甲硝唑注射液灭菌后混浊原因探讨

Study on the cause of turbidity in metronidazole injection after sterilization

甲硝唑注射液为抗厌氧菌的首选药物。1990年正式收载入中国药典的甲硝唑注射液,每100ml 含甲硝唑0.5g,并以适量氯化钠作等渗调节剂。我厂在生产250ml 规格注射液时,曾发现灭菌后偶有混浊现象,且混浊机率随灭菌温度升高及受热时间增加而增大。在配滤工序发现,滤机渗出的药液接触不锈钢材料时间较长后,

A phenomenon of turbidity in metronidazole injection might occasionally appears after sterilization.Study showed that thephenomenon to appear in the injection was attributed by the presence of iron ion,and the lowest limit of the ion concentrationwas about 0.6PPM.