evaluated according to the same criteria as described above.
- the reference example containing benzalkonium chloride, which is an antiseptic, is a positive control in this test example.
- Comparative Example 1 in which propylene glycol was added without benzalkonium chloride, the evaluation result was x, and the desired antiseptic power was not obtained.
- Comparative Example 2 in which 0.01 w/v % sodium hyaluronate was added without benzalkonium chloride or propylene glycol, the evaluation result was ⁇ , and the desired antiseptic power was not obtained.
- Comparative Example 3 in which 0.001 w/v% sodium hyaluronate and propylene glycol were blended without benzalkonium chloride, the evaluation result was ⁇ , and the desired antiseptic power was not obtained.
- Example 1 in which 0.01 w/v% sodium hyaluronate and propylene glycol were blended without benzalkonium chloride, the evaluation result was ⁇ , and an improvement in antiseptic power was recognized. Also in Example 2 in which the content of sodium hyaluronate was increased in Example 1, the evaluation result was ⁇ , and an improvement in antiseptic power was recognized. From this, it was confirmed that the combination of 0.01 w/v% or more of sodium hyaluronate with propylene glycol, which surprisingly has poor antiseptic properties, can enhance the antiseptic properties of eye wash compositions.
- Example 3 to 5 in which sodium edetate was further blended in Examples 1 and 2 Example 6 in which sodium chondroitin sulfate was further blended in Example 5, and pyridoxine hydrochloride in Example 6 were further blended.
- Example 7 which was blended, the evaluation result was ⁇ or ⁇ , and an improvement in antiseptic power was recognized. Further, even when the pH of Examples 1 to 7 was 6.2, an improvement in antiseptic properties similar to that of Examples 1 to 7 was observed.
- sodium hyaluronate is used in combination with propylene glycol, which has poor antiseptic properties, at 0.01 w/v% or more, and furthermore, sodium edetate, sodium chondroitin sulfate, and pyridoxine hydrochloride are used in combination. By doing so, it was confirmed that the antiseptic property of the eyewash composition can be enhanced.
- the eyewash compositions of Examples 1 to 7 do not use a preservative such as benzalkonium chloride, which is likely to be adsorbed to contact lenses, the antiseptic properties of the eyewash compositions can be enhanced, and thus the eyes can be washed while the contact lenses are worn. It is possible to
- An eye wash composition was prepared according to the blending ratio shown in Formulation Example Table 3, and the antiseptic power was evaluated in the same manner as in Test Examples. Improvement of antiseptic property was recognized to some extent.
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Abstract
[Problem] To provide an eyewash composition that contains propylene glycol but yet has excellent antiseptic properties. [Solution] An eyewash composition that contains 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof and propylene glycol but does not contain an antiseptic agent selected from quaternary ammonium salt antiseptic agents, paraoxybenzoates, chlorobutanol, sorbic acid and derivatives thereof.
Description
洗眼用組成物に関する。
Regarding eye wash compositions.
洗眼薬の浸透圧は涙液に近い値に調整することが望ましいとされており、その等張化剤としてプロピレングリコールが配合されることが多い。しかし、プロピレングリコールを配合すると防腐性が悪化するという問題があった。一方、塩化ベンザルコニウムのような防腐剤を使用することで防腐性を向上させることが知られているが（特許文献１）、角膜への影響やコンタクトレンズへの吸着が懸念され、防腐剤の使用は望ましくない。
It is desirable to adjust the osmotic pressure of the eyewash to a value close to that of tears, and propylene glycol is often added as a tonicity agent. However, when propylene glycol is blended, there is a problem that the antiseptic property is deteriorated. On the other hand, it is known that antiseptic properties can be improved by using antiseptic agents such as benzalkonium chloride (Patent Document 1). is not recommended.
そこで、本発明者は、プロピレングリコールを配合しながらも、防腐性に優れた洗眼用組成物を提供することを目的とする。
Therefore, the present inventor aims to provide an eye wash composition that has excellent antiseptic properties while containing propylene glycol.
本発明者は、前記課題に鑑み鋭意検討を行ったところ、洗眼用組成物においてプロピレングリコールに０．０１ｗ／ｖ％以上のヒアルロン酸を組み合わせて使用することにより、防腐剤を配合していないにもかかわらず、また、プロピレングリコールを配合しているにもかかわらず、洗眼用組成物に防腐性を付与できることを見出した。本発明は該知見に基づき更に検討を重ねた結果完成されたものであり、次に掲げるものである。
項１．（Ａ）ヒアルロン酸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０．０１ｗ／ｖ％以上、及び（Ｂ）プロピレングリコールを含有し、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しない、洗眼用組成物。
項２．更に、（Ｃ）エデト酸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０．０５ｗ／ｖ％以上含有する、項１に記載の洗眼用組成物。
項３．更に、（Ｄ）ピリドキシン、コンドロイチン硫酸及びこれらの塩からなる群より選択される少なくとも１種を含有する、項１または２に記載の洗眼用組成物。
項４．コンタクトレンズ装着中に使用される、項１～３のいずれか一項に記載の洗眼組成物。 The present inventors have conducted intensive studies in view of the above problems, and have found that by using a combination of 0.01 w/v% or more of hyaluronic acid with propylene glycol in an eye wash composition, the antiseptic agent is not added. Nevertheless, the present inventors have found that antiseptic properties can be imparted to eye wash compositions despite the fact that propylene glycol is incorporated. The present invention has been completed as a result of further studies based on this knowledge, and is described below.
Section 1. (A) 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof, and (B) propylene glycol, quaternary ammonium salt preservative, paraoxybenzoic acid ester A preservative-free eye wash composition selected from chlorobutanol and sorbic acids.
Section 2. Item 2. The eyewash composition according to Item 1, further comprising (C) at least one selected from the group consisting of edetic acid and salts thereof at 0.05 w/v% or more.
Item 3. Item 3. The eyewash composition according to Item 1 or 2, further comprising (D) at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof.
Section 4. Item 4. The eye wash composition according to any one of items 1 to 3, which is used while wearing a contact lens.
項１．（Ａ）ヒアルロン酸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０．０１ｗ／ｖ％以上、及び（Ｂ）プロピレングリコールを含有し、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しない、洗眼用組成物。
項２．更に、（Ｃ）エデト酸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０．０５ｗ／ｖ％以上含有する、項１に記載の洗眼用組成物。
項３．更に、（Ｄ）ピリドキシン、コンドロイチン硫酸及びこれらの塩からなる群より選択される少なくとも１種を含有する、項１または２に記載の洗眼用組成物。
項４．コンタクトレンズ装着中に使用される、項１～３のいずれか一項に記載の洗眼組成物。 The present inventors have conducted intensive studies in view of the above problems, and have found that by using a combination of 0.01 w/v% or more of hyaluronic acid with propylene glycol in an eye wash composition, the antiseptic agent is not added. Nevertheless, the present inventors have found that antiseptic properties can be imparted to eye wash compositions despite the fact that propylene glycol is incorporated. The present invention has been completed as a result of further studies based on this knowledge, and is described below.
