ICP-MS结合化学计量学的血塞通注射液中40种无机元素分析及风险评估

ICP-MS combined with chemometrics analysis of 40 inorganic elements in Xuesaitong injection and risk Assessment

目的测定血塞通注射液中40种无机元素的含量,并进行风险评估。方法2018年2月至2022年6月,建立电感耦合等离子体质谱法(ICP-MS)测定血塞通注射液中无机元素含量的方法,测定样品中40种元素含量,通过特征图谱及化学计量学方法分析数据,使用危害识别、危害特征描述、暴露评估和风险特征描述的方法进行风险评估。结果建立的测定方法线性、灵敏度、准确性良好;共检出26种无机元素,特征图谱显示不同企业样品差异明显,但趋势基本一致;风险评估结果表明血塞通注射液健康风险较低。结论血塞通注射液中无机元素之间存在一定的相互作用,应重点关注与有害元素表现出极显著性正相关的Na、K、Mg等元素;血塞通注射液正常使用剂量不会对正常人群产生不可接受的健康风险。

Objective To determine the content of 40 inorganic elements in Xuesaitong injection,summarize its composition characteristics and common rules,and carry out risk assessment.METHODS February 2018 to June 2022,ICP-MS was established to determine the content of inorganic elements in Xuesaitong injection,and the contents of samples from different enterprises were determined.Hazard identification,hazard characterization,chemometrics analysis and risk characterization were used for risk assessment.Results The ICP-MS method for the determination of 40 inorganic elements in Xuesaitong injection was established with good linearity,sensitivity and accuracy.A total of 26 inorganic elements were detected,and characteristic atlas of inorganic elements in Xuesaitong injection showed obvious differences among samples from different enterprisesThe health risk of heavy metals and harmful elements in Xuesaitong injection was low.Conclusion There is some interaction between inorganic elements in Xuesaitong injection,and more attention should be paid to the elements such as Na,K and Mg,which showed highly significant positive correlation with harmful elements.Normal dosage of Xuesaitong injection would not cause unacceptable health risk to the normal population.