JPH0829744A - Cleaning composition for contact lens, storing solution composition for contact lens, cleaning method of contact lens and disinfecting method of contact lens - Google Patents

Abstract

PURPOSE:To stabilize an enzyme soln. by using a component having a specified enzyme stabilizing system and a specified component having surface activity, to enable optimum cleaning and disinfection of a contact lens without giving an influence on the lens by using a mixture of the enzyme soln. with a storing liquid compsn. having specified physical properties, and to easily care the contact lens. CONSTITUTION:The stabilizing enzyme soln. compsn. consists of (A) 30-50wt.% polyol, (B) 0.01-4wt.% boric acid or its salt, (C) 0.1-5wt.% compd. having surface activating performance selected from polyoxyethylene alkyl ethers or polyoxyethylene-polyoxypropylene block copolymers having 700-2500mol.wt. or polyethylene glycols of 500-1500mol.wt. and the balance water. A contact lens is cleaned by using this compsn. or disinfected by boi ling the compsn.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for cleaning and disinfecting contact lenses, and a composition necessary for properly performing these methods.

[0002]

2. Description of the Related Art Contact lenses are washed by a method using a detergent containing a surfactant as a main component, or by immersion washing in an enzyme-containing agent to emulsify and decompose protein stains and lipid stains on the contact lens surface. . In particular, the washing method using an enzyme has been confirmed to be useful, and powders, granules, tablets or concentrated liquid enzyme preparations are diluted and dissolved with a preservative solution or a rinse solution before use. The enzyme is a protease,
Lipid-degrading enzymes, polysaccharide-degrading enzymes, lysozyme, etc. are used. These techniques are disclosed in, for example, Japanese Patent Publication No. 53-478.
No. 10 discloses a cleaning method using a composition containing an effective amount of proteolytic enzyme and a cleaning agent composed of a specific proteolytic enzyme such as papain. JP-A-62-913 discloses that a specific enzyme such as amylase or cellulase and urea,
A detergent comprising an activator such as an amino acid is disclosed. Japanese Unexamined Patent Publication (Kokai) No. 53-125412 discloses a detergent using lipase.

However, enzymes are generally unstable in a solution state and it is difficult to store them for a long period of time. A combination of a polyol and a boron compound is known as a stabilizer for solving this problem. Canadian Patent No. 10920
No. 36, a proteolytic enzyme and / or a starch degrading enzyme,
In addition, an enzyme stabilizing system containing a polyol such as ethylene glycol, glycerin and glucose and a boron compound capable of reacting with the polyol is disclosed.
Can be included up to 60%. U.S. Pat. No. 4,4041,
No. 55 discloses a stable system of enzyme liquid detergent using a combination of alkali metal pentaborate and optionally alkali metal sulfite and / or polyol. British Patent No. 2079305 contains from 4 to 25% of enzyme, polyol to boric acid in a weight ratio greater than the weight ratio of boric acid and boric acid and 0.1 to 2% of neutralized cross-linked polyacrylate and 1 to 10% of surfactant. Disclosed is an enzyme stabilization system that can contain up to 60%. Japanese Patent Publication No. 53-28515 discloses an enzyme stabilizing system comprising a combination of borax and a polyol such as sorbitol or glycerin.

Another similar patent is European Patent No. 8022.
3, US Pat. No. 4,537,707, US Pat. No. 446.
5619 and U.S. Pat. No. 4,238,345. From these patents, the stabilization of enzymes by polyols and boron compounds is a well-known fact, and enzyme stabilization systems such as JP-A-63-159822 and JP-A-1-180515 can be easily imagined. Furthermore, in a composition system containing a surfactant in a known enzyme stabilization system, the enzyme stability is generally lowered by the addition of the surfactant. In order to overcome this drawback, a composition system containing a specific surfactant is disclosed in JP-A-2-41398. Also, soft contact lenses require disinfection in addition to cleaning. There are two types of disinfection, a boiling method and a chemical disinfection method using a disinfectant. In Japan, the boiling disinfection method is generally used.

