JP2014015453A - Ophthalmic composition for soft contact lens - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an ophthalmic composition for soft contact lens containing a nonionic surfactant with high hydrophilic property having an HLB of 11 or more, the ophthalmic composition for soft contact lens allowing reduction in the increase of surface friction of soft contact lens and hardly causing deformation to soft contact lens.SOLUTION: An ophthalmic composition for soft contact lens which contains (A) a nonionic surfactant having an HLB of 11 or more and (B) a polyoxyethylene castor oil with an ethylene oxide having an average addition molar number of 2 to 20 can reduce the increase of surface friction of soft contact lens caused by contact of the ophthalmic composition with soft contact lens and suppress deformation of soft contact lens.

Description

  The present invention relates to an ophthalmic composition for soft contact lenses. More specifically, the present invention relates to an ophthalmic composition for a soft contact lens that can suppress an increase in friction on the surface of the soft contact lens and deformation of the soft contact lens in a composition containing a nonionic surfactant.

  In recent years, the number of wearers of contact lenses (CL) has increased, and in particular, the number of wearers of soft contact lenses (hereinafter also referred to as SCL) has increased. In general, it has been pointed out that when a soft contact lens is worn, the amount of oxygen supplied from the atmosphere decreases, which may result in suppression of corneal epithelial cell division and thickening of the cornea. Therefore, development of soft contact lenses having higher oxygen permeability has been advanced.

  Under such circumstances, silicone hydrogel contact lenses have been developed in recent years as soft contact lenses having high oxygen permeability. Silicone hydrogel contact lenses achieve oxygen permeability several times that of conventional hydrogel contact lenses by blending silicone into the hydrogel. Therefore, it is highly expected that the oxygen supply shortage, which is a weak point of the soft contact lens, can be improved and the adverse effects on the cornea due to the oxygen shortage can be greatly suppressed.

  However, it is known that a silicone hydrogel contact lens has a very large frictional force (Patent Document 1). Further, the surface of a silicone hydrogel contact lens is found on the surface of a normal hydrogel contact lens. It has been reported that there is no remarkable unevenness (Non-Patent Document 1). Such prominent irregularities are not only easy to attach biological substances and dirt, but also cause increased friction compared to those with a smooth surface, especially in sensitive eye tissues. It is also possible to cause discomfort such as a feeling of foreign matter and dryness.

  On the other hand, it is indispensable to design an ophthalmic composition to be used for a contact lens in consideration of safety and other effects depending on the type of contact lens. In particular, soft contact lenses vary in the presence or absence of ionicity and the level of water content depending on the material, so ophthalmic compositions used for soft contact lenses are designed according to the characteristics of the target soft contact lens. It is important to do it. Among these, special attention is required for ophthalmic compositions used for silicone hydrogel contact lenses.

  In general, in the ophthalmic field, solubilizing agents are blended in many formulations, and particularly in ophthalmic compositions for soft contact lenses, various solubilizing agents are used for the purpose of solubilizing physiologically active components and additives having relatively low water solubility. A special solubilizer formulation has been devised. As one of the solubilizing agents used in the ophthalmic field, a surfactant can be mentioned, and a nonionic surfactant is often used from the viewpoint of safety and the like. In particular, in an aqueous ophthalmic composition, a nonionic surfactant having good hydrophilicity is mainly used in order to stably disperse or dissolve an oil component in a medium containing water.

  However, an ophthalmic composition containing a nonionic surfactant, particularly a nonionic surfactant having good hydrophilicity (high HLB value) is brought into contact with a soft contact lens, particularly a silicone hydrogel contact lens. The current situation is that the effects of these cases have not been fully elucidated.

JP 2011-51982 A

Akemi Hariya et al., 51st Annual Meeting of the Japanese Contact Lens Society Program Abstracts, 110 pages

  The present inventors have conducted various studies on ophthalmic compositions for contact lenses containing a nonionic surfactant. As a result, it was confirmed that when the ophthalmic composition for soft contact lenses containing a highly hydrophilic nonionic surfactant having an HLB of 11 or more was brought into contact with the soft contact lens, the friction on the lens surface increased. did. Friction on the lens surface may cause discomfort (such as a foreign object or dry feeling) and eye damage when wearing a soft contact lens. In particular, the silicone hydrogel contact lens has a very large frictional force on the contact lens itself, has irregularities on the surface, and is harder than other soft contact lenses. There is a tendency to have adverse effects.

  Accordingly, a main object of the present invention is an ophthalmic composition for soft contact lenses containing a highly hydrophilic nonionic surfactant having an HLB of 11 or more, and an increase in friction on the surface of the soft contact lens is suppressed. Another object of the present invention is to provide an ophthalmic composition for soft contact lenses.

  The present inventors may cause lens swelling when an ophthalmic composition for soft contact lenses containing a highly hydrophilic nonionic surfactant having an HLB of 11 or more is brought into contact with a soft contact lens. It was confirmed that the silicone hydrogel contact lens tends to change in lens size. It is known that it is difficult to detect even when ocular mucosal damage occurs when wearing soft contact lenses, and there is a risk of wearing a deformed soft contact lens for a long time and leaving it until the ocular mucosal damage becomes serious is there. Furthermore, there is a concern that a change in the shape of the contact lens may adversely affect the visual acuity correction power of the contact lens.

  Accordingly, another object of the present invention is an ophthalmic composition for soft contact lenses containing a highly hydrophilic nonionic surfactant having an HLB of 11 or more, which causes deformation of the soft contact lens. It is to provide an ophthalmic composition for soft contact lenses that is difficult.

  As a result of intensive studies to solve the above problems, the present inventors have found that an average of ethylene oxide is contained in an ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more. It has been found that by adding polyoxyethylene castor oil having an addition mole number of 2 to 20, the increase in friction on the contact lens surface that occurs when the soft contact lens and the ophthalmic composition come into contact with each other can be reduced.

  Further, by blending polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20 in an ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more The present inventors have found that deformation of a soft contact lens caused by contact between the soft contact lens and the ophthalmic composition can be suppressed.

  The present invention has been completed as a result of further studies based on these findings.

