动态比浊法测定糖盐钾注射液中细菌内毒素含量

目的: 建立糖盐钾注射液细菌内毒素定量检测方法.方法: 采用中国药典2000年版附录检测细菌内毒素含量的动态浊度法.结果: 糖盐钾注射液稀释2倍时对鲎试剂无干扰作用,回收率在50%～200%范围内.结论: 使用动态比浊法定量检测糖盐钾注射液细菌内毒素的含量是可行的,可用细菌内毒素定量检查法代替家兔热原试验法.

Content of Bacterial Endotoxin in Glucose and Sodium Chloride and Potassium Chloride Injection Determined by Kinetic Turbidimetry Method

Objective: To establish a method to determine the content of bacterial endotoxin in glucose and sodium chloride and potassium chloride injection.Method: The kinetic turbidimetry for testing the content of bacterial endotoxins in the appendix of Chinese Pharmacopeia was used.Result: The test showed that the tachyplens amebocyte lysate had not interfering effect when glucose and sodium chloride and potassium chloride injection were diluted to 2 times.the recovery of endotoxins was more than 50 percent and less than 200 percent.Conclusion: It is feasible to use kinetic turbidimetry method for quantitative determination of the content of bacterial endotoxin in glucose and sodium chloride and potassium chloride injection, so the method can be used instead of the rabbit pyrogen test.