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題名 | 臺灣地區市售Cephalexin、Cefadroxil膠囊製劑之力價調查=Investigation on the potency of Cephalexin and Cefadroxil Capsules in Taiwan |
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作者 | 鄭美釵; 陳苾芬; 邱進益; 林嘉伯; Cheng, Mei-chai; Chen, Pi-fen; Chiou, Jin-yi; Lin, Chia Po; |
期刊 | 藥物食品檢驗局調查研究年報 |
出版日期 | 19971100 |
卷期 | 15 1997.11[民86.11] |
頁次 | 頁32-37 |
分類號 | 418.4 |
語文 | chi |
關鍵詞 | 賜福力欣; 西華卓西; 力價; |
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 capstules 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%). |
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