斑蝥酸钠维生素B_6注射液细菌内毒素检查法研究

Study on bacterial endotoxins test of disodium cantharidinate and vitamin B_6 injection

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 method for determination of the bacterial endotoxin test in disodium cantharidinate and vitamin B6 injection. Methods： Inhibition and bacterial endotoxin test was performed with amebcyte lysate manufactured by different companies with different specifications according to the method of bacterial endotoxin test approved by Chinese Pharmacopoeia 2005 edition. Results： The original solution had non-interference with the bacterial endotoxin test.The results of bacteria endotoxin test in six batchs all accorded with the standard of the quality control. Conclusion： The results suggested that bacteria endotoxin test can be used as an alternative method for the rabbit pyrogen test for disodium cantharidinate and vitamin B6 injection. The limits of bacterial endotoxin was 6EU·mg^–1.