Comparison of stability of infusion of different cefuroxime injection preparations

REN Xiao-kai; LI Xiao; ZHANG Lei; AN Jing; LI Ying; ZHAO Yue; FENG Yun-jia; DONG Zhan-jun

doi:10.20251/j.cnki.1003-3734.2025.08.014

Abstract：Objective:To investigate the stability of infusion of different cefuroxime injection preparations stored at different temperatures to provide a reference for the selection and use of intravenous drugs in clinical practice.Methods:The traditional cefuroxime powder for injection formulations purchased through centralized procurement were prepared into infusion in the ward environment and the Pharmacy intravenous admixture service(PIVAS),respectively.The cefuroxime powder-liquid double-chamber bag formulation purchased through national negotiations was directly opened in the ward environment.The changes in appearance,pH value,insoluble particles,osmotic pressure,cefuroxime content,and content of impurity A of each prepared infusion were examined after being stored at refrigeration(2 ℃～8 ℃),room temperature[(25±5)℃],and high temperature(40 ℃)for 0,4,8,12,and 24 h.Results:The color of all the prepared infusion deepened gradually with the increase of temperature and the extension of storage time from 0 to 24 h,while the pH value and osmotic pressure showed no significant changes.Regarding the number of insoluble particles,the powder-liquid double-chamber bag group had significantly fewer particles with a diameter of 2 μm from 0 to 24 h and particles with a diameter of 5 μm from 0 to 4 h than the traditional PIVAS group and the traditional ward group(P＜0.05);the traditional PIVAS group had significantly fewer particles with a diameter of 2 μm from 0 to 24 h than the traditional ward group(P＜0.05).The cefuroxime content of the prepared infusions from the traditional ward group and the traditional PIVAS group did not meet the pharmacopoeia's specified limit(＜90％)after being stored at room temperature for 12 h,and the cefuroxime content of the prepared infusions from all three groups did not meet Chinese Pharmacopoeia's limit(＜90％)after being stored at high temperature for 4 h;the content of impurity A of the prepared infusions from all three groups exceeded Chinese Pharmacopoeia's limit(＞1％)after being stored at room temperature for 24 h or at high temperature for 4 h.Conclusion:The prepared cefuroxime infusions tend to degrade more severely with the increase of temperature and the extension of storage time.It is recommended to use the infusion within 12 h at room temperature and prepare and use them immediately at high temperature.Compared with traditional powder for injections,the powder-liquid double-chamber bag can effectively ensure that the number of insoluble particles in the prepared infusion is at low level;it can truly achieve immediate preparation and use,ensuring that the actual drug concentration and dosage are consistent with the theoretical values,avoiding the degradation risks brought by long-term storage of the prepared infusions,and can better guarantee the effectiveness and safety of clinical medication.