Eyewash composition

Abstract

To provide an eyewash composition having excellent antiseptic properties.SOLUTION: The eyewash composition contains allantoin and polyoxyethylene hardened castor oil, but does not contain any antiseptic agents selected from quaternary ammonium salt-based antiseptic agents, p-hydroxybenzoic acid esters, chlorobutanol, and sorbic acid.SELECTED DRAWING: None

Description

Technical Field

[0001] Relates to an eye-washing composition.

Background Art

[0002] Conventionally, an eye-washing method using an eye-washing cup (eye cup) and an eye-washing method by eye drops are known. As an example of the eye-washing method using an eye-washing cup, an appropriate amount (for example, about 5 mL) of an eye-washing solution is poured into the eye-washing cup, and then the cup is pressed against the periphery of one eye to bring the eye-washing solution in the cup into contact with the eye, and eye-washing is performed by blinking several times. As an example of the eye-washing method by eye drops, a method of directly dropping an eye-washing solution into the eye for eye-washing can be mentioned (for example, Patent Document 1).

[0003] In the eye-washing method using an eye-washing cup, compared with the eye-washing method by eye drops, a large amount of eye-washing solution is required, so the eye-washing solution is often stored in a container with a relatively large capacity. However, with the opening and closing of the container and the injection of the cleaning solution into the eye-washing cup, etc., the risk of the eye-washing solution being exposed to microbial contamination is also high. Therefore, it is desirable to be able to suppress the growth of microorganisms in the cleaning solution. Also, the eye-washing method by eye drops has the advantages that an eye-washing cup is not required and it has excellent portability and is easy to use even when away from home. The eye-washing method by eye drops is thus convenient to use, but it is used by directly dropping it into the eye, and there are also many situations where it is used away from home, so the risk of the eye-washing solution being exposed to microbial contamination is high.

[0004] In order to reduce such a contamination risk, it is known to incorporate a preservative such as benzalkonium chloride into the eye-washing solution. However, from the viewpoints of the influence on the cornea and the adsorption to contact lenses, etc., the incorporation of such a preservative tends to be unfavorable. For this reason, there is a demand for an eye-washing composition having excellent antiseptic properties without incorporating a preservative such as benzalkonium chloride.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] Therefore, an object of the present disclosure is to provide an eye-washing composition having excellent antiseptic properties.

[0007] In view of the above problems, the present inventor conducted intensive studies and found that by using allantoin and polyoxyethylene hydrogenated castor oil in combination in an eye-washing composition, the desired antiseptic property can be imparted to the eye-washing composition without containing a preservative. The present invention has been completed by further studies based on such findings. That is, the present disclosure includes the inventions listed below. Item 1. An eye-washing composition containing allantoin and polyoxyethylene hydrogenated castor oil and not containing a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids. Item 2. The eye-washing composition according to Item 1, further containing at least one selected from the group consisting of chlorpheniramine and its salts. Item 3. The eye-washing composition according to Item 1 or 2, having a pH of 5 to 7. Item 4. The eye-washing composition according to any one of Items 1 to 3, for use in eye-washing using an eye-washing cup or for use in eye-washing by instillation.

EFFECTS OF THE INVENTION

[0008] By blending allantoin and polyoxyethylene hydrogenated castor oil into an eye-washing composition that does not contain a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids, an antiseptic action can be imparted to the eye-washing composition. Thus, it is possible to provide an eye-washing composition that contains allantoin and polyoxyethylene hydrogenated castor oil and does not contain the preservative and has the antiseptic action imparted thereto.

MODE FOR CARRYING OUT THE INVENTION

[0009] Hereinafter, the embodiments included in the present disclosure will be described in more detail.

[0010] The eye wash composition included in the present disclosure contains allantoin and polyoxyethylene hydrogenated castor oil, and does not contain a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids.

[0011] Allantoin is a known compound represented by the chemical formula C4H6N4O3. In the eye wash composition, the content of allantoin is not limited as long as the effects of the present disclosure can be obtained. However, from the viewpoint of improving the preservative property of the composition, it is preferably 0.003 to 0.05 w / v%, more preferably 0.005 to 0.04 w / v%, still more preferably 0.008 to 0.03 w / v%, and particularly preferably 0.015 to 0.03 w / v%.

