| 顶空气相色谱法测定醋酸烯诺孕酮埋植剂中环氧乙烷的残留量 |
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| 引用本文： | 杨清华,潘华先,王传栋,郈秀菊.顶空气相色谱法测定醋酸烯诺孕酮埋植剂中环氧乙烷的残留量[J].生物医学工程研究,2003,22(2):37-38. |
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| 作者姓名： | 杨清华 潘华先 王传栋 郈秀菊 |
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| 作者单位： | 1. 山东省医疗器械研究所,济南,250013
2. 国家药品监督管理局济南医疗器械质量监督检验中心,济南,250013 |
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| 摘 要： | 用顶空气相色谱法测定醋酸烯诺孕酮埋植剂中环氧乙烷的残留量，结果表明，线性试验与精密度良好，平均回收率为99．8％，残留量为0．93％。样品在灭菌后，室温放置3天，其环氧乙烷残留量均在0．0001％以下，符合环氧乙烷残留量应不大于0．001％的规定。表明采用顶空气相色谱法测定醋酸烯诺孕酮理植剂中环氧乙烷残留量，方法简便，结果准确，适用于对该产品中环氧乙烷残留量的检测与控制。
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| 关 键 词： | 顶空气相色谱法 醋酸烯诺孕酮埋植剂 环氧乙烷残留量 避孕 |
| 文章编号： | 1006-4915(2003)02-0037-02 |
| 修稿时间： | 2003年4月20日 |
Determination of the Residual Ethylene Oxide in Nestorone Implant by GC |
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| Yang Qinghua,Pan Huaxian,Wang Chuandong,Gou Xiuju.Determination of the Residual Ethylene Oxide in Nestorone Implant by GC[J].Journal Of Blomedical Englneerlng Research,2003,22(2):37-38. |
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| Authors: | Yang Qinghua Pan Huaxian Wang Chuandong Gou Xiuju |
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| Institution: | Yang Qinghua 1 Pan Huaxian 2 Wang Chuandong 1 Gou Xiuju 1 1 |
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| Abstract: | The residual ethylene oxide in nestorone implant were determined by GC.Results showed that the linear ranges and the precision were ideal.The average recovery rate was 99.8% with RSD of 0.93%.After sterilized and placed at room temperature,the residual ethylene oxide in the nestorone implant was lower 0.0001%,according with the regulation.The GC methed is simple and accurate to determine the residual ethylene oxide in nestorone implant for the determination and control of the residual ethylene oxide. |
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| Keywords: | GC Nestorone implant Residual ethylene oxide |
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