九十九年市售苯甲香豆醇鈉錠劑品質調查

Investigation on the Quality of Marketed Warfarin Sodium Tablets in Taiwan Area

10.6945/ARFDR.201112.0239

范孟棋(Meng-Chi Fan)；王博譽(Po-Yu Wang)；陳玉盆(Yu-Pen Chen)；羅吉方(Chi-Fang Lo)

苯甲香豆醇鈉 ； 檢驗 ； warfarin sodium ； analysis

食品藥物研究年報

2期（2011 / 12 / 08）

237 - 242

繁體中文

苯甲香豆醇鈉（Warfarin sodium），為心血管病患使用之抗凝血劑，屬於治療指數狹窄之藥品，為瞭解市售產品之品質，本計畫選定含苯甲香豆醇鈉（Warfarin sodium）主成分之製劑（錠劑），委由各縣市衛生局於99年4月至9月間分別至轄區之進口代理商及國內之製藥廠抽驗檢體，取得目前國內生產及輸入之產品共6件檢體，依據中華藥典第六版之檢驗規格及方法進行鑑別、溶離度試驗、含量均一度及含量測定等項目之檢驗，檢驗結果6件檢體之品質均符合藥典規定。

In order to survey the quality of the marketed warfarin tablets in Taiwan area, a total of 6 samples were collected from different counties and cities in Taiwan during April thru September 2010. Samples were analyzed by the methods as described in the CHP 6(superscript th) ed. The items of analysis included components identification, dissolution test, content uniformity and assay. All samples met the compendia requirement for warfarin tablets.