摘要
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).
出处
《中国药房》
CAS
CSCD
北大核心
2010年第37期3509-3510,共2页
China Pharmacy
关键词
醋酸艾司利卡西平
片剂
制备
稳定性
Eslicarbazepine acetate
Tablets
Preparation
Stability