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注射用泮托拉唑钠的稳定性考察 被引量:32

Study on the Stability of Injectable Pantoprazole Sodium
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摘要 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。 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.
机构地区 山东省立医院
出处 《中国药房》 CAS CSCD 北大核心 2005年第21期1655-1657,共3页 China Pharmacy
关键词 注射用泮托拉唑钠 输液 PH值 离子 稳定性 Injectable pantoprazole sodium Infusion pH value Ion Stability
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参考文献1

  • 1Ekpe A,Jacobsen B.Effect of various salts on the stability of lansoprazole, omeprazole, and pantoprazole as determined by high-performance liquid chromatography[J ]. Drug Dev Ind Pharm, 1999,25(9): 1 057.

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