市售Nalidixic Acid錠劑之溶離度品質調查

EVALUATION ON DISSOLUTION QUALITY OF NALIDIXIC ACID TABLETS FROM DOMESTIC MARKET

為明瞭現階段國產口服固體製劑之溶離度狀況，以配合優良藥品製造標準之推行，乃於73年4月分赴全省各縣市抽購NalidixicAcid錠劑50件，依照美國藥典第二十版所載方法進行檢體之溶離度試驗。結果發現，50件檢體中，僅有21件溶離度符合藥典規定，占全部檢體的42.0％。另加做檢體的崩散度、重量差異及含量測定三項檢驗。結果發現，50件檢體若照一般藥廠自定規格（不含溶離度試驗）判定，合格率可達82.0％；若按美國藥典第二十版所定規格（溶雜度試驗取代崩散度試驗）加以判定，則檢體之合格率僅38.0％。雖然中華藥典尚未收載該品，品質上顯見國內大部分藥廠均未注意到產品溶離度問題。 In order to understand the dissolution quality of the oral solid dosage form of domestic pharmaceutical products and the correlation of the dissolution quality with the implementation of GMP, fifty samples of Nalidixic Acid Tablets were taken from various location of domestic market and tested for dissolution, weight variation, disintegration, and assay using USP XX method. The results indicated that 42% of the samples passed the criteria of USP XX dissolution test, and only 38% of the samples met USP XX specifications if the results of weight variation test and assay were also taken into consideration. However, if the dissolution test is replaced by the disintegration test as in the case of current factory specifications, as high as 82% of the samples would have passed the tests. This figure, obviously, showed that importance of dissolution test for systemic oral solid dosage forms has been neglected by most of the domestic manufacturers. For upgrading the quality of domestic drug products, it is critically important for the Department of Health to advise pharmaceutical manufacturers to revise and update the standard and specifications for their products, and especially, to include dissolution test as the necessary criterion for systemic oral solid dosage forms, before the fourth edition of Chinese Pharmacopoeia is published.