人参再造丸中6种乌头类生物碱的含量测定方法研究  

The content determination method of six aconitum alkaloids in Renshen Zaizao pills

作　　者：黄晓燕 孙辉 丁野 李文莉 HUANG Xiaoyan;SUN Hui;DING Ye;LI Wenli(Hunan Institute for Drug Control,Changsha Hunan 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001

出　　处：《中兽医医药杂志》2024年第3期48-52,共5页Journal of Traditional Chinese Veterinary Medicine

基　　金：国家药品监督管理局2023年国家药抽检项目(编号55)。

摘　　要：建立人参再造丸(浓缩丸)中6种乌头类生物碱含量的检测方法。采用超高效液相色谱-质谱联用法(UPLC-MS)对人参再造丸(浓缩丸)中双酯型生物和单酯型生物碱的含量进行测定,梯度洗脱模式下,以0.1%甲酸溶液-乙腈为流动相,电喷雾离子源(正离子模式),监测模式为多反应监测。结果表明,6种生物碱均有良好的线性关系,精密度试验、稳定性试验、重复性试验中RSD均低于5%,平均回收率和RSD分别为97.27%~108.29%和1.99%~4.01%。所建立的方法能同时准确、快速地测定人参再造丸(浓缩丸)中6种乌头类生物碱成分的含量,专属性强、灵敏度高、重复性好,能为全面有效管控人参再造丸(浓缩丸)质量提供参考。The study aims to establish a method for detecting the content of six aconite alkaloids in concentrated Renshen Zaizao pills.Ultra performance liquid chromatography mass spectrometry(UPLC-MS)was used to determine the content of diester and monoester alkaloids in concentrated Renshen Zaizao pills.Under gradient elution mode,0.1%formic acid solution-acetonitrile was used as mobile phase,electrospray ion source(positive ion mode)was adopted,and the monitoring mode was multi reaction monitoring.The results showed that all six alkaloids had good linear relationships,and their RSD values were below 5%in precision,stability,and repeatability experiments.The average recovery rate and RSD were 97.27%-108.29%and 1.99%-4.01%,respectively.The established method can accurately and quickly determine the content of six aconite alkaloids in concentrated Renshen Zaizao pills,with strong specificity,high sensitivity,and good repeatability,providing reference for comprehensive and effective quality control of concentrated Renshen Zaizao pills.

关 键 词：人参再造丸(浓缩丸) 超高效液相色谱-质谱联用 制附子 双酯型生物 单酯型生物碱 

分 类 号：S853.7[农业科学—临床兽医学]