Eye drop-type eye-wash composition

Abstract

To provide an eye drop-type eye-washing composition capable of effectively improving the foreign-body sensation of the eye even though being free of antihistamine, and to provide a method for improving the foreign-body sensation of the eye.SOLUTION: Provided is an eye drop-type eye-wash composition comprising a refreshing agent and being free of antihistamine. Also provided is a method for improving the foreign-body sensation of the eye due to an eye drop-type eye-washing composition free of antihistamine, the method comprising blending a refreshing agent into the eye drop-type eye-wash composition.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a drop-type eyewash composition. [Background technology]

[0002] Conventionally, eye washing methods using an eye cup (eye cup) have been known, and one example of such a method is to pour an appropriate amount of eye wash (for example, about 5 mL) into the eye cup, then press the cup against the area around one eye to bring the eye wash in the cup into contact with the eye, and then blink several times to wash the eye. However, this method requires an eye cup, and has a problem of lack of portability.

[0003] Another method of washing the eyes that is different from the above method is to drop the eyewash solution directly onto the eyes. This method is highly portable because it does not require an eyewash cup. However, in this method of washing the eyes by dropping the eyewash solution, the amount of eyewash solution applied to the eyes is less than that in the above method that uses an eyewash cup, and the effect of washing the eyes may be insufficient. In addition, foreign matter such as dust and pollen can cause foreign body sensation in the eyes, itching, etc.

[0004] Thus, there have been many conventional eye drops and eye washes containing antihistamines that suppress itching, etc., and such eye drops and eye washes are considered to be useful in that they reduce the foreign body sensation while suppressing itching (Patent Document 1). On the other hand, antihistamines are known to have side effects such as a decrease in tear volume, temporary dry mouth, and drowsiness, and their use may be restricted in people who are highly sensitive to antihistamines. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2011-246449 A Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, the present invention aims to provide a drop-type eyewash composition that does not contain an antihistamine but can effectively improve foreign body sensation in the eye, and also to provide a method for improving foreign body sensation in the eye. [Means for solving the problem]

[0007] The present inventors have conducted intensive research in view of the above problems and have found that the sensation of foreign matter in the eyes can be improved by adding a cooling agent to an eye drop-type eyewash composition that does not contain an antihistamine. The present invention has been completed as a result of further research based on this finding, and is as follows. Item 1. A drop-type eyewash composition containing a cooling agent but not containing an antihistamine. Item 2. The eye drop-type eyewash composition according to Item 1, further comprising at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof. Item 3. The eye drop-type eyewash composition according to Item 1 or 2, further comprising at least one member selected from the group consisting of tocopherol, its derivatives, and salts thereof. Item 4. The drop-type eyewash composition according to any one of Items 1 to 3, which does not contain at least one selected from the group consisting of a thickener, an amino acid salt, and a quaternary ammonium compound-based preservative. Item 5. The drop-type eyewash composition according to any one of Items 1 to 4, which is administered in an amount of 3 to 8 drops per eye at a time. Item 6. An eye drop type eyewash composition that does not contain an antihistamine and is blended with a cooling agent. A method for improving foreign body sensation in the eye caused by an eyewash composition. Item 7. The method according to Item 6, further comprising blending at least one selected from the group consisting of the following (1) and (2) into the drop-type eyewash composition: (1) at least one member selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof; (2) At least one member selected from the group consisting of tocopherol, its derivatives, and salts thereof. Effect of the Invention

[0008] According to the present invention, the eye drop-type eyewash composition does not contain an antihistamine, but by incorporating a cooling agent, it is possible to effectively improve the foreign body sensation in the eye. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present invention will now be described in more detail.

[0010] The present invention provides a drop-type eyewash composition that contains a cooling agent and does not contain an antihistamine.

