- 期刊
心血管用藥（amlodipine besylate）之品質監測
Surveillance on the Quality of Marketed Cardiotonics Preparation in Taiwan
摘要
99年度藥品品質監測計畫係以風險評估為原則，選定心血管用藥amlodipine besylate成分之口服藥品進行監測，並於1至9月間委由全國各縣市衛生局，前往轄區內醫院、診所、藥局、製藥廠及代理商抽驗市售檢體共27件（國產22件，輸入5件），檢驗項目參照美國藥典第34版之檢驗規格及方法，進行溶離度試驗、含量均一度試驗、含量測定及有機雜質檢查等之檢驗。結果計2件不符合美國藥典第34版有機雜質檢查之規範，其餘部分皆符合藥典規範。
並列摘要
In order to survey the quality of the marketed cardiotonics preparations in Taiwan area, a total of 27 samples of amlodipine besylate cardiac vessel drug preparations were acquired from different counties and cities in Taiwan from January to September 2010. Samples were analyzed by the methods as described in the USP 34 with authorized specifications. The items of analysis included the appearance, average weight, identifcation, assay, dissolution, content uniformity, and percentage of organic impurity. The results showed that two samples (7.4%) failed to meet the specification of organic impurity. Others met the compendia requirements for amlodipine besylate.
延伸閱讀
- 吳珍瑗、陳玉盆、呂理福、黃明權、鄒玫君（2008）。市售降血脂用藥之品質監測。藥物食品檢驗局調查研究年報，()，1-6。https://doi.org/10.6946/ASRNL.200812.0001
- 黃秋羽、吳珍瑗、張淑涵、張靜嘉、林美智、陳玉盆、王德原、周秀冠、陳惠芳（2017）。105年度心血管用藥(Atenolol)、解熱鎮痛藥品藥(Atenolol)及抗生素(Rifampin)等製劑之品質監測。食品藥物研究年報，(8)，87-93。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201711-201801120009-201801120009-87-93
- 許富雄（2011）。探討血管加壓素受體阻斷劑類抗高血壓藥與心肌梗塞相關性之研究〔碩士論文，高雄醫學大學〕。華藝線上圖書館。https://www.airitilibrary.com/Article/Detail?DocID=U0011-2508201116053400
- （2007）。心臟血管疾病用藥問答。人醫心傳－慈濟醫療人文月刊，(38)，68-70。https://doi.org/10.30151/MH.200702.0022
- 黃水坤（2000）。Special Consideration on the Implementation of Primary Care Medicine in Taiwan。Journal of Medical Education，4(3)，368-374。https://doi.org/10.6145/jme.200009_4(3).0011