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

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。

The aim of this survey is to assess the quality of antibiotic products manufactured in mainland China. Twentyseven 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%).