专利蓝Ⅴ号钠盐注射液细菌内毒素检查法的研究

Study on Bacterial Endotoxin Test for Patent Blue V Sodium Salt Injection

目的:建立肿瘤检测用药物专利蓝Ⅴ号钠盐注射液细菌内毒素检查方法。方法:按《中国药典》2015年版细菌内毒素检查法,对不同批号的样品进行干扰试验和细菌内毒素检查。结果:高浓度专利蓝Ⅴ号钠盐注射液对鲎试剂与细菌内毒素的凝集反应有干扰作用,在稀释120倍时可排除干扰。结论:本试验建立的细菌内毒素检查方法可用于专利蓝Ⅴ号钠盐注射液的细菌内毒素检查,控制其产品质量。

Objective： To establish a method of bacterial endotoxin test for tumors-detected drugs patent blueⅤ（PBⅤ） sodium salt injection. Methods： Interference test and bacterial endotoxin test of different batches of samples were carried out according to Chinese Pharmacopoeia（2015 edition）. Results： Agglutination interference to tachypleus amebocyte lysate（TAL） and bacterial endotoxin occurred at a high concentration of PB V sodium salt injection which was eliminated after being diluted to 120 times. Conclusion： The bacterial endotoxin test may be suitable for PBⅤ sodium salt injection to control its quality effectively.