茵栀黄注射液中细菌内毒素检查法的研究

Study on the Bacterial Endotoxin Test for Yinzhihuang Injection

目的建立茵栀黄注射液的细菌内毒素检查法。方法用不同厂家的鲎试剂对不同厂家不同批号的茵栀黄注射液分别进行干扰试验,考察确立茵栀黄注射液细菌内毒素检查方法。结果将茵栀黄注射液稀释40倍可消除干扰作用,结果准确可靠。结论细菌内毒素检查法用于茵栀黄注射液的内毒素检查是可行的。

Aim To study the bacterial endotoxin test of yinzhihuang injection using limulus lysate agent. Methods The maximum valid dilution（MVD） was found according to the inhibition/enhancement test. Results When the limulus lysate＇s sensitivity （ λ ） was 0.125 EU · ml ^- 1, and the maximum validity was 1 ： 40, the interference between the sample and the relative TAL could be eliminated. Conclusion The result of the bacterial endotoxins test was consistent with that of the pyrogen test with healthy mature rabbits.