动态比浊法检测刺五加注射液的细菌内毒素  

Application of Kinetic Turbidimetric Method in Determining Bactrial Endotoxin in Ciwujia Injection

作　　者：范能全 彭兰[2] 

机构地区：[1]重庆市药品检验所,重庆401121 [2]重庆医药高等专科学校

出　　处：《中国药师》2011年第1期59-60,共2页China Pharmacist

摘　　要：目的:应用同体系模型动态比浊法定量检测刺五加注射液中的细菌内毒素。方法:用刺五加注射液代替细菌内毒素检查用水配制不同浓度的细菌内毒素标准液,进行标准曲线的可靠性试验;对不同浓度的刺五加注射液中定量添加内毒素标准液,分别计算回收率,从中筛选出适宜的稀释倍数;再对3批刺五加注射液进行干扰试验,检测细菌内毒素的含量。结果:3批刺五加注射液的回收率均在50%～200%之间,对鲎试剂无干扰,可检测细菌内毒素的含量。结论:同体系模型动态比浊法可用于检测中药注射剂的细菌内毒素。Objective： The experiment was designed to determine thebacterial endotoxin concentration in Ciwujia injection by using the kinetic turbidimetic method with Homologous system model. Method： The assessing water for bacterial endotoxin was replaced by Ciwujia injection, and standard solutions with different concentration were made to analyze the reliability of the standard curve. The bacterial endotoxin standard solution was added into the Ciwujia solutions with different concentration to calculate the recovery, and the optimal dilution fold was selected. Interference test was used to assess the bacterial endotoxin concentration in three groups of Ciwujia injection. Result： The recovery of the three groups of Ciwujia endotoxin injection was 50% to 200% with no interference on Limulus agent. Thus, the concentration of bacterial endotoxin was determined. Conclusion ： The kinetic turbidimetic method could be used to assess the bacterial endotoxin in Ciwujia injection.

关 键 词：动态比浊法 同体系模型 刺五加注射液 细菌内毒素 鲎试剂 

分 类 号：R927.12[医药卫生—药学]