倍他米松磷酸钠注射液与7种注射用药物的配伍稳定性  

Compatibility stability of betamethasone sodium phosphate injection with 7 injectable drugs

作　　者：邓博文 郑媛元 张超锋[1] 陈迪 DENG Bowen;ZHENG Yuanyuan;ZHANG Chaofeng;CHEN Di(Department of Pharmaceutical Analysis,College of Pharmacy,Zhengzhou University,Zhengzhou 450001)

机构地区：[1]郑州大学药学院药物分析系,郑州450001

出　　处：《郑州大学学报(医学版)》2025年第2期211-215,共5页Journal of Zhengzhou University(Medical Sciences)

基　　金：河南省科技攻关项目(242102311184)。

摘　　要：目的:考察倍他米松磷酸钠注射液与注射用头孢唑林钠、注射用哌拉西林钠他唑巴坦钠等7种临床常用药物的配伍稳定性。方法:将倍他米松磷酸钠注射液分别与注射用头孢唑林钠、注射用哌拉西林钠他唑巴坦钠、注射用头孢哌酮钠舒巴坦钠、注射用头孢呋辛钠、注射用头孢他啶、注射用青霉素钠和盐酸利多卡因注射液7种药物按照临床常用剂量进行配伍,在4、25和40℃条件下观察配伍液外观性状、测定pH值,采用高效液相色谱法检测药物含量。结果:在4和25℃放置24 h以及40℃放置8 h条件下,7种配伍液均澄清透明,无浑浊、沉淀和絮状物产生;倍他米松磷酸钠注射液与注射用头孢呋辛钠和头孢他啶配伍液发生颜色变化,由无色逐渐向黄色转变。7种配伍液pH值在24 h内逐渐降低或升高,且随着温度的升高pH值变化幅度增大。7种配伍液中倍他米松磷酸钠含量变化均不超过4%,且随着温度降低药物稳定性提高。结论:倍他米松磷酸钠注射液与其他7种药物的配伍液在4和25℃放置24 h和40℃放置8 h条件下稳定性良好。Aim:To investigate the compatibility stability of betamethasone sodium phosphate injection with 7 commonly used clinical drugs including cefazolin sodium for injection,piperacillin sodium and tazobactam sodium for injection,etc.Methods:Betamethasone sodium phosphate injection was mixed with 7 drugs including cefazolin sodium for injection,piperacillin sodium and tazobactam sodium for injection,cefoperazone sodium and sulbactam sodium for injection,cefuroxime sodium for injection,ceftazidime for injection,benzylpenicillin sodium for injection,lidocaine hydrochloride injection at clinically common doses.The compatibility solutions were observed for appearance,pH value was measured,and changes in drug content were determined by high-performance liquid chromatography under conditions of 4,25,and 40℃.Results:Under 4 and 25℃for 24 hours and 40℃for 8 hours,all 7 compatibility solutions were clear and transparent without turbidity,precipitation,or flocculation.The compatibility solution of betamethasone sodium phosphate injection with cefuroxime sodium and ceftazidime for injection changed color from colorless to yellow gradually.The pH values of the 7 compatibility solutions gradually decreased or increased within 24 hours,and the changes increased with temperature.The change in betamethasone sodium phosphate content in the 7 compatibility solutions did not exceed 4%,and as the temperature decreased,the stability of the drug increased.Conclusion:The compatibility solutions of betamethasone sodium phosphate injection with the other 7 drugs remain stable within 24 hours at 4 and 25℃,and within 8 hours at 40℃.

关 键 词：倍他米松磷酸钠注射液 外观性状 PH值 配伍稳定性 

分 类 号：R917[医药卫生—药物分析学]