JP5587359B2 - Contact lens composition - Google Patents

Description

  The present invention relates to a contact lens composition used as, for example, a contact lens mounting liquid.

  Conventionally, various contact lens compositions used for contact lenses have been devised, such as contact lens cleaning solutions, contact lens preserving solutions, contact lens mounting solutions, eye drops, and eye wash solutions.

  By the way, such a composition for contact lenses is required to suppress the feeling of foreign matter and discomfort that tend to occur when the contact lens is worn. For example, Japanese Patent Application Laid-Open No. 2001-125052 (Patent Document 1) describes a contact lens mounting liquid that improves the feeling of wearing a contact lens by improving the wettability of the contact lens. In the contact lens composition described in Patent Document 1, the wettability of the contact lens surface is improved by blending polyvinyl alcohol or hypromellose (hydroxypropylmethylcellulose) as a thickener.

  However, even when such a contact lens composition is used, there is a case where the feeling of foreign matter or discomfort is not sufficiently eliminated. One reason for this is considered to be that dirt is easily attached to the contact lens by improving the wettability of the contact lens. That is, the foreign object feeling and discomfort at the time of wearing the contact lens are not only caused by the contact lens itself, but may also be caused by dirt attached to the contact lens. As a solution to the dirt adhering to such a contact lens, for example, a contact lens composition described in JP-A-2002-322048 (Patent Document 2) has been devised. This composition for contact lenses is designed to suppress adhesion of protein stains to contact lenses by blending hypromellose having a weight average molecular weight of 50,000 to 400,000.

  However, even when such a contact lens composition is used, there is still a case where the effect of improving wearing feeling cannot be sufficiently obtained. That is, the presence of not only protein stains but also lipid stains is known as stains attached to contact lenses. In particular, in recent years, silicone hydrogel soft contact lenses are becoming more popular as lenses with better oxygen permeability. However, silicone hydrogel soft contact lenses have more lipid stains than conventional lenses. There is a tendency to be easy. Therefore, in the market, there is an increasing demand for a composition for contact lenses that can eliminate the feeling of foreign matter and discomfort caused by lipid contamination. On the other hand, contact lens compositions are often used in situations where they are directly touched. Surfactants with a high detergency and adhesion-suppressing ability for lipids generally cause eye irritation, so there is a problem that they are difficult to adopt for such contact lens compositions, and for contact lenses that can meet such market demands. The composition has not yet been completed. In particular, the contact lens composition suitable for the silicone hydrogel soft contact lens as described above is not only safe, but also (1) a detergency for lipids and (2) a lipid adhesion inhibitory force for lens surfaces, (3) Improving the wearing feeling of the contact lens, that is, reducing the friction due to the contact between the anterior eye part and the contact lens, and it is extremely important to balance the elements (1) to (3) in a well-balanced manner. is there. However, achieving these elements simultaneously has been difficult with the prior art.

JP 2001-125052 JP 2002-322048 A

  The present invention has been made in the background of the above-mentioned circumstances, and the problem to be solved is to use a highly safe substance for the human body to clean the lipid dirt adhered to the contact lens and to create a new lipid dirt. It is an object of the present invention to provide a novel composition for a contact lens that can simultaneously reduce the friction generated between the contact lens and the anterior ocular segment of the eye while simultaneously exerting the effect of suppressing the adhesion of the contact lens.

In the first aspect of the present invention, hypromellose having a viscosity of 5.1 mPa · s or less of a 2 w / w% aqueous solution at 20 ° C is contained at a concentration of 0.5 to 1.5 w / v%, and 20 ° C Polyvinyl alcohol having a viscosity of 10 to 35 mPa · s in a 4 w / w% aqueous solution is contained at a concentration of 0.8 to ² w / v%, and a kinematic viscosity at 20 ° C. is 3.0 to 8.0 mm ^2. / S.

  According to this aspect, with respect to hypromellose (hydroxypropylmethylcellulose) and polyvinyl alcohol, which have been conventionally used in contact lens compositions as thickeners, etc., those having specific viscosities are adopted and combined in combination with each other. The overall kinematic viscosity was adjusted to a predetermined range. Moreover, the concentration of hypromellose and polyvinyl alcohol was adjusted to be in a specific range. As a result, it is possible to exert a cleaning effect on lipid dirt adhered to the contact lens, which has been difficult to cope with, and to prevent new lipid dirt from adhering to the contact lens surface. Thereby, the fall of the wearing feeling of the contact lens resulting from lipid dirt can be suppressed favorably.

Furthermore, according to this aspect, it is also possible to suitably suppress foreign object feeling and discomfort caused by contact between the contact lens itself and the eye. That is, when the inventors examined, as a factor of discomfort caused by the contact lens itself when the contact lens is mounted, friction generated between the contact lens and the anterior eye portion of the eye is a problem. It was found. According to this aspect, the specific viscosity and specific concentration of hypromellose and polyvinyl alcohol are combined to adjust the overall kinematic viscosity at 20 ° C. to 3.0 to 8.0 mm ² / s, thereby generating on the contact lens surface. Friction can be advantageously reduced. Therefore, according to this aspect, while using a highly safe compound that has been used in the past, it is possible to effectively suppress any foreign body sensation caused by lipid contamination and the contact lens itself, and use of the contact lens The feeling can be advantageously improved.

  According to a second aspect of the present invention, in the contact lens composition described in the first aspect, a contact lens mounting solution, a contact lens cleaning solution, a contact lens preserving solution, a contact lens rinsing solution, an eye drop, an eye wash, It is used as at least one of contact lens packaging solution and eye drops.

  According to this aspect, by providing a combination of hypromellose and polyvinyl alcohol having a specific viscosity and a specific concentration, a contact lens mounting solution and the like excellent in lipid cleaning power, lipid adhesion suppression power, and friction reduction effect are provided. Can do. In addition, it is desirable that this aspect be adopted in combination with the second aspect. According to the second aspect, by blending hypromellose and polyvinyl alcohol having a specific viscosity and concentration and polyhexanide hydrochloride having a specific concentration, an excessive antiseptic effect is sufficiently suppressed and sufficient antiseptic action is exhibited. It becomes possible to make it. As a result, it is possible to provide a contact lens mounting liquid or the like excellent in convenience while suppressing the influence on the eyes and the like. Moreover, the composition for contact lenses according to the present embodiment may be used as a multipurpose liquid for contact lenses having both functions of a contact lens cleaning liquid and a contact lens preserving liquid among the liquids used in the various applications described above. Good.

  Another preferred embodiment of the present invention is the contact lens composition described in the first or second embodiment, wherein the blending ratio of polyvinyl alcohol to hypromellose is 1: 1 to 1: 3.

  According to this aspect, it is possible to effectively exert a lipid cleaning power, a lipid adhesion suppressing power, and a friction reducing effect.

  According to the composition for contact lenses according to the present invention, both hypromellose having a specific viscosity and concentration and polyvinyl alcohol, which are a combination of highly safe substances for the human body, simultaneously exert a cleaning action and an adhesion suppressing action against lipid stains. Can be made. Moreover, the friction which arises between a contact lens and the anterior eye part of eyes can be reduced by mix | blending these substances. Thereby, both the foreign material sensation etc. resulting from lipid dirt and the contact lens itself can be effectively reduced, and the wearing feeling of the contact lens can be improved.

  Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention relating to a composition for contact lenses will be described in detail.

The contact lens composition according to an embodiment of the present invention contains hypromellose having a viscosity of 5.1 mPa · s or less at 20 ° C. at a concentration of 0.5 to 1.5 w / v%. In addition, polyvinyl alcohol having a viscosity of 10 to 35 mPa · s of a 4 w / w% aqueous solution at 20 ° C is contained at a concentration of 0.8 to 2 w / v%, and a kinematic viscosity at 20 ° C is 3. It is set to 0-8.0 mm < ² > / s. That is, the composition for contact lenses according to the present embodiment is a combination of hypromellose having a specific viscosity and polyvinyl alcohol in a range where the kinematic viscosity at 20 ° C. of the whole preparation is 3.0 to 8.0 mm ² / s. As a result, it is possible to reduce the feeling of foreign matter and discomfort when wearing the contact lens.

