丹红注射液中细菌内毒素的检测

摘要

Objective: To explore the feasibility of the bacterial endotoxin test for Danhong Injection. Methods: The experiment was based on the bacterial endotoxin test method stated in Chinese Pharmacoperia 2010 Edition (Vol II), which helped to identify the effective dilution of Danhong Injection and the limits of bacteria endotoxin. Results: When the Danhong Injection was diluted 10 times, it had no interference effects on the TAL. The limit of bacterial endotoxin was 5.0 ELJ/ ml. Conclusion: The bacterial endotoxin test can be used to replace the pyrogen test.%目的:探讨丹红注射液细菌内毒素检查方法的可行性.方法:依据<中国药典>2010年版二部附录细菌内毒素检查法,确定丹红注射液的有效稀释浓度和细菌内毒素限值.结果:丹红注射液经稀释10倍后对鲎试剂无干扰作用,细菌内毒素的限值为5.0 EU/ml.结论:可用细菌内毒素检查取代热原检查.