大陸抗生素安全性之調查評估

EVALUATION OF THE SAFETY OF SEVERAL ANTIBIOTICS MANUFACTURED IN MAINLAND CHINA

抗生素係由各不同種、屬的微生物如黴苗、細菌及放射線菌等所分泌之化學物質或其代謝物，此等物質能殺死或抑制其他微生物之繁殖。除了療效外，抗生素亦會對人們直接或間接地產生毒性或不良影響，間接傷害的結果可能改變體內正常菌叢的生態平衡或引起過敏反應。本實驗條評估由大陸不同藥廠製造之26種抗生素的急性毒性。進行急性毒性試驗的方法有兩種，第一種為尾靜脈注射法，第二種為經口灌餵法，以尾靜脈注射法測試的9件抗生素顯示不具急性毒性，經口灌餵法測試的17件抗生素中有13 件抗生素不具急性口服毒性，其餘4件檢驗結果如下：經口灌餵紅黴素琥珀酸酯片（0.1g，北京新康製藥廠製造）溶液後，經過14 天的觀察後發現有1隻小鼠體重下降；灌餵交沙黴素片及頭孢氨苄片溶液後，於第1天即各有1隻小鼠死亡，而灌餵四環素溶液後則於第8天有1隻小鼠死亡，其餘小鼠無異常症狀，顯示以上4種抗生素似具有急性口服毒性。

Antibiotics are the chemicals or metabolites secreted by microorganisms such as fungi, bacteria and Actinomyces. These chemicals can kill or inhibit the proliferation of many microorganisms. In addition to their therapeutic effect, antibiotics may produce some adverse effects in man, either directly as toxicity or indirectly (Betina, 1983). Indirect harm may alternate the balance of normal microflora or induce allergic reactions. This study evaluated the safety of 26 antibiotics manufactured by different pharmaceutical companies on mainland China. Two methods of acute toxicity test were adopted. The first method was the tail vein injection tests. The second, the oral perfusion method. The nine antibiotics tested by tail vein injection method were safe. Thirteen antibiotics showed no oral toxicity. The body weight of one mouse decreased after it was given a solution of Tabellae erythromycin ethylsuccinatis by mouth during the 14 - day observation period. One mouse died on the second day after receiving a solution of Tabellae Josamycini and Tabellae Cefalexini respectively. On the eighth day after being given a solution of Tetracycline, one mouse died. These results show that the four antibiotics tested may be acutely orally toxic.