顶空气相色谱法测定一次性使用无菌导尿管中环氧乙烷残留量  

Determination of Ethylene Oxide Residual Quantity in Single-Use Sterile Urethral Catheter by Headspace Gas Chromatography

作　　者：张成[1] 王刚林 

机构地区：[1]陕西省医疗器械检测中心,陕西西安710075 [2]重庆医疗器械质量检验中心,重庆401147

出　　处：《中国药业》2013年第14期61-62,共2页China Pharmaceuticals

摘　　要：目的建立一次性使用无菌导尿管中环氧乙烷残留量的测定方法。方法采用顶空进样毛细管气相色谱法,FID检测器,应用P/NAgilent 19091J-413 HP-5毛细管柱(30.0 m×320μm,0.25μm),载气为氮气,柱温采取恒温80℃、保持4 min,测定一次性使用无菌导尿管中环氧乙烷的残留量。结果环氧乙烷质量浓度在0.523 4～16.748 2μg/mL范围内与峰面积呈良好的线性关系,回归方程Y=0.462 8 X-0.048 39,r=0.999 97(n=6),平均回收率为92.56%,RSD为0.72%(n=6)。结论该方法快速简便、结果准确、可靠、重现性好,可作为一次性使用无菌导尿管中环氧乙烷残留量的测定方法。Objective To establish the method for the determination of ethylene oxide residual quantity in the single-use sterile urethral catheter.Methods The ethylene oxide residual quantity in the single-use sterile urethral catheter was tested by headspace gas chromatography with FID detector,the P / N Agilent 19091 J-413 HP-5 capillary column（30.0 m × 320 μm,0.25 μm） was adopted with N 2 as the carrier gas.The column temperature was kept at the constant temperature of 80 ℃ for 4 min.Results The mass concentration of ethylene oxide in the range of 0.523 4-16.748 2 μg / mL showed the good linear relation with the peak area.The regression equation was Y = 0.462 8 X-0.048 39,r = 0.999 97（ n = 6）.The average recovery rate was 92.56%,RSD was 0.72%（ n = 6）. Conclusion This established method is rapid,simple,accurate and reliable with good reproducibility,and can be used as the determination method for the ethylene oxide residual quantity in single-use sterile urethral catheter.

关 键 词：顶空气相色谱法 一次性使用无菌导尿管 环氧乙烷残 留量 

分 类 号：R927.11[医药卫生—药学] R194.5