頁籤選單縮合
| 題 名 | 市售降血脂用藥之品質監測=Surveillance on the Quality of Marketed Hypolipemic Preparations in Taiwan |
|---|---|
| 作 者 | 吳珍瑗; 陳玉盆; 呂理福; 黃明權; 鄒玫君; | 書刊名 | 藥物食品檢驗局調查研究年報 |
| 卷 期 | 26 2008.10[民97.10] |
| 頁 次 | 頁1-6 |
| 分類號 | 412.36 |
| 關鍵詞 | 降血脂用藥; Hypolipemic preparations; Gemfibrozil; Clofibrate; Bezafibrate; Simvastatin; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 民國96 年1月至6月間,由北、高兩市及各縣市衛生局,於醫院診所、藥局、藥廠及代理商抽驗市售檢體,抽得降血脂用藥中含Gemfibrozil 成分錠劑及其膠囊劑計20 件、含Clofibrate 成分膠囊劑計1件、含Bezafibrate 成分錠劑計6件, 含Simvastatin 成分錠劑計11 件,總共38 件,其中國產品31 件,輸入品7件。參照USP 26 版之檢驗規格方法或自行開發且經過確效之檢驗方法進行一般檢查(外觀及重量差異)、鑑別及含量測定等重點項目檢驗,結果均合格。本調查計畫之結果並提供藥政管理之參考。 |
| 英文摘要 | In order to survey the quality of the marketed hypolipemic preparations in Taiwan area, a total of 38 samples (gemfibrozil, clofibrate, bezafibrate and simvastatin capsules and tablets) were collected from different counties and cities in Taiwan during January thru June 2007. Samples were analyzed by the methods as described in the USP XXVI. The items of analysis include the appearance, components identifcation and assay. All samples fulfilled the compendial requirement for Gemfibrozil, Clofibrate, Bezafibrate and Simvastatin. |
本系統中英文摘要資訊取自各篇刊載內容。