eyewash composition

Abstract

To provide an eyewash composition that can be used to cleanse the eyes by direct instillation. [Solution] An eyewash composition for use by instilling 3 to 12 drops at a time to wash the eyes.

Description

Technical Field

[0001] The present invention relates to an eye wash composition.

Background Art

[0002] Conventionally, an eye cup has been used when washing the eyes with an eye wash (for example, Patent Document 1). However, since an eye cup is substantially essential, the scenes where eye washing with an eye wash is possible are limited, and for example, inconvenience has been imposed for eye washing when going out or the like.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] An object of the present invention is to provide an eye wash composition that can directly eye-drop to wash the eyes.

Means for Solving the Problems

[0005] As a result of intensive studies to solve the above problems, the present inventors have found that water-soluble foreign substances and solid foreign substances can be sufficiently removed and the eyes can be washed by eye-dropping 3 to 12 drops at a time. The present invention is based on this finding and provides the following inventions.

[0006] [1] An eye wash composition for use in washing the eyes by eye-dropping 3 to 12 drops at a time. [2] The eye wash composition according to [1], which contains an antihistamine agent, the content of component (A) is 0.00006 to 0.05 w / v% based on the total amount of the eye wash composition, and the pH is 5.0 to 8.5. [3] (B) an eye wash composition according to [1] or [2], further comprising a lipid-soluble component and (C) a nonionic surfactant. [4] (B) The eye wash composition according to [3], wherein component (B) is at least one selected from the group consisting of a cooling agent, vitamin E, vitamin A, and oil. [5] The eye wash composition according to [3], wherein component (C) is at least one selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene polyoxypropylene glycol, and polyethylene glycol monostearate. [6] An eye wash composition according to [1], which contains a cooling agent and has a pH of 5.0 to 8.5. [7] The eye wash composition according to [6], wherein the cooling agent is at least one selected from the group consisting of menthol, camphor, borneol, and geraniol. [8] The eye wash composition according to [6], further containing a nonionic surfactant. [9] The eye wash composition according to [8], wherein the nonionic surfactant is at least one selected from the group consisting of polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyethylene polyoxypropylene glycol, and polyethylene glycol monostearate.

[10] An eyewash composition according to any one of [1] to [9], wherein the viscosity is 1 to 10 mPa·s.

[11] An eyewash composition according to any one of [1] to

[10] , wherein the eyewash composition is housed in a container in which at least a portion of the part that comes into contact with the eyewash composition is made of polyethylene. [Effects of the Invention]

[0007] According to the present invention, it is possible to provide an eyewash composition that can be used to cleanse the eyes by directly instilling it into the eyes. [Brief explanation of the drawing]

[0008] [Figure 1] This graph shows the cleansing effect on water-soluble foreign matter (trypan blue) after eye washing with eye drops or using an eye cup in Test Example 1. [Figure 2] This graph shows the cleaning effect on solid foreign matter (polystyrene beads) after eye washing with eye drops or using an eye cup in Test Example 2. [Figure 3] This graph in Test Example 3 shows the cleaning effect on solid foreign objects (polystyrene beads) after eye rinsing with eye drops while wearing soft contact lenses. [Figure 4] In Test Example 4, the graph shows the improvement rate of chlorpheniramine maleate stability in each eyewash composition from Examples 1 to 8. [Figure 5] In Test Example 4, the graph shows the improvement rate of chlorpheniramine maleate stability in each eyewash composition from Examples 9 to 11. [Figure 6] This graph in Test Example 5 shows the evaluation of the effect of the cooling agent on the cleansing sensation during eye washing (cleansing score). [Modes for carrying out the invention]

[0009] The embodiments for carrying out the present invention will be described in detail below. However, the present invention is not limited to the following embodiments.

[0010] In this specification, unless otherwise specified, the unit of content "%" means "w / v%" and is synonymous with "g / 100mL".

[0011] [1. Eyewash composition] The eyewash composition according to this embodiment is used by instilling 3 to 12 drops into the eyes at a time.

[0012] When instilling the eye drop composition according to this embodiment, the number of drops per application may be 3 to 12 drops. However, from the viewpoint of more significantly demonstrating the effects of the present invention, it is preferably 4 to 12 drops, more preferably 4 to 9 drops, and even more preferably 4 to 6 drops.

[0013] When instilling the eye drop composition according to this embodiment, the dropping amount per drop is not particularly limited as long as it is a dropping amount that exhibits the effects of the present invention. However, from the viewpoint of more significantly demonstrating the effects of the present invention, it is preferably 5 to 100 μL, more preferably 10 to 80 μL, even more preferably 20 to 60 μL, and even more preferably 30 to 50 μL. Note that the dropping amount per drop can be adjusted by appropriately setting the material of the container, the area of the opening of the middle stopper (nozzle) or the pouring outlet, the thickness of the container body, the compressive strength on the peripheral surface, and the like.

[0014] The eye drop composition according to this embodiment preferably contains (A) an antihistamine agent (also simply referred to as “component (A)”). By containing component (A) in the eye drop composition, the effects of the present invention are more significantly exhibited.

[0015] [(A) component] The antihistamine agent is a compound having an antihistamine action and its salts. The antihistamine agent is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.

[0016] Specific examples of the antihistamine agent include chlorpheniramine, iproheptine, diphenhydramine, ketotifen, olopatadine, levocabastine, and their salts. As the antihistamine agent, chlorpheniramine and its salts, diphenhydramine and its salts are preferred, chlorpheniramine maleate and diphenhydramine hydrochloride are more preferred, and chlorpheniramine maleate is even more preferred.

[0017] Over-the-counter antihistamines may be used. Antihistamines may be used individually or in combination of two or more types.

[0018] The content of component (A) in the eyewash composition according to this embodiment is not particularly limited and is set appropriately depending on the type of component (A), the types and content of other components, the use and formulation form of the eyewash composition, etc. As for the content of component (A), from the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of component (A) is preferably 0.00006 to 0.05 w / v%, more preferably 0.0001 to 0.01 w / v%, and even more preferably 0.0006 to 0.005 w / v%, based on the total amount of the eyewash composition.

