维生素K1注射液细菌内毒素检查方法的研究

Study on Bacterial Endotoxins Test for Vitamin K1 Injection

目的:建立维生素K1注射液的细菌内毒素检查方法。方法:对两个生产厂家的5批样品,采用不同厂家和不同规格的鲎试剂(TAL),进行了干扰试验和细菌内毒素检查。结果:本品高浓度对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可以排除。结论:本品可采用细菌内毒素检查法控制质量。

Objective：To establish a test method of bacterial endotoxins for Vitamin K1 Injection. Methods：Different products of tachypleus amebocyte lysate（TAL） were used for the investigation of disturbing and bacterial endotoxin test on five groups of sample from two factories. Results：At high concentration Vitamin K1 Injection disturbed the reaction of TAL and bacterial endotoxin,and the interference can be eliminated after dilution. Conclusion ：Bacterial endotoxin test can be adopted for quality control of Vitamin K1 Injection.