摘要
目的:对晕可平糖浆中重金属有害元素进行含量测定及风险评估。方法:采用ICPMS法测定晕可平糖浆中Cu、As、Cd、Hg和Pb的含量,并结合《中药中外源性有害残留物安全风险评估技术指导原则》,分别采用危害指数法(HI)和暴露限值法(MOE)对晕可平糖浆的重金属风险进行评估。结果:10批晕可平糖浆中重金属Cu、As、Cd、Hg和Pb残留量范围分别为0.048~0.198μg·mL^-1、0.073~0.129μg·mL^-1、0.003~0.005μg·mL^-1、未检出和0.002~0.019μg·mL^-1;Cu和Cd的HI值均小于1,As、Pb的MOE值均大于1,提示重金属引起的健康风险在安全范围内。结论:本研究考察了晕可平糖浆中重金属残留情况,科学地评估其重金属对人体的健康风险,为中成药的安全性评价提供了研究思路。
Objective: To determine the contents and assess the risks of heavy metal harmful elements in Yunkeping Syrups. Methods: The contents of heavy metals Cu, As, Cd, Hg and Pb were determined by using inductively coupled plasma mass spectrometry(ICP-MS). Moreover, combined with the Guideline of Risk Assessment of Exogenous Harmful Residues in Traditional Chinese Medicines, the hazard index(HI)method and the margin of exposure(MOE) method were used to assess the risks of heavy metals. Results:The results showed that the total contents of Cu, As, Cd, Hg and Pb in 10 batches of Yunkeping Syrups were from 0.048 to 0.198 μg·mL^-1, from 0.073 to 0.129 μg·mL^-1, from 0.003 to 0.005 μg·mL^-1, non-detected and from 0.002 to 0.019 μg·m L^-1, respectively. HI values of Cu and Cd for all batches of Yunkeping Syrups were less than 1, the MOE values of As and Pb for all batches were greater than 1,which suggested that the risks of heavy metals were at safe levels. Conclusion: This study investigated the contents of heavy metals in Yunkeping Syrups and estimated the health risks of heavy metals to human body scientifically, which provides research ideas for safety evaluation of Chinese traditional patent medicines.
作者
丁爱华
谢斌
陈玲玲
葛玉松
周会芹
支荣荣
郑灏
DING Aihua;XIE Bin;CHEN Lingling;GE Yusong;ZHOU Huiqin;ZHI Rongrong;ZHENG Hao(Yancheng Food and Drug Supervision and Testing Center,Yancheng 224055,China)
出处
《药学与临床研究》
2020年第4期259-262,共4页
Pharmaceutical and Clinical Research