[0019] The pH of the eyewash composition according to this embodiment is preferably 5.0 to 8.5, more preferably 5.0 to 8.0, even more preferably 5.0 to 7.5, even more preferably 5.0 to 7.0, and particularly preferably 5.0 to 6.5, in terms of the stability of component (A) (especially chlorpheniramine and its salts).

[0020] The pH of the eyewash composition according to this embodiment can be adjusted as needed using a pH adjusting agent. Examples of pH adjusting agents include inorganic acids such as hydrochloric acid, sulfuric acid, phosphoric acid, and boric acid; organic acids such as acetic acid and citric acid; inorganic bases such as sodium hydroxide, potassium hydroxide, calcium hydroxide, and magnesium hydroxide; organic bases such as triethanolamine and diisopropanolamine; salts of weak acids and strong bases such as sodium phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, sodium acetate, sodium citrate, sodium carbonate, sodium bicarbonate, and borax; and salts of strong acids and weak bases such as zinc chloride and zinc sulfate.

[0021] The eyewash composition according to this embodiment preferably contains (B) a lipid-soluble component (also simply referred to as "component (B)") and (C) a nonionic surfactant (also simply referred to as "component (C)") in terms of the stability of component (A) (particularly chlorpheniramine and its salts). The effects of the present invention are more pronounced when the eyewash composition contains components (B) and (C).

[0022] Furthermore, when the eye wash composition according to this embodiment contains components (B) and (C), the pH of the eye wash composition according to this embodiment is preferably 6.5 to 8.5, more preferably 7.0 to 8.5, and even more preferably 7.5 to 8.5, in which the stabilizing effect of component (A) (especially chlorpheniramine and its salts) is more pronounced.

[0023] [(B) component] Lipid-soluble components are components with low affinity for water molecules. Lipid-soluble components are not particularly limited as long as they are pharmaceutically, pharmacologically (pharmaceutically), or physiologically acceptable.

[0024] Fat-soluble components include cooling agents, vitamin E, vitamin A, and oils.

[0025] Specific examples of cooling agents include menthol, menthone, camphor, borneol, geraniol, cineole, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, thymol, cymene, terpineol, pinene, camphene, isoborneol, fencienne, nerol, myrcene, myrcenol, linalool acetate, lavandulol, eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, rose oil, and camphor oil. Preferred cooling agents include menthol, camphor, borneol, geraniol, eucalyptus oil, peppermint oil, and peppermint oil, more preferred are menthol, camphor, borneol, and geraniol, and even more preferred is menthol.

[0026] Examples of vitamin E include tocopherol and its derivatives. Specific examples of tocopherol derivatives include tocopherol acetate, tocopherol succinate, and tocopherol nicotinate. Tocopherol derivatives are preferred as vitamin E, and tocopherol acetate is more preferred.

[0027] Examples of vitamin A include retinol and its derivatives. Specific examples of retinol derivatives include retinyl palmitate, retinyl acetate, retinal, and retinoic acid. Retinol derivatives are preferred as vitamin A, retinyl palmitate and retinyl acetate are more preferred, and retinyl palmitate is even more preferred.

[0028] Examples of oils include vegetable oils, animal oils, and mineral oils. Specific examples of vegetable oils include sesame oil, castor oil, olive oil, soybean oil, peanut oil, almond oil, wheat germ oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, and coconut oil. Specific examples of animal oils include squalane. Mineral oils include liquid paraffin and petrolatum. Vegetable oils are preferred, sesame oil and castor oil are more preferred, and sesame oil is even more preferred.

[0029] Commercially available lipid-soluble components may be used. Lipid-soluble components may be used individually or in combination of two or more types.

[0030] The content of component (B) in the eyewash composition according to this embodiment is not particularly limited and is set appropriately depending on the type of component (B), the types and content of other components, the use of the eyewash composition, and the formulation form. As for the content of component (B), from the viewpoint of more significantly exhibiting the effects of the present invention, for example, based on the total amount of the eyewash composition, the total content of component (B) is preferably 0.00003 to 0.5 w / v%, more preferably 0.00006 to 0.1 w / v%, and even more preferably 0.0003 to 0.05 w / v%. Also, if component (B) is vitamin A, based on the total amount of the eyewash composition, the total content of vitamin A is preferably 50 to 50000 IU, more preferably 100 to 10000 IU, and even more preferably 500 to 5000 IU.

[0031] In the eyewash composition according to this embodiment, the content ratio of component (B) to component (A) is not particularly limited and is set appropriately depending on the types of component (A) and component (B), the types and content of other components, the use and formulation form of the eyewash composition, etc. As for the content ratio of component (B) to component (A), from the viewpoint of further enhancing the effects of the present invention, for example, the total content of component (B) in the eyewash composition according to this embodiment is preferably 0.001 to 50 parts by mass, more preferably 0.01 to 30 parts by mass, and even more preferably 0.1 to 10 parts by mass, per 1 part by mass of the total content of component (A) contained in the eyewash composition according to this embodiment.

[0032] [(C) component] Nonionic surfactants are surfactants that do not have a group that dissociates into an ion. Nonionic surfactants are not particularly limited as long as they are pharmaceutically, pharmacologically (pharmaceutically), or physiologically acceptable.

