Analysis,risk assessment,and theoretical maximum limit values of 40 elements in Shenmai Granules
LEI Rong
CAO Chun-qi
LIU Ya-ru
HAO Xiao-fei
LI Zhen
LIU Yong-li
Abstract：Objective:To establish a method for determination of 40 elements in Shenmai Granules and evaluate the risk of heavy metal elements Pb,Cd,As,Hg and Cu,in order to provide a reference for the safe use of Shenmai Granules.Methods:Inductively coupled plasma mass spectrometry(ICP-MS)method was used to determine the contents of 40 elements in 85 batches of Shenmai Granules samples from three manufacturers.Hazard index(HI)and margin of exposure(MOE)methods were used to evaluate the risk of Pb,Cd,As,Hg and Cu,and formulate the theoretical values of the maximum limits based on the results of the evaluation.Results:The ICP-MS method showed good linear relationships(r＞0.998)for all elements,with recovery rates ranging from 87.2％to 113.8％.The measured results for the certified reference materials were consistent with the indicated values.Twenty-nine elements were detected in Shenmai Granules,with Na,K,Mg,Ca,Al,and Fe having higher concentrations(＞20 mg·kg-1),and heavy metals Pb,Cd,As and Cu were detected.The HIs of Cd and Cu were less than 1,and the MOEs of Pb and As were more than 1.Based on the risk assessment results,the limits for Pb,Cd,As and Cu in Shenmai Granules were 2,1,2,and 20 mg·kg-1,respectively.Conclusion:The safety risk of heavy metals and harmful elements in Shenmai Granules is relatively low.This method provides a reference for the medication safety and quality control of Shenmai Granules.
Keywords：Shenmai Granulesinductively coupled plasma mass spectrometryheavy metalsharmful elementsrisk assessmentmaximum limit theoretical values
Publication Date：2025-02-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 297-303 )