JP4634024B2 - Contact lens solution - Google Patents

Description

  The present invention relates to a contact lens solution and a buffer used in the solution. Specifically, the present invention relates to a contact lens solution that has a high disinfection effect and safety for eyes and is useful for all soft contact lenses including ionic high water content lenses, and a buffer used in the solution.

  Soft contact lenses are required to be disinfected before wearing because of the high risk of infection with bacteria. Recently, disinfection methods using hydrogen peroxide and multi-purpose solution (MPS) are widely used because of their simplicity. MPS is a multipurpose solution that can be cleaned, disinfected, rinsed, and stored with a single solution, and can treat soft contact lenses by simply immersing and storing. Therefore, it is indispensable that MPS itself has a high disinfection effect and sufficiently secures high safety for eyes as a storage / rinsing solution.

  As a disinfectant used in the MPS disinfection method, polyhexamethylene biguanide (PHMB) having a high molecular weight is widely used even from conventional biguanide disinfectants due to problems such as adsorption to soft contact lenses. . Since PHMB has a molecular size larger than the pore size of the soft contact lens, it can prevent incorporation into the lens matrix. However, when used in MPS, high concentrations of PHMB have adverse effects such as irritation to the ocular mucosa, so it is necessary to suppress the blending amount to a low concentration, and the disinfection effect is not fully satisfactory. .

  Thus, studies have been conducted for the purpose of obtaining a higher disinfection effect at a low concentration when using a biguanide disinfectant. A method has been proposed in which a nonionic osmotic pressure adjusting agent is used in a PHMB-containing contact lens solution to exhibit a high disinfection effect at a low concentration of PHMB (for example, see Patent Document 1). Furthermore, a method of containing a nonionic osmotic pressure regulator and / or an amino acid together with a polyquaternium-based disinfectant has been proposed (see, for example, Patent Document 2). However, a soft contact lens (ionic high water content lens: water content) belonging to Group IV described in Pharmaceutical Examined No. 645 is added to a solution for contact lenses using a nonionic osmotic pressure regulator or an amino acid as an osmotic pressure regulator. In the case of immersion of 50% or more), there is a problem in lens compatibility, because a phenomenon occurs in which the lens dimensions, particularly the lens size, fluctuate significantly (swell or shrink). It has been found that this phenomenon is manifested by the ion concentration in the solution, the ionic strength, etc. even at physiologically appropriate pH and osmotic pressure.

  Also, by coexisting biguanide disinfectant and polyquaternium disinfectant in the presence of low molecular amino acids, the disinfecting effect is synergistically enhanced, and high disinfecting effect and high eye safety are achieved with a low concentration disinfectant. And a method of suppressing the size change of the ionic high water content lens has been proposed (for example, see Patent Document 3). However, this method is also not satisfactory because the variation in the size change of the ionic high water content lens is about the display value ± 1.0 mm of the product (lens). In addition, by combining an amino acid having an isoelectric point of 4 or more and a molecular weight of 89 or more, or a salt or derivative thereof, and an acidic component that does not generate metal ions in an aqueous solution, the disinfecting effect is synergistically enhanced and a low concentration disinfectant In addition, a method has been proposed that has a high disinfecting effect and high eye safety, and suppresses a change in the size of an ionic high water-containing lens (for example, see Patent Document 4). In this method, the variation in the lens size change can be stabilized to about the display value ± 0.2 mm of the product (lens), but the disinfection effect is sufficient to meet the primary performance standard of the ISO stand-alone test. Not evaluated.

