目的 对润明颗粒中重金属及有害元素的残留进行测定和风险评估,为润明颗粒的安全用药提供参考依据。方法 采用电感耦合等离子体质谱(inductively coupled plasma mass spectrometry,ICP-MS)法测定其18种重金属及有害元素的残留量,并结合各元素测定值对其进行风险评估。结果 20批次样品中各元素的危害系数均低于风险值,基于风险评估结果,得出润明颗粒中Pb、Cd、As、Hg的限度分别为2、1、2、0。2 mg·kg-1。结论 润明颗粒中重金属及有害元素的安全风险较低,该方法为润明颗粒的用药安全和质量控制提供参考。
Determination and risk assessment of 18 heavy metals and harmful elements in Runming Granules
Objective To carry out content analysis and risk assessment of the residues of heavy metals and harmful elements in Runming Granules,so as to provide references for the safe medication of Runming Granules.Methods After microwave digestion,ICP-MS was used to determine the residues of 18 heavy metals and harmful elements,and combined with the measured values of each element,the risk assessment was carried out.Results The hazard coefficients of each element in 20 batches of samples were lower than the risk value.Based on the risk assessment results,the limits of Pb,Cd,As and Hg in Runming Granules were 2,1,2 and 0.2 mg·kg-1.Conclusion The safety risks of heavy metals and harmful elements in Runming Granules are low.This study provides a reference for the drug safety and quality control of Runming Granules.