That is, this invention provides the ophthalmic composition for soft contact lenses of the following aspect.
Item 1-1. An ophthalmic composition for soft contact lenses, comprising (A) a nonionic surfactant having an HLB of 11 or more and (B) polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20.
Item 1-2. (A) component is polysorbate 80, polyoxyethylene hydrogenated castor oil having an average addition mole number of ethylene oxide of 30 or more, polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 30 or more, polyoxyethylene ( 196) At least one selected from the group consisting of polyoxypropylene (67) glycol, polyoxyethylene (200) polyoxypropylene (70) glycol and polyethylene glycol monostearate having an average addition mole number of ethylene oxide of 10 or more The ophthalmic composition for soft contact lenses according to Item 1-1, wherein
Item 1-3. The component (B) is polyoxyethylene castor oil 3, polyoxyethylene castor oil 4, polyoxyethylene castor oil 6, polyoxyethylene castor oil 7, polyoxyethylene castor oil 10, polyoxyethylene castor oil The ophthalmic composition for soft contact lenses according to Item 1-1 or Item 1-2, which is at least one selected from the group consisting of oil 13.5, polyoxyethylene castor oil 17 and polyoxyethylene castor oil 20.
Item 1-4. Item 4. The aqueous ophthalmic composition according to any one of Items 1-1 to 1-3, wherein the component (B) is polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 12.
Item 1-5. Item 5. The soft contact lens according to any one of Items 1-1 to 1-4, wherein the total content of the component (A) is 0.001 to 5 w / v% based on the total amount of the ophthalmic composition for soft contact lens Ophthalmic composition.
Item 1-6. Item 1. The soft contact lens according to any one of Items 1-1 to 1-5, wherein the total content of component (B) is 0.0005 to 5 w / v% based on the total amount of the ophthalmic composition for soft contact lens Ophthalmic composition.
Item 1-7. The soft contact according to any one of Items 1-1 to 1-6, wherein the total content of the component (B) is 0.001 to 100 parts by weight with respect to 1 part by weight of the total content of the component (A) Ophthalmic composition for lenses.
Item 1-8. Item 8. The ophthalmic composition for soft contact lens according to any one of Items 1-1 to 1-7, wherein the soft contact lens is a silicone hydrogel contact lens.
Item 1-9. Item 9. The ophthalmic composition for soft contact lens according to any one of Items 1-1 to 1-8, which is an aqueous solution.
Item 1-10. Item 10. The ophthalmic composition for soft contact lens according to any one of Items 1-1 to 1-9, which is an eye drop for soft contact lens or a solution for soft contact lens care.

Moreover, this invention provides the method of reducing the increase in the friction of the soft contact lens surface of the aspect hung up below.
Item 2-1. An ophthalmic composition for soft contact lenses, comprising (A) a nonionic surfactant having an HLB of 11 or more, and (B) polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20, A method for reducing an increase in friction on the surface of a soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens, the method comprising a step of contacting the soft contact lens.
Item 2-2. Item 2. The method according to Item 2-1, wherein the soft contact lens is a silicone hydrogel contact lens.

Moreover, this invention provides the method of providing the effect | action which reduces the increase in the friction of a soft contact lens of the aspect hung up below to the ophthalmic composition for soft contact lenses.
Item 3-1. (A) An ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more is blended with (B) polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20 A method of imparting to the ophthalmic composition an action of reducing an increase in friction on the surface of the soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens. .
Item 3-2. Item 3. The method according to Item 3-1, wherein the soft contact lens is a silicone hydrogel contact lens.

Moreover, this invention provides the method of suppressing a deformation | transformation of a soft contact lens of the aspect hung up below.
Item 4-1. An ophthalmic composition for soft contact lenses, comprising (A) a nonionic surfactant having an HLB of 11 or more, and (B) polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20, A method for suppressing deformation of a soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens, which comprises contacting the soft contact lens.
Item 4-2. Item 5. The method according to Item 4-1, wherein the soft contact lens is a silicone hydrogel contact lens.

Moreover, this invention provides the method of providing the effect | action which suppresses a deformation | transformation of a soft contact lens to the ophthalmic composition for soft contact lenses of the aspect hung up below.
Item 5-1. (A) An ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more is blended with (B) polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20 A method of imparting to the ophthalmic composition an action of suppressing deformation of the soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens.
Item 5-2. Item 5. The method according to Item 5-1, wherein the soft contact lens is a silicone hydrogel contact lens.

Furthermore, the present invention also provides the use of the following aspects.
Item 6. For production of an ophthalmic composition for soft contact lenses, (A) a nonionic surfactant having an HLB of 11 or more, and (B) a poly (ethylene oxide) having an average addition mole number of 2 to 20 Use of oxyethylene castor oil.
Item 7. Item 7. The use according to Item 6, wherein the ophthalmic composition for soft contact lenses is the composition according to any one of Items 1-1 to 1-10.

Furthermore, the present invention also provides the use of the embodiments listed below.
Item 8. As an ophthalmic composition for soft contact lenses, (A) a nonionic surfactant having an HLB of 11 or more, and (B) a polyoxyethylene castor having an average added mole number of ethylene oxide of 2 to 20 Use of a composition comprising oil.
Item 9. The use according to Item 8, wherein the composition is the composition according to any one of Items 1-1 to 1-10.

Furthermore, this invention also provides the composition of the aspect hung up below.
Item 10. For use as an ophthalmic composition for soft contact lenses, (A) a nonionic surfactant having an HLB of 11 or more, and (B) an average added mole number of ethylene oxide is 2 to 20. A composition comprising polyoxyethylene castor oil.
Item 11. The composition according to Item 10, which is described in any one of Items 1-1 to 1-10.

Furthermore, this invention also provides the manufacturing method of the ophthalmic composition for soft contact lenses of the aspect hung up below.
Item 12. To a carrier containing water, (A) a nonionic surfactant having an HLB of 11 or more and (B) polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20 are added. The manufacturing method of the ophthalmic composition for soft contact lenses including this.
Item 13. The method according to Item 12, wherein the ophthalmic composition for soft contact lens is the composition according to any one of Items 1-1 to 1-10.

According to the present invention, the following remarkable effects are achieved.
(1) According to the ophthalmic composition for soft contact lens of the present invention, the contact lens produced when the ophthalmic composition for soft contact lens containing a nonionic surfactant having an HLB of 11 or more comes into contact with the soft contact lens. Increase in surface friction can be reduced. For this reason, by using the ophthalmic composition for soft contact lenses of the present invention, it is possible to reduce discomfort and eye fatigue when wearing contact lenses, and to suppress the occurrence of keratoconjunctival epithelial disorder.
(2) According to the ophthalmic composition for soft contact lenses of the present invention, the soft contact lens ophthalmic composition containing a nonionic surfactant having an HLB of 11 or more is brought into contact with the soft contact lens. Contact lens deformation can be suppressed. For this reason, by using the ophthalmic composition for soft contact lens of the present invention, it becomes possible to use the soft contact lens without impairing the feeling of use. In addition, according to the ophthalmic composition for soft contact lens of the present invention, deformation of the soft contact lens can be suppressed, so that it is possible to wear the soft contact lens for a long period of time with high safety (for example, continuous wearing for a long period of time). In addition, the soft contact lens can be used in a state where the original vision correction power is maintained.

