磺达肝癸钠注射液细菌内毒素检查方法的建立

目的:建立磺达肝癸钠注射液细菌内毒素的检查方法。方法:按2010年版《中国药典》版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无干扰质量浓度,并进行方法学验证。结果:样品稀释至质量浓度0.01 mg/ml(鲎试剂标示灵敏度为0.25 EU/ml)或0.005 mg/ml(鲎试剂标示灵敏度为0.125 EU/ml)时对细菌内毒素检查无干扰作用。结论:建立的方法可用于磺达肝癸钠注射液的细菌内毒素检查。

Establishment of Bacterial Endotoxin Test of Fondaparinux Sodium Injection

OBJECTIVE： To establish a method for bacterial endotoxin test of Fondaparinux sodium injection. METHODS： Maximal non-interference mass concentration of samples was determined by interference test according to appendix of Chinese Phar- macopeia （2010 edition）. RESULTS： The interference on bacterial endotoxin test can be excluded when sample was diluted to be- low 0.01 mg/ml [Tachypleus amebocyte lysate （TAL） ： λ=0.25 EU/ml] and 0.005 mg/ml （TAL： λ=0.125 EU/ml）. CONCLU- SIONS： The established method is feasible to detect the bacterial endotoxin of Fondaparinux sodium injection.