摘要
目的:考察葛根素注射液细菌内毒素检查方法的可行性。方法:依据《中国药品检验标准操作规程》2000年版细菌内毒素检查法,确定葛根素注射液的有效稀释浓度和细菌内毒素限值。结果:葛根素注射液在最大有效稀释浓度下对鲎试剂无干扰作用,其内毒素限值符合规定。结论:可用细菌内毒素检查法取代《中国药典》2000年版(二部)规定的热原检查法。
Objective To investigate feasibility of bacterial endotoxins on puerarin injection. Methods The valid concentration of Puerarin injection and it＇s bacterial endotoxin limit were detrained by the principle of bacterial endotoxin test method. Results The experiment showed that the interfereneelements can be excluded by diluting Puerarin injection 2 times, it is effective and endotoxin can be tested by ameboeyte lysaly with aeeualy of 0.5Eu.ml-1.Conclusion Bacterial endotoxin test can be used to replace the pyrogen test which is set depsrtmental standard.
出处
《安徽卫生职业技术学院学报》
2005年第4期52-53,共2页
Journal of Anhui Health Vocational & Technical College
关键词
葛根素注射液
细菌内毒素
干扰试验
鲎试剂
puerarin injection
bacterial endotoxins
interference test
tachyleus ameboeyte lysate
