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| 恩替卡韦分散片的稳定性研究 | |
| 引用本文： | 易毛,韩晋,吴素体,张诗龙,谢进,李正明,刘峰群,丁晋彪,楼金芳.恩替卡韦分散片的稳定性研究[J].解放军药学学报,2012,28(2):164-165. |
| 作者姓名： | 易毛 韩晋 吴素体 张诗龙 谢进 李正明 刘峰群 丁晋彪 楼金芳 |
| 作者单位： | 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 |
| 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。 |
| 关 键 词： | 恩替卡韦分散片 抗病毒药 稳定性 有效期 |
Stability Trial of Entecavir Dispersible Tablets |
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| YI Mao , HAN Jin , WU Su-ti , ZHANG Shi-long , XIE Jin , LI Zheng-ming , LIU Feng-qun , DING Jin-biao , LOU Jin-fang.Stability Trial of Entecavir Dispersible Tablets[J].Pharmaceutical Journal of Chinese People's Liberation Army,2012,28(2):164-165. | |
| Authors: | YI Mao HAN Jin WU Su-ti ZHANG Shi-long XIE Jin LI Zheng-ming LIU Feng-qun DING Jin-biao LOU Jin-fang |
| Institution: | ①Department of Pharmacy,②Department of Medical Affairs,Hospital 302 of PLA,Beijing 100039,China; ③ Hangzhou Sunyou Pharmaceutics-Technology Corporation Limited,Hangzhou 310018,China |
| Abstract: | 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. |
| Keywords: | entecavir dispersible tablets antiviral agents stability trial expiry date |
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