帕拉米韦注射液细菌内毒素检查法的研究

Study on Bacterial Endotoxin Test for Peramivir Injection

目的:建立帕拉米韦注射液的细菌内毒素检查方法。方法:对3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 method of bacterial endotoxin test for Peramivir Injection. Methods： Different products of tachypleus amebocyte lysate（TAL） were used for the investigation of interference and bacterial endotoxin test on three batches of sample. Results： High concentration of Peramivir Injection disturbed the reaction between TAL and bacterial endotoxin, and the interference can be eliminated after certain dilution. Conclusion： Bacterial endotoxin test can be adopted for the quality control of Peramivir Injection.