脂溶性维生素注射液细菌内毒素的检查方法

Study of Bacterial Endotoxin Test for Liposoluble Vitamin Injection

脂溶性维生素注射液的细菌内毒素检查法,收载于卫生部药品标准中(1996年),其限值为L≤1Eu·ml^(-1)。然而,试验中发现,该产品对一些厂生产的鲎试剂有很强的干扰作用,无法测定其细菌内毒素。通过试验,确定了二个厂生产的鲎试剂对其作细菌内毒素检查。

The method of bacterial endotoxin test for liposoluble Vitamin injection has been developed in the Drug standard (1996)by Ministry of Health PRC.however the results of the test were greatly interfered by different TAL regents. Through the study, TAL reagents of 5 sources were examined,and only two factorie's TAL regents are sure to conduct the test successfully.