[0012] Polyoxyethylene hydrogenated castor oil is not limited as long as it can be used in the fields of eye drops and eye washes. Examples of polyoxyethylene (POE) hydrogenated castor oil include POE(60) hydrogenated castor oil, POE(50) hydrogenated castor oil, POE(40) hydrogenated castor oil, POE(10) hydrogenated castor oil, POE(80) hydrogenated castor oil, etc. Here, the numbers in parentheses mean the average number of moles of ethylene oxide added. These may be used alone or in combination of two or more. In the composition, the content of POE hydrogenated castor oil is not limited as long as the effects of the present disclosure can be obtained. However, from the viewpoint of improving the preservative property of the composition, it is preferably 0.003 to 2 w / v%, more preferably 0.05 to 1.5 w / v%, still more preferably 0.08 to 1 w / v%, and particularly preferably 0.1 to 1 w / v%. Further, the content of POE hydrogenated castor oil is not limited as long as the effects of the present disclosure can be obtained. In the composition, per 1 part by mass of allantoin, it is preferably 0.01 to 65 parts by mass, more preferably 0.03 to 35 parts by mass, and still more preferably 2 to 20 parts by mass.

[0013] The eye wash composition does not contain a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids. The preservative is a conventionally known preservative in the fields of eye drops and eye washes. Examples of the quaternary ammonium-based preservative include benzalkonium chloride and benzethonium chloride. Examples of the paraoxybenzoic acid esters include paraoxybenzoic acid esters such as methyl paraoxybenzoate, propyl paraoxybenzoate, and butyl paraoxybenzoate, and salts of paraoxybenzoic acid esters (such as alkali metal salts such as sodium salt). Examples of the sorbic acids include sorbic acid and salts of sorbic acid (such as alkali metal salts such as sodium salt and potassium salt, alkaline earth metal salts such as calcium salt and magnesium salt).

[0014] The eye wash composition may further contain at least one selected from the group consisting of chlorpheniramine and its salts. Chlorpheniramine and its salts are known as antihistamines, and the salts of chlorpheniramine are not limited, but examples of the salts include chlorpheniramine maleate. These may be used alone or in combination of two or more. When chlorpheniramine and its salts are contained, the content thereof is not limited, but from the viewpoint of improving the preservative property of the composition, in the composition, the total amount of at least one selected from the group consisting of chlorpheniramine and its salts is preferably 0.0002 to 0.005 w / v%, more preferably 0.0003 to 0.004 w / v%, still more preferably 0.0005 to 0.003 w / v%, and particularly preferably 0.001 to 0.003 w / v% is exemplified. Also, the content of one selected from the group consisting of chlorpheniramine and its salts is not limited as long as the effects of the present disclosure can be obtained, but in the eye wash composition, per 1 part by mass of the content of allantoin, preferably 0.01 to 50 parts by mass, more preferably 0.05 to 35 parts by mass, still more preferably 0.1 to 35 parts by mass is exemplified. / v% is exemplified. Also, the content of one selected from the group consisting of chlorpheniramine and its salts is not limited as long as the effects of the present disclosure can be obtained, but in the eye wash composition, per 1 part by mass of the content of allantoin, preferably 0.01 to 50 parts by mass, more preferably 0.05 to 35 parts by mass, still more preferably 0.1 to 35 parts by mass is exemplified.

[0015] The eye wash composition may further contain any other components that are acceptable for use in eye drops or eye washes. Examples of such other components, without limiting the present disclosure, include buffering agents, stabilizers, isotonic agents, solvents, pH adjusters, thickeners, medicinal components, cooling agents, and the like. These other components may be appropriately selected according to the purpose and the like, as long as they do not interfere with the effects of the present disclosure. They may be used alone or in combination of two or more, and their blending amounts may also be appropriately determined.

[0016] As an example of such other components, when a buffering agent is mentioned, examples of the buffering agent include boric acid, borax, and the like. The buffering agent may be used alone or in combination of two or more. For example, when the composition contains boric acid, the content of boric acid in the composition is preferably exemplified as 0.03 to 2.5 w / v%, more preferably 0.08 to 1 w / v%. When the composition contains borax, the content may also be appropriately determined. Further, the composition may contain both boric acid and borax, for example, or may contain only one of them. Also, the composition may or may not contain a buffering agent other than boric acid and borax.

