標題: | Stability of Mometasone Furoate in a Cream Formulation Mometasone Furoate於乳膏中安定性之研究 |
作者: | Chun-Ren Chen K. C. Sung Jeng-Fen Huang Yi-Hsin Lin Su-Jong Chen |
貢獻者: | 藥學系 |
關鍵字: | Mometasone Furoate Cream Stability Shelf life Mometasone Furoate 乳膏 安定性 架儲期 |
日期: | 2004 |
上傳時間: | 2009-06-01 09:12:03 (UTC+8) |
摘要: | Stability of 0.1% w/w mometasone furoate in a cream formulation in aluminum tubes or plastic bottles was studied. The samples were stored at 25±2℃/60±5%RH condition and assayed at three months intervals for one year for long term stability testing. The samples were also stored at 40±2℃/75±5%RH condition and assayed at two month intervals for six
months for accelerated stability testing. A HPLC system with reverse phase column was used to assay the stability samples. The results were analyzed by the least squares linear regression and the lower 95% confidence intervals were also calculated. The shelf life of the cream formulation in either tubes or bottles is estimated over two years. 本研究旨在探討Mometasone Furoate在塑膠瓶裝及鋁質軟管裝乳膏劑中之藥品安定性及其架儲期之研究。本研究將不同包裝之Mometasone Furoate儲存在25±2℃/60±5%RH環境下一年,並在每三個月取樣一次來分析其藥品含量以評估其長期安定性。此外,本研究也將不同包裝之Mometasone Furoate在40±2℃/75±5%RH環境下儲存
6個月並每2個月取樣一次,以評估其加速安定性。所得到的含量數據以線性回歸及95%信賴區間之統計方式作分析,顯示Mometasone Furoate乳膏劑無論在塑膠瓶裝或鋁質管內皆具有超過兩年之藥品架儲期。 |
關聯: | 嘉南學報(科技類)30期:p.141-148 |
顯示於類別: | [嘉南學報] 30 期 (2004) [藥學系(所)] 期刊論文
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