摘要
目的 :建立儿童用复方毛冬青注射液 (MCI)细菌内毒素检查的方法。方法 :根据MCI的实际临床用药 ,确定其内毒素限值 ;对MCI进行BET法的抑制增强试验和以及其与 2个厂家各 3个批号TAL(λ =0 .2 5EU/mL)的干扰试验。结果 :MCI的细菌内毒素限值定为 1 9.2 3EU/mL。MCI原液及其不大于 4 0倍的稀释液对BET法有抑制作用 ;其 5 0倍以上的稀释液对试验无干扰作用。 1 0批MCI应用BET法检查均为合格 ,并将其应用于儿科临床无任何不良反应。结论 :MCI可用BET法检查 ,作为其制剂质量控制标准之一。
Objective:To establish the method for determination of bacterial endotoxin in Maodongqing compound injection(MCI) for children.Methods:According to MCI clinical administration for children,it was used as the limit of the bacterial endotoxin for MCI. The inhibition and enhancement test was carried out with BET method and the interference test with tachypleus amebocyte lysate reagents (λ was 0.25EU/ml) manufactured by two different factories.Results:The maximum allowable limit of bacterial endotoxin in MCI for children was 19.23EU/ml. There were inhibition action in bacterial endotoxin test with <40-fold diluted liquid of MCI.It was proved that the maximum non-interference concentration was MCI 50-fold dilution.The inspection results are the same as that of children clinical administration without adverse reactions in ten different batches of MCI.Conclusion:MCI may be tested by BET as a quality control method.
出处
《广州医学院学报》
2003年第3期68-71,共4页
Academic Journal of Guangzhou Medical College
关键词
儿童用药
复方毛冬青注射液
细菌内毒素
限值
干扰试验
childrens medicine
Maodongqing compound injection(MCI)
limit
bacterial endotoxin
interference test