  More specifically, the composition for contact lenses according to the present embodiment comprises various solutions used in direct or indirect contact with contact lenses, such as contact lens mounting liquid, contact lens cleaning liquid, contact lens preserving liquid, contact It is used as a lens rinsing solution, a protein treatment agent, a multipurpose solution for contact lenses (MPS), a contact lens disinfectant, eye drops, eye wash, contact lens packaging solution, eye drops, and the like. Among them, the composition for contact lenses according to the present embodiment is a contact lens mounting solution, a contact lens cleaning solution, a contact lens preserving solution, a contact lens rinsing solution, an eye drop, an eye wash, a contact lens packaging solution, and an eye drop application. It is desirable to be used as at least one of the following.

  The composition for contact lenses according to this embodiment can be used for various known contact lenses. Specifically, for example, hard contact lenses, oxygen permeable hard contact lenses, soft contact lenses, silicone hydrogel soft contact lenses, hybrid contact lenses (contact lenses that combine oxygen permeable hard contact lenses and soft contact lenses, etc. Contact lenses made by combining two or more materials), orthokeratology lenses, fashionable color contact lenses, and cornea contact lenses. Further, the usage form of the contact lens is not particularly limited. That is, it may be a disposable contact lens that is used only for a short period such as one day or one week to several months, or a normal contact lens that is used for a longer period.

  As hypromellose (hydroxymethylpropylcellulose) blended in the composition for contact lenses, the viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less, preferably 2.5 to 5.1, more preferably The thing of 2.5-3.5 mPa * s is used. The viscosity of this hypromellose is a value measured according to the hypromellose viscosity measurement method described in the 15th revised Japanese Pharmacopoeia. Moreover, such hypromellose can be easily obtained on the market, and furthermore, various substitution degrees of hypromellose can be selected. For example, the substitution degree type is selected from 2208, 2906, and 2910. Among them, the substitution degree type of 2910 is particularly preferably selected. Specifically, for example, TC-5E and TC-5M manufactured by Shin-Etsu Chemical Co., Ltd. can be employed.

  Moreover, as a polyvinyl alcohol, the viscosity of 4 w / w% aqueous solution in 20 degreeC is 10-35 mPa * s, Preferably it is 12-30 mPa * s, More preferably, it is 21-29 mPa * s, More preferably, it is 23-27 mPa * s. Things are used. Polyvinyl alcohol having such a specific viscosity is also readily available in the market, and various saponification degrees of polyvinyl alcohol can be selected. For example, the saponification type is selected from complete saponification type, intermediate saponification type, and partial saponification type. Among them, the partial saponification type and intermediate saponification type are particularly preferably selected. Specifically, for example, P-610, GOHSENOL EG-25, GOHSENOL EG-30 manufactured by Nippon Synthetic Chemical Co., Ltd., and VP-18 manufactured by Nippon Vinegar Poval Co., Ltd. can be used. In addition, the viscosity of polyvinyl alcohol is a value measured according to the polyvinyl alcohol test method described in JIS K 6726 in the case of P-610 which is a product for industrial use. In addition, in the case of products such as GOHSENOL EG-25, GOHSENOL EG-30, VP-18, etc. according to pharmaceutical additive standards, the values are measured according to the test method described in the pharmaceutical additive standard polyvinyl alcohol (partially saponified product). .

  According to the present embodiment, by combining hypromellose and polyvinyl alcohol of these specific viscosities in combination, a cleaning effect on lipid attached to the contact lens, a lipid adhesion inhibiting effect that suppresses lipid adhesion, and a contact lens Any friction reducing effect that reduces friction with the anterior segment of the eye can be exhibited well. As a result, it is possible to reduce both the foreign body sensation and discomfort caused by lipid stains adhering to the contact lens, and the foreign object sensation and discomfort caused by the contact lens itself, thereby advantageously improving the wearing feeling of the contact lens. It is possible.

  In particular, even when these hypromellose and polyvinyl alcohol are within the above-mentioned specific viscosity range, when only one of them is blended, a sufficient effect cannot be exhibited. For example, when only hypromellose having a specific viscosity is blended, a slight lipid cleaning effect can be exhibited, but a lipid adhesion inhibiting effect and a friction reducing effect can hardly be exhibited. Similarly, when only polyvinyl alcohol having a specific viscosity is blended, the lipid adhesion suppressing effect and the friction reducing effect can be slightly exhibited, but the lipid cleaning effect is hardly exhibited. On the other hand, although the detailed reason is unknown, when hypromellose having such a specific viscosity and polyvinyl alcohol are combined, the three effects of lipid cleaning effect, lipid adhesion inhibiting effect, and friction reducing effect are obtained as a single substance. This is a significant improvement over the case of adding in.

  Moreover, if any one of hypromellose and polyvinyl alcohol is out of the above-mentioned specific viscosity range, such a specific effect cannot be sufficiently exhibited. That is, in this embodiment, the viscosity and molecular weight of hypromellose are relatively small, and the viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less, preferably 2.5 to 5.1, more preferably 2 A specific hypromellose of 5 to 3.5 mPa · s is employed. Moreover, as polyvinyl alcohol, the viscosity of a 4 w / w% aqueous solution at 20 ° C. having a medium viscosity and molecular weight is 10 to 35 mPa · s, preferably 12 to 30 mPa · s, more preferably 21 to 29 mPa · s, The thing of the range of 23-27 mPa * s is employ | adopted preferably. And by adopting hypromellose and polyvinyl alcohol of such a specific viscosity in combination with each other, the lipid washing and lipid adhesion inhibitory effect, which has been difficult to exhibit in the past, and the friction reducing effect, Both can be expressed effectively and more effectively than when added alone. The combination of hypromellose and polyvinyl alcohol having specific viscosities as active ingredients is a lipid cleaning agent for the contact lens surface, a lipid adhesion inhibitor for the contact lens surface, or a contact lens and an anterior segment in this embodiment. It goes without saying that it works as a friction reducing agent.

  The detailed reason why such a synergistic effect is manifested is unknown, but one guess is that by combining hypromellose with a relatively low molecular weight and a medium molecular weight polyvinyl alcohol with each other, a relatively small The molecular weight hypromellose molecule exhibits a good surface-active effect and exhibits a sufficient detergency, and a slightly larger molecular weight of polyvinyl alcohol collects around the contact lens and coats the lens to adhere lipids. It is possible to suppress it. Further, on the contact lens surface, only a substance having a low molecular weight cannot be well adapted to the contact lens surface, and even a substance having a high molecular weight becomes too viscous, and it is difficult to reduce friction. However, the combination of a specific range of low-viscosity hypromellose molecules and medium-viscosity polyvinyl alcohol molecules results in proper slipping and slimming on the contact lens surface, resulting in the friction generated on the contact lens surface. It is estimated that it can be effectively reduced.

In the contact lens composition of the present embodiment, the kinematic viscosity at 20 ° C. of the contact lens composition is 3.0 to 8.0 mm ² / s. The kinematic viscosity at 20 ° C. of the composition for contact lenses is more preferably 3.0 to 5.0 mm ² / s, and still more preferably 3.1 to 4.4 mm ² / s. Thus, when the kinematic viscosity of the composition for contact lenses is in a specific range of 3.0 to 8.0 mm ² / s, the intended lipid cleaning effect, lipid adhesion inhibiting effect, friction reducing effect However, both are effective. On the other hand, when the kinematic viscosity of the contact lens composition is out of the range of 3.0 to 8.0 mm ² / s, at least one of the lipid cleaning effect, the lipid adhesion inhibiting effect, and the friction reducing effect is sufficiently exhibited. There is a risk of not getting. The kinematic viscosity of the contact lens composition is a value measured in accordance with General Test Method 2.53 Viscosity Measurement Method Method 1 described in the 15th revised Japanese Pharmacopoeia.

The specific concentrations of hypromellose and polyvinyl alcohol having the above-mentioned specific viscosities employed in the contact lens composition according to the present embodiment are such that the kinematic viscosity at 20 ° C. of the contact lens composition is 3.0 to 8.0 mm ^2. / S, and can be arbitrarily changed without particular limitation as long as the desired effect of cleaning the lipid, the effect of suppressing lipid adhesion, and the effect of reducing friction are sufficiently exhibited. Specifically, for example, the concentration of hypromellose is preferably 0.5 to 1.5 w / v%, more preferably 0.6 to 1.0 w / v%. The concentration of polyvinyl alcohol is preferably in the range of 0.8 to 2.0 w / v%, more preferably 0.9 to 2.0 w / v%. Furthermore, it is desirable that the blending ratio of polyvinyl alcohol to hypromellose is 1: 1 to 1: 3. When the concentration of hypromellose and polyvinyl alcohol and the ratio of the amount of polyvinyl alcohol to hypromellose are within such specific ranges, the lipid cleaning effect, lipid adhesion inhibiting effect, and friction reducing effect are more advantageously exhibited. . However, the specific concentration and relative ratio of these hypromellose and polyvinyl alcohol can be appropriately changed depending on the viscosity of the hypromellose and polyvinyl alcohol used.

