【摘要】 眼用药物及可能接触眼睛的受试物均应考虑进行眼刺激试验。Draize试验一直是公认的测定急性眼刺激性的国际标准,但随着"3R"原则的实施,体外替代方法逐渐成为眼刺激性评价研究的发展方向。目前已有多种体外替代方法得到了欧洲化学品局(European Chemical Agency, ECHA)、美国国家环境保护局(US Environmental Protection Agency, US EPA)及经济合作与发展组织(The Organization for Economic Co-operation and Development, OECD)的认可,其中有5种替代试验得到了OECD的认可,分别是牛角膜不透明度和渗透性试验,离体鸡眼试验、短时暴露试验、重组人角膜上皮模型试验试验以及荧光素渗漏试验。在使用体外替代方法时,由于单一的方法不能蕴含所有的观察终点,所以应根据每种替代方法的特点及应用范围进行组合以覆盖整个分层测试策略。相信随着体外替代试验研究的不断深入,有希望在未来能够完全替代体内试验。本文就眼刺激评价的体外替代方法和评价标准进行了综述。更多还原

【Abstract】 Eye irritation tests should be considered for both ophthalmic drugs and objects which may be in contact with eyes. Draize test has always been recognized as the international standard for the determination of acute eye irritation, but with the implementation of the "3 R" principle, in vitro alternative methods have gradually become the tendency of eye irritation evaluation research. At present, many in vitro alternative methods have been recognized by the European Chemical Agency(ECHA), the US Environmental Protection Agency(US EPA) and The Organization for Economic Co-operation and Development(OECD), among them, five alternative methods were approved by the OECD, namely bovine corneal opacity and permeability(BCOP) test, isolated chicken eye(ICE) test, short time exposure(STE) test, and reconstructed human cornea-like epithelial(RhCE) test and fluorescein leakage(FL) test. When using an in vitro alternative method, since a single method does not cover all endpoints, it should be combined based on the characteristics and scope of each alternative to cover the entire stratified test strategy. With the development of research, it is hoped that there will be a complete replacement for in vivo testing in the future. This paper reviews the in vitro alternative methods and evaluation criteria for eye irritation evaluation.更多还原