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HK1249934B - Contact lens packaging and method for manufacturing same - Google Patents

Contact lens packaging and method for manufacturing same Download PDF

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Publication number
HK1249934B
HK1249934B HK18109296.2A HK18109296A HK1249934B HK 1249934 B HK1249934 B HK 1249934B HK 18109296 A HK18109296 A HK 18109296A HK 1249934 B HK1249934 B HK 1249934B
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packaging
contact lens
nonionic surfactant
mass
silicone hydrogel
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HK18109296.2A
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Chinese (zh)
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HK1249934A1 (en
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小畑梓
小川晋
马场雅树
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株式会社目立康
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Priority claimed from PCT/JP2015/077746 external-priority patent/WO2017056235A1/en
Publication of HK1249934A1 publication Critical patent/HK1249934A1/en
Publication of HK1249934B publication Critical patent/HK1249934B/en

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Description

隐形眼镜包装及其制造方法Contact lens packaging and manufacturing method thereof

技术领域Technical Field

本发明涉及隐形眼镜包装及其制造方法。The present invention relates to contact lens packaging and a method for making the same.

背景技术Background Art

以往,作为隐形眼镜包装,提出了使用含有聚山梨醇酯、泊洛沙姆作为表面活性剂的用于疏水性隐形眼镜的包装用溶液的隐形眼镜包装(例如参见专利文献1)。对于该包装用溶液而言,能够实质上防止隐形眼镜粘附在包装材料的表面上。另外,作为隐形眼镜包装,提出了将软质镜片保存在含有甲基纤维素作为表面活性剂的包装用溶液中(例如参见专利文献2)。对于该包装用溶液而言,能够抑制软质镜片粘附在疏水性包装材料上。Conventionally, contact lens packaging has been proposed using a packaging solution for hydrophobic contact lenses containing polysorbate or poloxamer as a surfactant (see, for example, Patent Document 1). This packaging solution can substantially prevent contact lenses from adhering to the surface of the packaging material. Furthermore, contact lens packaging has been proposed in which soft lenses are stored in a packaging solution containing methylcellulose as a surfactant (see, for example, Patent Document 2). This packaging solution can inhibit soft lenses from adhering to the hydrophobic packaging material.

现有技术文献Prior art literature

专利文献Patent Literature

专利文献1:日本特表2004-523777号公报Patent Document 1: Japanese Patent Application No. 2004-523777

专利文献2:日本特表2007-512554号公报Patent Document 2: Japanese Patent Application No. 2007-512554

发明内容Summary of the Invention

发明所要解决的课题Problems to be solved by the invention

但是,对于专利文献1的包装用溶液而言,存在无法抑制柔软的镜片粘附在包装容器上的问题。另外,在专利文献2中,作为表面活性剂使用的甲基纤维素在水中的溶解性低,例如在溶解时需要进行加热等,此外存在杂质的混入、过滤性差而难以制造的问题。However, the packaging solution of Patent Document 1 has the problem of being unable to prevent soft lenses from sticking to the packaging container. Furthermore, the methylcellulose used as a surfactant in Patent Document 2 has low solubility in water, requiring heating for dissolution. Furthermore, there are problems with contamination of impurities and poor filterability, making production difficult.

另外,近年来,出于提高佩戴感的目的,对弹性模量(杨氏模量)低、更柔软的有机硅水凝胶隐形眼镜进行了研究。这种材料由于其柔软性而与包装容器的接触面积变大,例如容易粘附在疏水性强的包装容器等、隐形眼镜发生变形或破损等的可能性增加。Furthermore, in recent years, research has been underway into silicone hydrogel contact lenses, which have a lower elastic modulus (Young's modulus) and are more flexible, to improve wearability. This flexibility increases the contact area between these materials and the packaging, making them more susceptible to adhesion to, for example, highly hydrophobic packaging, increasing the potential for deformation or damage to the contact lenses.

本发明是鉴于这样的课题而完成的,其主要目的在于提供一种隐形眼镜包装及其制造方法,其具有优异的有机硅水凝胶隐形眼镜与由聚丙烯形成的包装容器的吸附抑制效果。The present invention has been made in view of the above problems, and its main object is to provide a contact lens package and a method for producing the same, which have an excellent effect of inhibiting adsorption of silicone hydrogel contact lenses to a packaging container formed of polypropylene.

用于解决课题的手段Means for solving problems

为了实现上述目的进行了深入研究,结果本发明人发现,在使用含有所期望量的规定的非离子型表面活性剂的包装溶液时,具有优异的吸附抑制效果,从而完成了本发明。As a result of intensive studies to achieve the above-mentioned object, the present inventors discovered that the use of a packaging solution containing a desired amount of a predetermined nonionic surfactant exhibits an excellent adsorption inhibitory effect, thereby completing the present invention.

即,本发明的隐形眼镜包装具备:That is, the contact lens package of the present invention comprises:

有机硅水凝胶隐形眼镜、Silicone hydrogel contact lenses,

由聚丙烯形成的包装容器、和Packaging container formed of polypropylene, and

包装溶液,其含有非离子型表面活性剂,该非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,该非离子型表面活性剂的1摩尔中的上述氧化乙烯的平均加成摩尔数为30以上。A packaging solution containing a nonionic surfactant having a linear alkyl moiety having 12 or more carbon atoms and an ethylene oxide moiety, wherein the average number of added moles of the ethylene oxide per mole of the nonionic surfactant is 30 or more.

本发明的隐形眼镜包装的制造方法包含下述工序:The method for manufacturing a contact lens package of the present invention comprises the following steps:

向由聚丙烯形成的包装容器中封入有机硅水凝胶隐形眼镜和包装溶液,该包装溶液含有非离子型表面活性剂,该非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,该非离子型表面活性剂的1摩尔中的上述氧化乙烯的平均加成摩尔数为30以上。A silicone hydrogel contact lens and a packaging solution are enclosed in a packaging container formed of polypropylene. The packaging solution contains a nonionic surfactant having a linear alkyl moiety having 12 or more carbon atoms and an ethylene oxide moiety, wherein the average number of added moles of the ethylene oxide per mole of the nonionic surfactant is 30 or more.

发明效果Effects of the Invention

在本发明的隐形眼镜包装及其制造方法中,能够进一步抑制有机硅水凝胶隐形眼镜与由聚丙烯形成的包装容器的粘附(吸附)。据推测其原因在于,例如非离子型表面活性剂具有碳原子数为12以上的直链的烷基部,氧化乙烯的平均加成摩尔数为30以上,因此与有机硅水凝胶的疏水性部分的相容性良好。通常有机硅水凝胶的疏水性强,因此推测在水中与非离子表面活性剂的疏水性部分强烈地相互作用。由此推测,被镜片表面吸引的表面活性剂将亲水性的单元朝向表面(液体中),作为结果,能够赋予镜片表面亲水性。但是,非离子表面活性剂的亲水性过强的情况下,表面活性剂本身不会被镜片本身吸引,从而难以赋予镜片表面亲水性。另一方面,非离子表面活性剂的疏水性过强的情况下,虽然表面活性剂本身能够牢固地附着在镜片上,但难以赋予镜片充分的亲水性。因此,这些疏水性、亲水性的平衡非常重要。在本发明中,非离子型表面活性剂的这些疏水性、亲水性的平衡良好,因此推测有效地起到吸附抑制效果。In the contact lens packaging and manufacturing method of the present invention, the adhesion (adsorption) of silicone hydrogel contact lenses to the packaging container formed by polypropylene can be further suppressed. It is speculated that the reason is that, for example, the non-ionic surfactant has a straight-chain alkyl portion with a carbon number of 12 or more, and the average number of added moles of ethylene oxide is 30 or more, so it has good compatibility with the hydrophobic part of the silicone hydrogel. Generally, silicone hydrogel has strong hydrophobicity, so it is speculated that it interacts strongly with the hydrophobic part of the non-ionic surfactant in water. It is speculated that the surfactant attracted by the lens surface will face the hydrophilic unit toward the surface (in the liquid), and as a result, it can impart hydrophilicity to the lens surface. However, when the hydrophilicity of the non-ionic surfactant is too strong, the surfactant itself will not be attracted by the lens itself, making it difficult to impart hydrophilicity to the lens surface. On the other hand, when the hydrophobicity of the non-ionic surfactant is too strong, although the surfactant itself can be firmly attached to the lens, it is difficult to impart sufficient hydrophilicity to the lens. Therefore, the balance of these hydrophobicity and hydrophilicity is very important. In the present invention, the nonionic surfactant has a good balance between the hydrophobicity and the hydrophilicity, and therefore is presumed to effectively exhibit the adsorption inhibitory effect.