[0011] The eye drop type eyewash composition of the present invention contains a cooling agent as described above. The cooling agent is not limited as long as it is acceptable for use in eye drops and eyewashes, and examples thereof include menthol, borneol, geraniol, anethole, eugenol, limonene, cymene, terpineol, pinene, cineol, citronellol, carvone, menthone, camphor, isoborneol, linalool, linalool acetate, linalyl acetate, etc. When d-, l-, or dl-isomers are present in these, they may be any of them. As cooling agents, from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye, or, as described later, from the viewpoint of improving the effect of improving itching in addition to the above, preferably, l-menthol, d-borneol, dl-camphor, etc. are exemplified. The cooling agents may be used alone or in combination of two or more. When two or more kinds are used, there is no upper limit, but examples include 2 to 5 kinds, 2 to 4 kinds, and 2 to 3 kinds.

[0012] The content of the cooling agent in the composition is not limited, and from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye and / or, in addition, improving the effect of improving itching, the content of the cooling agent in the composition is, for example, 0.0015 to 0.07 w / v%, preferably 0.002 to 0.05 w / v%, more preferably 0.002 to 0.03 w / v%, even more preferably 0.004 to 0.03 w / v%, and particularly preferably 0.004 to 0.02 w / v%.

[0013] As described above, the eye drop-type eyewash composition of the present invention does not contain an antihistamine. Examples of the antihistamine include conventionally known antihistamines, such as diphenhydramine and its salts (diphenhydramine hydrochloride, etc.), and chlorpheniramine and its salts (chlorpheniramine maleate, etc.).

[0014] The eye drop type eyewash composition of the present invention may contain at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and their salts. Examples of derivatives of glycyrrhizinic acid include methyl glycyrrhizinate and stearyl glycyrrhizinate. Examples of salts of glycyrrhizinic acid and its derivatives include alkali metal salts such as sodium salts and potassium salts, and ammonium salts. As at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and their salts, from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye, or in addition, improving the effect of improving itching, a preferable example is dipotassium glycyrrhizinate. These may be used alone or in combination of two or more. may be used.

[0015] When the eye drop-type eyewash composition of the present invention contains at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, the content of the at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof in the composition is not limited, but from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye in the composition, or in addition, improving the effect of improving itching, an example of the content is 0.005 to 0.025 w / v%, preferably 0.006 to 0.025 w / v%, more preferably 0.08 to 0.025 w / v%, and even more preferably 0.01 to 0.025 w / v%.

[0016] The eye drop type eyewash composition of the present invention may contain at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof. Examples of tocopherol derivatives include tocopherol organic acid esters such as tocopherol acetate, tocopherol succinate, tocopherol nicotinate, and tocopherol linoleate. These include, for example, esters of α-, γ-, or δ-tocopherol with organic acids. Tocopherol and its Examples of salts of the derivatives include organic acid salts such as acetates, nicotinates, and succinates, and inorganic acid salts such as ammonium salts. As at least one selected from the group consisting of tocopherol, its derivatives, and their salts, from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye, or in addition, improving the effect of improving itching, preferred examples include tocopherol acetate, more preferred examples include esters of α-tocopherol and acetic acid, e.g. Examples include dl-α-tocopherol acetate and d-α-tocopherol acetate, and a particularly preferred example is d-α-tocopherol acetate, which is called natural vitamin E. These may be used alone or in combination of two or more.

[0017] When the eye drop-type eyewash composition of the present invention contains at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, the content of at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof in the composition is not limited, but from the viewpoint of further enhancing the effect of improving foreign body sensation in the eye in the composition, or in addition, improving the effect of improving itching, an example of the content is 0.0005 to 0.005 w / v%, preferably 0.0008 to 0.005 w / v%, more preferably 0.001 to 0.005 w / v%, even more preferably 0.002 to 0.005 w / v%, and particularly preferably 0.0025 to 0.005 w / v%.

[0018] The eye drop type eyewash composition of the present invention may further contain any other components acceptable for use in eye drops or eyewashes. Examples of such other components include, but are not limited to, buffers, stabilizers, isotonicity agents, solvents, pH adjusters, thickeners, preservatives, medicinal ingredients, etc. The other components may be appropriately selected according to the purpose, etc., as long as they do not impair the effects of the present invention, and may be used alone or in combination of two or more, and the amount of each component may be appropriately determined.