[0033] Specific examples of nonionic surfactants include POE(20) sorbitan monolaurate (polysorbate 20), POE(20) sorbitan monopalmitate (polysorbate 40), POE(20) sorbitan monostearate (polysorbate 60), POE(20) sorbitan tristearate (polysorbate 65), POE(20) sorbitan monooleate (polysorbate 80), and other POE sorbitan fatty acid esters; POE(5) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 5), POE(10) hydrogenated castor oil (polyoxyethylene POE hydrogenated castor oils such as POE(3) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 20), POE(3) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 30), POE(40) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 40), POE(60) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 60), POE(80) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 80), POE(100) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 100); POE(3) castor oil (polyoxyethylene hydrogenated castor oil Castor oils such as POE(10) castor oil (polyoxyethylene castor oil 10), POE(35) castor oil (polyoxyethylene castor oil 35), POE(70) castor oil (polyoxyethylene castor oil 70); POE alkyl ethers such as POE(9) lauryl ether; POE-POP alkyl ethers such as POE(20) POP(4) cetyl ether; POE(20) POP(20) glycol (Pluronic L44), POE(42) POP(67) glycol (poloxamer 403, Pluronic P123), POE(5 4) Examples include POE-POP glycols such as POP(39) glycol (poloxamer 235, Pluronic P85), POE(120)POP(40) glycol (Pluronic F87), POE(160)POP(30) glycol (poloxamer 188, Pluronic F68), POE(196)POP(67) glycol (poloxamer 407, Pluronic F127), and POE(200)POP(70) glycol; and polyethylene glycol monostearate such as polyoxyl 10 stearate and polyoxyl 40 stearate.In the compounds exemplified above, the numbers in parentheses indicate the number of moles added. The abbreviation "POE" means polyoxyethylene, and the abbreviation "POP" means polyoxypropylene. Preferred nonionic surfactants include POE sorbitan fatty acid esters, POE hydrogenated castor oil, POE castor oil, POE-POP glycol, and polyethylene glycol monostearate; more preferably polysorbate 80, polyoxyethylene hydrogenated castor oil 60, and poloxamer 407; and even more preferably polysorbate 80 and polyoxyethylene hydrogenated castor oil 60.

[0034] Commercially available nonionic surfactants may be used. Nonionic surfactants may be used individually or in combination of two or more types.

[0035] The content of component (C) in the eyewash composition according to this embodiment is not particularly limited and is set as appropriate depending on the type of component (C), the types and content of other components, the use and formulation form of the eyewash composition, etc. As for the content of component (C), from the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of component (C) is preferably 0.01 to 10 w / v%, more preferably 0.01 to 5 w / v%, and even more preferably 0.01 to 1 w / v%, based on the total amount of the eyewash composition.

[0036] In the eyewash composition according to this embodiment, the content ratio of component (C) to component (B) is not particularly limited and is set appropriately depending on the types of component (B) and component (C), the types and content of other components, the use and formulation form of the eyewash composition, etc. As for the content ratio of component (C) to component (B), from the viewpoint of further enhancing the effects of the present invention, for example, the total content of component (C) in the eyewash composition according to this embodiment is preferably 0.1 to 100 parts by mass, more preferably 1 to 80 parts by mass, and even more preferably 5 to 50 parts by mass, per 1 part by mass of the total content of component (B) contained in the eyewash composition according to this embodiment.

[0037] In another embodiment, it is preferable that the eyewash composition according to this embodiment contains a cooling agent. The inclusion of a cooling agent in the eyewash composition enhances the cleansing sensation during eye washing.

[0038] Specific examples of cooling agents include menthol, menthone, camphor, borneol, geraniol, cineole, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, thymol, cymene, terpineol, pinene, camphene, isoborneol, fencienne, nerol, myrcene, myrcenol, linalool acetate, lavandulol, eucalyptus oil, bergamot oil, peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, rose oil, and camphor oil. Preferred cooling agents include menthol, camphor, borneol, geraniol, eucalyptus oil, peppermint oil, and peppermint oil, more preferred are menthol, camphor, borneol, and geraniol, and even more preferred is menthol.

[0039] You may use commercially available cooling agents. You may use one type of cooling agent alone, or two or more types in combination.

[0040] The amount of cooling agent in the eyewash composition containing a cooling agent according to this embodiment is not particularly limited and is set appropriately depending on the type of cooling agent, the types and amounts of other ingredients, the use of the eyewash composition, and the formulation form. From the viewpoint of more significantly enhancing the cleansing sensation during eye washing, for example, the total amount of cooling agent based on the total amount of the eyewash composition is preferably 0.0001 to 0.1 w / v%, more preferably 0.005 to 0.05 w / v%, and even more preferably 0.001 to 0.03 w / v%.

[0041] In this embodiment, the pH of the eyewash composition containing a cooling agent is preferably 5.0 to 8.5, more preferably 5.5 to 8.0, even more preferably 5.0 to 7.5, even more preferably 5.0 to 7.0, and particularly preferably 5.0 to 6.5, from the viewpoint of further enhancing the cleansing sensation during eye washing.

[0042] In this embodiment, the eyewash composition containing a cooling agent preferably contains a nonionic surfactant in terms of the stability of the cooling agent. The effects of the present invention are more pronounced when the eyewash composition containing a cooling agent contains a nonionic surfactant.

[0043] Specific examples of nonionic surfactants include POE(20) sorbitan monolaurate (polysorbate 20), POE(20) sorbitan monopalmitate (polysorbate 40), POE(20) sorbitan monostearate (polysorbate 60), POE(20) sorbitan tristearate (polysorbate 65), POE(20) sorbitan monooleate (polysorbate 80), and other POE sorbitan fatty acid esters; POE(5) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 5), POE(10) hydrogenated castor oil (polyoxyethylene POE hydrogenated castor oils such as POE(3) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 20), POE(3) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 30), POE(40) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 40), POE(60) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 60), POE(80) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 80), POE(100) hydrogenated castor oil (polyoxyethylene hydrogenated castor oil 100); POE(3) castor oil (polyoxyethylene hydrogenated castor oil Castor oils such as POE(10) castor oil (polyoxyethylene castor oil 10), POE(35) castor oil (polyoxyethylene castor oil 35), POE(70) castor oil (polyoxyethylene castor oil 70); POE alkyl ethers such as POE(9) lauryl ether; POE-POP alkyl ethers such as POE(20) POP(4) cetyl ether; POE(20) POP(20) glycol (Pluronic L44), POE(42) POP(67) glycol (poloxamer 403, Pluronic P123), POE(5 4) Examples include POE-POP glycols such as POP(39) glycol (poloxamer 235, Pluronic P85), POE(120)POP(40) glycol (Pluronic F87), POE(160)POP(30) glycol (poloxamer 188, Pluronic F68), POE(196)POP(67) glycol (poloxamer 407, Pluronic F127), and POE(200)POP(70) glycol; and polyethylene glycol monostearate such as polyoxyl 10 stearate and polyoxyl 40 stearate.In the compounds exemplified above, the numbers in parentheses indicate the number of moles added. The abbreviation "POE" means polyoxyethylene, and the abbreviation "POP" means polyoxypropylene. Preferred nonionic surfactants include POE sorbitan fatty acid esters, POE hydrogenated castor oil, POE castor oil, POE-POP glycol, and polyethylene glycol monostearate; more preferably polysorbate 80, polyoxyethylene hydrogenated castor oil 60, and poloxamer 407; and even more preferably polysorbate 80 and polyoxyethylene hydrogenated castor oil 60.