[0017] As an example of such other components, when a stabilizer is mentioned, examples of the stabilizer include polysorbate (polysorbate 80, polysorbate 65, polysorbate 60, etc.), sodium edetate (including hydrate), and the like. These may be used alone or in combination of two or more. When the composition contains a stabilizer, the content of the stabilizer in the composition is preferably exemplified as 0.001 to 0.5 w / v%, more preferably 0.01 to 0.15 w / v%. When the composition contains a stabilizer, for example, it may contain only one selected from polysorbate and sodium edetate, or may be an eye wash composition without containing these. It should be noted that polyoxyethylene hydrogenated castor oil mentioned above is also known as a stabilizer, but in the present disclosure, polyoxyethylene hydrogenated castor oil is not included in the description of the stabilizer. Therefore, the content of polyoxyethylene hydrogenated castor oil is not included in the content of the stabilizer.

[0018] As an example of the other components, if a medicinal ingredient is mentioned, examples of the medicinal ingredient include amino acids, anti-inflammatory agents (anti-inflammatory drugs), corneal surface protectants, vitamins, etc. These may be used alone or in combination of two or more.

[0019] Without limiting the present disclosure, for example, as amino acids, amino acids and their salts such as glutamic acid and its salts (sodium glutamate, etc.), aspartic acid and its salts (potassium aspartate, etc.); amino acid analogs such as taurine, etc. are exemplified. These may be used alone or in combination of two or more. The amino acid referred to here means an amino acid that can be a constituent unit of a protein having both functional groups of an amino group and a carboxyl group.

[0020] Without limiting the present disclosure, for example, as anti-inflammatory agents, zinc sulfate, zinc lactate, epsilon-aminocaproic acid, glycyrrhizic acid and its salts (dipotassium glycyrrhizate, etc.) are exemplified. These may be used alone or in combination of two or more. Without limiting the present disclosure, the eye wash composition of the present disclosure preferably does not contain zinc sulfate and / or zinc lactate.

[0021] Without limiting the present disclosure, for example, as corneal surface protectants, chondroitin sulfate and its salts, hyaluronic acid and its salts are exemplified, and as salts, preferably alkali metal salts such as sodium salts are exemplified. These may be used alone or in combination of two or more. When the eye wash composition of the present disclosure contains chondroitin sulfate and / or its salts, the composition can also be prepared without blending hyaluronic acid and its salts. Also, without limiting the present disclosure, as the molecular weight of chondroitin sulfate or its salts, preferably the weight average molecular weight is about 0.5×10⁴ to 4.5×10⁴, more preferably about 1.5×10⁴ to 3×10⁴. The weight average molecular weight used in the examples described later is measured by gel filtration chromatography.

[0022] When the eye - washing composition of the present disclosure contains a medicinal ingredient, the content of the medicinal ingredient is not restricted as long as the effects of the present disclosure are not hindered. In the composition, the content of the medicinal ingredient is preferably 0.01 - 1 w / v%, more preferably 0.025 - 0.8 w / v%, and still more preferably 0.05 - 0.3 w / v%. It should be noted that the aforementioned allantoin, chlorpheniramine and its salts are also known as medicinal ingredients, but these ingredients are not included in the description of the medicinal ingredients in the present disclosure. Therefore, the content of allantoin, chlorpheniramine and its salts is not included in the content of the medicinal ingredient.

[0023] When the eye - washing composition of the present disclosure contains a cooling agent, examples of the cooling agent include menthol, camphor, borneol, etc. When there are d - form, l - form, and dl - form in the cooling agent, their differences are not a concern. The cooling agent may be used alone or in combination of two or more. The content of the cooling agent is not restricted as long as the effects of the present disclosure are not hindered. In the composition, it is preferably 0.0001 - 0.05 w / v%, more preferably 0.002 - 0.01 w / v%.

[0024] The eye - washing composition of the present disclosure can be produced by mixing at least one selected from the group consisting of allantoin, polyoxyethylene hydrogenated castor oil, and optionally chlorpheniramine and its salts with other components. Also, the composition does not contain a preservative selected from quaternary ammonium salt - type preservatives, para - oxybenzoic acid esters, chlorobutanol, and sorbic acids.

