清开灵注射液细菌内毒素检查法的建立

目的建立清开灵注射液的细菌内毒素检查方法。方法采用《中华人民共和国药典》（2010年版）附录细菌内毒素检查法,考察清开灵注射液对细菌内毒素检查的干扰作用,确定其最大不干扰浓度。结果清开灵注射液稀释至60倍后可消除干扰作用,使用灵敏度为0.125EU/mL的鲎试剂进行细菌内毒素检查,无干扰因素的影响。结论使用鲎试剂检查清开灵注射液的细菌内毒素是可行的,可以用细菌内毒素检查法取代热原检查法。

The establish of Bacterial Endotoxin test method for Qingkailing injection

Objective To establish the bacterial endotoxin test method for Qingkailing injection.Methods The bacterial endotoxins test of appendix in China Pharmacopoeia (2010 version) was used to investigate the interference effect of Qingkailing injection in the bacterial endotoxin test method,and the maximum noninterference concentration was confirmed.Results The interference effect could be eliminated when Qingkailing injection was diluted 60 times.When the sensitive of tachypleus amebocyte lysate with 0.125 EU/mL to do the bacterial endotoxins test,the results were no interference.Conclusion It is feasible to check the bacterial enolotoxin in Qingkailing injection by using tachypleus amebocyte lysate,and the bacterial enolotoxin test method can replaced the pyrogen test method.