复方山莨菪碱新斯的明缓释片的制备及体外释药行为研究  

Preparation of Compound Anisodamine and Neostigmine Sustained-release Tablet and Study on the in vitro Drug Release Behavior

作　　者：李雨霏[1] 周小莉 金拓[1] 

机构地区：[1]上海交通大学药学院,上海200240 [2]无锡圆道医药科技研究院有限公司,江苏无锡214092

出　　处：《中国药房》2017年第22期3129-3132,共4页China Pharmacy

基　　金：上海市科技创新支撑计划项目(No.15DZ1942402)

摘　　要：目的:制备复方山莨菪碱新斯的明缓释片,研究其体外释药行为。方法:以消旋山莨菪碱和甲硫酸新斯的明为主药,羟丙基甲基纤维素K4M为缓释骨架材料,硬脂酸镁为润滑剂,聚乙烯吡咯烷酮为黏合剂,预胶化淀粉为稀释剂,微晶纤维素为崩解剂和填充剂,采用湿法制粒和直接压片法制备复方山莨菪碱新斯的明缓释片,高效液相色谱法检测2个主药12 h内的体外累积释放度。结果:成功制得复方山莨菪碱新斯的明缓释片,其在12 h内体外释放基本完成,山莨菪碱累积释放度为91.3%,新斯的明累积释放度为96.5%。结论:成功制得可累积释药12 h的复方山莨菪碱新斯的明缓释片。OBJECTIVE：To prepare the Compound anisodamine and neostigmine sustained-release tablet and study the in vitro drug release behavior. METHODS：Using raceanisodamine and neostigmine methyl sulfate as main medicines,hydroxypropyl methyl cellulose as sustained release skeleton material,magnesium stearate as the lubricant,polyvinyl pyrrolidone as the adhesive,pregelatinized starch as the thinner,microcrystalline cellulose as the disintegrant and filler,Compound anisodamine and neostigmine sustained-release tablet was prepared by wet granulation method and direct compression method. The in vitro cumulative release rate within 12 h of the 2 main medicines was detected by HPLC method. RESULTS：Compound anisodamine and neostigmine sustained-release tablet was successfully prepared,and the in vitro release was basically completed within 12 h,with accumulative release rate of 91.3% for anisodamine and 96.5% for neostigmine. CONCLUSIONS：Compound anisodamine and neostigmine sustained-release tablet that can cumulatively release for 12 h is successfully prepared.

关 键 词：山莨菪碱 新斯的明 复方缓释片 体外释药 

分 类 号：R943[医药卫生—药剂学]