台灣地區市售Cefaclor、Cephradine膠囊製劑力價之調查

AN INVESTIGATION OF THE POTENCY OF CEPHRADINE AND CEFACLOR CAPSULES IN TAIWAN

本計畫於民國八十三年度（82年9月至83年3月），由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：西華定（Cephradine）及西華克樂（Cefaclor）之膠囊製劑共100件。其中西華定膠囊共70件，包括國產11家廠牌60件及進口3家廠牌10件；西華克樂膠囊30件則均為同廠牌之國產品。依據美國藥典第二十二版（The United States Pharmacopeia，USP XXII） 及日本抗生物質醫藥品基準解說1990年版（Minimum Requirements For Antibiotic Products of Japan，MRAP 1990）上所載之高效液相層析法（High Performance Liquid Chromatography）測定其力價，不合格者再以微生物法（Bioassay）檢驗，結果西華定有10件未符合公定書之合格標準（90-120%），不合格率為14.3%，西華克樂則均符合藥典規定，合格率100%。

In order to assess/ evaluate the potency of cephalosporin capsules, seventy cephradine capsules (60 domestic, 10 imported) and thirty cefaclor capsules (all domestic) were randomly purchased from different counties and cities in Taiwan from September 1993 to March 1994. All samples were assessed by HPLC and cylinder-plate methods as described in USP and MRAP. The results showed that the potency of 10 cephradine capsules (14.3%) failed to meet the Pharmacopeia requirements (90～120%).