By the way, the disinfection effect of the contact lens solution is evaluated based on a test implementation rule referring to “Stand-alone method of disinfectant product (stand-alone test)”. This evaluation method is based on the contact lens care product according to the pre-market notification (510 (k)) guidance document (May 1, 1997) of the contact lens care product prepared by the US Food and Drug Administration (FDA) ophthalmic device division. Conforms to the disinfection test method. This test implementation rule conforms to the latest ISO standard for contact lens disinfection (revised in 1995, hereinafter ISO stand-alone test). In addition, in this ISO stand-alone test, a primary performance standard and a secondary performance standard are defined. Many of the contact lens solutions that have been marketed in the past do not meet the primary performance standard of the ISO stand-alone test, but meet the secondary performance standard. When this secondary implementation standard is met, the disinfection effect is complemented by “scrubbing” and “rinsing” which are essential as part of the actual contact lens disinfection processing operation. On the other hand, if the primary performance standard is met, a sufficient disinfecting effect can be obtained without “scrubbing” and “rinsing”. The operation becomes simple and it is not necessary to impose complicated work on the user. For this reason, as a solution for contact lenses, a product having a high disinfecting effect that meets the primary performance standard of the ISO stand-alone test is desired.
JP-A-10-108899 Japanese Patent Laid-Open No. 11-249087 JP 2001-242428 A JP 2003-160482 A

  Citric acid-based, boric acid-based, and phosphate-based buffering agents are known as buffering agents used in conventional contact lens solutions. However, there is a problem in using any buffer as a contact lens solution having a disinfecting effect that meets the primary performance standard of the ISO stand-alone test. That is, the citric acid system does not have a disinfecting effect on specific microorganisms, and the boric acid system and phosphoric acid system have not only an insufficient disinfecting effect but also have a problem in compatibility with lenses. In particular, in phosphate systems, acidic and basic components that generate metal ions such as sodium and potassium are used in the aqueous solution to develop a buffering effect in the neutral range. It becomes difficult to make it. Moreover, as an osmotic pressure regulator used for the contact lens solution, ionic osmotic pressure regulators such as sodium chloride and potassium chloride, and nonionic osmotic pressure regulators such as propylene glycol and glycerin are known. Since the ionic osmotic pressure regulator generates metal ions in an aqueous solution, it has an advantageous effect on the compatibility of the ionic high water content lens, but the stability of the pH and the disinfection effect are reduced. On the other hand, the nonionic osmotic pressure adjusting agent works advantageously on the stability of pH and the disinfection effect, but there is a problem in the compatibility of the lens.

  The present invention has been made in view of the circumstances as described above, and as a solution to the problem, it has a disinfection effect conforming to the primary performance standard of ISO stand-alone test, while having high safety for eyes and high ionicity. An object of the present invention is to provide a contact lens solution useful for all soft contact lenses including a water-containing lens. In detail, disinfecting effect that conforms to the primary standards of ISO stand-alone testing with one low-concentration biguanide disinfectant without the addition of other disinfecting components such as polyquaternium-based disinfectants and disinfection auxiliary components It is to provide a contact lens solution that has high safety for the eyes and can suppress the size variation of the ionic high water content lens within the range of the display value ± 0.2 mm of the product (lens). .

The present invention is a solution for contact lenses containing polyhexamethylene biguanide as a disinfectant, and has an acidic component, a basic component, and an osmotic pressure regulator,
  For contact lenses, wherein the acidic component is pyrrolidone carboxylic acid, the basic component contains at least one of L-arginine and trishydroxymethylaminomethane, and the osmotic pressure adjusting agent is trimethylglycine. It is a solution.

In the present invention, the concentration of polyhexamethylene biguanide is 0.70 to 1.00 w / v%, the concentration of pyrrolidonecarboxylic acid is 0.80 to 1.00 w / v%, and the concentration of L-arginine is 0.90 to 1 The contact lens solution is characterized in that the concentration of .80 w / v%, the concentration of trishydroxymethylaminomethane is 0.60 to 1.20 w / v%, and the concentration of trimethylglycine is 1.50 w / v%.

Further, the present invention provides a combination of 1.80 w / v% L-arginine and 1.50 w / v% trimethylglycine or 1.80 w / v when the concentration of pyrrolidone carboxylic acid is 0.80 w / v%. A combination of v% L-arginine, 0.75 w / v% trimethylglycine and 0.75 w / v% propylene glycol is used at a pyrrolidone carboxylic acid concentration of 0.90 w / v%. When a pyrrolidone carboxylic acid concentration is 1.00 w / v%, a combination of / v% L-arginine, 0.60 w / v% trishydroxymethylaminomethane and 1.50 w / v% trimethylglycine is used. , 1.20 w / v% trishydroxymethylaminomethane and 1.50 w / v% trimethylglycine in combination, respectively It is a lens solution.