  In addition, hypromellose and polyvinyl alcohol may be blended one type each of hypromellose and polyvinyl alcohol within the specific viscosity range, for example, two or more types of hypromellose and polyvinyl alcohol within the specific viscosity range, respectively. You may mix | blend combining. In addition, if at least one kind of hypromellose and polyvinyl alcohol within the specific viscosity range is blended, hypromellose outside the specific viscosity range can be used as long as the lipid cleaning effect, the lipid adhesion suppressing effect, and the friction reducing effect are not limited. You may mix | blend polyvinyl alcohol further combining.

  Further, in the remainder other than hypromellose and polyvinyl alcohol, additives used in known contact lens compositions, etc. as long as they do not impair the lipid cleaning effect, lipid adhesion inhibiting effect, and friction reducing effect of the present contact lens composition, etc. May be blended in an ophthalmologically acceptable range. Specifically, for example, known buffering agents, pH adjusting agents, surfactants, thickeners, tonicity agents, chelating agents, wetting agents, stabilizers, fragrances or cooling agents, drugs, antibacterial agents, vitamins , Preservatives, bactericides and the like may be blended in one kind or a combination of two or more.

  Examples of the buffer include boric acid, borax and borate buffer, carbonate buffer, citric acid and citrate buffer, carboxylic acids such as acetic acid, acids such as oxycarboxylic acid and salts thereof, aminoethyl Amino acids such as sulfonic acid, aspartic acid, glycine, arginine, glutamic acid, ε-aminocaproic acid, 2-amino-2-methyl-1,3-propane (AMP) buffer, tris (hydroxymethyl) aminomethane (Tris) Buffers, bis (2-hydroxyethyl) iminotris (hydroxymethyl) methane (Bis-Tris), phosphoric acid and phosphate buffers, Good-Buffer, and the like.

  Examples of the pH adjusting agent include hydrochloric acid, citric acid, acetic acid, sodium hydroxide, potassium hydroxide, sodium carbonate, sodium hydrogen carbonate, sodium hydrogen phosphate, sodium dihydrogen phosphate, phosphates, sulfuric acid and the like. .

  As the surfactant, any of conventionally known anionic surfactants, nonionic surfactants, and amphoteric surfactants can be appropriately employed. Examples of such surfactants include polyglycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkylphenyl ether formaldehyde condensate, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkylphenyl ether, polyoxyethylene glycerin. Fatty acid ester, polyoxyethylene sorbite fatty acid ester, polyoxyethylene castor oil, polyoxyethylene sterol, polyoxyethylene hydrogenated sterol, polyoxyethylene fatty acid ester, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene block Copolymers (poloxamers), polyoxyethylene polyoxypropylene substituted ethylenediamine (polo Samines), polyoxyethylene lanolin alcohol, polyoxyethylene alkylamine, polyoxyethylene alkylamide, polyoxyethylene alkyl ether phosphate, polysorbate, polyoxyethylene alkyl ether carboxylate, polyoxyethylene alkyl ether sulfate, alkyl Fatty acid salt, alkyl phosphate, N-acyl taurine salt, alkyl glutamate, alkyl glycine salt, alkyl alanine salt, cocoyl fatty acid arginine, alkyl sulfate, alkyl sulfonate, betaine acetate type double-acting agent, alkyloxyhydroxypropyl Arginine salt, cocoyl arginine ethyl PCA, etc. are mentioned.

As the thickener, for example, synthetic organic polymer compounds such as polyethylene glycol, polypropylene glycol, polyvinyl pyrrolidone, polyacrylamide, poly (meth) acrylic acid, Copolymer 845 (copolymer of polyvinyl pyrrolidone and dimethylaminoethyl methacrylate), etc. Cellulose derivatives such as methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, carboxyethylcellulose, starch derivatives, polysaccharides such as alginic acid (salt), pectin, chitosan and their salts, heteropolysaccharides such as gellan gum, and hyaluron Examples include mucopolysaccharides such as acid (salt) and chondroitin sulfate (salt). Moreover, the viscosity of a 2 w / w% aqueous solution at 20 ° C. is greater than 5.1 mPa · s, and the viscosity of a 4 w / w% aqueous solution at 20 ° C. is less than 10 mPa · s or greater than 35 mPa · s. It is also possible to mix polyvinyl alcohol as a thickener. In particular, polyethylene glycol, polyvinyl pyrrolidone, hydroxypropyl methylcellulose, carboxymethylcellulose, because they are safe for the eyes and have little influence on contact lenses, and further improve the feeling of use of the composition for contact lenses. Alginic acid (salt), gellan gum, hyaluronic acid (salt), and chondroitin sulfate (salt) are preferably employed. Moreover, a thickener is added in the range from which the kinematic viscosity in 20 degreeC of the composition for contact lenses becomes 3.0-8.0 mm < ² > / s.

  Examples of tonicity agents include inorganic salts such as sodium chloride, potassium chloride, sodium bisulfite, sodium sulfite, magnesium chloride, potassium acetate, sodium acetate, sodium thiosulfate, and magnesium sulfate, and polyhydric alcohols such as propylene glycol and glycerin. Alternatively, ethers or esters thereof may be mentioned.

  Examples of the chelating agent include ethylenediaminetetraacetic acid (EDTA) and salts thereof, ethylenediaminetetraacetic acid · disodium (EDTA · 2Na), ethylenediaminetetraacetic acid · 3sodium (EDTA · 3Na), ethylenediaminetetraacetic acid · 4sodium (EDTA · 4Na). ), Phytic acid, citric acid and the like.

  Examples of the wetting agent include sugar alcohols such as glycerin, xylitol, sorbitol, mannitol, erythritol, cellulose derivatives such as polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, cationized cellulose, hydroxyethyl cellulose, and methyl cellulose, ethanol, isopropanol, oleyl alcohol, and lauryl. Lower or higher alcohols such as alcohol, almond oil, lanolin, olive oil, oleic acid and / or salt thereof, liquid paraffin, triglyceride, squalane, petrolatum, silicone oil, sesame oil, perilla oil, soybean oil, camellia oil, jojoba oil, Examples include fats and oils such as corn oil and castor oil. Sugar alcohols such as glycerin, xylitol, sorbitol, mannitol, and erythritol are safe for the eyes and reduce the influence on contact lenses, and further improve the feeling of use of the contact lens composition. Cellulose derivatives such as polyethylene glycol, propylene glycol, polyvinyl pyrrolidone, cationized cellulose, hydroxyethyl cellulose and methyl cellulose are preferably selected.

  Stabilizers include ascorbic acid, sodium edetate, cyclodextrin, condensed phosphoric acid, sulfite, citric acid, dibutylhydroxytoluene, trometamol, sodium formaldehyde sulfoxylate (Longalite), tocopherol, sodium pyrosulfite, monoethanolamine, Examples thereof include aluminum monostearate.

  Examples of the fragrance or refreshing agent include anethole, eugenol, camphor, chlorobutanol, geraniol, cineol, borneol, menthol, limonene, ryuuno, fennel oil, cool mint oil, cinnamon oil, spearmint oil, peppermint water, peppermint oil, peppermint Oil, bergamot oil, eucalyptus oil, rose oil and the like.

  Examples of the drug include cromoglycic acid, tranilast, chlorpheniramine maleate, diphenhydramine hydrochloride, amlexanox, ibudilast, pemirolast potassium, emedastine fumarate, ketotifen fumarate, olopatadine hydrochloride, ebastine, acitazanolast, levocabastine hydrochloride, etc. Anti-allergic agents, glycyrrhizic acid and its salts, ε-aminocaproic acid, allantoin, sodium azulenesulfonate, berberine chloride, berberine sulfate, zinc sulfate, zinc lactate, lysozyme, fluorometholone and other anti-inflammatory agents Vasoconstriction such as epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, naphazoline hydrochloride, nafazoline nitrate, phenylephrine hydrochloride, tetrahydrozoline hydrochloride , Agents for improving focus control such as neostigmine methylsulfate, intraocular pressure-lowering agents such as betaxolol, timolol, dipivefrin, carteolol, latanoplast, tafluplast, travoplast, nipradilol, levobanol, etc., mucin secretion production promoters such as rebamipide, diquafosol sodium And amino acids such as aspartic acid and salts thereof, aminoethylsulfonic acid, arginine, alanine, lysine, and glutamic acid.

