注射用磷酸肌酸钠中细菌内毒素的检测

Detection of bacterial endotoxin in creatine phosphate sodium for injection

考察采用鲎试剂方法检测注射用磷酸肌酸钠中细菌内毒素的可行性.选择灵敏度为0.5 EU/mL的鲎试剂,通过对不同浓度的注射用磷酸肌酸钠供试品溶液进行细菌内毒素与鲎试剂之间凝集反应的干扰试验,结果显示:浓度为2.0 mg/mL的供试品溶液对鲎试剂与细菌内毒素之间的凝集反应既无抑制作用,也无增强作用。因此,使用鲎试剂方法检测注射用磷酸肌酸钠中细菌内毒素具有简便、快捷、可靠等优点.

The feasibility for detecting the bacterial endotoxin in creatine phosphate sodium for injection via tachypleus amebocyte lysate test was evaluated.Using the tachypleus amebocyte lysate with sensitivity of 0.5 EU/mL,the experiment was carried out to study the interference effect of sample＇s concentration on the congregating reactivity between tachypleus amebocyte lysate and bacterial endotoxin.The results showed that samples had no inhibitive or enhanced effect on the congregating reactivity when sample＇s concentration was 2.0 mg/mL,indicating that the method of tachypleus amebocyte lysate test for detecting the bacterial endotoxin in creatine phosphate sodium for injection is simple,rapid and reliable.