摘要
目的考察注射用哌拉西林钠他唑巴坦钠与3种输液的配伍稳定性,为临床使用和储存提供参考。方法模拟临床用法,通过考察外观、pH值、溶液的澄清度与颜色、不溶性微粒、渗透压,并测定有关物质及含量,进行稳定性考察。结果注射用哌拉西林钠他唑巴坦钠与乳酸钠林格注射液、0.9%氯化钠注射液、5%葡萄糖注射液在室温(25℃)25 h内、冷藏(2~8℃)8 d内的各项指标与0时相比均无明显变化,符合规定。结论乳酸钠林格注射液与注射用哌拉西林钠他唑巴坦钠配伍时渗透压相对变化更小且数值更低,可作为临床使用新选择。配伍溶液尽量选择冷藏保存,若在室温条件下放置应在25 h内尽早使用,以防药品的稳定性发生变化,从而影响产品质量。
Objective To investigate the compatible stability of Piperacillin Sodium and Tazobactam Sodium for Injection with three types of infusions,and provide reference for its clinical use and storage.Methods The clinical usage was simulated,and the stability was investigated by examination of the appearance,pH value,clarity and color of the solution,insoluble particles,osmotic pressure,and determination of related substances and content assay.Results There were no significant changes in various indicators of Piperacillin Sodium and Tazobactam Sodium for Injection,Sodium Lactate Ringer’s Injection,0.9%Sodium Chloride Injection,and 5%Glucose Injection within 25 h at room temperature(25℃)and 8 d at refrigerated temperature(2-8℃)compared to 0 h,which met the requirements.Conclusion When Sodium Lactate Ringer’s Injection is combined with Piperacillin Sodium and Tazobactam Sodium for Injection,the relative change of osmotic pressure is smaller and the value is lower,making it a new clinical option.For compatible solution,refrigerated preservation should be chosen.If it is left at room temperature,it should be used as early as possible within 25 h to prevent changes in drug stability that may affect product quality.
作者
刘联
张传斌
王娜
祝兴战
LIU Lian;ZHANG Chuan-bin;WANG Na;ZHU Xing-zhan(Shandong Lukang Pharmaceutical Co.,Ltd.,Jining 272100,China;Jining Institute of Food and Drug Control,Jining 272100,China;Market Supervision and Administration Bureau of Dingtao District,Heze 274100,China)
出处
《食品与药品》
2026年第1期18-23,共6页
Food and Drug
关键词
注射用哌拉西林钠他唑巴坦钠
乳酸钠林格
注射液
配伍实验
稳定性
Piperacillin Sodium and Tazobactam Sodium for Injection
Sodium Lactate Ringer’s Injection
injection
compatibility study
stability
