丹红注射液中细菌内毒素定量检查研究

Quantitative Test of Bacterial Endotoxin in Danhong Injection

目的:通过对丹红注射液进行细菌内毒素回收干扰试验,建立定量检测丹红注射液中污染内毒素的试验方法.方法:采用<中国药典2000年版>二部附录中检测细菌内毒素的动态浊度法.结果:丹红注射液用细菌内毒素定量检测无干扰因素影响,内毒素回收率在(50～200)%范围内.结论:使用细菌内毒素动态浊度法定量检测丹红注射液中的污染内毒素是可行的,可用细菌内毒素定量检查法代替家兔热原检查法.

Objective： To establish a quantitatwe test method tor enaotoyan m Dannong injecuon by recovery and interference test. Methods： The test was performed by the Turbidimetric - kinetic method that had been given by The Chinese Pharmacopoeia （Edition 2000）. Results： There was no interference factor in the Danhong injection through the Turbidimetric - kinetic method and the endotoxin recovery rate was 50 % - 200%. Conclusion ： The Turbidimetric - kinetic method is feasible for endotoxin detection in Danhong injection and is better than the rabbit pyrogen test.