  The contact lens solution of the present invention achieves both a high level of disinfection effect conforming to the primary performance standard of the ISO stand-alone test and eye safety. Therefore, in the actual disinfection treatment of contact lenses, sufficient disinfecting effect can be obtained simply by immersing them for a predetermined time in a storage case filled with the contact lens solution of the present invention without performing “rubbing” and “rinsing”. Is obtained. Therefore, it is possible to wear the eye as it is after processing for a predetermined time. In addition, when the lens removed from the eye is “rubbed” and “rinse” using the contact lens solution of the present invention, microorganisms attached to the lens are greatly reduced. For example, a disinfecting effect can be obtained in which the processing is completed in a short time of 10 minutes to 60 minutes. That is, the same treatment can be performed with a simple operation and a shortened time as compared with a commercially available contact lens solution. Furthermore, even in the case of an ionic high water content lens, size fluctuations can be ultimately suppressed, so as a contact lens solution suitable for all contact lenses, lens displacement and foreign object sensation during wearing (immediately after wearing) Can be avoided in advance.

In the contact lens solution of the present invention, water-soluble salts such as polyhexamethylene biguanide (PHMB) and chlorhexidine gluconate are advantageously used as the biguanide antiseptic component, with polyhexamethylene biguanide (PHMB) being preferred. A commercial product of PHMB is Zeneca's trademark Cosmocil ^™ CQ. The blending amount is usually in the range of 0.00001 to 0.001 w / v%. If it is less than 0.00001 w / v%, the disinfection effect meeting the primary performance standards of the ISO stand-alone test is insufficient, and if it exceeds 0.001 w / v%, safety for the eye becomes a problem. Particularly preferably, it is used in the range of 0.00005 w / v% to 0.0005 w / v%.

  As a buffering agent, metal ions are generated in an aqueous solution such as pyrrolidone carboxylic acid as an acidic component, basic amino acid of L-arginine, L-lysine, L-histidine, trishydroxymethylaminomethane, BIS-Tris as a basic component. At least one selected from the basic compounds without any is used.

  Pyrrolidone carboxylic acid can be used in both optically active form and racemic form. In general, pyrrolidone carboxylic acid is known to be used as a pH adjuster for cosmetics, and sodium pyrrolidone carboxylate, which is a salt thereof, is used as a moisturizing and warming agent for cosmetics. However, it is not known that pyrrolidone carboxylic acid is used as an acidic component as a buffer for a contact lens solution and combined with a basic component. For example, in the present invention, when sodium pyrrolidonecarboxylate is used in place of pyrrolidonecarboxylic acid, not only sufficient pH stability is not obtained, but also its liquidity is substantially within the neutral range. I can't. In addition, the compatibility of the lens and the disinfection effect are also impaired.

  The basic component combined with pyrrolidone carboxylic acid does not generate metal ions in an aqueous solution such as L-arginine, L-lysine, L-histidine basic amino acid, trishydroxymethylaminomethane, BIS-Tris. At least one kind is selected as an essential component from basic compounds. The basic components can be used alone or in appropriate combination, but L-arginine and trishydroxymethylaminomethane are preferably used, and L-arginine is particularly preferably used. Usually, the contact lens solution is used within a substantially neutral range of pH 5-9, preferably pH 5.5-8.5. Even if the pH is lower than 5 or higher than 9, problems such as irritation or damage to the eyes may occur. In the contact lens solution of the present invention, in order to adjust and maintain the pH of the solution within a substantially neutral range of 5.5 to 8.5, a buffering agent combining pyrrolidone carboxylic acid and the above basic component is added. Use. The blending amount is usually in the range of 0.1 to 10.0 w / v%. If it is less than 0.1 w / v%, sufficient pH stability cannot be obtained, and if it exceeds 10.0 w / v%, not only remarkable pH stability is observed, but also when storing under cold temperature, Problems such as precipitation of the buffer may occur.

