Objective:To determine the contents of aristolochic acid components in Shangtongning Tablets.Method:The contents of aristolochic acid Ⅰ,aristolochic acid Ⅱ,aristolochic acid Ⅲa,aristolochic acid AA-Ⅳa,and aristolochic lactam Ⅰ in Shangtongning Tablets were determined by ultra-high performance liquid chromatography-mass spectrometry.Agilentporoshell C18 chromatographic column(100 mm×2.1 mm,2.7 μm)was used,with acetonitrile(A)-0.1%formic acid solution(B)as mobile phase for gradient elution.Under Electrospray positive ion mode(ESI+)and multi-reaction monitoring(MRM)mode,the sample injection volume was 1 μL,and the contents of five aristolochic acid components in Shangtongning Tablets were calculated using the matrix standard curve external standard method.Results:The contents of aristolochic acid Ⅰ,aristolochic acid AA Ⅳa,and aristolochic lactam Ⅰ were 0.01-0.05,0.26-1.00 and 0.40-2.17 mg·kg-1,respectively,in 18 batches of samples,with aristolochic acid Ⅱ and aristolochic acid Ⅲa not detected.Conclusion:The content determination method established in this study can provide a reference for the clinical application and safety supervision of Shangtongning Tablets and traditional Chinese medicine preparations containing aristolochic acids.
关键词
伤痛宁片/马兜铃酸/马兜铃酸Ⅰ/马兜铃酸Ⅱ/质量控制
Key words
Shangtongning Tablets/aristolochic acids/aristolochic acid Ⅰ/aristolochic acid Ⅱ/quality control
维普
万方数据