外用阴道杀微生物避孕凝胶剂稳定性研究  

Study of the Stability of the Vaginal Microbicide Contraceptive Gel

作　　者：邵长凤[1] 沈丽琳[1] 张颖[1] 陈坚[1] 

机构地区：[1]天津市计划生育研究所,天津300191

出　　处：《国际生殖健康／计划生育杂志》2008年第4期259-260,共2页Journal of International Reproductive Health/Family Planning

基　　金：天津市科技计划发展项目(编号:05YFSYSF01400)

摘　　要：目的:评价外用阴道杀微生物避孕凝胶剂的稳定性。方法:对凝胶剂中两种主药成分辛苯聚醇和聚甲酚磺醛的理化性质和含量进行测定。分别将其在(30±2)℃、相对湿度(65±5)%条件下进行加速3个月,在室温条件下放置1年和在照度(4000±500)LX(勒克斯)下放置1,3,5,7和10d做稳定性考察试验。结果:在上述试验条件下,3批样品中辛苯聚醇的标示量均在90%～110%,聚甲酚磺醛的标示量均在85%～115%。结论:该制剂具有较好的稳定性。Objective： To study the stability of the vaginal microbicide contraceptive gel. Methods：The physicochemical property and content of octoxynol 9 and policresulen which were the two main components of contraceptive gel were determined. The contents of the preparations were being examined at condition of （30±2）% and relative humidity of （65±5）%, respectively, for 3 months, and placed at room temperature for one year and at 4 000 LX±500 LX light for 1, 3, 5, 7 and 10 d. These samples were determined at regular intervals. Results：Labelled amount of octoxynol 9 and policrusulen was 90%- 110% and 85%- 115%, respectively. Conclnsions： Vaginal microbicide contraceptive gel is relatively stable.

关 键 词：阴道杀微生物避孕凝胶剂 辛苯聚醇 聚甲酚磺醛 稳定性 

分 类 号：R169.42[医药卫生—公共卫生与预防医学] R446.5