CAJ | 학술논문

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.
목적 고찰염산알전동포의맥충편적은정성.방법 이편제외관성상、시체시간、흡습증중화함량위평개지표,채용광조、고온、고습、가속시험고찰포의맥충편적은정성.결과 광조、고온、고습조건하해염산알전동포의맥충편적외관、증중균무명현변화,알전동함량재97.6％이상,시체시간6h좌우;가속시험적6개월내외관무명현변화,증중보지재3.1％이내,알전동함량재98.3％이상,시체시간6h좌우;염산알전동포의맥충편대광、습、열은정.결론 염산알전동포의맥충편능유효해결대광、습、열적불은정성문제.
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.