| 气相色谱法测定预充注射式无菌溶药器中环氧乙烷残留量 |
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| 引用本文： | 刘小冬,陈伟.气相色谱法测定预充注射式无菌溶药器中环氧乙烷残留量[J].现代医药卫生,2011,27(4):507-508. |
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| 作者姓名： | 刘小冬 陈伟 |
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| 作者单位： | 1. 解放军169中心医院药械科,湖南,衡阳,421000
2. 山东鲁抗医药股份有限公司,山东,济宁,272100 |
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| 摘 要： | 目的:探讨气相色谱法测定预充注射无菌溶药器中环氧乙烷残留量的方法.方法:顶空气相色谱法.色谱柱为ZB-WAX毛细管柱(0.32 mm×30m×0.25umDF);氢火焰离子化检测器(FID);柱温80℃;气化室温度200℃;检测器温度250℃;氮气为载气;分流比1:5.结果:环氧乙烷在1-10 ug/mL范匍内呈良好的线性关系(r=0.992),平均回收率为99.45%,RSD为0.65%.结论:本方法操作简便、快速、准确,可作为预充注射无菌溶药器中环氧乙烷残留量的测定方法.
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| 关 键 词： | 环氧乙烷 气相色谱 预充注射无菌溶药器 |
Residual quantity determination of epoxyethane in prefilled injection asepsis drug dissolution utensil |
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| LIU Xiao-dong
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ZHANG Gui-qin.Residual quantity determination of epoxyethane in prefilled injection asepsis drug dissolution utensil[J].Modern Medicine Health,2011,27(4):507-508. |
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| Authors: | LIU Xiao-dong ZHANG Gui-qin |
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| Affiliation: | LIU Xiao-dong,ZHANG Gui-qin(1.Department of Pharmacy and Instrument,169 Hospital of PLA,Hengyang,Hunan421000,China,2.Shandong Lukang Pharmaceutical Co.,Ltd.,Jining,Shandong 272100,China) |
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| Abstract: | To establish a GC metho for the determination of residual quanmy of epoxyemane in prefilled injection asepsis drug dissolution utensiLMethods：Headspace gas chromatography was used with the PEG-20M capillary column （0.32 mmx30m, 0.25 umDF） at 80℃.The temperature of aerification room： 200℃ ;the temperature of detector： 250℃ ;The carrier gas：helium.The split ratio：l：5.Results ：The good linearity was obtained over the range of 1-10μg/mL （r=0.992）,the average recovery rate was 99.45% ,RSD 0.65%.Conclusion ：This method is accurate ,rapid and accurate ,which can be applied to determine the residual quantity of epoxyethane in prefilled injection asepsis drug dissolution residual. |
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| Keywords: | Epoxyethane GC Prefilled injection asepsis drug dissolution |
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