CN106414514A - 用于制备人工晶状体（iol）的配制物和晶状体制造方法 - Google Patents

用于制备人工晶状体（iol）的配制物和晶状体制造方法 Download PDF

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CN106414514A
CN106414514A CN201580023725.5A CN201580023725A CN106414514A CN 106414514 A CN106414514 A CN 106414514A CN 201580023725 A CN201580023725 A CN 201580023725A CN 106414514 A CN106414514 A CN 106414514A
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T·伊尔马兹伊南
H·多甘
N·贝基尔
Z·科尔鲁
M·詹代米尔
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Scientific and Technological Research Council of Turkey TUBITAK
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Abstract

本发明涉及药物、眼科学、白内障和白内障手术领域中用于主要生产人工晶状体(IOL)的配制物和晶状体制造方法，所述人工晶状体是柔韧的、生物相容的并且具有长的保存期。

Description

用于制备人工晶状体(IOL)的配制物和晶状体制造方法
技术领域
本发明涉及药物、眼科学、白内障和白内障手术领域中用于主要制备人工晶状体(IOL)的配制物和晶状体制造方法，所述人工晶状体是柔韧的、生物相容的并且具有长的保存期。
背景技术
人类眼睛中的天然眼内晶状体由于在晶状体表面上的积累问题或由老化和/或疾病发生引起的晶状体损伤而失去其视觉。今天，天然晶状体上的积累问题通过称为白内障手术的操作被新合成晶状体替代。国内在人类眼睛中的天然眼睛晶状体在1949年首次使用甲基丙烯酸甲酯系硬质聚合晶状体替代。一般地，不同的丙烯酸酯晶状体被用于此目的。
近年来，外科医生更愿意使用具有高反应性指数的晶状体，使用生物相容、可折叠的人工晶状体，为微创手术提供方便。
人工晶状体制造技术通常基于热聚合方法，所述方法使用模具，并且通过与激光技术结合的车床将其形成晶状体。然而，该方法耗时并且昂贵，以及归因于所使用的生产方法而具有尺寸稳定性问题。此外，由于使用车削方法，在晶状体的表面上可能遇到由不可见的断裂而引起的所谓闪光问题。
生产人工晶状体的另一种制造方法是光聚合方法，所述光聚合方法是一种环境友好并且节约能量的方法。就生产成本而言，所述方法是合适的方法。在在先美国专利文献US6201036中提及了通过使用光聚合方法而获得人工晶状体产品。
近年来，蓝光(400-500nm)被确定对视网膜具有潜在的危害。在美国专利文献US6353069中，提及了在芳族结构中使用两种或多种含有丙烯酸酯和/或甲基丙烯酸酯的共聚物生产具有高折射率的晶状体。在美国专利文献US5470932中提及了将黄色颜料加入到配制物中。然而，这种非反应性的进料(input)例如丙烯酸酯会引起散射问题，从而引起成分的活性随着时间而降低。
如在日本专利JP10282302和欧洲专利EP 1785747以及WO97/27223中提及的UV(紫外线)阻隔方法也可以通过晶状体的表面涂层而获得。然而，在非均匀涂层的情况下无法获得理想的结果。在300-430nm范围中具有非阻隔特性的晶状体可能引起二次白内障的形成，并且引起源自生物相容性测试的负面结果，所述生物相容性测试是晶状体的长期使用结果的指标。
ALCON公司生产的″The AcrySof Natural Lens SN60AT″黄色透镜在400-475nm的光谱透射率值中具有紫外线阻隔特性。据信并且在眼睛移植手术中观察到，尤其在54岁之后，天然晶状体变黄以降低400-475nm的光对于视网膜的损伤。人体天然地调节自身以免于此波长的光的损伤。研究白内障手术的研究人员相信这种性能也应当被带入54岁以上年龄病人的合成晶状体。ALCON公司使用可以吸收蓝光的成分并且″AcrySofNatural″是市场上的商购产品。为了使蓝光吸收成分自晶状体的散射最小化，ALCON将丙烯酸基团添加至如在US5470932、US7803359和US20100113641命名的美国专利中所提及的蓝光吸收成分中。所有前述提及的晶状体均通过热模制和使用与激光结合的车削成型获得。
US20120232648美国专利提及具有形状记忆聚合物(SMP)的人工晶状体可以具有大于1.45的折射率，10-60℃之间的Tg，包含微量或不含闪光，和在可见光谱中基本100％的光透过率。之后在大于SMP材料的Tg的温度下轧制人工晶状体。眼内器件在模具中被放射状地压制至小于或等于1.8mm的直径，同时保持温度大于Tg。经压制的人工晶状体器件可以插入通过角膜或巩膜或其它解剖结构中小于2mm宽的切口。所述晶状体可以通过所述切口插入囊袋、睫状沟或其它腔体。所述SMP可以基本上实现大于或等于1.45的折射率值。
