芪苈强心胶囊对照品溶液稳定性研究

Stability of Reference Substance Solution for Qili Qiangxin Capsules

目的：本文探讨芪苈强心胶囊鉴别对照品溶液的保存条件和有效期,规范中药检验对照品的管理,节约药品检验成本,提高检验效率。方法：按照《中国药典2010年版一部》中药的薄层色谱法对芪苈强心胶囊橙皮苷、香加皮对照品溶液进行成像实验,通过比较橙皮苷饱和溶液不同时间、不同保存条件的成像效果和香加皮不同浓度、不同时间、不同保存条件下的成像效果,找到两种对照品溶液的最佳保存条件和期限。结果：橙皮苷饱和溶液最佳保存时间为配制后120天,保存条件常温即可;香加皮溶液最佳保存时间为配制后30天,10倍浓缩溶液于2-8℃下保存效果更佳。结论：本研究结果为中药对照品标准化管理和保存有效期限的设定提供一定依据,通过明确对照品溶液的保存期限,减少检验使用量,节约药品检验成本,提高检验精度。本课题规范中药检验对照品的管理,为中药检验标准化提供了借鉴。

Objective： In order to standardize the management of the reference substance which was used for the testing of traditional Chinese medicine,the authors comparatively studied the preservation condition and expiry date of the Hesperidin reference solution and Corex Periplocae reference solution. The study was good to reduce the cost of testing and improving the efficiency. Methods： The reference substance solutions were preserved in different conditions,and these solutions were analyzed by TLC according to Chinese Pharmacopoeia 2010 version（Vol I）. Results： The best preservation period of Hesperidin reference solution was 120 days under normal temperature condition or 2 - 8℃ refrigerator storage condition. The best preservation period of Corex Periplocae reference solution was 30 days,and the 10 times concentration of the solution under 2 - 8℃ refrigerator storage condition was superior to other solutions. Conclusion： The study is conducive to save the cost of testing by reducing the usage amount of the reference substance,and it may improve the inspection accuracy. The study is good to the reference substance management of traditional Chinese medicine.