作　　者： (刘园园）; (颜敏）; (黄海萍）; (刘磅）; (孙会敏）; (贺瑞玲）;

机构地区： 湖南省医疗器械检验检测所,长沙410014

出　　处： 《中国药学杂志》 2017年第16期1447-1450,共4页

摘　　要： 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 establish a method for determining arsenic（ As） and antimony（ Sb） released from pharmaceutical glass packing materials to provide reference for improving the existing quality standard. METHODS The samples were filled with 4% acetic acid to leach As and Sb. The extracting temperature was 98 ℃,and the extracting time was 2 h. Graphite furnace atomic absorption spectrometry（ GFAAS） was used for the determination. RESULTS As and Sb showed good linear relationship in a certain concentration range with linear correlation coefficients of 0. 999 9 and 0. 999 5. The recovery rates were 94. 7%-106. 9% and 100. 0%-106. 3%. The relative standard deviations of precision were 2. 3% and 2. 9%. The relative standard deviations of repeatability were 6. 5% and 6. 9%. The limits of detection were 1. 67 and 2. 54 ng·mL-1,respectively. The elements were nearly not detected in 16 batches of samples. CONCLUSION The method is efficient and accurate and can be used for determination of As and Sb released from pharmaceutical glass packing materials,which brings supplementary contents to the existing quality standard.

关 键 词： 原子吸收石墨炉法 玻璃类药包材 金属元素浸出量 砷 锑