UPLC-MS/MS检测补肾益脑胶囊中人参掺伪情况  

Detection of Panax ginseng Adulteration in Bushen Yinao Capsules by UPLC-MS/MS

作　　者：李欣 高天鹏 张明童 王娟弟 李冬华 杨玲霞 LI Xin;GAO Tian-peng;ZHANG Ming-tong;WANG Juan-di;LI Dong-hua;YANG Ling-xia(Gansu Provincial Institute of Drug Control,Lanzhou 730070,China;NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Lanzhou 730070,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070

出　　处：《中国现代中药》2024年第6期1085-1091,共7页Modern Chinese Medicine

基　　金：中药材及饮片质量控制重点实验室项目(2022GSMPA-KL12,2023GSMPA-KL06);甘肃省药品科研项目(2022GSMPA0075)。

摘　　要：目的:建立一种可测定补肾益脑胶囊制剂中非法添加西洋参的超高效液相色谱-质谱法,考察企业是否存在使用西洋参或其边角料替代人参投料的现象,为中药监管提供技术支持。方法:Phenomenex C_(18)色谱柱(100 mm×2.1 mm,2.6μm),以10 mmoL·L^(-1)的乙酸铵(A)-乙腈(B)为流动相梯度洗脱;流速为0.3 mL·min^(-1);柱温为40℃。采用电喷雾负离子模式进行多反应监测。结果:60批补肾益脑胶囊中有29批检出西洋参的专属成分拟人参皂苷F_(11),检出率为48.3%。结论:补肾益脑胶囊中存在人参掺伪的现象,该方法准确可靠,可作为补肾益脑胶囊中人参掺混西洋参的补充检验方法。Objective:This study aims to establish an ultra-high performance liquid chromatography-mass spectrometry(UPLC-MS/MS)method for determining Panax quinquefolium illegally added in Bushen Yinao Capsule preparation and to investigate whether enterprises use P.quinquefolium or its leftover ingredients to replace Panax ginseng,so as to provide technical support for traditional Chinese medicine(TCM)supervision.Methods:Phenomenex C_(18) column(100 mm×2.1 mm,2.6μm)was used,with 10 mmoL·L^(-1) ammonium acetate l(A)-acetonitrile(B)as the mobile phase for gradient elution.The flow rate was 0.3 mL·min^(-1),and the column temperature was 40℃.Electrospray negative ion mode(ESI–)was employed for multiple reaction monitoring(MRM).Results:Pseudo-ginsenoside F_(11),a special component of P.quinquefolium,was detected in 29 batches of 60 Bushen Yinao Capsules,with a detection rate of 48.3%.Conclusion:There was P.ginseng C.A.Mey.adulteration in Bushen Yinao Capsules.The method was accurate and reliable and could be used as a supplementary test method for P.quinquefolium illegally added in Bushen Yinao Capsules.

关 键 词：补肾益脑胶囊 红参 西洋参 拟人参皂苷F_(11) 

分 类 号：R286[医药卫生—中药学]