在美国专利文献US20130107201中，提及公开了一种多焦点眼科器件，其中晶状体本体包含姜黄素类化合物作为UV光稳定剂和/或共聚组合物，其从限定单体的预聚合混合物得到，形成多焦点眼科器件的晶状体。使用多个同心环状区域，所述同心环状区域影响入射光的衍射和折射二者，并且通过倾斜的步骤分离，所述步骤基本上全无任何衍射或折射力。
发明内容
本发明涉及药物、眼科学、白内障和白内障手术领域中用于主要生产人工晶状体(IOL)的配制物和晶状体制造方法，所述人工晶状体是柔韧的、生物相容的，并且具有长的保存期。
本发明的另一个目的是实现提供具有紫外线阻隔性能的人工晶状体的配制物和人工晶状体制造方法，该方法使用包含可以在300-475nm UV光区域反应的反应性官能团的配制物。
本发明的另一个目的是使用热和/或光聚合(UV/紫外LED/发光器件或UV/LED)和/或通过两种方法的结合使用来生产晶状体。
本发明的另一个目的是提供人工晶状体配制物和用以获得具有高折射率的人工晶状体的生产方法。
本发明的另一个目的是提供人工晶状体配制物和用于生产一件疏水性人工晶状体的生产方法。
本发明的另一个目的是通过使用光聚合方法提供人工晶状体配制物和生产方法。
本发明的另一个目的是取决于进料和它们的比例来提供一种人工晶状体配制物和生产方法，以获得具有白颜色或黄颜色的两种不同类型的晶状体。
发明详述
本发明涉及一种配制物和使用光聚合的晶状体制造方法，其赋予晶状体以紫外线阻隔性能和光滑的表面、柔韧、高折射率值、不昂贵、疏水和无车削应用导致的闪光问题。
根据本发明的配制物包含：
20-80重量％的丙烯酸酯和/或甲基丙烯酸酯系低聚物成分，其用作配制物中的粘合剂，
5-40重量％的丙烯酸酯和/或甲基丙烯酸酯系单体成分，其用作反应性稀释剂，
1-5重量％的丙烯酸酯和/或甲基丙烯酸酯系紫外线阻隔成分，其用作紫外线阻隔剂，和
0.1-5重量％的光引发剂成分，其用于引发光聚合过程。
用于根据本发明的配制物中的低聚物为20％-80％并且结构为基于氨基甲酸酯丙烯酸酯和/或氨基甲酸酯甲基丙烯酸酯的。
配制物中的单官能化丙烯酸酯和/或甲基丙烯酸酯系反应性单体在5重量％-40重量％的范围内，并且可以使用不同的结构，例如，甲基丙烯酸、甲基丙烯酸甲基卡必醇酯(metilkarbitol)、甲基丙烯酸苯氧基乙酯、甲基丙烯酸辛酯、甲基丙烯酸甲酯、甲基丙烯酸羟乙酯、甲基丙烯酸乙氧基乙酯、二甲基丙烯酸乙二醇酯、N-乙烯基吡咯烷酮、甲基丙烯酸烯丙酯、N，N-二甲基甲酰胺(Dimetakrilamif)、甲基丙烯酸甘油酯和二甲基丙烯酸四甘醇酯。
配制物中的紫外线阻隔成分占配制物的1-5重量％。作为本发明优选实施方案中的紫外线阻隔剂，使用了2-(4-苯甲酰基-3-羟基苯氧基(hidrokisfenoks))乙基丙烯酸酯)、4-甲基丙烯酰氧基(Methakriloks)-2-羟基二苯甲酮、2-(2′-羟基-5′-甲基丙烯酰氧基乙基苯基(metakriloksietilfenil))-2H-苯并三唑、香豆素或聚芳基醚结构物质。
本发明的配制物具有光引发剂来引发光聚合。在配制物中的光引发剂比为0.1-5重量％并且可以使用不同的结构，例如，2，4，6-三甲基苯甲酰基二苯基氧化膦(trimetilbenzoildifenilfosf oxide)、(2-苄基-2-N-二甲基氨基-1-(4-吗啉代丙烷-1)、(羟基环己基)苯基酮、2-苄基2-N-二甲基氨基-1-(4-吗啉基苯基)-1-丁酮、苯、二甲基缩酮、异丙基苯偶姻缩酮、2-正丙氧基-9H-噻吨-9和4-(二甲基氨基)苯甲酸乙酯。
通过使用本发明的配制物获得的人工晶状体获得了具有聚合结构的柔韧和疏水性晶状体。所述晶状体的折射率为大于或等于1.5。一件(单块)的晶状体以经济的方式生产，无光聚合方法中的散射问题。
本发明涉及一种配制物和使用光聚合方法的晶状体制造方法，其赋予晶状体光滑的表面和UV-阻隔性能、柔韧、高折射率值、不昂贵和疏水性。所有之前提及的晶状体通过热模制和与激光结合的车削成型获得。所述方法包括以下步骤：
配制物的制备；
将配制物置于模具中；
通过光聚合方法固化配制物；
从模具中取出固化的配制物；
使用异丙醇萃取并且对脱模的(dedied)配制物进行灭菌处理。
在根据本发明的方法中，使用以下物质制备配制物：20-80重量％的丙烯酸酯和/或甲基丙烯酸酯系低聚物作为粘合剂，5-40重量％的丙烯酸酯和/或甲基丙烯酸酯系单体作为反应性稀释剂，0.1-5重量％的光引发剂以引发反应；1-5重量％的丙烯酸酯和/或甲基丙烯酸酯系紫外线阻隔剂作为UV吸收成分。优选将该配制物转移至石英(石英)模具中。模具中包含的配制物通过光聚合方法固化。在本发明优选的实施方案中，对于光聚合方法而言，可以将紫外光、LED或紫外光和LED二者用作光源。所述配制物(晶状体)在固化操作之后从模具中移出，在异丙醇中萃取。最后，产物通过经历灭菌而被清洁。
本发明中获得的人工晶状体具有聚合物的结构以及柔韧和疏水性能。所述晶状体的折射率大于或等于1.5。该晶状体是一件(单块)的，其以经济的方式生产，无光聚合方法的散射问题。
围绕这些基本概念，本发明“人工晶状体制备提供了一种配制物和方法”的相关多种应用的发展是可能的，本发明不限于本文中描述的实例，并且本质上依据权利要求。