[0005]

The enzyme stabilizing system can be made of a polyol and a boron compound, but when a surfactant is contained in this, a sufficient enzyme stabilization is difficult to achieve. It is considered that the main reason for this is that the three-dimensional structure of the proteolytic enzyme is destroyed by the emulsification by the surfactant, the osmotic action and the like. In addition, the interaction due to ionic charge is one of the causes. Previously disclosed enzyme stabilization systems, such as Canadian Patent No. 1092036, US Patent No. 44041.
55, JP-A-63-159822, JP-A-1-
When a surfactant is added to 180515, etc., 2
Enzyme stability can be maintained for about a week, but it is difficult for a long period of several months. As a method for improving this, JP-A-2-41398 discloses an enzyme stabilizing system containing a specific amphoteric surfactant, but it is not satisfactory.
In addition, when an ordinary surfactant is used for treatment of a soft contact lens, a phenomenon occurs in which the surfactant is adsorbed and remains on the soft contact lens. If such a state is continued, deformation, discoloration or eye damage of the soft contact lens may occur, which is not preferable. Therefore, the surfactant to be used should also be appropriately selected, and this solution is one of the objects of the present invention.

Next, when actually used as a cleaning agent, an enzyme cleaning agent is appropriately diluted and dissolved with a diluting solution such as a preservative solution or a dedicated preservative solution, and then the soft contact lens is treated. The osmotic pressure may increase and the shape of the contact lens may change, resulting in an undesirable state. In addition, if the material is boiled and sterilized in this state, dirt components and enzyme agent components may enter the inside of the contact lens, resulting in white turbidity, deformation, and tear of the contact lens, which is not preferable. Further, in order to increase the activity of the enzyme agent, a method of adding SH group activator such as cysteine or Ca to the diluent as an activating component is used. However, the SH group activator causes yellowing of the contact lens due to the formation of sulfide bond. However, Ca is problematic because it causes water insolubilization of proteins and stain deposit formation. In order to avoid such a problem, generally, after washing with an enzyme agent or a cleaning agent, it is sterilized by boiling using physiological saline or a special rinse solution, but the operation is complicated and damage to the contact lens and It is also one of the reasons why the risk of loss is high. Furthermore, if a dedicated diluent for dissolving the enzyme preparation and a physiological saline solution or a dedicated storage solution are set separately, contact lenses may be deformed or physiologically undesirable components may be adsorbed if used incorrectly. .
Also, when a dedicated diluent or water is used alone as a preservative solution, boiling disinfectant solution and rinse solution, contact lens deformation due to low osmotic pressure, fitting abnormalities during wearing, adsorption of undesirable components, etc. are problems. . Therefore, the present invention has been achieved by earnestly conducting research aiming at solving these problems.

[0007]

[Means for Solving the Problems] As technical means taken to solve the above problems, a stabilized enzyme solution composition comprising a specific enzyme stabilizing system and a component having a specific surface-active ability was found. In addition, they have found a method capable of optimally cleaning and disinfecting a contact lens without affecting the contact lens by mixing with a preservative composition having a certain physical property.

The present invention has been completed based on these findings. (1) (A) polyol 30 to 50% by weight, (B) boric acid and / or its salt 0.01 to 4% by weight, ( C) molecular weight 70
0 to 2500 polyoxyethylene alkyl ether or polyoxyethylene polyoxypropylene block copolymer, 0.1 to 5% by weight of a compound having a surface activity of at least one compound selected from polyethylene glycol having a molecular weight of 500 to 1500, and the balance water. A cleaning composition for contact lenses, which is a stabilized enzyme solution composition, (2) Osmolarity of 150 to 280 mmol / kg and pH
Is a diluting solution of the cleaning agent of 6 to 8 and has at least one function of a preserving solution, a boiling disinfecting solution and a rinsing solution, (3) A stabilized enzyme solution composition according to claim 1 and claim 2.
A cleaning composition for contact lenses, which is used as a mixture with the storage solution composition described above.