  Trimethylglycine is used as the osmotic pressure adjusting agent blended in the contact lens solution in the present invention. Trimethylglycine, also called glycine betaine, has a zwitterionic betaine structure, and is used in cosmetics, bath preparations and the like by utilizing its moisturizing and water retaining effects. For example, in JP-A-9-87126, a cosmetic that gives tension and moisture to skin and hair by combining each component known as a moisturizing agent in the cosmetic field such as trimethylglycine, pyrrolidone carboxylate, and amino acid. Has proposed.

  The present invention relates to a contact lens solution, and is completely different from the above technique in that pyrrolidone carboxylic acid, which is not a sodium salt, is used as an acidic component of a buffer. As a contact lens solution, it is known that trimethylglycine is blended for the purpose of stabilizing a proteolytic enzyme (Japanese Patent Laid-Open No. 11-178570). However, it is not known that trimethylglycine used as an osmotic pressure adjusting agent, together with the buffer of the present invention, can exhibit excellent lens compatibility while contributing to improvement in pH stability and disinfection effect. Therefore, according to the present invention, the coexistence of the buffer of the present invention with trimethylglycine and PHMB exhibits a disinfecting effect conforming to the primary performance standard of ISO stand-alone test at a low concentration of PHMB, and high safety to the eyes. A solution for contact lenses having

  The blending amount of the osmotic pressure adjusting agent is usually used in the range of 0.1 to 10.0 w / v%, but 200 to 400 mmol / kg, preferably 220 to 380 mmol, where the osmotic pressure of the solution is substantially equal to the physiological osmotic pressure. The blending amount is adjusted to be / kg.

  In the present invention, in addition to trimethylglycine, conventionally known nonionic osmotic pressure regulators such as glycerin, ethylene glycol, propylene glycol, polyethylene glycol (average molecular weight: 100 to 400), glucose, fructose, mannitol, sorbitol, It can be blended alone or in appropriate combination from among xylitol, cyclodextrin, trehalose and the like. The blending amount is in a range that does not inhibit the effects of the present invention, and is preferably within 1: 1 with respect to trimethylglycine. In addition to the above, it can be used as long as it is highly safe for the eyes and is useful as an osmotic pressure regulator, but it is possible to use conventionally known ionic osmotic pressure regulators such as sodium chloride and potassium chloride. This is not preferable because it reduces the disinfection effect. In addition, divalent ionic osmotic pressure regulators such as calcium chloride and magnesium chloride cannot be used because the size of soft contact lenses belonging to Group IV is irreversibly significantly reduced.

  Furthermore, in the case of the present invention, the physiologically appropriate ranges of pH and osmotic pressure are maintained, and the size fluctuation amount of the ionic high water content lens is controlled within the range of the display value ± 0.2 mm of the product (lens). In addition, the blending amounts of the buffer and the osmotic pressure adjusting agent are adjusted. The total blending amount of the buffer and the osmotic pressure regulator is usually in the range of 1.0 to 10.0 w / v%.

  In the present invention, a surfactant may be further added for the purpose of improving the effect of removing stains such as proteins and eye grease adhering to the contact lens and the cleaning effect. As a surfactant, the safety to the eye is high, and there is no influence on the contact lens material. The disinfecting effect of the present invention is an anionic surfactant, a positive ion in a kind and blending amount that does not impair safety and lens compatibility. Any one of an ionic surfactant, a nonionic surfactant, and an amphoteric surfactant can be used. Among these, nonionic surfactants are preferred, and examples include polyoxyethylene ether, polyoxypropylene ether, polyoxyethylene-polyoxypropylene block copolymer, and polyoxypropylene-polyoxyethylene adduct of ethylenediamine. . Particularly preferably, a polyoxyethylene-polyoxypropylene block copolymer or a polyoxypropylene-polyoxyethylene adduct of ethylenediamine is used. The blending amount is usually 0.001 to 10.0 w / v%, preferably 0.01 to 1.0 w / v%.

  Furthermore, in the present invention, a metal ion sequestering agent (chelating agent) can be added in order to remove inorganic soil such as calcium. As the chelating agent, ethylenediaminetetraacetic acid (EDTA) and a salt thereof (disodium) are preferable, and the blending amount is usually in the range of 0.002 to 0.2 w / v%.