[0044] Commercially available nonionic surfactants may be used. Nonionic surfactants may be used individually or in combination of two or more types.

[0045] The content of the nonionic surfactant in the eyewash composition containing a cooling agent and a nonionic surfactant according to this embodiment is not particularly limited and is appropriately set depending on the type of nonionic surfactant, the type and content of other ingredients, the use of the eyewash composition and the formulation form, etc. As for the content of the nonionic surfactant, from the viewpoint of more significantly enhancing the cleansing sensation during eye washing, for example, the total content of the nonionic surfactant is preferably 0.01 to 10 w / v%, more preferably 0.01 to 5 w / v%, and even more preferably 0.01 to 1 w / v%, based on the total amount of the eyewash composition.

[0046] In the eyewash composition containing a cooling agent and a nonionic surfactant according to this embodiment, the ratio of the nonionic surfactant to the cooling agent is not particularly limited and is set appropriately depending on the type of cooling agent and nonionic surfactant, the type and content of other components, the use of the eyewash composition and the formulation form, etc. As for the ratio of the nonionic surfactant to the cooling agent, from the viewpoint of further enhancing the effects of the present invention, for example, the total content of the nonionic surfactant in the eyewash composition according to this embodiment is preferably 0.1 to 100 parts by mass, more preferably 1 to 80 parts by mass, and even more preferably 5 to 50 parts by mass, per 1 part by mass of the total content of the cooling agent.

[0047] [Anti-inflammatory drugs] The eyewash composition according to this embodiment preferably further contains an anti-inflammatory agent. The effects of the present invention are more pronounced when the eyewash composition further contains an anti-inflammatory agent. The anti-inflammatory agent is a compound having anti-inflammatory or soothing properties, and a salt thereof. The anti-inflammatory agent is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.

[0048] Specific examples of anti-inflammatory agents include epsilon-aminocaproic acid, allantoin, berberine, azulenes (azulene, azulene sulfonic acid, chamazulene, guaiazulene, etc.), glycyrrhizic acid, zinc salts (zinc sulfate, zinc lactate, etc.), lysozyme, celecoxib, lofecoxib, indomethacin, diclofenac, bromfenac, piroxicam, meloxicam, methyl salicylate, ibuprofen, ibuprofen piconol, bufexamac, flufenamate butyl, bendazac, ketoprofen, felbinac, pranoprofen, and their salts. Preferred anti-inflammatory agents include epsilon-aminocaproic acid and its salts, allantoin, berberine and its salts, azulene sulfonic acid and its salts, glycyrrhizic acid and its salts, and zinc salts; more preferably epsilon-aminocaproic acid, allantoin, berberine chloride, berberine sulfate, sodium azulene sulfonate, dipotassium glycyrrhizinate, zinc sulfate, and zinc lactate; and even more preferably epsilon-aminocaproic acid, allantoin, and dipotassium glycyrrhizinate.

[0049] Commercially available anti-inflammatory drugs may be used. Anti-inflammatory drugs may be used individually or in combination of two or more.

[0050] The content of the anti-inflammatory agent in the eyewash composition according to this embodiment is not particularly limited and is appropriately set depending on the type of anti-inflammatory agent, the types and content of other ingredients, the use of the eyewash composition, and the formulation form. From the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of the anti-inflammatory agent is preferably 0.00005 to 0.2 w / v%, more preferably 0.0001 to 0.1 w / v%, and even more preferably 0.0004 to 0.55 w / v%, based on the total amount of the eyewash composition.

[0051] [Water-soluble vitamins] The eyewash composition according to this embodiment preferably further contains a water-soluble vitamin. The effects of the present invention are more pronounced when the eyewash composition further contains a water-soluble vitamin. The water-soluble vitamin is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.

[0052] Specific examples of water-soluble vitamins include flavin adenine dinucleotide and its salts (e.g., flavin adenine dinucleotide sodium), cobalamins (e.g., cyanocobalamin, methylcobalamin), pyridoxine or its salts (e.g., pyridoxine hydrochloride), panthenol, pantothenic acid and its salts (e.g., sodium pantothenate, potassium pantothenate, calcium pantothenate, magnesium pantothenate), pyridoxal and its salts (e.g., pyridoxal phosphate), and ascorbic acid and its salts (e.g., sodium ascorbate, calcium ascorbate). Preferred water-soluble vitamins include flavin adenine dinucleotide and its salts, cobalamins, pyridoxine or its salts, panthenol, pantothenic acid and its salts, and more preferably pyridoxine or its salts and panthenol.

[0053] Water-soluble vitamins may be commercially available. Water-soluble vitamins may be used individually or in combination of two or more types.

[0054] The content of water-soluble vitamins in the eyewash composition according to this embodiment is not particularly limited and can be appropriately set depending on the type of water-soluble vitamin, the type and content of other ingredients, the use of the eyewash composition, and the formulation form. From the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of water-soluble vitamins based on the total amount of the eyewash composition is preferably 0.0001 to 0.1 w / v%, more preferably 0.0005 to 0.05 w / v%, and even more preferably 0.0002 to 0.02 w / v%.

[0055] 〔amino acid〕 The eyewash composition according to this embodiment preferably further contains amino acids. The effects of the present invention are more pronounced when the eyewash composition further contains amino acids. Amino acids are compounds having an amino group and a carboxyl group in their molecule, their derivatives, and salts thereof. The amino acids are not particularly limited as long as they are pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable, and can be appropriately selected from known amino acids.