(4) A contact lens cleaning composition, wherein the stabilized enzyme solution composition and the preservative solution composition are water-soluble, (5) the pH of the stabilized enzyme solution composition is 6-8. A cleaning composition for contact lenses, characterized in that (6) a cleaning solution for contact lenses, characterized in that the mixed solution of the stabilized enzyme solution composition and the preservation solution composition has an osmotic pressure of 150 to 350 mmol / kg. Composition, (7) Stabilized enzyme solution At least one enzyme selected from the group consisting of proteolytic enzyme, lipolytic enzyme and polysaccharide degrading enzyme as the enzyme of the composition.
(8) A mixed solution of a stabilized enzyme solution composition and a preservative solution composition containing Mg ions as an enzyme activating component at 1 × 10 ^{−5 to} 5
X 10 ^-3 mEq / l cleaning composition for contact lenses, (9) Immersing a contact lens in a mixed solution of a stabilized enzyme solution composition and a preservative solution composition, followed by washing at room temperature or by heating. A method for cleaning a contact lens, which comprises sterilizing by boiling, and (10) immersing the contact lens in a mixed solution of a stabilized enzyme solution composition and a preservative solution composition, followed by washing at room temperature or by heating to prepare a preservative solution composition. A method for cleaning a contact lens, which comprises completely replacing and sterilizing by boiling, (11) immersing the contact lens in a mixed solution of a stabilized enzyme solution composition and a preservation solution composition, and washing at room temperature or by heating. (12) Disinfecting a contact lens, characterized in that the contact lens is boiled and disinfected in a preservative solution composition. Law,
It is the gist.

The present invention will be described in detail. Polyols 30 to 50 are used as an enzyme stabilizing system for a stabilized enzyme solution composition.
Weight percent applies. If it is less than 30% by weight, the enzyme stability is not sufficient, and if it exceeds 50% by weight, the stability can be secured but the osmotic pressure becomes high, which is not preferable in terms of the influence on the contact lens during preparation and use. The number of polyols used is preferably two or more than one, and the composition ratio of the main component to the remaining components of the two polyols used is 4: 1.
Most preferably, it is ˜1: 1. Further, a non-reducing polyol having 2 to 6 carbon atoms is most preferable, for example, threose, sorbitol, xylitol, ethylene glycol, glycerin, propylene glycol, glycero-1-phosphate, glycero-2-phosphate, Examples thereof include glycero-1,2-diphosphate and glycero-1,3-diphosphate.

The boric acid and / or its salt used in the present invention is applied in an amount of from 0.05 to 4% by weight. If the amount is less than 0.05% by weight, sufficient enzyme stability is not exhibited, and even if it exceeds 4% by weight, it is not possible. The above improvements in enzyme stability are not observed. In addition, boric acid and / or its salt also has a buffering effect, which is advantageous.

The compound having surface active ability used in the present invention is a high molecular weight type nonionic compound, and is suitable for the reaction of carboxy group, carbonyl group, sulfonyl group, amide group, amino group, quaternary amine group and the like. Since it does not contain a functional group that is easily involved, the interaction with the contact lens is low and adsorption or the like does not easily occur. Therefore, in the present invention, the molecular weight is 700 to 2
It is selected from one or more of 500 polyoxyethylene alkyl ether or polyoxyethylene polyoxypropylene block copolymer and polyethylene glycol having a molecular weight of 500 to 1500. If the molecular weight is less than the lower limit, adsorption and incorporation into the contact lens is severe, which is not preferable, and if the molecular weight is more than the upper limit, surface activity and water solubility are lowered, which is not preferable. The concentration usually used is 0.1 to 5% by weight, and if it is less than 0.1% by weight, it is difficult to obtain the surfactant activity during preparation and use, and if it exceeds 5% by weight, the stability of the enzyme is affected, which is not preferable. Suitable examples include polyoxyethylene (15) lauryl ether and polyoxyethylene (3
0) cetyl ether, polyoxyethylene (40) nonyl ether, polyoxyethylene (5) polyoxypropylene (15) block copolymer, polyoxyethylene (10) polyoxypropylene (20) block copolymer, polyoxyethylene (15) Polyoxypropylene (25) block copolymer, polyethylene glycol 500, polyethylene glycol 800, polyethylene glycol 1000, polyethylene glycol 15
00 etc. are mentioned.

