田光彩（河南濮阳市药品检验所，濮阳 457000）
摘要 目的：探讨用细菌内毒素法检查清开灵注射液的热原，以替代热原检查，提高内毒素的检出率，避免临床热原反应的发生。方法：利用不同厂家生产的鲎试剂与同厂家和不同厂家生产的清开灵注射液进行干扰试验，全面考察清开灵注射液对细菌内毒素检查的干扰作用，以确定其最大不干扰浓度及最佳试验浓度。结果：试验证明清开灵注射液最大不干扰浓度为4倍，最佳试验浓度为8倍。结论:清开灵注射液内毒素限值按1.0EU/ml进行细菌内毒素检查安全可靠，可以代替热原检查。
关键词:清开灵注射液；鲎试剂；细菌内毒素检查法
Discussion on about Bacterial Endotoxin Test in Qing kai ling Injection
Tian Guang cai
(Puyang Institute For Drug Control of Henan Province，Puyang 457000)
Abstact Objective:Study on the bacterial endotoxin test in Qing kai ling injection instead of pyrogem examination.Methods:The interference test was conducted by using the reagent from the same and different factories in order to establish the maximum noninterference concentration and the best testing concentration.Results:It was proved that Qing kai ling injection the maximum noninterference concentration was 4 times diluted liquid and the best testing concentration was 8 times diluted liquid
.Conclusion:The most suitable limit of bacterial endotoxin in Qing kai ling injection was 1.0 EU/ml.This method for bacterial endotoxin was accurate and reliable and can replace the pyrogen test
Key words： Qing kai Ling Injection; Limulus Amebocyte; Bacterial Endotoxin Test.