国际医药卫生导报2012，Vol.18Issue(16)：2325-2327,3.DOI:10.3760/cma.j.issn.1007-1245.2012.16.004
盐酸胺碘酮包衣脉冲片稳定性初步研究
Preliminary study on stability of amiodarome hydrochloride pulsatile-coated tablets
摘要
Abstract
Objective To study the stability of amiodarone hydrochloride pulsatile-coated tablets.Methods The appearance,release,moisture absorption rate and content of tablets xere were recorded as the indexes of evaluation.Light,heat,high humidity and acceleration test were used to study the stability of the pulsatile-coated tablets.Results Through the stability test,under the light,heat,high humidity conditions,amiodarome hydrochloride pulsatile-coated tablets' appearance,increase weight were not significantly changed,amiodarone content was 97.6％ or more,after around 6 hours,the pulsatile tablets began to released; accelerate test in the six months appeared to have no change,increase weight kept within 3.1％,amiodarone content was 98.3％ or more,release delay time was in 6 hours or so.The amiodarome hydrochloride pulsatile-coated tablets were stable under light,heat and wet condition.Conclusion Amiodarome hydrochloride pulsatile-coated tablets can effectively improve the instability to the light,heat and wet condition.关键词
盐酸胺碘酮/包衣脉冲片/稳定性/加速试验Key words
Amiodarome Hydrochloride/Coated/Pulsatile tablets/Stability/Acceleration test引用本文复制引用
谭常青,蔡小连,吴海文,何文斌..盐酸胺碘酮包衣脉冲片稳定性初步研究[J].国际医药卫生导报,2012,18(16):2325-2327,3.基金项目
广东省佛山市医学类科技攻关项目(201008151) （201008151）