[0025] Accordingly, as one embodiment of the eye-washing composition of the present disclosure, there is exemplified a composition containing (1) allantoin, (2) polyoxyethylene hydrogenated castor oil, optionally containing at least one selected from the group consisting of (3) chlorpheniramine and its salts, and optionally containing at least one selected from the group consisting of (4) buffer, stabilizer, isotonic agent, solvent, pH adjuster, thickener, medicinal ingredient, and cooling agent, and not containing a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids. Further, as the one embodiment, there is exemplified a composition comprising the component (1), the component (2), and at least one selected from the group consisting of the components (3) and (4). Further, as shown in the examples described later, as the one embodiment, there is exemplified a composition not containing components generally used as preservatives in the fields of eye drops and eye washes.

[0026] The pH of the eye-washing composition of the present disclosure is not limited as long as it is within the range usable as an eye drop or an eye wash. However, from the viewpoint of improving the preservative property of the composition, at room temperature (24 °C), the pH is preferably 5 to 8, more preferably 5.5 to 7, still more preferably 5.5 to 6.5, further more preferably 5.5 to 6, particularly preferably 5.5 to 5.8, and particularly still more preferably 5.5 to 5.7. The pH is measured with a desktop pH meter F-52 (manufactured by Horiba, Ltd.). 。

[0027] The form of the eye-washing composition of the present disclosure is liquid at room temperature. Further, the method of using the eye-washing composition of the present disclosure is not limited as long as the eyes can be washed in the same manner as conventionally known methods. Usually, it is used for eye washing using an eye cup or for eye washing by eye drops. For this reason, the eye-washing composition of the present disclosure is contained in a container, and the composition is poured from the container into an eye cup for use or directly instilled into the eyes from the container. The viscosity and osmotic pressure (osmotic pressure ratio) of the composition are not limited as long as it can be used in this way.

[0028] The eye-washing composition of the present disclosure may be used with contact lenses worn or without contact lenses worn. The contact lenses may be either hard contact lenses or soft contact lenses without distinction.

[0029] The eye-washing composition of the present disclosure is not limited as long as it can be used as described above. However, when it is used with an eye-washing cup, it is usually contained in a conventionally known general container (for example, including a container body and a cap) as described in the examples below. The container may be of a type in which the container body and the cap are independent or an integral type, and may also have a stopper (inner lid). The stopper may have a hole for pouring the eye-washing composition into the eye-washing cup. The capacity of the container is not limited either, but from the viewpoint of good usability, etc., the capacity is preferably 350 to 550 mL, more preferably 400 to 550 mL, and still more preferably 450 to 550 mL.

[0030] Eye-washing using an eye-washing cup may follow the normal procedure. For example, an appropriate amount of the eye-washing composition of the present disclosure, such as 4 to 6 mL per eye per time, is poured from the container into the eye-washing cup, and then the cup is pressed against the periphery of one eye to bring the eye-washing composition in the cup into contact with the eye, and it is used by blinking several times. The number of times of use per day of the composition is not limited either, and may be any of, for example, 1 to 6 times, 2 to 6 times, 3 to 6 times, etc. per eye per day. In this way, the eyes can be washed according to the eye-washing composition of the present disclosure.

[0031] In addition, when the eye wash composition of the present disclosure is used for eye wash by eye drops, from the viewpoint of good usability and the like, the composition is usually contained in an eye drop container for use. The eye drop container is not limited as long as it can contain the composition and be used for eye drops. For example, eye drop containers (including, for example, a container body, an inner stopper (nozzle), and a cap) used in conventionally known eye drops, eye drop type eye washes, etc. are exemplified. The eye drop container may be of any type, such as 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 the inner stopper (nozzle) is provided with a hole, or a type in which the inner stopper (nozzle) has no hole and a hole is opened in the inner stopper (nozzle) by tightening the cap during use.

[0032] The capacity of the eye drop container is not limited, but from the viewpoint of good usability and the like, examples of the capacity are 8 to 20 mL, preferably 10 to 15 mL, and more preferably 12 to 14 mL. The capacity may be appropriately determined in consideration of the difference between the multi-dose type and the unit-dose type.

[0033] Eye wash by eye drops is used by instilling 3 to 8 drops of the eye wash composition of the present disclosure per eye per time. Although not limited to this extent, from the viewpoint of more efficiently washing the eyes, the composition is preferably instilled with 4 to 8 drops, more preferably 4 to 6 drops, per eye per time. The drop volume per drop is also not limited, but examples of the drop volume per drop are 30 to 50 μL, preferably 35 to 40 μL, and more preferably 35 to 37 μL. In addition, the number of times of use of the composition 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. In this way, the eyes can be washed with the eye wash composition of the present disclosure. Thus, the eyes can be washed.

