维生素B_6注射液的细菌内霉素检查方法的探析

Vitamin B_6 injection of bacteria Analysis of inspection methods within the ADM

目的:根据实验建立用于维生素B6类注射液的细菌内霉素检测法。方法:采用两个厂家的6个批号的维生素B6类注射液样品分别与两个厂家的鲎试剂进行干扰实验,观察并确立该样品的细菌内霉素检查方法。结果:维生素B6注射液对细菌内霉素检查方法的干扰作用在浓度低于0.500mg/mL时消除。结论:细菌内霉素检查方法对于维生素B6注射液的细菌内霉素限定值为0.5EU/mg。

Objective： According to the experimental set up for the class of vitamin B6 injection of bacteria within the ADM assay. Methods： The two manufacturers of the six batches of vitamin B6 class injection samples were two manufacturers of LAL in the interference experiment, observe and establish the bacterial neomycin sample screening method. Results： Vitamin B6 injection of bacterial neomycin interference checking method when the concentration is lower than 0.500mg/mL eliminated. Conclusion： bacterial neomycin screening method for vitamin B6 injection of bacterial neomycin limit value 0.5EU/mg.