特异性鲎试剂检查生脉注射液细菌内毒素

Detection of bacterial endotoxins of Shengmai injection with TAL ES-TEST

目的建立生脉注射液的细菌内毒素检查方法,以控制药品质量。方法按中国药典2000年版二部检查法,考察生脉注射液对细菌内毒素检查法的干扰。结果确定生脉注射液细菌内毒素限值为3.75EU/mL,最佳检测条件为供试品稀释10倍,特异性鲎试剂灵敏度为0.25EU/mL。结论用特异性鲎试剂检查生脉注射液细菌内毒素,方法简便、灵敏、准确、重现性好,可替代家兔法用于生脉注射液的热原检查。

OBJECTIVE To establish a method for the test of bacterial endotoxins in order to replace the test for pyrogen in Shengmai injection, METHODS The inhibition and enhancement test were carried out by tachypleus amebocyte lysate ES-Test according to the bacteria endotoxin content by Chinese Pharmacopoeia （2000）. RESULTS The bacterial endotoxins limit value of Shengmai injection was 3.75EU/mL and the experiment showed that the interference elements could be excluded by diluting Shengmai injection 10 times, CONCLUSION The method is convenient,sensitive,accurate and can replaces the pyrogen test of Shengmai injection.