氟尿嘧啶氯化钠注射液细菌内毒素的检测

Determination of Bacterial endotoxin in Fliorouracil Sodium Chloride Injection

目的 确立氟尿嘧啶氯化钠注射液热原检测方法。方法 以细菌内毒素检查法(鲎试剂法)对氟尿嘧啶氯化钠注射液进行热原检测,确定了细菌内毒素限值及样品的有效稀释倍数。结果 细菌内毒素限值为每毫升含内毒素应小于0.6EU;样品的有效稀释倍数为2.4～20倍,即样品按1∶2.4浓度稀释的供试液对细菌内毒素检查法没有干扰作用。结论

Objective To establish the determination method of Bacterial endotoxin in Fliorouracil Sodium Chloride Injection.Methods Pyrogen in Fliorouracil Sodium Chloride Injection was examined by Bacterial endotoxin test (Tachypleus Ameboyte Lysatesolvent test). The limit of Bacterial endotoxin and dilution times of sample were determinated. Results The limit of Bacterialendotoxin should be lower than 0.6EU·m-l, and MVD was 2.4～20, ie the sample could be diluted 2.4 times without confusion.Conclusion This method was accurate and suitable for Bacterial endotoxin test.