乙肝扶正胶囊中重金属及有害元素的含量测定

Determination of heavy metals and harmful elements in Yigan Fuzheng Capsules

目的测定11批次市售乙肝扶正胶囊中的铅、镉、砷、汞4种重金属及有害元素含量,并进行风险评估。方法样品经微波消解后,采用电感耦合等离子体质谱仪测定铅、镉、砷、汞元素含量,并采用ICH和JECFA评估数据计算各元素最大允许残留量。结果 11批次样品中,镉、汞均未超标,部分样品砷、铅元素含量较高,存在安全风险。结论分析评估了不同生产企业乙肝扶正胶囊中重金属及有害元素残留情况,为乙肝扶正胶囊及其他中药制剂的限量制订和安全评价提供参考。

Objective To determine the contents of Pb, Cd, As, Hg in 11 batches of Yigan Fuzheng Capsules and perform risk assessment to evaluate the safety.Methods ICP-MS combined with microwave digestion method used in sample pretreatment was used to measure the contents of Pb, Cd, As, Hg in Yigan Fuzheng Capsules, residual limits for Pb, Cd, As, Hg in the drug were formulated using ICH and JECFA database.Results Cd and Hg in the samples were within the limits range, but the contents of Pb, As in some batches were high, implying safety risk of the drug.Conclusion Analysis of heavy metals and harmful elements residuals in Yigan Fuzheng Capsules from different factories was performed, which provided reference for limit formulation and risk assessment of Yigan Fuzheng Capsules and other Chinese medicines.