鲎试剂方法检测异甘草酸镁注射液中细菌内毒素

Detection of bacterial endotoxins in magnesium isoglycyrrhizinate injection by tachypleus amebocyte lysate test

目的建立异甘草酸镁注射液的细菌内毒素检查法。方法按照中国药典2010年版二部附录ⅪE细菌内毒素检查法进行试验。结果异甘草酸镁注射液经30倍稀释后,用灵敏度λ为0.25 EU.mL-1的鲎试剂进行实验,供试品不干扰细菌内毒素检查。结论建立的异甘草酸镁注射液细菌内毒素检查法可行。

Objective To establish a method for the detection of bacterial endotoxins in magnesium isoglycyrrhizinate injection.Methods The experiment was carried out according to the guideline and procedure specified in Appendix Ⅺ E,Volume two,China Pharmacopoeia 2010.Results Tachypleus amebocyte lysate was used with the sensitivity of 0.25 EU·mL-1.The sample did not interfere with the bacterial endotoxins test when it was diluted 30 times.Conclusion The established method of tachypleus amebocyte lysate test for the detection of bacterial endotoxins in magnesium isoglycyrrhizinate injection is feasible.