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极微量细菌内毒素与鲎试剂发生特异性凝胶反应,其反应过程常因不同环境下诸多因素的影响,出现抑制或增强,导致实验结果失去真实性。复方枸橼酸钠注射液能否采用鲎试剂检测细菌内毒素,文献报道不一。我们根据中国药典(95版)附录项下原理和方法及中国医院制剂规范该品种热原检查项下规定,进行了兔注射量推导试验,证实该法可靠,报告如下。1 实验材料与仪器 鲎试剂(971127,灵敏度:λ_b=0.25EU·ml~(-1),每
A very small amount of bacterial endotoxin gel reagent occurs with a specific reaction, the reaction process often due to many factors under different circumstances, inhibition or enhancement, resulting in the loss of authenticity of experimental results. Compound sodium citrate injection can be used to detect bacterial endotoxin reagent, reported in the literature. According to the principles and methods of appendix of Chinese Pharmacopoeia (95th Edition) and the regulations of pyrogen test of the variety of Chinese hospital preparations, we carried out the inference test of rabbit’s injection quantity, and confirmed that this method is reliable. The report is as follows. 1 Experimental Materials and Instruments 鲎 reagent (971127, sensitivity: λ_b = 0.25EU · ml -1, each