Claims (12)

1.一种配制物，用于通过光聚合制造柔韧、不昂贵、疏水、具有高反应指数值以及紫外线阻隔性质和适用于眼内用途晶状体的光滑表面的方法中，其特征在于所述配制物包含：
作为粘合剂的20-80重量％的丙烯酸酯和/或甲基丙烯酸酯系低聚物，
作为反应性稀释剂的5-40重量％的丙烯酸酯和/或甲基丙烯酸酯系单体，
用于吸收光的1-5重量％的丙烯酸酯和/或甲基丙烯酸酯系紫外线阻隔剂，和
0.1-5重量％的光引发剂，以引发反应。
2.根据权利要求1的配制物，其特征在于配制物中所使用的低聚物为氨基甲酸酯丙烯酸酯系低聚物。
3.根据权利要求1的配制物，其特征在于配制物中所使用的低聚物为氨基甲酸酯甲基丙烯酸酯系低聚物。
4.根据权利要求1的配制物，其特征在于配制物中所使用的单体为单官能化丙烯酸酯系单体。
5.根据权利要求1的配制物，其特征在于配制物中所使用的单体为甲基丙烯酸酯系单体。
6.根据权利要求1的配制物，其特征在于用作反应性稀释剂的单体可以选自包括以下的组：甲基丙烯酸、甲基丙烯酸甲基卡必醇酯、甲基丙烯酸苯氧基乙酯、甲基丙烯酸辛酯、甲基丙烯酸甲酯、甲基丙烯酸羟乙酯、甲基丙烯酸乙氧基乙酯、二甲基丙烯酸乙二醇酯、N-乙烯基吡咯烷酮、甲基丙烯酸烯丙酯、N，N-二甲基甲酰胺、甲基丙烯酸甘油酯和二甲基丙烯酸四甘醇酯。
7.根据权利要求1的配制物，其特征在于光引发剂可以选自包括以下的组：2，4，6-三甲基苯甲酰基二苯基氧化膦、(2-苄基-2-N-二甲基氨基-1-(4-吗啉代丙烷-1)、(羟基环己基)苯基酮、2-苄基-2-N-二甲基氨基-1-(4-吗啉基苯基)-1-丁酮、苯、二甲基缩酮、异丙基苯偶姻缩酮、2-正丙氧基-9H-噻吨-9、4-(二甲基氨基)苯甲酸乙酯。
8.根据权利要求1的配制物，其特征在于紫外线阻隔剂可以选自2-(4-苯甲酰基-3-羟基苯氧基)乙基丙烯酸酯)、4-甲基丙烯酰氧基-2-羟基二苯甲酮、2-(2′-羟基-5′-甲基丙烯酰氧基乙基苯基))-2H-苯并三唑、香豆素或多芳基醚。
9.用于通过光聚合制造柔韧、不昂贵、疏水、具有高反应指数值以及紫外线阻隔性质和适用于眼内用途晶状体的光滑表面的方法，其特征在于所述方法包含以下步骤：
-制备配制物，
-将该配制物置于模具中，
-通过光聚合方法固化该配制物，
-从模具中取出经固化的配制物，
-用异丙醇萃取，并且对脱模的(dedied)配制物进行灭菌处理。
10.根据权利要求9的方法，其特征在于所述配制物通过使用以下物质制备：作为粘合剂的20-80重量％的丙烯酸酯和/或甲基丙烯酸酯系低聚物；作为反应性稀释剂的5-40重量％的丙烯酸酯和/或甲基丙烯酸酯系单体；用以引发反应的0.1-5重量％的光引发剂；作为UV吸收成分的1-5重量％的丙烯酸酯和/或甲基丙烯酸酯基紫外线阻隔剂。
11.根据权利要求9的方法，其特征在于所述配制物优选转移至石英(石英)模具中。
12.根据权利要求9的方法，其特征在于在通过光聚合方法固化配制物的步骤中使用LED和/或紫外LED或二者。
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