长春西汀注射剂及其原料和辅料中15种微量元素的测定  

Determination of 15 kinds of trace elements in Vinpocetine Injections,vinpocetine and excipients

作　　者：陈小英 薛晓文 妙苗 王嫦鹤 刘海静[1,2] CHEN Xiaoying;XUE Xiaowen;MIAO Miao;WANG Changhe;LIU Haijing(Shaanxi University of Chinese Medicine,Xianyang 712046,China;Shaanxi Institute for Food and Drug Control,Xi′an 710065,China)

机构地区：[1]陕西中医药大学,咸阳712046 [2]陕西省食品药品检验研究院,西安710065

出　　处：《西北药学杂志》2021年第5期717-724,共8页Northwest Pharmaceutical Journal

基　　金：国家科技重大专项重大新药创制专项(编号:2017Z09101001);陕西省创新能力支撑计划项目(编号:2020PT-041)。

摘　　要：目的测定长春西汀注射剂及原料和辅料中镉(Cd)、汞(Hg)、铅(Pb)、钒(V)、砷(As)等15种微量元素的含量,并对长春西汀注射剂及其原料和辅料中的微量元素进行风险评估。方法采用微波消解法对样品进行前处理,电感耦合等离子体质谱(ICP-MS)法对15种重金属和有害元素进行含量测定,参考国内外相关要求,对长春西汀注射剂及其原辅料中15种微量元素潜在的风险进行探讨。结果在一定质量浓度范围内,15种元素响应值与质量浓度的线性关系良好,加样回收率在90.3%~101.6%范围内。长春西汀注射剂中Cd、Hg、Pb、V的含量较高,个别药品生产企业提供的原料中Pb的含量较高。结合相关要求,拟定出12种微量元素的限度。结论该方法操作简单,检测结果准确,可用于长春西汀注射剂及原料和辅料中15种微量元素的检测。Objective To determine the contents of 15 kinds of trace elements such as Cd,Hg,Pb and As in Vinpocetine Injections,vinpocetine and excipients,and to evaluate the risk of the trace elements.Methods The samples were pretreated by microwave digestion.The contents of 15 heavy metals and harmful elements in Vinpocetine Injections,vinpocetine and excipients,were determined by inductively coupled plasma mass spectrometry(ICP-MS),and the potential risks of trace elements were investigated based on relevant requirements at home and abroad.Results The 15 trace elements showed a good linear relationship between the response value and the concentration in a certain range of mass concentration.Recoveries were ranged in 90.3%-101.6%.The contents of Cd,Hg,Pb and V in Vinpocetine Injections were relatively high.The contents of Pb in raw materials provided by some enterprises was relatively high.The limits of 12 trace elements were drawn up based on relevant regulation.Conclusion This method is simple and accurate,which can be used for the determination of 15 kinds of trace elements in Vinpocetine Injections,vinpocetine and excipients.

关 键 词：长春西汀 电感耦合等离子体质谱法(ICP-MS) 微量元素 风险评估 

分 类 号：R917[医药卫生—药物分析学]