含生药原粉的中成药中重金属残留量测定和风险评估  

Determination and Risk Assessment of Heavy Metals Residues in Chinese Patent Medicines Containing Raw Drug Powder

作　　者：冯永刚 熊瑛 Feng Yonggang;Xiong Ying(Zhuhai Institute for Food and Drug Control,Zhuhai 51900,China)

机构地区：[1]珠海市食品药品检验所,广东珠海519000

出　　处：《广东化工》2024年第23期140-143,共4页Guangdong Chemical Industry

基　　金：珠海市社会发展领域科技计划项目(2220004000245)。

摘　　要：目的:测定含生药原粉中成药中的重金属残留量,并评估其风险。方法:通过电感耦合等离子体质谱仪(inductively coupled plasma mass spectrometer,ICP-MS)测定Pb、As、Hg、Cd和Cu的残留量,选用《中药中外源性有害残留物安全风险评估技术指导原则》、健康风险评估(health risk assessment,HRA)模型和有害重金属残留量阈值(maximum residue limit,MRL)对重金属进行评估。结果:两批次活血止痛胶囊总危害指数(hazard index,HI)值>1,提示这两个批次的中成药存在一定的健康风险;其他批次中成药HI值均<1;10批中成药中的铅、2批中成药中的砷和1批中成药中的镉超过MRL。结论:考察了中成药中重金属的残留情况,评估了其对人体的健康风险,为含生药原粉的中成药的质量控制和安全用药提供了参考。Objective:To determine the contents and assess the risks of heavy metals in Chinese patent medicine containing raw drug powder.Methods:The contents of Pb,As,Hg,Cd and Cu were determined by inductively coupled plasma mass spectrometer(ICP-MS),Heavy metals were evaluated using the Technical Guidelines for Safety Risk Assessment of Exogenous Harmful Residues in Traditional Chinese Medicine,the health risk assessment(HRA)and maximum residue limit(MRL)of harmful heavy metals residue.Results:The total hazard index(HI)value of the two batches of Huoxue Zhitong capsules was greater than 1,suggesting that the two batches of Chinese patent medicine had certain health risks;The HI value of other batches of Chinese patent medicine were less than 1;Pd in 10 batches,As in 2 batches and Cd in 1 batch exceeded the MRL of harmful heavy metals.Conclusions:This study investigates the residual condition of heavy metals in Chinese patent medicine,assesses its health risks to human body,and provides a reference for the quality control and safe drug use of Chinese patent medicine containing raw drug powder.

关 键 词：生药原粉 中成药 风险评估 电感耦合等离子体质谱 重金属 

分 类 号：R286.0[医药卫生—中药学]