CAJ | 학술논문

目的：研制琥珀酸S-美托洛尔24 h缓释片，考察其体外释放特征，并对其体外释放机制进行初步研究。方法以羟丙基甲基纤维素（ HPMC）为骨架材料制备缓释片，以单因素试验法对缓释片释放因素进行考察，采用正交试验设计选择最佳处方，并对优化处方的释药机制进行探讨。结果最优处方以K100M和K15M规格HPMC的混合物作为骨架材料，质量分数各占总质量的20％，微晶纤维素为填充剂，质量分数占总质量的50％。制备的琥珀酸S-美托洛尔缓释片释放规律符合Ritger-Peppas方程曲线，释药行为是药物扩散和骨架溶蚀协同作用。结论琥珀酸S-美托洛尔缓释片处方合理，有良好的24 h体外释药行为，处方工艺基本满足设计要求。
목적：연제호박산S-미탁락이24 h완석편，고찰기체외석방특정，병대기체외석방궤제진행초보연구。방법이간병기갑기섬유소（ HPMC）위골가재료제비완석편，이단인소시험법대완석편석방인소진행고찰，채용정교시험설계선택최가처방，병대우화처방적석약궤제진행탐토。결과최우처방이K100M화K15M규격HPMC적혼합물작위골가재료，질량분수각점총질량적20％，미정섬유소위전충제，질량분수점총질량적50％。제비적호박산S-미탁락이완석편석방규률부합Ritger-Peppas방정곡선，석약행위시약물확산화골가용식협동작용。결론호박산S-미탁락이완석편처방합리，유량호적24 h체외석약행위，처방공예기본만족설계요구。
Objective To prepare 24-hour S-Metoprolol Succinate sustained release tablets and to investigate its in vitro release mecha-nism.Methods HPMC as matrix material was used for the preparation of sustained-release tablets.The single factor test method was used to evaluate release profile of sustained-release tablets.Orthogonal design to choose the optimal prescription and release mechanism was discussed.Results The mixture of HPMC K100M and K15M as a skeletal material,the mass fraction each accounted for 20%of total mass.MCC as filler,the mass fraction of it was 50%.The release of S-metoprolol succinate sustained release tablets was in line with Ritger-Peppas equation of the curve.The release process of drug was synergistic by diffusion and skeleton dissolution.Conclusions The prescription of S-Metoprolol Succinate sustained release tablets were reasonable with stable process,which meets the general re-quirements of the design.