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頁籤選單縮合
題名 | Stability of Mometasone Furoate in a Cream Formulation=Mometasone Furoate於乳膏中安定性之研究 |
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作者 | 陳俊仁; 宋國峻; 黃正芬; 林意馨; 陳素容; Chen, Chun-ren; Sung, K. C.; Huang, Jeng-fen; Lin, Yi-hsin; Chen, Su-jong; |
期刊 | 嘉南學報. 科技類 |
出版日期 | 20041200 |
卷期 | 30 民93.12 |
頁次 | 頁141-148 |
分類號 | 418.1 |
語文 | eng |
關鍵詞 | 乳膏; 安定性; 架儲期; Mometasone furoate; Cream; Stability; Shelf life; |
中文摘要 | 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。 |
英文摘要 | 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 stroed 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. |
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