Section 1. (A) 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof, and (B) propylene glycol, quaternary ammonium salt preservative, paraoxybenzoic acid ester A preservative-free eye wash composition selected from chlorobutanol and sorbic acids.
Section 2. Item 2. The eyewash composition according to Item 1, further comprising (C) at least one selected from the group consisting of edetic acid and salts thereof at 0.05 w/v% or more.
Item 3. Item 3. The eyewash composition according to Item 1 or 2, further comprising (D) at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof.
Section 4. Item 4. The eye wash composition according to any one of items 1 to 3, which is used while wearing a contact lens.
ヒアルロン酸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０．０１ｗ／ｖ％以上と、プロピレングリコールとを組み合わせて用いることにより、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しなくても、防腐性に優れた洗眼用組成物を提供することができる。
By using 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof in combination with propylene glycol, quaternary ammonium salt preservatives, paraoxybenzoic acid esters, An eye wash composition excellent in antiseptic properties can be provided even if it does not contain an antiseptic selected from chlorobutanol and sorbic acids.
以下、本開示に包含される実施形態について更に詳細に説明する。
Hereinafter, embodiments included in the present disclosure will be described in further detail.
本開示は、ヒアルロン酸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０．０１ｗ／ｖ％以上、及びプロピレングリコールを含有し、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しない、洗眼用組成物を包含する。
The present disclosure contains 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof, and propylene glycol, quaternary ammonium salt preservatives, paraoxybenzoic acid esters, It includes preservative-free eye wash compositions selected from chlorobutanol and sorbic acids.
ヒアルロン酸及びその塩からなる群より選択される少なくとも１種（成分（Ａ）と称することがある）は、従来公知の物質であり、ヒアルロン酸の塩として、好ましくはナトリウム塩等のアルカリ金属塩等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。
At least one selected from the group consisting of hyaluronic acid and salts thereof (sometimes referred to as component (A)) is a conventionally known substance, and as a salt of hyaluronic acid, preferably an alkali metal salt such as sodium salt. etc. are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type.
成分（Ａ）の含有量は、本開示の洗眼用組成物中０．０１ｗ／ｖ％以上である限り制限されず、好ましくは０．０１～０．０８ｗ／ｖ％、より好ましくは０．０１～０．０２ｗ／ｖ％、更に好ましくは０．０１５～０．０２ｗ／ｖ％が例示される。
The content of component (A) is not limited as long as it is 0.01 w/v% or more in the eye wash composition of the present disclosure, preferably 0.01 to 0.08 w/v%, more preferably 0.01. ~0.02 w/v%, more preferably 0.015 to 0.02 w/v% is exemplified.
プロピレングリコール（成分（Ｂ）と称することがある）は、従来公知である。プロピレングリコールの含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、好ましくは０．０１～２ｗ／ｖ％、より好ましくは０．０５～１．５ｗ／ｖ％、更に好ましくは０．１～１ｗ／ｖ％が例示される。また、プロピレングリコールの含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、成分（Ａ）１質量部あたり、好ましくは１～１００質量部、より好ましくは１０～５５質量部、更に好ましくは２０～５０質量部が例示される。
Propylene glycol (sometimes referred to as component (B)) is conventionally known. The content of propylene glycol is not limited as long as the effects of the present disclosure can be obtained, but it is preferably 0.01 to 2 w/v%, more preferably 0.05 to 1.5 w/v% in the eye wash composition. , and more preferably 0.1 to 1 w/v%. The content of propylene glycol is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 100 parts by mass, more preferably 10 to 100 parts by mass, per 1 part by mass of component (A) in the eye wash composition. 55 parts by mass, more preferably 20 to 50 parts by mass is exemplified.
本開示の洗眼用組成物は、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しない。該防腐剤は、点眼、洗眼分野で従来公知の防腐剤である。第４級アンモニウム系防腐剤として、ベンザルコニウム塩化物、ベンゼトニウム塩化物等が例示される。パラオキシ安息香酸エステル類として、パラオキシ安息香酸メチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル等のパラオキシ安息香酸エステル、パラオキシ安息香酸エステルの塩（ナトリウム塩等のアルカリ金属塩等）等が例示される。ソルビン酸類として、ソルビン酸、ソルビン酸の塩（ナトリウム塩、カリウム塩等のアルカリ金属塩、カルシウム塩、マグネシウム塩等のアルカリ土類金属等）等が例示される。
The eye wash composition of the present disclosure does not contain a preservative selected from quaternary ammonium salt preservatives, paraoxybenzoic acid esters, chlorobutanol and sorbic acids. The antiseptic is a conventionally known antiseptic in the fields of eye drops and eye washes. Examples of quaternary ammonium preservatives include benzalkonium chloride and benzethonium chloride. Examples of paraoxybenzoic acid esters include paraoxybenzoic acid esters such as methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butyl parahydroxybenzoate, and salts of paraoxybenzoic acid esters (alkali metal salts such as sodium salts, etc.). Examples of sorbic acids include sorbic acid, salts of sorbic acid (alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as calcium salts and magnesium salts, etc.), and the like.
本開示の洗眼用組成物は、更に、エデト酸及びその塩からなる群より選択される少なくとも１種（成分（Ｃ）と称することがある）を含有してもよい。エデト酸は、エチレンジアミン四酢酸（ＥＤＴＡ）とも称され従来公知である。エデト酸の塩としては、エデト酸一ナトリウム、エデト酸二ナトリウム、エデト酸三ナトリウム、エデト酸四ナトリウム、エデト酸二カリウム、エデト酸三カリウム、エデト四カリウム等（水和物を含む）が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。
The eyewash composition of the present disclosure may further contain at least one selected from the group consisting of edetic acid and salts thereof (sometimes referred to as component (C)). Edetic acid is also known as ethylenediaminetetraacetic acid (EDTA). Edetate salts include monosodium edetate, disodium edetate, trisodium edetate, tetrasodium edetate, dipotassium edetate, tripotassium edetate, and tetrapotassium edetate (including hydrates). be done. These may be used individually by 1 type, and may be used in combination of 2 or more type.
本開示の洗眼用組成物が成分（Ｃ）を含有する場合、その含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、成分（Ｃ）は０．０２ｗ／ｖ％以上、好ましくは０．０５ｗ／ｖ％以上、より好ましくは０．０５～０．１ｗ／ｖ％、更に好ましくは０．０５～０．０８ｗ／ｖ％が例示される。また、成分（Ｃ）の含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、成分（Ａ）１質量部あたり、好ましくは１～８質量部、より好ましくは２～６質量部、更に好ましくは２．５～５質量部が例示される。
When the eyewash composition of the present disclosure contains component (C), its content is not limited as long as the effect of the present disclosure is obtained, but component (C) in the eyewash composition is 0.02 w/ v % or more, preferably 0.05 w/v % or more, more preferably 0.05 to 0.1 w/v %, still more preferably 0.05 to 0.08 w/v %. The content of component (C) is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 8 parts by mass, more preferably 1 to 8 parts by mass per 1 part by mass of component (A) in the eye wash composition. Examples are 2 to 6 parts by mass, more preferably 2.5 to 5 parts by mass.
