文章詳目資料
藥物食品檢驗局調查研究年報
加入收藏
下載文章
中文摘要
爲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版及曰本抗生物質醫藥品 基準解説1990年版來進行鑑别及力價之分析試驗。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 標準是以檢體標德含量之90%〜120%爲合格範圍。其中2件含NORVANCOMYCIN成分之檢體，因本局無法作鑑别及力價測定，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 norvancomycin which were not tested due to lack of reference standard and proper testing method, the other twenty-five jnjection samples were found to meet identifcation and potency requirements (90-120%).