复方二氯醋酸二异丙胺注射液的细菌内毒素检查法研究

目的:建立复方二氯醋酸二异丙胺注射液的细菌内毒素检查方法。方法:按2010年版《中国药典》(二部)附录细菌内毒素检查法,采用2个厂家不同规格的鲎试剂对4个厂家7批样品进行干扰试验和细菌内毒素检查。结果:本品原液稀释2倍以上时对细菌内毒素检查法无干扰作用;按拟定标准,4个厂家7批样品均符合规定。结论:采用本文建立的细菌内毒素检查法检查复方二氯醋酸二异丙胺注射液方法可行,其细菌内毒素的限值确定为0.5 EU/ml。

Study on Bacterial Endotoxins Test of Compound Diisopropylamine Dichloroacetate Injection

OBJECTIVE： To establish a method for bacterial endotoxin test of Compound diisopropylamine dichloroacetate in- jection. METHODS： According to the bacterial endotoxin test stated in Chinese Pharmacopeia （2010 edition） II , interference test and bacterial endotoxin test were carried out by using tachypleus amebocyte lysate （TAL） with different specifications from 2 manu- facturers for 7 bacthes of Compound diisopropylamine ascorbate injection from 4 manufacturers. RESULTS： No interference was found in the bacterial endotoxin test after the sample was diluted over 2-fold. The results of bacterial endotoxin test of 7 bacthes from 4 manufacturers were all accorded with the standard of the quality control. CONCLUSIONS： Established method is feasible for quality control of Compound diisopropylamine dichloroacetate injection. The endotoxin limit of it is 0.5 EU/ml.