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孕二烯酮宫内节育器的研制
引用本文:邵海浩,余丽宁,兰梦宁,李芳,陈建兴.孕二烯酮宫内节育器的研制[J].生殖与避孕,2010,30(7):469-472.
作者姓名:邵海浩  余丽宁  兰梦宁  李芳  陈建兴
作者单位:上海市计划生育科学研究所,上海,200032
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。

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)

Development of Gestodene-releasing Intrauterine Device
Hai-hao SHAO,Li-ning YU,Meng-ning LAN,Fang LI,Jian-xing CHEN.Development of Gestodene-releasing Intrauterine Device[J].Reproduction and Contraception,2010,30(7):469-472.
Authors:Hai-hao SHAO  Li-ning YU  Meng-ning LAN  Fang LI  Jian-xing CHEN
Institution:(Shanghai Institute of Planned Parenthood Research,Shanghai,200032)
Abstract: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.
Keywords:gestodene(Ges)  intrauterine device(IUD)  controlled  silicone elastomer which modified by ethylene-vinyl acetate copolymer(EVA)
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