头孢吡肟在5%葡萄糖注射液中的稳定性研究  

Stability study of cefepime in 5 % glucose injection

作　　者：张渊[1] 许根英[2] 赵志英[1] 

机构地区：[1]上海市第一人民医院药剂科,上海200080 [2]复旦大学附属中山医院药剂科,上海200032

出　　处：《中国新药与临床杂志》2004年第4期206-209,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :研究头孢吡肟在 5 %葡萄糖注射液中的稳定性 ,并对其贮存期进行预测。方法 :应用化学动力学原理 ,参考临床用药特点 ,配制头孢吡肟在5 %葡萄糖注射液中的溶液 ,将药物溶液分别置于5 0 ,6 0 ,70 ,80℃下 ,每 0 .5h取样 ,用HPLC方法测定溶液中头孢吡肟的含量。结果 :各温度下头孢吡肟百分含量的对数 (lgC)与时间 (t)具有线性关系 ,符合一级动力学反应 ;经预测室温 (2 5℃ )下K为0 .0 0 4 0 92 6h- 1,τ0 .9为 2 5 .8h ;冷藏 (5℃ )下K为0 .0 0 0 4 116 2h- 1,τ0 .9为 10 .7d。结论 :在 2 5℃ ,头孢吡肟与 5 %葡萄糖注射液配液的应在 1d内使用完 ,在 5℃时 ,应在AIM: To determine the stability of cefepime in 5 % glucose injection and certify its shelf life. METHODS: Prepared solution of cefepime in 5 % glucose injection was made by referring to the clinical prescription, and warmed in 50 ℃ , 60 ℃ , 70℃ and 80 ℃ , separately. Samples were taken every 0.5 h . The cefepime contents in the solutions were assayed by HPLC. RESULTS: There was a linearity between the cefepime contents in the solutions in logarithm (lg C ) and time ( t ) at each temperature. It responded to the first order kinetic reaction. Degradation rate constants ( K ) were predicted, the K value was 0.0040926 h -1 (τ 0.9 = 25.8 h ) at room temperature ( 25 ℃ ), and 0.00041162 h -1 (τ 0.9 = 10.7 d ) at cold temperature (5℃ ). CONCLUSION: In order to ensure the safety and efficancy of the drug therapy , cefepime in 5 % glucose injection shoutd be used up within 1 d at room temperature ( 25 ℃ ); and 10 d at cold temperature ( 5 ℃ ).

关 键 词：高压液相色谱法 葡萄糖注射液 配伍禁忌 头孢吡肟 稳定性 医院药学 

分 类 号：R942[医药卫生—药剂学]