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目的测定玻璃类药包材中砷(As)、锑(Sb)元素的浸出量,为提高现有标准提供支持和参考。方法样品灌装4%乙酸(HOAc)溶液浸提,采用原子吸收石墨炉法测定浸提液中As、Sb含量。结果 As、Sb在一定的浓度范围内均呈良好的线性关系,线性相关系数分别为0.999 9、0.999 5;加样回收率分别为94.7%~106.9%、100.0%~106.3%;精密度试验的RSD分别为2.3%、2.9%;重复性试验的RSD分别为6.5%、6.9%;检出限分别为1.67、2.54 ng·mL~(-1)。测定样品16批,结果测得As、Sb元素浸出量均较低,大多为未检出。结论该方法准确可靠,可用于测定玻璃类药包材中As、Sb元素的浸出量,补充和丰富现有药包材国家标准中As、Sb的测定方法。
Objective To determine the amount of arsenic (As) and antimony (Sb) leaching in glass-based packaging materials and provide support and reference for improving the existing standards. Methods The samples were filled with 4% acetic acid (HOAc) solution and the contents of As and Sb in the extract were determined by atomic absorption graphite furnace method. The results showed that As and Sb showed a good linear relationship in a certain concentration range with linear correlation coefficients of 0.999 9 and 0.999 5, respectively. The recovery rates of As and Sb were 94.7% -106.9% and 100.0% -106.3%, respectively. RSD were 2.3% and 2.9%, respectively; RSD of repeatability test were 6.5% and 6.9%, respectively. The detection limits were 1.67 and 2.54 ng · mL -1, respectively. Determination of 16 batches of samples, the results measured As, Sb leaching amounts were low, mostly undetected. Conclusion The method is accurate and reliable, which can be used to determine the amount of As and Sb leaching in glass-based medicine packaging materials and to supplement and enrich the determination methods of As and Sb in the national standards of existing drug packaging materials.