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目的:建立动态浊度法定量检测注射用磷酸川芎嗪中细菌内毒素含量。方法:通过3批样品中的干扰试验,确定不干扰检测的最大样品浓度。结果:样品在0.1 mg.ml-1及以下浓度时,内毒素的加样回收率均在在50%～200%之间,不存在干扰作用。结论:动态浊度法可有效检测注射用磷酸川芎嗪中的内毒素含量。
Objective: To establish a dynamic turbidimetric method for the quantitative determination of bacterial endotoxin in ligustrazine phosphate injection. Method: The interference test in 3 batches of samples was used to determine the maximum sample concentration that did not interfere with the test. Results: The recoveries of endotoxin were between 50% and 200% at the concentrations of 0.1 mg.ml-1 and below, with no interference effect. Conclusion: The dynamic turbidity method can effectively detect endotoxin in ligustrazine phosphate injection.