摘要
目的采用超级微波消解平台-电感耦合等离子体串联质谱(ICP-MS/MS)法对儿童口服液体制剂中20种无机元素进行分析,为儿童口服液体制剂安全性评价提供参考。方法样品经超级微波消解平台消解完全后,采用ICPMS/MS法测定儿童口服液体制剂中20种无机元素含量,通过单因子污染指数对儿童液体制剂安全性进行评价。结果所测20种元素线性关系良好,相关系数均在0.9990~0.9999之间;检出限为0.001~0.129 mg/kg,各元素回收率在90.6%~111.1%之间,RSD在1.2%~4.8%之间。结论建立的方法快速、灵敏、可靠,易于大批量分析,可应用于儿童口服液体制剂中20种无机元素的测定。Pb、Cd、As、Cu 4种重金属污染指数评价在正常范围,方法可为其安全性评价提供参考依据。
Objective Using a super microwave digestion platform inductively coupled plasma tandem mass spectrometry(ICP-MS/MS)method to analyze 20 inorganic elements in children's oral liquid formulations and provide reference for the safety evaluation of children's oral liquid formulations.Methods After the sample was completely digested by the super microwave digestion platform,the content of 20 inorganic elements in children's oral liquid formulations was determined by ICP-MS/MS method.The safety of children's liquid formulations was evaluated through a single factor pollution index.Results The linear relationship of the 20 elements measured was good,and the correlation coefficients were all between 0.9990 and 0.9999;the detection limit was 0.001-0.129 mg/kg,the recovery rates of each element were between 90.6%-111.1%,and the RSD of each element was between 1.2%-4.8%.Conclusion The established method is fast,sensitive,reliable,and easy to analyze in large quantities,it can be applied to the determination of 20 inorganic elements in children's oral liquid formulations.The evaluation of Pb,Cd,As,and Cu heavy metal pollution indices is within the normal range,and the method can provide a reference basis for their safety evaluation.
作者
王行智
陈婷
张文
朱仁愿
张菁菁
陈敏
WANG Xingzhi;CHEN Ting;ZHANG Wen;ZHU Renyuan;ZHANG Jingjing;CHEN Min(Lanzhou Institute of Food and Drug Inspection and Testing,Lanzhou Gansu 730000,China)
出处
《药品评价》
CAS
2024年第7期814-818,共5页
Drug Evaluation
基金
甘肃省药品监督管理局科技计划项目(2022GSMPA0066)。
关键词
超级微波消解平台
电感耦合等离子体串联质谱
儿童口服液体制剂
无机元素
Super microwave digestion platform
Inductively coupled plasma tandem mass spectrometry
Oral liquid preparations for children
Inorganic elements
