论文部分内容阅读
眼用新剂型在提高眼部生物利用度同时,也引入了大量以表面活性剂、高分子聚合物、阳离子材料等具有刺激性的物质。因此,在保证眼部制剂有效性的同时,其安全性也越来越受到关注。由于体外实验缺乏相关的酶系和组织结构的整体反应,其结果外推至动物实验的合理性和关联性也有待于进一步研究证明。本文综述了常用的体内(眨眼、组织病理切片、Draize评分、共聚焦显微镜法等)眼部刺激性实验方法,并对这些方法进行了评估和分析。
Ophthalmic new formulations to improve eye bioavailability, but also the introduction of a large number of surfactants, polymers, cationic materials and other irritating substances. Therefore, to ensure the effectiveness of eye preparations at the same time, its safety is also more and more attention. Due to the lack of overall response of enzyme and tissue structure in vitro, its rationality and relevance extrapolated to animal experiments needs to be further studied. This review summarizes commonly used eye irritation testing methods in vivo (blinking, histopathology, Draize, confocal microscopy, etc.) and evaluates and analyzes these methods.