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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。
Objective To determine the content of bacterial endotoxin in Radix Astragali by dynamic nephelometry. Methods The concentration of the test sample was determined by interference test and a standard curve was established for the quantitative determination of bacterial endotoxin in different samples. Results The sample was made into a 1: 5 dilution with BET water. No interference was observed in the test. The bacterial endotoxin recovery was between 50% and 200%. Endotoxin content in the sample can be quantitatively determined, the test results and the gel test results have some relevance. Conclusion The dynamic turbidity method can be used for quantitative detection of bacterial endotoxin in Astragalus injection.