摘要
目的考察3种市售阿德福韦酯制剂(A、B、C药品)的加速试验稳定性。方法采用桨法进行阿德福韦酯制剂溶出度试验,采用HPLC法测定药物含量及有关物质。结果 3种药品的加速试验稳定性有显著差异。A药品在加速试验6 mo期间含量较稳定,有关物质无明显增加而且溶出度显著优于另2种产品;B药品含量呈现显著减小趋势,有关物质不断升高;C药品经加速试验,溶出度显著减小。结论 A药品稳定性显著优于B、C。
AIM To compare the stability of three marketed adefovir dipivoxil products through accelerated stability test.METHODS The dissolution test was performed using paddle method.Drug content and related substance were determined by HPLC.RESULTS The stability of three marketed products were significantly different.During the accelerated stability test of six months,the drug content of product A was stable,the related substances just increased slightly and the dissolution was significantly better than the other drugs.While the drug content of product B underwent sharp decrease with continuous increase in related substances.And after accelerated test,the dissolution of product C was significantly low.CONCLUSION Product A possesses the superior stability features.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2010年第12期923-927,共5页
Chinese Journal of New Drugs and Clinical Remedies
关键词
阿德福韦酯
片剂
胶囊
稳定性
adefovir dipivoxil
tablets
capsules
stability