  As described above, according to the ophthalmic composition for soft contact lenses of the present invention, the ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more is brought into contact with the soft contact lens. The increase in friction on the surface of the soft contact lens can be reduced, and further, deformation of the soft contact lens can be suppressed. Therefore, according to the present invention, it is possible to effectively use a highly hydrophilic nonionic surfactant having an HLB of 11 or more while eliminating adverse effects on the soft contact lens as much as possible.

The graph which shows the raise suppression rate (%) of the logarithmic decay rate of the pendulum amplitude calculated | required in Test Example 1. FIG.

  In the present specification, the unit “%” of content means “w / v%” and is synonymous with “g / 100 mL”.

  In the present specification, unless otherwise specified, the abbreviation “POE” means polyoxyethylene.

  In this specification, unless otherwise specified, the abbreviation “POP” means polyoxypropylene.

[1. Ophthalmic composition for soft contact lens]
The ophthalmic composition for soft contact lenses of the present invention contains a nonionic surfactant having an HLB of 11 or more (hereinafter sometimes referred to as component (A)). In the ophthalmic composition for soft contact lenses containing the component (A), polyoxyethylene castor oil (hereinafter sometimes referred to as the component (B)) having an average added mole number of ethylene oxide of 2 to 20 described later is included. By mix | blending, the increase in the friction of the contact lens surface which arises when the ophthalmic composition for soft contact lenses containing (A) component contacts a soft contact lens can be reduced. In addition, by blending the component (B) in the ophthalmic composition for soft contact lenses containing the component (A), the ophthalmic composition for soft contact lenses containing the component (A) is brought into contact with the soft contact lens. It is possible to suppress the deformation of the soft contact lens that occurs when

  The nonionic surfactant having an HLB of 11 or more that can be used in the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. These are known compounds as solubilizers, solubilizers, and the like, and may be synthesized by a known method or obtained as a commercial product.

  Specific examples of the nonionic surfactant having an HLB of 11 or more that can be used in the present invention include monolauric acid POE (20) sorbitan (polysorbate 20), monopalmitic acid POE (20) sorbitan (polysorbate 40). POE sorbitan fatty acid esters such as monostearic acid POE (20) sorbitan (polysorbate 60), tristearic acid POE (20) sorbitan (polysorbate 65), monooleic acid POE (20) sorbitan (polysorbate 80); POE (40) Hardened castor oil (polyoxyethylene hardened castor oil 40), POE hardened castor oil such as POE (60) hardened castor oil (polyoxyethylene hardened castor oil 60); polyoxyethylene having an average addition mole number of ethylene oxide of 35 Castor oil 35, polyoxyethylene castor oil 40 having an average added mole number of ethylene oxide of 40, Polyoxyethylene castor oil 50 having an addition mole number of 50, polyoxyethylene castor oil 60 having an average addition mole number of ethylene oxide of 60, polyoxyethylene castor oil 70 having an average addition mole number of ethylene oxide of 70, etc. Polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 30 or more; POE alkyl ether such as POE (9) lauryl ether; POE-POP alkyl ether such as POE (20) POP (4) cetyl ether; POE (196) Polyoxyethylene / polyoxypropylene block copolymers such as POP (67) glycol (poloxamer 407, Pluronic F127), POE (54) POP (39) glycol (Pluronic P85), POE (200) POP (70) glycol, etc. Monostearic acid having an average addition mole number of ethylene oxide such as polyoxyl 40 stearate of 10 or more It may be mentioned triethylene glycol. In the compounds exemplified above, the numbers in parentheses indicate the number of added moles.

  The nonionic surfactants having an HLB of 11 or more may be used alone or in combination of two or more.

  Among the above-mentioned components (A), in particular, polysorbate 80, polyoxyethylene hydrogenated castor oil having an average addition mole number of ethylene oxide of 30 or more, polyoxyethylene castor having an average addition mole number of ethylene oxide of 30 or more Oil, POE (196) POP (67) glycol (poloxamer 407, Pluronic F127), POE (200) POP (70) glycol, polyethylene glycol monostearate with an average added mole number of ethylene oxide of 10 or more are safe. From the point that the property is high and preferable, and the effect of the present invention is obtained well, polysorbate 80, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene hydrogenated castor oil 40, polyoxyethylene castor oil 35, polyoxyethylene castor oil 40, Polyoxyethylene castor oil 50, polyoxyethylene castor oil 60, polyoxy More preferred are ethylene castor oil 70, POE (196) POP (67) glycol (poloxamer 407, Pluronic F127), POE (200) POP (70) glycol, and polyoxyl 40 stearate. Polysorbate 80, polyoxyethylene hydrogenated castor oil 60 Polyoxyethylene castor oil 35 is particularly preferable.

  According to the present invention, in the ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more, deformation of the soft contact lens and increase in friction can be suppressed. A widely used nonionic surfactant can be used effectively.

  In the ophthalmic composition for soft contact lenses of the present invention, the content of the component (A) is not particularly limited, the type of the component (A), the type and content of the component (B) to be used together, the ophthalmology for the soft contact lens It is appropriately set according to the use of the composition, the form of preparation, the method of use and the like. For example, based on the total amount of the ophthalmic composition for soft contact lenses of the present invention, the total content of the component (A) is 0.001 to 5 w / v%, preferably 0.005 to 4 w / v%, more preferably Is from 0.01 to 3 w / v%, more preferably from 0.02 to 2 w / v%, particularly preferably from 0.05 to 1 w / v%.

  The ophthalmic composition for soft contact lenses of the present invention contains polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20 together with the component (A) in order to exert the above-described effects of the present invention. It is necessary to.

  Polyoxyethylene castor oil is a known compound obtained by addition polymerization of ethylene oxide to castor oil, and several types having different average added mole numbers of ethylene oxide are known.

  Specific examples of polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20 mol that can be used in the present invention include polyoxyethylene castor oil 3 having an average addition mole number of ethylene oxide of 3 Polyoxyethylene castor oil 4 having an average addition mole number of ethylene oxide of 4, polyoxyethylene castor oil 6 having an average addition mole number of ethylene oxide of 6, polyoxyethylene having an average addition mole number of ethylene oxide of 7 Ethylene castor oil 7, Polyoxyethylene castor oil 10 with an average addition mole number of ethylene oxide of 10, Polyoxyethylene castor oil 13.5 with an average addition mole number of ethylene oxide of 13.5, Average addition of ethylene oxide Polyoxyethylene castor oil 17 having a mole number of 17 and polyoxyethylene having an average addition mole number of ethylene oxide of 20 And ethylene castor oil 20 and the like.

  Among these, polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 12 mol can be mentioned as an example of a component that can exhibit the effect of the present invention particularly well.

  The above polyoxyethylene castor oil may be used alone or in any combination of two or more. In addition, the polyoxyethylene castor oil used by this invention is a compound different from the polyoxyethylene hydrogenated castor oil obtained by addition-polymerizing ethylene oxide to hydrogenated castor oil, and is distinguished from this.

