中医药导报
中醫藥導報
중의약도보
GUIDING JOURNAL OF TCM
2013年
2期
84-85
,共2页
王适%何群%郭畅%陈光宇%许江丽%毛骁丽
王適%何群%郭暢%陳光宇%許江麗%毛驍麗
왕괄%하군%곽창%진광우%허강려%모효려
长期试验法%九香止泻肠溶片%有效期
長期試驗法%九香止瀉腸溶片%有效期
장기시험법%구향지사장용편%유효기
Long term test method%Jiu Xiang Zhi Xie Enteric Coated Tables%Valid Period
目的:初步确定九香止泻肠溶片的有效期.方法:利用HPLC法分别测量第1月至第24月内9个时间点九香止泻肠溶片中秦皮甲素与秦皮乙素的含量,与第0月所测含量进行比较,求得含量下降到90%时的时间.结果:数据通过分析处理,秦皮甲素与秦皮乙素的含量之和下降到90%的时间区间为16.27-19.99个月.结论:长期试验法能较好的测定九香止泻肠溶片的有效期.综合考虑取上限,即该制剂的有效期为20个月.
目的:初步確定九香止瀉腸溶片的有效期.方法:利用HPLC法分彆測量第1月至第24月內9箇時間點九香止瀉腸溶片中秦皮甲素與秦皮乙素的含量,與第0月所測含量進行比較,求得含量下降到90%時的時間.結果:數據通過分析處理,秦皮甲素與秦皮乙素的含量之和下降到90%的時間區間為16.27-19.99箇月.結論:長期試驗法能較好的測定九香止瀉腸溶片的有效期.綜閤攷慮取上限,即該製劑的有效期為20箇月.
목적:초보학정구향지사장용편적유효기.방법:이용HPLC법분별측량제1월지제24월내9개시간점구향지사장용편중진피갑소여진피을소적함량,여제0월소측함량진행비교,구득함량하강도90%시적시간.결과:수거통과분석처리,진피갑소여진피을소적함량지화하강도90%적시간구간위16.27-19.99개월.결론:장기시험법능교호적측정구향지사장용편적유효기.종합고필취상한,즉해제제적유효기위20개월.
Objective: To identificate the valid period of Jiu Xiang Zhi Xie enteric coated tables preliminary. Methods: A-corrding to determinating the content of aesculin and aesculetin on nine time points from 1st to 24 th months, and then com-paring with the zero month, the time of content down to 90% was calculated. Results: The time interval of content which summate the aesculin and aesculetin down to 90% is 16.27-19.99 months. Conclusion: Long term test method can determinate the valid period of Jiu Xiang Zhi Xie enteric coated tables well, and the valid period of this preparation is twenty months.