Objective To study the compatibility stability of carbazochrome sodium sulfonate for injection and cefotiam hydrochloride for injection in 0.9％ sodium chloride injection.Methods Carbazochrome sodium sulfonate for injection was combined with cefotiam hydrochloride for injection in 0.9％ sodium chloride injection.The contents of carbazochrome sodium sulfonate and cefotiam in mixture were determined by reversed phase high-performance liquid chromatography at ambient temperature [(20 ± 1) ℃] within 8 h and external appearance and pH were observed.Results The recovery rates of carbazochrome sodium sulfonate and cefotiam were 99.5％,99.7％,and the relative standard deviation were 0.73％,0.90％.There was no significant change in appearance,pH and the contents of carbazochrome sodium sulfonate and cefotiam under room temperature [(20 ± 1) ℃] condition within 8 h[pH:4.57,4.58,4.59,4.61,、4.62,4.63,4.65,4.68,respectively; contents of carbazochrome sodium sulfonate:100.0％,99.5％,100.3％,99.8％,99.0％,99.5％,99.1％,99.0％,respectively; contents of cefotiam:100.0％,100.6％,99.9％,99.5％,99.1％,98.9％,99.0％,98.8％,respectively].Conclusion Carbazochrome sodium sulfonate for injection combined with cefotiam hydrochloride for injection in 0.9％ sodium chloride injection can be used within 8 h at room temperature [(20 ± 1) ℃].%目的 考察注射用卡络磺钠与注射用头孢替安在0.9％氯化钠注射液中的配伍稳定性.方法 采用反相高效液相色谱法测定卡络磺钠与头孢替安在0.9％氯化钠注射液中配伍后8h内各时间点的含量,并测定pH值,观察配伍液的外观变化.结果 卡络磺钠的平均回收率为99.5％,相对标准偏差(RSD)为0.73％；头孢替安的平均回收率为99.7％,RSD为0.90％.在室温[(20±1)℃]下0、1、2、3、4、5、6、8h时,配伍液外观、pH值及含量均无明显变化.配伍液外观均为橙红色澄明,无肉眼可见的气泡产生及沉淀生成.配伍液pH值分别为4.57、4.58、4.59、4.61、4.62、4.63、4.65、4.68,卡络磺钠含量分别为100.0％、99.5％、100.3％、99.8％、99.0％、99.5％、99.1％、99.0％,头孢替安含量分别为100.0％、100.6％、99.9％、99.5％、99.1％、98.9％、99.0％、98.8％.结论 在室温[(20±1)℃]下,注射用卡络磺钠与注射用头孢替安在0.9％氯化钠注射液中8h内可以配伍使用.
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