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 meth-yl cellulose as sustained release skeleton material,magnesium stearate as the lubricant,polyvinyl pyrrolidone as the adhesive,pre-gelatinized 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 sus-tained-release tablet was successfully prepared,and the in vitro release was basically completed within 12 h,with accumulative re-lease rate of 91.3% for anisodamine and 96.5% for neostigmine. CONCLUSIONS:Compound anisodamine and neostigmine sus-tained-release tablet that can cumulatively release for 12 h is successfully prepared.
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