  Antibacterial agents include, for example, sulfamethoxazole, sulfamethoxazole sodium, sulfisoxazole, sulfisomidine sodium and other sulfa drugs, ofloxacin, norfloxacin, levofloxacin, gatifloxacin, moxifloxacin, tosufloxacin New quinolone antibacterial agents such as lomefloxacin and ciprofloxacin, aminoglycoside antibacterial agents such as tobramycin, gentamicin, micronomycin, dibekacin and sisomycin, tetracycline antibacterial agents such as tetracycline and minocycline, and macrolide antibacterial agents such as erythromycin And chloramphenicol antibacterial agents such as chloramphenicol, and cephem antibacterial agents such as cefmenoxime.

  Examples of vitamins include vitamin A (including retinol palmitate, β-carotene, etc.), vitamin B2 (flavin adenine nucleotide, etc.), vitamin B6 (pyridoxine hydrochloride, etc.), vitamin B12 (cyanocobalamin, etc.), vitamin C ( Ascorbic acid and the like), vitamin Es (acetic acid-d-α-tocopherol and the like), panthenol and the like.

  Examples of preservatives and bactericides include sorbic acid, potassium sorbate, benzoic acid or salts thereof, ethyl paraoxybenzoate, butyl paraoxybenzoate, propyl paraoxybenzoate, methyl paraoxybenzoate, chlorobutanol, benzalkonium chloride, Polyhexanone hydrochloride (polyhexamethylene biguanide; PHMB), alkyldiaminoethylglycine hydrochloride, cetylpyridinium chloride (CPC), chlorhexidine, alexidine, chlorpheniramine or salts thereof, allantoin, chlorine dioxide, sodium perborate, polydronium chloride, etc. And the like. In addition, when such a preservative is used, it is possible to set the expiration date of the product after opening the product to, for example, 2 to 3 months. However, the composition for contact lenses according to the present embodiment includes a preservative. It is also possible to make a so-called preservative-free composition for contact lenses that is not added. In the case of preservative-free, in addition to the normal multi-dose type, a single-dose type that can be used once, a multi-dose type that can be used several times, or the growth of bacteria in contact lens compositions A mode such as a multi-dose type using a discharge container with a filter having a structure capable of maintaining sterility so as not to occur can be appropriately selected.

  Of the above-mentioned compounds, polyhexanide hydrochloride is particularly preferably employed as the preservative / bactericide. The concentration of polyhexanide hydrochloride can be arbitrarily set. Particularly, when polyhexanide hydrochloride is used as a preservative, polyhexanide hydrochloride is blended at a concentration of 0.00005 to 0.0001 w / v%. If polyhexanide hydrochloride is blended in such a specific range of concentration, hypromellose having a specific viscosity and polyvinyl alcohol are blended in combination, thereby suppressing polyhexanide hydrochloride from exerting an excessive disinfecting effect. In addition, the desired antiseptic action can be exhibited sufficiently.

That is, when used at a high concentration, polyhexanide hydrochloride exhibits not only an antiseptic action that suppresses the growth of bacteria, but also a more powerful sterilizing and disinfecting action. Such bactericidal action is useful when the contact lens composition is used as a disinfectant for contact lenses, but the contact lens composition is used for applications other than disinfectants, such as contact lens mounting liquids and eye drops. When used as a liquid or the like, there is a risk of bactericidal action even against harmless resident bacteria present in the eye. Therefore, when the contact lens composition is used as other than the disinfectant, it is desirable that the disinfecting action of the polyhexanide hydrochloride is suppressed while the sufficient antiseptic action is exhibited. Here, in the conventional contact lens composition, it is difficult to exert only a desired antiseptic action while suppressing the disinfecting action of polyhexanide hydrochloride. However, according to the present embodiment, the combination of hypromellose with a specific viscosity and polyvinyl alcohol is combined with polyhexanide hydrochloride in the range of 0.00005 to 0.0001 w / v%, thereby suppressing the expression of bactericidal / disinfecting action. Meanwhile, a desired antiseptic action can be exhibited. Therefore, it is possible to provide a highly safe contact lens composition that can effectively prevent the growth of bacteria during the storage period while suppressing the influence on the eye. In particular, such antiseptic action is particularly useful because contact lens compositions are often used several times after being opened by a user. If the concentration of polyhexanide hydrochloride is 0.00005 w / v% or less, sufficient antiseptic action may not be exhibited. On the other hand, when it is set to 0.0001 w / v% or more, even if hypromellose having a specific viscosity and polyvinyl alcohol are blended, the disinfection action may not be sufficiently suppressed. In addition, even when the concentration of polyhexanide hydrochloride is in the range of 0.00005 to 0.0001 w / v%, particularly when the viscosity of hypromellose or polyvinyl alcohol is outside the range according to this embodiment, the disinfection inhibiting effect Is not suitably exhibited. As a further aspect of the present invention, by blending hypromellose with a specific viscosity and polyvinyl alcohol as active ingredients as a bactericidal / disinfectant inhibitor, the desired preservative action of polyhexanide hydrochloride in the predetermined concentration is exhibited, Also included is a method of inhibiting sterilization and disinfection while maintaining. That is, it contains hypromellose whose viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less and polyvinyl alcohol whose viscosity of a 4 w / w% aqueous solution at 20 ° C. is 10 to 35 mPa · s, and 20 ° C. By adding polyhexanide hydrochloride at a concentration of 0.00005 to 0.0001 w / v% to the composition for contact lenses having a kinematic viscosity of 3.0 to 8.0 mm ² / s in The present invention provides a method for suppressing the sterilizing / disinfecting action while exhibiting and maintaining the antiseptic action of the composition.

  In addition, the structure containing such a polyhexanide hydrochloride at a concentration in the range of 0.00005 to 0.0001 w / v% is used for applications other than the contact lens disinfectant as described above. When used, it is particularly preferably employed. Specifically, when used as at least one of contact lens mounting solution, contact lens cleaning solution, contact lens preserving solution, contact lens rinsing solution, eye drops, eye wash, contact lens packaging solution, eye drops is there. In addition, among these uses, for example, a multipurpose liquid for contact lenses having both the action of a contact lens cleaning solution and a contact lens preserving solution may be used. The contact lens composition used in such applications is particularly likely to be in direct contact with the eye, and when the contact lens composition is used by a user, it is divided into multiple times after opening. Often used. Therefore, it is desirable to have sufficient antiseptic properties while suppressing excessive bactericidal properties. When the contact lens composition is used as a disinfectant or as a multipurpose liquid for contact lenses having the effect of a disinfectant, the concentration of polyhexanide hydrochloride may be higher than 0.0001 w / v%. .

In addition, it is known that polyhexanide hydrochloride is likely to be adsorbed by a filter for filtration sterilization in a process such as filtration sterilization performed at the time of producing a contact lens composition. For example, when a conventional contact lens composition containing no hypromellose and polyvinyl alcohol is filtered using a filtration filter, about 20% of polyhexanide hydrochloride is adsorbed with respect to the total amount of polyhexanide hydrochloride. In such a conventional contact lens composition, the concentration of polyhexanide hydrochloride in the composition after filtration decreases due to adsorption to the filtration filter, and as a result, the desired antiseptic action and bactericidal action are fully exhibited. There was a problem that there was a risk that it would not. However, in the composition for contact lenses according to this embodiment, hypromellose having a predetermined viscosity and polyvinyl alcohol are combined and blended, so that even when sterilization using a filtration filter is performed, polyhexanide hydrochloride is filtered. Adsorption on the filter is advantageously reduced. That is, according to the composition for contact lenses according to this embodiment containing hypromellose and polyvinyl alcohol having a specific viscosity, the adsorption amount of polyhexanide hydrochloride to the filtration filter is about 10% or less with respect to the total amount of polyhexanide hydrochloride. Can be suppressed. As a further aspect of the present invention, a polyhexanide hydrochloride filtration filter is used for sterilization using a filtration filter by blending it as an adsorption inhibitor to the filtration filter containing hypromellose and polyvinyl alcohol having the specific viscosity as active ingredients. Also included is a method of inhibiting adsorption to the surface. That is, to the composition for contact lenses containing polyhexanide hydrochloride, the viscosity of a 2 w / w% aqueous solution at 20 ° C is 5.1 mPa · s or less, and the viscosity of a 4 w / w% aqueous solution at 20 ° C is 10 to 35 mPas. -In the sterilization process using a filtration filter by mix | blending the polyvinyl alcohol which is s, and setting the kinematic viscosity in 20 degreeC of this contact lens composition to 3.0-8.0mm < ² > / s, A method for suppressing adsorption of polyhexanide hydrochloride to a filtration filter is provided.