The enzyme used in the present invention is a proteolytic enzyme,
It is selected from at least one or more of lipolytic enzymes and polysaccharide degrading enzymes. The proteolytic enzyme is derived from a microorganism, and examples thereof include penicillium-derived proteolytic enzyme and Bacillus-derived proteolytic enzyme. Examples of the lipolytic enzyme include Pseudomonas-derived lipolytic enzyme, liquiniform-derived lipolytic enzyme, and Bacillus-derived lipolytic enzyme. Examples of the polysaccharide degrading enzyme include chitosan degrading enzyme, mucin degrading enzyme, lysozyme,
Examples include heparinase and hyaluronidase.

Further, conventionally known components can be added to the stabilized enzyme solution composition of the present invention within a range that does not impair the enzyme stability. Examples thereof include preservatives such as sorbate and hinokitiol, metal chelating agents such as ethylenediaminetetraacetate and citrate, and enzyme activators such as magnesium ions.

In the present invention, the contact lens can be washed under optimum conditions by dissolving the stabilized enzyme solution composition in a specific solution and using it as an appropriate preparation solution. The preparative solution used for the stabilized enzyme solution composition is preferably a diluting solution for dissolution and a preservative solution composition that can be used as a preservative solution, a boiling disinfectant solution, and a rinse solution. Such a preservation solution composition has an osmotic pressure of 150 to 2
It is preferable that the osmotic pressure of 80 mmol / kg or the mixed solution with the stabilized enzyme solution composition is 150 to 350 mmol / kg. Osmotic pressure of storage solution composition is 150mmo
If it is less than 1 / kg, the shape of the contact lens is significantly changed, and if it is more than 280 mmol / kg, the osmotic pressure after mixing with the stabilized enzyme solution composition is high, which affects the shape change of the contact lens, which is not preferable. Further, when the osmotic pressure of the mixed solution of the stabilized enzyme solution composition and the storage solution composition is less than 150 mmol / kg, the shape of the contact lens is drastically changed, and when it exceeds 350 mmol / kg, the contact lens may be deformed due to high osmotic pressure. It is not preferable because the contact lens is liable to turn cloudy and yellow due to infiltration of dirt components into the contact lens. The pH of the stabilized enzyme solution composition and the storage solution composition is 6-8, preferably 6.5-7.5. Departing from this range is not suitable because it is physiologically unfavorable, and lens deformation and polymer chain breakage occur. Therefore, by using the cleaning composition of the present invention, efficient cleaning, disinfection without affecting contact lenses, simplification of user care method by using a diluting solution of a cleaning agent and a boiling disinfecting solution and a rinse solution. There are advantages.

Further, the present invention may contain a component for activating the action of the enzyme. The preferred activating component is M
g ion, and the final concentration is 1 × 10 ⁻⁵ to 1 × 10
^-3 mEq / l can be included. 1 x 10 ^-5 mEq / l
If it is less than 1, the activation effect is not recognized and 1 × 10 ⁻³ mEq /
If it exceeds l, not only the activation effect is not observed, but also Mg is attached to the lens and precipitation due to boiling disinfection occurs, which is not preferable. In addition, conventionally known components can be used in the preservative solution composition within a range that does not affect the enzyme activity and the contact lens. That is, an inorganic salt such as sodium chloride or potassium chloride for maintaining an appropriate osmotic pressure, a metal chelating agent such as ethylenediaminetetraacetic acid salt or citric acid capable of chelating and removing metal ions such as calcium ions and iron ions. Etc. can be included.

