左旋泮托拉唑钠肠溶片的制备及其稳定性考察

Preparation and stability study of (l) -pantoprazole sodium enteric tablets

目的:制备左旋泮托拉唑钠肠溶片并考察其稳定性。方法:以3因素3水平(碳酸钠的含量0,5％, 10％;黏合剂的种类MC,HPMC和PVP;浓度2％,5％,8％)的正交试验设计进行片芯处方筛选,并参考中国药典2000年版附录考察了制剂的稳定性。结果:确定了以聚乙烯吡咯烷酮(PVP)为黏合剂、10％碳酸钠为稳定剂的处方,恒温加速试验及长期留样试验6个月,含量及有关物质未见明显改变。结论:本法制备肠溶片的处方工艺简便,易于控制和操作。

Objective：To investigate the preparation and stability of （l）-pantoprazole sodium enteric tablets. Methods： The formulation of （l）-pantoprazole sodium enteric tablets was optimized by an orthogonal design involved in 3 factors and 3 levels [quantity of sodium carbonate （0,5%,10% ） , types of binders （MC,HPMC,PVP） and concentration of binders （2%,5%,8%）]. The stability of （l） -pantoprazole sodium enteric tablets was studied as defined in China Pharmacopoeia 2000. Results： The PVP and sodium carbonate were considered the optimal binder and stabilizer, respectively. No changes in the content and the related substances of the tablets were observed after the tablets were placed under an accelerated storage conditions for 6 months. Conclusion： The easily manipulated and stable formulation process of （l）-pantoprazole sodium enteric tablets was achieved.