摘要
目的:以黄芪精为例,对液体制剂中黄芪甲苷含量测定的方法进行改进和优化。方法:以黄芪甲苷为对照品,乙腈-水(32∶68)为流动相,采用ELSD检测器,以黄芪精为例采用直接碱化处理的前处理方式建立黄芪甲苷的液相色谱含量测定方法。结果:黄芪精中黄芪甲苷含量测定方法前处理简单、专属性好,在0.33~2.4μg范围内与峰面积的线性良好(r=0.9997),平均加样回收率102.5%(RSD 3.0%,n=6),符合方法建立的要求。结论:建立的方法可用于黄芪精含量测定方法标准的提高,为含黄芪甲苷的制剂尤其是液体制剂方法优化提供参考。
Objective:To improve and optimize the content determination method of astragalosideⅣin liquid preparations such us Huangqi Jing.Methods:The contents of astragalosideⅣin Huangqi Jing was analyzed by high performance liquid chromatography(HPLC)and evaporative light scattering detector with mobile phase of acetonitrile-water(32∶68),flow rate of 1.0 mL·min-1 and direct alkalization pretreatment.Results:Astragaloside IV showed a good linearity with peak area in the range of 0.33μg~2.4μg,the average recoveries of these two ingredients wer 102.5%(RSD 3.0%,n=6),meet the requirements of method establishment.Conclusion:The established method is simple,specific and reproducible,which can be used to improve the quality control standard of Huangqi Jing and provides a reference for the method optimization of astragalosideⅣ,especially in liquid preparations.
作者
陈勇
杨欢
CHEN Yong;YANG Huan(Zhejiang Provincial Institute of Food and Drug Control,Zhejiang hangzhou 310052,China;NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Zhejiang hangzhou 310052,China)
出处
《中国药物评价》
2022年第2期122-124,共3页
Chinese Journal of Drug Evaluation
关键词
前处理
黄芪甲苷
黄芪精
含量测定
Pretreatment
AstragalosideⅣ
Huangqi Jing
Content determination
