氟尿嘧啶配置后输液在输液泵中的稳定性考察

Investigation on the Stability of Fluorouracil Infusion after Admixture in Infusion Pump

目的:考察氟尿嘧啶(5-FU)配置后输液在输液泵中的稳定性。方法:模拟临床实际情况,将由奥沙利铂或伊立替康/亚叶酸/5-FU组成的化疗方案(mFOLFOX6或FOLFIRI)中常用量的氟尿嘧啶注射液以氯化钠注射液或葡萄糖注射液稀释至230 ml的溶液置于一次性配套储药袋中,观察溶液在不同温度下(4℃冰箱内、25℃室内不避光和37℃室内不避光)72 h内是否出现外观变化,同时测定溶液的不溶性微粒、pH和含量变化。结果:储药袋中的5-FU溶液在不同温度下72 h内的外观和pH均无明显改变,不溶性微粒符合输液标准,5-FU相对初始含量均大于95.0%。结论:在临床常见情况下,5-FU配置后输液在输液泵中稳定性良好,可满足输液泵持续泵入46 h的临床要求。

Objective:To investigate the stability of fluorouracil(5-FU)infusion in infusion pump.Methods:To simulate the actual clinical situation,fluorouracil injection,which was commonly used in the chemotherapy regimen consisting of oxaliplatin or irinotecan/folinic acid/fluorouracil(mFOLFOX6/FOLFIRI),was diluted to 230 ml by sodium chloride or glucose injection in a disposable package,and the dissolution was observed.The appearance of the solution was observed within 72 hours at different temperatures(4℃,25℃and 37℃).The changes of insoluble particles,pH value and content of the solution were also determined.Results:The appearance and pH value of 5-FU infusion in the disposable package did not change significantly within 72 hours at different temperatures.The insoluble particles met the infusion standard,and the relative initial content of 5-FU was more than 95.0%.Conclusion:Under the common clinical conditions,the stability of 5-FU infusion in infusion pump is good,which can meet the requirements of continuous infusion for 46 hours.