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

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。

OBJECTIVE： To explore the stability of Omeprazole sodium for injection combined with 4 kinds of common sol- vents. METHODS： Omeprazole sodium for injection were respectively combined with 5 % glucose injection （GS）, 10% GS, glu- cose and normal saline injection （GNS） and 0.9%NaCl injection. The color of solution was observed at different time and pH was determined. HPLC was conducted to determine the content of Omeprazole sodium. RESULTS： The contents had no significant de- crease after the combination of Omeprazole sodium for injection and 4 kinds of common solvents; the admixture showed clear and light yellow aider 4 h of combination with 5% GS, 10% GS and GNS; the admixture showed clear and achromatic color after com- bined with 0.9%NaC1 injection. The pH value had great influence on the stability, the lower the pH value, the worse the drug sta- bility and the faster the decomposition rate. CONCLUSIONS： When Omeprazole sodium for injection is used in clinic, the pH val- ue of solutions should be noticed to possibly avoid the combination with partial acidic and acidic solvents; the optimal solvent is 0.9 %NS injection. The admixture should be use up within 3 h when combined with 5 %GS, 10 %GS and GNS.