  Thus, according to the contact lens composition according to the present embodiment, by suppressing the decrease in the concentration during filtration sterilization, in the sterilized contact lens composition after filtration, the desired antiseptic action And can fully exert the disinfection action. In other words, conventionally, when performing filtration sterilization, the amount of adsorption to the filtration filter is large, so that polyhexanide hydrochloride is blended in anticipation of the adsorbed amount, and the concentration of polyhexanide hydrochloride in the composition after filtration is in an appropriate range. However, according to this embodiment, even when sterilization using a filtration filter is performed, the amount of polyhexanide hydrochloride adsorbed on the filtration filter is small. The concentration of polyhexanide hydrochloride in the product can be adjusted more easily and more precisely.

  Any type of filtration filter can be used as long as it can adjust a sterile solution. For example, a membrane filter having a pore size of 0.1 to 5.0 μm, a disposable syringe filter, or the like is employed. According to the present embodiment, even if such a filter is used for a contact lens composition containing polyhexanide hydrochloride, adsorption to the filter filter of polyhexanide hydrochloride can be suppressed. The contact lens composition can be made aseptic by sterilization using a filtration filter without performing high-pressure steam sterilization, which is highly likely to affect the modification of each compound and pH fluctuation. Accordingly, the physical properties and the like of the contact lens composition after sterilization can be made more stable as compared to the contact lens composition sterilized by autoclaving.

Further, as described above, in the composition for contact lenses according to the present embodiment, as long as the kinematic viscosity at 20 ° C. of the composition for contact lenses is adjusted within the range of 3.0 to 8.0 mm ² / s, Any thickening agent such as sodium hyaluronate, sodium chondroitin sulfate, sodium alginate and the like can be contained. The specific blending amount of these thickeners is adopted as long as the kinematic viscosity at 20 ° C. of the contact lens composition is adjusted within a range of 3.0 to 8.0 mm ² / s. Although it can be appropriately changed according to the type of the thickener, for example, it is 0.001 to 1.0 w / v% or the like. In the contact lens composition according to the present embodiment, as long as the kinematic viscosity at 20 ° C. of the contact lens composition is adjusted within a range of 3.0 to 8.0 mm ² / s, for example, a thickener. Even when the blending amount is less than 0.001 w / v% or when it is blended at a concentration exceeding 1.0 w / v%, the intended lipid cleaning effect, lipid adhesion inhibiting effect The friction reducing effect is effectively exhibited.

  Furthermore, according to the present embodiment, by blending hypromellose with a specific viscosity and polyvinyl alcohol, it is possible to sufficiently exert a cleaning action particularly on lipids. The amount can be reduced, or nothing can be added. That is, according to the present embodiment, by combining hypromellose and polyvinyl alcohol, which are excellent in safety and stability with respect to the human body and contact lenses, the contact can be made without adding any surfactant other than hypromellose and polyvinyl alcohol. It is also possible to constitute a lens composition. Thereby, it is possible to provide a contact lens composition that has a high effect of improving wearing feeling and is also excellent in safety.

  The pH and osmotic pressure of the composition for contact lenses are appropriately adjusted within a range that does not affect the target lipid cleaning effect, lipid adhesion suppression effect, friction reduction effect, physical properties of the user's eyes and contact lenses, etc. It is desirable. For example, the pH is desirably adjusted to a range of 3.0 to 9.0, preferably 5.0 to 9.0, and more preferably 5.5 to 8.0. The osmotic pressure is preferably 100 to 1000 mOsm / kg, preferably 170 to 450 mOsm / kg, more preferably 250 to 450 mOsm / kg. In addition, water is desirable as a solvent for hypromellose and polyvinyl alcohol and other additives. Specifically, for example, normal water, purified water, sterilized purified water, and water for injection prescribed by the Japanese Pharmacopoeia, Pure water, distilled water, filtered water or the like is arbitrarily employed.

  The form of use of the composition for contact lenses is not particularly limited. For example, it may be used for a contact lens alone before or after wearing, such as a conventional contact lens preservative solution or a contact lens multipurpose solution, or it may be used while wearing like conventional eye drops or eye wash solutions. It may be used for contact lenses. According to the composition for contact lenses according to the present embodiment, in any case, it is possible to exert a cleaning action on lipid, a lipid adhesion action, a friction reduction action, and improve the wearing feeling of the contact lens composition. Is possible. In particular, when exerting a cleaning effect on lipids, for example, when the contact lens composition according to the present embodiment is used as an ophthalmic solution or a mounting solution, the contact lens composition is applied to the eye wearing the lens. The lipid dirt adhering to the surface of the contact lens can also be washed by the user blinking. On the other hand, lipid stains may be removed by scrubbing the contact lens with a finger or the like while the contact lens composition is in contact with the lens, as in conventional contact lens cleaning solutions and multipurpose solutions. Of course, the contact lens composition according to the present embodiment can be used in combination with other compositions such as a known contact lens preservation solution or multipurpose liquid agent.

As described above, according to the composition for contact lenses according to the present embodiment, the viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less and the viscosity of a 4 w / w% aqueous solution at 20 ° C. In combination with polyvinyl alcohol in the range of 10 to 35 mPa · s, the kinematic viscosity at 20 ° C. is adjusted to 3.0 to 8.0 mm ² / s. It is possible to sufficiently exhibit the cleaning effect, the lipid adhesion suppressing effect, and the friction reducing effect on the lipids that have been difficult. Therefore, by removing lipid stains adhering to the contact lens and effectively preventing the reattachment of new lipid stains and lipid stains removed from the lens, it is possible to advantageously reduce the feeling of foreign matter caused by lipid stains. can do. Furthermore, since the occurrence of friction between the surface of the contact lens and the anterior eye portion of the eye can be suppressed, it is possible to reduce the feeling of foreign matter and irritation caused by the resin contact lens itself. As a result, the contact lens itself and the irritation caused by dirt attached to the lens are all suppressed or eliminated, and the wearing feeling of the contact lens can be effectively improved.

  Moreover, according to the composition for contact lenses according to the present embodiment, the concentration of hypromellose is 0.5 to 1.5 w / v%, and the concentration of polyvinyl alcohol is 0.8 to 2.0 w / v%. As a result, the lipid cleaning effect, the lipid adhesion inhibiting effect, and the friction reducing effect are exhibited particularly effectively. Furthermore, when the blending ratio of polyvinyl alcohol to hypromellose is in the range of 1: 1 to 1: 3, these lipid washing, lipid adhesion inhibiting effect, and friction reducing effect are particularly effectively exhibited.

  Furthermore, according to the composition for contact lenses according to the present embodiment, hypromellose having a specific viscosity and concentration and polyvinyl alcohol are combined, and polyhexanide hydrochloride is in the range of 0.00005 to 0.0001 w / v%. In this case, sufficient antiseptic action can be exerted while suppressing the bactericidal / disinfecting effect to the extent that it does not affect harmless resident bacteria present in the eye. Moreover, according to this embodiment, the adsorption | suction of the polyhexanide hydrochloride at the time of filter sterilization is suppressed by mix | blending the hypromellose and polyvinyl alcohol of a specific viscosity and density | concentration. Therefore, even when sterilized by filtration sterilization, the occurrence of the problem of a decrease in the concentration of polyhexanide hydrochloride in the contact lens composition is suppressed, and sufficient antiseptic action can be stably exhibited. .

