摘要
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。
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.
作者
施法
许彦涛
张蕾
刘佳
殷莉莉
SHI Fa;XU Yantao;ZHANG Lei;LIU Jia;YIN Lili(Shenyang Institute for Food and Drug Control,Shenyang 110122,China;Shenyang He Vision Industrial Group Co.Ltd.,Shenyang 110163,China)
出处
《沈阳药科大学学报》
CAS
CSCD
2024年第2期201-205,共5页
Journal of Shenyang Pharmaceutical University
关键词
润明颗粒
中成药
重金属
有害元素
风险评估
Runming Granule
Chinese patent medicine
heavy metal
harmful element
risk assessment
作者简介
施法(1982-),男(满族),辽宁沈阳人,副主任药师,主要从事中药质量研究工作,E-mail:Ljfeihuo123@163.com;通信作者:殷莉莉(1981-),女(汉族),辽宁沈阳人,硕士生导师,主要从事药物新剂型的研究,E-mail0820qaq@sina com。
