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目的:研制石杉碱甲双层缓释片并考察其体外释药特征。方法:缓释层以HPMC K4M为缓释骨架材料,乳糖为稀释剂;速释层以淀粉-碳酸钙为稀释剂,羧甲基淀粉钠为崩解剂,压制双层片,高效液相色谱法检测释放度。结果:制备的石杉碱甲双层片速释层在1~2min崩解,呈粉末状,符合要求;缓释层的释药曲线用Higuchi方程拟合,可维持12h释药。结论:该处方下研制的石杉碱甲双层缓释片可达到既速效又长效的目的。
Objective: To develop huperzine A sustained-release tablets and study its in vitro release characteristics. Methods: The sustained-release layer was sustained-release HPMC K4M matrix material with lactose as diluent. The immediate-release layer was starch-calcium carbonate as diluent and sodium carboxymethyl starch as disintegrating agent. The double-layer tablet and high performance liquid chromatography Law test release. Results: The sustained release layer of Huperzine A was disintegrated in 1 ~ 2min, which was in accordance with the requirements. The release curve of sustained release layer was fit with Higuchi equation and could be released for 12h. Conclusion: The huperzine A sustained-release tablets developed under this prescription can achieve both rapid and long-term effects.