  In the present invention, a thickener, a pH adjuster, a protein removing agent and the like can be added in addition to the above components as long as the object, effect, and action of the present invention are not inhibited. For example, as a natural and synthetic water-soluble polymer having a thickening action, polyethylene oxide, polyvinyl alcohol, polyvinyl pyrrolidone, hydroxyethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, carboxymethylcellulose, pullulan, sodium alginate, chondroitin sulfate, poly Examples include natural and synthetic water-soluble polymers such as (meth) acryloyloxyethyl phosphorylcholine, and these can be used alone or in appropriate combination. In the composition of the present invention, polyvinyl alcohol, hydroxypropylmethylcellulose, and poly (meth) acryloyloxyethyl phosphorylcholine are preferred as components that can be expected to improve the hydrophilicity of the lens surface in addition to the thickening action. The blending amount is usually in the range of 0.01 to 10 w / v%.

  In particular, poly (meth) acryloyloxyethyl phosphorylcholine, which is an amphoteric polymer, can be expected to improve the hydrophilicity of the lens surface in combination with the moisturizing / water-retaining action of trimethylglycine having a betaine structure. It is suitable for. This polymer is commercially available as a single or copolymer.

  As a pH adjuster, hydrochloric acid, phosphoric acid, sodium hydroxide and the like can be appropriately added, and as a protein remover, a proteolytic enzyme can be appropriately added in an appropriate amount.

  In order to clarify the present invention, some examples will be shown below.

  Test solutions having the formulations of Examples 1 to 9 and Comparative Examples 1 and 2 shown in Table 1 as contact lens solutions were prepared, and the following evaluation items 1 to 3 were tested. The units in Table 1 are w / v% unless otherwise specified.

1. 1. Effectiveness test as disinfectant Safety test (cytotoxicity test)
3. Lens compatibility test (size change measurement of ionic high water content lens)

-1. Effectiveness test as disinfectant
As test strains, Pseudomonas aeruginosa (ATCC 9027), Staphylococcus aureus (ATCC 6538), three types of bacteria (Serratia marcescens: ATCC 13880), and Candida albicans (ATCC 10231) Two fungi of Fusarium solani (ATCC 36031) were used. For the three types of bacteria, a suspension (10 ⁸ to 10) was collected by adding sterilized Dulbeccolic Acid Hygiene Saline to a mycelia of 35 ° C. × 24 hours on a slant medium of soy bean casein agar medium. ⁹ cfu / mL) was used as a test bacterial stock solution. In addition, as for two types of fungi, a suspension (10 ⁸⁾ was obtained by adding sterilized Dulbecco's mild sanitary saline solution to a mycelia obtained by culturing on a slope medium of glucose peptone agar at 35 ° C. for 24 hours. 10 ⁹ cfu / mL) was used as a test bacterial stock solution.

10 mL of the contact lens solution of the present invention sterilized in advance was inoculated with 0.1 mL of each test bacterial stock solution so as to have a final concentration of 10 ⁵ to 10 ⁶ cfu / mL, and then stored in an incubator at 25 ° C. After a predetermined disinfection time, 1 mL of each test solution was collected and added to 9 mL of a sterilized inactive agent-containing liquid medium (Letheen Broth) (diluted 10 times) to neutralize and inactivate PHMB. Next, a continuous 10-fold dilution series is prepared using sterilized dulbeccolic acid mild sanitary saline, and 1 mL of a test solution diluted at 3 concentrations at an appropriate dilution ratio is taken in a sterilized disposable dish, and an agar medium is prepared. In addition, the number of viable bacteria was measured after pour.

  On the other hand, in the case of the initial number of bacteria inoculated into the contact lens solution (initial number of inoculated bacteria), all are diluted with sterilized Dulbecco's phosphate buffered saline, and the number of viable bacteria is measured by the same operation as above. did. As the agar medium, soybean casein agar medium was used for three types of bacteria, and glucose peptone agar medium was used for two types of fungi. The culture conditions in this agar pour plate method were 35 ° C. × 48 hours for both bacteria and fungi. The logarithmic difference after the disinfection time (logarithm of the decrease in the number of viable bacteria) is calculated by calculating the number of initial bacteria and the number of live bacteria (logarithmic value) in the test solution after inoculation. It calculated | required from the difference with the logarithm value of the viable count of a test liquid after inoculation.