本開示の洗眼用組成物は、更に、ピリドキシン、コンドロイチン硫酸及びこれらの塩からなる群より選択される少なくとも１種（成分（Ｄ）と称することがある）を含有してもよい。
The eyewash composition of the present disclosure may further contain at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof (sometimes referred to as component (D)).
ピリドキシン及びその塩は、公知の物質であり制限されないが、ピリドキシンの塩として塩酸塩（塩酸ピリドキシン）、リン酸塩等の無機酸塩が例示される。
Pyridoxine and its salts are known substances and are not limited, but examples of salts of pyridoxine include hydrochloride (pyridoxine hydrochloride) and inorganic acid salts such as phosphate.
コンドロイチン硫酸は、Ｄ－グルクロン酸とＮ－アセチルガラクトサミンの２糖が反復する糖鎖に硫酸がエステル結合した構造を有するムコ多糖である。コンドロイチン硫酸の塩としては、本発明を制限するものではないが、ナトリウム塩、カリウム塩等のアルカリ金属塩、マグネシウム塩、カルシウム塩等のアルカリ土類金属塩等が例示される。本発明を制限するものではないが、コンドロイチン硫酸の塩として、好ましくはコンドロイチン硫酸エステルナトリウム等が例示される。
Chondroitin sulfate is a mucopolysaccharide that has a structure in which sulfuric acid is ester-bonded to a sugar chain of repeating disaccharides of D-glucuronic acid and N-acetylgalactosamine. Examples of chondroitin sulfate salts include, but are not limited to, alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as magnesium salts and calcium salts, and the like. Examples of chondroitin sulfate salts, which are not intended to limit the scope of the present invention, include sodium chondroitin sulfate and the like.
本開示において使用されるコンドロイチン硫酸やその塩はこの限りにおいて制限されないが、その分子量として、好ましくは重量平均分子量が０．５万～４．５万程度が例示され、より好ましくは１万～４万程度、更に好ましくは１．５万～３万程度が例示される。重量平均分子量はゲルろ過クロマトグラフィーにより測定される。コンドロイチン硫酸やその塩は市販されており、例えば商品名局外規コンドロイチン硫酸ナトリウム（生化学工業株式会社製、重量平均分子量２００００）で販売されている。
The chondroitin sulfate and salts thereof used in the present disclosure are not limited in this respect, but the molecular weight thereof is preferably exemplified by a weight-average molecular weight of about 05,000 to 45,000, more preferably 10,000 to 4,000. About 10,000, more preferably about 15,000 to 30,000 are exemplified. Weight average molecular weight is measured by gel filtration chromatography. Chondroitin sulfate and salts thereof are commercially available, for example, under the trade name of sodium chondroitin sulfate (manufactured by Seikagaku Corporation, weight average molecular weight: 20,000).
ピリドキシンやその塩、コンドロイチン硫酸やその塩は、１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。
Pyridoxine and its salts, chondroitin sulfate and its salts may be used singly or in combination of two or more.
本開示の洗眼用組成物が成分（Ｄ）を含有する場合、その含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、成分（Ｄ）は好ましくは０．００１～０．１ｗ／ｖ％、より好ましくは０．０１～０．０７ｗ／ｖ％、更に好ましくは０．０４～０．０６ｗ／ｖ％が例示される。また、成分（Ｄ）含有量は、本開示の効果が得られる限り制限されないが、該洗眼用組成物中、成分（Ａ）１質量部あたり、好ましくは１～１０質量部、より好ましくは２～６質量部、更に好ましくは２～４質量部が例示される。
When the eye wash composition of the present disclosure contains component (D), its content is not limited as long as the effect of the present disclosure is obtained, but component (D) in the eye wash composition is preferably 0.5. 001 to 0.1 w/v%, more preferably 0.01 to 0.07 w/v%, and still more preferably 0.04 to 0.06 w/v%. The content of component (D) is not limited as long as the effects of the present disclosure can be obtained, but is preferably 1 to 10 parts by mass, more preferably 2 parts by mass per 1 part by mass of component (A) in the eye wash composition. Up to 6 parts by mass, more preferably 2 to 4 parts by mass are exemplified.
また、本開示を制限するものではないが、より好ましくは、ピリドキシン及びその塩からなる群より選択される少なくとも１種は、該洗眼用組成物中、０．００８～０．０１ｗ／ｖ％、更に好ましくは０．００１～０．０１ｗ／ｖ％、特に好ましくは０．００５～０．０１ｗ／ｖ％が例示される。
In addition, although not limiting the present disclosure, more preferably, at least one selected from the group consisting of pyridoxine and its salts is 0.008 to 0.01 w/v% in the eye wash composition, More preferably 0.001 to 0.01 w/v%, particularly preferably 0.005 to 0.01 w/v%.
また、本開示を制限するものではないが、より好ましくは、コンドロイチン硫酸及びその塩からなる群より選択される少なくとも１種が、該洗眼用組成物中、０．００５５～０．０５ｗ／ｖ％、更に好ましくは０．０１～０．０５ｗ／ｖ％、特に好ましくは０．０２５～０．０５ｗ／ｖ％が例示される。
In addition, although not limiting the present disclosure, more preferably, at least one selected from the group consisting of chondroitin sulfate and salts thereof is 0.0055 to 0.05 w/v% in the eye wash composition. , more preferably 0.01 to 0.05 w/v%, particularly preferably 0.025 to 0.05 w/v%.
本開示の洗眼用組成物は、点眼や洗眼における使用に許容可能な任意の他の成分を更に含有してもよい。該他の成分として、本開示を制限するものではないが、緩衝剤、安定剤、等張化剤、溶剤（水等）、ｐＨ調整剤、薬効成分、清涼化剤、刺激剤、増粘剤等が例示される。該他の成分は、本開示の効果を妨げないことを限度として、目的等に応じて適宜選択すればよく、１種単独で使用してもよく、２種以上を組み合わせて使用してもよく、その配合量も適宜決定すればよい。なお、前記成分（Ａ）～（Ｄ）は、その成分に応じて例えば薬効成分、安定剤、増粘剤等としても知られているが、本開示において前記成分（Ａ）～（Ｄ）は該任意の他の成分には包含されない。
The eye wash composition of the present disclosure may further contain any other component acceptable for use in eye drops or eye wash. Other ingredients include, but are not limited to, buffers, stabilizers, tonicity agents, solvents (such as water), pH adjusters, medicinal ingredients, cooling agents, stimulants, and thickeners. etc. are exemplified. The other components may be appropriately selected according to the purpose, etc., as long as they do not interfere with the effects of the present disclosure, and may be used singly or in combination of two or more. , and the blending amount thereof may be appropriately determined. The components (A) to (D) are also known as, for example, medicinal ingredients, stabilizers, thickeners, etc., depending on the component, but in the present disclosure, the components (A) to (D) are It is not included in any other component.
