鲎试剂检测注射用肌氨肽苷中细菌内毒素

Bacterial Endotoxin Limulus Amebocyte Lysate Test in Muscular Amino Acids and Peptides and Nucleosides Injection

目的考察使用鲎试剂方法检测注射用肌氨肽苷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4个批号的注射用肌氨肽苷进行干扰试验。结果注射用肌氨肽苷原液对鲎试剂与细菌内毒素之间的凝集反应有抑制作用,将注射用肌氨肽苷样品质量浓度稀释至1.4μg/mL后,使用灵敏度为0.25 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注射用肌氨肽苷中细菌内毒素是可行的。

Objective The feasibility for detecting the bacterial endotoxins in Muscular Amino Acids and Peptides and Nucleosides Injection via tachypleus amebocytelysate test was evaluated. Methods Using the tachypleus amebocyte lysate produced by two manufacturers,interference test of 4 batches of samples was performed in accordance with appendix XI E,volume two,Chinese pharmacopoeia （2010 edition）. Results Muscular Amino Acids and Peptides and Nucleosides Injection had inhibitive effect on the bacterial endotoxins test, but this interference was eliminated when the samples was diluted in 1.4μg/mL below, using tachypleus amebocyte lysates with the sensitivity k of 0.25 EU/mL. Conclusion The method of tachypleus amebocytelysate test is feasible for detecting＇the bacterial endotoxins in Muscular Amino Acids and Peptides and Nucleosides Injection.