[0056] Specific examples of amino acids include amino acids and their salts, amino acid derivatives and their salts, and mucopolysaccharides and their derivatives and their salts. Specific examples of amino acids and their salts include, for example, monoaminomonocarboxylic acids such as glycine, alanine, aminobutyric acid, and aminovaleric acid, monoaminodicarboxylic acids such as aspartic acid and glutamic acid, diaminomonocarboxylic acids such as arginine and lysine, and their salts. Specific examples of amino acid derivatives and their salts include, for example, aminoethylsulfonic acid and its salts. Examples of mucopolysaccharides and their derivatives and their salts include chondroitin sulfate and its salts. Amino acids may be D-isomers, L-isomers, or DL-isomers. Preferred amino acids include monoaminodicarboxylic acids and their salts, amino acid derivatives and their salts, mucopolysaccharides and their salts; more preferably aspartic acid and its salts, aminoethylsulfonic acid and its salts, chondroitin sulfate and its salts; even more preferably potassium aspartate, magnesium aspartate, magnesium-potassium aspartate (equal mixture), aminoethylsulfonic acid, and sodium chondroitin sulfate; and even more preferably potassium aspartate, aminoethylsulfonic acid, and sodium chondroitin sulfate.

[0057] Commercially available amino acids may be used. Amino acids may be used individually or in combination of two or more.

[0058] The amino acid content in the eyewash composition according to this embodiment is not particularly limited and is appropriately set depending on the type of amino acid, the type and content of other ingredients, the use of the eyewash composition, and the formulation form. From the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total amino acid content is preferably 0.0005 to 1 w / v%, more preferably 0.001 to 0.5 w / v%, and even more preferably 0.005 to 0.3 w / v%, based on the total amount of the eyewash composition.

[0059] [Cushioning material] The eyewash composition according to this embodiment preferably further contains a buffering agent. The effects of the present invention are more pronounced when the eyewash composition further contains a buffering agent. The buffering agent is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable.

[0060] Examples of buffering agents include inorganic buffering agents derived from inorganic acids, and organic buffering agents derived from organic acids or organic bases.

[0061] Examples of inorganic buffers include borate buffers, phosphate buffers, and carbonate buffers. Examples of borate buffers include boric acid or its salts (alkali metal borate, alkaline earth metal borate, etc.). Examples of phosphate buffers include phosphoric acid or its salts (alkali metal phosphate, alkaline earth metal phosphate, etc.). Examples of carbonate buffers include carbonic acid or its salts (alkali metal carbonate, alkaline earth metal carbonate, etc.). In addition, hydrates of borates, phosphates, or carbonates may be used as borate buffers, phosphate buffers, or carbonate buffers. More specific examples include boric acid buffers such as boric acid or its salts (sodium borate, potassium tetraborate, potassium metaborate, ammonium borate, borax, etc.); phosphoric acid buffers such as phosphoric acid or its salts (disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, trisodium phosphate, tripotassium phosphate, calcium monohydrogen phosphate, calcium dihydrogen phosphate, etc.); and carbonate buffers such as carbonate or its salts (sodium bicarbonate, sodium carbonate, ammonium carbonate, potassium carbonate, calcium carbonate, potassium bicarbonate, magnesium carbonate, etc.).

[0062] Examples of organic buffers include citrate buffers, acetate buffers, lactic acid buffers, succinate buffers, Tris buffers, and AMPD buffers. Examples of citrate buffers include citric acid or its salts (alkali metal citrate, alkaline earth metal citrate, etc.). Examples of acetate buffers include acetic acid or its salts (alkali metal acetate, alkaline earth metal acetate, etc.). Examples of lactic acid buffers include lactic acid or its salts (alkali metal lactate, alkaline earth metal lactate, etc.). Examples of succinate buffers include succinic acid or its salts (alkali metal succinate, etc.). In addition, citrate, acetate, lactate, or succinate hydrates may be used as citrate buffers, acetate buffers, lactic acid buffers, or succinate buffers. More specific examples include citric acid or its salts (sodium citrate, potassium citrate, calcium citrate, sodium dihydrogen citrate, disodium citrate, etc.) as citrate buffers; acetic acid or its salts (ammonium acetate, sodium acetate, potassium acetate, calcium acetate, etc.) as acetic acid buffers; lactic acid or its salts (sodium lactate, potassium lactate, calcium lactate, etc.) as lactic acid buffers; and succinic acid or its salts (monosodium succinate, disodium succinate, etc.) as succinic acid buffers. Examples of Tris buffers include trometamol or its salts (trometamol hydrochloride, etc.). Examples of AMPD buffers include 2-amino-2-methyl-1,3-propanediol or its salts.

[0063] Preferred buffering agents include boric acid buffers (e.g., a combination of boric acid and borax), phosphate buffers (e.g., a combination of disodium hydrogen phosphate and sodium dihydrogen phosphate), and Tris buffers (e.g., trometamol). Boric acid buffers are more preferred, boric acid and its salts are even more preferred, and a combination of boric acid and borax is even more preferred.

[0064] You may use commercially available cushioning material. You may use one type of cushioning material alone, or you may use two or more types in combination.

[0065] The buffering agent content in the eyewash composition according to this embodiment is not particularly limited and is set appropriately depending on the type of buffering agent, the types and amounts of other components, the use of the eyewash composition, and the formulation form. From the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total buffering agent content is preferably 0.001 to 10 w / v%, more preferably 0.1 to 5 w / v%, and even more preferably 0.5 to 3 w / v%, based on the total amount of the eyewash composition.

