抗微生物避孕凝胶剂的制备及质量控制  

Preparation and Quality Control of Anti-Microbicide Contraceptive Gel

作　　者：沈丽琳[1] 刘苗苗[1] 邵长风[1] 张颖[1] 陈坚[1] 

机构地区：[1]天津市计划生育研究所,天津市300191

出　　处：《中国药房》2010年第9期828-830,共3页China Pharmacy

基　　金：天津市科技计划发展项目(05YFSYSF01400)

摘　　要：目的:制备抗微生物避孕凝胶剂,并建立其质量控制方法。方法:以辛苯聚醇、聚甲酚磺醛为主药,羟丙甲纤维素等为基质制备凝胶。采用高效液相色谱法测定辛苯聚醇的含量,滴定法测定聚甲酚磺醛的含量。结果:所制制剂质地均匀、细腻、黏稠度适中,鉴别、检查项均符合相关规定。辛苯聚醇检测浓度的线性范围为250～1500mg·L-(1r=0.9996),平均回收率为100.84%(RSD=0.74%,n=9);聚甲酚磺醛平均标示量106.64%(n=3)。结论:该制剂制备工艺可行,质量稳定,质控方法简单、结果准确。OBJECTIVE： To prepare anti-microbicide contraceptive gel and establish its quality control method. METHODS： The gel was prepared with octoxynol and policresulen as main ingredients and HPMC as matrix. The content of octoxynol in the gel was determined by HPLC, and the content of policresulen in the gel was determined by titration method. RESULTS： Prepared gel was well-proportioned and of good viscidity and its identification and test were up to the standard. The linear rang of octoxynol was 250-1 500 mg·L^-1 （r=0.999 6） with an average recovery of 100.84% （RSD=0.74%, n=9）. The average labeled amount of policresulen was 106.64% （n=3）. CONCLUSION： This preparation is feasible and stable in quality, and the quality control method is simple and accurate.

关 键 词：辛苯聚醇 聚甲酚磺醛 凝胶剂 质量控制 

分 类 号：R927.11[医药卫生—药学] R979.21