摘要
建立宣肺止嗽合剂及鱼腥草中4种马兜铃酸类成分的超高效液相色谱-串联质谱(UPLCMS/MS)检查方法。采用Waters C18色谱柱(100.0 mm×2.1 mm,1.8µm),以0.1%甲酸溶液(含5 mmol/L乙酸铵)-乙腈为流动相,梯度洗脱,流速0.3 mL/min,柱温40℃;电喷雾正离子扫描,多反应监测模式。结果表明,制剂基质抑制效应明显;4种马兜铃酸类物质成分在各自浓度范围内线性关系良好(r>0.9990),平均回收率为90.52%~96.33%(n=6),相对标准偏差为0.92%~2.78%。10批宣肺止嗽合剂及相应投料的10批鱼腥草中均未检出4种成分。本研究建立的方法准确、可靠,可用于宣肺止嗽合剂及鱼腥草中马兜铃酸A、马兜铃酸B、马兜铃酸C、马兜铃酸D的筛查及定量分析,可为药品监管及公众用药安全提供技术保障。
The objective was to establish an UPLC-MS/MS method for detecting 4 aristolochic acids in Xuanfei Zhisou mixture and Houttuyniae Herba.The analysis method was performed on Waters C18 column(100.0 mm×2.1 mm,1.8µm),using acetonitrile and 0.1%fomic acid solution containing 5 mmol/L ammonium acetate solution as mobile phase for gradient elution at a flow rate of 0.3 mL/min,and column temperature was 40℃.The analyte was detected by electrospray cation scanning and multiple reaction monitoring mode.The results showed that the preparation had an obvious matrix inhibitory effect;4 aristolochic acids showed good linearity in their corresponding range(r>0.9990),their average recovery rate was 90.52%-96.33%(n=6)with RSD of 0.92%-2.78%.The four aristolochic acids were not detected in 10 batches of Xuanfei Zhisou mixture and 10 batches of Houttuyniae Herba.The established method in this study is accurate and reliable,which can be applied to screen and quantitative analy aristolochic acid A,aristolochic acid B,aristolochic acid C,aristolochic acid D in Xuanfei Zhisou mixture and Houttuyniae Herba.This study can provide technical support for drug supervise and public safety.
作者
王丽梅
张明童
史小亚
马潇
WANG Limei;ZHANG Mingtong;SHI Xiaoya;MA Xiao(State Drug Administration-Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces,Gansu Institute for Drug Control,Lanzhou Gansu 730070,China)
出处
《中兽医医药杂志》
CAS
2024年第6期59-63,共5页
Journal of Traditional Chinese Veterinary Medicine
基金
国家药品监督管理局中药材及饮片质量控制重点实验室项目(2023GSMPA-KL08)
甘肃省药品监管科学科研项目(2022GSMPA0031)。
作者简介
王丽梅(1988-),女,主管药师,研究方向为药品检验及质量控制。Email:1039775410@qq.com;通信作者:马潇(1974-),男,主任中药师,研究方向为中药鉴定与质量控制。Email:2484649834@qq.com。
