台灣地區市售Cephalexin、Cefadroxil膠囊製劑之力價調查

INVESTIGATION ON THE POTENCY OF CEPHALEXIN AND CEFADROXIL CAPSULES IN TAIWAN

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說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%），合格率為100%。

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%).