具体实施方式DETAILED DESCRIPTION

本发明的隐形眼镜包装具备:有机硅水凝胶隐形眼镜、由聚丙烯形成的包装容器、和含有非离子型表面活性剂的包装溶液。在该包装溶液中,非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,非离子型表面活性剂的1摩尔中的氧化乙烯的平均加成摩尔数为30以上。需要说明的是,“直链的烷基部”是指,碳原子呈一条链状连接的结构,而不是环状或分支的结构。The contact lens package of the present invention comprises a silicone hydrogel contact lens, a packaging container made of polypropylene, and a packaging solution containing a nonionic surfactant. The nonionic surfactant in the packaging solution comprises a linear alkyl moiety having 12 or more carbon atoms and an ethylene oxide moiety, with the average number of added moles of ethylene oxide per mole of the nonionic surfactant being 30 or more. It should be noted that the term "linear alkyl moiety" refers to a structure in which carbon atoms are linked in a chain, rather than a cyclic or branched structure.

作为有机硅水凝胶隐形眼镜,可以采用公知的有机硅水凝胶隐形眼镜。例如有机硅水凝胶隐形眼镜可以举出含有与亲水性单体共聚的有机硅单体的聚合物等。作为制作这样的有机硅水凝胶的材料,可以举出例如acquafilcon A、asmofilcon A、balafolcon A、comfilcon A、enfilcon A、galyfilcon A、lenefilcon A、lotorafilcon A、lotorafilconB、senofilcon A、comfilcon A、stenfilcon A、narafilcon A等。另外,作为有机硅水凝胶所含有的有机硅单体,可以举出例如3-(甲基)丙烯酰氧基丙基三(三甲基甲硅烷氧基)硅烷、单(甲基)丙烯酰氧基丙基末端聚二甲基硅氧烷、3-(甲基)丙烯酰氧基丙基-双(三甲基甲硅烷氧基)甲基硅烷、(甲基)丙烯酰氧基丙基五甲基二硅氧烷等。从与其它单体的相容性优异、能够蒸馏、容易得到纯度高的单体的方面出发,更优选3-甲基丙烯酰氧基丙基三(三甲基甲硅烷氧基)硅烷(TRIS)。As silicone hydrogel contact lenses, known silicone hydrogel contact lenses can be used. For example, silicone hydrogel contact lenses include polymers containing silicone monomers copolymerized with hydrophilic monomers. Examples of materials for making such silicone hydrogels include acquafilcon A, asmofilcon A, balafolcon A, comfilcon A, enfilcon A, galyfilcon A, lenefilcon A, lotorafilcon A, lotorafilcon B, senofilcon A, comfilcon A, stenfilcon A, and narafilcon A. Examples of silicone monomers contained in silicone hydrogels include 3-(meth)acryloxypropyl tris(trimethylsiloxy)silane, mono(meth)acryloxypropyl-terminated polydimethylsiloxane, 3-(meth)acryloxypropyl-bis(trimethylsiloxy)methylsilane, and (meth)acryloxypropyl pentamethyldisiloxane. 3-Methacryloxypropyltris(trimethylsiloxy)silane (TRIS) is more preferred because it has excellent compatibility with other monomers, can be distilled, and can easily obtain a highly pure monomer.

另外,作为制作有机硅水凝胶的材料,可以举出例如有机硅大单体。作为该有机硅大单体,可以为例如具有聚氨酯结构、乙烯型不饱和结构、聚二甲基硅氧烷结构、和聚合基团的化合物。该聚合基团可以为例如丙烯酰基和甲基丙烯酰基中的一者以上。该有机硅大单体可以具有例如化学式(1)的结构。此处,式(1)中,c优选为30以上50以下。作为该有机硅大单体的例子,可以举出化学式(2)所表示的化合物等。或者,有机硅大单体可以为化学式(3)所表示的化合物。In addition, as materials for making silicone hydrogels, silicone macromonomers can be cited, for example. As the silicone macromonomer, it can be a compound having, for example, a polyurethane structure, an ethylenically unsaturated structure, a polydimethylsiloxane structure, and a polymeric group. The polymeric group can be, for example, one or more of an acryloyl group and a methacryloyl group. The silicone macromonomer can have, for example, a structure of chemical formula (1). Here, in formula (1), c is preferably 30 or more and 50 or less. As examples of the silicone macromonomer, compounds represented by chemical formula (2) can be cited. Alternatively, the silicone macromonomer can be a compound represented by chemical formula (3).

[化1][Chemistry 1]

[化2][Chemistry 2]

[化3][Chemistry 3]

作为有机硅水凝胶所含有的亲水性单体,可以举出例如甲基丙烯酸、丙烯酸等不饱和羧酸、甲基丙烯酸-2-羟乙酯、丙烯酸-2-羟乙酯等丙烯酸取代的醇、1-甲基-3-亚甲基-2-吡咯烷酮、N-乙烯基吡咯烷酮等乙烯基内酰胺、甲基丙烯酰胺、N,N-二甲基丙烯酰胺等丙烯酰胺、具有聚乙二醇部位的(甲基)丙烯酸酯等。其中,N-乙烯基吡咯烷酮、N,N-二甲基丙烯酰胺、1-甲基-3-亚甲基-2-吡咯烷酮等与其它单体的相容性优异、相对于疏水性的有机硅水凝胶能够以少量赋予高亲水性,因此是优选的。Examples of hydrophilic monomers included in the silicone hydrogel include unsaturated carboxylic acids such as methacrylic acid and acrylic acid, acrylic acid-substituted alcohols such as 2-hydroxyethyl methacrylate and 2-hydroxyethyl acrylate, vinyl lactams such as 1-methyl-3-methylene-2-pyrrolidone and N-vinylpyrrolidone, acrylamides such as methacrylamide and N,N-dimethylacrylamide, and (meth)acrylates having a polyethylene glycol moiety. Among these, N-vinylpyrrolidone, N,N-dimethylacrylamide, and 1-methyl-3-methylene-2-pyrrolidone are preferred because they have excellent compatibility with other monomers and can impart high hydrophilicity to the hydrophobic silicone hydrogel with a small amount.

该有机硅水凝胶隐形眼镜的杨氏模量优选为1.2MPa以下。该杨氏模量为1.2MPa以下时,镜片柔软,能够进一步抑制由于镜片与眼表面摩擦而会产生的充血等,因此是优选的。从进一步提高佩戴感的观点出发,该杨氏模量更优选为1.1MPa以下。另外,有机硅水凝胶隐形眼镜的杨氏模量超过1.2MPa的情况下,特别是在1.4MPa以上时,镜片比较硬、与包装容器的接触面积不易变大,因此不易产生隐形眼镜与包装容器的粘附。对于本发明的隐形眼镜包装而言,杨氏模量小于1.4MPa等对于更柔软的有机硅水凝胶隐形眼镜更有效。The Young's modulus of the silicone hydrogel contact lens is preferably 1.2 MPa or less. When the Young's modulus is 1.2 MPa or less, the lens is soft and can further suppress congestion caused by friction between the lens and the eye surface, so it is preferred. From the perspective of further improving the wearing experience, the Young's modulus is more preferably 1.1 MPa or less. In addition, when the Young's modulus of the silicone hydrogel contact lens exceeds 1.2 MPa, especially when it is above 1.4 MPa, the lens is relatively hard and the contact area with the packaging container is not easy to increase, so it is not easy for the contact lens to adhere to the packaging container. For the contact lens packaging of the present invention, a Young's modulus of less than 1.4 MPa is more effective for softer silicone hydrogel contact lenses.