  In the ophthalmic composition for soft contact lenses of the present invention, the content of the component (B) is not particularly limited, the type of the component (B), the type and content of the component (A) to be used together, the soft contact lens It is appropriately set according to the use, formulation form, method of use and the like of the ophthalmic composition. For example, based on the total amount of the ophthalmic composition for soft contact lenses, the total content of the component (B) is 0.0005 to 5 w / v%, preferably 0.001 to 3 w / v%, more preferably 0.002. ˜2 w / v%, more preferably 0.005 to 1 w / v%, particularly preferably 0.01 to 0.5 w / v%.

  In the ophthalmic composition for soft contact lenses of the present invention, the content ratio of the (B) component to the (A) component is the types of the (A) component and the (B) component, the use and formulation of the ophthalmic composition for the soft contact lens It is appropriately set according to the form, usage method, and the like. For example, with respect to 1 part by weight of the total content of component (A) contained in the ophthalmic composition for soft contact lenses of the present invention, the total content of component (B) is preferably 0.001 to 100 parts by weight, preferably The amount is 0.005 to 50 parts by weight, more preferably 0.01 to 20 parts by weight, still more preferably 0.05 to 10 parts by weight, and particularly preferably 0.1 to 5 parts by weight.

  By containing the component (A) and the component (B) within the range of the content ratio described above, the effect of reducing the increase in friction on the surface of the soft contact lens and suppressing the deformation of the soft contact lens is particularly exhibited. The

  The ophthalmic composition for soft contact lenses of the present invention preferably further contains a buffer. Thereby, pH of the ophthalmic composition for soft contact lenses of this invention can be adjusted. The buffer that can be incorporated into the ophthalmic composition for soft contact lenses of the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Specific examples of the buffer that can be used in the present invention include borate buffer, phosphate buffer, carbonate buffer, citrate buffer, acetate buffer, Tris buffer, aspartic acid, aspartate and the like. Can be mentioned. These buffering agents may be used in combination. Examples of the boric acid buffer include boric acid or boric acid salts such as alkali metal borate and alkaline earth metal borate. Examples of the phosphate buffer include phosphoric acid or phosphates such as alkali metal phosphates and alkaline earth metal phosphates. Examples of the carbonate buffer include carbonates or carbonates such as alkali metal carbonates and alkaline earth metal carbonates. Examples of the citrate buffer include citric acid, alkali metal citrate, and alkaline earth metal citrate. Moreover, you may use the borate or the hydrate of a phosphate as a borate buffer or a phosphate buffer. As a more specific example, boric acid or a salt thereof (sodium borate, potassium tetraborate, potassium metaborate, ammonium borate, borax, etc.); as a phosphate buffer, phosphoric acid or a salt thereof Salt (disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, trisodium phosphate, dipotassium phosphate, calcium monohydrogen phosphate, calcium dihydrogen phosphate, etc.); Or a salt thereof (sodium bicarbonate, sodium carbonate, ammonium carbonate, potassium carbonate, calcium carbonate, potassium bicarbonate, magnesium carbonate, etc.); citric acid or a salt thereof (sodium citrate, potassium citrate, citric acid, etc.) Calcium acetate, sodium dihydrogen citrate, disodium citrate, etc.); with acetate buffer Examples thereof include acetic acid or a salt thereof (ammonium acetate, potassium acetate, calcium acetate, sodium acetate, etc.); aspartic acid or a salt thereof (sodium aspartate, magnesium aspartate, potassium aspartate, etc.). Among these buffering agents, phosphate buffering agents and boric acid buffering agents are preferable, and boric acid buffering agents (particularly, a combination of boric acid and borax) are more preferable.

  When a buffering agent is blended in the ophthalmic composition for soft contact lenses of the present invention, the content is the type of the buffering agent, the type and content of other blending components, the use of the ophthalmic composition for soft contact lenses, It is appropriately set according to the formulation form, usage method and the like. For example, based on the total amount of the ophthalmic composition for soft contact lenses, the total content of the buffer is 0.01 to 15 w / v%, preferably 0.05 to 10 w / v%, more preferably 0.1. -7.5 w / v%, particularly preferably 0.5-5 w / v%.

  The ophthalmic composition for soft contact lenses of the present invention preferably further contains an isotonic agent. The isotonic agent that can be incorporated into the ophthalmic composition of the present invention is not particularly limited as long as it is pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. Specific examples of isotonic agents that can be used in the present invention include disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, sodium hydrogen sulfite, sodium sulfite, potassium chloride, calcium chloride, sodium chloride. , Magnesium chloride, potassium acetate, sodium acetate, sodium bicarbonate, sodium carbonate, sodium thiosulfate, magnesium sulfate, glycerin, propylene glycol, polyethylene glycol, glucose, mannitol, sorbitol and the like. Among these isotonic agents, glycerin, propylene glycol, sodium chloride, potassium chloride, calcium chloride, and magnesium chloride are preferable, sodium chloride or propylene glycol is more preferable, and sodium chloride is particularly preferable. These isotonic agents may be used alone or in any combination of two or more.

  When an isotonic agent is blended in the ophthalmic composition for soft contact lenses of the present invention, the content is the type of the tonicity agent, the type and content of other compounding ingredients, the ophthalmic composition for soft contact lenses. It is set as appropriate according to the use of the product, the formulation form, the method of use and the like. For example, based on the total amount of the ophthalmic composition for soft contact lenses of the present invention, the total content of the tonicity agent is 0.01 to 10 w / v%, preferably 0.05 to 5 w / v%, more preferably Is 0.1 to 3 w / v%.

  Various pharmacologically active ingredients, physiologically active ingredients and the like can be blended with the ophthalmic composition for soft contact lenses of the present invention, and various additives can be blended. In this case, in order to improve the solubility of physiologically active ingredients and additives, in addition to the components (A) and (B), other surfactants can be further blended as a solubilizing agent.

  Surfactants other than the components (A) and (B) that can be incorporated into the ophthalmic composition for soft contact lenses of the present invention include pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. The surfactant is not particularly limited and may be any of a nonionic surfactant, an amphoteric surfactant, an anionic surfactant, and a cationic surfactant.

  The nonionic surfactant other than the component (A) and the component (B) that can be used in the present invention has an HLB of less than 11, and is a nonionic surfactant other than the component (B). Examples include polyoxyethylene hydrogenated castor oil 5, polyoxyethylene hydrogenated castor oil 10, sorbitan tristearate, and the like.

  Specific examples of the amphoteric surfactant that can be used in the present invention include alkyldiaminoethylglycine or a salt thereof (for example, hydrochloride).

  Specific examples of the cationic surfactant that can be used in the present invention include benzalkonium chloride and benzethonium chloride.

  Specific examples of the anionic surfactant that can be used in the present invention include alkylbenzene sulfonate, alkyl sulfate, polyoxyethylene alkyl sulfate, aliphatic α-sulfomethyl ester, α-olefin sulfonic acid. Etc.

