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題 名 | 101年度心血管藥、降血糖藥及尿路防腐劑等口服劑型之品質監測=Surveillance on the Quality of Marketed Cardiotonics, Antidiabetic Agents and Urinary Tract Antiseptics Oral Dosage Form Preparations in Taiwan |
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作 者 | 黃秋羽; 楊明玉; 王博譽; 陳玉盆; 闕麗卿; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 4 2013.11[民102.11] |
頁 次 | 頁142-147 |
分類號 | 412.36 |
關鍵詞 | 心血管藥; 糖尿病; 尿路防腐劑; 口服劑型; Dipyridamole; Glimepiride; Nifedipine; Nitrofurantoin; Nitrofurazone; Urinary tract antiseptics; Cardiotonics; Antidiabetic agents; |
語 文 | 中文(Chinese) |
中文摘要 | 101年度藥品品質監測計畫係以風險評估為原則,參考國內外不良品回收事件不合格率較高、生產過程易產生類緣化合物 /分解物及慢性病患長期使用之藥品等因子,選定心血管藥 (含dipyridamole及nifedipine成分 )、糖尿病 (含glimepiride成分 )及尿路防腐劑 (含 nitrofurantoin成分 )等口服劑型之市售品進行藥品品質監測,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、藥商及製藥廠抽驗市售檢體共 83件(國產 65件,輸入 18件),參照藥典之規範及原核准之檢驗規格與方法,進行鑑別、溶離度、含量均一度、含量測定及類緣化合物相關項目等之檢驗。總計 83件檢體中 3件不合格,分別為含 dipyridamole成分之溶離度試驗 1件不合格,含 nifedipine成分之溶離度試驗 2件不合格。另含 nitrofurantoin成分之製劑有 2件不符合中華藥典第 7版nitrofurazone限度試驗之檢驗規格。 |
英文摘要 | In order to survey the quality of the marketed cardiotonics, antidiabetic agents and urinary tract antiseptics oral dosage form preparations in Taiwan area, a total of 83 samples of dipyridamole/glimepiride/ nifedipine/nitrofurantoin preparations were acquired from different counties and cities in Taiwan from January to September in 2012. Samples were analyzed by the methods as described in the CHP 7 or USP 34 with authorized specifications. The analytical items included the appearance, average weight, identifcation, assay, dissolution, content uniformity, and percentage of related compounds. The results showed that 3 samples (3.6%) failed to meet the specification of dissolution and 2 samples (2.4%) failed to meet the specification of limit of nitrofurazone. Others met the compendia requirements. |
本系統中英文摘要資訊取自各篇刊載內容。