该有机硅水凝胶隐形眼镜可以进行表面改性处理。通过表面改性处理能够进一步提高有机硅水凝胶隐形眼镜的表面的水濡性。作为表面改性处理,可以应用例如本领域技术人员公知的低温等离子体处理、大气压等离子体、电晕放电等。该表面改性处理可以在减压下进行,也可以在大气压下进行。例如在减压条件下进行的低温等离子体处理等中,可以应用碳原子数为1~6的烷烃、氟取代的烷烃、O2、N2、CO2、氩、氢、空气和水蒸汽等中的1种以上作为载气。The silicone hydrogel contact lens may be subjected to a surface modification treatment. The surface modification treatment can further improve the water wettability of the surface of the silicone hydrogel contact lens. As a surface modification treatment, for example, low-temperature plasma treatment, atmospheric pressure plasma, corona discharge, and the like, which are well known to those skilled in the art, may be applied. The surface modification treatment may be performed under reduced pressure or at atmospheric pressure. For example, in low-temperature plasma treatment performed under reduced pressure, one or more of alkanes having 1 to 6 carbon atoms, fluorine-substituted alkanes, O₂ , N₂ , CO₂ , argon, hydrogen, air, and water vapor may be used as a carrier gas.

对于包装容器,以往以来研究了聚丙烯、聚乙烯、尼龙、烯烃、共聚物、丙烯酸类树脂、橡胶、聚氨酯、聚碳酸酯或氟碳树脂等,但从水蒸汽透过性低、耐高压蒸汽灭菌性、耐久性、原料费低、透明性的观点出发,优选由聚丙烯形成包装容器。在该包装容器中形成有容纳有机硅水凝胶隐形眼镜的容纳部。进一步,优选具备覆盖该包装容器的镜片容纳部开口而不透流体地密封的盖片的隐形眼镜包装。需要说明的是,盖片优选由层积片等形成,该层积片由使铝箔和合成树脂为层状或箔状而层积一体化的复合材料构成。While polypropylene, polyethylene, nylon, olefins, copolymers, acrylic resins, rubber, polyurethane, polycarbonate, or fluorocarbon resins have been studied as packaging containers, polypropylene is preferred due to its low water vapor permeability, resistance to high-pressure steam sterilization, durability, low raw material costs, and transparency. A housing for silicone hydrogel contact lenses is formed within the packaging container. Furthermore, contact lens packaging preferably includes a cover sheet that covers the lens housing opening of the packaging container and seals it fluid-tight. It should be noted that the cover sheet is preferably formed from a laminated sheet, for example, comprising a composite material comprising aluminum foil and a synthetic resin laminated in layers or foils.

包装溶液含有非离子型表面活性剂,该非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,非离子型表面活性剂的1摩尔中的氧化乙烯的平均加成摩尔数为30以上。在使包装溶液含有这样的非离子型表面活性剂时,能够进一步抑制有机硅水凝胶隐形眼镜与包装容器的粘附。在该非离子型表面活性剂中,直链的烷基部的碳原子数为12以上时,能够充分表现出疏水性,从容易获得的观点出发,也是优选的。该碳原子数更优选为15以上,进一步优选为17以上。另外,从容易溶解于溶液的观点出发,该碳原子数优选为20以下。有机硅水凝胶具有疏水性的部分,因此对于表现出隐形眼镜与包装容器的吸附抑制效果而言,优选具有能够表现出一定程度的疏水性的直链的烷基部分。为了表现出所需的充分的疏水性,该烷基链的碳原子数优选为12以上20以下。另外,从容易溶解于溶液和赋予亲水性的观点出发,该非离子型表面活性剂的氧化乙烯的平均加成摩尔数优选为30以上,更优选为40以上。从容易获得的观点出发,该氧化乙烯的平均加成摩尔数优选为100以下。作为该非离子型表面活性剂,可以举出例如聚氧乙烯固化蓖麻油。作为该聚氧乙烯固化蓖麻油,可以举出例如聚氧乙烯固化蓖麻油40(氧化乙烯的平均加成摩尔数=40)、聚氧乙烯固化蓖麻油60(氧化乙烯的平均加成摩尔数=60)、聚氧乙烯固化蓖麻油100(氧化乙烯的平均加成摩尔数=100)等。The packaging solution contains a nonionic surfactant comprising a linear alkyl moiety having 12 or more carbon atoms and an ethylene oxide moiety, wherein the average number of added moles of ethylene oxide per mol of the nonionic surfactant is 30 or more. The inclusion of such a nonionic surfactant in the packaging solution can further suppress adhesion of silicone hydrogel contact lenses to packaging containers. For this nonionic surfactant, a linear alkyl moiety having 12 or more carbon atoms exhibits sufficient hydrophobicity, which is also preferred from the perspective of availability. This carbon number is more preferably 15 or more, and even more preferably 17 or more. Furthermore, from the perspective of ease of solubility in solution, this carbon number is preferably 20 or less. Silicone hydrogels have a hydrophobic portion, so in order to exhibit an effect that inhibits adsorption between contact lenses and packaging containers, it is preferable to have a linear alkyl moiety that exhibits a certain degree of hydrophobicity. To achieve the desired sufficient hydrophobicity, the alkyl chain preferably has 12 or more carbon atoms and 20 or less carbon atoms. In addition, from the viewpoint of easy solubility in a solution and imparting hydrophilicity, the average number of moles of ethylene oxide added to the nonionic surfactant is preferably 30 or more, more preferably 40 or more. From the viewpoint of easy availability, the average number of moles of ethylene oxide added is preferably 100 or less. Examples of such nonionic surfactants include polyoxyethylene-hydrogenated castor oil. Examples of such polyoxyethylene-hydrogenated castor oils include polyoxyethylene-hydrogenated castor oil 40 (average number of moles of ethylene oxide added = 40), polyoxyethylene-hydrogenated castor oil 60 (average number of moles of ethylene oxide added = 60), and polyoxyethylene-hydrogenated castor oil 100 (average number of moles of ethylene oxide added = 100).

包装溶液优选以0.001质量%以上0.1质量%以下的范围含有非离子型表面活性剂。该含量为0.001质量%以上时,能够更加显著地发挥出隐形眼镜与包装容器的吸附抑制效果。为了得到目标效果,该含量更优选为0.005质量%以上。另外,该含量为0.1质量%以下时,含量不会过多,能够进一步抑制产生起泡等,容易进行制造。另外,能够抑制隐形眼镜过度溶胀,容易从包装容器取出隐形眼镜,因此是优选的。该含量更优选为0.08质量%以下的范围。The packaging solution preferably contains a nonionic surfactant in a range of 0.001% to 0.1% by mass. A content of 0.001% by mass or greater can significantly inhibit adsorption of the contact lens to the packaging container. To achieve the desired effect, this content is more preferably 0.005% by mass or greater. Furthermore, a content of 0.1% or less will not be excessive, further suppressing blistering and facilitating manufacturing. This is also preferred because it can inhibit excessive swelling of the contact lens, making it easier to remove the contact lens from the packaging container. A more preferred content is 0.08% by mass or less.

只要不损害本发明的效果,则该包装溶液中除了上述的非离子型表面活性剂之外,还可以含有添加到包装溶液中的物质。作为该添加的物质,可以举出例如螯合剂、等渗剂、pH调节剂、缓冲剂、表面活性剂、增稠剂、防腐剂(保存剂)、湿润剂等。这些物质可以将一种物质添加到包装溶液中,也可以将2种以上组合来添加到包装溶液中。In addition to the nonionic surfactant described above, the packaging solution may contain other substances that can be added to the packaging solution, as long as the effects of the present invention are not impaired. Examples of such added substances include chelating agents, isotonicity agents, pH adjusters, buffers, surfactants, thickeners, preservatives (preservatives), and wetting agents. These substances may be added to the packaging solution alone or in combination of two or more.