  Said surfactant may be used individually by 1 type, and may be used in combination of 2 or more type.

  Moreover, the ophthalmic composition for soft contact lenses of this invention can suppress the deformation | transformation of the soft contact lens which arises by contact with the ophthalmic composition containing the nonionic surfactant whose HLB is 11 or more. For this reason, it is particularly useful as an ophthalmic composition containing a fat-soluble component that needs to be dissolved with a large amount of surfactant. Such fat-soluble components are not particularly limited as long as they are pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. For example, vegetable oils such as sesame oil, castor oil and soybean oil; liquid paraffin , Menthol, camphor, borneol, geraniol, etc .; essential oils such as peppermint oil, cool mint oil, peppermint oil, bergamot oil; fat-soluble vitamins such as retinol palmitate, tocopherol acetate; antioxidants such as dibutylhydroxytoluene Is mentioned. These fat-soluble components may be used alone or in combination of two or more.

  In addition, in the ophthalmic composition for soft contact lenses of this invention, the polyoxyethylene whose average addition mole number of nonionic surfactant ((A) component) whose HLB is 11 or more, and ethylene oxide is 2-20. When castor oil (component (B)) is used in combination, when the total amount of surfactant (A) and component (B) is the same, compared to the case where only component (A) is used In addition, it is possible to suppress the size change of the soft contact lens while maintaining substantially the same dissolution performance with respect to a component having low water solubility.

  In general, when the total amount of the surfactant is increased to aid dissolution of a component having low water solubility such as a fat-soluble component, the size of the soft contact lens tends to change. According to the ophthalmic composition of the present invention, as described above, the combined use of the component (A) and the component (B) has a large effect on the size change of the soft contact lens without substantially reducing the dissolution performance (A ) The content of the component can be relatively reduced. Therefore, even when the total amount of surfactant is increased to improve the solubility of low water-soluble components such as fat-soluble components, it is possible to suppress an increase in the content of component (A) Thus, the size change of the soft contact lens can be suppressed.

  In this case, from the viewpoint of maintaining dissolution performance while suppressing the size change of the soft contact lens, the total content of component (B) is based on the total amount of component (A) and component (B). The amount is preferably about 1 to 60% by weight, more preferably about 10 to 50% by weight, and still more preferably about 20 to 50% by weight.

  The pH of the ophthalmic composition of the present invention is not particularly limited as long as it is within a pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable range. As pH of the ophthalmic composition for soft contact lenses of this invention, it is 4.0-9.5, for example, Preferably it is 5.0-9.0, More preferably, it is 5.5-8.5.

  Further, the osmotic pressure of the ophthalmic composition of the present invention is not particularly limited as long as it is within a range acceptable for a living body. The osmotic pressure ratio of the ophthalmic composition for soft contact lens of the present invention is, for example, 0.5 to 5.0, preferably 0.6 to 3.0, more preferably 0.7 to 2.0, particularly preferably. 0.9 to 1.55. The adjustment of the osmotic pressure can be performed by a method known in the art using an inorganic salt, a polyhydric alcohol, a sugar alcohol, a sugar or the like. The osmotic pressure ratio is the ratio of the osmotic pressure of the sample to 286 mOsm (0.9 w / v% sodium chloride aqueous solution) based on the 16th revised Japanese Pharmacopeia. Measured with reference to the method (freezing point depression method). In addition, about the standard solution for osmotic pressure ratio measurement (0.9 w / v% sodium chloride aqueous solution), after drying sodium chloride (Japanese Pharmacopoeia standard reagent) at 500-650 degreeC for 40-50 minutes, it is a desiccator (silica gel). It is allowed to cool, and 0.900 g is accurately weighed and dissolved in purified water to prepare exactly 100 mL, or a commercially available standard solution for osmotic pressure ratio measurement (0.9 w / v% sodium chloride aqueous solution) may be used. .

  The viscosity of the ophthalmic composition of the present invention is not particularly limited as long as it is within a range acceptable for a living body. For example, the viscosity at 25 ° C. measured with a rotational viscometer (RE550 type viscometer, manufactured by Toki Sangyo Co., Ltd., rotor: 1 ° 34 ′ × 24) is 0.01 to 1000 mPa · s, preferably 0.05 to 100 mPa · s. s, more preferably 0.1 to 10 mPa · s.

  The ophthalmic composition of the present invention may contain an appropriate amount of various pharmacologically active components and / or physiologically active components in addition to the above components, as long as the effects of the present invention are exhibited. Such components are not particularly limited, and specific examples of components used in ophthalmic drugs include the following components.

  Antihistamine or antiallergic agent: for example, iproheptin, diphenhydramine hydrochloride, chlorpheniramine maleate, ketotifen fumarate, potassium pemirolast, sodium cromoglycate, and the like.

  Decongestant: For example, tetrahydrozoline hydrochloride, naphazoline hydrochloride, naphazoline sulfate, epinephrine hydrochloride, ephedrine hydrochloride, methylephedrine hydrochloride, and the like.

  Eye muscle modulating agent: for example, cholinesterase inhibitor having an active center similar to acetylcholine, specifically, neostigmine methyl sulfate, tropicamide, atropine sulfate helenien.

  Vitamins: for example, flavin adenine dinucleotide sodium, cyanocobalamin, retinol acetate, retinol palmitate, pyridoxine hydrochloride, panthenol, calcium pantothenate, tocopherol acetate, etc.

  Amino acids: For example, potassium aspartate, magnesium aspartate, magnesium / potassium aspartate, aminoethylsulfonic acid, sodium chondroitin sulfate and the like.

  Anti-inflammatory agents: for example, zinc sulfate, zinc lactate, epsilon-aminocaproic acid, bromfenac sodium, dipotassium glycyrrhizinate, pranoprofen, allantoin, azulene, sodium azulenesulfonate, guaiazulene, berberine chloride, berberine sulfate, lysozyme chloride, Licorice etc.

  Other: For example, sodium hyaluronate, sulfamethoxazole, sulfamethoxazole sodium and the like.

  In addition, in the ophthalmic composition for soft contact lenses of the present invention, various additives are appropriately selected according to conventional methods depending on the use, formulation form, etc., as long as the effects of the present invention are exhibited. One or more types may be used in combination to contain an appropriate amount. Typical additives include the following additives.

  Carrier: An aqueous carrier such as water or hydrous ethanol.

  Sugar: For example, cyclodextrin and the like.

  Sugar alcohol: For example, xylitol, sorbitol, mannitol and the like. These may be d-form, l-form or dl-form.