該他の成分の一例として緩衝剤を挙げると、緩衝剤としてホウ酸、ホウ砂等が例示される。緩衝剤は、１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。例えば、該組成物がホウ酸を含有する場合、ホウ酸の含有量は、本開示の効果を妨げない限り制限されず、該組成物中、好ましくは０．１～２．５ｗ／ｖ％が例示され、より好ましくは０．５～２ｗ／ｖ％が例示される。例えば、該組成物がホウ砂を含有する場合、ホウ砂の含有量は、本開示の効果を妨げない限り制限されず、該組成物中、好ましくは０．００５～０．５ｗ／ｖ％が例示され、より好ましくは０．００５～０．０５ｗ／ｖ％が例示される。該組成物は、ホウ酸、ホウ砂以外の緩衝剤を含有してもよく、含有しなくてもよい。また、該組成物はホウ酸やホウ砂のいずれか一方のみを配合してもよい。
Examples of other components include buffering agents such as boric acid and borax. A buffering agent may be used individually by 1 type, and may be used in combination of 2 or more type. For example, when the composition contains boric acid, the content of boric acid is not limited as long as it does not interfere with the effects of the present disclosure. exemplified, more preferably 0.5 to 2 w/v%. For example, when the composition contains borax, the content of borax is not limited as long as it does not interfere with the effects of the present disclosure. exemplified, more preferably 0.005 to 0.05 w/v%. The composition may or may not contain buffering agents other than boric acid and borax. Also, the composition may contain only one of boric acid and borax.
該他の成分の一例として安定剤を挙げると、安定剤としてポリソルベート（ポリソルベート８０、ポリソルベート６０等）、ポリオキシエチレン（ＰＯＥ）硬化ヒマシ油（ＰＯＥ（８０）硬化ヒマシ油、ＰＯＥ（６０）硬化ヒマシ油等、括弧内の数字は酸化エチレンの平均付加モル数を意味する）、ＰＯＥポリオキシプロピレングリコール、トロメタモール等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。該組成物が安定剤を含有する場合、その含有量は、本開示の効果を妨げない限り制限されず、該組成物中、好ましくは０．０１～１ｗ／ｖ％が例示され、より好ましくは０．０５～０．１ｗ／ｖ％が例示される。該組成物が安定剤を含有する場合、例えばポリソルベート、ＰＯＥ硬化ヒマシ油、ＰＯＥポリオキシプロピレングリコール及びトロメタモールから選択されるいずれか１種のみ、または２種のみを含有してもよく、また、例えば、ポリソルベートを含有する場合、ＰＯＥ硬化ヒマシ油、ＰＯＥポリオキシプロピレングリコール及び／またはトロメタモールを配合しないで調製することもできる。
Examples of stabilizers include stabilizers such as polysorbate (polysorbate 80, polysorbate 60, etc.), polyoxyethylene (POE) hydrogenated castor oil (POE (80) hydrogenated castor oil, POE (60) hydrogenated castor oil, The number in parentheses means the average number of added moles of ethylene oxide), POE polyoxypropylene glycol, trometamol and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type. When the composition contains a stabilizer, its content is not limited as long as it does not interfere with the effects of the present disclosure, preferably 0.01 to 1 w / v% in the composition, more preferably 0.05 to 0.1 w/v% is exemplified. When the composition contains a stabilizer, it may contain only one or only two selected from, for example, polysorbate, POE hydrogenated castor oil, POE polyoxypropylene glycol and trometamol. , polysorbate, it can also be prepared without POE hydrogenated castor oil, POE polyoxypropylene glycol and/or trometamol.
該他の成分の一例として薬効成分を挙げると、薬効成分として、アミノ酸類、抗炎症剤、ビタミン類、抗ヒスタミン剤等が挙げられる。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。
Examples of other ingredients include amino acids, anti-inflammatory agents, vitamins, antihistamines, and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type.
本開示を制限するものではないが、例えばアミノ酸類として、グルタミン酸及びその塩等のアミノ酸及びその塩；タウリンなどのアミノ酸類似物等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示の洗眼用組成物は、アミノ酸及び／またはその塩を配合しないで調製することもできる。ここでいうアミノ酸とは、アミノ基とカルボキシ基の両方の官能基を持つ蛋白質の構成ユニットとなりえるアミノ酸を意味し、例えばＬ－アスパラギン酸等が含まれる。また、本開示の洗眼用組成物は、アミノ酸類似物を配合しないで調製することもできる。
Although not intended to limit the present disclosure, examples of amino acids include amino acids such as glutamic acid and salts thereof and salts thereof; amino acid analogues such as taurine. These may be used individually by 1 type, and may be used in combination of 2 or more type. The eyewash composition of the present disclosure can also be prepared without the amino acid and/or salt thereof. The term "amino acid" as used herein means an amino acid having both an amino group and a carboxyl group and capable of becoming a structural unit of a protein, and includes, for example, L-aspartic acid. The eyewash composition of the present disclosure can also be prepared without the amino acid analogue.
本開示を制限するものではないが、例えば抗炎症剤として、硫酸亜鉛、乳酸亜鉛、イプシロン－アミノカプロン酸、アラントイン、グリチルリチン酸及びその塩、アズレン類（アズレン、ジメチルイソプロピルアズレン、ジメチルエチルアズレン、これらの塩等）等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示を制限するものではないが、該組成物は好ましくは硫酸亜鉛及び／または乳酸亜鉛を含有しない。また、該組成物は、イプシロン－アミノカプロン酸、アラントイン、グリチルリチン酸及びその塩を配合しないで調製することもできる。
Non-limiting examples of anti-inflammatory agents include zinc sulfate, zinc lactate, epsilon-aminocaproic acid, allantoin, glycyrrhizic acid and its salts, azulenes (azulene, dimethylisopropylazulene, dimethylethylazulene, these salt etc.) and the like are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type. While not limiting the disclosure, the composition preferably does not contain zinc sulfate and/or zinc lactate. The composition can also be prepared without epsilon-aminocaproic acid, allantoin, glycyrrhizic acid and salts thereof.
本開示を制限するものではないが、例えばビタミン類として、ビタミンＡ（パルミチン酸レチノール、酢酸レチノール、レチノール、レチナール、レチノイン酸等）、ビタミンＢ（フラビンアデニンジヌクレオチド、シアノコバラミン等）、ビタミンＥ（酢酸トコフェロール、コハク酸トコフェロール、ニコチン酸トコフェロール、リノレン酸トコフェロール等）等が挙げられる。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示を制限するものではないが、該組成物は、ビタミン類の少なくとも１種を配合しないで調製することもできる。
Examples of vitamins that do not limit the present disclosure include vitamin A (retinol palmitate, retinol acetate, retinol, retinal, retinoic acid, etc.), vitamin B (flavin adenine dinucleotide, cyanocobalamin, etc.), vitamin E (acetic acid tocopherol, tocopherol succinate, tocopherol nicotinate, tocopherol linolenate, etc.). These may be used individually by 1 type, and may be used in combination of 2 or more type. While not limiting the disclosure, the composition may be prepared without at least one of the vitamins.
本開示を制限するものではないが、例えば抗ヒスタミン剤として、クロルフェニラミン及びその塩（マレイン酸クロルフェニラミン等）、ジフェンヒドラミン及びその塩（ジフェンヒドラミン塩酸塩等）等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示の組成物は、抗ヒスタミン剤を配合しないで調製することもできる。
Although not intended to limit the present disclosure, examples of antihistamines include chlorpheniramine and its salts (chlorpheniramine maleate, etc.), diphenhydramine and its salts (diphenhydramine hydrochloride, etc.), and the like. These may be used individually by 1 type, and may be used in combination of 2 or more type. Compositions of the present disclosure may also be prepared without an antihistamine.
