摘要
目的 :建立快速的甘草酸二铵注射液细菌内毒素检查法 ,替代热原检查法。方法 :用不同厂家的鲎试剂对不同批号的甘草酸二铵注射液分别进行干扰试验 ,考察确立甘草酸二铵注射液内毒素检查法。结果 :将甘草酸二铵注射液稀释 1 0倍以上可消除干扰作用 ,结果准确可靠。结论
Objetive:To establish a bacterial endotoxins test for diammonium glycyrrhizinate injection using limulus lysate reagent. Method:The maximum valid dilution(MVD) was obtained according to inhibition/enhancement test. Results and Conclusion: When the limulus lysate's sensitivity(λ) was 0.25Eu/ml,the maximum valid dilution was 1∶10,the interference between the sample and the relative TAL was eliminable. The result of bacterial endotoxins test was the same as that of pyrogen test using healthy mature rabbits.
出处
《广东药学院学报》
CAS
2002年第3期195-197,共3页
Academic Journal of Guangdong College of Pharmacy
关键词
甘草酸二铵注射液
细菌内毒素
鲎试剂
热原检查
diammonium glycyrrhizinate injection
bacterial endotoxins
limulus lysate reagent