[0066] The eyewash composition according to this embodiment can be adjusted to an osmotic pressure ratio within a range acceptable to the body, as needed. An appropriate osmotic pressure ratio can be set as appropriate depending on the use, formulation, and method of use of the eyewash composition, but for example, it can be 0.5 to 5.0, preferably 0.6 to 3.0, more preferably 0.7 to 2.0, and even more preferably 0.8 to 1.55. The osmotic pressure ratio is the ratio of the osmotic pressure of the sample to 286 mOsm (osmotic pressure of 0.9 w / v% sodium chloride aqueous solution) based on the 17th edition of the Japanese Pharmacopoeia, and the osmotic pressure is measured by referring to the osmotic pressure measurement method (freezing point depression method) described in the Japanese Pharmacopoeia. The standard solution for osmotic pressure ratio measurement (0.9 w / v% sodium chloride aqueous solution) can be prepared by drying sodium chloride (Japanese Pharmacopoeia standard reagent) at 500-650°C for 40-50 minutes, then allowing it to cool in a desiccator (silica gel), accurately weighing 0.900 g of it, dissolving it in purified water to make exactly 100 mL, or by using a commercially available standard solution for osmotic pressure ratio measurement (0.9 w / v% sodium chloride aqueous solution).

[0067] The viscosity of the eyewash composition according to this embodiment is not particularly limited, as long as it is within a range that is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. The viscosity of the eyewash composition according to this embodiment is preferably 1 to 1000 mPa·s, more preferably 1 to 100 mPa·s, even more preferably 1 to 50 mPa·s, even more preferably 1 to 30 mPa·s, particularly preferably 1 to 10 mPa·s, and most preferably 1 to 5 mPa·s, as measured at 20°C with a rotational viscometer (RE550 type viscometer, manufactured by Toki Sangyo Co., Ltd., rotor: 1°34' × R24).

[0068] The eyewash composition according to this embodiment may contain, in addition to the above-mentioned components, an appropriate amount of components selected from various pharmacologically active and physiologically active components, provided that the effects of the present invention are not impaired. The components are not particularly limited, and examples include the active ingredients in ophthalmic drugs listed in the 2012 edition of the Standards for Approval of Manufacturing and Marketing of Over-the-Counter Drugs (supervised by the Regulatory Science Society of Japan). Specifically, examples of components used in ophthalmic drugs include the following: Antiallergic agents: For example, sodium cromoglycate, tranilast, pemirolast potassium, etc. Steroids: For example, fluticasone propionate, fluticasone furoate, mometasone furoate, beclomethasone propionate, flunisolide, etc. Decongestants: For example, tetrahydrozoline hydrochloride, tetrahydrozoline nitrate, naphazoline hydrochloride, naphazoline nitrate, epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, phenylephrine hydrochloride, dl-methylephedrine hydrochloride, etc. Ocular muscle modulating agents: For example, cholinesterase inhibitors that have an active site similar to acetylcholine, specifically neostigmine methylsulfate, tropicamide, helenien, atropine sulfate, etc. Inorganic salts: For example, metal chlorides such as calcium chloride, magnesium chloride, sodium chloride, and potassium chloride; ammonium chloride; metal sulfates such as calcium sulfate, magnesium sulfate, sodium sulfate, potassium sulfate, and ammonium sulfate. Astringent agents: For example, zinc oxide. Others: For example, sulfamethoxazole, sulfisoxazole, sulfisomidine, and their salts.

[0069] The facial cleansing composition according to this embodiment may contain, in accordance with conventional methods, various additives selected appropriately and used in combination in appropriate amounts, one or more types, depending on its intended use and formulation, as long as the effects of the present invention are not impaired. Examples of such additives include the various additives listed in the 2007 Dictionary of Pharmaceutical Additives (edited by the Japan Pharmaceutical Additives Association). The following are some typical additives. Carrier: For example, an aqueous solvent such as water or aqueous ethanol. Chelating agents: For example, ethylenediaminediacetic acid (EDDA), ethylenediaminetriacetic acid, ethylenediaminetetraacetic acid (EDTA), N-(2-hydroxyethyl)ethylenediaminetriacetic acid (HEDTA), diethylenetriaminepentaacetic acid (DTPA), etc. Base: For example, octyldodecanol, titanium dioxide, potassium bromide, Plastibase, etc. Anionic surfactants: For example, polyoxyethylene alkyl ether phosphates, polyoxyethylene alkyl ether sulfates, alkylbenzene sulfonates, alkyl sulfates, N-acyl taurine salts, etc. Amphoteric surfactants: For example, lauryldimethylaminoacetic acid betaine, etc. Stabilizers: For example, sodium formaldehyde sulfoxylate (Longalit), sodium bisulfite, sodium pyrosulfite, aluminum monostearate, glyceryl monostearate, cyclodextrin, monoethanolamine, dibutylhydroxytoluene, etc. Preservatives, disinfectants, or antibacterial agents: for example, zinc chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, potassium sorbate, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, biguanide compounds (specifically, polyhexanide hydrochloride (polyhexamethylene biguanide), etc.), Glokill (a trade name of Rhodia), chlorites, etc. Isotonic agents: For example, sodium bisulfite, sodium sulfite, potassium chloride, calcium chloride, sodium chloride, magnesium chloride, potassium acetate, sodium acetate, sodium bicarbonate, sodium carbonate, sodium thiosulfate, magnesium sulfate, glycerin, propylene glycol, etc. Thickeners: For example, cellulosic polymers (e.g., methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, sodium carboxymethylcellulose, etc.), polyvinyl polymers (e.g., polyvinylpyrrolidone, polyvinyl alcohol, etc.), carboxyvinyl polymers, guar gum, hydroxypropyl guar gum, acacia gum, karaya gum, xanthan gum, agar, alginic acid and its salts (sodium salts, etc.), mucopolysaccharides (e.g., heparinoids, heparin, heparin sulfate, heparan sulfate, heparinoids, hyaluronic acid and its salts (sodium salts, etc.)), starch, chitin and its derivatives, chitosan and its derivatives, carrageenan, etc. Sugars: For example, glucose, cyclodextrin, etc. Sugar alcohols: For example, xylitol, sorbitol, mannitol, glycerin, etc. These may be in d-isomer, l-isomer, or dl-isomer.

[0070] If the eyewash composition according to this embodiment contains water, from the viewpoint of more significantly exhibiting the effects of the present invention, the water content is preferably 80 w / v% or more and less than 100 w / v%, more preferably 85 w / v% or more and 99.5 w / v%, and even more preferably 90 w / v% or more and 99.2 w / v%, based on the total amount of the eyewash composition.

