恩替卡韦分散片的稳定性研究  

Stability Trial of Entecavir Dispersible Tablets

作　　者：易毛[1] 韩晋[1] 吴素体[1] 张诗龙[1] 谢进[1] 李正明[1] 刘峰群[1] 丁晋彪[2] 楼金芳 

机构地区：[1]解放军302医院药学部,北京100039 [2]解放军302医院医务部,北京100039 [3]杭州盛友医药技术开发有限公司,浙江杭州310018

出　　处：《解放军药学学报》2012年第2期164-165,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的研究恩替卡韦分散片在加速试验和长期试验条件下的稳定性并测算其有效期。方法在模拟市售包装条件下,通过加速试验和室温贮存18个月,参照《中国药典》附录对其性状、鉴别、分散均匀性、溶出度、有关物质、微生物限度检查及含量测定等项指标进行定期考察。结果在考察期内,各项指标均符合规定。结论本品在温度40℃、相对湿度75%条件下放置6个月或常温、相对湿度60%条件下放置18个月,药物制剂稳定,故其有效期定为18个月。Objective To determine the expiry date of entecavir dispersible tablets from accelerating and long-term stability experiments.Methods According to references and under simulated packing conditions,the quality indexes of entecavir,such as shape,properties,and content determination,were periodically checked duing 18 months.Results All the detectable results conformed to regulations on quality standards.Conclusion The shelf life of dispersible tablets is defined as 18 months,as the quality is stable after they are kept for 6 months under 40℃ or under 18 months in room temperature.

关 键 词：恩替卡韦分散片 抗病毒药 稳定性 有效期 

分 类 号：R954[医药卫生—药学]