左旋奥拉西坦注射液细菌内毒素检查方法的研究

Study on Bacterial Endotoxins Test for L-Oxiracetam Injection

目的:建立左旋奥拉西坦注射液的细菌内毒素检查方法。方法:按中国药典2015年版四部通则1143细菌内毒素检查凝胶法,使用2个不同厂家的鲎试剂对3个批号的左旋奥拉西坦注射液进行了细菌内毒素检查法的方法学研究。结果:样品浓度稀释至8.3 mg·ml^(-1)时,可排除干扰作用。结论:左旋奥拉西坦注射液可适用细菌内毒素检查法,其内毒素限值确定为3 EU·ml^(-1)。

Objective： To establish a bacterial endotoxins testing method for L-oxiracetam injection. Methods： According to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia （2015 edition, volume Ⅳ, general rule 1143 ）, tachypleus amebocyte lysate （TAL） from two different manufacturers were used for bacterial endotoxins test on 3 batches of L-oxiracetam injection with methodology studies. Results： Diluted to 8.3 mg . ml - 1, the samples showed no interference a- gainst the bacterial endotoxins test. Conclusion： The bacterial endotoxins test method for L-oxiracetam injection is applicable with the endotoxin limit of 3 EU .ml-1.