  Moreover, according to the composition for contact lenses according to this embodiment, the physical properties after sterilization are compared with the composition for contact lenses sterilized by high-pressure steam sterilization by being sterilized using a filtration filter. Etc. are in a more stable state. In particular, according to the present embodiment, even if the contact lens composition includes polyhexanide hydrochloride, the contact lens composition contains hypromellose and polyvinyl alcohol having a specific viscosity. Since the adsorption to the filtration filter is advantageously suppressed, the concentration of polyhexanide hydrochloride after sterilization can be sufficiently adequately managed even when filtration sterilization using a filtration filter is performed.

  Further, according to the present embodiment, since the lipid cleaning effect, the lipid adhesion suppressing effect, and the friction reducing effect are all effectively exhibited, the contact lens mounting liquid, the contact lens cleaning liquid, the contact lens preserving liquid, A contact lens composition used as at least one of a contact lens rinsing solution, eye drops, eye wash, contact lens packaging solution, and eye drops can be advantageously provided. In particular, when polyhexanide hydrochloride is blended in the range of 0.00005 to 0.0001 w / v%, it can exhibit sufficient antiseptic action while suppressing sterilization / disinfection action. It can be particularly advantageously used as at least one of a cleaning solution, a contact lens preserving solution, a contact lens rinsing solution, an eye drop, an eye wash, a contact lens packaging solution, and an eye drop wearing agent.

  The present invention relating to the composition for contact lenses has been described in detail with specific examples of preferred embodiments. However, these are merely examples, and the present invention is not limited to the specific description described above. It should not be construed as limiting. For example, the composition for contact lenses according to the present embodiment is desirably sterilized to be in a sterile state, but the specific sterilization method is not limited to filtration sterilization using a filtration filter, High-pressure steam sterilization treatment may be employed. Further, a combination of high-pressure steam sterilization treatment and filtration sterilization treatment may be employed.

  The results of experiments conducted to further clarify the technical significance of the present invention are shown below.

  First, Table 1 below shows details of hypromellose, polyvinyl alcohol, and polyhexanide hydrochloride used in each experiment. Table 2 shows the details of the thickener used in each experiment. As shown in Table 1, two types of TC-5E and TC-5M were used as the hypromellose having a viscosity of 5.1 mPa · s or less at 20 ° C. according to the present embodiment at 20 ° C. Four types of TC-5R, TC-5S, 60SH-50, and 60SH-4000 were used. Moreover, as polyvinyl alcohol whose viscosity of 4 w / w% aqueous solution in 20 degreeC according to this embodiment is the range of 10-35 mPa * s, four types, P-610, VP-18, EG-25, and EG-30, are included. Using. On the other hand, as a comparative example of polyvinyl alcohol, two types of EG-05 and EG-40 were used. The method for measuring the viscosity of hypromellose follows the 15th revised Japanese Pharmacopoeia. Moreover, in the case of P-610 which is a product for industrial use, the measurement method of the viscosity of polyvinyl alcohol follows the polyvinyl alcohol test method described in JIS K 6726, and VP-18 which is a product in accordance with a pharmaceutical additive standard. In the case of EG-25, EG-30, EG-05, and EG-40, the test method described in the pharmaceutical additive standard polyvinyl alcohol (partially saponified product) is followed. In Table 1, the viscosity values of hypromellose and polyvinyl alcohol indicate the standard value of the viscosity of each product indicated by the manufacturer, and are included in () in each product calculated by the manufacturer's announcement or official standard. The range of viscosity values obtained was indicated. In the following description, the viscosity of hypromellose and polyvinyl alcohol used will be described based on the manufacturer's standard values for easy understanding.

  Using these hypromellose and polyvinyl alcohol, as examples and comparative examples of contact lens compositions, test solutions of the blending components shown in Tables 3 to 8 below were prepared and used in the following Experimental Examples 1 to 6 did. In addition, as shown in Tables 3 to 8, additives such as a buffering agent are appropriately blended in each test solution. The unit of the concentration of each compounding component in Tables 3 to 8 is w / v%, and each test solution is dissolved in purified water so that each compounding component has a predetermined concentration (w / v%). It is adjusted by. At the time of dissolution, the mixture was stirred with a magnetic stirrer and appropriately heated. Each test solution after adjustment was measured for kinematic viscosity according to General Test Method 2.53 Viscosity Measurement Method 1 described in the 15th revised Japanese Pharmacopoeia. The measured kinematic viscosity is shown together in Tables 3 to 8.

  Further, in the following experimental examples 1 to 4, each test solution as an example of a contact lens composition and each test solution as a comparative example were used to test each of lipid cleaning power, lipid adhesion suppression power, and friction reduction effect. did. The test method of each test and the criteria for judging the effect are as follows.

Details of the lipid detergency test are shown below. First, triglyceride and Sudan I
(Nacalai Tesque Co., Ltd.) was mixed at 99: 1 and solidified in a plate shape on the bottom of a glass vial to prepare a colored fat plate. 10 mL of the test solution is put in a glass vial on which the colored oil / fat plate is spread, and shaken at 25 ° C. for 6 hours. Thereafter, each test solution was collected and the absorbance at 485 nm was measured. The lipid washing effect of each test solution was determined by comparing the absorbance with the test solution 14 or the test solution 33 containing neither hypromellose nor polyvinyl alcohol. That is, in Experimental Examples 1 and 2, the percentage (%) of the absorbance of each test solution with respect to the absorbance of the test solution 14 was determined and evaluated according to the following four criteria: ◎, ○, Δ, ×. Further, in Experimental Examples 3 and 4, the percentage (%) of the absorbance of each test solution with respect to the absorbance of the test solution 33 was determined, and similarly evaluated in the following four grades, ◎, ○, Δ, and ×.
◎: 200% or more ○: 150% or more and less than 200% △: 100% or more and less than 150% ×: less than 100%

Details of the lipid adhesion inhibitory test are shown below. First, a test lens (Menicon 2 Week Premio, manufactured by Menicon Co., Ltd.) was immersed in 2 mL of physiological saline for one night or more, and then immersed in 2 mL of each test solution for one night or more. Next, after dissolving Sudan Black (manufactured by Wako Pure Chemical Industries, Ltd.) in 10 mL of 70% ethanol, each test lens was transferred to 2 mL of Sudan Black solution prepared by adding 90 mL of distilled water and immersed for 2 hours. Thereafter, the test lens was transferred into 2 mL of 100% ethanol, and Sudan black was extracted. The amount of sudan black adsorbed on the test lens was measured by measuring the absorbance at 600 nm of the solution from which this sudan black was extracted. The lipid adhesion inhibitory power of each test solution was evaluated by comparison with the absorbance when the test solution 14 or the test solution 33 containing neither hypromellose and polyvinyl alcohol was used. That is, in Experimental Examples 1 and 2, the percentage (%) of the absorbance of each test solution with respect to the absorbance of the test solution 14 was determined and evaluated according to the following four criteria: ◎, ○, Δ, and ×. Further, in Experimental Examples 3 and 4, the percentage (%) of the absorbance of each test solution with respect to the absorbance of the test solution 33 was determined, and similarly evaluated in the following four grades, ◎, ○, Δ, and ×.
◎: Less than 30% ○: 30% or more and less than 50% △: 50% or more and less than 100% ×: 100% or more

Details of the friction reduction test are shown below. In this test, the friction reducing effect was confirmed by measuring the static friction force between the test lens (Menicon 2 Week Premio, manufactured by Menicon Co., Ltd.) and the PMMA plate (acrylic plate). First, lightly wipe the moisture of the test lens immersed in 2 mL of physiological saline for one night or more and fix it to the jig. Next, the surface of the test lens is brought into contact with the PMMA plate. Then, one drop of the test solution was dropped between the test lens and the PMMA plate, and the static friction force when the PMMA plate was moved with a universal tensile tester was measured. The friction reducing effect of each test solution was evaluated by comparison with the friction force (N) when using the test solution 14 or the test solution 33 containing neither hypromellose and polyvinyl alcohol. That is, in Experimental Examples 1 and 2, the percentage (%) of the friction force (N) of each test solution with respect to the friction force (N) of the test solution 14 was determined, and ◎, ○, Δ, × based on the following criteria: It was evaluated in four stages. In Experimental Examples 3 and 4, the percentage (%) of the frictional force (N) of each test solution with respect to the frictional force (N) of the test solution 33 was determined. Similarly, based on the following criteria, ◎, ○, Δ , X was evaluated in four stages.
◎: Less than 60% ○: 60% or more and less than 80% △: 80% or more and less than 100% ×: 100% or more

(Experimental example 1)
As shown in Table 3 below, hypromellose having a 2 w / w% aqueous solution viscosity of 3 mPa · s at 20 ° C. and various polyvinyl alcohols having a 4 w / w% aqueous solution viscosity of 5 to 40 mPa · s at 20 ° C. are used. Then, test solutions as examples and comparative examples of the composition for contact lenses were prepared, and the respective lipid detergency, lipid adhesion inhibitory force, and friction reduction effect were confirmed. Table 3 shows the composition and kinematic viscosity of each test solution, and the test results of each lipid detergency, lipid adhesion inhibitory force, and friction reduction effect.

