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《中国药典》(1995年版)收载了鲎试剂细菌内毒素检查法,对控制药品质量起到了重要作用。为扩大应用范围,作者对鲎试剂直接测定复方氯化钠注射液中细菌内毒素可能性进行了研究。报告如下: 1.试验材料 鲎试剂,批号970515、971230,λ_b=0.5Eu/ml,每支0.1ml;批号9712130,λ_b=0.5Eu/ml,每支0.1ml;批号971210,λ_b=0.25Eu/ml,每支0.1ml,细菌内毒素工作品;批号970425,10Eu/支。细菌内毒素检查用水,批号970720,2ml/支。以上均由厦门鲎试剂厂生产。
The Chinese Pharmacopoeia (1995 Edition) contains a test kit for bacterial endotoxin, which plays an important role in controlling the quality of medicines. To broaden the range of applications, the authors have investigated the possibility of direct determination of bacterial endotoxins in the compound sodium chloride injection by tocopherol. The report is as follows: 1. Test Materials 鲎 Reagents, batch numbers 970515,971230, lambda_b = 0.5Eu / ml, each 0.1ml; Lot 9712130, lambda_b = 0.5Eu / ml, each 0.1ml; Lot 971210, lambda_b = 0.25Eu / ml, each 0.1ml, bacterial endotoxin works; batch number 970425,10Eu / support. Bacterial endotoxin test water, lot number 970720, 2ml / support. These are all produced by Xiamen Luan Reagent Factory.