复方甘草甜素氯化钠注射液的细菌内毒素检查

Study of bacterial endotoxin test for Compound Glycyrrhizin and Sodium Chloride Injection

目的探讨复方甘草甜素氯化钠注射液中细菌内毒素的检查方法。方法选择一定灵敏度的鲎试剂考察复方甘草甜素氯化钠注射液对细菌内毒素检查的干扰作用。结果复方甘草甜素氯化钠注射液对细菌内毒素反应有干扰,将其稀释成1∶8的浓度可消除其干扰作用。结论在1∶8的稀释度下,可用灵敏度为0.25EU.mL-1的鲎试剂进行细菌内毒素检查,从而控制细菌内毒素的限量。

OBJECTIVE To study the bacterial endotoxin test of Compound Glycyrrhizin and Sodium Chloride Injection. METHODS The interference actions of the different dilutabilities of injection at the greatest effective diluent range were observe with some sensitivity of TAL. RESULTS When the limulus lysate＇s sensitivity（k） was 0.25EU· mL ^-1 ,the maximum valid dilution was 1 ： 8, the interference between the sample and the relative TAL was eliminable. CONCLUSION The bacterial endotoxin test can be carried out with 0.25EU · mL^-1 sensitivity of TAL when the dilutability of sample 1 ： 8,the limit dose of bacterial endotoxin was controlled thereby.