作为螯合剂,可以举出例如乙二胺四乙酸(EDTA)及其水合物、乙二胺四乙酸二钠(EDTA-2Na)及其水合物、乙二胺四乙酸三钠(EDTA-3Na)及其水合物、乙二胺四乙酸四钠(EDTA-4Na)及其水合物、植酸、柠檬酸等。该螯合剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,在用户使用隐形眼镜时不易给眼带来影响。另外,该混配量优选为0.001质量%以上。混配量为0.001质量%以上时,能够进一步发挥螯合剂的效果。Examples of chelating agents include ethylenediaminetetraacetic acid (EDTA) and its hydrates, disodium ethylenediaminetetraacetate (EDTA-2Na) and its hydrates, trisodium ethylenediaminetetraacetate (EDTA-3Na) and its hydrates, tetrasodium ethylenediaminetetraacetate (EDTA-4Na) and its hydrates, phytic acid, and citric acid. The amount of the chelating agent in the packaging solution is preferably in the range of 0% by mass or more and 1.0% by mass or less. When the amount is 1.0% by mass or less, the user is less likely to experience eye problems when using contact lenses. Furthermore, the amount is preferably 0.001% by mass or more. When the amount is 0.001% by mass or more, the chelating agent's effect can be further enhanced.

作为等渗剂,可以举出例如甘油、丙二醇、氯化钠、氯化钾、山梨糖醇、甘露醇等。该等渗剂在包装溶液中的混配量优选为0质量%以上2.0质量%以下的范围。混配量为2.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥等渗剂的效果。As isotonic agents, for example, glycerol, propylene glycol, sodium chloride, potassium chloride, sorbitol, mannitol, etc. can be mentioned. The compounding amount of the isotonic agent in the packaging solution is preferably in the range of 0 mass % or more and 2.0 mass % or less. When the compounding amount is below 2.0 mass %, it is safe for the eyes and is not easy to cause eye irritation or foreign body sensation when the user uses contact lenses. In addition, the compounding amount is preferably above 0.01 mass %. When the compounding amount is above 0.01 mass %, the effect of the isotonic agent can be further exerted.

作为pH调节剂,可以举出例如盐酸、柠檬酸、乙酸、氢氧化钠、氢氧化钾、碳酸钠、碳酸氢钠等。该pH调节剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,在用户使用隐形眼镜时不易给眼带来影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥pH调节剂的效果。Examples of pH adjusters include hydrochloric acid, citric acid, acetic acid, sodium hydroxide, potassium hydroxide, sodium carbonate, and sodium bicarbonate. The amount of the pH adjuster blended into the packaging solution is preferably in the range of 0% by mass to 1.0% by mass. A blending amount of 1.0% by mass or less reduces the risk of eye problems when the user wears contact lenses. Furthermore, the blending amount is preferably 0.01% by mass or greater. A blending amount of 0.01% by mass or greater further enhances the effectiveness of the pH adjuster.

作为缓冲剂,可以举出例如磷酸、磷酸盐缓冲剂、硼酸、硼砂和硼酸盐缓冲剂、碳酸盐缓冲剂、乙酸、柠檬酸、ε-氨基己酸、2-氨基-2-甲基-1,3-丙烷(AMP)缓冲剂、三(羟基甲基)氨基甲烷(Tris)缓冲液、双(2-羟基乙基)亚氨基三(羟基甲基)甲烷(Bis-Tris)等。该缓冲剂在包装溶液中的混配量优选为0质量%以上2.0质量%以下的范围。混配量为2.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥缓冲剂的效果。Examples of buffering agents include phosphoric acid, phosphate buffers, boric acid, borax and borate buffers, carbonate buffers, acetic acid, citric acid, ε-aminocaproic acid, 2-amino-2-methyl-1,3-propane (AMP) buffer, tris(hydroxymethyl)aminomethane (Tris) buffer, and bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane (Bis-Tris). The amount of the buffer in the packaging solution is preferably in the range of 0% by mass or more and 2.0% by mass or less. When the amount is 2.0% by mass or less, the eye is safer and is less likely to cause eye irritation or foreign body sensation when the user uses contact lenses. In addition, the amount is preferably 0.01% by mass or more. When the amount is 0.01% by mass or more, the effect of the buffer can be further exerted.

作为表面活性剂,可以举出例如聚甘油脂肪酸酯、聚氧乙烯烷基醚、聚氧乙烯/聚氧丙烯嵌段共聚物、聚氧乙烯/聚氧丙烯乙二胺、聚氧乙烯山梨聚糖脂肪酸酯、聚氧乙烯烷基苯基醚甲醛缩合物、聚氧乙烯烷基苯基醚、聚氧乙烯甘油脂肪酸酯、聚氧乙烯山梨糖醇脂肪酸酯、聚氧乙烯固化蓖麻油、聚氧乙烯甾醇、聚氧乙烯氢化甾醇、聚氧乙烯脂肪酸酯、聚氧乙烯聚氧丙烯烷基醚、聚氧乙烯羊毛脂醇、聚氧乙烯烷基胺、聚氧乙烯烷基酰胺、聚氧乙烯烷基醚磷酸、聚山梨醇酯等。该表面活性剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.001质量%以上。混配量为0.001质量%以上时,能够进一步发挥表面活性剂的效果。As surfactant, for example, polyglycerol fatty acid ester, polyoxyethylene alkyl ether, polyoxyethylene/polyoxypropylene block copolymer, polyoxyethylene/polyoxypropylene ethylenediamine, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene alkylphenyl ether formaldehyde condensate, polyoxyethylene alkylphenyl ether, polyoxyethylene glycerol fatty acid ester, polyoxyethylene sorbitol fatty acid ester, polyoxyethylene solidified castor oil, polyoxyethylene sterol, polyoxyethylene hydrogenated sterol, polyoxyethylene fatty acid ester, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene lanolin alcohol, polyoxyethylene alkylamine, polyoxyethylene alkylamide, polyoxyethylene alkyl ether phosphoric acid, polysorbate etc. can be enumerated.The compounding amount of this surfactant in the packaging solution is preferably the scope of 0 mass % or more and 1.0 mass % or less. When compounding amount is 1.0 mass % or less, it is high for the safety of eyes, is difficult for bringing eye irritation or foreign body sensation when the user uses contact lenses. In addition, this compounding amount is preferably 0.001 mass % or more. When the compounding amount is 0.001 mass % or more, the effect of the surfactant can be further exhibited.

作为增稠剂,可以举出例如聚乙烯醇、聚乙烯吡咯烷酮、聚乙二醇、聚丙二醇、聚丙烯酰胺等、羟基甲基纤维素、羟基丙基纤维素等纤维素衍生物、淀粉衍生物、合成有机高分子化合物等。该增稠剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥增稠剂的效果。Examples of thickeners include polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, polypropylene glycol, polyacrylamide, cellulose derivatives such as hydroxymethylcellulose and hydroxypropylcellulose, starch derivatives, and synthetic organic polymers. The amount of thickener blended into the packaging solution is preferably in the range of 0% by mass to 1.0% by mass. A blending amount of 1.0% by mass or less provides enhanced eye safety and is less likely to cause eye irritation or foreign body sensation when the user wears contact lenses. Furthermore, the blending amount is preferably 0.01% by mass or greater. A blending amount of 0.01% by mass or greater further enhances the effectiveness of the thickener.

作为防腐剂(保存剂),可以举出例如山梨酸、山梨酸钾、苯扎氯铵、苄索氯铵、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、氯丁醇等。该防腐剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥防腐剂的效果。As the preservative (preservative), for example, sorbic acid, potassium sorbate, benzalkonium chloride, benzethonium chloride, methylparaben, propylparaben, chlorobutanol, etc. can be enumerated. The compounding amount of the preservative in the packaging solution is preferably in the range of 0 mass % or more and 1.0 mass % or less. When the compounding amount is below 1.0 mass %, it is high for the safety of the eyes and is difficult to bring about eye irritation or foreign body sensation when the user uses contact lenses. In addition, the compounding amount is preferably above 0.01 mass %. When the compounding amount is above 0.01 mass %, the effect of the preservative can be further brought into play.

