动态浊度法定量测定黄芪注射液中细菌内毒素的含量

目的应用动态浊度法鲎试验定量测定黄芪注射液中的细菌内毒素含量。方法通过干扰试验确定样品检测浓度,并建立标准曲线对不同的样品进行细菌内毒素的定量测定。结果样品用BET水制成1∶5稀释液,对鲎试验检查无干扰,细菌内毒素回收率在50%～200%之间。样品中的内毒素含量可定量测定,检测结果与凝胶法检测的结果有一定的相关性。结论动态浊度法可用于黄芪注射液中细菌内毒素定量检测。

Detection of Bacterial Endotoxin in Huangqi Injection by the Method of Kinetic Turbidimetric Limulus Test

OBJECTIVE To detect the quantity of endotoxin in huangqi injection by the method of kinetic turbidimetric limulus test. METHODS The kinetic turbidimetric limulus test was applied to detect the quantity of endotoxin in several samples. The standard endotoxin working curve was set up and the interference test was studied to range the effective concentrations of sample. RESULTS Dilution ratio of Huangqi injection at 1 ; 5 show no inference in the test. The endotoxin recovery rate was more than 50% and less than 200%. The endotoxin level in samples could be quantified exactly, and the results were accorded with the results obtained by gel-clot technique assay. CONCLUSION The kinetic turbidimetric limulus test can be used to quantitate the endotoxin level in huangqi injection.