[0019] Although the present invention is not limited to this, examples of the buffer include boric acid, borax, etc. These may be used alone or in combination of two or more. Although the present invention is not limited to this, for example, when boric acid is contained, the content of boric acid in the composition is preferably 0.5 to 2.2 w / v%, more preferably 1 to 2 w / v%. Furthermore, although the present invention is not limited to this, when borax is contained, the content of borax in the composition is preferably 0.005 to 0.05 w / v%, more preferably 0.01 to 0.025 w / v%.

[0020] In addition, although not limiting the present invention, when the eye drop-type eyewash composition of the present invention contains a stabilizer, the stabilizer may be used alone or in combination of two or more kinds. The content of the stabilizer is not limited as long as it does not impede the effects of the present invention, and is preferably, for example, 0.001 to 0.5 w / v %, and more preferably, 0.08 to 0.12 w / v %, in the composition.

[0021] In addition, although not limiting the present invention, examples of the medicinal component include amino acids, vitamins, corneal surface layer protective agents, anti-inflammatory agents (anti-inflammatory agents), etc. These may be used alone or in combination of two or more.

[0022] Although the present invention is not limited thereto, examples of amino acids include amino acids and their salts such as glutamic acid and its salts (such as sodium glutamate); amino acid analogs such as taurine, and the like, and preferably amino acid analogs such as taurine. These may be used alone or in combination of two or more. The eye drop type eyewash composition of the present invention can be prepared without adding amino acids and / or their salts. The amino acid referred to here means an amino acid that can be a structural unit of a protein having both functional groups of an amino group and a carboxy group, and includes, for example, L-aspartic acid.

[0023] Although the present invention is not limited thereto, for example, corneal surface layer protective agent is exemplified by chondroitin sulfate and its salt, hyaluronic acid and its salt, and as salt, alkali metal salt such as sodium salt is preferably exemplified. These may be used alone or in combination of two or more. In addition, when chondroitin sulfate and / or its salt is blended as corneal surface layer protective agent in the eyewash composition of the present invention, it is preferable not to blend hyaluronic acid and its salt.

[0024] Although not limiting the present invention, examples of anti-inflammatory agents (anti-phlogistic agents) include zinc sulfate, zinc lactate, epsilon-aminocaproic acid, etc. These may be used alone or in combination of two or more. Although not limiting the present invention, the eye drop-type eyewash composition of the present invention preferably does not contain zinc sulfate and / or zinc lactate.

[0025] When the eye drop type eyewash composition of the present invention contains a medicinal ingredient, the content of the medicinal ingredient is not limited as long as it does not impede the effect of the present invention, and the content of the medicinal ingredient in the composition is, for example, 0.02 to 5 w / v%, preferably 0.025 to 2 w / v%, more preferably 0.05 to 1 w / v%, even more preferably 0.1 to 0.5 w / v%, and particularly preferably 0.2 to 0.35 w / v%. Note that tocopherol, its derivatives and salts thereof, and glycyrrhizic acid, its derivatives and salts thereof are also known as medicinal ingredients, but these ingredients are not included in the description of the medicinal ingredients here, and therefore the content of the medicinal ingredient does not include the content of tocopherol, its derivatives and salts thereof, or glycyrrhizic acid, its derivatives and salts thereof.

[0026] As one embodiment of the present invention, the eye drop-type eyewash composition of the present invention contains a cooling agent but does not contain an antihistamine, although this is not intended to limit the present invention.

[0027] Furthermore, as one embodiment of the present invention, without being limiting the present invention, the eye drop-type eyewash composition of the present invention contains (1) a cooling agent and (2) at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, and does not contain an antihistamine.

[0028] In addition, as one embodiment of the present invention, the eye drop-type eyewash composition of the present invention contains (1) a cooling agent and (2) at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, and does not contain an antihistamine. .

[0029] Furthermore, as one embodiment of the present invention, without being limiting the present invention, the eye drop-type eyewash composition of the present invention contains (1) a cooling agent, (2) at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, and (3) at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, and does not contain an antihistamine.

[0030] In addition, as one embodiment of the present invention, although not limiting the present invention, the eye drop-type eye wash composition of the present invention, in the above-mentioned embodiment, further contains (4) at least one selected from the group consisting of a buffering agent, a stabilizer, an isotonicity agent, a solvent, a pH adjuster, and a medicinal ingredient.

