注射用头孢哌酮钠舒巴坦钠配伍稳定性研究

Study on Compatibility Stability of Cefoperazone Sodium and Sulbactam Sodium for Injection

目的:以原研制剂作对比,全面考察不同溶媒对自研产品注射用头孢哌酮钠舒巴坦钠的配伍稳定性,为临床头孢哌酮钠舒巴坦钠的用药安全提供参考。方法:将注射用头孢哌酮钠舒巴坦钠与不同溶媒配伍,于不同时间点测定混合液中头孢哌酮及舒巴坦的浓度、有关物质、聚合物,观察溶液颜色、pH值变化。结果:注射用头孢哌酮钠舒巴坦钠与各溶液配伍12 h后药物的主要指标均无明显变化。结论:注射用水、5%葡萄糖注射液、生理盐水、5%葡萄糖和0.225%氯化钠注射液、5%葡萄糖和0.9%氯化钠注射液、乳酸钠林格注射液与头孢哌酮钠舒巴坦钠配伍的稳定性较高,临床上能安全使用。

Objective:Compare the reference preparations,to comprehensively investigate the compatibility stability of different solvents and the self-developed cefoperazone sodium and sulbactam sodium for injection,so as to provide a reference for the clinical safe medication.Methods:Combined cefoperazone sodium and sulbactam sodium for injection with different solvents,determine the contents of cefoperazone and sulbactam,related substances,and polymers in mixed solutions at different time points,and observe changes in color,and pH of solutions.Results:There was no significant change in the main indexes of cefoperazone sodium for injection and sulbactam sodium after 12 h of compatibility with each solution.Conclusion:The compatibility of water for injection,5%glucose injection,normal saline,5%glucose and 0.225%sodium chloride injection,5%glucose and 0.9%sodium chloride injection,sodium lactate Ringer's injection with cefoperazone sodium and sulbactam sodium has high stability,can be used safely in clinic.