盐酸胺碘酮包衣脉冲片稳定性初步研究

目的 考察盐酸胺碘酮包衣脉冲片的稳定性.方法 以片剂外观性状、时滞时间、吸湿增重和含量为评价指标,采用光照、高温、高湿、加速试验考察包衣脉冲片的稳定性.结果 光照、高温、高湿条件下该盐酸胺碘酮包衣脉冲片的外观、增重均无明显变化,胺碘酮含量在97.6％以上,时滞时间6h左右;加速试验的6个月内外观无明显变化,增重保持在3.1％以内,胺碘酮含量在98.3％以上,时滞时间6h左右;盐酸胺碘酮包衣脉冲片对光、湿、热稳定.结论 盐酸胺碘酮包衣脉冲片能有效解决对光、湿、热的不稳定性问题.

Preliminary study on stability of amiodarome hydrochloride pulsatile-coated tablets

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 hydro- chloride pulsatile-coated tablets can effectively improve the instability to the light, heat and wet condition.