依托泊苷注射液细菌内毒素检查法的建立

Establishment of bacterial endotoxins test for etoposide injection

目的建立依托泊苷注射液的细菌内毒素检查法。方法按照《中国药典》2010年版二部附录ⅪE细菌内毒素检查法(凝胶法),用两个不同厂家的鲎试剂对3批依托泊苷注射液进行干扰试验和细菌内毒素检查。结果质量浓度为1.0mg/ml的依托泊苷注射液对鲎试剂与细菌内毒素之间的凝集反应有抑制现象,而质量浓度≤0.5 mg/ml的供试品溶液不干扰细菌内毒素检查。结论建立的依托泊苷注射液细菌内毒素检查法可行,样品的细菌内毒素限值为0.5 EU/mg。

Objective To establish a method for determining the bacterial endotoxins in etoposide injection.Methods The interference test and bacterial endotoxin test of 3 batches of etoposide injection were carried out according to the guideline and procedures specified in appendix Ⅺ E of Chinese Pharmacopoeia（2010 edition,volume 2） using tachypleus amebocyte lysates（TAL） produced by two manufactures.Results The agglutination reaction between tachypleus amebocyte lysate and bacterial endotoxins was inhibited by etoposide injection at the concentration of 1.0 mg/ml.However,this inhibition was eliminated at the concentration of no more than 0.5 mg/ml for the samples.Conclusion The established method of bacterial endotoxin test for etoposide injection is feasible and the limit of bacterial endotoxin for samples is 0.5 EU/mg.