本開示の組成物が薬効成分を含有する場合、本開示の効果を妨げない限り、薬効成分の含有量は制限されず、該組成物中、薬効成分の含有量は好ましくは０．０５～０．３ｗ／ｖ％、より好ましくは０．１～０．３ｗ／ｖ％、更により好ましくは０．２～０．２７ｗ／ｖ％が例示される。
When the composition of the present disclosure contains a medicinal ingredient, the content of the medicinal ingredient is not limited as long as it does not interfere with the effects of the present disclosure, and the content of the medicinal ingredient in the composition is preferably 0.05 to 0. .3 w/v%, more preferably 0.1 to 0.3 w/v%, and even more preferably 0.2 to 0.27 w/v%.
該他の成分の一例として清涼化剤を挙げると、清涼化剤としてメントール、カンフル、ボルネオール等が例示される。清涼化剤は１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示の組成物は、清涼化剤を含有してもよく、清涼化剤を配合しないで調製することもできる。
Examples of other components include cooling agents such as menthol, camphor, and borneol. A cooling agent may be used individually by 1 type, and may be used in combination of 2 or more types. The compositions of the present disclosure may contain cooling agents or may be prepared without cooling agents.
該他の成分の一例として刺激剤を挙げると、刺激剤としてプロピオンアルデヒド等のアルデヒド等が例示される。本開示を制限するものではないが、本開示の組成物は、刺激剤を含有してもよく、刺激剤を配合せず調製することもできる。
An example of the other component is an irritant, and examples of the irritant include aldehydes such as propionaldehyde. Without limiting the disclosure, compositions of the present disclosure may contain a stimulant or may be prepared without a stimulant.
該他の成分の一例として増粘剤を挙げると、増粘剤としてアルギン酸やその塩、ヒドロキシエチルセルロース、メチルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、ポリエチレングリコール、ポリビニルピロリドン、ポリビニルアルコール、カルボキシビニルポリマー、これらの塩、グリセリン等が例示される。これらは１種単独で使用してもよく、２種以上を組み合わせて使用してもよい。本開示の洗眼用組成物は、これらの増粘剤を配合せず調製することもできる。
Examples of other components include thickeners, such as alginic acid and salts thereof, hydroxyethylcellulose, methylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, carboxyvinyl polymer, and these. Salt, glycerin and the like are exemplified. These may be used individually by 1 type, and may be used in combination of 2 or more type. The eyewash composition of the present disclosure can also be prepared without these thickening agents.
本開示の洗眼用組成物は、前記成分（Ａ）及び（Ｂ）、必要に応じて前記成分（Ｃ）、（Ｄ）、前記他の成分を混合することにより製造することができる。該混合は、これらの成分を混合できる限り制限されず、通常の手順に従い混合すればよい。
The eye wash composition of the present disclosure can be produced by mixing the components (A) and (B), and optionally the components (C) and (D), and the other components. The mixing is not limited as long as these components can be mixed, and may be mixed according to a normal procedure.
本開示の洗眼用組成物のｐＨは、点眼剤や洗眼剤として使用可能な範囲であれば制限されないが、室温（２５℃）でｐＨ５～８、好ましくはｐＨ５．５～６．５、より好ましくはｐＨ５．５～６、更に好ましくはｐＨ５．５～５．８が例示される。
The pH of the eye wash composition of the present disclosure is not limited as long as it can be used as an eye drop or an eye wash. is pH 5.5 to 6, more preferably pH 5.5 to 5.8.
本開示の洗眼用組成物の形態は、室温で液状であり、従来公知の方法と同様に眼を洗浄できる限りその使用方法は制限されず、通常、洗眼カップ（アイカップ）を用いた洗眼に使用されるか、点眼による洗眼に使用される。
The form of the eye wash composition of the present disclosure is liquid at room temperature, and the method of use is not limited as long as the eye can be washed in the same manner as in conventionally known methods. used or used to wash the eyes with eye drops.
本開示の洗眼用組成物は、コンタクトレンズを装着した状態で使用してもよく、装着していない状態で使用してもよい。コンタクトレンズは、ハードコンタクトレンズ、ソフトコンタクトレンズの別を問わない。
The eye wash composition of the present disclosure may be used with or without contact lenses. Contact lenses may be either hard contact lenses or soft contact lenses.
本開示の洗眼用組成物は、前述のようにして使用できる限り制限されないが、洗眼カップを用いて使用される場合、通常、従来公知の一般的な洗眼剤用の容器（例えば、容器本体、キャップを含む）に収容すればよい。該容器の容量も制限されないが、使い勝手が良い等の観点から、容量は好ましくは４５０～５５０ｍＬが例示される。
The eye wash composition of the present disclosure is not limited as long as it can be used as described above. (including the cap). Although the volume of the container is not limited, the volume is preferably 450 to 550 mL from the viewpoint of ease of use.
洗眼カップを用いる洗眼は、通常の手順に従えばよく、例えば、洗眼カップに本開示の洗眼用組成物を前記容器から適量、例えば１眼あたり１回に４～６ｍＬを注ぎ、次いで、該カップを片側の眼周辺に押し当てて該カップ内の洗眼用組成物と眼とを接触させ、数回まばたきを行うことにより使用される。
Eyewashing using an eyewash cup may follow a normal procedure. For example, an appropriate amount of the eyewash composition of the present disclosure is poured from the container into the eyewash cup, for example, 4 to 6 mL per eye at a time, and then the cup is poured. is pressed around the eye on one side to bring the eye wash composition in the cup into contact with the eye, and the eye is blinked several times.
また、本開示の洗眼用組成物が点眼による洗眼に使用される場合、通常、点眼容器に収容して使用される。点眼容器としては、該組成物を収容して点眼できる限り制限されず、例えば、従来公知の点眼剤や点眼型洗眼剤等に使用されている点眼容器（例えば、容器本体、中栓（ノズル）及びキャップの少なくとも２つが一体型となっているタイプ）が例示される。該容器の容量は制限されないが、使い勝手が良い等の観点から、容量は８～２０ｍＬが例示される。
In addition, when the eyewash composition of the present disclosure is used for eyewash by eyedrops, it is usually housed in an eyedropper container for use. The eye drop container is not limited as long as the composition can be accommodated and applied to the eye. and at least two of the caps are integrated) is exemplified. Although the volume of the container is not limited, a volume of 8 to 20 mL is exemplified from the viewpoint of ease of use.
点眼による洗眼は、通常の使用方法に従えばよく、本開示の洗眼用組成物を、１眼あたり１回に４～６滴点眼することにより使用される。１滴あたりの滴下量も制限されないが、１滴あたり、好ましくは３５～４０μＬが例示される。
The eye wash by instillation may follow the usual method of use, and the eye wash composition of the present disclosure is used by instilling 4 to 6 drops per eye at a time. The amount to be dropped per drop is also not limited, but preferably 35 to 40 μL is exemplified per drop.
