摘要
目的:建立肾必氨注射液细菌内毒素鲎试剂检查法。方法:用不同厂家的鲎试剂对不同批号的肾必氨注射液分别进行干扰试验,考察肾必氨注射液细菌内毒素检查的影响因素。结果:肾必氨注射液稀释2倍后,不干扰鲎试剂与细菌内毒素的凝集反应。结论:肾必氨注射液可以用鲎试剂检查法取代家兔热原检查法。
Objective:To study the bacterial endotoxins test for shenbi'an injection using limulus lysate agent.Methods:By interfering test,the inhibition/enhancement action of amino acid with limulus lysate agent was studied.Results:There was not interference between the sample and the relative TAL when the sample is diluted below 1 ∶2.Conclusion:The result of bacterial endotoxins test is the same as that of pyrogen test with healthy mature rabbits.
出处
《中国药业》
CAS
2004年第12期40-41,共2页
China Pharmaceuticals
