解熱鎮痛類藥品之品質監測

Surveillance on the Quality of Marketed Antipyretics and Analgesics Preparation in Taiwan

楊明玉(Ming-Yu Yang) ； 黃秋羽(Chiu-Yu Huang) ； 王博譽(Po-Yu Wang) ； 陳玉盆(Yu-Pen Chen) ； 羅吉方(Chi-Fang Lo)

《食品藥物研究年報》 2期 (2011/12) Pp. 249-253

https://doi.org/10.6945/ARFDR.201112.0251

摘要

99年度藥品品質監測計畫係以風險評估為原則，選定解熱鎮痛類藥品Aspirin及Ibuprofen成分口服之藥品進行監測。於1月至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31件，其中Aspirin成分者11件（國產9件，輸入2件）；Ibuprofen成分者20件（國產19件，輸入1件），檢驗項目參照中華藥典第6版進行鑑別、溶離度試驗、含量均一度試驗、含量測定及不純物相關項目等之檢驗。結果計2件含Aspirin成分製劑之游離水楊酸限度試驗不合格，其餘部分皆符合藥典規範。

關鍵字

解熱鎮痛類藥品 ； Aspirin ； Ibuprofen

並列摘要

In order to survey the quality of the marketed antipyretics and analgesics preparations in Taiwan area, a total of 31 samples, including aspirin and ibuprofen preparations, were acquired from different counties and cities in Taiwan from January to September in 2010. Samples were analyzed by the methods as described in the Ch. P. VI, with authorized specifications. The items of analysis included the appearance, average weight, identification, assay, dissolution, content uniformity, and the limit of free salicylic acid in aspirin preparations, or the limit of 4-isobutylacetophenone in ibuprofen preparations. The results indicated that two samples failed to meet the specification of the limit of free salicylic acid. Others met the compendia requirements for aspirin and ibuprofen.

並列關鍵字

antipyretics and analgesics preparations ； aspirin ； ibuprofen