缓解体力疲劳类中成药及保健食品中非法添加化学药物高通量筛查模式的建立  

Establishment of a high-throughput screening model for illegal addition of chemical drugs in anti-fatigue Chinese patent medicine and health foods

作　　者：赵琪 张珊珊 冯哲玺 张超 陈卫 贾昌平 ZHAO Qi;ZHANG Shan-shan;FENG Zhe-xi;ZHANG Chao;CHEN Wei;JIA Chang-ping(Suzhou Institute for Drug Control,Suzhou Jiangsu 215000)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215000

出　　处：《中南药学》2025年第3期745-755,共11页Central South Pharmacy

基　　金：国家市场监督管理总局科技计划项目(No.2024MK044)。

摘　　要：目的建立缓解体力疲劳类中成药及保健食品中非法添加化学药物的超高效液相色谱-高分辨质谱联用仪(UPLC-ESI-Q-TOF/MS)匹配数据库的高通量筛查检测方法。方法通过收集保健食品中可能添加的所有缓解体力疲劳类化学药物及其衍生物,建立数据库。根据其结构特征归类,按照油水分配系数(logP值)排序,选取每一类代表性物质组成化合物集,开发UPLC-ESI-Q-TOF/MS分析方法。样品的筛查通过质谱一、二级精确质量数比对进行,定量则依据一级质谱响应。结果各化学药物在1~20μg·mL^(-1)内与峰面积线性关系良好、精密度RSD小于3%、回收率在86.46%~114.07%。10批样品中,育亨宾、达泊西汀、西地那非杂质12分别各有一批检出;6批检测出西地那非;2批检出促进剂M、他达拉非;3批检出西地那非。结论该方法快速、高效,可以快速完成缓解体力疲劳类中成药及保健食品中八大类,275种化学药物的筛查、确证及定量。Objective To establish an ultra-performance liquid chromatography-high resolution mass spectrometry(UPLC-ESI-Q-TOF/MS)matching database with high-throughput screening of banned antibiotic components in anti-fatigue Chinese patient medicine and health food.Methods A compound database of antibiotics that might added in aiti-fatigue Chinese patient medicine and health food was established.All component were classified according to their structural characteristics,and sorted according to the oil-water partition coeffcient(logP value).The representative materials were collected to develop the UPLC-ESI-Q-TOF/MS analysis method.The screening of samples was conducted through the comparison of primary and secondary accurate mass numbers of mass spectrometry,while quantification was based on the primary mass spectrometry response.Results The method was validated.A good linear relationship was showed at 1~20μg·mL^(-1)(RSD<3%)and the recovery ranged 86.46%~114.07%.Among the 10 batches of samples,yohimbine,dapoxetine,and sildenafil impurities were detected in 1 batch;sildenafil were detected in 6 batches;accelerators M and tadalafil were detected in 2 batches;sildenafil were detected in 3 batches.Conclusion The method is fast and efficient,and can quickly screen eight categories including 275 chemical drugs.

关 键 词：缓解体力疲劳保健食品 中成药 非法添加 高通量筛查 数据库 

分 类 号：R927[医药卫生—药学]