恩替卡韦分散片的质量检查及溶出度对比研究  

Study of entecavir dispersible tablets quality inspection and contrast dissolution

作　　者：袁慧[1] 徐小明[1] 张欣欣[1] 史琼[1] 程铁峰[1] 

机构地区：[1]河南大学药学院,河南开封475000

出　　处：《河南大学学报（医学版）》2016年第3期175-177,共3页Journal of Henan University:Medical Science

基　　金：河南省高等学校重点科研项目(15A360012)

摘　　要：〔目的〕制备恩替卡韦分散片,对自制分散片进行质量检查,并与市售恩替卡韦分散片进行体外溶出曲线比较研究。〔方法〕以微晶纤维素为稀释剂、60 g/L PVPK30水溶液为黏合剂、PVPP为崩解剂、欧伦包衣预混液为包衣材料,制成恩替卡韦分散片,并对自制分散片进行一系列质量检查。以0.05 mol/L的磷酸二氢钠为溶出介质,用小杯法测定了自制分散片与市售分散片在介质中的溶出曲线。〔结果〕自制恩替卡韦分散片的质量符合要求,其体外溶出度符合《中国药典》(2015年版)的规定。〔结论〕制备的恩替卡韦分散片外观良好、质量符合标准,比市售分散片的体外溶出略快,且制备工艺简单。〔Objective〕To prepare entecavir dispersible tablets, make quality inspection on self-made tablets and compare the dissolution curves of self-made and market available entecavir dispersible tablets. 〔Methods〕Entecavir dispersible tablets were prepared using MCC, PVPP, PVP K30 and European Lun coating. A series of quality inspection put on entecavir dispersible tablets.The solubility of the market available entecavir tablets and self-made tablets respectively were compared in 0. 05 mol / L Na H2PO4 as dissolution medium. The dissolution of entecavir dispersible tablets was determined by cup method.〔Results〕The self-made entecavir dispersible tablets compliance with legal quality. The dissolution of entecavir dispersible tablets was determined by cup method. Dispersible tablets in vitro dissolution comply with the regulations of the 2015 Chinese Pharmacopoeia.〔Conclusion〕Entecavir dispersible tablets have external characteristics, conform to the standard and preparation technology is simple. The dissolution profiles of self-made entecavir tablets are faster as that of market available ones.

关 键 词：恩替卡韦 分散片 溶出度 

分 类 号：R927.1[医药卫生—药学]