Logarithmic difference (logarithm of viable cell count reduction) =
Initial number of bacteria (logarithmic value)-Number of viable bacteria in test solution after inoculation (logarithmic value)

  Judgment criteria for the disinfection effect are based on the primary implementation standard of the ISO stand-alone test. The logarithmic difference in a predetermined disinfection time is a logarithmic difference of 3.0 or more for three types of bacteria, and a logarithmic difference of 1.0 or more for two types of fungi. It was decided that. The test was conducted with a disinfection time of 4 hours.

  From Table 2, in Examples 1-9, in the disinfection effect with respect to all the test object microorganisms (three kinds of bacteria, two kinds of fungi), the disinfection effect (logarithmic difference bacteria: 3.0 which meets the primary performance standard of ISO stand-alone test) As described above, fungus: 1.0 or more was observed. In particular, in Examples 1 and 2, a disinfecting effect conforming to the primary performance standard of the ISO stand-alone test was recognized at a PHMB prescription amount (0.7 ppm) at a lower concentration than before. On the other hand, in Comparative Examples 1 and 2, even when PHMB was added at 2.0 ppm, the disinfection effect for Candida albicans (ATCC 10231) was not found to be compatible with the primary performance standard of the ISO stand-alone test.

-2. Safety test: Cytotoxicity test-
In order to evaluate the safety of the contact lens solution according to the present invention, referring to Chapter 3 “Cytotoxicity Test” in “Guidelines for Basic Biological Testing of Medical Devices and Medical Materials 1995”, the colony method Evaluation was performed.

  The test uses "Chinese hamster-derived V79 cells" as the cell line, Eagle's MEM (Minimum Essential Medium), L-glutamine (0.292 g / L), sodium bicarbonate (2.2 g / L), and The culture was performed in a medium (ME10 medium) supplemented with fetal calf serum (10 v / v%).

  In the test method, 50 V79 cells were seeded in each well of a 12-well plate for cell culture in which 2 mL of ME10 medium had been dispensed in advance, and the contact lens solution was 20.0 v / v%, 10.0 v / Three wells of each concentration were added so as to be v%, 5.0 v / v%, and 2.5 v / v%, and the cells were cultured in a carbon dioxide incubator at 37 ° C. for 7 days to form colonies.

  After completion of the culture, the medium was discarded, the cell surface was washed with a balanced salt solution, and methanol was added to immobilize the cells. After fixing the cells, methanol was discarded and Giemsa staining solution for staining the colonies was added to stain the colonies. After staining, the number of colonies in each well was counted.

  In the evaluation method, the number of colonies produced from cells cultured only in a fresh medium as a control was defined as 100% colony formation rate, and the relative colony formation rate (%) at each added concentration of the contact lens solution was calculated by the following formula.

Relative colony formation rate (%) = (number of colonies at each added concentration after test / number of control colonies) × 100
Since the safety test is a relative evaluation with respect to the control, no clear criterion is set, but the closer the relative colony formation rate is to the control (colony formation rate 100%), the higher the safety. That is, in this test, even when the concentration of the contact lens solution is 20 v / v%, it is determined that the relative colony formation rate is 100%, which is the highest safety.

  From Table 3, the relative colony formation rate at a test solution addition concentration of 20% was 90% or more in Examples 1 to 8, and 75% or more in Example 9, and high safety was recognized. On the other hand, in Comparative Examples 1 and 2 (containing 2.0 ppm of PHMB), the relative colony formation rate is 20% or less at a test solution addition concentration of 20%, and the relative colony formation rate is 70% or less even at a test solution addition concentration of 10%. There was low safety.

