注射用头孢他啶溶液的稳定性研究

Investigation of the stability of the Ceftazidime injection

目的研究注射用头孢他啶在生理盐水、5%葡萄糖注射液、乳酸钠注射液中的稳定性。方法采用HPLC法测定在室温放置0、0.5、1、2、4、8、12、16、24 h以及冰箱2～8℃放置24 h后,头孢他啶溶液中吡啶、聚合物和有关物质的含量。结果室温放置时,头孢他啶溶液中吡啶含量随放置时间的增加呈线性增加。3种溶液作溶剂,国产样品单个杂质和总杂质至12 h均合格;进口品至16 h均合格。用5%葡萄糖和乳酸钠溶液配制的国产样品聚合物含量至8 h合格,进口样品至16 h合格;用氯化钠配制的进口样品至24 h聚合物合格、国产样品不合格。3种溶液配制的样品置冰箱24 h,除国产样品中的有关物质外,均合格。结论注射用头孢他啶在配制后应立即使用,不能立即使用时应置2～8℃放置,尽快使用。

OBJECTIVE To investigate the stability of Ceftazidime solution in normal saline,5% glucose solution and sodium lactate solution.METHODS Ceftazidime solution was placed at room temperature and refrigerator（2-8 ℃）separately and the quantities of pyridine,relative substance and Ceftazidime polymer were determined by HPLC at 0,0.5,1,2,4,8,12,16 and 24 h.RESULTS At room temperature,the quantities of pyridine in Ceftazidime solution was increased linearly.In three solution,single/total impurity were qualified within 12 h for domestic products,while the time were 16 h for GlaxoSmithKline products.When Ceftazidime was dissolved in 5% glucose solution or sodium lactate solution,Ceftazidime polymer is qualified with 8 h for domestic products,while the time was 16 h for GlaxoSmithKline products.In normal saline,Ceftazidime polymer from GlaxoSmithKline are qualified at 24 h while it was unqualified for domestic products.When three kinds of Ceftazidime solution were placed in refrigerator（2-8 ℃）,except the relative substence in domestic products,the Ceftazidime solution was qualified at 24 h.CONCLUSION Ceftazidime solution must be used immediately,otherwise Ceftazidime solution must be placed in refrigerator（2-8 ℃） and used as soon as possible.