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藥物食品檢驗局調查研究年報

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篇名 市售Piroxicam膠囊之溶離度試驗及其品質調查
卷期 6
並列篇名 Evaluation on Dissolution Quality of Piroxicam Capsules from Domestic Market
作者 林宗昌徐廷光莊清堯羅美顯
頁次 026-028
關鍵字 Piroxicam溶離度試驗含量測定高效液相層析法TSCI
出刊日期 198809

中文摘要

本調查於75年9月至12月自全省各縣市藥房抽購Piroxicam膠囊檢體五十件,依據USP XXI,Second Supplement溶離度試驗、含量測定之方法及ChP Ⅲ之內容量差異試驗之方法予以試驗判定。結果溶離度試驗不合格者十八件,不合格率佔36%,其中一件含量測定亦不合格(不合格率佔2%),內容量差異試驗均為合格。

英文摘要

Fifty samples of commercial piroxicam capsules were collected between September and December 1986. All samples were evalvated on weight variation dissolution and strength according to the methods described in the ChP Ⅲ and the USP XXI Second Supplement. All samples met weight varivation test. On the other hand, 18 samples failed to meet USP requirements for dissolution test, including one with assay result out of compendial limits.

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