聚丙烯输液瓶中添加剂的迁移研究

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。

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.