注射用氨磷汀细菌内毒素检查方法的建立

Establishment of Bacterial Endotoxin Test of Amifostine for Injection

目的:建立注射用氨磷汀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,通过预干扰和干扰试验确定样品最大无干扰浓度,并进行方法学验证。结果:样品稀释至5.00 mg/ml时对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查注射用氨磷汀的细菌内毒素可行。

OBJECTIVE： To establish a method for bacterial endotoxin test of Amifostine for injection. METHODS： Maximal non-interference concentrations of samples were determined by pre-interferenee test and interference test according to the appendix of Chinese Pharmacopiea （2010 edition）. And then methodology validation was conducted. RESULTS： The interference on bacteri- al endotoxin test can be excluded when the sample was diluted to below 5.00 mg/ml. CONCLUSIONS： The established method is feasible to detect the bacterial endotoxin of Amifostine for injection.