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

黃秋羽(Chiu-Yu Huang) ； 楊明玉(Ming-Yu Yang) ； 王博譽(Po-Yu Wang) ； 陳玉盆(Yu-Pen Chen) ； 闕麗卿(Lih-Ching Chiueh) ； 施養志(Daniel Yang-Chih Shih)

《食品藥物研究年報》 4期 (2013/11) Pp. 142-147

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。

關鍵字

心血管藥 ； 糖尿病 ； 尿路防腐劑 ； 口服劑型

並列摘要

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.

並列關鍵字

cardiotonics ； antidiabetic agents ； urinary tract antiseptics ； dipyridamole ； glimepiride ； nifedipine ； nitrofurantoin