頁籤選單縮合
題名 | 大陸抗生素製劑鑑別及力價試驗之調查評估=A Survey on the Quality of Antibiotic Injections Manufactured in Mainland China |
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作者 | 許鳳麟; 邱進益; 林嘉伯; Hsu, Fong-ling; Chiou, Jin-yi; Lin, Chia-op; |
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22-31 |
分類號 | 418.281 |
語文 | chi |
關鍵詞 | 大陸抗生素; 力價試驗; |
中文摘要 | 為加強國人對大陸藥品之認識,配合藥政管理之需要,針對大陸抗生素藥品品質 加以檢驗調查,本年度共計委託相關民間團體人員,前往大陸各省價購大陸抗生素注射劑檢 體27件,並依據美國藥典第22版及日本抗生物質醫藥品基準解說1990年版來進行鑑別及力價 之分析試驗。美中定性部份採用HPLC法,TLC法或呈色法,定量部份採用HPLC法或微生物試 驗法。其合格之判定標準是以檢體標誌含量之90%∼120%為合格範圍。其中2件含 Norvancomycin成分之檢體,因本局無法作鑑別及力價測定,故其結果不予判定外,其餘25 件檢體經檢驗結果皆符合規定。 |
英文摘要 | The aim of this survey is to assess the quality of antibiotic products manufactured in mainland China. Twenty-seven antibiotic injections including twelve antibiotic categories were tested for identification and potency using the methods in USP XXⅡ and MRAP (1990). Aside from two injection samples containing norvacomycin which were not tested due to lack of reference standard and proper testing method, the other twenty-five jnjection samples were found to meet identification and potency requirements (90∼120%). |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。