首页|基于UPLC-QTOF-MS和UNIFI软件的中药非法添加色素筛查平台建设

基于UPLC-QTOF-MS和UNIFI软件的中药非法添加色素筛查平台建设

扫码查看
目的:基于超高效液相色谱-四级杆飞行时间质谱法(UPLC-QTOF-MS)分析和UNIFI软件,建立包含 45 种常见中药非法添加色素的筛查平台,以期为中药材(饮片)质量监管提供技术方法,提高监管效率.方法:采用Waters ACQUITY UPLC BEH-C18 色谱柱,以 5 mmol·L-1 的乙酸铵水溶液和乙腈为流动相梯度洗脱,流速为0.4 mL·min-1,同时利用UPLC-QTOF-MS/MSE进行质谱检测分析,基于电喷雾离子源(ESI)在m/z 50~1200 范围内进行正、负离子扫描,并与色素对照试剂进行比对.最后,将 45 种色素的名称、CAS号、分子式、结构图(.mol格式)、碎片离子等信息导入UNIFI软件,构建中药非法添加色素筛查平台并进行验证分析.结果:成功构建了包含 45 种添加色素的快速筛查平台,45 种色素检测下限为 0.33~24.83 ng·mL-1,此外对蒲黄、红花、五味子3 个品种的市售中药进行了色素筛查,检出有红色和黄色添加色素如金橙Ⅱ、柠檬黄和皂黄等.结论:建立的色素快速筛查平台可快速、简便、高效地实现中药非法添加色素的筛查并有效提高药品监管效率.
Construction of A Screening Platform for Illegally Added Pigments in Chinese Medicine Based on UPLC-QTOF-MS and UNIFI Software
Objective:Based on ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UPLC-QTOF-MS)analysis and UNIFI software,a screening platform was established for 45 common illegally added pigments in Chinese medicine(Chinese herbal pieces),aiming to provide a technical method for the quality supervision of Chinese medicine and improve the efficiency of supervision.Methods:The analysis was conducted using a Waters ACQUITY UPLC BEH-C18 column with a gradient elution system of 5 mmol·L-1 ammonium acetate solution and acetonitrile as the mobile phase at a flow rate of 0.4 mL·min-1.Mass spectrometry detection was performed with a UPLC-QTOF-MS system,using the ESI ion source to scan positive and negative ions in the range of m/z 50-1200,and compared with pigment reference standards.The names,CAS numbers,molecular formulas,structural diagrams(.mol format),fragment ions,and other information of the 45 pigments were imported into UNIFI software to construct and validate the screening platform for illegally added pigments in Chinese medicine.Results:A rapid screening platform containing 45 added pigments was successfully established,with lower limit of detection for the 45 pigments ranging from 0.33 to 24.83 ng·mL-1.Additionally,this platform was used to screen three commercially available Chinese medicines:Typhae Pollen,Carthami Flos,and Schisandrae Chinensis Fructus.Red and yellow added pigments such as orange Ⅱ,tartrazine,and metanil yellow were detected.Conclusion:The established rapid screening platform effectively enables the rapid,simple,and efficient detection of illegally added pigments in Chinese medicine and significantly improves drug supervision efficiency.

pigmentUPLC-QTOF-MSadded illegallyUNIFI software

李明华、张佳婷、王献瑞、张萍、张毅、周娟、程显隆、魏锋

展开 >

中国食品药品检定研究院,北京 102629

国家药品监督管理局 药品监管科学全国重点实验室,北京 102629

重庆市食品药品检验检测研究院,重庆 401121

四川省食品药品检验检测院,四川 成都 611731

展开 >

色素 超高效液相色谱-四级杆飞行时间质谱法 非法添加 UNIFI软件

2024

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子:0.65
ISSN:1673-4890
年,卷(期):2024.26(12)