论文部分内容阅读
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 determine the reasonable limits of bacterial endotoxin in chloramphenicol injection, and to determine the content of bacterial endotoxin in chloramphenicol injection by dynamic nephelometry. Methods: The limit of endotoxin of chloramphenicol injection was determined according to the total endotoxemia of the combination liquid. Through the interference test of quantitatively adding standard endotoxin to the sample, the recovery rate should be in the range of 50% ~ 200% . Results: According to the clinical application, the limit of endotoxin of chloramphenicol injection was 0.2EU / mg. The results showed that the maximum non-interference concentration was 100 times. Conclusion: This method is accurate and reliable, can replace the pyrogen test.