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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 prepare Gestrinone intrauterine device (Ges-IUD) by using ethylene-vinyl acetate copolymer (EVA) modified methyl vinyl polysiloxane (silicone rubber) as controlled release material. Methods: Octadecyl-bonded silica gel was used as the filler. Methanol: water (65:35) was used as the mobile phase. The flow rate was 1 ml / min and the detection wavelength was 240 nm. The drug release was determined by high performance liquid chromatography Test and determine the drug permeability in the controlled release membrane. Results: The drug release in line with zero-order kinetics, the drug release rate and release tube wall thickness reciprocal linear relationship, indicating that the product release process in line with the characteristics of controlled release film. CONCLUSION: The IUD with slow release of Ges can be prepared with EVA modified silicone rubber with volume fraction of 20%.