阴道刺激性试验的规范化研究  

Standardization of vaginal irritation tests

作　　者：金毅[1] 王平[1] 王晓炜[1] 谢天柱[1] 

机构地区：[1]深圳市药品检验所,深圳518057

出　　处：《中国新药杂志》2012年第15期1718-1721,共4页Chinese Journal of New Drugs

摘　　要：通过阴道刺激性试验对与阴道黏膜直接接触的药物进行临床前安全性检验,判断是否存在对阴道黏膜的刺激性,及其刺激反应程度是否属于可接受范围等,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详细的实验规范,在比较中国、美国FDA与香港的药物指导原则,以及借鉴医疗器械在该试验的国际标准和大量研究数据的基础上,结合工作经验和心得,全面总结并提出规范化建议,确保试验结果科学准确。仅供参考。With regard to drugs directly contacting the vaginal mucosa, vaginal irritation tests for preclinical safety determine if there is stimulus response on vaginal mucosa, and if the result is in the acceptable range. It is an important inspection for new drug R＆D and registration. There is no detailed experimental regulation about drug stimulation in vaginal mucosa tests in our country. In comparison to guidelines among China, the United States （FDA） and HongKong as well as international standards of medical devices in such tests and a lot of research data, we combined our experience, and summed up a comprehensive suggestion as the reference for standardization to guarantee scientific and accurate results

关 键 词：阴道刺激性试验 临床前试验 安全性评价 

分 类 号：R95[医药卫生—药学]