石杉碱甲双层缓释片的研制及体外释药研究

Preparation of Huperzine A Double-layer Sustained Release Tablets and Their in Vitro Release Characteristics

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HPMCK4M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 study the preparation of Huperzine - A double - layer sustained release tablets and their in vitro release characteristics. METHODS： With HPMC K4M as matrix and lactose as diluting agent for the sustained release layer, and with starch - calcium carbonate as diluting agent and sodium carboxymethyl starch as disintegrating agent for the fast release layer to prepare the double- layer tablets by compression, with the release rate of the compressed tablets determined by HPLC. RESULTS： The fast release layer of the prepared Huperzine- A double- layer tablets disintegrated within 1--2 min and appeared as fine powder, meeting the requirement; the release curve of the sustained release layer of the tablets was in line with Higuchi equation and maintained a sustained release of 12 hours. CONCLUSION： The prepared Huperzine- A double- layer tables achieved the goal of both immediate release and sustained release.