注射用卡络磺钠与注射用盐酸头孢替安的配伍稳定性考察  

Compatibility stability of carbazochrome sodium sulfonate for injection and cefotiam hydrochloride for in-jection

作　　者：郑芳[1] 李鹏[1] 朱雪松[1] 

机构地区：[1]十堰市湖北医药学院附属东风医院药学部,湖北省442008

出　　处：《中国医药》2013年第11期1644-1646,共3页China Medicine

摘　　要：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[（20-4-1）℃]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[（204-1）℃]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。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 sul- fonate 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-per- formance liquid chromatography at ambient temperature [ （20 ± 1 ） ℃ ] within 8 h and external appearance and pH were observed. Results The recovery rates of carbazoehrome 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 eefotiam： 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 ） ℃ ].

关 键 词：高效液相色谱法 卡络磺钠 头孢替安 配伍 稳定性 

分 类 号：R927.1[医药卫生—药学]