输液系统中抗氧剂迁移量测定的方法学研究

Determination of Antioxidant Migration in Infusion System

输液系统的构造复杂,组件较多,不同组件的添加剂种类也多,用HPLC法对输液系统中可能存在的5种常见抗氧剂的迁移量进行方法学研究,包括线性试验、精密度试验、稳定性试验、重复性试验、检测限、回收率试验,结果表明该方法适用性好,能够准确检测出迁移液中抗氧剂的含量,可作为评价输液系统与药液相容性的依据,并可为进一步评价其安全性提供参考。

The HPLC method was used to study the migration of 5 kinds of common antioxidants that may exist in the infusion system,including linear test,precision test,stability test,repeatability test,detection limit and recovery test.The results show that the method is good and can accurately detect the content of antioxidants in the fluid.