摘要
目的:探讨用细菌内毒素法检查清开灵注射液的热原,提高内毒素的检出率。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稀释4倍,最佳试验浓度为稀释8倍。结论: 清开灵注射液内毒素限值按1.0 EU·ml-1进行细菌内毒素检查安全可靠。
Objective: To explore the bacterial endotoxin test in Qingkailing injection instead of pyrogem examination. Method: The interference test was conducted by using the TAL from the different factories and Qingkailing injection produced from the same and different factories to investigate the interference effects of Qingkailing on bacterial endotoxins tests in order to determine a maximum interference concentration and the best testing concentration. Result: It was proved that the maximum noninterference concentration of Qingkailing injection was 4 times of diluted liquid, the best testing concentration was 8 times of diluted liquid. Conclusion: The most suitable limit of bacterial endotoxin in Qingkailing injection was 1.0 EU·ml-1. This method for bacterial endotoxins test was accurate and reliable, and could be used for replacing the pyrogen test.
出处
《中国药师》
CAS
2005年第5期430-431,共2页
China Pharmacist
