国产静注奥美拉唑的稳定性研究  

Study on stability of omeprazole for injection

作　　者：许东航[1] 徐翔[1] 张仲苗[1] 孙晓译[1] 朱晓静[1] 

机构地区：[1]浙江大学医学院附属第二医院,杭州310009

出　　处：《药物分析杂志》2006年第2期271-273,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:考察国产静注奥美拉唑和4种常见输液配伍的稳定性。方法:收集不同批号2个厂家生产的静注奥美拉唑,将40mg 奥美拉唑加入到4种40mL 的不同输液中,室温条件下放置6h,观察外观及 pH 的变化,并用 HPLC 法测定输液中奥美拉唑含量,同时考察温度对稳定性的影响及放置过程杂质峰的变化。结果:洛凯和输液配伍后 pH、含量均未发生明显改变,且和洛赛克无显著性差别。批与批之间无显著性差别。但温度对奥美拉唑稳定性影响大,且奥美拉唑和5%葡萄糖、10%葡萄糖和5%葡萄糖氯化钠输液配伍,都出现杂质峰超标。结论:国产奥美拉唑质量稳定,可满足临床需要。奥美拉唑宜与0.9%氯化钠配伍,输液体积以40mL 为宜,且需注意温度对稳定性的影响,临用临配。若与5%葡萄糖、10%葡萄糖和5%葡萄糖氯化钠输液配伍,要求2h 内用完。Objective：To evaluate the drug stability of omeprazole in 4 kind of solutions in vitro. Methods： 40 mg omeprzole was added into 4 different solutions respectively at room temperature, pH and visual appearance of the admixture were surveyed in 6 hours, omeprzole concentrations were also determined by HPLC method. The effect of temperature on the stability of omeprazole and the change of impurity peak were also determined. Results： The pH and concentration of omeprazole solutions didn＇ t show the significant difference when omeprazole admixed with 0. 9% NaCl. But omeprazole becomes unstable at high temperature. Conclusion：It is indicated that the stability of Omeprazole made in domatic products is good enough to meet the clinical use. Omeprazole should be admixed with 0. 9% NaCl at room temperature,and must be used up in 2 hours when admixed with 5% GS,10% GS and 5% GNS.

关 键 词：奥美拉唑 稳定性 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]