摘要
目的研究山药、大枣、三七中11种微量元素的含量分布特征,并对其进行安全性和有效性评估。方法以硝酸为消解试剂,采用微波消解法进行前处理,在线加入内标消除基体效应,利用电感耦合等离子体质谱法(inductively coupled plasma-mass spectrometry,ICP-MS)同时测定3种中药材中铜、锌、铬、镍、砷、铅、镉、汞、钪、钡和硒的含量。结果11种元素线性关系良好,相关系数均大于0.9991,检测限为0.001~0.152 mg·kg^(-1),回收率为90.6%~107.7%,RSD为1.1%~5.6%。风险评估结果表明,3种中药材中铅、镉、砷和汞每周平均摄入量均小于世界卫生组织(world health organization,WHO)规定的暂定每周耐受摄入量(provisional tolerable weekly intake,PTWI)的10%,总体风险较低。结论本研究可为山药、大枣、三七药材安全性和有效性制定有害元素残留限量标准提供依据,对确保疗效减少毒性及不良反应具有参考价值。
Objective To determine 11 trace elements in Dioscoreae Rhizoma,jujubae fructus and Notoginseng Radix et Rhizoma and provide reference for the safety assessment.Methods After the treatment of microwave digestion by nitric acid,inductively coupled plasma mass spectrometry(ICP-MS)method was established for the determination of Sc,Cr,Ni,Cu,Zn,As,Se,Cd,Ba,Hg and Pb.The matrix and spectra interference of the ICP-MS were eliminated by online internal standard addition and octopole reaction/collision cell.Results The standard liquid working curves of 11 trace elements had good linearity,with the correlation coefficients of larger than 0.9991.The RSDs of repeatabilities for 11 trace elements in Chinese herbal medicines(CHM)were all less than 5.6%.Their limits of detection were between 0.001~0.152 mg·kg^(-1).The spiked recoveries were in the range of 90.6%-107.7%with relative standard deviation(RSD)of in the range of 1.1%-5.6%.The results of risk assessment showed that the weekly average intake of Pb,Cd,As and Hg in the three species was less than 10%of provisional tolerable weekly intake(PTWI)value recommended by WHO,therefore the risks of 11 trace elements in the three species were relatively low.Conclusion This experiment provides the evidence for the quality safety evaluation of Dioscoreae Rhizoma,jujubae fructus and Notoginseng Radix et Rhizoma,and it is recommended to establish residual limit standards on the basis of safety and effectiveness assessment results.
作者
马永青
陈佩强
耿韫
王璐
MA Yongqing;CHEN Peiqiang;GENG Yun;WANG Lu(Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050200,China;The 980 Hospital of PLA Joint Logistic Surpport Force,Hebei,Shijiazhuang 050082,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2023年第2期151-157,共7页
Journal of Shenyang Pharmaceutical University
基金
新药创制-中药质量安全检测和风险控制技术平台资助项目(2014ZX09304-307-002)
作者简介
马永青(1978-),女(汉族),河北石家庄人,副主任药师,博士,主要从事药物分析质量控制研究,E-mailmyq610@126.com。
