注射用头孢西丁钠在不同配伍溶液中的稳定性研究

Stability Study of Cefotaxime Sodium for Injection in Different Compatibilityy Solutions

目的:考察注射用头孢西丁钠和参比制剂在不同种配伍溶液中的稳定性。方法:采用注射用头孢西丁钠和参比制剂在0.9%氯化钠注射液、5%葡萄糖注射液中进行配伍试验,测定其含量、有关物质、酸度、可见异物、溶液的澄清度与颜色、不溶性微粒、5-羟甲基糠醛在各个时间点的变化,评估自制制剂与配伍溶液的稳定性与参比制剂的一致性。结果:在0 h、3 h、6 h、12 h内,自制制剂与参比制剂变化趋势基本一致。结论:注射用头孢西丁钠在不同配伍溶液中稳定性良好,符合临床用药要求。

Objective:To investigate the stability of cefoxitin sodium for injection and reference preparations in different compatibility solutions.Method:A compatibility test is conducted using ceftriaxone sodium for injection and a reference formulation in 0.9%sodium chloride injection and 5%glucose injection.The content,related substances,acidity,visible foreign substances,clarity and color of the solution,insoluble particles,and 5-hydroxymethylfurfural are measured at various time points to evaluate the stability of the self-made formulation and the compatibility solution,as well as the consistency with the reference formulation.Result:Within O h,3 h,6 h,and 12 h,the trend of changes between the self-made formulation and the reference formulation is basically consistent.Conclusion:Cefotaxime sodium for injection has good stability in different compatibility solutions and meets clinical medication requirements.