注射用头孢噻肟钠在4种不同包装输液中的稳定性考察

Investigation on Stability of Cefotaxime Sodium for Injections in 4 Different Infusion Packages

目的考察注射用头孢噻肟钠在聚氯乙烯(PVC)输液袋、聚丙烯(PP)塑料输液瓶、非聚氯乙烯(NPVC)多层共挤膜输液袋及玻璃瓶包装输液中的稳定性差异。方法将注射用头孢噻肟钠分别以0.9%氯化钠及5%葡萄糖注射液配制于PVC输液袋、PP塑料输液瓶、NPVC多层共挤膜输液袋及玻璃瓶中,各于4℃、25℃条件下放置,并于0、0.5、1、2、4、6h时取样,观察外观,测定pH值,另用紫外分光光度法测定含量。结果注射用头孢噻肟钠在各温度条件下于4种包装输液中各检测项目均无明显变化,4组间比较无显著性差异(P>0.1)。仅25℃时在PVC输液袋装5%葡萄糖注射液中浓度下降超过10%。结论临床上应避免头孢噻肟钠在高温下于PVC输液袋装5%葡萄糖注射液中使用。

OBJECTIVE： To observe the stability of cefotaxime sodium for injection in PVC infusion bags, PP plastic infusion bottle, non- PVC multilayer polymer infusion bags and glass bottles.METHODS： Cefotaxime sodium for injection prepared respectively with 0.9% NaCl injection and 5% GS injection were stored under 4℃ and 25℃ respectively with PVC infusion bags, PP plastic infusion bottle non- PVC multilayer polymer infusion bags and glass bottles, the appearances of the samples taken respectively at 0h,0.5h, lh,2h,4h,and 6 h were observed,the pH levels of which were detected and the contents of which were determined with UV- spectrophotometry.RESULTS： No significant change was noted in the detection results of all the items of cefotaxime sodium for injection in 4 kinds of infusion packages and under different temperatures; and no significant difference was noted among 4 groups（P 〉 0.1） except for a concentration reduction by more than 10% in 5% glucose injection in PVC infusion packages at 25℃ .CONCLUSION：5% glucose injections in PVC infusion packages should not be used under high temperatures in the clinic.