麻仁丸中15种元素的含量测定及风险评估

Determination and Risk Assessment of Fifteen Elements in Maren Wan

目的:测定麻仁丸中重金属及有害元素的含量,并进行风险评估。方法:微波消解后采用电感耦合等离子体质谱法测定麻仁丸中重金属及有害元素;以人工胃液模拟人体消化过程,测定重金属的溶出率。结果:15种元素线性关系良好,相关系数r≥0.9990;精密度、稳定性和重复性试验的RSD<5%(n=6);回收率在86.56%~95.26%,RSD<5.0%(n=6)。在麻仁丸样品中,Pb含量相对较高,在人工胃液中,Li、V、Cr、Sn、Sb几乎不溶出,其他元素均有溶出。风险评估结果显示15种元素均无显著的重大健康风险。结论:考察了麻仁丸的重金属及有害元素残留情况和模拟人体消化过程在人工胃液中重金属元素的溶出率,为麻仁丸的安全用药和质量控制提供研究基础。

Objective:The contents of metallic elements in Maren Wan were determined for risk assessment.Method:The contents of 15 inorganic elements in Maren Wan were analyzed by microwave digestion and inductively coupled plasma mass spectrometry(ICP-MS).Artificial gastric digestion model was used to determine transfer rates of metallic elements.Results:The 15 elements showed good linearities in the selected concentration ranges(r≥0.9990).The relative standard deviations(RSDs)of the precision,stability and repeatability were less than 5.0%(n=6).The average recovery ranged from 86.56%to 95.26%,with RSD<5.0%(n=6).The content of Pb in Maren Wan was relatively high.Li,V,Cr,Sn and Sb were almost insoluble in artificial gastric juice,while the other elements were dissolved.The risk assessment of the 15 elements showed that there was no significant health risk.Conclusion:The contents of 15 metallic elements in Maren Wan and the dissolution rates of heavy metals in artificial gastric juice by simulated human digestion can be investigated by the established method,which provides the basis for the safety research and quality control of the medicine.