  As shown in Table 3, in test solutions 1 to 7 as comparative examples in which only one of hypromellose or polyvinyl alcohol was blended, evaluation was performed in at least any of the items of lipid cleaning power, lipid adhesion suppression power, and friction reduction effect. X or △. On the other hand, although both hypromellose and polyvinyl alcohol are mix | blended with the test solutions 8-13, in these test solutions, a result differs greatly with the viscosity of the used polyvinyl alcohol. That is, in the test solutions 9 to 12 as examples of the present invention in which polyvinyl alcohol having a viscosity of a 4 w / w% aqueous solution at 20 ° C. in the range of 10 to 35 mPa · s was adopted, all evaluations were ◎ or In particular, in the test solutions 10 and 11, all evaluations are ◎. On the other hand, in the test solutions 8 and 13 as comparative examples in which the viscosity of the 4 w / w% aqueous solution at 20 ° C. is out of the range of 10 to 35 mPa · s, all or a part of the evaluation items are × or Δ It has become.

  From these results, lipid washing power and lipid adhesion inhibition are only achieved when polyvinyl alcohol having different viscosities is used in combination with hypromellose within a range of 10 to 35 mPa · s of a 4 w / w% aqueous solution at 20 ° C. It can be seen that both the force and friction reducing effects are highly demonstrated. In particular, these specific polyvinyl alcohols and hypromellose are combined in combination with polyvinyl alcohol and hypromellose of these specific viscosities, even though they have only obtained effects as low as x or Δ when mixed alone. In this case, it is understood that each effect is synergistically improved and exhibits an excellent effect.

(Experimental example 2)
As shown in Table 4 below, hypromellose with various viscosities of a 2 w / w% aqueous solution at 20 ° C. of 3 to 4000 mPa · s, and polyvinyl alcohol with a viscosity of 24 mPa · s of 4 w / w% aqueous solution at 20 ° C. The test solutions as examples and comparative examples of the composition for contact lenses were prepared, and each lipid detergency, lipid adhesion inhibitory force, and friction reduction effect were confirmed. Table 4 shows the composition and kinematic viscosity of each test solution, and the test results of each lipid detergency, lipid adhesion inhibitory force, and friction reduction effect. Some of the test solutions are the same as those used in Experimental Example 1 above.

  As shown in Table 4, in the test solutions 4, 1 and 15 to 19 as comparative examples containing only one of hypromellose or polyvinyl alcohol, at least one of the lipid detergency, lipid adhesion inhibitory force, and friction reduction effect The evaluation is x or Δ. On the other hand, although both hypromellose and polyvinyl alcohol are mix | blended with the test solutions 10 and 20-24, a result differs greatly with the viscosity of the used hypromellose. That is, in the test solutions 10 and 20 as examples of the present invention in which the viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less as hypromellose, all evaluations are ◎. . On the other hand, in the test solutions 21 to 24 as comparative examples in which the viscosity of the 2 w / w% aqueous solution at 20 ° C. is larger than 5.1 mPa · s, “x” or “Δ” exists in at least one of the evaluation items.

  From these results, only when hypromellose having different viscosities, a 2 w / w% aqueous solution at 20 ° C. with a viscosity of 5.1 mPa · s or less is used in combination with polyvinyl alcohol having a specific viscosity, lipid detergency, lipid adhesion It can be seen that both the restraining force and the friction reducing effect are highly exhibited. Also in this experiment, when these specific polyvinyl alcohol and hypromellose were blended alone, only an effect as low as x or Δ was mainly obtained, whereas when hypromellose and polyvinyl alcohol having a specific viscosity were combined, Each effect is synergistically improved.

(Experimental example 3)
As shown in Table 5 below, using polyvinyl alcohol having a viscosity of 24 mPa · s at 4 ° C. in 4% aqueous solution at 20 ° C. and hypromellose having 3 mPa · s in 2% w / w aqueous solution at 20 ° C. Test solutions with different concentrations of alcohol and hypromellose were prepared, and the lipid cleaning ability, lipid adhesion inhibiting ability, and friction reducing effect were confirmed. Table 5 shows the composition and kinematic viscosity of each test solution, and the test results of each lipid detergency, lipid adhesion inhibitory force, and friction reduction effect.

As shown in Table 5, in the test solutions 25 to 32, the same types of hypromellose and polyvinyl alcohol are blended, but the test solution at 20 ° C. changes with the blending amount of hypromellose and polyvinyl alcohol. The kinematic viscosity and concentration are different. In this experiment, the kinematic viscosity is in the range of 3.0 to 8.0 mm ² / s, the concentration of hypromellose is 0.5 to 1.5 w / v%, and the concentration of polyvinyl alcohol is 1 to 2 w. In the test solutions 27 to 29, 31, and 32 that are / v%, all of the lipid detergency, the lipid adhesion inhibitory force, and the friction reducing effect are exhibited well. On the other hand, even when the same hypromellose and polyvinyl alcohol used in the preparation of these test solutions are blended, the test solutions 25 and 26 whose kinematic viscosity is out of the range of 3.0 to 8.0 mm ² / s. , 30, the evaluation is x or Δ in at least any of the items of lipid detergency, lipid adhesion inhibitory force, and friction reduction effect, indicating that the desired effect is not obtained.

(Experimental example 4)
As shown in Table 6 below, hypromellose having a 2 w / w% aqueous solution viscosity of 3 or 4.5 mPa · s and a concentration of 0.5 to 1.5 w / v% at 20 ° C. and 4 w / w at 20 ° C. % Aqueous solution having a viscosity of 24 or 25 mPa · s and a concentration of 1 to 2 w / v% and a kinematic viscosity at 20 ° C. of the test solution of 3.0 to 8.0 mm ² / s Various thickeners were blended to prepare test solutions as examples of contact lens compositions, and lipid detergency, lipid adhesion inhibition, and friction reduction effects were confirmed. As a thickener, in addition to various substances shown in Table 2, hypromellose whose viscosity of a 2 w / w% aqueous solution at 20 ° C. is 4000 mPa · s, and viscosity of a 4 w / w% aqueous solution at 20 ° C. is 5 or 40 mPa · s. Polyvinyl alcohol which is s was used. Table 6 shows the composition and kinematic viscosity of each test solution, and the test results of each lipid detergency, lipid adhesion inhibitory force, and friction reduction effect.

From this result, the kinematic viscosity at 20 ° C. is 3.0 to 8.0 mm ² / s, the concentration of hypromellose is 0.5 to 1.5 w / v%, and the concentration of polyvinyl alcohol is 0.8 to 1.5 w / v. %, It can be seen that even if various thickeners are added, the lipid detergency, the lipid adhesion inhibitory force, and the friction reduction effect are all exhibited without problems.

  Next, in Experimental Example 5 below, two test solutions, an antiseptic effect and a bactericidal effect, were tested using each test solution as a contact lens composition example and a comparative example. The test method of each test and the criteria for judging the effect are as follows.

Details of the preservative effect test are shown below. Preservative effect test is 15th revised Japanese Pharmacopoeia Reference Information 28. The test was conducted based on the preservation efficacy test method. Specifically, green bacterium (Psudomonas aeruginosa) was inoculated into the test solution so as to be 10 ⁵ to 10 ⁶ per mL, and cultured at 22 ° C. for 14 days. And the viable cell count after culture | cultivation was measured, and the survival rate of the microbe was computed from the viable cell count after culture | cultivation with respect to the inoculum count. In addition, using Escherichia coli and Staphylococcus aureus as test bacteria, a culture test was performed in the same manner, and the survival rate of the bacteria was calculated. Based on the survival rate of these three types of bacteria, the antiseptic effect was evaluated in four stages of ４, ○, Δ, and × according to the following criteria.
A: Bacteria were not detected in any bacterial species. B: A bacterial species with a survival rate of less than 0.1% was present.
Δ: Bacterial species having a survival rate of 0.1% or more and less than 100% existed.
X: The bacterial species in which the bacteria had grown was present.

