頁籤選單縮合
題 名 | 卡巴氮平(Carbamazepine)製劑之品質調查=Investigation on the Quality of Marketed Carbamazepine Tablets in Taiwan Area |
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作 者 | 吳珍瑗; 岳宗漢; 蘇雅玲; 王博譽; 陳玉盆; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 3 2012.11[民101.11] |
頁 次 | 頁210-214 |
分類號 | 412.36 |
關鍵詞 | 溶離度試驗; 溶離度試驗第4型; 持效錠; Carbamazepine; CBZ; Dissolution test; Extended-release tablets; Quality; |
語 文 | 中文(Chinese) |
中文摘要 | Carbamazepine (CBZ)是治療癲癇與三叉神經痛的常用藥物,但易引起嚴重皮膚過敏不良反應(史蒂文生氏強生症候群/毒性表皮溶解症,Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis, SJS/TEN)。根據統計,88-100年藥害救濟給付案,carbamazepine高居排行榜第二名,然因該藥品之臨床效益仍高於其風險,為保障病人用藥安全,瞭解本成分錠劑之市售產品品質,委請各縣市衛生局於100年3至5月間,分別至進口之代理商或國內之製劑廠抽驗檢體,取得目前國內有生產或輸入之產品共7件檢體,依據原查驗登記核准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,有1件錠劑之溶離度試驗不符合原核准查驗登記之檢驗規格,其餘6件檢體均合格。 |
英文摘要 | Carbamazepine (CBZ) is the preferred agent for the treatment of triageminal neuralgia and seizure disorders. However, CBZ frequently causes cutaneous adverse drug reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In order to survey the quality of the marketed carbamazepine tablets in Taiwan area, 7 samples were collected from different counties and/or cities in Taiwan during March thru May 2011. Samples were analyzed by the previously approved analytical method. The result showed that 6 samples met the requirements. One sample failed to fulfill the dissolution test requirements. |
本系統中英文摘要資訊取自各篇刊載內容。