三层共挤输液用袋的添加剂测定和迁移量测定  

Determination of additives of three-layer co-extrusion bags used for infusion and the migration of additives

作　　者：王悦雯[1] 陈蕾[1] 冯靖[1] 刘言[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物分析杂志》2016年第1期138-143,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:三层共挤输液用袋是高风险的输液类药品包装容器,本研究建立三层共挤输液用袋中添加剂(抗氧剂及铝、镁元素)的含量测定方法并对添加剂的迁移量进行考察。方法:采用欧洲药典项下色谱条件,以乙腈为提取溶剂,利用高效液相色谱法对三层共挤输液用袋的抗氧剂含量进行测定;采用硝酸消解溶样,利用原子吸收分光光度法对三层共挤输液用袋中的铝、镁元素含量进行测定。对2种测量方法进行方法学验证,并对三层共挤输液用袋装药液中的抗氧剂和铝、镁元素的迁移量进行考察。结果:10批三层共挤输液用袋的抗氧剂及铝、镁元素含量均符合欧洲药典要求,建立的抗氧剂提取方法与欧洲药典项下提取方法无显著差异;10批三层共挤输液用袋装的0.9%氯化钠注射液中均未检测出迁移的抗氧剂,铝元素的迁移量均小于25μg·L^(-1),镁元素的迁移量均小于50μg·L^(-1)。结论:本文建立的三层共挤输液用袋添加剂的检测方法简便,准确,可用于三层共挤输液用袋中添加剂的含量和迁移量的检测和质量控制。Objective： To establish a method for determination of the additives （ antioxidant aluminum, and magnesium ） in three-layer co-extrusion bags used for infusion which are high risk containers and to inspect the migration of additives. Methods： With acetonitrile as the extraction solvent, the high performance liquid chromatography was used for antioxidant content determination in three-layer co-extrusion bags by the European pharmacopoeia chromatographic conditions. Nitric acid was used to dissolve the samples and the atomic absorption spectrophotometry was used for the determination of aluminum and magnesium contents in the three- layer co-extrusion bags. The above two measurement methods were validated by methodology, and the migration of antioxidant, aluminum and magnesium in the three-layer co-extrusion bags were investigated. Results- After testing 10 batches of samples, the contents of the antioxidant, aluminum and magnesium were in compliance with European pharmacopoeia requirements. There were no significant differences between the established antioxidant extraction method and the extraction method of the European pharmacopoeia. There were no leachable antioxidants that could be detected in 0. 9% sodium chloride injection contained in the 10 batches of samples, and the leachable aluminum was lower than 25 μ g· L^-1, while leachable magnesium was lower than 50 μ g· L^-1. Conclusion： The additive detection method established in this article for three-layer co-extrusion bags used for infusion is simple, accurate, and can be used in assay of additive content and the migration amount and quality control.

关 键 词：药品包装容器 三层共挤输液用袋 相容性 抗氧剂 铝 镁 添加剂 迁移 药品安全评价 

分 类 号：R917[医药卫生—药物分析学]