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

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.