摘要
目的:探讨用BioOcular^TM角膜上皮模型EIT法评价眼用制剂包装材料眼刺激性的可行性。方法:在眼用制剂包装材料的浸提液中加入不同浓度的阳性物质,同时进行BioOcular^TM角膜上皮模型EIT试验和Draize试验,比较两种方法所得结果的一致性。结果:与Draize法比较,BioOcular^TM角膜上皮模型EIT法对含不同浓度阳性物质浸提液的眼刺激性分级与体内试验的一致程度为100%。结论:BioOcular^TM角膜上皮模型EIT法有潜力作为眼用制剂包装材料眼刺激性试验的替代方法。
Objective:To explore the possibility to evaluate eye irritation of containers for the ophthalmic preparation with BioOcular^TM corneal epithelium model EIT method.Methods:The different concentrations of positive control substance were added into the extracts of containers for the ophthalmic preparation,then they were tested by BioOcular^TM corneal epithelium model EIT method and Draize method.The consistency of the results obtained with two methods was compared.Results:Compared with Draize test,the consistency of eye irritation classification of the extracts with different positive control substance concentration between BioOcular^TM corneal epithelium medel EIT method and in vivo test was 100%.Conclusion:BioOcular^TM corneal epithelium model EIT methodhas the potential to be an alternative method for eye irritation evaluation of containers for the ophthalmic preparation.
作者
谢珍
张劲松
沈琴
桑晶
刘璐
匡荣
李杨
XIE Zhen;ZHANG Jinsong;SHEN Qin;SANG Jing;LIU Lu;KUANG Rong;LI Yang(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Shaoxing Modern Medicine Public Service Center,Shaoxing 312073,China)
出处
《中国药品标准》
CAS
2019年第6期469-473,共5页
Drug Standards of China
基金
国家药品监督管理局化妆品动物替代试验技术重点实验项目(国药监科外函[2019]82号)
浙江省药品接触材料质量控制研究重点实验室(2014E10006)
