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篇名 |
台灣地區市售Cephalexin、Cefadroxil膠囊製劑之力價調查
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並列篇名 |
INVESTIGATION ON THE POTENCY OF CEPHALEXIN AND CEFADROXIL CAPSULES IN TAIWAN |
作者 |
鄭美釵、陳苾芬、邱進益、林嘉伯 |
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%。 |
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%). |
起訖頁 |
32-37 |
關鍵詞 |
賜福力欣、西華卓西、力價 |
刊名 |
藥物食品檢驗局調查研究年報 |
期數 |
1997 (15期) |
出版單位 |
衛生福利部食品藥物管理署
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該期刊-上一篇 |
大陸抗生素製劑鑑別及力價試驗之調查評估 |
該期刊-下一篇 |
針灸針生物學檢驗方法之建立 |
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