Details of the bactericidal action inhibitory effect test are shown below. The bactericidal action inhibitory effect was tested with reference to the stand-alone test of ISO 14729 (Ophthalmic optics-Contact lens care products-Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, 2001). Specifically, green bacterium (Psudomonas aeruginosa) was inoculated into the test solution at 10 ⁵ to 10 ⁶ per mL and cultured at 22 ° C. for 4 hours. And the viable cell count after culture | cultivation was measured, and the survival rate of the microbe was computed from the viable cell count after culture | cultivation with respect to the inoculum count. Based on the survival rate, the bactericidal action inhibitory effect was evaluated in four stages of で, ○, Δ, and × according to the following criteria.
A: Bacterial survival rate is 5% or more B: Bacterial survival rate is 0.5% or more and less than 5% B: Bacterial survival rate is 0.1% or more and less than 0.5% X: Bacterial survival rate is 0 Less than 1%

(Experimental example 5)
As shown in Table 7 below, hypromellose having a 2 w / w% aqueous solution viscosity of 3 mPa · s or 4000 mPa · s at 20 ° C. and polyvinyl alcohol having a 4 w / w% aqueous solution viscosity of 20 mPa · s at 20 ° C. are used. Test solutions were prepared, and the antiseptic effect and the bactericidal / disinfecting inhibitory effect when the concentration of polyhexanide hydrochloride was varied were confirmed. Table 7 shows the composition and kinematic viscosity of each test solution, and the test results of the antiseptic effect and the bactericidal action suppressing effect. In this experiment, the blending amount of hypromellose is adjusted according to the viscosity of hypromellose so that the kinematic viscosity of the test solution is constant.

  As shown in Table 7, first, regarding the antiseptic effect, as apparent from the test solutions 43 to 49, 51, if the concentration of polyhexanide hydrochloride is in the range of 0.001 to 0.00005 w / v%, In any case, a sufficient antiseptic effect is obtained. On the other hand, regarding the bactericidal action inhibitory effect that does not exhibit an excessive disinfecting action, the viscosity of a 2 w / w% aqueous solution at 20 ° C. is 4000 mPa · s and the concentration even if it contains only the same amount of polyhexanide hydrochloride as the test solutions 43 and 48. In the test solutions 44 and 49 as comparative examples containing 0.06 w / v% hypromellose, the evaluation is x. That is, even in a test solution containing the same amount of polyhexanide hydrochloride, hypromellose having a viscosity of 3 mPa · s, a concentration of 0.8 w / v%, and 1.0 w / v% in a 2 w / w% aqueous solution at 20 ° C. In the test solutions 43 and 48 as blended examples, the bactericidal action inhibitory effect is exhibited, while a 2 w / w% aqueous solution having a viscosity of 4000 mPa · s and a concentration of 0.06 w / v% hypromellose is a comparative example. It can be seen that in the test solutions 44 and 49, the bactericidal action suppressing effect is not exhibited.

As is clear from the results of the test solution 51, even when hypromellose having a viscosity of 3 mPa · s and a concentration of 0.8 w / v% is used, the concentration of polyhexanide hydrochloride is too high at 0.001 w / v%. In some cases, the bactericidal action inhibitory effect cannot be exhibited. Further, as apparent from the results of the test solution 50, when the polyhexanide hydrochloride concentration is too low as 0.00001 w / v%, an excessive bactericidal action is not exerted, but a sufficient antiseptic effect cannot be obtained. From these results, it can be seen that the concentration of polyhexanide hydrochloride is preferably in the range of 0.00005 to 0.0001 w / v%, particularly when the contact lens composition is used for purposes other than the disinfectant. Moreover, as mentioned above, even if the concentration of polyhexanide hydrochloride is in the range of 0.00005 to 0.0001 w / v%, hypromellose having a viscosity of 5.1 mPa · s or less of a 2 w / w% aqueous solution at 20 ° C., When polyvinyl alcohol having a viscosity of a 4 w / w% aqueous solution at 20 ° C. in the range of 10 to 35 mPa · s is not contained at a predetermined concentration, it exhibits a desired antiseptic effect and bactericidal action suppressing effect. Can not. As is clear from the results of the test solutions 46 to 48, 0.01 w / w% hyaluronic acid is used as long as the test solution has a kinematic viscosity at 20 ° C. of 3.0 to 8.0 mm ² / s. It can be seen that even when various thickeners such as sodium are added, the antiseptic effect and the bactericidal action suppressing effect are sufficiently exhibited.

  Next, in Experimental Example 6 below, the filter adsorption suppression effect was tested using each test solution as an example of a contact lens composition and a comparative example. Test methods and evaluation criteria are as follows.

Details of the test of the filter adsorption suppression effect are shown below. 5 mL of each test solution was filtered using a mini-Salto high flow (manufactured by Sartorius Stedim Japan) having a pore size of 0.2 μm, and the absorbance (273 nm) of the test solution before and after filtration was measured. And about each test solution, the light absorbency (237 nm) of each test solution measured before filtering and the light absorbency after filtration (237 nm) were compared, and the residual amount of polyhexanide hydrochloride after filtration was confirmed. The determination of the filter adsorption inhibitory effect was determined by obtaining the percentage (%) of the absorbance (237 nm) after filtration with respect to the absorbance (237 nm) of each test solution measured before filtration, and the following four steps: ◎, ○, Δ, × Evaluated.
◎: 95% or more ○: 90% or more and less than 95% △: 85% or more and less than 90% ×: less than 85%

(Experimental example 6)
As shown in Table 8 below, hypromellose having a 2 w / w% aqueous solution viscosity of 3 mPa · s or 4000 mPa · s at 20 ° C. and polyvinyl alcohol having a 4 w / w% aqueous solution viscosity of 20 mPa · s at 20 ° C. are used. A test solution was prepared to confirm the filter adsorption suppression effect of polyhexanide hydrochloride. Table 8 also shows the composition and kinematic viscosity of each test solution and the test results of the filter adsorption inhibiting effect.

  As shown in Table 8, in the test solution 53 as a comparative example containing neither hypromellose and polyvinyl alcohol, or the test solutions 54-60 as comparative examples containing only one of hypromellose or polyvinyl alcohol, the filter adsorption inhibiting effect is X or Δ indicates that a large amount of polyhexanide hydrochloride is adsorbed. On the other hand, although both hypromellose and polyvinyl alcohol are mix | blended with the test solutions 61-70, in these test solutions, a result differs greatly with the viscosity of the used hypromellose and polyvinyl alcohol. That is, a combination of hypromellose whose viscosity of a 2 w / w% aqueous solution at 20 ° C. is 5.1 mPa · s or less and polyvinyl alcohol whose viscosity of a 4 w / w% aqueous solution at 20 ° C. is in the range of 10 to 35 mPa · s. In the test solutions 62 to 66 as examples of the present invention, the effect is ◎ or ○. On the other hand, in the case of test solutions 61 and 67 to 70 as comparative examples using hypromellose and polyvinyl alcohol but having a viscosity outside the above specific viscosity range, the result is only x or Δ. Yes. From these results, it can be seen that an excellent filter adsorption suppression effect is exhibited only when polyvinyl alcohol and hypromellose in a specific viscosity range are combined with each other. As is clear from the results of the test solutions 64 and 65, an appropriate amount of a thickening agent such as 0.01 w / v% sodium hyaluronate or about 0.25 w / v% sodium chondroitin sulfate was added. It can also be seen that the filter adsorption suppressing effect is sufficiently effective.

Claims (1)

Hypromellose having a viscosity of 5.1 mPa · s or less at 20 ° C. in a 2 w / w% aqueous solution is contained at a concentration of 0.5 to 1.5 w / v%, and the viscosity of the 4 w / w% aqueous solution at 20 ° C. A composition for contact lenses containing 10 to 35 mPa · s of polyvinyl alcohol at a concentration of 0.8 to ² w / v% and a kinematic viscosity at 20 ° C. of 3.0 to 8.0 mm ² / s. .