氯霉素注射液动态浊度法鲎试验研究及其限值的确定

Study on the kinetic turbidimetric limulus tes for chloramphenicol injection

目的 :确定合理的氯霉素注射液细菌内毒素限值 ,应用动态浊度法鲎试验定量测定氯霉素注射液中的细菌内毒素含量。方法 :根据联合药液的内毒素总限量确定氯霉素注射液的内毒素限值 ,通过对样品中定量添加标准内毒素的干扰试验 ,检测其回收率应在 50 %～ 2 0 0 %范围。结果 :根据临床实际应用情况 ,将氯霉素注射液的内毒素限值定为 0 .2EU/mg较为合适 ,结果表明最大不干扰浓度为 1 0 0倍。结论 :该法准确可靠 ,可以替代热原检查。

Objective : To set up a reasonable limit of bacterial endotoxin for chloramphenicol injection and to apply the kinetic turbidimetric limulus test in the endotoxin assay of chloramphenicol injection. Methods : The limit of bacterial endotoxi for chloramphenicol injection was established according to the total limit of bacterial endotoxin in the combined medicines.The interference test was fulfilled ,when the amount of endotoxin added in chloramphenicol injection sample was recovered in the range of 50%～200%.Results :The most suitable limit of bacterial endotoxin in chloramphenicol injection was 0.2 EU/mg. It was proved that the maximum noninterference concentration was 100 times diluted liquid.Conclusion : This method was accurate and reliable for bacterial endotoxin assay and can replace the pyrogen test.