统一阴道刺激性试验方法的建议  

Suggestions for unifying the experimental methods of vaginal stimulation test in drug safety evaluation

作　　者：金毅[1,2] 徐峰[2] 王晓炜[1] 鲁艺[1] 王平[1] 钟敏[1] 赵承兵[1] 

机构地区：[1]深圳市药品检验所,深圳518057 [2]沈阳药科大学,沈阳110016

出　　处：《中国新药杂志》2013年第12期1383-1384,共2页Chinese Journal of New Drugs

摘　　要：与阴道黏膜直接接触的药物通过阴道刺激性试验进行临床前安全性检验,是该类新药研发和申报注册检验的重要项目。由于我国药品的阴道刺激性试验尚无细化的实验规范,本文比较了中国、美国与香港的药物指导原则,借鉴了医疗器械在该试验的国际标准和大量研究数据,并结合工作经验和心得,提出统一实验方法的建议。Vaginal stimulation test for preclinical safety is an important inspection for new drug R＆D and registration for drugs directly contacting the vaginal mucosa. However, there is no detailed experimental regulation of vaginal stimulation test in our country. We compared and analyzed the guidelines among China, the United States FDA and Hong Kong, as well as the international standards for related medical devices. Here, we suggested a standardization for reference based on lots of research data and experience.

关 键 词：阴道刺激性试验 实验方法 组织病理学 

分 类 号：R95[医药卫生—药学]