作为湿润剂,可以举出例如甘油、聚乙二醇、丙二醇、聚乙烯醇、聚乙烯吡咯烷酮、阳离子纤维素聚合物、羟基丙基甲基纤维素、羟基乙基纤维素、甲基纤维素等。该湿润剂在包装溶液中的混配量优选为0质量%以上1.0质量%以下的范围。混配量为1.0质量%以下时,对于眼的安全性高、在用户使用隐形眼镜时不易带来眼刺激或异物感等影响。另外,该混配量优选为0.01质量%以上。混配量为0.01质量%以上时,能够进一步发挥湿润剂的效果。Examples of wetting agents include glycerin, polyethylene glycol, propylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, cationic cellulose polymers, hydroxypropyl methylcellulose, hydroxyethyl cellulose, and methylcellulose. The amount of the wetting agent blended into the packaging solution is preferably in the range of 0% by mass to 1.0% by mass. A blending amount of 1.0% by mass or less provides enhanced eye safety and is less likely to cause eye irritation or a foreign body sensation when the contact lens is used. Furthermore, the blending amount is preferably 0.01% by mass or greater. A blending amount of 0.01% by mass or greater further enhances the wetting agent's effectiveness.

包装溶液与20℃的有机硅水凝胶隐形眼镜的比重差优选为0.1以下。在该比重差的范围,能够防止或进一步抑制由于有机硅水凝胶隐形眼镜浮起从包装溶液露出并与空气接触会产生的变形等。该比重差是指从有机硅水凝胶隐形眼镜的比重减去包装溶液的比重得到的值。该比重差优选为0.08以下,更优选为0.06以下。The difference in specific gravity between the packaging solution and the silicone hydrogel contact lens at 20°C is preferably 0.1 or less. Within this specific gravity difference range, deformation caused by the silicone hydrogel contact lens floating out of the packaging solution and coming into contact with air can be prevented or further suppressed. The specific gravity difference is the value obtained by subtracting the specific gravity of the packaging solution from the specific gravity of the silicone hydrogel contact lens. This specific gravity difference is preferably 0.08 or less, and more preferably 0.06 or less.

包装溶液的pH优选为4.0以上9.0以下的范围。包装溶液的pH在该范围时,例如能够进一步抑制高压灭菌处理中的有机硅水凝胶的劣化,能够充分维持有机硅水凝胶隐形眼镜的强度。该pH的范围例如更优选5.0以上8.0以下的范围。The pH of the packaging solution is preferably in the range of 4.0 to 9.0. When the pH of the packaging solution is within this range, for example, degradation of the silicone hydrogel during autoclaving can be further suppressed, and the strength of the silicone hydrogel contact lens can be adequately maintained. For example, the pH range is more preferably in the range of 5.0 to 8.0.

包装溶液的渗透压优选为200mOsm以上500mOsm以下的范围,更优选为250mOsm以上400mOsm以下的范围。渗透压在该范围时,例如不易给用户的眼带来刺激等影响,并且能够进一步防止产生隐形眼镜的变形等不良情况。The osmotic pressure of the packaging solution is preferably in the range of 200 mOsm to 500 mOsm, more preferably in the range of 250 mOsm to 400 mOsm. When the osmotic pressure is within this range, it is less likely to cause irritation to the user's eyes and can further prevent problems such as deformation of the contact lens.

包装溶液优选以0.01ml以上5.0ml以下的范围封入包装容器内,更优选为0.1ml以上2.5ml以下的范围。The packaging solution is preferably sealed in the packaging container in a range of 0.01 ml to 5.0 ml, more preferably in a range of 0.1 ml to 2.5 ml.

本发明的隐形眼镜包装的制造方法包含下述工序,向由聚丙烯形成的包装容器中封入有机硅水凝胶隐形眼镜和包装溶液,该包装溶液含有非离子型表面活性剂,非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,非离子型表面活性剂的1摩尔中的氧化乙烯的平均加成摩尔数为30以上。在该制造方法中,可以适当采用上述的有机硅水凝胶隐形眼镜、包装容器、包装溶液的形态。The method for producing a contact lens package of the present invention comprises the steps of enclosing a silicone hydrogel contact lens and a packaging solution in a packaging container made of polypropylene, the packaging solution containing a nonionic surfactant, wherein the nonionic surfactant contains a linear alkyl moiety having 12 or more carbon atoms and an ethylene oxide moiety, and the average number of added moles of ethylene oxide per mole of the nonionic surfactant is 30 or more. In this production method, the aforementioned forms of the silicone hydrogel contact lens, packaging container, and packaging solution can be appropriately adopted.

在以上详细说明的本实施方式的隐形眼镜包装及其制造方法中,能够进一步抑制有机硅水凝胶隐形眼镜与由聚丙烯形成的包装容器的粘附。另外,由于能够抑制该粘附,因此能够使镜片形状保持一定。进一步,能够更有效地抑制产生由于隐形眼镜的粘附所导致的变形或破损、光学特性的变化、佩戴感的降低等现象。据推测其原因如下。据推测是因为,例如包装溶液所含有的非离子型表面活性剂具有碳原子数为12以上的直链的烷基部,氧化乙烯的平均加成摩尔数为30以上,因此与有机硅水凝胶的疏水性的部分的相容性良好。通常有机硅水凝胶的疏水性强,因此推测在水中与非离子表面活性剂的疏水性的部分强烈地相互作用。由此推测,被镜片表面吸引的表面活性剂使亲水性的单元朝向表面(液体中),作为结果,能够赋予镜片表面亲水性。但是,非离子表面活性剂的亲水性过强的情况下,表面活性剂本身不会被镜片本身吸引,从而难以赋予镜片表面亲水性。另一方面,非离子表面活性剂的疏水性过强的情况下,虽然表面活性剂本身能够牢固地附着在镜片上,但难以赋予镜片充分的亲水性。本发明中的非离子型表面活性剂的这些疏水性、亲水性的平衡良好,因此认为对于有机硅水凝胶与聚丙烯制的包装容器的吸附,有效地带来高抑制效果。In the contact lens packaging and manufacturing method of the present embodiment described in detail above, adhesion of the silicone hydrogel contact lens to the packaging container formed from polypropylene can be further suppressed. In addition, since this adhesion can be suppressed, the lens shape can be maintained. Furthermore, deformation or damage caused by adhesion of the contact lens, changes in optical properties, and a reduction in wearing comfort can be more effectively suppressed. The reason for this is presumably as follows. It is presumed that, for example, the nonionic surfactant contained in the packaging solution has a linear alkyl moiety with 12 or more carbon atoms and an average number of added moles of ethylene oxide of 30 or more, and therefore has good compatibility with the hydrophobic portion of the silicone hydrogel. Silicone hydrogels are generally highly hydrophobic, and therefore it is presumed that they interact strongly with the hydrophobic portion of the nonionic surfactant in water. It is therefore presumed that the surfactant attracted to the lens surface directs its hydrophilic units toward the surface (in the liquid), resulting in the lens surface being rendered hydrophilic. However, if the nonionic surfactant is too hydrophilic, the surfactant itself will not be attracted to the lens itself, making it difficult to impart hydrophilicity to the lens surface. On the other hand, if the nonionic surfactant is too hydrophobic, while the surfactant itself can firmly adhere to the lens, it is difficult to impart sufficient hydrophilicity to the lens. The nonionic surfactant in the present invention has a good balance between these hydrophobic and hydrophilic properties, and is therefore believed to effectively inhibit the adsorption of silicone hydrogel to polypropylene packaging containers.

