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 。
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.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2004年第5期390-392,共3页
Chinese Journal of Modern Applied Pharmacy