本開示の洗眼用組成物によれば、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を配合していないにもかかわらず、ヒアルロン酸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０．０１ｗ／ｖ％以上と、プロピレングリコールとを組み合わせて用いることにより、洗眼用組成物に優れた防腐性を付与することができる。また、更に、エデト酸及びその塩からなる群より選択される少なくとも１種を配合したり、ピリドキシン、コンドロイチン硫酸及びこれらの塩からなる群より選択される少なくとも１種を配合することにより、後述の実施例に示す通り防腐剤を配合していないにもかかわらず、洗眼用組成物に一層優れた防腐性を付与することができる。また、該組成物が前述の薬効成分等を更に含有している場合は、該薬効成分等に基づく有用作用も得ることができる。
According to the eye wash composition of the present disclosure, hyaluronic acid and By using 0.01 w/v% or more of at least one selected from the group consisting of salts thereof in combination with propylene glycol, excellent antiseptic properties can be imparted to the eye wash composition. Further, by blending at least one selected from the group consisting of edetic acid and salts thereof, or blending at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof, As shown in the examples, the eyewash composition can be provided with even better antiseptic properties, although no antiseptic is added. In addition, when the composition further contains the above-mentioned active ingredients and the like, useful effects based on the active ingredients and the like can also be obtained.
以下、例を示して本開示をより詳細に説明するが、本開示はこれらに限定されない。
The present disclosure will be described in more detail below with examples, but the present disclosure is not limited to these.
試験例
１．洗眼用組成物の調製
次の表１に示す配合割合に従い各成分を混合し、得られた混合物を滅菌フィルターに通した（実施例１～５、参考例、比較例１～３）。調製直後の各組成物のｐＨを測定した。ｐＨは、室温（２５℃）で、卓上型ｐＨメーターＦ－５２（株式会社堀場製作所製）を用いて測定した。なお、表中のコンドロイチン硫酸エステルナトリウムは、局外規コンドロイチン硫酸ナトリウム（重量平均分子量２００００）を使用した。 Test example
1. Preparation of eyewash composition Each component was mixed according to the mixing ratio shown in Table 1 below, and the resulting mixture was passed through a sterilizing filter (Examples 1 to 5, Reference Examples, Comparative Examples 1 to 3). The pH of each composition immediately after preparation was measured. The pH was measured at room temperature (25° C.) using a desktop pH meter F-52 (manufactured by Horiba, Ltd.). As sodium chondroitin sulfate ester in the table, a pharmacologically approved sodium chondroitin sulfate (weight average molecular weight: 20,000) was used.
１．洗眼用組成物の調製
次の表１に示す配合割合に従い各成分を混合し、得られた混合物を滅菌フィルターに通した（実施例１～５、参考例、比較例１～３）。調製直後の各組成物のｐＨを測定した。ｐＨは、室温（２５℃）で、卓上型ｐＨメーターＦ－５２（株式会社堀場製作所製）を用いて測定した。なお、表中のコンドロイチン硫酸エステルナトリウムは、局外規コンドロイチン硫酸ナトリウム（重量平均分子量２００００）を使用した。 Test example
1. Preparation of eyewash composition Each component was mixed according to the mixing ratio shown in Table 1 below, and the resulting mixture was passed through a sterilizing filter (Examples 1 to 5, Reference Examples, Comparative Examples 1 to 3). The pH of each composition immediately after preparation was measured. The pH was measured at room temperature (25° C.) using a desktop pH meter F-52 (manufactured by Horiba, Ltd.). As sodium chondroitin sulfate ester in the table, a pharmacologically approved sodium chondroitin sulfate (weight average molecular weight: 20,000) was used.
２．防腐力評価
＜カンジダ菌＞
滅菌した生理食塩水にカンジダ菌（Candida albicans）を懸濁して菌液（１×１０８ｃｆｕ／ｍＬ）を調製した。前述のようにして得た各組成物１０ｍＬに菌液を１×１０６ｃｆｕ／ｍＬとなるように接種し、３０℃、暗所で１４日間保存した。保存後、カンジダ菌を接種した各組成物０．１ｍＬを市販のＧＰＬＰ寒天培地（ＧＰＬＰ寒天培地「ダイゴ」、富士フイルム和光純薬株式会社製）にコンラージ棒で塗布し、３０℃で４８時間培養後、コロニー数を目視でカウントし、カウントした値に１００を乗じた値を、保存から１４日後の各組成物の菌数とした。接種時の菌数を１００％として、１４日間保存後の各組成物における菌数の割合（生存率）を算出した。算出した値から次の基準に従って洗眼用組成物の防腐力を評価した。
［評価基準］
◎：生存率が接種量の０．１％以下に減少
○：生存率が接種量の１％以下に減少
△：生存率が接種量の１０％以下に減少
×：前記△の基準を満たさない 2. Evaluation of antiseptic power <Candida>
A bacterial solution (1×10 8 cfu/mL) was prepared by suspending Candida albicans in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1×10 6 cfu/mL and stored at 30° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Candida was applied to a commercially available GPLP agar medium (GPLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick and cultured at 30 ° C. for 48 hours. After that, the number of colonies was visually counted, and the value obtained by multiplying the counted value by 100 was defined as the number of bacteria in each composition after 14 days of storage. Taking the number of bacteria at the time of inoculation as 100%, the ratio of the number of bacteria (survival rate) in each composition after storage for 14 days was calculated. Based on the calculated value, the antiseptic power of the eye wash composition was evaluated according to the following criteria.
[Evaluation criteria]
◎: Survival rate decreased to 0.1% or less of the inoculated dose ○: Survival rate decreased to 1% or less of the inoculated dose △: Survival rate decreased to 10% or less of the inoculated dose ×: Does not meet the above △ criteria
＜カンジダ菌＞
滅菌した生理食塩水にカンジダ菌（Candida albicans）を懸濁して菌液（１×１０８ｃｆｕ／ｍＬ）を調製した。前述のようにして得た各組成物１０ｍＬに菌液を１×１０６ｃｆｕ／ｍＬとなるように接種し、３０℃、暗所で１４日間保存した。保存後、カンジダ菌を接種した各組成物０．１ｍＬを市販のＧＰＬＰ寒天培地（ＧＰＬＰ寒天培地「ダイゴ」、富士フイルム和光純薬株式会社製）にコンラージ棒で塗布し、３０℃で４８時間培養後、コロニー数を目視でカウントし、カウントした値に１００を乗じた値を、保存から１４日後の各組成物の菌数とした。接種時の菌数を１００％として、１４日間保存後の各組成物における菌数の割合（生存率）を算出した。算出した値から次の基準に従って洗眼用組成物の防腐力を評価した。
［評価基準］
◎：生存率が接種量の０．１％以下に減少
○：生存率が接種量の１％以下に減少
△：生存率が接種量の１０％以下に減少
×：前記△の基準を満たさない 2. Evaluation of antiseptic power <Candida>
A bacterial solution (1×10 8 cfu/mL) was prepared by suspending Candida albicans in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1×10 6 cfu/mL and stored at 30° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Candida was applied to a commercially available GPLP agar medium (GPLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick and cultured at 30 ° C. for 48 hours. After that, the number of colonies was visually counted, and the value obtained by multiplying the counted value by 100 was defined as the number of bacteria in each composition after 14 days of storage. Taking the number of bacteria at the time of inoculation as 100%, the ratio of the number of bacteria (survival rate) in each composition after storage for 14 days was calculated. Based on the calculated value, the antiseptic power of the eye wash composition was evaluated according to the following criteria.