另外,对于隐形眼镜,通常为了提供与各用户的视力、角膜形状的偏差等恰当匹配的镜片,除了镜片直径(DIA)之外,度数(屈光度)、基础曲线形状(BC)等、各种镜片尺寸等规格也严格地设定。根据本实施方式的隐形眼镜包装,能够更加有效地抑制有机硅水凝胶隐形眼镜与包装容器的粘附(吸附),因此除了能够长期间良好地保存镜片之外,还能够防止用户使用时的镜片破损。Furthermore, contact lenses are typically designed to precisely match individual users' vision, corneal shape variations, and other factors. In addition to lens diameter (DIA), specifications such as diopter, base curve shape (BC), and various lens sizes are also strictly defined. The contact lens packaging of this embodiment effectively prevents adhesion (adsorption) of silicone hydrogel contact lenses to the packaging container, thereby ensuring long-term lens preservation and preventing lens breakage during user use.

需要说明的是,本发明完全不限于上述的实施方式,只要在属于本发明的技术范围,则自然可以以各种方式实施。It should be noted that the present invention is not limited to the above-mentioned embodiments, and can be implemented in various forms as long as it falls within the technical scope of the present invention.

实施例Example

以下,以具体地制作、使用本发明的隐形眼镜包装的例子作为实施例进行说明。Hereinafter, an example in which the contact lens package of the present invention is specifically produced and used will be described as an embodiment.

[隐形眼镜][Contact lenses]

作为市售品1,使用Johnson&Johnson制造的1-DAY ACUVUE TruEye。作为预处理,将15ml的包装溶液和5片市售品1的镜片放入日电理科硝子株式会社制造的螺纹口瓶SV-20中,进行3小时以上液体置换。另外,对于材料1~4的隐形眼镜,如下进行制作。即,将如表1所示那样进行混配的聚合性组合物放入隐形眼镜形状的聚丙烯制的隐形眼镜模具中,对于材料1、2,利用蓝色荧光灯照射15分钟后,利用高照度蓝色LED灯照射15分钟,由此制作出隐形眼镜。对于材料3、4,利用高压汞灯照射20分钟紫外光,由此制作出隐形眼镜。需要说明的是,表1所示的含氨基甲酸酯键的聚二甲基硅氧烷大单体具有化学式(2)所表示的结构。另外,使用等离子体发生装置,对材料1、2、4的隐形眼镜实施表面改性处理。使载气为CO2、在减压状态下以80W输出功率进行该表面改性处理。对于材料3的隐形眼镜,未实施表面改性处理。另外,制作进行大气压等离子体处理的隐形眼镜。首先,将如表1所示那样进行混配的材料1的聚合性组合物放入隐形眼镜形状的聚丙烯制的隐形眼镜模具中,利用蓝色LED灯照射12分钟后,使用高照度蓝色LED灯照射15分钟,由此制造出隐形眼镜。对于该隐形眼镜,使用大气压等离子体处理装置在大气压下实施表面改性处理(材料5)。As commercial product 1, 1-DAY ACUVUE TruEye manufactured by Johnson & Johnson was used. As a pretreatment, 15 ml of the packaging solution and 5 lenses of commercial product 1 were placed in a screw-mouth bottle SV-20 manufactured by Nippon Glass Co., Ltd., and liquid replacement was performed for more than 3 hours. In addition, contact lenses of materials 1 to 4 were produced as follows. That is, the polymerizable composition mixed as shown in Table 1 was placed in a contact lens mold made of polypropylene in the shape of a contact lens, and for materials 1 and 2, after irradiation with a blue fluorescent lamp for 15 minutes, a high-intensity blue LED lamp was used to irradiate for 15 minutes, thereby producing contact lenses. For materials 3 and 4, ultraviolet light was irradiated for 20 minutes using a high-pressure mercury lamp, thereby producing contact lenses. It should be noted that the polydimethylsiloxane macromonomer containing an urethane bond shown in Table 1 has a structure represented by chemical formula (2). In addition, a plasma generator was used to perform surface modification treatment on the contact lenses of materials 1, 2, and 4. This surface modification treatment was performed using CO 2 as the carrier gas and at an output of 80 W under reduced pressure. The contact lens of Material 3 was not subjected to surface modification treatment. Separately, a contact lens treated with atmospheric pressure plasma was produced. First, the polymerizable composition of Material 1, mixed as shown in Table 1, was placed in a contact lens-shaped polypropylene contact lens mold. After irradiation with a blue LED lamp for 12 minutes, it was then irradiated with a high-intensity blue LED lamp for 15 minutes to produce a contact lens. This contact lens was subjected to surface modification treatment at atmospheric pressure using an atmospheric pressure plasma treatment apparatus (Material 5).

对于材料1~3,浸渍在2.8ml/镜片的包装溶液中,放置3小时,使镜片水合。材料4在2.2ml/镜片的蒸馏水中浸渍10分钟后,在2.2ml/镜片的蒸馏水中进一步浸渍10分钟,并且在24-WELL PLATES中利用2.2ml/镜片的比较例1的液体进行浸渍。然后,进一步利用Yamato科学株式会社制造的高压蒸汽灭菌器SM-22在121℃进行20分钟灭菌。材料5的镜片通过使用表2所示的实施例的包装溶液和蒸馏水使其溶胀直至达到平衡而使其水合。然后,在隐形眼镜用泡罩中利用实施例2的液体进行浸渍,利用高压蒸汽灭菌器在121℃进行20分钟灭菌。将所得到的镜片作为材料5的隐形眼镜。Materials 1 to 3 were immersed in 2.8 ml/lens of packaging solution and allowed to stand for 3 hours to hydrate the lenses. Material 4 was immersed in 2.2 ml/lens of distilled water for 10 minutes, then immersed in 2.2 ml/lens of distilled water for another 10 minutes, and then immersed in 24-well plates with 2.2 ml/lens of the liquid of Comparative Example 1. They were then sterilized at 121°C for 20 minutes using a high-pressure steam sterilizer SM-22 manufactured by Yamato Scientific Co., Ltd. The lenses of Material 5 were hydrated by swelling them with the packaging solution of the examples shown in Table 2 and distilled water until equilibrium was reached. They were then immersed in the liquid of Example 2 in a contact lens blister and sterilized at 121°C for 20 minutes using a high-pressure steam sterilizer. The resulting lenses were designated as contact lenses of Material 5.

[表1][Table 1]

[实施例1~7的包装溶液][Packaging Solutions of Examples 1 to 7]

以表2所示的混配比制备实施例的包装溶液。作为共通成分,包装溶液含有作为等渗剂的NaCl和丙二醇(PG)、作为缓冲剂的磷酸氢钠水合物和磷酸二氢钠、作为螯合剂的乙二胺四乙酸三钠。另外,将使用聚氧乙烯固化蓖麻油(HCO-60:直链烷基链=碳原子数17、氧化乙烯的平均加成摩尔数=60)作为非离子型表面活性剂的实施例作为实施例1~4。另外,将使用聚氧乙烯固化蓖麻油(HCO-40:直链烷基链=碳原子数17、氧化乙烯的平均加成摩尔数=40)作为非离子型表面活性剂的实施例作为实施例5,将使用聚氧乙烯固化蓖麻油(HCO-100:直链烷基链=碳原子数17、氧化乙烯的平均加成摩尔数=100)作为非离子型表面活性剂的实施例作为实施例6、7。Packaging solutions for the examples were prepared using the mixing ratios shown in Table 2. Common components included NaCl and propylene glycol (PG) as isotonicity agents, sodium hydrogen phosphate hydrate and sodium dihydrogen phosphate as buffers, and trisodium ethylenediaminetetraacetic acid as a chelating agent. Examples 1 to 4 used polyoxyethylene-solidified castor oil (HCO-60: linear alkyl chain = 17 carbon atoms, average number of added ethylene oxide moles = 60) as the nonionic surfactant. Example 5 used polyoxyethylene-solidified castor oil (HCO-40: linear alkyl chain = 17 carbon atoms, average number of added ethylene oxide moles = 40) as the nonionic surfactant, and Examples 6 and 7 used polyoxyethylene-solidified castor oil (HCO-100: linear alkyl chain = 17 carbon atoms, average number of added ethylene oxide moles = 100) as the nonionic surfactant.

