鲎试剂检测乌司他丁中细菌内毒素探讨

Determination of Endotoxin of Ulinastatin

根据中国药典 2 0 0 0版二部内毒素检查法 ,对不同批号的乌司他丁进行了细菌内毒素检测 ,并与家兔法进行了比较。

Ulinastatin is the second new drug that our company have developed and produced since 1999.The pyrogen of its final products was tested under national standards.But there were many middle products in the process and costed a lot of time to test pyrogen by rabbit test,can not do next step until the results came out.According to the ability of endotoxin to clot the LAL reagent,the possibility of BET were researched and compared with RT.