注射用泮托拉唑钠的稳定性考察

目的:考察注射用泮托拉唑钠在4种输液中的稳定性。方法:采用高效液相色谱法测定注射用泮托拉唑钠与4种输液配伍 后在4h内的含量变化,并观察溶液外观;同时考察钾、镁、钙离子及pH值变化对注射用泮托拉唑钠稳定性的影响。结果:注射用泮 托拉唑钠在4种常用输液以及钾、镁、钙离子水溶液中于4h内其含量、外观、pH值、最大紫外吸收波长均无明显改变。溶液pH值 低于7．0时泮托拉唑钠极不稳定;pH值为7．0时,颜色可出现微黄变化,但含量降低不明显;溶液pH值在8．0以上时泮托拉唑钠 在4h内稳定。结论:注射用泮托拉唑钠在4种常用输液以及钾、镁、钙离子水溶液中于4h内可保持稳定,pH值对泮托拉唑钠溶液 的稳定性影响较大。

Study on the Stability of Injectable Pantoprazole Sodium

OBJECTIVE:To investigate the stability of injectable pantoprazole sodium in 4 kinds of infusions.METHODS: A HPLC method was adopted in this determination, the content change of injectable pantoprazole sodium was determined within 4 hours' mixing with 4 kinds of infusions and its change of color was observed; meanwhile the effects of pH value, potassium,magnesium,calcium ions on the stability of injectable pantoprazole sodium were investigated.RESULTS:No obvious changes were noted in terms of contents, appearances, pH value, UV - absorption maximum wavelength for the injectable pantoprazole sodium solution within 4 hours either in 4 kinds of common infusions or in potassium,magnesium,calcium ions water solutions.It was extremely unstable when pH value of pantoprazole sodium solution was lower than 7.0;when its pH value was 7.0, its color became yellowish yet without obvious loss of content; it is stable within 4h when its pH value was above 8.0.CONCLUSIONS:Injectable pantoprazole sodium remains stable within 4 hours either in 4 kinds of common infusions or in potassium, magnesium, calcium ions water solutions, the pH value has a great influence on the stability of pantoprazole sodium solution.