目的:建立斑蝥酸钠维生素B6注射液的细菌内毒素检查方法。方法:按中国药典2005年版二部附录ⅪE细菌内毒素检查法进行,用不同厂家不同规格的鲎试剂对不同批号的斑蝥酸钠维生素B6注射液进行了干扰试验和细菌内毒素检查。结果:本品原液对细菌内毒素检查无干扰作用。按拟定标准检验,该品种6批样品细菌内毒素检查结果均符合规定。结论:本品可用细菌内毒素检查法代替家兔热原检查法,其细菌内毒素的限值(L)为6 EU.mL-1。 Objective: To establish a bacterial endotoxin test method of sodium cantharidate vitamin B6 injection. Methods: According to the bacterial endotoxin test of Appendix ⅡE of Chinese Pharmacopoeia 2005 edition, interference test and bacterial endotoxin test were carried out on different doses of sodium cantharidin vitamin B6 injection with different specifications of different manufacturers. Results: The original liquid of the bacterial endotoxin test without interference. According to the proposed standard test, the bacterial endotoxin test results of six batches of the samples all met the requirements. Conclusion: Bacterial endotoxin test can be used instead of pyrogen test in rabbits. The bacterial endotoxin limit (L) is 6 EU.mL-1.