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Title:: Study on migration of additives in pre-filled catheter flusher in sodium chloride injection

作者:: 李永贵1; 张锡霞1; 赵琦2; 胡瑞瑞1; 王晶1; 尹弢1△; 毋立华3△; 1.山东省药学科学院山东省化学药物重点实验室，济南 250101；2.山东省荣军总医院，山东济南 250000；3.山东省食品药品审评查验中心，济南 250014

Author(s):: LI Yonggui1; ZHANG Xixia1; ZHAO Qi2; HU Ruirui1; WANG Jing1; YIN Tao1; WU Lihua3; 1.Shandong Academy of Pharmaceutical Sciences，Shandong Provincial Key Laboratory of Chemical Drug, Jinan 250101,China；2.Shandong Rongjun General Hospital， Jinan 250000；3.Shandong Center for Food and Drug Evaluation & Inspection，Jinan 250014

Keywords:: Pre-filled catheter flusher; Polypropylene; Drug packaging materials; Antioxidant; Migration; HPLC; ICP-MS

摘要:: 本研究建立了预充式导管冲洗器中添加剂的检测方法，对添加剂的迁移量进行考察。采用HPLC法对抗氧剂1010、抗氧剂168、抗氧剂BHT和硫进行检测，采用ICP-MS法对铝、镁元素进行检测。完成两种检测方法的方法学验证及加速实验样品检测。结果表明预充式导管冲洗器中添加剂的迁移量不影响药品安全使用。

Abstract:: We established the detection methods of additives in the pre-filled catheter irrigator to investigate the migration of the additives.HPLC method was used to detect antioxidant 1010, antioxidant 168, antioxidant BHT and sulfur. The ICP-MS method was used to detect aluminum and magnesium. The accelerated experimental samples were detected when finished the methodological verification of the two detection methods. The results show that the migration of additives in the pre-filled catheter flusher does not affect the safe use of drugs.