[0031] Furthermore, as one embodiment of the present invention, without limiting the present invention, the eye drop-type eyewash composition of the present invention may further contain at least one selected from the group consisting of thickeners, amino acid salts and preservatives (particularly quaternary ammonium-based preservatives (e.g., benzalkonium chloride, benzethonium chloride, etc.)), but preferably does not contain at least one selected from the group.

[0032] In addition, as one embodiment of the present invention, without limiting the present invention, the eye drop-type eyewash composition of the present invention may be composed of (1) a refreshing agent, (2) at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, and (3) at least one selected from the group consisting of buffers, stabilizers, isotonicity agents, solvents, pH adjusters, and medicinal ingredients; (1) a refreshing agent, (2) at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, and (3) at least one selected from the group consisting of buffers, stabilizers, isotonicity agents, solvents, pH adjusters, and medicinal ingredients; (1) a refreshing agent, (2) at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, (3) at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, and (4) at least one selected from the group consisting of buffers, stabilizers, isotonicity agents, solvents, pH adjusters, and medicinal ingredients.

[0033] The eye drop-type eyewash composition of the present invention can be produced by mixing a cooling agent, and optionally at least one selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof, and optionally at least one selected from the group consisting of tocopherol, its derivatives, and salts thereof, and optionally the other ingredients described above, but not mixing an antihistamine.

[0034] The pH of the eye drop type eyewash composition of the present invention is not limited as long as it is within a range that can be used as an eye drop or eyewash, and is exemplified by a pH of 5 to 8, preferably a pH of 5.5 to 7, and more preferably a pH of 5.8 to 6.2 at room temperature (24° C.). The pH is measured with a tabletop pH meter F-52 (manufactured by Horiba, Ltd.).

[0035] The form of the eye drop-type eyewash composition of the present invention is not limited, and is usually liquid at room temperature.

[0036] The eye drop type eyewash composition of the present invention is usually contained in an eye drop container and instilled in the eye, as described below. For this reason, the viscosity of the composition is not limited as long as it can be instilled in the eye, but is preferably 0.9 to 2.5 mPa·s, more preferably 0.9 to 1.6 mPa·s, and even more preferably 0.9 to 1.2 mPa·s at room temperature. The viscosity is measured using a cone-plate viscometer (rheometer MCR302, manufactured by Anton Paar) at a shear rate of 100 s -1 The measurement is performed at a measurement temperature of 25°C. More specifically, the sample plate of the rheometer is Add 5 mL of the composition, set a cone plate sensor with a radius of 50 mm and a cone angle of 1°, and measure the shear rate of 100 s at 25 °C. -1 The sensor is rotated so that the viscosity is measured. Measurements are carried out for 100 seconds, with one point of data being obtained every 2 seconds, and the average value of the five data points, 45th to 49th, is calculated and used as the viscosity.

[0037] The osmolality of the eye drop type eyewash composition of the present invention is not limited as long as it is within the range usable as an eye drop or eyewash, but for example, the osmolality ratio is 0.6 to 1.6, preferably 0.7 to 1.3, and more preferably 0.8 to 1.2. The osmolality ratio is a value measured and calculated using an automatic osmolality analyzer (OsmoStation OM-6060, manufactured by Arkray, Inc.) according to 2.47 Osmolality Measurement Method (Osmolarity Measurement Method) of the 17th Revised Japanese Pharmacopoeia, and is a value obtained by measuring the osmolality of the composition and physiological saline (0.9 w / v% sodium chloride aqueous solution) and assuming the measured value of physiological saline to be 1.

[0038] The eye drop-type eyewash composition of the present invention may be used with or without contact lenses, regardless of whether the contact lenses are hard or soft.

[0039] The eye drop type eyewash composition of the present invention is not limited as long as it can be used by instillation, but from the viewpoint of ease of use, the composition is usually contained in an eye drop container before use.