[0071] The water used in the eyewash composition according to this embodiment may be any water that is pharmaceutically, pharmacologically (pharmaceutically), or physiologically acceptable. Examples of such water include distilled water, tap water, purified water, sterile purified water, water for injection, and distilled water for injection. These definitions are based on the 17th edition of the Japanese Pharmacopoeia.

[0072] The eyewash composition according to this embodiment can be prepared, for example, by adding and mixing component (A) and, if necessary, other components in desired amounts. Specifically, it can be prepared, for example, by dissolving or suspending the above components in purified water, adjusting to a predetermined pH and osmotic pressure, and sterilizing by filtration sterilization or the like.

[0073] The eyewash composition according to this embodiment can take various dosage forms depending on the purpose, such as liquid, gel, or semi-solid (ointment, etc.). Among these, liquid formulations are preferred, and aqueous liquid formulations are more preferred.

[0074] The eyewash composition according to this embodiment can be applied while wearing contact lenses. "Contact lenses" includes hard contact lenses and soft contact lenses (including both ionic and nonionic types, and both silicone hydrogel contact lenses and non-silicone hydrogel contact lenses). The eyewash composition according to this embodiment is preferable to be used while wearing contact lenses (preferably soft contact lenses) as it exhibits the effects of the present invention more significantly.

[0075] The number of times the eyewash composition according to this embodiment is administered per day is not particularly limited and may be, for example, 1 to 12 times, 2 to 9 times, 3 to 6 times, etc.

[0076] 〔container〕 The eyewash composition according to this embodiment is provided in any container. The container may be any packaging having a portion (surface) that comes into contact with the eyewash composition, and may consist of, for example, a container body for containing the eyewash composition, an inner stopper (nozzle) including the dispenser opening of the container, a cap, etc. The material of the container is not particularly limited, and may be glass or plastic, for example, but plastic is preferred from the viewpoint of more significantly demonstrating the effects of the present invention.

[0077] When the container material is plastic, specific examples include polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate, polyarylate, polycarbonate, polyethylene (PE; high-density polyethylene (HDPE), low-density polyethylene (LDPE)), polypropylene (PP), polystyrene (PS), acrylonitrile butadiene styrene (ABS), polymethylpentene (PMP), polyimide, copolymers of monomers comprising these materials, and mixtures of two or more of these. Among these, polyethylene (PE) is preferred. These plastics may also contain additives such as stabilizers and reinforcing agents such as glass fibers.

[0078] The container may have at least a portion of the part that comes into contact with the eyewash composition made of the above material. Here, the part of the container that comes into contact with the eyewash composition may include, for example, the inner surface of the container body (the innermost layer if the container has a structure consisting of multiple layers) and the stopper (nozzle). For example, in the case of a container having a stopper (nozzle), only the stopper (nozzle) may be made of the above material (preferably polyethylene), the container body other than the stopper (nozzle) may be made of the above material (preferably polyethylene), or the entire part that comes into contact with the eyewash composition may be made of the above material (preferably polyethylene). From the viewpoint of more significantly demonstrating the effects of the present invention, it is preferable that the entire part of the container that comes into contact with the eyewash composition is made of the above material (preferably polyethylene).

[0079] The type of container is not particularly limited as long as it is a container commonly used in the field of ophthalmology and from which the contained eyewash composition can be dispensed by dropping. Specifically, for example, it may be a container having an inner stopper (nozzle). Preferably, the container is one used as an eye drop container.

[0080] The shape and capacity of the container are not particularly limited and may be set as appropriate depending on the application. Furthermore, the container may be one that can hold an eyewash composition for multiple uses (e.g., 25 or more uses), one that can hold an eyewash composition for a few uses (e.g., 2 or more but less than 25 uses), or one that can hold an eyewash composition for a single use.

[0081] If the container is for an eyewash composition intended for multiple uses (e.g., 25 or more uses), the capacity may be, for example, 1 mL to 200 mL, preferably 1 mL to 100 mL, and more preferably 1 mL to 50 mL. If the container is for an eyewash composition intended for a small number of uses (e.g., 2 to less than 25 uses) or a single use, the capacity may be, for example, 0.01 mL to 7 mL, preferably 0.05 mL to 6 mL, more preferably 0.1 mL to 5 mL, even more preferably 0.1 mL to 3 mL, even more preferably 0.2 mL to 2 mL, and particularly preferably 0.2 mL to 1 mL. The container may also be a multi-dose type that contains multiple uses, or a unit-dose type that contains a single use.

[0082] The container may be one in which the container body and the spout are integrally molded. For containers used a small number of times (for example, 2 times or more but less than 25 times) or for single use, and with a capacity of 0.1 mL or more and 3 mL or less, it is preferable that the container body and the spout be integrally molded.

[0083] The eyewash composition according to this embodiment may also be provided as a product (such as an eyewash) in which the eyewash composition is contained in a container.

[0084] The eyewash composition according to this embodiment can be used, for example, for washing the eyes and preventing eye diseases (after swimming; when dust or sweat gets into the eyes, etc.). [Examples]

[0085] The present invention will be described in detail below based on test examples, but the present invention is not limited to these.

[0086] [Test Example 1: Evaluation of cleaning effect against water-soluble foreign matter] As a foreign matter, 10 μL of 2% trypan blue aqueous solution was instilled into the eyes of Japanese white rabbits (3 kg or more, 16-18 weeks old). After washing the eyes by instillation or using an eye cup according to the method described below, the washing effect was evaluated based on the amount of foreign matter washed out. In this study, physiological saline solution was used as the eyewash composition.