  Antiseptics, bactericides or antibacterials: for example, cetylpyridinium, benzalkonium chloride, benzethonium chloride, chlorhexidine hydrochloride, chlorhexidine gluconate, polyhexanide hydrochloride, alkyldiaminoethylglycine hydrochloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, Potassium sorbate, sodium dehydroacetate, methyl paraoxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, butyl paraoxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, glowkill (trade name, Rhodia), polyhexanide hydrochloride, etc. .

  Thickener or thickener: gum arabic powder, sodium alginate, propylene glycol alginate, sodium chondroitin sulfate, sorbitol, dextran 70, tragacanth powder, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, carboxyvinyl polymer, polyvinyl Alcohol, polyvinyl pyrrolidone, macrogol 4000, etc.

  Oils: sesame oil, castor oil, etc.

  Perfume or refreshing agent: menthol, anethole, eugenol, camphor, geraniol, cineol, borneol, limonene, ryuno and the like. These may be either d-form, l-form or dl-form, and are formulated as essential oils such as peppermint oil, cool mint oil, spearmint oil, peppermint oil, fennel oil, cinnamon oil, bergamot oil, eucalyptus oil, rose oil, etc. May be.

  Others: ethanol, dibutylhydroxytoluene, sodium edetate, etc.

  The ophthalmic composition for soft contact lenses of the present invention can take various preparation forms depending on the purpose. For example, the form of the ophthalmic composition for soft contact lenses of the present invention includes a liquid agent, a semi-solid agent (such as an ointment) and the like. A liquid is preferable, and an aqueous liquid is more preferable. Here, the aqueous liquid agent means a liquid agent containing water, and usually 1% by weight or more, preferably 5% by weight or more, more preferably 50% by weight or more, and still more preferably 90% by weight of water in the composition. % Or more is meant. The water contained in the aqueous liquid may be any pharmaceutical, pharmacological (pharmaceutical) or physiologically acceptable. For example, distilled water, normal water, purified water, sterilized purified water, water for injection, distilled water for injection, and the like can be used. These definitions are based on the 16th revised Japanese Pharmacopoeia.

  When preparing the ophthalmic composition for soft contact lenses of the present invention as an aqueous liquid preparation, for example, the desired amount of the above-mentioned components (A) and (B), and other compounding components as required, with a desired concentration. It can be prepared by adding to a carrier, dissolving or suspending the components with purified water, adjusting to a predetermined pH and osmotic pressure, and sterilizing by filtration sterilization or the like. Regarding the dissolution of the above component (B) and other highly hydrophobic components, after stirring together with the component (A) and other components having a solubilizing action such as other surfactants, purified water is further added. And may be mixed or dissolved or suspended.

  Accordingly, the present invention provides, from another point of view, a carrier containing water, (A) a nonionic surfactant having an HLB of 11 or more, and (B) a polysiloxane having an average addition mole number of ethylene oxide of 2 to 20. The present invention provides a method for producing an ophthalmic composition for soft contact lenses, which comprises adding oxyethylene castor oil.

  If the ophthalmic composition for soft contact lenses of this invention is used in the ophthalmic field | area and is used so that it may contact a soft contact lens, the form and application will not be restrict | limited. For example, eye drops for soft contact lenses (eye drops that can be used while wearing soft contact lenses), eye drops for soft contact lenses (eye wash that can be used while wearing soft contact lenses), soft contact lens mounting solutions, Soft contact lens care solution (soft contact lens disinfectant, soft contact lens preserving solution, soft soft contact lens cleaning solution, soft contact lens cleaning preserving solution, etc.). Among these, the ophthalmic solution for soft contact lenses and the solution for soft contact lens care are preparations that are frequently used per day or have a long contact time with the soft contact lens, and the component (A) It tends to be used in a form that most easily causes an increase in friction and deformation of the lens. According to the ophthalmic composition for soft contact lens of the present invention, the eye drop for soft contact lens which tends to cause increased friction and deformation of the lens due to the component (A) from the viewpoint of use frequency and contact time. In addition, in the liquid for soft contact lens care, it is possible to effectively suppress the increase in friction and the deformation of the lens due to the component (A). In view of the effects of the present invention, a suitable example of the ophthalmic composition for soft contact lens of the present invention includes an eye drop for soft contact lens and a solution for soft contact lens care.

  As a container for storing the ophthalmic composition for soft contact lenses of the present invention, a container usually used as a container for storing the ophthalmic composition for soft contact lenses can be used, and it may be made of glass or made of plastic. It may be. When the plastic container is used as the container for storing the ophthalmic composition for soft contact lens of the present invention, the constituent material of the plastic container is not particularly limited. For example, polyethylene naphthalate, polyarylate, polyethylene terephthalate, polypropylene , Any one of polyethylene and polyimide, a copolymer thereof, or a mixture of two or more thereof. In addition, as the copolymer, ethylene-2,6-naphthalate unit, arylate unit, ethylene terephthalate unit, propylene unit, ethylene unit, imide unit is mainly used, and other polyester units and imide units are included. Examples of the copolymer include. In the present invention, for example, a container made of polyethylene terephthalate means that the polyethylene terephthalate is 50 w / w% or more based on the weight of the entire material constituting the container.

  Also, the structure, constituent materials, etc. of the peripheral portion of the container inlet such as a nozzle provided in the container for accommodating the ophthalmic composition for soft contact lens of the present invention are not particularly limited. The structure around the container inlet such as a nozzle may be a structure generally employed as a spout (for example, a nozzle) of a container for an ophthalmic composition (for example, an eye drop container), and is integrated with the container body. It may be molded or may be molded separately from the container body. As the constituent material of the spout peripheral portion or the spout (for example, nozzle), for example, the same material as that of the plastic container is exemplified.

  Further, the method for using the ophthalmic composition for soft contact lens of the present invention is not particularly limited as long as it is a known method having a step of bringing the ophthalmic composition for soft contact lens into contact with the soft contact lens. . For example, in the case of eyedrops for soft contact lenses, an appropriate amount of the eyedrops may be instilled before or during wearing of the soft contact lens (immediately before wearing; for example, within 10 minutes before wearing the soft contact lens). Also, in the case of an eyewash for soft contact lenses, an appropriate amount of the eyewash may be used for eye washing before wearing the soft contact lens (immediately before wearing) or during wearing (while wearing the soft contact lens). In addition, when the ophthalmic composition for soft contact lenses of the present invention is an eye drop for soft contact lenses or an eye wash for soft contact lenses, not only when wearing a soft contact lens, but also when not wearing Can be used for eyewash purposes. In the case of a soft contact lens mounting liquid, the soft contact lens is used by contacting an appropriate amount of the mounting liquid with the soft contact lens when the soft contact lens is mounted. Further, in the case of a soft contact lens care solution, it is used by immersing the soft contact lens in an appropriate amount of the care solution or by rubbing the soft contact lens in contact with the care solution. The

  In the ophthalmic composition for soft contact lens of the present invention, the type of soft contact lens to be applied is not particularly limited, and all soft contact lenses currently marketed or marketed in the future can be applied. Among these, it has been confirmed that the silicone hydrogel contact lens tends to have a large degree of increase in friction and deformation of the lens caused by contact with the component (A). According to the ophthalmic composition for soft contact lenses of the present invention, it is possible to effectively suppress the increase in friction and deformation of the silicone hydrogel contact lens. Therefore, the ophthalmic composition for soft contact lenses of the present invention is preferably applied. Examples thereof include silicone hide gel contact lenses, and more preferably nonionic silicone hydrogel contact lenses. Here, the term “nonionic” means that the ionic component content in the contact lens material is less than 1 mol% in accordance with US FDA (US Food and Drug Administration) standards, as is generally understood by those skilled in the art.