[0040] The eye drop container is not limited as long as it can contain the composition and can instill it into the eye, and examples thereof include eye drop containers (e.g., including a container body, an inner stopper (nozzle), and a cap) used for conventionally known eye drops, eye drop-type eyewashes, etc. The eye drop container may be any of the following types: a type in which the container body, the inner stopper (nozzle), and the cap are each independent, a type in which at least two of the container body, the inner stopper (nozzle), and the cap are integrated, a type in which a hole is provided in the inner stopper (nozzle), a type in which there is no hole in the inner stopper (nozzle) and the cap is tightened when used to make a hole in the inner stopper (nozzle), and the like.

[0041] The volume of the eye drop container is not limited, but from the viewpoint of ease of use, the volume is, for example, 8 to 20 mL, preferably 10 to 15 mL, and more preferably 12 to 14 mL. The volume may be appropriately determined taking into consideration whether the eye drop container is a multi-dose type or a unit-dose type.

[0042] The eye drop type eyewash composition of the present invention is used by instilling 3 to 8 drops per eye at one time. Although not limited thereto, the composition is preferably instilled at 4 to 8 drops per eye at one time, and more preferably at 4 to 6 drops from the viewpoint of efficiently improving the effect of improving foreign body sensation in the eye and / or improving the effect of improving itching.

[0043] The amount of the composition to be dropped per drop is not limited as long as the effects of the present invention can be obtained, but is exemplified by 30 to 50 μL, preferably 35 to 40 μL, and more preferably 35 to 37 μL per drop.

[0044] The number of times the composition is used per day is not particularly limited, and may be, for example, 1 to 12 times, 2 to 8 times, 3 to 6 times, etc. per eye per day.

[0045] In this way, the eye can be cleaned by the drop-type eyewash composition of the present invention. In particular, the eye foreign body sensation can be effectively improved by the eye drop-type eyewash composition of the present invention, even though it contains a refreshing agent but does not contain an antihistamine. Furthermore, as shown in the examples described later, the eye foreign body sensation was improved more effectively in a composition that does not contain an antihistamine but contains a refreshing agent than in a composition that contains an antihistamine but does not contain a refreshing agent. Therefore, the eye drop-type eyewash composition of the present invention has a more effective effect of improving the eye foreign body sensation. It can be said that the eye drops can be improved. Furthermore, as can be understood from the examples described later, the eye drop-type eyewash composition of the present invention can effectively improve not only the foreign body sensation in the eye but also eye itching. When the composition further contains the above-mentioned medicinal ingredient, it can also provide a useful effect based on the medicinal ingredient.

[0046] From this, the present invention can also be said to provide a method for improving eye itching caused by an eye drop type eyewash composition by blending a refreshing agent into an antihistamine-free eyewash composition, and further, a method for improving and improving eye itching.The present invention can also be said to provide a method for improving eye itching caused by an eye drop type eyewash composition by blending a refreshing agent into an antihistamine-free eyewash composition, and further, a method for improving and improving eye itching.

[0047] In the method, the drop-type eyewash composition may further contain at least one selected from the group consisting of the following (1) and (2). (1) At least one member selected from the group consisting of glycyrrhizinic acid, its derivatives, and salts thereof. (2) At least one member selected from the group consisting of tocopherol, its derivatives, and salts thereof.

[0048] In this method, the eye drop-type eyewash composition, the cooling agent, at least one selected from the group consisting of glycyrrhizinic acid, its derivatives and their salts, at least one selected from the group consisting of tocopherol, its derivatives and their salts, and other components, as well as the contents of these components, are all as described above, and the above descriptions apply equally to the method of the present invention. EXAMPLES

[0049] The present invention will be described in more detail below by showing examples, but the present invention is not limited to these.

[0050] Test Example 1 Each composition was prepared by mixing the components according to the mixing ratio shown in Table 1 below, and 13 mL of the composition was filled into a general eye drop container (capacity 15 mL, made of polyethylene terephthalate resin, multi-dose type, manufactured by Shinko Chemical Co., Ltd.) (Examples 1 to 4 and Comparative Example 1).

