首页> 中文期刊> 《医药导报》 >注射用埃索美拉唑钠与6种常用溶媒配伍的稳定性

注射用埃索美拉唑钠与6种常用溶媒配伍的稳定性

         

摘要

目的 探讨注射用埃索美拉唑钠在6种常见溶媒中的稳定性,为临床合理配制提供参考依据.方法 将注射用埃索美拉唑钠与100 mL的5%葡萄糖注射液、5%葡萄糖氯化钠注射液、10%葡萄糖注射液、0.9%氯化钠注射液、果糖注射液及木糖醇注射液配伍,测定溶液的pH,采用高效液相色谱法测定配伍液中埃索美拉唑钠的含量,定时观察溶液的颜色及澄明度.结果 注射用埃索美拉唑钠标准曲线在0.05 ~ 1.60 mg·mL-1浓度范围内,线性关系良好(R2=0.9999);与0.9%氯化钠注射液、木糖醇注射液配伍后,24 h内pH、澄明度及含量无明显变化;与10%葡萄糖注射液、5%葡萄糖注射液、5%葡萄糖氯化钠注射液配伍后分别在12,8,6h内pH、澄明度及含量无明显变化,溶液稳定;与果糖注射液配伍后,pH、澄明度及含量均有明显变化.结论 埃索美拉唑钠不宜与果糖配伍,宜与0.9%氯化钠注射液、木糖醇注射液配伍,若与10%葡萄糖注射液、5%葡萄糖注射液、5%葡萄糖氯化钠注射液配伍,应分别在12,8.6 h内滴注完.%Objective To investigate the appropriate HPLC detection for studying the stability of esomeprazole ( Eso) sodium for injection with six kinds of common solvents,and thus provide an evidence for using reasonable compound preparation in clinical use. Methods The Eso sodium fur injection was compatible with 100 mL six kinds of common solvents respectively, and the pH value was detected. The content of Eso sodium in the compatible solution was analyzed by HPLC. The color and clarity were observed at regular time. Results Eso showed a good linear relationship within the range of 0. 05-1. 60 mg · mL (R2 =0. 999 9). There were no significant changes on pH value,color,clarity and content within 24 h after being mixed with 0.9% sodium chloride injection and xylitol one. No distinct changes appeared 12 h,8 h and 6 h after being mixed with 10%GS,5%GS, 5%GNS injection, and the Eso solutions of which were relatively stable. While,the situation was different for Eso mixed with fructose injection. Conclusion Eso is incompatible with fructose injection and shows better compatibility with 0.9% NS or 5% xylitol injection. The drip of admixture should be finished withinl2 h,8 h and 6 h when mixing with 10% GS, 5% GS,5% GNS,respectively.

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