大陸抗生素安全性之調查評估——第二報

EVALUATION OF THE SAFETY OF SEVERAL ANTffiiOTICS MANUFACTURED IN MAINLAND CHINA -- THE SECOND REPORT

為配合行政院「加強消費者藥物食品檢驗及資訊服務」行政革新方案，乃加強對大陸藥品品質調查，本年度共計委託民間學術團體赴大陸地區價購27件大陸抗生素，並已完成檢驗。本實驗係評估由大陸不同藥廠製造之27種抗生素的急性毒性，其中注射液有8件，乾粉注射劑有19件，以小鼠尾靜脈注射法測試的27件抗生素，經過14天觀察，偶有發現試驗動物體重有稍微下降之現象，但隨後又恢復正常生長，因此顯示這27件抗生素無急性毒性，最後將檢驗結果整理，評估這些抗生素的品質以供現階段藥物行政管理單位之參考。

Twenty-seven antibiotics manufactured by different pharmaceutical companies in mainland China were tested for their acute toxicity. Eight antibiotics were man factured in solution form and the remainder m powdered form. Tail vein injection of mice was used as the route of administration. During fourteen days of subsequent observation, the body weight of only several animals declined at first but rapidly recovered. The growth curves of all experimental mice were normal and indicated no acute toxicity from the antibiotics studies.