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| 阿德福韦酯片的稳定性 | |
| 引用本文： | 易毛,韩晋,吴素体,刘峰群,李正明,郑绯,丁晋彪,王迪杰,杜成德. 阿德福韦酯片的稳定性[J]. 传染病信息, 2011, 24(4): 237-238 |
| 作者姓名： | 易毛 韩晋 吴素体 刘峰群 李正明 郑绯 丁晋彪 王迪杰 杜成德 |
| 作者单位： | 1. 解放军第三○二医院药学部,北京,100039 2. 解放军第三○二医院医务部,北京,100039 3. 山东世博金都医药科技发展有限公司,淄博,255086 |
| 基金项目： | 国家“十一五”重大新药创制课题 |
| 摘 要： | 目的 研究阿德福韦酯片的稳定性并测算其有效期.方法 根据《新药临床前研究指导原则汇编》,在模拟市售包装条件下,通过室温贮存12个月,对阿德福韦酯片的性状、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 本品常温放置12个月,其质量稳定,故有效期定为12个月. |
| 关 键 词： | 阿德福韦酯片 抗病毒药 稳定性 有效期 |
Stability trial of adefovir dipivoxil tablet |
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| YI Mao,HAN Jin,WU Su-ti,LIU Feng-qun,LI Zheng-ming,ZHENG Fei,DING Jin-biao,WANG Di-jie,DU Cheng-de. Stability trial of adefovir dipivoxil tablet[J]. Infectious Disease Information, 2011, 24(4): 237-238 | |
| Authors: | YI Mao HAN Jin WU Su-ti LIU Feng-qun LI Zheng-ming ZHENG Fei DING Jin-biao WANG Di-jie DU Cheng-de |
| Affiliation: | Department of Pharmacy,302 Hospital of PLA,Beijing 100039,China |
| Abstract: | Objective To investigate the stability of adefovir dipivoxil tablet and determine the expiry date.Methods Ac-cording to the Collection of Preclinical Guidelines for new Drugs,under market packing circumstances,the quality indexes of adefovir dipivoxil tablet such as shape and properties and content determination,were periodically checked in the storage time of 12 months.Results All the indexes conformed to regulations of its quality standard.Conclusion Adefovir dipivoxil tablet has high and stable quality after it is kept for 12 months in room temperature,so the shelf life of the tablet is defined as 12 months. |
| Keywords: | adefovir dipivoxil tablet antiviral agents stability expiry date |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |