JP2000292754A - Solution for care of contact lens - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a solution for care of contact lenses which has high safety, ease of manipulation and high simplicity and has sufficient antimicrobial power and detergency to stains of protein, etc., in combination. SOLUTION: The solution for care of the contact lenses containing fatty acid ester of sucrose soluble in water is provided. The fatty acid ester of the sucrose has the antimicrobial power and the detergency to the stains of the protein in combination and is capable of providing the solution for care of the contact lenses which has the high safety, the ease of manipulation and the high simplicity and has the sufficient antimicrobial power and the detergency to the stains of the protein, etc., in combination.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a contact lens care solution and a contact lens care method using the same.

[0002]

2. Description of the Related Art The daily care or care of contact lenses can generally be broadly divided into cleaning, storage, rinsing and disinfection.

The purpose of cleaning a contact lens is to remove stains such as proteins and lipids, which are deposited on the lens during wearing and are derived from tears, a wearing environment, and the like. These stains must be removed using a cleaning agent designed specifically for contact lenses, and scrubbing with surfactants and abrasives and immersion cleaning with proteolytic enzymes are widely used. .

[0004] The storage of contact lenses is generally performed in a solution, and the solution used for the storage must be designed so as not to impair the performance and safety of the contact lens during storage. Preservatives and the like are added.

The rinsing of the contact lens is intended to remove the cleaning agent after cleaning, the dirt removed by cleaning, or the disinfectant after disinfection from the lens. Scientifically safe things are desired. Tap water is often used for hard contact lenses, but isotonic liquid such as physiological saline is used for hydrophilic soft contact lenses, and is often used also as the preservative solution.

[0006] A conventionally used method of disinfecting hydrophilic contact lenses is by boiling. This method uses a dedicated contact lens boiling disinfection device and container, and generally performs boiling disinfection at a high temperature near the boiling point of physiological saline. This boiling disinfection has an advantage that a high disinfection effect can be expected.

A chemical disinfection method in which a contact lens is immersed in a disinfectant solution at room temperature is generally used as a disinfection method other than boiling. This method is called cold soaking. For disinfection by cold soaking, a disinfectant for contact lenses using hydrogen peroxide as a body having an antibacterial activity is commercially available. This hydrogen peroxide has a strong antibacterial activity. In the disinfection by cold soaking using hydrogen peroxide, after the disinfection is completed, the disinfectant solution and the hydrogen peroxide remaining on the contact lens are neutralized by a chemical method such as reduction using a reducing agent to detoxify. .

A contact lens disinfecting and preserving solution using biguanide as a disinfectant as disclosed in Japanese Patent No. 25555437 and a soft contact lens disinfecting and preserving solution using polydronium chloride as a disinfectant, which are already sold. There is a disinfecting storage solution using a polymer chemical disinfectant. It is said that these chemical disinfectants have a large molecular weight and disinfectant molecules do not penetrate into pores on the lens surface, and therefore have little adsorption on the lens surface. In addition, since the toxicity of the disinfectant itself is low, there is no need for an operation such as neutralization after the disinfection, and there is an advantage that the lens taken out of the disinfecting storage solution can be used as it is. In addition, since the formulation contains a surfactant and the like, it has not only disinfection and storage, but also cleaning effects. Such care products are commonly referred to as multi-purpose solutions.

[0009]

The above-mentioned methods or agents used for the care of contact lenses have generally been applied independently in order to fulfill their functions. That is, products according to functions such as a cleaning solution or a cleaning agent for cleaning, a boiling or disinfectant for disinfection, and a preservative for storage are sold, and a user can use a plurality of drugs and devices for the care of one contact lens. Had to be prepared and carried.

[0010] Considering the user's benefits, that is, simplicity and economy, and the improvement of compliance to ensure that care is carried out, it is often the case that a single drug used for such care has all functions. desirable.

As a solution to this problem, there is a multi-purpose solution using a chemical disinfectant as described above, but its cleaning ability is mainly to remove lipids, and an enzyme detergent is additionally provided for protein washing. Need to use.

An object of the present invention is to provide a contact lens care solution that is highly safe, easy to operate, easy to use, and has sufficient antibacterial activity and detergency against proteins and other stains. I do.

