鲎试剂法检测间苯三酚注射液中的细菌内毒素

Test of bacterial endotoxin on phloroglucinol injection

目的建立间苯三酚注射液中细菌内毒素鲎试剂检查法。方法按《中国药典》2005年版二部“细菌内毒素检查法”进行干扰试验,考察确立间苯三酚注射液细菌内毒素检查法。结果间苯三酚注射液浓度为0.2 g.L-1时,对鲎试剂无增强抑制作用,其细菌内毒素限值为3.75 EU.mg-1。结论可用细菌内毒素检查法(凝胶法)代替家兔热原检查法。

Aim To establish a method for test of bacterial endotoxin on Phloroglucinol Injection. Methods The inhibitive action of phloroglucinol injection was studied by interfernece test. Results The injection did not interfere with tachypl EUs amebocyte lysate in the concentration diluted to 0.2 g · L^-1. The endotoxin limit of the injection is 3.75 EU· mg^-1. Conclusion Bacterial endotoxin test （gel-clot method） can be used as an alternative method for the rabbit pyrogen test for phloroglucinol injection.