市售Cimetidine製劑之溶離度試驗調查

INVESTIGATION ON DISSOLUTION QUALITY OF CIMETIDINE TABLETS FROM DOMESTIC MARKET

衛生署於78年2月頒發公告，增列Cimetidine為必需實施溶離度試驗藥物之一，本組於78年11月下旬起分批赴北、中、南各縣市抽購市售Cimetidine製劑30件，依美國藥典第廿二版所載方法，進行檢驗。結果30件製劑檢體中，不符合美國藥典規定者5件，其不合格率達16.7%。

Thirty samples of commercial Cime-tidine tablets were purchased between November 1989 and January 1990 around Taiwan area. All samples were evaluatedon weight variation and Dissolution according to USP XXII. Only one sample didn't meet Weight Variation Test, 5 samples failed to meet USP requirement for Dissolution test.