  Further, the moisture content of the soft contact lens to be applied is not particularly limited, and examples thereof include 90% or less, preferably 60% or less, and more preferably 50% or less. In addition, since a soft contact lens contains a hydrogel raw material, it needs to contain a water | moisture content, and usually contains about 1% or more of water | moisture content. From the viewpoint of exhibiting the effects of the present invention more remarkably, it is preferably 20% or more, more preferably 35% or more, and particularly preferably 40% or more. From another point of view, a silicone hydrogel contact lens in which the lens surface is not subjected to plasma treatment is preferable in that the effect of the present invention is more remarkably exhibited.

  In another aspect, the present invention provides (A) a nonionic surfactant having an HLB of 11 or more and (B) an average addition mole of ethylene oxide for the production of an ophthalmic composition for soft contact lenses. Also provided is the use of polyoxyethylene castor oil having a number of 2-20.

  Further, according to another aspect of the present invention, as an ophthalmic composition for soft contact lenses, (A) a nonionic surfactant having an HLB of 11 or more, and (B) an average added mole number of ethylene oxide is 2. Also provided is the use of a composition comprising polyoxyethylene castor oil that is ˜20.

  Furthermore, the present invention provides, from another viewpoint, (A) a nonionic surfactant having an HLB of 11 or more and (B) an average addition of ethylene oxide for use as an ophthalmic composition for soft contact lenses. A composition comprising polyoxyethylene castor oil having 2 to 20 moles is provided.

[2. Method for Reducing Increase in Friction of Soft Contact Lens and Method for Giving Ophthalmic Composition Action to Reduce Increase in Friction on Soft Contact Lens Surface]
As described above, the ophthalmic composition for soft contact lenses contains the components (A) and (B), so that the ophthalmic composition for soft contact lenses containing the component (A) is brought into contact with the soft contact lens. The increase in friction on the surface of the generated soft contact lens can be suppressed.

  Accordingly, the present invention provides, from another viewpoint, (A) a nonionic surfactant having an HLB of 11 or more, and (B) a polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20. The surface of a soft contact lens produced by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens, the method comprising contacting the ophthalmic composition for soft contact lens containing the soft contact lens with the soft contact lens A method for reducing the increase in friction is provided.

  Furthermore, from another viewpoint, the present invention provides (A) an ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more, and (B) an average added mole number of ethylene oxide is 2 to 2. Reducing the increase in friction on the surface of the soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens, comprising blending polyoxyethylene castor oil which is 20 A method for imparting an action to the ophthalmic composition is provided.

  In these methods, as long as the component (A) and the component (B) coexist, they may be added simultaneously or separately, and the order thereof is not particularly limited. Types of component (A) and component (B) to be contained, their content (or blending amount), their content ratio, other types of components to be contained, content (or blending amount), ophthalmic composition preparation The form, type of container, combination, implementation method, and the like are the same as those in “1. Ophthalmic composition for soft contact lens”.

  Especially, this method is applied suitably when the soft contact lens is a silicone hydrogel contact lens.

  Note that whether or not the friction of the lens is reduced by the above-described method can be determined by the method described in Examples described later.

[3. Method for suppressing deformation of soft contact lens, and method for imparting action to suppress deformation of soft contact lens to ophthalmic composition]
As described above, by blending the components (A) and (B) with the ophthalmic composition for soft contact lenses, the ophthalmic composition for soft contact lenses containing the component (A) is brought into contact with the soft contact lens. The deformation | transformation of the soft contact lens which arises can be suppressed.

  Accordingly, the present invention provides, from another viewpoint, (A) a nonionic surfactant having an HLB of 11 or more, and (B) a polyoxyethylene castor oil having an average added mole number of ethylene oxide of 2 to 20. A soft contact lens produced by contacting the ophthalmic composition for soft contact lens containing the component (A) with the soft contact lens, comprising contacting the ophthalmic composition for soft contact lens containing the soft contact lens with the soft contact lens. A method of suppressing deformation is provided.

  Furthermore, from another viewpoint, the present invention provides (A) an ophthalmic composition for soft contact lenses containing a nonionic surfactant having an HLB of 11 or more, and (B) an average added mole number of ethylene oxide is 2 to 2. The action which suppresses the deformation | transformation of the soft contact lens produced by making the ophthalmic composition for soft contact lenses containing the (A) component contacted with a soft contact lens including mix | blending the polyoxyethylene castor oil which is 20 A method of applying to an ophthalmic composition is provided.

  In these methods, as long as the component (A) and the component (B) coexist, they may be added simultaneously or separately, and the order thereof is not particularly limited. Types of component (A) and component (B) to be contained, their content (or blending amount), their content ratio, other types of components to be contained, content (or blending amount), ophthalmic composition preparation The form, type of container, combination, implementation method, and the like are the same as those in “1. Ophthalmic composition for soft contact lens”.

  Especially, this method is applied suitably when the soft contact lens is a silicone hydrogel contact lens.

  Whether or not the lens deformation is suppressed by the above-described method can be determined by the method described in Examples described later.

  Hereinafter, the present invention will be described in detail with reference to Examples and Test Examples, but the present invention is not limited to these Examples and the like.

[ Test Example 1 SCL surface friction test ]
The composition shown in Table 1 below was prepared by a conventional method, and the friction force on the surface of the soft contact lens was measured by the following method using a rigid pendulum physical property tester RPT-3000W (manufactured by A & D Co., Ltd.). Evaluation was performed.

  The rigid pendulum physical property tester RPT-3000W is a device for evaluating changes in surface physical properties such as adhesiveness, viscoelasticity, and drying property in terms of increase / decrease in friction. As the soft contact lens, Galyconcon A (main material name, nonionic silicone hydrogel contact lens: moisture content -47.0%, BC-8.7, DIA-14.0 mm) was used. As the polyoxyethylene castor oils 3 and 10, those having an average added mole number of ethylene oxide of 3 and 10 that conforms to the standard of polyoxyethylene castor oil of the pharmaceutical additive standard 2003 were used.

