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篇名 |
巿售Acetaminophen錠劑之溶離度試驗及其品質調查
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並列篇名 |
EVALUATION ON DISSOLUTION QUALITY OF COMMERCIAL ACETAMINOPHEN TABLETS |
作者 |
許淑纓、魏念慈、李鳳儀、徐廷光、莊清堯 |
中文摘要 |
為了解現階段市售口服固型製劑之溶離度管制狀況,於74年7月至75年6月抽購Acetaminophen錠劑132件,依據美國藥典廿一版所載方法予以檢驗重量差異、崩散度、含量測定及其溶離度,結果在132件檢體當中,溶離度不符合規定者21件,占15.9%顯見溶離度試驗尚未受到普遍的重視,有加強此項品質管制試驗的必要。 |
英文摘要 |
The hundred and thirty-two samples of commercial Acetaminophen Tablets were collected between July 1985 and June 1986. All samples were subjected to tests for dissolution、weight variation、disintegration and strength. We found that there were 21 samples unqualified (15.9%) in dissolution test. It reveals that dissolution test has not been popularly emphasized. Obviously, we have to put more stress on the said test for quality control purpose. |
起訖頁 |
43-46 |
關鍵詞 |
溶離度試驗、含量測定、紫外線分光光度法、Acetaminophen |
刊名 |
藥物食品檢驗局調查研究年報 |
期數 |
1988 (6期) |
出版單位 |
衛生福利部食品藥物管理署
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