[Evaluation criteria]
◎: Survival rate decreased to 0.1% or less of the inoculated dose ○: Survival rate decreased to 1% or less of the inoculated dose △: Survival rate decreased to 10% or less of the inoculated dose ×: Does not meet the above △ criteria
＜黄色ブドウ球菌＞
滅菌した生理食塩水に黄色ブドウ球菌（Staphylococcus aureus）を懸濁して菌液（１×１０８ｃｆｕ／ｍＬ）を調製した。前述のようにして得た各組成物１０ｍＬに菌液を１×１０６ｃｆｕ／ｍＬとなるように接種し、３５℃、暗所で１４日間保存した。保存後、黄色ブドウ球菌を接種した各組成物０．１ｍＬを市販のＳＣＤＬＰ寒天培地（ＳＣＤＬＰ寒天培地「ダイゴ」、富士フイルム和光純薬株式会社製）にコンラージ棒で塗布し、３５℃で４８時間培養後、コロニー数を目視でカウントし、カウントした値に１００を乗じた値を、保存から１４日後の各組成物の菌数とした。接種時の菌数を１００％として、１４日間保存後の各組成物における菌数の割合（生存率）を算出した。算出した値から前述と同じ基準に従って洗眼用組成物の防腐力を評価した。 <Staphylococcus aureus>
A bacterial solution (1×10 8 cfu/mL) was prepared by suspending Staphylococcus aureus in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1×10 6 cfu/mL, and stored at 35° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Staphylococcus aureus was applied to a commercially available SCDLP agar medium (SCDLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick, and kept at 35 ° C. for 48 hours. After culturing, the number of colonies was visually counted, and the value obtained by multiplying the counted value by 100 was defined as the number of bacteria in each composition after 14 days of storage. Taking the number of bacteria at the time of inoculation as 100%, the ratio of the number of bacteria (survival rate) in each composition after storage for 14 days was calculated. Based on the calculated value, the antiseptic power of the eye wash composition was evaluated according to the same criteria as described above.
滅菌した生理食塩水に黄色ブドウ球菌（Staphylococcus aureus）を懸濁して菌液（１×１０８ｃｆｕ／ｍＬ）を調製した。前述のようにして得た各組成物１０ｍＬに菌液を１×１０６ｃｆｕ／ｍＬとなるように接種し、３５℃、暗所で１４日間保存した。保存後、黄色ブドウ球菌を接種した各組成物０．１ｍＬを市販のＳＣＤＬＰ寒天培地（ＳＣＤＬＰ寒天培地「ダイゴ」、富士フイルム和光純薬株式会社製）にコンラージ棒で塗布し、３５℃で４８時間培養後、コロニー数を目視でカウントし、カウントした値に１００を乗じた値を、保存から１４日後の各組成物の菌数とした。接種時の菌数を１００％として、１４日間保存後の各組成物における菌数の割合（生存率）を算出した。算出した値から前述と同じ基準に従って洗眼用組成物の防腐力を評価した。 <Staphylococcus aureus>
A bacterial solution (1×10 8 cfu/mL) was prepared by suspending Staphylococcus aureus in sterilized physiological saline. 10 mL of each composition obtained as described above was inoculated with the bacterial solution at 1×10 6 cfu/mL, and stored at 35° C. in the dark for 14 days. After storage, 0.1 mL of each composition inoculated with Staphylococcus aureus was applied to a commercially available SCDLP agar medium (SCDLP agar medium "Daigo", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) with a conlarge stick, and kept at 35 ° C. for 48 hours. After culturing, the number of colonies was visually counted, and the value obtained by multiplying the counted value by 100 was defined as the number of bacteria in each composition after 14 days of storage. Taking the number of bacteria at the time of inoculation as 100%, the ratio of the number of bacteria (survival rate) in each composition after storage for 14 days was calculated. Based on the calculated value, the antiseptic power of the eye wash composition was evaluated according to the same criteria as described above.
３．結果
結果を表１及び２に示す。
3. result
Results are shown in Tables 1 and 2.
結果を表１及び２に示す。
3. result
Results are shown in Tables 1 and 2.
防腐剤である塩化ベンザルコニウムを配合した参考例は、本試験例におけるポジティブコントロールを意味し、表１に示す通り、評価結果は◎であり、防腐力に優れていた。これに対して、塩化ベンザルコニウムを配合せず、プロピレングリコールを配合した比較例１では評価結果が×であり、所望の防腐力は得られなかった。また、塩化ベンザルコニウムやプロピレングリコールを配合せず、ヒアルロン酸ナトリウムを０．０１ｗ／ｖ％で配合した比較例２では評価結果が△であり、所望の防腐力は得られなかった。また、塩化ベンザルコニウムを配合せず、ヒアルロン酸ナトリウム０．００１ｗ／ｖ％とプロピレングリコールとを配合した比較例３では評価結果が△であり、所望の防腐力は得られなかった。
The reference example containing benzalkonium chloride, which is an antiseptic, is a positive control in this test example. On the other hand, in Comparative Example 1, in which propylene glycol was added without benzalkonium chloride, the evaluation result was x, and the desired antiseptic power was not obtained. In Comparative Example 2, in which 0.01 w/v % sodium hyaluronate was added without benzalkonium chloride or propylene glycol, the evaluation result was Δ, and the desired antiseptic power was not obtained. In Comparative Example 3, in which 0.001 w/v% sodium hyaluronate and propylene glycol were blended without benzalkonium chloride, the evaluation result was Δ, and the desired antiseptic power was not obtained.
これに対して、塩化ベンザルコニウムを配合せず、ヒアルロン酸ナトリウム０．０１ｗ／ｖ％とプロピレングリコールとを配合した実施例１では評価結果が○であり、防腐力の向上が認められた。実施例１においてヒアルロン酸ナトリウムの含有量を高めた実施例２においても、評価結果が○であり、防腐力の向上が認められた。このことから、驚くべきことに防腐性が劣るプロピレングリコールにヒアルロン酸ナトリウムを０．０１ｗ／ｖ％以上で組み合わせて使用することにより、洗眼用組成物における防腐性を高められることが確認された。
On the other hand, in Example 1, in which 0.01 w/v% sodium hyaluronate and propylene glycol were blended without benzalkonium chloride, the evaluation result was ◯, and an improvement in antiseptic power was recognized. Also in Example 2 in which the content of sodium hyaluronate was increased in Example 1, the evaluation result was ◯, and an improvement in antiseptic power was recognized. From this, it was confirmed that the combination of 0.01 w/v% or more of sodium hyaluronate with propylene glycol, which surprisingly has poor antiseptic properties, can enhance the antiseptic properties of eye wash compositions.
