| 聚丙烯输液瓶中添加剂的迁移研究 |
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| 引用本文： | 王峰,李樾,孙会敏.聚丙烯输液瓶中添加剂的迁移研究[J].药物分析杂志,2012(3):414-415,446. |
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| 作者姓名： | 王峰 李樾 孙会敏 |
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| 作者单位： | 中国食品药品检定研究院 |
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| 摘 要： | 目的:聚丙烯输液瓶是高风险的输液类包装容器,本研究重点考察我国聚丙烯输液瓶中添加剂的迁移是否会影响所包装的药品质量和安全。方法:分别采用HPLC法、ICP法对聚丙烯输液瓶中药液的抗氧剂1010、抗氧剂168和水滑石中的铝、镁在药液中的迁移量进行研究。结果:39个企业的59批药品溶液中均未检出抗氧剂,镁、铝2种离子在其中的迁移量大都小于0.05 mg.L-1。结论:研究结果表明,所检测的聚丙烯输液瓶中的添加剂的迁移不影响药品使用的安全。
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| 关 键 词： | 聚丙烯输液瓶 药品包装材料 抗氧剂 水滑石(水合铝酸碳酸镁) 镁 铝 添加剂 迁移 相容性 药品质量 安全评价 高效液相色谱 电感耦合等离子光谱 |
Migration studies on the additives of polypropylene infusion bottle |
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| WANG Feng,LI Yue,SUN Hui-min.Migration studies on the additives of polypropylene infusion bottle[J].Chinese Journal of Pharmaceutical Analysis,2012(3):414-415,446. |
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| Authors: | WANG Feng LI Yue SUN Hui-min |
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| Institution: | (National Institute for Food and Drug Contorl,Beijing 100050,China) |
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| Abstract: | Objective: Because polypropylene(PP) infusion bottle is a high risk container,so the research is in order to examination whether the additives will be migrated to pharmaceutical products or not.Methods:The content of the antioxidant 1010 and antioxidant 168 which are leached from the contact materials was determined by the HPLC and inductive coupled plasma(ICP) method.Results: After testing 59 batches of samples which come from 39 manufacturers,there are no leachable antioxidants can be detected,and the leachable magnesium and aluminum are lower than 0.05 mg·L-1.Conclusion:The leachable additives have no influence on the container and the drug. |
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| Keywords: | polypropylene(PP) infusion bottle drug packaging materials antioxidant hydrotalcite(magnesium aluminum hydroxide carbonate) magnesium aluminium additives migration compatibility drug quality safety evaluation HPLC inductive coupled plasma(ICP) |
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