牛角膜浑浊和渗透性试验方法结合组织病理学对化妆品眼刺激性的预测价值  

Predictive value of bovine corneal opacification and permeability test in combination with histopathology in eye irritation of cosmetic products

作　　者：谢珍 陈舒怀 刘璐 何立成 朱社敏 匡荣 XIE Zhen;CHEN Shuhuai;LIU Lu;HE Licheng;ZHU Shemin;KUANG Rong(Zhejiang Institute of Food and Drug Control,Zhejiang Province,Hangzhou 310052,China)

机构地区：[1]浙江省食品药品检验研究院,浙江杭州310052

出　　处：《中国医药导报》2021年第4期14-17,共4页China Medical Herald

基　　金：浙江省科技计划项目(2018C37122);国家药品监督管理局化妆品动物替代试验技术重点实验室(国药监科外函〔2019〕82号)。

摘　　要：目的建立牛角膜浑浊和渗透性(BCOP)结合角膜上皮组织学评分用于评价化妆品眼刺激性的方法。方法采用BCOP法对9种市售的沐浴露类和染发类化妆品进行眼刺激性检测,同时将角膜制成HE染色的组织学切片,观察角膜的组织病理学变化并对上皮的组织病理学变化评分(H),依据BCOP测试结果、角膜上皮组织学评分及Draize试验结果,建立预测模型。结果无刺激性的物质体外刺激评分值(IVIS)≤3,且H=0;微刺激性的物质IVIS≤6,且H≤1;而轻刺激性的物质6<IVIS<25,且角膜基质及内皮无异常。结论结合角膜上皮损伤组织病理学评估的BCOP法可提高其预测性,适用于化妆品眼刺激性的评价。Objective To establish a method for evaluating cosmetic eye irritation with bovine corneal opacity and permeability(BCOP)combined with corneal epithelial histological score.Methods BCOP method was used for nine commercial body wash and dye hair cosmetics eye irritation test,at the same time to make HE dyeing from corneal histology slice,the histopathological changes of the cornea and histopathological changes of epithelial score(H)were observed,on the basis of the BCOP test results,corneal epithelium histological grading and Draize test results,prediction model was established.Results The non-irritating substance was that IVIS≤3 and H=0;the slightly irritating substance was that IVIS≤6 and H≤1;and the light irritating substance was that 6<IVIS<25,and the corneal stroma and endothelium were not abnormal.Conclusion BCOP method combined with histopathological assessment of corneal epithelial injury can improve its predictability and is suitable for the evaluation of cosmetic eye irritation.

关 键 词：化妆品 眼刺激性 牛角膜浑浊和渗透性试验 角膜上皮 组织学 

分 类 号：TQ658[化学工程—精细化工]