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目的:建立药用玻璃容器中13种金属元素的测定方法,并测定16批药用玻璃容器样品的浸出量。方法:采用ICP-MS法测定药用玻璃容器中Al、Cr、Mn、Fe、Cu、Zn、As、Cd、Sn、Sb、Ba、Ce、Pb共13种金属元素。ICP-MS工作参数:一般测定模式,同心雾化器,射频功率为1.55 kW,等离子体氩气流速为15 L·min~(-1),载气流速为1.07 L·min~(-1),采样深度为10.0 mm,蠕动泵速为0.1 r·s~(-1),雾化室温度为2℃,分析模式为全定量,内标工作液在线加入。结果:各元素质量浓度在1~100 ng·mL~(-1)范围内呈良好的线性关系,相关系数均大于0.999,加样回收率为91.6%~109.6%,各元素检出限分别为0.563 ng·mL~(-1)(Al)、0.033 ng·mL~(-1)(Cr)、0.046 ng·mL~(-1)(Mn)、0.167 ng·mL~(-1)(Fe)、1.028 ng·mL~(-1)(Cu)、2.527 ng·mL~(-1)(Zn)、0.154 ng·mL~(-1)(As)、0.019 ng·mL~(-1)(Cd)、3.286 ng·mL~(-1)(Sn)、0.012 ng·mL~(-1)(Sb)、0.066 ng·mL~(-1)(Ba)、0.004 ng·mL~(-1)(Ce)和0.162 ng·mL~(-1)(Pb)。16批样品中Cu、Zn、Cd、Sn、Sb、Pb元素均未检出,仅部分样品检出微量Cr、Mn、Fe、As、Ba、Ce元素,16批样品均检出Al元素;浸出量在131.7~5 160.7 ng·mL~(-1)。结论:本法经方法学验证,可用于药用玻璃容器中金属元素的测定。根据样品测定结果,建议增加输液类药用玻璃容器中Al元素浸出量的监测。
Objective: To establish a method for determination of 13 kinds of metal elements in medicinal glass containers and determine the leaching amount of 16 samples of medicinal glass containers. METHODS: Thirteen metal elements, Al, Cr, Mn, Fe, Cu, Zn, As, Cd, Sn, Sb, Ba, Ce and Pb, were measured by ICP- ICP-MS operating parameters: the general mode of measurement, concentric nebulizer, RF power of 1.55 kW, the plasma argon flow rate of 15 L · min -1, the carrier gas flow rate of 1.07 L · min -1 , The sampling depth is 10.0 mm, the peristaltic pump speed is 0.1 r · s ~ (-1), the temperature of the atomization chamber is 2 ℃, the analysis mode is the full quantitation, and the internal standard working solution is added online. Results: The linear correlations were obtained between the concentration of each element in the range of 1 ~ 100 ng · mL ~ (-1), the correlation coefficient was greater than 0.999, and the recoveries were 91.6% -109.6%. The detection limits of each element were 0.563 ng · mL -1 Al, 0.033 ng · mL -1 Cr, 0.046 ng · mL -1 Mn, 0.167 ng · mL -1 Fe , 1.028 ng · mL -1 Cu, 2.527 ng · mL -1 Zn, 0.154 ng · mL -1 As (0.019 ng · mL -1) (Cd), 3.286 ng · mL -1 (Sn), 0.012 ng · mL -1 (Sb), 0.066 ng · mL -1 (Ba), 0.004 ng · mL -1 1) (Ce) and 0.162 ng · mL -1 (Pb). All 16 samples showed no detectable elements of Cu, Zn, Cd, Sn, Sb and Pb. Only a few samples detected trace elements of Cr, Mn, Fe, As, Ba and Ce, The amount of 131.7 ~ 5 160.7 ng · mL ~ (-1). Conclusion: This method is validated by methodology and can be used for the determination of metallic elements in medicinal glass containers. According to the results of the sample measurement, it is suggested to increase the amount of Al leaching in the transfusion medicinal glass containers.