[0034] Thus, in the eye-washing composition of the present disclosure, although no preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids is formulated, by formulating allantoin and polyoxyethylene hydrogenated castor oil, an antiseptic action can be imparted to the eye-washing composition. Further, when the composition further contains the above-described medicinal ingredients and the like, useful effects based on the medicinal ingredients and the like can also be provided.

Example

[0035] Hereinafter, the present disclosure will be described in more detail with reference to examples, but the present disclosure is not limited thereto.

[0036] Test Example 1 1. Preparation of Eye-Washing Composition and Evaluation of Antiseptic Action Each component was mixed according to the blending ratios shown in Table 1 below to prepare each composition (Examples 1 to 6, Comparative Examples 1 to 4, and Reference Example). 10 mL of the obtained composition was poured into a general eye-washing agent container (capacity 15 mL, made of polyethylene terephthalate resin, manufactured by Noboru Chemical Co., Ltd.). Next, a liquid (bacterial solution) obtained by suspending Pseudomonas aeruginosa in sterilized physiological saline was inoculated into each container so as to have a concentration of 1×10 7 cfu / mL, and the mixture was stored at 30°C in the dark for 21 days. After storage, 0.1 mL of each composition inoculated with Pseudomonas aeruginosa was taken out from the container, and this was applied to a commercially available SCDLP agar medium (SCDLP agar medium "Daiichi", manufactured by Fujifilm Wako Pure Chemical Corporation) with a spreader. After culturing at 30°C for 48 hours, the number of colonies was visually counted, and the value obtained by multiplying the counted value by 100 was taken as the number of bacteria in each composition 21 days after storage. Based on the number of bacteria at the time of inoculation being 100%, the ratio (survival rate) of the number of bacteria in each composition after storage for 21 days was calculated. The antiseptic power of the eye-washing composition was evaluated according to the following criteria based on the calculated values. [Evaluation Criteria] ◎: The survival rate decreased to 0.1% or less of the inoculum amount ○: The survival rate decreased to 3% or less of the inoculum amount △: The survival rate decreased to 5% or less of the inoculum amount ×: Does not meet the criteria of △ above

[0037] Also, the pH of each composition immediately after preparation was measured. The pH was measured at room temperature (24 °C) using a desktop pH meter F-52 (manufactured by Horiba, Ltd.).

[0038] 2. Results The results are shown in Table 1.

[0039]

Table 1

[0040] The reference example in which benzalkonium chloride, a typical preservative, was added means the positive control in this test example. As shown in Table 1, the evaluation result was ◎, and it had excellent preservative power. Incidentally, the survival rate of Pseudomonas aeruginosa in the composition after storage in the reference example was 0.001%. On the other hand, in Comparative Examples 2 to 4 in which benzalkonium chloride was not added and instead any one of polyoxyethylene hydrogenated castor oil, allantoin, and chlorpheniramine maleate was added, the evaluation result was ×, and the desired preservative power could not be obtained.

[0041] In contrast, in Example 1 in which polyoxyethylene hydrogenated castor oil and allantoin were used in combination, the evaluation result was ○, and the desired antiseptic power was obtained. The survival rate in Example 1 was 1.901%. In addition, in Example 2 in which the content of allantoin was increased in Example 1, the evaluation result was ⊚, and a higher antiseptic power was obtained. Also, in Examples 3 to 6 in which chlorpheniramine maleate was used in combination with polyoxyethylene hydrogenated castor oil and allantoin, the evaluation results were also ⊚, and a high antiseptic power was obtained. The survival rates after storage in Examples 2 to 6 were 0.012%, 0.006%, 0.003%, 0.001%, and 0.001%, respectively. In Examples 4 to 6 in which the pH was lowered in the composition of Example 3, the antiseptic property was further improved. Also, when evaluated in the same manner for the composition in which polyoxyethylene hydrogenated castor oil was changed to 0.5 w / v% in the composition of Example 1, the evaluation result was ⊚ (survival rate 0.001%), and a high antiseptic power was obtained. From this, it was confirmed that by blending polyoxyethylene hydrogenated castor oil and allantoin into an eye wash composition not containing a preservative, or by further using chlorpheniramine maleate in combination, the desired antiseptic action can be imparted or enhanced in the eye wash composition.

