中国药业2026，Vol.35Issue(11)：93-97,5.DOI:10.3969/j.issn.1006-4931.2026.11.017
超高效液相色谱串联质谱法同时检测小儿止咳平喘类中成药中28种非法添加化学成分
Determination of 28 Chemical Compounds Illegally Added in Pediatric Chinese Patent Medicines for Relieving Cough and Asthma by UPLC-MS/MS
摘要
Abstract
Objective To establish an ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method for the simultaneous determination of 28 chemical components illegally added in pediatric Chinese patent medicines for relieving cough and asthma.Methods The chromatographic column was Waters UPLC BEH C18 column(100 mm×2.1 mm,1.7 µm),the mobile phase was acetonitrile-5 mmol/L ammonium formate containing 0.1%formic acid(gradient elution),the flow rate was 0.3 mL/min,the column temperature was 40℃,and the injection volume was 2 µL.The ionization mode was the electrospray ionization positive ion mode(ESI+),and the quantitative analysis was carried out by the multi-reaction monitoring(MRM)mode.Results The 28 chemical components showed a good linear relationship with the peak area of ion pairs within their respective mass concentration ranges(R2＞0.995,n=11).The limit of detection was in the range of 0.005-0.010 µg,and the limit of quantification was in the range of 0.015-0.050 µg.The RSDs of precision,stability,and repeatability test results were all lower than 8.0%(n=6).The average recovery rates of 28 chemical components ranged from 80.23%to 114.02%,and the RSDs ranged from 0.82%to 7.71%(n=6).Among the twelve batches of four varieties of pediatric Chinese patent medicines(three batches of Xiao'er Cough Syrup,three batches of Xiao'er Kechuanling Oral Liquid,three batches of Xiao'er Kechuanling Granules,and three batches of Xiao'er Qingfei Huatan Granules),caffeine was detected in two batches of Xiao'er Kechuanling Granules samples,with the contents of 2.75 mg/kg and 2.98 mg/kg,respectively,while the other 27 components were not detected in samples,with a comprehensive detection rate of 16.67%.Conclusion The established method is sensitive,accurate,and rapid,which can be used for the quantitative analysis of multiple illegally added chemical components in pediatric Chinese patent medicines for relieving cough and asthma.关键词
超高效液相色谱串联质谱法/止咳平喘/儿童/中成药/非法添加化学成分Key words
UPLC-MS/MS/relieving cough and asthma/children/Chinese patent medicines/illegal addition of chemical components分类
医药卫生引用本文复制引用
高萌,崔佳惠,撖志明,贺凯,张家萌..超高效液相色谱串联质谱法同时检测小儿止咳平喘类中成药中28种非法添加化学成分[J].中国药业,2026,35(11):93-97,5.基金项目
宁夏药品质量控制与评价重点实验室科研课题(2024年). （2024年）