[0051] Evaluation of improvement of foreign body sensation in the eye Five subjects who felt a foreign body sensation in their eyes were asked to wash their eyes using an eyecup (commercially available Eyebon Mild (manufactured by Kobayashi Pharmaceutical Co., Ltd.)) according to the instructions. Six hours after washing the eyes, five drops (35 μL per drop) of the composition of Example 1 were dropped into both eyes of the five subjects so as to rinse the eyes. The composition that had flowed out around the eyes was wiped off with tissue. Five minutes after the eye drops were applied, the subjects were asked to evaluate the foreign body sensation in both eyes.

[0052] Evaluation was based on a 10-point VAS (Visual Analog Scale) rating (10: marked improvement, 0: no change). Specifically, five subjects were asked to score the foreign body sensation of the washed eyes (VAS value) based on the VAS method, and the average value of the five subjects was rounded off to the nearest tenth to obtain a calculated value. The compositions of Examples 2 to 4 and the composition of Comparative Example 1 were also dropped into both eyes in the same manner as the composition of Example 1, and the average value of the five subjects was rounded off to the nearest tenth to obtain a calculated value. A higher calculated value means a higher effect of improving foreign body sensation in the eyes.

[0053] In the VAS method, the VAS value when a foreign body sensation is felt in the eye, similar to that felt immediately before washing the eye, is set to 0, and the VAS value when no foreign body sensation is felt at all between 2 and 5 minutes after instillation is set to 0. The test was conducted after five subjects had agreed on a common understanding of the score, which was set at 10.

[0054] In addition, since the subject in this test example also felt itchy eyes, the itchy eyes were evaluated 2 hours after the above-mentioned eye drop time by a 10-point VAS evaluation (10: marked improvement, 0: unchanged). Specifically, five subjects were asked to score the itchy eyes after washing based on the VAS method (VAS value), and the average value of the five subjects was rounded off to the nearest tenth place to obtain a calculated value. The compositions of Examples 2 to 4 and the composition of Comparative Example 1 were also dropped into both eyes in the same manner as the composition of Example 1, and the average value of the five subjects was rounded off to the nearest tenth place to obtain a calculated value. The higher the calculated value, the higher the effect of improving itching after eye drop.

[0055] In the VAS method, a VAS value of 0 was assigned to a condition in which the subject felt itching similar to that experienced immediately before washing the eyes, and a VAS value of 10 was assigned to a condition in which the subject did not rub or touch the eyes with hands or fingers even once between 30 minutes and 2 hours after applying the eye drops. The five subjects were then refined and agreed on a common understanding before the test was conducted.

[0056] ·result The results are shown in Table 1.

[0057] [Table 1]

[0058] Chlorpheniramine maleate contained in the composition of Comparative Example 1 is a type of typical antihistamine. The calculated value in the foreign body sensation evaluation for the composition of Comparative Example 1 containing chlorpheniramine maleate was 3.3, and the effect of improving foreign body sensation by instillation was observed.

[0059] In the compositions of Examples 1 and 2, which did not contain chlorpheniramine maleate but contained menthol or borneol, the calculated values ​​were 7.8 and 7.7, respectively, which were significantly greater than the improvement effect in Comparative Example 1. In the compositions of Examples 3 and 4, which did not contain chlorpheniramine maleate but contained menthol and borneol, the calculated values ​​were 8.0 and 8.2, respectively, which were even greater than the improvement effect in Comparative Example 1. In the compositions of Examples 2 to 4 in which borneol was replaced with camphor, the effect of improving foreign body sensation when instilled in the eyes was observed similar to that of Examples 2 to 4.

[0060] In addition, the composition of Comparative Example 1 had a calculated value of 4.9 in the itching evaluation, and was found to have an itching relief effect when instilled in the eye. In the compositions of Examples 1 and 2, which contained menthol or borneol, the calculated values ​​were both 6.2, which was significantly greater than the improvement effect in Comparative Example 1. Furthermore, in the compositions of Examples 3 and 4, which did not contain chlorpheniramine maleate but contained menthol and borneol, the calculated values ​​were 7.3 and 8.2, respectively, which was even greater than the improvement effect in Comparative Example 1. Furthermore, the compositions in Examples 2 to 4 in which borneol was replaced with camphor also showed the same effect of improving itching when instilled in the eyes as in Examples 2 to 4.

