市售Cimetidine錠劑之溶離度試驗調查   全文下載

Investigation of Dissolution of Cimetidine Tablets from Domestic Market

為瞭解現階段市售Cimetidine錠劑之溶離度品質管制狀況，本局於民國八十六年十一月函請台灣省政府衛生處、台北市政府衛生局、高雄市政府衛生局協助抽取檢體共38件。依據中華藥典第四版所記載之規格及方法進行重量差異、鑑別、含量及溶離度試驗。試驗結果顯示重量差異、鑑別及含量均合於規定，溶離度試驗結果不合於規定者共3件，其不合格率為7.9%。

Thirty-eight samples of commercial Cimetidine tablets were collected by health authorities from local markets. All samples were evaluated on weight variation, identification, assay and dissolution according to Ch.p IV. Three samples failed to meet the requirement for dissolution test.