注射用单磷酸阿糖腺苷细菌内毒素检查法的建立

目的:建立注射用单磷酸阿糖腺苷的细菌内毒素检查方法。方法:按照2010年版《中国药典》(二部)附录细菌内毒素检查法,采用2个厂家的鲎试剂对5个厂家的5批样品,通过预干扰和干扰试验确定样品最大无干扰质量浓度,并进行细菌内毒素检查。结果:将供试品溶液稀释至质量浓度为50 mg/ml时,不干扰细菌内毒素试验;确定其细菌内毒素限值为0.5 EU/mg。结论:采用细菌内毒素检查法检查注射用单磷酸阿糖腺苷中的细菌内毒素是可行的。

Establishment of Bacterial Endotoxin Test for Vidarabine Monophosphate for Injection

OBJECTIVE： To establish a method for the determination of bacterial endotoxin of Vidarabine monophosphate for injection. METHODS： According to bacterial endotoxin test stated in appendix II of Chinese Pharmacopeia （2010 edition）, maximal non-interference concentrations of 5 bacthes of samples from 5 manufacturers were determined by pre-interference test and inter- ference test, using TAL from 2 manufacturers. And bacterial endotoxin test was conducted. RESULTS： When test sample was diluted to 50 mg/ml, the limit of bacteria endotoxin was 0.5 EU/mg in non-interference bacteria endotoxin test. CONCLUSIONS： It is feasible to detect the bacterial endotoxin of Vidarabine monophosphate for injection by the method of bacterial endotoxin test.