[0061] Conventionally, chlorpheniramine maleate has been used for the purpose of improving foreign body sensation and itching, but it has been found that by using menthol or borneol instead of chlorpheniramine maleate, it is possible to obtain a better effect of improving foreign body sensation than when chlorpheniramine maleate is used.In addition, it has been found that by using menthol or borneol instead of chlorpheniramine maleate, it is possible to obtain a better effect of improving itching than when chlorpheniramine maleate is used.

[0062] Test Example 2 Except for preparing each composition by mixing each component according to the blending ratio shown in Table 2 below, 13 mL of the composition was filled in an eye drop container in the same manner as in Test Example 1 (Examples 5 to 7 and Comparative Example 1). The same five subjects as in Test Example 1 were given eyewash in advance in the same manner as in Test Example 1, and each composition of Examples 5 to 7 and Comparative Example 1 was dropped on them. The composition that flowed around the eye was wiped off with a tissue. After 5 minutes from the time of eye drop, the foreign body sensation in the eye was quantified using a 10-point VAS evaluation (10: marked improvement, 0: unchanged) using the same criteria as above, and the average value of the five subjects was rounded off to the nearest tenth place to obtain a calculated value. In addition, after 2 hours from the time of eye drop, the itching in the eye was quantified using a 10-point VAS evaluation (10: marked improvement, 0: unchanged) using the same criteria as above, and the average value of the five subjects was rounded off to the nearest tenth place to obtain a calculated value.

[0063] ·result The results are shown in 2.

[0064] [Table 2]

[0065] For the composition of Comparative Example 1 containing chlorpheniramine maleate, the calculated value in the foreign body sensation evaluation was 3.3, demonstrating the effect of improving foreign body sensation by instillation.

[0066] In contrast, the calculated value for the composition of Example 5, which did not contain chlorpheniramine maleate but contained menthol, borneol, and dipotassium glycyrrhizinate, was 8.9, which was significantly greater than the improvement effect in Comparative Example 1. In addition, the calculated values ​​for the compositions of Examples 6 and 7, which did not contain chlorpheniramine maleate but contained menthol, borneol, and tocopherol acetate, were also 8.9 and 9.6, respectively. The improvement effect was much greater than that in Comparative Example 1. Furthermore, in the compositions of Examples 5 to 7 in which borneol was replaced with camphor, the same effect of improving foreign body sensation by instillation as in Examples 5 to 7 was observed.

[0067] In addition, the calculated value in the itching evaluation for the composition of Comparative Example 1 was 4.9, and an itching improving effect by instillation was observed. The calculated value for the composition of Example 5 was 8.5, which was significantly greater than the improving effect in Comparative Example 1. Furthermore, the calculated values ​​for the compositions of Examples 6 and 7 were 8.8 and 9.1, respectively, which were even greater than the improving effect in Comparative Example 1. In addition, the compositions in Examples 5 to 7 in which borneol was replaced with camphor also showed the same effect of improving itching when instilled into the eyes as in Examples 5 to 7.

[0068] From this, it was found that by using dipotassium glycyrrhizinate or tocopherol acetate together with a freshening agent instead of chlorpheniramine maleate, it was possible to obtain a better effect of improving the foreign body sensation than when chlorpheniramine maleate was used.In addition, it was found that by using dipotassium glycyrrhizinate or tocopherol acetate together with a freshening agent instead of chlorpheniramine maleate, it was possible to obtain a better effect of improving the itching than when chlorpheniramine maleate was used.

[0069] Prescription Examples Formulation examples are shown below. The compositions shown in Formulation Examples 1 to 9 were found to have an improved effect of improving foreign body sensation in the eye and eye itching, compared to compositions of the same composition except that they do not contain a cooling agent, dipotassium glycyrrhizinate, and tocopherol acetate (they are replaced with water).

[0070] [Table 3]

Claims

[Claim 1] A drop-type eyewash composition containing a refreshing agent and at least one selected from the group consisting of glycyrrhizic acid, its derivatives and salts thereof, and containing no antihistamine. (However, this does not include eye drop-type eyewash compositions containing aspartic acid and / or its salts.)

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