长期试验法测定九香止泻肠溶片的有效期研究  

Study on Valid Period of Jiu Xiang Zhi Xie Enteric Coated Tables by Long Term Test Method

作　　者：王适[1] 何群[1] 郭畅[2] 陈光宇[2] 许江丽[2] 毛骁丽[2] 

机构地区：[1]湖南中医药大学第二附属医院,湖南长沙410005 [2]湖南中医药大学,湖南长沙410208

出　　处：《中医药导报》2013年第2期84-86,共3页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：湖南省教育厅重点项目(05A0312)

摘　　要：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。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.

关 键 词：长期试验法 九香止泻肠溶片 有效期 

分 类 号：R284.1[医药卫生—中药学]