动态浊度法测定人参多糖注射液中细菌内毒素的含量

目的：建立测定人参多糖注射液中细菌内毒素含量的方法。方法建立动态浊度法测定细菌内毒素标准曲线，通过测定供试液中外加内毒素的回收率进行干扰试验，确定样品检测浓度线性范围，并定量测定样品中的细菌内毒素。结果内毒素检测浓度线性范围为0.03125~2.0 EU·mL-1（r＝-0.9989）；样品在稀释36倍及以下时，对试验无干扰作用，细菌内毒素回收率在50%~200%范围内，样品中的内毒素含量可定量测定。结论动态浊度法可用于人参多糖注射液中细菌内毒素的定量检测。

Determination of bacterial endotoxin in Ginseng Polysacchride Injection by kinetic turbidimetric limulus method

Objective To establish a method for the determination of bacterial endotoxin in Ginseng Polysacchride In-jection. Methods Four endotoxin concentrations were prepared to generate the standard curve by kinetic turbidimetric lim-ulus method. Bacterial endotoxin was added into test sample for interference test. Linear range and bacterial endotoxin in samples were determined. Results The linear range of bacterial endotoxin was 0. 031 25~2. 0 EU·mL-1（ r= -0. 998 9）. The diluted solution of sample down to 36 times can be effective measured and the recovery rate of bacterial endotoxin was within 50% to 200%. Conclusion The kinetic turbidimetric limulus method was available to bacterial endotoxin test of Ginseng Polysacchride Injection.