In the cleaning method of the present invention, a contact lens is immersed in a mixed solution prepared by diluting a stabilized enzyme solution composition with a preservative solution composition, and then cleaned at room temperature or in a heated state. In order to maximize the enzyme activity, the washing temperature is preferably 20 to 70 ° C, more preferably 40 to 6
0 ° C. After the washing, the temperature is increased to about 100 ° C. to sterilize by boiling, or the washing solution is completely replaced with the preservative solution composition and then sterilized by boiling. In addition, since the preservative solution composition of the present invention can be used alone as a preservative or rinse solution for contact lenses, the contact lens is immersed in the preservative solution composition and sterilized by boiling after washing by a separate method. By these methods, appropriate and easy contact lens care can be performed without deformation or discoloration of the contact lens.

[0018]

EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited thereto.

(Example 1) 0.3 g of boric acid was added to 60 g of distilled water.
g, threose 5g, glycerin 35g, Aroase A
3 g of P (proteolytic enzyme manufactured by Yakult Honsha Co., Ltd.) and 1 g of polyoxyethylene (20) lauryl ether were mixed and dissolved. Add 0.5 ml of 5% sodium hydroxide solution,
The pH was adjusted to 6.7 to obtain a stabilized enzyme solution composition.
In order to confirm the enzyme stability, the enzyme activity and pH were measured immediately after preparation and after storage at 40 ° C. for 4 months. The enzyme activity was measured by the dairy casein digestion method using the Folin reagent color development method, and the residual rate of the enzyme activity after storage immediately after preparation was calculated. As a result, pH was 6.6 and residual enzyme activity was 93.
%, Indicating good stability.

(Examples 2 to 6) In the same manner as in Example 1, the compositions shown in Table 1 were prepared and the stability was confirmed.
As a result, good stability was shown in each case.

Example 7 0.5 g of sodium chloride, 0.1 g of potassium chloride and 0.1 g of disodium ethylenediaminetetraacetate were dissolved in 99 g of distilled water to obtain a stock solution composition. The osmotic pressure of this solution is 225 mmol / kg, p
H was 6.8.

Example 8 0.65 g of sodium chloride,
Boric acid 0.01, borax 0.1 g, and ethylenediaminetetraacetic acid disodium 0.08 g were dissolved in distilled water 99 g to obtain a storage solution composition. The osmotic pressure of this solution is 250 mm
ol / kg, pH was 7.6.

(Example 9) 2.5 ml of the solution of Example 7
About 30 mg of the solution of Example 1 was put in a lens case (manufactured by Seiko Contact Lens Co., Ltd.) and mixed, and then a soft contact lens (manufactured by Seiko Contact Lens Co., Ltd.,
CSI soft lens), and a washing and boiling process using a boiling biodisinfector Microbiolyzer (manufactured by Seiko Contact Lens Co., Ltd.) having a heating process of 45 ° C for 20 minutes and a boiling disinfection process of 100 ° C for 15 minutes. It was sterilized. After cooling, it was rinsed with the stock solution composition used in this example. This operation was repeated 300 times. In all cases, no change in shape or discoloration of the soft contact lens was observed, and no change in ultraviolet transmittance was observed, and there was no effect on the contact lens.

(Example 10) For Examples 2 to 6, the same tests as in Example 9 were conducted. As a result, there was no effect on contact lenses. Table 2 shows the results.

Example 11 Solution of Example 7 2.5 m
l, about 30 mg of the solution of Example 2 was put in a lens case (manufactured by Seiko Contact Lens Co., Ltd.) and mixed for 1 week, and then a soft contact lens (manufactured by Seiko Contact Lens Co., Ltd., CSI soft lens) with dirt attached was worn. The sample was put in and washed and boiled and sterilized by using a boiler-disinfector Microbiolyzer (manufactured by Seiko Contact Lens Co., Ltd.). After cooling, the contact lens after rinsing with the preservative solution composition used in this example, washed and sterilized by boiling was observed with a differential interference microscope for adhesion of dirt. As a result, the dirt was cleanly removed.

[0026]

[Table 1]

[0027]

[Table 2]

(Comparative Examples 1 to 5) In the same manner as in Example 1, the compositions shown in Table 3 were prepared and their stability was confirmed.
As a result, when the content of the polyol was less than 30% by weight, the enzyme stability was lowered, and in the compounds having surface active ability other than the present invention, the enzyme activity was also lowered, and the stability was not preferable.