[0042] Test Example 2 1. Preparation of Eye-Washing Composition and Evaluation of Antiseptic Action Each component was mixed according to the blending ratios shown in Table 2 below, and each composition was prepared (Examples 7 and 8, Comparative Example 5). In the table, sodium chondroitin sulfate was externally regulated sodium chondroitin sulfate (manufactured by Seikagaku Corporation, weight average molecular weight 20,000). The pH of each composition immediately after preparation was measured in the same manner as described above.

[0043] 500 mL of each of the obtained compositions was passed through a sterilizing filter and then placed in a sterilized eye wash container (Eye Bon AL d, manufactured by Kobayashi Pharmaceutical Co., Ltd.). The composition container thus obtained was used to fill an eye wash cup (Eye Cup) (Eye Bon AL d, manufactured by Kobayashi Pharmaceutical Co., Ltd.) Pour 5 mL of the composition, and perform eye washing using the eye cup. A general bacteria test was conducted on the composition remaining in the container. Specifically, for 10 panelists, both eyes were washed with the composition poured into the eye cup at 5 mL per eye each time, used three times a day for one week, and a general bacteria count test was conducted on the composition remaining in the container. This may be described as the eye cup type below.

[0044] Separately, 10 mL of each obtained composition was passed through a sterilizing filter and then placed into a sterilized general eye drop type eye wash container (capacity 13 mL, made of polyethylene terephthalate resin, multi-dose type, manufactured by Nobori Chemical Co., Ltd.). For 10 panelists, both eyes were washed by instilling 4 drops per eye each time, three times a day for 5 days, and a general bacteria count test was conducted on the composition remaining in the container. This may be described as the eye drop type below.

[0045] The general bacteria count test was carried out according to the following procedure. 1 mL was collected from the composition remaining in the container in the aforementioned cup type. All 1 mL of each composition collected from 10 samples was mixed to obtain a 10 mL mixed solution. 1 mL was collected from the obtained mixed solution, diluted 10-fold with sterilized water, and the entire amount was applied to a standard agar medium (Standard Agar Medium (granules) "Nissui", manufactured by Nissui Pharmaceutical Co., Ltd.) and cultured at 35 °C for 48 hours. After culturing, the number of colonies was visually counted, and the counted number was multiplied by 10 to obtain the general bacteria count (cfu / mL). In the aforementioned eye drop type, the general bacteria count was also measured and calculated in the same manner using the composition remaining in the container (10 samples). (The detection limit value for all is 10 cfu / mL.)

[0046] 2. Results The results are shown in Table 2.

[0047]

Table 2

[0048] As shown in Table 2, the general bacterial count of Comparative Example 5, which does not contain allantoin, polyoxyethylene hydrogenated castor oil, and chlorpheniramine maleate, was 130 cfu / mL in the eye cup type and 170 cfu / mL in the eye drop type. In contrast, in Examples 7 and 8 to which allantoin, polyoxyethylene hydrogenated castor oil, and chlorpheniramine maleate were added, the mixed bacteria could be suppressed to non-detection (below the detection limit). Also, as shown in Comparative Example 5, the bacterial count was higher in the eye drop type than in the eye cup type. This was presumably because bacteria were more likely to contaminate the composition in the container, such as the frequency of contact with the eyelashes being higher in the eye drop type than in the eye cup type. However, even in the eye drop type, which is likely to come into contact with the eyelashes and skin and has a higher usage frequency outside than the eye cup type, an increase in the bacterial count could be suppressed. From this, it was confirmed that by using polyoxyethylene hydrogenated castor oil, allantoin, and chlorpheniramine maleate in combination, a desired antiseptic effect (antiseptic power) can be imparted or enhanced to an eye wash composition that does not contain a preservative.

[0049] Formulation Example Table 3 shows formulation examples of the eye wash composition of the present invention. When the formulation examples shown in Table 3 were evaluated for antiseptic power in the same manner as in Test Examples 1 and 2, it was confirmed that all of the compositions of Formulation Examples 1 to 8 were excellent in antiseptic preservability.

[0050]

Table 3

Claims

【Claim 1】 An eye wash composition containing allantoin and polyoxyethylene hydrogenated castor oil and not containing a preservative selected from quaternary ammonium salt-based preservatives, paraoxybenzoic acid esters, chlorobutanol, and sorbic acids.

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