OBJECTIVE To study the bacterial endotoxins test of Renshen Duotang Injection using limulus lysate agent. METHODS To find the maximum valid dilution(MVD) according to inhibition test.RESULTS Using the especral limulus lysate agent, the bacterial endotoxins test is viable to replace the house rabit test.CONCLUSIONS When the limulus lysate's sensitivity(λ) is 0.5 EU·mL-1,the maximum valid dilution is 1∶25, the interference between the sample and the relative TAL is eliminable. And the result of bact erialendotoxins test is the same as that of pyrogen test with healthy mature rabbits.