[0013]

According to the first aspect of the present invention,
Disclosed is a contact lens care solution, which comprises a water-soluble fatty acid ester of sucrose.

According to the above-mentioned structure, a contact lens care solution having high safety, easy operation, high simplicity, and sufficient antibacterial activity and detergency against proteins and other stains can be provided. it can.

According to a second aspect of the present invention, there is provided the contact lens care solution according to the first aspect, wherein the fatty acid ester of sucrose is a sucrose monofatty acid ester.

In general, a monofatty acid ester in which one of the hydroxyl groups of sucrose is esterified has a higher solubility in water than a polyester body in which two or more of the hydroxyl groups are esterified. Therefore, according to the above configuration, it is possible to adjust the contact lens care solution containing a high concentration of sucrose fatty acid ester in the contact lens care solution according to claim 1, thereby further improving the antibacterial and detergency. A contact lens care solution having a high degree of care can be obtained.

According to a third aspect of the present invention, there is provided the contact lens care solution according to the first or second aspect, wherein the sucrose fatty acid ester is particularly a lauric acid ester or an octanoic acid ester.

Among the sucrose fatty acid esters, lauric acid esters or octanoic acid esters are known to have a particularly strong antibacterial activity, and according to the above-mentioned composition, in the contact lens care solution according to claim 1 or 2,
A contact lens care solution having a higher antibacterial activity can be obtained. In addition, since these sucrose laurate esters or octanoate esters have a stronger ability to dissolve proteins than other sucrose fatty acid esters, a contact lens care solution that is highly useful as a detergent can be obtained.

According to a fourth aspect of the present invention, there is provided the contact lens care solution according to any one of the first to third aspects, further comprising an antibacterial agent.

According to the above-mentioned constitution, a care solution for contact lenses having a wide antibacterial spectrum can be obtained by the combined use of an antibacterial agent, and the effectiveness as a disinfectant can be enhanced.

According to a fifth aspect of the present invention, there is provided the contact lens care solution according to any one of the first to third aspects, further comprising a buffer.

According to the above arrangement, the oxygen ion concentration, that is, the pH of the contact lens care solution can be stabilized.

The invention according to claim 6 includes tylenediaminetetraacetic acid or a salt thereof, citric acid or a salt thereof, polyphosphoric acid or a salt thereof, or a mixture thereof. 3. A contact lens care solution according to item 1.

Ethylenediaminetetraacetic acid or a salt thereof,
It has been known that citric acid or a salt thereof and polyphosphoric acid or a salt thereof have an action of enhancing the antibacterial activity of sucrose fatty acid ester. According to the above configuration, in the contact lens care solution according to any one of claims 1 to 3, a contact lens care solution having higher antibacterial activity can be obtained.

According to a seventh aspect of the present invention, a contact lens care solution is used for cleaning, storing, rinsing, and disinfecting a contact lens using the contact lens care solution according to any one of the first to sixth aspects. Provide a way.

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention for care of contact lenses will be described, but the present invention is not limited to the following embodiments.

In the contact lens care solution of the present invention, the antibacterial activity of the fatty acid ester of sucrose is used for disinfecting contact lenses, and the detergency as a surfactant is used for cleaning contact lenses.

Sucrose is represented by the following chemical formula 1.

[0029]

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## EQU2 ## Sucrose has eight hydroxyl groups, and sucrose fatty acid esters can be obtained by reacting them with other fatty acids to form esters. The sucrose fatty acid ester may include eight kinds of esters from a monoester in which one of the eight hydroxyl groups is esterified to an octaester in which all eight are esterified. Further, among sucrose fatty acid esters in which the same number of hydroxyl groups are esterified, a plurality of isomers in which the position of the esterified hydroxyl group is different may be considered. Therefore, even if the fatty acid used for the esterification is a single substance, 324 combinations of sucrose fatty acid esters can be considered. However, not all of these combinations can be made in the same way, and the structure that can be easily formed due to the reactivity of the hydroxyl group of sucrose, steric hindrance, and the like is determined. It is known that esterification occurs at the hydroxyl group at the 6-position as shown in the above formula or at the hydroxyl group at the 6'-position as shown in Chemical formula 3.