  First, soft contact lenses were immersed one by one in 5 mL of physiological saline and left for 24 hours. After 24 hours, two lenses were immersed in 20 mL of each composition and allowed to stand at room temperature overnight. On the next day, the moisture on the lens surface was gently wiped, and the logarithmic decay rate of the amplitude of the pendulum after about 60 seconds was measured under the conditions of a temperature of 25 ° C. and a relative humidity of 60% and a pendulum weight of 200 g and a sensor diameter of 4 mm. In this case, the larger the logarithmic decay rate, the greater the friction.

  From the logarithmic reduction rate when using the compositions of Examples and Comparative Examples and the measured value of the logarithmic decay rate when using the composition of Control 1, with respect to the case of using the composition of Comparative Example 1 according to the following formula The increase suppression rate of the logarithmic decay rate was calculated. It means that the increase in friction is reduced, so that a raise suppression rate is large. The results are shown in Table 1 and FIG.

  Increase suppression rate of logarithmic decay rate (%) = {1- (Logarithmic decay rate of Example or Comparative Example 2−Logarithmic decay rate of Control 1) / (Logarithmic decay rate of Comparative Example 1−Logarithmic decay rate of Control 1) } × 100

  Example 1 containing polyoxyethylene castor oil 3 or polyoxyethylene castor oil 10 together with polyoxyethylene castor oil 35 which is a nonionic surfactant having an HLB of 11 or more as shown in Table 1 and FIG. When the composition of Example 2 and the composition of Example 2 were brought into contact with the soft contact lens, the logarithm of the surface of the soft contact lens was compared with the case of using the composition of Comparative Example 1 containing only the polyoxyethylene castor oil 35. It was confirmed that the increase in the attenuation rate was remarkably suppressed and the increase in friction on the soft contact lens surface was reduced. In addition, when the same amount of the polyoxyethylene castor oil 35 was added instead of the polyoxyethylene castor oil 3 or 10, it was confirmed that the increase in friction was not reduced but increased further. (Comparative Example 2)

[ Test Example 2 Test for Evaluation of SCL Lens Size Change ]
The composition shown in the following Table 2 was prepared by a conventional method, and the change in lens size when contacting with a soft contact lens was evaluated by the following method. As the polysorbate 80, one that conforms to the standard of pharmaceutical additives 2003 was used. The same polyoxyethylene castor oil 3 and soft contact lens as those used in Test Example 1 were used.

  First, soft contact lenses were immersed one by one in 5 mL of physiological saline and allowed to stand for 24 hours to stabilize the lens size. After 24 hours, the lens was transferred to a cell filled with physiological saline, the cell was set on a universal projector (product name: PROFILE PROJECTOR V-12B, manufactured by Nikon), and the lens size (start value) was measured. .

Subsequently, the lens was immersed in 4 mL of each composition described in Table 1 and stored at room temperature for 2 hours. After 2 hours, the cells were co-washed with each composition, filled with each composition and immersed in the lens. Next, the cell was set in a universal projector, and the lens size (post-storage value) was measured. By subtracting the start value from the measured lens size after storage, the amount of change in size of each lens is calculated. Further, the amount of change in lens size when Comparative Example 3 is used is used for comparison according to the following formula. The size change inhibition rate for Example 3 was calculated. The calculation results are also shown in Table 2.
Size change suppression rate (%) = (1−size change amount of Example 3 (mm) / size change amount of Comparative Example 3 (mm)) × 100

  As shown in Table 2, when the composition of Example 3 containing polyoxyethylene castor oil 3 was brought into contact with a soft contact lens together with polysorbate 80, which is a nonionic surfactant having an HLB of 11 or more, It was confirmed that expansion of the lens size due to polysorbate 80 was suppressed.

[ Test Example 3 Test for Evaluation of SCL Lens Size Change (2) ]
The compositions shown in Table 3 below were prepared by a conventional method, and the change in lens size when contacting with a soft contact lens was evaluated in the same manner as in Test Example 2. As the polyoxyethylene hydrogenated castor oil 60, one that complies with the standard for pharmaceutical additives 2003 was used. Moreover, as polyoxyethylene castor oil 3, 10, 35, and a soft contact lens, the thing similar to Test Example 1 and 2 was used.

First, the lens was immersed in 4 mL of each composition described in Table 3 in the same manner as in Test Example 2, and stored at room temperature. After 6 hours, the size change amount of each lens was measured, and the size change suppression rate for the corresponding comparative example was calculated according to the following formula. The calculation results are also shown in Table 3. The corresponding comparative example specifically refers to Comparative Example 4 in Examples 4 and 5, and Comparative Example 5 in Examples 6 and 7.
Size change suppression rate (%) = (1−size change amount of each example (mm) / size change amount of corresponding comparative example (mm)) × 100

  As shown in Table 3, a composition containing polyoxyethylene castor oil 3 or 10 together with polyoxyethylene castor oil 35 or polyoxyethylene hydrogenated castor oil 60 which is a nonionic surfactant having an HLB of 11 or more is softened. When contacted with a contact lens, when the total amount of nonionic surfactant is the same as that when only a nonionic surfactant having an HLB of 11 or more is used, the lens size It was confirmed that the expansion was suppressed (Examples 4 to 7 and Comparative Examples 4 to 5).

Formulation Examples With the formulations shown in Table 4 and Table 5, soft contact lens eye drops (Formulation Example 1-7) and soft contact lens care solutions (Formulation Example 8) are prepared.

Claims (6)

An ophthalmic composition for soft contact lenses, comprising (A) a nonionic surfactant having an HLB of 11 or more and (B) polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20. (A) component is polysorbate 80, polyoxyethylene hydrogenated castor oil having an average addition mole number of ethylene oxide of 30 or more, polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 30 or more, polyoxyethylene ( 196) At least one selected from the group consisting of polyoxypropylene (67) glycol, polyoxyethylene (200) polyoxypropylene (70) glycol and polyethylene glycol monostearate having an average addition mole number of ethylene oxide of 10 or more The ophthalmic composition for soft contact lenses according to claim 1, wherein   The ophthalmic composition for soft contact lenses according to claim 1 or 2, wherein the total content of the component (B) is 0.001 to 100 parts by weight with respect to 1 part by weight of the total content of the component (A).   The ophthalmic composition for soft contact lenses according to any one of claims 1 to 3, further comprising a borate buffer.   The ophthalmic composition for soft contact lenses according to any one of claims 1 to 4, wherein the soft contact lenses are silicone hydrogel contact lenses.   An ophthalmic composition for soft contact lenses comprising (A) a nonionic surfactant having an HLB of 11 or more and (B) polyoxyethylene castor oil having an average addition mole number of ethylene oxide of 2 to 20, A method for reducing an increase in friction on the surface of a soft contact lens caused by bringing the ophthalmic composition for soft contact lens containing the component (A) into contact with the soft contact lens, which comprises contacting the soft contact lens.

Images