【摘要】 根据中国药典2010年版(二部)附录ⅪE鲎试剂与细菌内毒素产生凝集反应的原理,对注射用二丁酰环磷腺苷钙中细菌内毒素的检测方法进行研究.选择灵敏度为0.5EU/mL的两个厂家生产的鲎试剂,对不同浓度的二丁酰环磷腺苷钙系列溶液进行干扰试验.试验结果表明浓度低于20mg/mL的二丁酰环磷腺苷钙溶液对凝集反应无干扰作用,高于供试品进行细菌内毒素检查所需的有效稀释浓度(0.2mg/mL).因此,鲎试剂方法可用于注射用二丁酰环磷腺苷钙中细菌内毒素的检测,细菌内毒素限值确定为2.5EU/mg.更多还原

【Abstract】 Bacterial endotoxins test for calcium dibutyryladenosine cyclophosphate for injection was studied based on the principle of congregating reaction between bacterial endotoxins and tachypleus amebocyte lysate specified in appendix Ⅺ E,volume two,Chinese pharmacopoeia 2010 edition.The interference tests for calcium dibutyryladenosine cyclophosphate at different concentrations were carried out using the tachypleus amebocyte lysate with the sensitivity of 0.5EU/mL produced by two manufacturers.The results showed that the samples had no interference effect on the congregating reactivity when its concentration was less than 20 mg/mL which was above the requisite effective concentration(0.2mg/mL)for bacterial endotoxins test,indicating that the method of tachypleus amebocyte lysate test for detecting the bacterial endotoxins in calcium dibutyryladenosine cyclophosphate for injection was feasible and the bacterial endotoxins limit was 2.5EU/mg.更多还原