TLC对复方制剂中马兜铃酸限量检查方法学研究

Limit test of aristolochic acid in the compound preparations by thin-layer chromatography

目的:建立简便、快捷、准确的复方制剂中马兜铃酸限量薄层色谱(TLC)检查法。方法:采用精确定量点样薄层色谱法(TLC)对复方止咳散中毒性成分马兜铃酸进行限量检查。结果:本方法测得马兜铃酸含量在0.0808μg/g以下,符合《中国药典》2010年版中细辛药材检查项下的马兜铃酸限量标准要求。结论:本方法简便、快速、准确,适用于复方制剂中马兜铃酸限量的检查。

Objective： To establish a simple,fast and accurate method of aristolochic acid limited TLC examination for compound agent.Methods： With the exact quantitative point-like thin layer chromatography（TLC） in limited inspection of aristolochic acid in the toxic components of the compound cough scattered preparations.Results： The method of aristolochic acid content measured in the 0.0808μg/g following,in line with limited requirements.Conclusion： The method is simple,rapid,accurate,and can be used in com-pound agent for the inspection limits of aristolochic acid.