注射用泮托拉唑钠使用过程中质量稳定性的探讨

目的: 考察注射用泮托拉唑钠使用过程中质量稳定性。 方法: 用pH计法测定溶解和稀释后的泮托拉唑钠pH值的变化,同时测定溶液中不溶性微粒的变化及观察颜色的变化。 结果: 注射用泮托拉唑钠与0.9%氯化钠注射液溶解和稀释,5 h内溶液较稳定,用其他输液溶解和稀释溶液均不太稳定,不溶性微粒均有显著增加(P＜0.05)),pH有明显下降,颜色有加深的现象。 结论: 注射用泮托拉唑钠最好用0.9%氯化钠注射液溶解和稀释且即配即用。

Objective: To study of pantoprazole sodium for injection using the process of quality stability. Methods: Determination of pH-meter dissolved and diluted in pH value of pantoprazole sodium changes,simultaneous determination of insoluble particles in solution and to observe the changes in color change. Results: Pantoprazole sodium for injection with 0.9% sodium chloride injection dissolution and dilution,5 hours more stable solution,dissolved and diluted with other infusion solutions are not very stable,insoluble particles were significantly increased(P＜0.05)),pH values have decreased significantly,color deepening phenomenon. Conclusion: Pantoprazole sodium for injection is best to use 0.9% sodium chloride injection and that the dissolved and diluted with the use.