CAJ | 학술논문

目的建立乌拉地尔注射液细菌内毒素检查方法.方法根据《中国药典2010年版二部》附录检验方法,用鲎试剂对乌拉地尔注射液进行干扰实验,确立乌拉地尔注射液细菌内毒素检查法.结果乌拉地尔注射液稀释浓度至0.2mg?ml-1后对鲎试剂无干扰作用,用标示灵敏度0.5EU?mL-1的鲎试剂检查实验有效.结论细菌内毒素检查法可用于检查乌拉地尔注射液中的内毒素.
목적건립오랍지이주사액세균내독소검사방법.방법근거《중국약전2010년판이부》부록검험방법,용후시제대오랍지이주사액진행간우실험,학립오랍지이주사액세균내독소검사법.결과오랍지이주사액희석농도지0.2mg?ml-1후대후시제무간우작용,용표시령민도0.5EU?mL-1적후시제검사실험유효.결론세균내독소검사법가용우검사오랍지이주사액중적내독소.
Objective To study the interference factors of BET for Urapidil Injection. Methods The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of China Pharmacopeia(second part,2010 Edition).By interfering test, the inhibition/enhancement action of Urapidil Injection was studied. Results 0.2mg?ml-1 solution of Urapidil Injection didn’t inhibit or enhance the test, and it was effective that endotoxin could be tested by amebocyte lysate with accuracy of 0.5EU?mL-1. Conclusion The Bacteria Endotoxin in Urapidil Injection can be determined with BET method.