不同头孢呋辛注射制剂成品输液的稳定性对比  

Comparison of stability of infusion of different cefuroxime injection preparations

作　　者：任晓凯 李宵[2,3] 张蕾 安静 李颖[2,3] 赵越 冯运佳[2,3] 董占军 REN Xiao-kai;LI Xiao;ZHANG Lei;AN Jing;LI Ying;ZHAO Yue;FENG Yun-jia;DONG Zhan-jun(Graduate School of Hebei Medical University,Shijiazhuang 050017,China;Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051,China;Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang 050051,China)

机构地区：[1]河北医科大学研究生学院,石家庄050017 [2]河北省人民医院药学部,石家庄050051 [3]河北省临床药学重点实验室,石家庄050051

出　　处：《中国新药杂志》2025年第8期881-890,共10页Chinese Journal of New Drugs

基　　金：河北省医学科学研究课题计划项目(20250307);河北省药学会静脉用药品输液稳定性专项课题研究项目(2024-Hbsyxhdx001)。

摘　　要：目的:考察不同头孢呋辛注射制剂成品输液在不同温度下放置的稳定性,为临床静脉药品的遴选和使用提供参考。方法:将头孢呋辛传统粉针制剂分别在病房环境、静脉用药调配中心(Pharmacy Intravenous Admixture Services,PIVAS)进行配置,将国家医保谈判药品头孢呋辛粉液双室袋制剂在病房环境中直接开通,考察各成品输液于冷藏(2℃~8℃)、室温[(25±5)℃]、高温(40℃)下,放置0,4,8,12,24 h后的外观、pH值、不溶性微粒、渗透压、头孢呋辛及杂质A含量的变化情况。结果:0~24 h各组成品输液颜色随温度升高、放置时间延长逐渐加深,pH值、渗透压无明显变化。关于不溶性微粒数量,0~24 h 2μm粒径、0~4 h 5μm粒径粉液双室袋组显著少于传统PIVAS组和传统病房组(P<0.05);0~24 h 2μm粒径传统PIVAS组显著少于传统病房组(P<0.05)。传统病房组及传统PIVAS组的成品输液室温放置12 h时及3组成品输液高温放置4 h时,头孢呋辛含量均不符合药典规定限度(<90%);3组成品输液室温放置24 h时,或高温放置4 h时,杂质A均超过药典规定限度(>1%)。结论:头孢呋辛成品输液随温度升高、放置时间延长呈现降解加剧趋势,室温下建议12 h内使用完毕,高温下建议即配即用。粉液双室袋相较传统粉针配置可有效保障成品输液不溶性微粒数在最低水平;其能真正实现即配即用,保障实际给药浓度、剂量与理论一致,避免成品输液久置带来的降解风险,更能保障临床使用的有效性和安全性。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 2μm from 0 to 24 h and particles with a diameter of 5μm 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 2μm 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 roo

关 键 词：头孢呋辛 稳定性 成品输液 不溶性微粒 粉液双室袋 

分 类 号：R965[医药卫生—药理学]