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藥物食品檢驗局調查研究年報
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中文摘要
本計畫於民國八十四年度（83年9月至84年3月），由北、高兩市及全 省各縣市抽購國產及進口二種頭孢子菌素類（Cephalosporin)抗生素製劑：賜福 力欣（Cephalexin)及西華卓西（Cefadroxil)之膠囊製劑共100件。其中賜福力欣 膠囊67件，國產66件涵蓋23家廠牌，進口 1件；西華卓西膠囊33件，國產 32件涵蓋10家廠牌，進口 1件。依據日本抗生物質醫藥品基準解説1993年版 (Minimum Requirements for Antibiotic Products of Japan，MRAP 1993)所載之高 效液相層析法（High Performance Liquid Chromatography)測定其力價，結果顯 示賜福力欣及西華卓西膠囊均符合藥典規定（90-120%)，合格率爲100%。
英文摘要
In an attempt to determine the quality of cephalosporin antibiotic capsules after the implementation of GMP，a total of 100 samples were purchased from Taiwan area in 1994. Among these samples 98 represented domestic products manufactured by 33 drug companies and the remaining 2 were imported and distributed by 2 comp-nies. 67 out of 100 samples were cephalexin while the remaining were cefadroxil. A high performance liquid chromatography (HPLC) method in MRAP 1993 was employed to test these samples. The results showed that all the samples met the potency requirement (90-120%).