[0031]

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[0032]

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On the other hand, various types of fatty acids may be used for the esterification, but generally include saturated or unsaturated straight-chain fatty acids, and also include branched fatty acids and cyclic fatty acids. Table 1 shows typical examples of fatty acids.

[0034]

[Table 1]

Although there are several reports on the antibacterial activity of sucrose fatty acid esters, monolaurate esters have been reported by A. et al. niger, P.M. The minimum inhibitory concentration (MIC) for fungi such as citrium is about 2 m
g / ml. B. subtilis, B .; The MIC for bacteria that form heat-resistant endogenous spores such as cereus is about 1 mg / ml. S. pyogenes or food poisoning bacteria, MIC for Aureus is about 1 mg / ml,
Compared to other antibacterial agents that are widely used, there is no inferiority,
An effective antibacterial activity can be obtained by prescribing at these concentrations or higher. Also, even if the prescription concentration is lower than the MIC, ethylenediaminetetraacetic acid or a salt thereof, citric acid or a salt thereof, polyphosphoric acid or a salt thereof,
It is known to enhance the antibacterial activity of sucrose fatty acid esters, and it is possible to obtain effective antibacterial activity by prescribing them at the same time, even if the prescribed concentration of sucrose fatty acid esters is below the MIC. It is. On the other hand, starch, protein, Tween 20, monopalmitin and the like are known to antagonize the antibacterial activity of sucrose fatty acid esters. A broad antibacterial spectrum can be obtained by using other antibacterial agents that do not correspond to these antagonists, and a more effective formulation can be obtained. The term "other antibacterial agents" as used herein refers to antibacterial agents having ophthalmologically acceptable safety, such as polyhexamethylene biguanide hydrochloride, chlorhexidine gluconate, polydronium chloride, and sodium pyrithione.

Further, as can be seen from the fact that the conventional use of sucrose fatty acid esters is a surfactant, the contact lens care solution of the present invention containing sucrose fatty acid esters has both detergency and cleaning ability. Use as an agent is also possible. In particular, as I have now discovered, sucrose fatty acid esters also have a detergency against protein stains that are not present in surfactants added to conventional contact lens care solutions. For this reason, the contact lens care solution of the present invention has an effective detergency for most stains on the contact lens.

As described above, the amount of the sucrose fatty acid ester is desirably equal to or higher than the MIC. On the other hand, the concentration required for securing the detergency is determined by the critical micelle concentration (CMC).
Above this concentration, it is possible to add detergency to the formulation, and by adding other antibacterial agents to the formulation, the amount of sucrose fatty acid ester added to the formulation can be increased. Even if is less than or equal to MIC, if it is more than or equal to CMC, it is possible to obtain a formulation having antibacterial activity and detergency. CM for monolaurate ester
C is 0.2 mg / ml, and monocaprate ester is 1.
2 mg / ml, which is a small value compared to MIC.

As described above, the lower limit of the amount of sucrose fatty acid ester can be set by the value of MIC or CMC, but the upper limit should be determined based on the safety or the physical effectiveness of the formulation. It is. The physical effectiveness of a formulation as referred to herein is a matter determined by whether the formulation can maintain its form so as not to impair its usefulness as a care solution for a contact lens to be used. The fatty acid ester of sucrose was approved in Japan in 1959 as a food additive, and has been applied in many food industries since then. Its safety has been widely acknowledged throughout its history of use and research. It is noteworthy that sucrose fatty acid esters are hypoallergenic and non-antigenic, which also demonstrates that sucrose fatty acid esters are suitable for disinfecting contact lenses used in ophthalmology. . Therefore, in the case of formulating a contact lens care solution, the prescription upper limit is set in consideration of the physical effectiveness of the above prescription, rather than in the case of considering the prescription upper limit in consideration of safety. In the case of loss of physical effectiveness,
The addition of sucrose fatty acid esters exceeding their solubility may cause precipitation of solids and the addition of high concentrations may increase osmotic pressure.However, in cases where such physical effectiveness is impaired, it is necessary to consider individual formulations. However, usually, less than 10% is considered to be an appropriate value in view of solubility in water and the like.

