替尼泊苷注射液细菌内毒素检查方法的建立

Establishment of Method for Bacterial Endotoxin Test of Teniposide Injection

目的:建立替尼泊苷注射液细菌内毒素的检查方法。方法:按2010年版《中国药典》附录细菌内毒素凝胶检查法的要求,通过干扰试验确定样品最大不干扰质量浓度,并进行方法学验证。结果:样品稀释至质量浓度0.02 mg/ml(λ=0.25 EU/ml)或0.01mg/ml(λ=0.125 EU/ml)以下时对细菌内毒素检查法无干扰作用。结论:所建立的方法可用于替尼泊苷注射液的细菌内毒素检查。

OBJECTIVE：To establish a method for bacterial endotoxin test of Teniposide injection. METHODS：Maximum noninterference concentration of sample was determined by interference test according to bacterial endotoxins gel-clot test stated in the appendix of Chinese Pharmacopeia（2010 edition）. And then methodology validation was conducted. RESULTS：The interference on bacterial endotoxin test can be excluded when sample was diluted to below 0.02 mg/ml（λ =0.25 EU/ml）or 0.01 mg/ml（λ=0.125 EU/ml）. CONCLUSIONS：The established method is feasible to detect the bacterial endotoxin of Teniposide injection.