聚丙烯输液瓶中抗氧剂的提取迁移及含量测定

Extraction and Migration and Determination of Antioxygen in Polypropylene Infusion Bottles

目的:考察聚丙烯输液瓶中抗氧剂1010、抗氧剂168的提取与迁移。方法:采用五种提取介质(pH=3.5提取液,pH=8.0提取液,注射用水提取液,0.9%氯化钠注射液提取液及15%乙醇提取液)对聚丙烯输液瓶提取,将注入三种注射液(葡萄糖注射液、葡萄糖氯化钠注射液、氯化钠注射液)的聚丙烯输液瓶进行加速试验,采用高效液相色谱法测定五种提取介质与三种注射液中抗氧剂的含量。结果:五种提取介质和三种注射液中均未检出抗氧剂1010、抗氧剂168。提取迁移试验抗氧剂1010平均回收率均高于90%,RSD%均小于1.0;抗氧剂168平均回收率均高于86%,RSD%均小于3.0。结论:该种聚丙烯瓶稳定性良好,可以作为大输液的药品包装容器。

Objective：To investigate the extraction and migration of antioxygen 1010,antioxygen 168.Methods：To extract polypropylene infusion bottle by Using five kinds of extraction medium（PH3.5 extract,PH8.0 extract,injected water extract,0.9% sodium chloride injection extract and 15% ethanol extract）,and carry out accelerated test on polypropylene infusion bottle into which three kinds of injection（（glucose injection,glucose and sodium chloride injection,and sodium chloride injection）had poured,then determinate the contents of antioxygen in five kinds of extract medium and three kinds of injection.Results：there has been no antioxygen 1010,antioxygen 168 checked out in five kinds of extract medium and three kinds of injection.The average recovery rates of antioxygen 1010 were higher than 90%,RSD% were lower than 1.0.antioxygen 168 were higher than 86%,RSD% were lower than 3.0.Conclusion：This kind of polypropylene bottles are of good stability,which can be used in drug package of large infusion.