摘要
目的考察使用鲎试剂方法检测丹参川芎嗪注射液中细菌内毒素的可行性。方法按照中国药典2010年版(二部)附录ⅪE细菌内毒素检查法,用2个厂家的鲎试剂对3个批号的丹参川芎嗪注射液进行干扰试验。结果丹参川芎嗪注射液原液对鲎试剂与细菌内毒素之间的凝集反应有抑制作用,经稀释2倍后,用灵敏度λ为0.5 EU/mL的鲎试剂进行实验,干扰消失。结论使用鲎试剂方法检测丹参川芎嗪注射液中细菌内毒素是可行的。
Objective The feasibility for detecting the bacterial endotoxins in danshen chuanxiongqin injection via tachypleus amebocyte lysate test was evaluated.Methods Using the tachypleus amebocyte lysate produced by two manufacturers,interference test of 3 batches of samples was performed in accordance with appendix Ⅺ E,volume two,Chinese pharmacopoeia（2010 edition）.Results Danshen chuanxiongqin injection had inhibitive effect on the bacterial endotoxins test,but this interference was eliminated when the samples were diluted 2 times,using tachypleus amebocyte lysates with the sensitivity λ of 0.5 EU/mL.Conclusion The method of tachypleus amebocyte lysate test is feasible for detecting the bacterial endotoxins in danshen chuanxiongqin injection.
出处
《湖北中医药大学学报》
2011年第5期39-41,共3页
Journal of Hubei University of Chinese Medicine
关键词
细菌内毒素
干扰试验
鲎试剂
丹参川芎嗪注射液
Bacterial endotoxins
Interference test
Tachypleus amebocyte lysate
Danshen chuanxiongqin injection