-3. Lens compatibility test: Size change measurement of ionic high water content lens-
A test lens is immersed in a 4 mL lens case in physiological saline (ISO 10344 (Optics and optical instruments-Contact lenses-Saline solution for contact lens testing)) and kept in a constant temperature bath at 25 ° C ± 1 ° C for 24 hours. The lens was taken out, and the lens size (diameter) in ISO physiological saline was measured as the initial lens size.The lens size was measured by using a reading microscope to enlarge the lens 200 times, and 25 ° C. ± 1 The diameter of the lens in 20 mL of physiological saline at 0 ° C. was measured three times per lens, and the average value was used as the actual measurement value. Place in 20 mL, after 5 minutes immersion, measure the lens size after 10 minutes immersion 3 times per sheet, and use the average value as the actual measurement value. It was immersed in the lens case and stored for 14 days in a constant temperature water bath at 25 ° C. ± 1 ° C. The lens size after immersion for 1 day, after 7 days and after immersion for 14 days was the same as above. The test lens was manufactured by Johnson & Johnson, trade name Accuview 2 (ionic high water content lens: Group IV, display value (standard): base curve. 8.7 mm, vertex refractive index -3.00 D, diameter 14.0 mm, water content 58%).

  Judgment criteria for the lens compatibility test are described in the “Contact Safety Standards for Contact Lens Cleaners / Preservatives / Cleaning Preservatives (Revised 5th Edition)” in the Contact Lens Association of Japan, “Contact Lens Compatibility Test” section, “ In accordance with the “diameter” standard, the display value of the product (lens) is within a range of ± 0.2 mm.

  From Table 4, in Examples 1-8, the size fluctuation | variation of the ionic high water content lens was able to be suppressed in the range of the display value (14.00 mm) +/- 0.2 mm of a product. On the other hand, in Comparative Examples 1 and 2, the size variation of the ionic high water content lens could not be suppressed within the range of the product display value (14.00 mm) ± 0.2 mm.

  As a result of the above, Examples 1 to 8 have a disinfection effect that complies with the primary performance standards of the ISO stand-alone test, and have a relative colony formation rate of 90% or more, high safety, and the variation in the size of the ionic high water content lens. However, it can be seen that the display value (14.00 mm) has high stability that can be suppressed within a range of ± 0.2 mm.

Moreover, when the hydrophilicity evaluation of the solution for contact lenses of this invention was performed by visual observation, it has confirmed that the solution of this invention which mix | blended trimethylglycine had favorable hydrophilicity. In particular, when a zwitterionic polymer was added, it was confirmed that the hydrophilicity was further improved.

Claims (4)

A contact lens solution containing polyhexamethylene biguanide as a disinfectant,
  Having an acidic component, a basic component, and an osmotic pressure regulator,
  For contact lenses, wherein the acidic component is pyrrolidone carboxylic acid, the basic component contains at least one of L-arginine and trishydroxymethylaminomethane, and the osmotic pressure adjusting agent is trimethylglycine. solution. The concentration of polyhexamethylene biguanide is 0.70 to 1.00 w / v%, the concentration of pyrrolidone carboxylic acid is 0.80 to 1.00 w / v%, and the concentration of L-arginine is 0.90 to 1.80 w / v. 2. The contact lens solution according to claim 1, wherein the concentration of trishydroxymethylaminomethane is 0.60 to 1.20 w / v%, and the concentration of trimethylglycine is 1.50 w / v%. When the concentration of pyrrolidone carboxylic acid is 0.80 w / v%, a combination of 1.80 w / v% L-arginine and 1.50 w / v% trimethylglycine or 1.80 w / v% L-arginine Of 0.75 w / v% trimethylglycine and 0.75 w / v% propylene glycol,
  When the concentration of pyrrolidone carboxylic acid is 0.90 w / v%, 0.90 w / v% L-arginine, 0.60 w / v% trishydroxymethylaminomethane, 1.50 w / v% trimethylglycine, A combination of
  When the concentration of pyrrolidone carboxylic acid is 1.00 w / v%, it has a combination of 1.20 w / v% trishydroxymethylaminomethane and 1.50 w / v% trimethylglycine, respectively. The contact lens solution according to claim 2. 4. The contact lens solution according to claim 3, which has 0.30 w / v% of polymethacryloyloxyethyl phosphorylcholine which is an amphoteric polymer.