醋酸艾司利卡西平片的制备及其稳定性研究

Preparation of Eslicarbazepine Acetate Tablets and Its Stability Study

目的:制备醋酸艾司利卡西平片并进行制剂稳定性研究。方法:以醋酸艾司利卡西平为主药,交联聚乙烯吡咯烷酮、预胶化淀粉等为辅料,采用等量递加法混合、直接压片制备片剂;按照2010年版《中国药典》要求对样品进行影响因素试验、加速试验和室温长期留样试验,以性状、溶出度、含量和有关物质含量等为指标考察制剂稳定性。结果:所制制剂在各项稳定性试验中考察指标均变化不大。结论:所制醋酸艾司利卡西平片对光、热、湿稳定,稳定性好,符合《中国药典》2010年版要求。

OBJECTIVE：To prepare Eslicarbazepine acetate tablets and to study its stability. METHODS：Eslicarbazepine acetate tablets were prepared using eslicarbazepine acetate as main component and crospolyvinypyrrolidone and amylum pregelatinisatum as excipients by equal quantity gradual-increasing method and direct compression. According to Chinese Pharmacopoeia（2010 edition）,influencing factor test,accelerated test and long-term observation test of samples were performed. The stability of tablets was investigated using property,dissolution,content and relevant substance as index. RESULTS：Eslicarbazepine acetate tablets was stable in light,heat and wet . For 3 monthes the Eslicarbazepine acetate tablets was consistent with the 2010 edition of Chinese Pharmacopoeia. CONCLUSION：Prepared Eslicarbazepine acetate tablets have good stability to light,heat,humidity in line with the standard of Chinese Pharmacopeia（2010 edition）.