As described above, according to the contact lens care solution containing the fatty acid ester of sucrose, bacteria, yeast or yeast which may propagate on the contact lens after wearing due to the antibacterial activity of the fatty acid ester of sucrose. In addition to being able to effectively disinfect microorganisms such as mold, it is possible to simultaneously remove dirt such as proteins and lipids on the lens. That is, the contact lens care solution of the present invention is characterized in that it can be used as a cleaning solution simultaneously with the disinfecting storage of the contact lens,
It is possible to wash, store and disinfect with one liquid,
It is possible to give simplicity to the user. Also,
As mentioned above, since the safety of sucrose fatty acid ester is very high, there is no need to neutralize the drug solution or rinse contact lenses after the disinfection operation, and wear the contact lenses taken out of the container used for disinfection as they are Things are possible. Therefore, according to the present invention, it is possible to perform all necessary contact lens care with one liquid.

Example 1 A contact lens care solution was prepared by the following procedure. Prepare about 80 ml of distilled water, and in it, 690 mg of boric acid, 120 mg of sodium borate decahydrate, 200 m of EDTA disodium salt
g, sodium chloride 600mg and potassium chloride 100
Add mg and dissolve. The solution is heated to 50 ° C., and 200 mg of sucrose fatty acid ester (DK Ester SS, manufactured by Daiichi Kogyo) is added and dissolved therein. After allowing to cool, distilled water is added to this solution to adjust the total volume to 100 ml. This solution is passed through a filter made of cellulose acetate having a pore size of 0.45 μm in a clean bench capable of aseptic operation to remove microscopic debris that may be mixed during the sterilization and preparation process. The filtered liquid is stored in a pre-sterilized container.

The contact lens care method using the above solution is as follows. First, the contact lens taken out of the eye is rinsed with the above solution, and then placed on the palm, a small amount of the above solution is added, and the finger of the other hand is used. Wash as if rubbing against palm. Turn the contact lens over and scrub as above. After rinsing the contact lens again with the above solution, the lens case is filled with the above solution so that the contact lens is completely immersed, and the contact lens is put into the lens case and stored tightly. It is disinfected by leaving it at room temperature for about 4 hours. After that, take out the contact lens and attach it when necessary.

In order to confirm the disinfecting ability of the above solution,
E. In the solution. E. coli has a bacterial count of 1.4 × 10 ⁸ cf
The bacterial solution was inoculated to give u / ml. When the number of bacteria was measured 4 hours after inoculation, the bactericidal efficacy was 94%.
It was shown to be capable of disinfection.

Example 2 A contact lens care solution was prepared in the following procedure. About 80 ml of distilled water is prepared, and 300 mg of citric acid, 200 mg of EDTA disodium salt, 600 mg of sodium chloride and 100 mg of potassium chloride are added and dissolved therein. There, sucrose monolaurate (reagent, Dojindo Laboratories) 20
Add 0 mg and dissolve. This solution is adjusted by adding 1N sodium hydroxide so that the pH becomes 7.0.
Distilled water is added to this solution to adjust the total volume to 100 ml. This solution is passed through a filter made of cellulose acetate having a pore size of 0.45 μm in a clean bench capable of aseptic operation to remove microscopic debris that may be mixed during the sterilization and preparation process. The filtered liquid is stored in a pre-sterilized container.

A contact lens care method using the above solution is as follows. First, the contact lens taken out of the eye is rinsed with the above solution, and then placed on the palm, a small amount of the above solution is added, and the finger of the other hand is used. Wash as if rubbing against palm. Turn the contact lens over and scrub as above. After rinsing the contact lens again with the above solution, the lens case is filled with the above solution so that the contact lens is completely immersed, and the contact lens is put into the lens case and stored tightly. It is disinfected by leaving it at room temperature for about 4 hours. After that, take out the contact lens and attach it when necessary.

In order to confirm the disinfecting ability of the above solution,
E. In the solution. E. coli has a bacterial count of 1.4 × 10 ⁸ cf
The bacterial solution was inoculated to give u / ml. When the number of bacteria was measured 4 hours after inoculation, the bactericidal efficacy was 97%.
It was shown to be capable of disinfection.

Example 3 A contact lens care solution is prepared according to the following procedure. Prepare about 80 ml of distilled water, in which 690 mg of boric acid, 120 mg of sodium borate decahydrate, and 100 m of EDTA disodium salt
g, sodium chloride 600mg and potassium chloride 100
Add mg and dissolve. Then, 100 mg of sucrose monolaurate (reagent, manufactured by Dojindo Laboratories) is added and dissolved. 100 ml of polyhexamethylene biguanide hydrochloride (Cosmosil CQ, manufactured by Zeneca Corporation) was added to this solution.
3.5 ml of a ppm solution is added, and distilled water is further added to adjust the total amount to 100 ml. This solution is passed through a filter made of cellulose acetate having a pore size of 0.45 μm in a clean bench capable of aseptic operation to remove microscopic debris that may be mixed during the sterilization and preparation process. The filtered liquid is stored in a pre-sterilized container.

The contact lens care method using the above solution is as follows. First, the contact lens taken out of the eye is rinsed with the above solution, and then placed on the palm, a small amount of the above solution is added, and the finger of the other hand is used. Wash as if rubbing against palm. Turn the contact lens over and scrub as above. After rinsing the contact lens again with the above solution, the lens case is filled with the above solution so that the contact lens is completely immersed, and the contact lens is put into the lens case and stored tightly. It is disinfected by leaving it at room temperature for about 4 hours. After that, take out the contact lens and attach it when necessary.

A test was conducted to confirm the detergency of the solution. A solution containing albumin, globulin, lysozyme, and mucin is added to a soft contact lens (Seiko CS
I-Soft, manufactured by Seiko Epson Contact Lens Co., Ltd.) and heated to allow the heat-denatured protein to adhere to the contact lens, thereby preparing a protein-adhered contact lens. The contact lens with protein attached was placed on the palm, a few drops of the above-mentioned contact lens care solution were dropped on the contact lens, and the lens was reciprocated by rubbing the lens with the finger of the other hand and washed. This washing is performed 10 times.
0 round trips were performed on the front and back of the lens. To compare the detergency, a cleaning and disinfecting preservative for soft contact lenses manufactured by Company A, which is sold in the United States and has protein detergency, a cleaning and disinfecting preservative for soft contact lenses, manufactured by Company B and sold in Japan. The same washing operation was performed with a saline solution. The protein remaining on the lens after washing was quantified by a colorimetric method using ninhydrin coloring. Assuming that the protein weight on the untreated lens which was not rubbed and washed was 100, the solution according to the present invention was 8, the product of the company A was 9, the product of the company B was 37, and the saline was 33. It has been shown that the solution according to the invention has a detergency against proteins.

[0049]

As described above, according to the present invention, it is possible to obtain a contact lens care solution having high antibacterial and detergency and high safety. Detergency is high when proteins adhere to the lens.Until now, separate chemicals such as enzyme cleaning for removing protein stains were required, but these are not required, and furthermore, operations such as neutralization are not required. Therefore, a very simple contact lens care solution can be obtained.

Claims (7)

[Claims] 1. A contact lens care solution comprising a water-soluble sucrose fatty acid ester. 2. The contact lens care solution according to claim 1, wherein the fatty acid ester of sucrose is a monofatty acid ester. 3. The contact lens care solution according to claim 1, wherein the sucrose fatty acid ester is lauric acid ester or caprylic acid ester. 4. The contact lens care solution according to claim 1, further comprising an antimicrobial agent. 5. The contact lens care solution according to claim 1, further comprising a buffer. 6. An ethylenediaminetetraacetic acid or a salt thereof,
The contact lens care solution according to any one of claims 1 to 5, comprising citric acid or a salt thereof, polyphosphoric acid or a salt thereof, or a mixture thereof. 7. A method for caring for a contact lens, comprising cleaning, storing, rinsing and disinfecting a contact lens using the solution for caring for a contact lens according to any one of claims 1 to 6. .