摘要
目的:建立注射用比阿培南的细菌内毒素检查法。方法:按照《中国药典》2005年版二部附录X I E中细菌内毒素检查法,使用两个厂家的的鲎试剂对注射用比阿培南进行干扰试验。结果:注射用比阿培南对细菌内毒素检查无干扰作用。结论:注射用比阿培南可以用细菌内毒素检查法代替兔热原检查法。
Objective：To develop the bacterial endotoxin test of biapenem for injection. Method： According to the bacterial endotoxin test in China Pharmacopoeia （2005, volume Ⅱ, Appendix XI E） , using the tachypleus a- mebocyte lysate produced by two factories to do interference test of biapenem for injection. Result： Biapenem for injection will never interfer with the bacterial endotoxin test. Conclusion ： The bacterial endotoxin test is feasible for the quality control of biapenem for injection.
出处
《药学与临床研究》
2007年第5期427-429,共3页
Pharmaceutical and Clinical Research
关键词
注射用比阿培南
细菌内毒素
鲎试剂
干扰试验
Biapenem for injection
Bacterial endotoxin
Limulus lysate
Interference test
