【摘要】 目的　建立快速的香丹注射液细菌内毒素检查法 ,替代热原检查法。方法　用特异性鲎试剂对不同批号的香丹注射液分别进行干扰试验 ,考察确立香丹注射液内毒素检查法。结果　将香丹注射液稀释 4 0倍利用特异性鲎试剂检测可消除干扰作用 ,结果准确可靠。结论　选用特异性鲎试剂 ,细菌内毒素检查法代替香丹注射液热原检查是可行的更多还原

【Abstract】 OBJECTIVE To study the bacterial endotoxins test of Xiangdan injection using limulus lysate agent. METHOD To find the maximum valid dilution(MVD) according to inhibition/enhancement test.RESULTS When the differential limulus lysate′s sensitivity(λ) was 0.25Eu/mL,the maximum valid dilution was 1∶40, the interference between the sample and the relative TAL was eliminable. CONCLUSION Bacterial endotoxins test is the same as pyrogen test with healthy mature rabbits.更多还原