【摘要】 目的对脉络宁注射液进行鲎试剂检查法实验,以替代热原检查,建立脉络宁注射液细菌内毒素检查法。方法利用不同厂家生产的鲎试剂对不同批号的脉络宁注射液进行干扰试验,全面考察脉络宁注射液对细菌内毒素检查的干扰作用,以确定其最大不干扰浓度及最佳试验浓度。结果试验证明脉络宁注射液20倍以上可消除干扰作用,为最佳试验浓度,检查结果全部为阴性,结果准确可靠。结论脉络宁注射液内毒素限值按2.5×103EU.L-1进行细菌内毒素检查,安全可靠,可以用鲎试剂检查法取代家兔热原检查法。更多还原

【Abstract】 Aim To establish the method of the limulus lysate agent in bacterial endotoxin test for mailuoning injection instead of pyrogen examination.Methods By interference test,the inhibition/enhancement action of mailuoning injection with limulus lysate agent was studied by using the reagent from the same and different factories in order to establish the maximum noninterference concentration and the best testing concentration.Results It was proved that the maximum noninterference concentration and the best testing concentration was 20 times diluted liquid.Conclusion The most suitable limit of bacterial endotoxin in mailuoning injection was 2.5×103 EU·L-1.This method for bacterial endotoxin test was accurate and reliable and can replace the pyrogen test.更多还原