顶空毛细管气相色谱法测定医疗器械中环氧乙烷的残留量

目的建立医疗器械中环氧乙烷残留量的顶空一毛细管气相色谱测定法。方法HP-5色谱柱（30m×250gm×0．25gm）．氢火焰离子化检测器（FID），柱温为120℃，保持8分钟：进样13温度为200℃．检测器温度为250℃。结果：环氧乙烷在5．1920—51．920μg范围内呈线性关系（r=0．997，n=6），检测限为1μg；注射器中的环氧乙烷的平均回收率为103．3％，输液器中环氧乙烷的平均回收率为81．04％。结论：经方法学验证，该方法灵敏度、准确度均达到有机溶剂残留量测定的要求，可用于输液器、注射器中环氧乙烷残留量的测定。

Determination of Residual Epoxyethane in Medical Instruments by Headspace Capillary Gas Chromatography

OBJECTIVE: To establish a method of determining the residual epoxyethane in medical instruments. METHOD: An HP-5 capillary column (30 m x 0.32 mm x 0.25 microm), an FID detecter and an oven were used in the determination. The oven temperature was kept at 120 degrees C for 8 minutes, the example inlet temperature was kept at 200 degrees C, while the detecter temperature was kept at 250 degrees C. RESULT: The method has a linear range between 5.1920-51.920 microg, (r = 0.997, n = 6). The average rate of recovery of the injecter is 103.3%. The average rate of recovery of the infusion devices is 81.04%. CONCLUSION: The method has been proved to be convenient, sensitive and accurate. It is suitable for the determination of residual organic solvents in medical instruments.