八十三年度市售 Nalidixic acid錠劑之溶離度品質調查

INVESTIGATION OF DISSOLUTION OF NALIDIXIC ACID PREPARATIONS FROM THE DOMESTIC MARKET

本計劃於民國83年度由全省北中南各縣市之醫院、藥局、藥房抽購含Nalidixic acid成分製劑共31件檢體，依據United State Pharmacopeia XXII上所載之方法進行溶離度試驗，結果21件檢體合格（68%），10件檢體不合格（32%），10件不合格檢體中，2件為膠囊劑，8件為錠劑。該數據與73年測試該藥品溶離度試驗之品質調查不合格率62%相比，略有進步，本品雖未列入衛生署公告實施溶離度試驗之品目，但以實行GMP 12年的成果而言，今後國內製藥界似仍應加強改進對處方之研究開發。

Thirty-one samples of commercial nalidixic acid preparations (tablets and capsules) were purchased during july to December, 1993 on various area of Taiwan. All samples were evaluated on weight variation and by dissolution test, according to USP XXII. It was found that ten samples failed to meet that test's requirement.