五层共挤输液袋及其浸提液中苯乙烯含量的测定

Determination of Styrene in Five-layer Co-extrusion Infusion Bags and Its Extraction

建立气质联用法测定五层共挤输液用袋中残留的,以及特定条件下五层共挤输液用袋中可提取的苯乙烯单体含量。五层共挤输液用袋中的残留的苯乙烯单体在0.110μg/m L范围内线性良好(R2=9993),平均回收率为102.2%,检测限为0.0004μg。五层共挤输液用袋在15%乙醇溶液、pH 3.5磷酸盐缓冲液、pH 7.88.0磷酸盐缓冲液中,经过121℃、1 h高压蒸汽灭菌,可提取的苯乙烯单体均小于定量限。该方法快速、准确、灵敏度高、重复性好,可用于五层共挤输液用袋的质量控制。

A method for determination of residual styrene in five-layer co-extrusion infusion bags was established and the residual styrene was extracted under certain conditions by GC-MS. The residual styrene monomer in the five- layer co-extrusion infusion bags had a good linearity （ R^2 = 9993 ） in the range of 0. 1 - 10 μg/mL. The average recovery was 102.2% and the detection limit was 0. 0004 μg. The five-layer co-extrusion infusion bags was sterilized for 1 h by high-pressure steam at 121% in 15% ethanol solution, pH 3.5 phosphate buffer and pH 7.8 -8.0 phosphate buffer, respectively. All of the extractable styrene monomers were less than limit of quantification. The method is rapid, accurate, sensitive and reproducible, can be used for quality control of five-layer co-extrusion infusion bags.