[0087] For eye washing by eye drops, a standard eye drop container (12 mL capacity, made of polyethylene terephthalate resin) was used, and 12 drops of physiological saline solution were administered to each eye of each rabbit. After every 3 drops, the lower eyelid was gently pressed down, and the excess physiological saline solution was collected using a pipette. The volume per drop was approximately 40 μL. In eye washing using eye cups, a standard plastic eye cup was used, and 5 mL of physiological saline solution was applied to the cornea and conjunctiva of one eye of each rabbit for 2 seconds, for a total of 10 times, after which the physiological saline solution was collected. The amount of trypan blue washed into physiological saline solution was determined by spectrophotometry, and the recovery rate was calculated. Each test was performed six times, and the average value was calculated. The results are shown in Figure 1.

[0088] As shown in Figure 1, the recovery rate of trypan blue, a water-soluble foreign substance, was approximately 90% with eye cup washing, whereas with eye drops, the recovery rate was approximately 75% with 3 drops, approximately 90% with 6 drops, approximately 95% with 9 drops, and approximately 98% with 12 drops. These results indicate that water-soluble foreign substances can be sufficiently removed with 3 to 12 drops of eye drops per treatment.

[0089] [Test Example 2: Evaluation of cleaning effect on solid foreign matter] The evaluation was carried out in the same manner as in Test Example 1, except that 200 polystyrene beads (particle size: 340-420 μm) suspended in 50 μL of 0.5% methylcellulose aqueous solution were used as the foreign matter, a standard eye drop container (capacity 13 mL, made of polyethylene resin) was used as the eye drop container, and the amount dispensed per drop was approximately 50 μL. The number of polystyrene beads was calculated from the dry weight. The results are shown in Figure 2.

[0090] As shown in Figure 2, the recovery rate of polystyrene beads, which are solid foreign objects, was approximately 80% when using an eye cup for eye washing, whereas the recovery rate of polystyrene beads was approximately 65% ​​with 3 drops and approximately 80% with 6, 9, and 12 drops for eye drop washing. These results indicate that solid foreign objects can be sufficiently removed with 3 to 12 drops of eye drops per wash.

[0091] [Test Example 3: Evaluation of the cleaning effect on solid foreign matter when wearing soft contact lenses] Each eyewash composition shown in Table 1 was prepared by conventional methods. Fifty polystyrene beads (340-420 μm) were suspended in 25 μL of a 0.5% methylcellulose aqueous solution as foreign matter and instilled into the eyes of Japanese white rabbits (3 kg or more, 16-18 weeks old). Soft contact lenses were then fitted immediately afterward. Subsequently, using a standard eye drop container (made of polyethylene resin), nine drops of the prepared eyewash composition 1 or 2 were dropped into each eye of each rabbit. After every three drops, the lower eyelid was gently pressed, and the overflowing eyewash composition was collected using a pipette. The amount dropped per drop was approximately 40 μL. The number of polystyrene beads was calculated from the dry weight. The results are shown in Figure 3.

[0092] [Table 1]

[0093] As shown in Figure 3, the recovery rates of polystyrene beads when using eyewash compositions 1 and 2 were approximately 75% and 50% with 3 drops, approximately 85% and 70% with 6 drops, and approximately 90% and 80% with 9 drops. These results indicate that solid foreign matter can be sufficiently removed by instilling 3 to 9 drops per application, even when wearing soft contact lenses.

[0094] [Test Example 4: Evaluation of the stability of chlorpheniramine maleate] The eyewash compositions shown in Tables 2 and 3 were prepared by conventional methods. The units for each component in Tables 2 and 3 are w / v%. The obtained eyewash compositions were each filled into polyethylene resin unit dose containers. The eyewash compositions shown in Table 2 were left standing at 60°C for 2 hours, and the eyewash compositions shown in Table 3 were left standing at 60°C for 3 days. After that, the chlorpheniramine maleate content was quantified, and its remaining percentage was determined. The stability improvement rate was calculated based on the following formula. Stability improvement rate (%) = [1 - (100 - Survival rate of the example) / (100 - Survival rate of the control)] × 100 The results are shown in Figures 4 and 5, respectively.

[0095] [Table 2]

[0096] [Table 3]

[0097] As shown in Figure 4, the stability of chlorpheniramine maleate improved by lowering the pH from 9.2, with improvements of over 30% at pH 8.3 or below, over 50% at pH 8.0 or below, over 70% at pH 7.5 or below, over 85% at pH 7.0 or below, and over 90% at pH 6.5 or below.

[0098] Furthermore, as shown in Figure 5, the stability of chlorpheniramine maleate was improved by the addition of l-menthol, d-α-tocopherol acetate, and retinol palmitate, with an improvement rate of over 20%.

[0099] [Test Example 5: Evaluation of the effect of cooling agents on the cleansing sensation during eye washing] Each of the eyewash compositions shown in Table 4 was prepared by conventional methods. The effect of cooling agents on the cleansing sensation during eye washing was evaluated using the Visual Analogue Scale (VAS) method. Specifically, five subjects were asked to instill four drops each of the prepared eyewash compositions 3 and 4 into each eye. A 100 mm scale was used, with the left end representing "no cleansing sensation" (0 points) and the right end representing "cleansing sensation" (100 points), and subjects were asked to check the degree of cleansing sensation they felt. Subjects were instilled with the eyewash compositions without wearing contact lenses. The length from the 0 point (left end) to the checked point was measured, and this length (mm) was used as the cleansing sensation score. Subsequently, a t-test was performed on the cleansing sensation scores of each eyewash composition. The results are shown in Figure 6.

[0100] [Table 4]

[0101] As shown in Figure 6, eyewash composition 4, which contains l-menthol as a cooling agent, had a significantly higher cleansing sensation score compared to eyewash composition 3, which does not contain a cooling agent. This result indicates that a cooling agent enhances the cleansing sensation when the eyes are washed with eye drops.

[0102] [Example prescription] Tables 5 and 6 below show examples of formulations. The units for each component in Tables 5 and 6 are w / v%. Formulations 1 to 19 are all eye washes, and the pH of the formulations was adjusted as needed using hydrochloric acid or sodium hydroxide. Formulations 1' to 19' are defined as each formulation filled into a polyethylene container.

[0103] [Table 5]

[0104] [Table 6]

Claims

[Claim 1] An eyewash composition for use by instilling 3 to 12 drops at a time to wash the eyes.

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