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注射用奥美拉唑钠与4种常用溶剂的配伍稳定性考察
Observation on the Stability of Omeprazole Sodium for Injection Combined with 4 Kinds of Common Solvents
【摘要】 目的:考察注射用奥美拉唑钠与4种常用溶剂的配伍稳定性。方法:将注射用奥美拉唑钠分别与5%葡萄糖注射液(GS)、10%GS、葡萄糖氯化钠注射液(GNS)及0.9%氯化钠注射液(NS)配伍后于不同时间观察配伍液的外观颜色及澄明度,测定溶液的p H值,并采用高效液相色谱法测定奥美拉唑钠的含量。结果:注射用奥美拉唑钠与4种常用溶剂配伍后含量均无显著下降。与5%GS、10%GS、GNS配伍4 h后,配伍液转为澄明微黄色;与NS配伍后,药液均显澄明无色。p H值对其稳定性有很大的影响,p H值越低,药物的稳定性越差,药物分解的速度也越快。结论:临床应用注射用奥美拉唑钠时应考虑溶剂的p H值,尽量避免与偏酸性或酸性溶剂配伍;其最佳溶剂应为NS。若与5%GS、10%GS、GNS配伍,宜在3 h内用完。
【Abstract】 OBJECTIVE:To explore the stability of Omeprazole sodium for injection combined with 4 kinds of common solvents. METHODS:Omeprazole sodium for injection were respectively combined with 5% glucose injection(GS),10% GS,glucose and normal saline injection(GNS)and 0.9%Na Cl injection. The color of solution was observed at different time and p H was determined. HPLC was conducted to determine the content of Omeprazole sodium. RESULTS:The contents had no significant decrease after the combination of Omeprazole sodium for injection and 4 kinds of common solvents;the admixture showed clear and light yellow after 4 h of combination with 5%GS,10%GS and GNS;the admixture showed clear and achromatic color after combined with 0.9%Na Cl injection. The p H value had great influence on the stability,the lower the p H value,the worse the drug stability and the faster the decomposition rate. CONCLUSIONS:When Omeprazole sodium for injection is used in clinic,the p H value of solutions should be noticed to possibly avoid the combination with partial acidic and acidic solvents;the optimal solvent is0.9%NS injection. The admixture should be use up within 3 h when combined with 5%GS,10%GS and GNS.
【Key words】 Omeprazole sodium for injection; Compatibility; Stability; Solvent;
- 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2015年14期
- 【分类号】R969.2
- 【被引频次】11
- 【下载频次】442