また、実施例１や２において更にエデト酸ナトリウムを配合した実施例３～５、また、実施例５において更にコンドロイチン硫酸エステルナトリウムを配合した実施例６、また、実施例６において更にピリドキシン塩酸塩を配合した実施例７においても評価結果が○または◎であり、防腐力の向上が認められた。また、実施例１～７のｐＨを６．２とした場合においても、それぞれ、実施例１～７と同程度の防腐性の向上が認められた。
Further, Examples 3 to 5 in which sodium edetate was further blended in Examples 1 and 2, Example 6 in which sodium chondroitin sulfate was further blended in Example 5, and pyridoxine hydrochloride in Example 6 were further blended. In Example 7, which was blended, the evaluation result was ◯ or ⊚, and an improvement in antiseptic power was recognized. Further, even when the pH of Examples 1 to 7 was 6.2, an improvement in antiseptic properties similar to that of Examples 1 to 7 was observed.
これらのことから、防腐性が劣るプロピレングリコールにヒアルロン酸ナトリウムを０．０１ｗ／ｖ％以上で組み合わせて使用することにより、更には、エデト酸ナトリウムやコンドロイチン硫酸エステルナトリウムやピリドキシン塩酸塩を組み合わせて使用することにより、洗眼用組成物における防腐性を高められることが確認された。また、実施例１～７の洗眼用組成物はコンタクトレンズへの吸着が懸念される塩化ベンザルコニウムのような防腐剤を使用せずに防腐性を高められるため、コンタクトレンズを装着したまま洗眼することが可能である。
For these reasons, sodium hyaluronate is used in combination with propylene glycol, which has poor antiseptic properties, at 0.01 w/v% or more, and furthermore, sodium edetate, sodium chondroitin sulfate, and pyridoxine hydrochloride are used in combination. By doing so, it was confirmed that the antiseptic property of the eyewash composition can be enhanced. In addition, since the eyewash compositions of Examples 1 to 7 do not use a preservative such as benzalkonium chloride, which is likely to be adsorbed to contact lenses, the antiseptic properties of the eyewash compositions can be enhanced, and thus the eyes can be washed while the contact lenses are worn. It is possible to
処方例
表３に示す配合割合に従い洗眼組成物を調製し、試験例と同様の方法で防腐力評価を行ったところ、処方例１～７のいずれの洗眼組成物においても、実施例７と同程度に防腐性の向上が認められた。
An eye wash composition was prepared according to the blending ratio shown in Formulation Example Table 3, and the antiseptic power was evaluated in the same manner as in Test Examples. Improvement of antiseptic property was recognized to some extent.
表３に示す配合割合に従い洗眼組成物を調製し、試験例と同様の方法で防腐力評価を行ったところ、処方例１～７のいずれの洗眼組成物においても、実施例７と同程度に防腐性の向上が認められた。
An eye wash composition was prepared according to the blending ratio shown in Formulation Example Table 3, and the antiseptic power was evaluated in the same manner as in Test Examples. Improvement of antiseptic property was recognized to some extent.
Claims (4)
- （Ａ）ヒアルロン酸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０．０１ｗ／ｖ％以上、及び（Ｂ）プロピレングリコールを含有し、第４級アンモニウム塩系防腐剤、パラオキシ安息香酸エステル類、クロロブタノール及びソルビン酸類から選択される防腐剤を含有しない、洗眼用組成物。 (A) 0.01 w/v% or more of at least one selected from the group consisting of hyaluronic acid and salts thereof, and (B) propylene glycol, quaternary ammonium salt preservative, paraoxybenzoic acid ester A preservative-free eye wash composition selected from chlorobutanol and sorbic acids.
- 更に、（Ｃ）エデト酸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０．０５ｗ／ｖ％以上含有する、請求項１に記載の洗眼用組成物。 2. The eyewash composition according to claim 1, further comprising (C) at least one selected from the group consisting of edetic acid and salts thereof in an amount of 0.05 w/v % or more.
- 更に、（Ｄ）ピリドキシン、コンドロイチン硫酸及びこれらの塩からなる群より選択される少なくとも１種を含有する、請求項１または２に記載の洗眼用組成物。 3. The eyewash composition according to claim 1, further comprising (D) at least one selected from the group consisting of pyridoxine, chondroitin sulfate and salts thereof.
- コンタクトレンズ装着中に使用される、請求項１～３のいずれか一項に記載の洗眼組成物。 The eye wash composition according to any one of claims 1 to 3, which is used while wearing contact lenses.
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| JPH09227385A (en) * | 1996-02-29 | 1997-09-02 | Ofutekusu:Kk | Adjuvant for ophthalmic operation |
| WO2010030725A1 (en) * | 2008-09-15 | 2010-03-18 | Bausch & Lomb Incorporated | Compositions comprising polymers having amino sugar units and methods of making and using same |
| CN104474009A (en) * | 2014-11-26 | 2015-04-01 | 杭州光祺力实业有限公司 | Eye cleaning liquid and preparation method thereof |
| WO2016143708A1 (en) * | 2015-03-06 | 2016-09-15 | 参天製薬株式会社 | Ophthalmic composition |
| JP2016175887A (en) * | 2014-03-26 | 2016-10-06 | ロート製薬株式会社 | Ophthalmic composition for color contact lens |
| CN106265720A (en) * | 2015-05-12 | 2017-01-04 | 上海昊海生物科技股份有限公司 | A kind of combined artificial tear and preparation method thereof |
| JP2017066065A (en) * | 2015-09-29 | 2017-04-06 | 小林製薬株式会社 | Ophthalmic composition |
-
2021
- 2021-08-03 JP JP2021127507A patent/JP2023022569A/en active Pending
-
2022
- 2022-08-02 WO PCT/JP2022/029621 patent/WO2023013628A1/en active Application Filing
- 2022-08-02 CN CN202280053727.9A patent/CN117835988A/en active Pending
- 2022-08-03 TW TW111129138A patent/TW202320811A/en unknown
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09227385A (en) * | 1996-02-29 | 1997-09-02 | Ofutekusu:Kk | Adjuvant for ophthalmic operation |
| WO2010030725A1 (en) * | 2008-09-15 | 2010-03-18 | Bausch & Lomb Incorporated | Compositions comprising polymers having amino sugar units and methods of making and using same |
| JP2016175887A (en) * | 2014-03-26 | 2016-10-06 | ロート製薬株式会社 | Ophthalmic composition for color contact lens |
| CN104474009A (en) * | 2014-11-26 | 2015-04-01 | 杭州光祺力实业有限公司 | Eye cleaning liquid and preparation method thereof |
| WO2016143708A1 (en) * | 2015-03-06 | 2016-09-15 | 参天製薬株式会社 | Ophthalmic composition |
| CN106265720A (en) * | 2015-05-12 | 2017-01-04 | 上海昊海生物科技股份有限公司 | A kind of combined artificial tear and preparation method thereof |
| JP2017066065A (en) * | 2015-09-29 | 2017-04-06 | 小林製薬株式会社 | Ophthalmic composition |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2023022569A (en) | 2023-02-15 |
| TW202320811A (en) | 2023-06-01 |
| CN117835988A (en) | 2024-04-05 |
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