[比较例1~7的包装溶液][Packaging Solutions of Comparative Examples 1 to 7]

以表2所示的混配比制作比较例的包装溶液。将未使用非离子型表面活性剂的比较例作为比较例1。另外,将使用聚山梨醇酯80(直链烷基链=碳原子数17、氧化乙烯的平均加成摩尔数=20)作为非离子型表面活性剂的比较例作为比较例2、3。另外,将使用Pluronic L44(直链烷基链=无、氧化乙烯的平均加成摩尔数=20)作为非离子型表面活性剂的比较例作为比较例4。另外,将使用Koliphor P407(直链烷基链=无、氧化乙烯的平均加成摩尔数=196)作为非离子型表面活性剂的比较例作为比较例5。另外,将使用PluronicP123(直链烷基链=无、氧化乙烯的平均加成摩尔数=42)作为非离子型表面活性剂的比较例作为比较例6。另外,将使用羟基丙基甲基纤维素(HPMC)TC-5(直链烷基链=无、氧化乙烯的平均加成摩尔数=0)作为非离子型表面活性剂的比较例作为比较例7。Comparative Example packaging solutions were prepared using the blending ratios shown in Table 2. A comparative example in which no nonionic surfactant was used was designated as Comparative Example 1. Comparative Examples 2 and 3 were designated as Comparative Examples in which polysorbate 80 (linear alkyl chain = 17 carbon atoms, average number of added ethylene oxide moles = 20) was used as the nonionic surfactant. Comparative Example 4 was designated as Comparative Example 5, in which Koliphor P407 (linear alkyl chain = no carbon atoms, average number of added ethylene oxide moles = 196) was used as the nonionic surfactant. Comparative Example 6 was designated as Comparative Example 7, in which Pluronic P123 (linear alkyl chain = no carbon atoms, average number of added ethylene oxide moles = 42) was used as the nonionic surfactant. Comparative Example 7 is a comparative example in which hydroxypropylmethylcellulose (HPMC) TC-5 (linear alkyl chain = no, average number of added moles of ethylene oxide = 0) was used as a nonionic surfactant.

(粘附评价)(Adhesion Evaluation)

在EVERGREEN SCIENTIFIC的聚丙烯制的24-WELL PLATES中分注实施例1~7或者比较例1~7的包装溶液各2.2ml,浸渍材料1~5的镜片各一片。将浸渍有镜片的24-WELLPLATES利用Yamato科学株式会社制造的高压蒸汽灭菌器SM-22在121℃进行20分钟灭菌。灭菌后,在将WELL PLATES倾斜30°的状态下,基于镜片是否发生移动来评价镜片对于容器的粘附。在各包装溶液中,将镜片发生粘附的比例为20%以下的情况判定为合格。2.2 ml of each packaging solution from Examples 1 to 7 or Comparative Examples 1 to 7 was dispensed into 24-well plates made of polypropylene from Evergreen Scientific, and one lens from each of Materials 1 to 5 was impregnated. The 24-well plates, with the impregnated lenses, were sterilized at 121°C for 20 minutes using an SM-22 autoclave manufactured by Yamato Scientific Co., Ltd. After sterilization, the well plates were tilted 30° to evaluate the adhesion of the lenses to the container based on whether the lenses moved. Lenses with a percentage of 20% or less of adherence in each packaging solution were considered acceptable.

(拉伸弹性模量的评价)(Evaluation of tensile elastic modulus)

使用冲切刃将与粘附评价同样地进行了灭菌处理的各镜片材料加工成哑铃形状试验片(平行部分的长度6mm、宽2mm)。在设定为20℃的恒温水槽(实测20.0℃)中放入浸渍在ISO生理盐液的试验片,进行状态调节。使用Mitutoyo Corporation制的LIGHT MAGIC对状态调节后的试验片的厚度进行测定。将该试验片的两端固定于株式会社岛津制作所制造的岛津精密万能试验机(自动绘图仪AG-IS(MS))的夹具上。以100mm/分钟的拉伸速度对试验片进行拉伸直至断裂,读取断裂时的应力,由拉伸应力-应变曲线的变形开始点的切线的斜率计算出拉伸弹性模量。Each lens material sterilized in the same manner as the adhesion evaluation was processed into a dumbbell-shaped test piece (parallel portion length 6mm, width 2mm) using a punching blade. The test piece immersed in ISO physiological saline was placed in a constant temperature water bath set at 20°C (actually measured 20.0°C) for state conditioning. The thickness of the state-conditioned test piece was measured using LIGHT MAGIC manufactured by Mitutoyo Corporation. The two ends of the test piece were fixed to the fixture of a Shimadzu precision universal testing machine (automatic plotter AG-IS (MS)) manufactured by Shimadzu Corporation. The test piece was stretched at a tensile speed of 100 mm/min until it broke, the stress at the time of fracture was read, and the tensile modulus of elasticity was calculated from the slope of the tangent line at the deformation starting point of the tensile stress-strain curve.

(比重测定(镜片))(Specific Gravity Determination (Lens))

使用与粘附评价同样地进行了灭菌处理的SARTORIUS制造的比重测定盒YDK01,对各镜片材料的比重进行测定。首先,将浸渍液放入烧杯中,保持为规定的温度,同时按照不与天平的可动部接触的方式放置在固定支撑台上。使用安装在固定支撑台的称量盘的上部称量盘,称量镜片在20℃的空气中的质量W1(g)至0.1mg的位数。镜片各使用10片,称量前利用吸水纸擦去镜片表面的水分。将温度计插入浸渍液中,在确认为20℃后,按照不使镜片产生气泡的方式放置于下部称量盘,称量浸渍液中的质量W2(g)至0.1mg的位数。使用规定温度的浸渍液的密度P(g/cm3)、规定温度的水的密度K(g/cm3),由下式(1)计算出比重。The specific gravity of each lens material was measured using a SARTORIUS specific gravity measuring kit YDK01, sterilized in the same manner as for the adhesion evaluation. First, the immersion liquid was placed in a beaker, maintained at a specified temperature, and placed on a fixed support table so that it did not come into contact with the movable part of the balance. Using the upper weighing pan of the weighing pan mounted on the fixed support table, the mass W1 (g) of the lens in air at 20°C was weighed to the nearest 0.1 mg. Ten lenses of each type were used, and moisture was wiped off the lens surface with absorbent paper before weighing. A thermometer was inserted into the immersion liquid. After confirming that it was at 20°C, it was placed on the lower weighing pan so that no bubbles formed in the lens. The mass W2 (g) in the immersion liquid was weighed to the nearest 0.1 mg. The specific gravity was calculated using the following formula (1) using the density P (g/ cm3 ) of the immersion liquid at the specified temperature and the density K (g/ cm3 ) of water at the specified temperature.

比重S=P/K×(W1/(W1-W2))…式(1)Specific gravity S = P/K × (W1/(W1-W2)) ... formula (1)

(比重测定(包装溶液))(Specific Gravity Determination (Packaging Solution))

利用电子天平测定Sprengel.Ostwald比重瓶的质量M(g)至小数点以下第四位。将Sprengel.Ostwald比重瓶的一个细管浸在利用20℃的恒温水槽进行了约15分钟调温的包装溶液中,将液体吸起至线上。确认设定为20℃的恒温水槽达到指定温度后,将Sprengel.Ostwald比重瓶浸在其中约15分钟,将滤纸片放在一端,使液体的前端与线一致。从恒温水槽取出,把外部擦干净后,利用电子天平测定质量M1(g)。使用相同的Sprengel.Ostwald比重瓶在纯净水中也进行同样地操作,测定质量M2(g)。由下式(2)求出比重d至小数点以下第三位,由下式(3)求出20℃的密度X至小数点以下第三位。Measure the mass M (g) of the Sprengel.Ostwald pycnometer to the fourth decimal place using an electronic balance. Immerse one capillary tube of the Sprengel.Ostwald pycnometer in the packaging solution, which has been temperature-controlled in a 20°C constant-temperature water bath, for approximately 15 minutes, and draw the liquid up onto the line. After confirming that the constant-temperature water bath set at 20°C has reached the specified temperature, immerse the Sprengel.Ostwald pycnometer in the solution for approximately 15 minutes. Place a piece of filter paper at one end so that the tip of the liquid is aligned with the line. Remove the Sprengel.Ostwald pycnometer from the constant-temperature water bath, wipe the outside clean, and measure the mass M1 (g) using an electronic balance. Perform the same procedure using the same Sprengel.Ostwald pycnometer in pure water to measure the mass M2 (g). Calculate the specific gravity d to the third decimal place using the following formula (2), and the density X at 20°C to the third decimal place using the following formula (3).

