孕二烯酮宫内节育器的研制  

Development of Gestodene-releasing Intrauterine Device

作　　者：邵海浩[1] 余丽宁[1] 兰梦宁[1] 李芳[1] 陈建兴[1] 

机构地区：[1]上海市计划生育科学研究所,上海200032

出　　处：《生殖与避孕》2010年第7期469-472,共4页Reproduction and Contraception

摘　　要：目的:采用乙烯-醋酸乙烯共聚物(EVA)改性的甲基乙烯基聚硅氧烷(硅橡胶)作为控释材料制备孕二烯酮宫内节育器(Ges-IUD)。方法:以十八烷基键合硅胶为填充剂,甲醇:水(65:35)为流动相,流速为1ml/min,检测波长为240nm,采用高效液相(HPLC)分析法进行体外药物释放试验及测定药物在控释膜中的通透率。结果:本品药物释放符合零级动力学,其释药速度与释药管管壁厚度的倒数成线性关系,表明本品释药过程符合膜控制释药的特性。结论:体积分数20%的EVA改性硅橡胶可制备缓释放Ges的IUD。Objective：To study gestodene-releasing intrauterine device（Ges-IUD） using the silicone elastomer which modified by ethylene-vinyl acetate copolymer（EVA） as the rate-controlling membrane material.Methods：A HPLC method was developed for the quantitative determination of release quantity of Ges-IUD in vitro and permeation ratio.The operation was carried out in the ODS-C18 column with the mobile phase consisting of a mixture of methanolwater（65：35）.The detection was done at 240 nm and the flow rate was 1.0 ml/min.Results：The in vitro release investigation showed zero-order kinetics.The release rate was found to be a linear function of the reciprocal thickness of tube.The drug release mechanism of this system conforms to a membrane controlling nature.Conclusion：The Ges-IUD was made of the silicone elastomer which modified by 20% ethylene-vinyl acetate copolymer.

关 键 词：孕二烯酮(Ges) 宫内节育器(IUD) 控制释放 乙烯-醋酸乙烯共聚物(EVA) 改性的甲基乙烯基聚硅氧烷(EVA硅橡胶) 

分 类 号：R984[医药卫生—药品]