| 三层共挤输液袋中残留苯乙烯在注射液中的迁移监测研究 |
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| 引用本文： | 赵霞,;何雄,;孙会敏.三层共挤输液袋中残留苯乙烯在注射液中的迁移监测研究[J].中国药事,2014(8):835-838. |
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| 作者姓名： | 赵霞 ;何雄 ;孙会敏 |
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| 作者单位： | [1]中国食品药品检定研究院,北京100050; [2]湖南省医疗器械与药用包装材料(容器)检测所,北京100050; |
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| 摘 要： | 目的 建立检测三层共挤输液用袋中残留苯乙烯单体在药液中迁移量的监测方法.方法 采用HPLC法,选用Sun Fire C18色谱柱（4.6 mm×150 mm,5μm）;以乙腈-水（60：40）为流动相,流速1.0 mL·min^-1,检测波长240 nm,柱温30℃,进样体积10 μμL.结果 苯乙烯在1～30 tg·mL^-1范围内线性良好,相关系数为0.9999,苯乙烯在精氨酸谷氨酸盐注射液中迁移的平均加样回收率为96.2％（n=9）,RSD为2.3％.经过多批样品检测,苯乙烯迁移量均在检测限以下.结论 该方法经方法学验证,可用于三层共挤输液用袋中苯乙烯单体在药液中迁移量的监测.
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| 关 键 词： | 药用包装材料 三层共挤输液袋 苯乙烯残留监测 高效液相色谱法 |
Study on the Migration of Residual Styrene to Injections from Three-layer Co-extrusion Bags |
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| Institution: | Zhao Xia ,He Xiong ,Sun Huimin(National Institutes for Food and Drug Control, Beijing 100050;1.Hunan Provincial Inspection Institute for Medical Instruments and Packaging Materials (Containers)) |
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| Abstract: | Objective To establish a method for monitoring the migration of residual styrene to injections from 3-layer co-extrusion bags. Methods The analysis was carried out on a Sun Fire C18 column （4.6 mm×150 mm, 5 μm） eluted with acetonitrile-water （60 ： 40） as the mobile phase at the flow rate of 1 mL · min^-1. The UV detection wavelength was 240 nm, and the temperature of the column was 30 ℃. The sample injection volume was 10 μL. Results The linear range of styrene was 1-30 μg · mL^-1 （r= 0. 9999）. The average recovery for migration of styrene to arginine glutamate injection was 96.2% （RSD= 2.3 %, n= 9）. The detection of multiple batches of samples showed the migration was all below the detection limit. Conclusion According to the method validation, the HPLC method can be used for determination of migration amount of styrene to injections from 3-layer co-extrusion bags. |
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| Keywords: | pharmaceutical packaging materials 3-layer co-extrusion bags used for infusion monitoring of styrene residues HPLC |
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