阿德福韦酯片的稳定性

Stability trial of adefovir dipivoxil tablet

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。

Objective To investigate the stability of adefovir dipivoxil tablet and determine the expiry date. Methods According 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.