(Comparative Example 6) With respect to the solutions of Comparative Examples 3 to 5, the influence on contact lenses was confirmed in the same manner as in Example 9. As a result, the compounds having surface activity other than the present invention were not preferable because deformation or discoloration of the contact lens or a decrease in transmittance was observed. (Comparative Example 7) Sodium chloride 0.9 g, boric acid 0.0
5, 0.3 g of borax and 0.2 g of disodium ethylenediaminetetraacetate were dissolved in 99 g of distilled water to obtain a storage solution composition. The osmotic pressure of this solution is 360 mmol / kg, p
H was 6.9. After mixing 2.5 ml of this solution with about 25 mg of the solution of Example 2, an influence test on contact lenses was conducted in the same manner as in Example 9, and as a result, a change in the base curve of the contact lens and deformation were observed, Further, a slight decrease in transmittance was observed, which was not preferable.

[0030]

[Table 3]

[0031]

[Table 4]

[0032]

INDUSTRIAL APPLICABILITY According to the present invention, an enzyme solution is stabilized by using a specific enzyme stabilizing system and a component having a specific surface-active ability, and is mixed with a storage solution composition having a certain physical property. By using it, it does not affect the contact lens, it is possible to optimally clean and disinfect the contact lens without deteriorating the optical performance and shape, and the contact lens care can be performed easily and easily. .

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Claims (12)

[Claims] 1. A (A) polyol 30 to 50% by weight, (B)
Boric acid and / or salt thereof 0.01 to 4% by weight, (C) one or more selected from polyoxyethylene alkyl ether or polyoxyethylene polyoxypropylene block copolymer having a molecular weight of 700 to 2500 and polyethylene glycol having a molecular weight of 500 to 1500 2. A cleaning composition for contact lenses, which is a stabilized enzyme solution composition comprising 0.1 to 5% by weight of the compound having surface-active ability and the balance water. 2. A diluent for a cleaning agent having an osmotic pressure of 150 to 280 mmol / kg and a pH of 6 to 8, and a preservation solution,
A preservative solution composition for contact lenses, which has at least one or more functions of a boiling disinfection solution and a rinse solution. 3. A contact lens cleaning composition, which is used as a mixture of the stabilized enzyme solution composition according to claim 1 and the preservative solution composition according to claim 2. 4. The contact lens cleaning composition according to claim 1, wherein the stabilized enzyme solution composition and the storage solution composition are water-soluble. 5. The cleaning composition for contact lenses according to claim 1, wherein the stabilized enzyme solution composition has a pH of 6-8. 6. The contact lens cleaning method according to claim 1, wherein the mixed solution of the stabilized enzyme solution composition and the storage solution composition has an osmotic pressure of 150 to 350 mmol / kg. Composition. 7. The cleaning composition for contact lenses according to claim 1, wherein the enzyme of the stabilized enzyme solution composition is at least one selected from proteolytic enzymes, lipolytic enzymes and polysaccharide degrading enzymes. Stuff. 8. A mixed solution of a stabilized enzyme solution composition and a preservative solution composition contains 1 × 10 6 Mg ions as an enzyme activating component.
^{-5 to} 5 x 10 ^-3 mEq / l is contained, The contact lens cleaning composition according to any one of claims 1 to 3 characterized by things. 9. A method of cleaning a contact lens, which comprises immersing a contact lens in a mixed solution of a stabilized enzyme solution composition and a preservative solution composition, cleaning the contact lens at room temperature or by heating, and then sterilizing by boiling. 10. A contact lens is immersed in a mixture of a stabilized enzyme solution composition and a preservative solution composition, washed at room temperature or by heating, and then completely replaced with the preservative solution composition for sterilization by boiling. How to clean contact lenses. 11. A method of cleaning a contact lens, which comprises immersing a contact lens in a mixed solution of a stabilized enzyme solution composition and a preservative solution composition, and cleaning the contact lens at room temperature or by heating. 12. A method of disinfecting a contact lens, which comprises sterilizing the contact lens by boiling in a preservative solution composition.