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Ceftriaxone Sodium與Tenoxicam於5%葡萄糖靜脈注射輸送液中之化學安定性之研究

Chemical Stabilities of Ceftriaxone Sodium and Tenoxicam in 5% Dextrose Injection

摘要


本研究以高壓液相層析儀進行探討ceftriaxone sodium及tenoxicam於5%葡萄糖靜脈注射輸送液中之化學安定性。本研究以5%葡萄糖靜脈注射輸送液製備含ceftriaxone 5.0 mg/ml及tenoxicam 0.2mg/ml之靜脈注射混合液,且分別將檢品儲存於4℃及25℃不同條件下,於一定時間,分別取樣4ml,予以測定pH值及觀察外觀外,同時應用所發展之高壓液相層析儀安定性指示分析法對ceftriaxone 及tenoxicam進行含量測定。實驗結果顯示,ceftriaxone與tenoxicam之5%葡萄糖靜脈注射輸送液中於25℃之條件下僅可儲存2小時,然4℃之條件下則可儲存168小時以上。

並列摘要


The chemical stability of ceftriaxone sodium and tenoxicam in 5% dextrose injection was studied using a HPLC method.Ceftriaxone sodium and tenoxicam were reconstituted and diluted with 5% dextrose injection to form an admixture with a ceftriaxone concentration of 5.0 mg/ml and a tenoxicam concentration 0.2 mg/ml. Three containers were stored at 25℃. A 4ml sample was taken from each container at 2, 5, 10, 24, 48, 96 and 168 hours. A stability-indicating high-performance liquid chromatographic method was developed to determine drug concentration. Triplicate studies were done for each storage condition.No precipitation was observated in any sample at any time during the stability studies, but the color of the sample was turned to brown, in the sample for 24hours, at 25℃. More than 90% drugs were remained for 2 hours at 25℃ and 168 hours at 4℃.Under the condition of this study, ceftriaxone 5.0 mg/ml and tenoxicam 0.2 mg/ml in admixture in 5% dextrose injection are stable only 2 hours at 25℃ and 168 hours at 4℃.

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