摘要
目的:建立快速的红花注射液细菌内毒素检查法来替代热原检查法。方法:用不同厂家的鲎试剂对不同批号的红花注射液分别进行干扰试验,考察确立红花注射液内毒素检查法。结果:将红花注射液稀释40倍可消除干扰作用,结果准确可靠。结论:利用细菌内毒素检查法代替红花注射液热原检查是可行的。
Objectives: To establsih a bacetrial endotoxins test of Honghua injection instead of limulus lysate test. Method: To explore the maximum valid dilution(MVD)according to inhibition/enhancement test. Results; When the limulus lysates sensitivity(λ) was 0.06 EU ml-1, the maximum valid dilution was 1:40, the interference between the sample and the relative TAL was able to eliminated. The bacterial endotoxin test for Honghua injection instead of limulus lysate test is feasible.
出处
《中国药师》
CAS
2002年第8期476-477,共2页
China Pharmacist