比重d=(M1-M)/(M2-M)…式(2)Specific gravity d = (M1-M)/(M2-M) ... formula (2)

密度X=0.99704×d…式(3)Density X = 0.99704 × d…Equation (3)

(结果与考察)(Results and Investigation)

在表2中汇总了实施例和比较例的包装溶液的组成以及粘附镜片的比例。另外,在表3中汇总了镜片、包装溶液的比重和镜片的拉伸弹性模量(杨氏模量)的结果。如表2、3所示,对于材料4的镜片而言,无论包装溶液如何,均未发生包装容器与隐形眼镜的粘附。据认为这是因为,材料4的镜片的杨氏模量高、隐形眼镜的接触面积未变大。另一方面可知,对于杨氏模量小于1.4MPa的镜片而言,产生了该粘附,但是,对于比较例1~7而言,无法充分得到吸附抑制效果。另一方面可知,对于使用了含有碳原子数为12以上的直链的烷基部和氧化乙烯部且氧化乙烯的平均加成摩尔数为30以上的非离子型表面活性剂(聚氧乙烯固化蓖麻油)的实施例1~7而言,包装容器与隐形眼镜的吸附抑制效果极高。另外可知,该非离子型表面活性剂的混配量优选为0.001质量%以上0.1质量%以下的范围。进一步可知,非离子型表面活性剂的氧化乙烯的平均加成摩尔数在40~100的范围能够得到吸附抑制效果。另外,由实施例7的结果可知,即使含有其它表面活性剂,在含有实施例的非离子型表面活性剂时,也能够得到高吸附抑制效果。另外,有机硅水凝胶隐形眼镜与包装溶液的比重差优选为0.1以下。另外,对于表面改性处理的条件进行研究的结果中,无论是在大气压下进行表面处理,还是在减压条件下进行表面处理,在实施例的包装溶液中,均未发生包装容器与隐形眼镜的粘附。即可知,对于实施例的包装溶液而言,能够不依赖于表面处理的条件而进一步抑制粘附。Table 2 summarizes the composition of the packaging solutions and the percentage of lenses adhering to the packaging solution for the Examples and Comparative Examples. Table 3 summarizes the specific gravity of the lenses, packaging solutions, and the tensile modulus (Young's modulus) of the lenses. As shown in Tables 2 and 3, no adhesion occurred between the packaging container and the contact lens for lenses made with Material 4, regardless of the packaging solution. This is believed to be because the Young's modulus of the lenses made with Material 4 was high, and the contact lens contact area did not increase. On the other hand, adhesion did occur for lenses with a Young's modulus less than 1.4 MPa, but the adsorption inhibition effect was not sufficiently achieved for Comparative Examples 1 to 7. On the other hand, Examples 1 to 7, which used a nonionic surfactant (polyoxyethylene-hardened castor oil) containing a linear alkyl moiety with 12 or more carbon atoms and an ethylene oxide moiety, and with an average added mole number of ethylene oxide of 30 or more, showed an extremely high effect in inhibiting adsorption between the packaging container and the contact lens. Furthermore, the compounding amount of this nonionic surfactant is preferably in the range of 0.001% by mass to 0.1% by mass. Furthermore, it was found that an average addition molar number of ethylene oxide in the nonionic surfactant within the range of 40 to 100 can achieve an adsorption-inhibiting effect. Furthermore, the results of Example 7 demonstrate that even when other surfactants are present, a high adsorption-inhibiting effect can be achieved when the nonionic surfactant of the example is present. Furthermore, the specific gravity difference between the silicone hydrogel contact lens and the packaging solution is preferably 0.1 or less. Furthermore, studies of surface modification treatment conditions revealed that adhesion between the packaging container and the contact lens did not occur in the packaging solutions of the examples, regardless of whether the surface treatment was performed under atmospheric pressure or under reduced pressure. This demonstrates that adhesion can be further suppressed in the packaging solutions of the examples, independent of the surface treatment conditions.

[表2][Table 2]

[表3][Table 3]

工业实用性Industrial Applicability

本发明能够用于制造、流通隐形眼镜包装的技术领域。The present invention can be used in the technical field of manufacturing and distributing contact lens packages.

Claims (3)

1.一种隐形眼镜包装,其具备:1. A contact lens packaging, comprising: 有机硅水凝胶隐形眼镜、Silicone hydrogel contact lenses 由聚丙烯形成的包装容器、Packaging containers made of polypropylene 包装溶液,其含有非离子型表面活性剂,该非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,该非离子型表面活性剂的1摩尔中的所述氧化乙烯的平均加成摩尔数为30以上,The packaging solution contains a nonionic surfactant comprising a straight-chain alkyl group having 12 or more carbon atoms and an ethylene oxide group, wherein the average molar addition of the ethylene oxide in 1 mole of the nonionic surfactant is 30 or more. 所述包装溶液以0.001质量%以上0.1质量%以下的范围含有所述非离子型表面活性剂,The packaging solution contains the nonionic surfactant in an amount ranging from 0.001% to 0.1% by mass. 所述非离子型表面活性剂是聚氧乙烯氢化蓖麻油,The nonionic surfactant is polyoxyethylene hydrogenated castor oil. 所述有机硅水凝胶隐形眼镜的杨氏模量为1.2MPa以下。The Young's modulus of the silicone hydrogel contact lens is below 1.2 MPa. 2.如权利要求1所述的隐形眼镜包装,其中,2. The contact lens packaging as described in claim 1, wherein, 所述包装溶液与所述有机硅水凝胶隐形眼镜的比重差为0.1以下。The specific gravity difference between the packaging solution and the silicone hydrogel contact lens is less than 0.1. 3.一种隐形眼镜包装的制造方法,其中,3. A method for manufacturing contact lens packaging, wherein, 向由聚丙烯形成的包装容器中封入有机硅水凝胶隐形眼镜和包装溶液,该包装溶液含有非离子型表面活性剂,该非离子型表面活性剂含有碳原子数为12以上的直链的烷基部和氧化乙烯部,该非离子型表面活性剂的1摩尔中的所述氧化乙烯的平均加成摩尔数为30以上,所述包装溶液以0.001质量%以上0.1质量%以下的范围含有所述非离子型表面活性剂,所述非离子型表面活性剂是聚氧乙烯氢化蓖麻油,所述有机硅水凝胶隐形眼镜的杨氏模量为1.2MPa以下。A silicone hydrogel contact lens and a packaging solution are sealed into a packaging container formed of polypropylene. The packaging solution contains a nonionic surfactant containing a straight-chain alkyl group with 12 or more carbon atoms and an ethylene oxide group. The average molar addition of the ethylene oxide in 1 mole of the nonionic surfactant is 30 or more. The packaging solution contains the nonionic surfactant in the range of 0.001% by mass to 0.1% by mass. The nonionic surfactant is polyoxyethylene hydrogenated castor oil. The silicone hydrogel contact lens has a Young's modulus of 1.2 MPa or less.
HK18109296.2A 2015-09-30 Contact lens packaging and method for manufacturing same HK1249934B (en)

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PCT/JP2015/077746 WO2017056235A1 (en) 2015-09-30 2015-09-30 Contact lens packaging and method for manufacturing same

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HK1249934A1 HK1249934A1 (en) 2018-11-16
HK1249934B true HK1249934B (en) 2022-01-28

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