基于HPLC-DAD数据库快速筛查降血脂类产品中非法添加的10种化学药物  

Rapid Screening of Ten Hypolipidemic Drugs Illegally Added in Products Based on a HPLC-DAD Database

作　　者：张萍 汤慧 李文斌 徐莹 ZHANG Ping;TANG Hui;LI Wen-bin;XU Ying(Wuhu Food and Drug Inspection Center,Wuhu 241006,China;Tianjin Dikema Experimental Equipment Co.,Ltd.,Tianjin 300499,China)

机构地区：[1]芜湖市食品药品检验中心,安徽芜湖241006 [2]天津迪科马实验设备有限公司,天津300499

出　　处：《海峡药学》2024年第8期48-52,共5页Strait Pharmaceutical Journal

基　　金：安徽省药品监督管理局科技创新项目(AHYJ-KJ-202012);芜湖市科技计划项目(2022JC05)。

摘　　要：目的建立一种能同时检测10种有降血脂作用化学药物的HPLC-DAD分析方法,建立各物质保留时间和紫外吸收光谱的二维定性数据库,并将此数据库用于降血脂药物非法添加的快速筛查。方法采用迪马Platisil ODS色谱柱;以0.5%甲酸为流动相A,以乙腈为流动性B,进行梯度洗脱。采集HPLC-DAD检测结果中的对照品的保留时间紫外吸收光谱信息,建立10种常见降血脂化学药物的二维定性数据库。结果本实验基于HPLC-DAD方法新建立了一个快速筛查降血脂类产品中非法添加的数据库,通过对市场抽检样品和模拟阳性样品的检测,结果准确可靠。结论本实验建立的HPLC-DAD数据库可快速筛查产品中是否添加了降血脂类化学药物,具有操作简便、快速的特点,为基层监督检验机构提供了一个可靠的方法学参考。OBJECTIVE To establish a HPLC-DAD analysis method for simultaneous determination of ten hypolipidemic drugs,and a two-dimensional qualitative database was established based on the retention time and ultraviolet absorption spectrum of various substances.This database was used for rapid screening of illegal addition in hypolipidemic products.METHODS The gradient elution was used with 0.5%formic acid as mobile phase A and acetonitrile as mobile phase B.The retention time and ultraviolet absorption spectra of 10 reference materials were collected,and a two-dimensional qualitative database was established on this basis.RESULTS Based on the HPLC-DAD method,a new database for rapid screening of illegal addition of lipid-lowering products was established in this experiment.The results were accurate and reliable through the detection of market sampling samples and simulated positive samples.CONCLUSION The HPLC-DAD database established in this experiment can quickly screen the illegally added chemical drugs in products.This method is simple and fast,and provides a reliable methodological reference for the basic inspection institutions.

关 键 词：HPLC-DAD数据库 降血脂药物 非法添加 

分 类 号：R927[医药卫生—药学]