柴胡注射液的细菌内毒素检查法的建立

Method of bacterial endotoxins test in Chaihu Injection

目的建立柴胡注射液的细菌内毒素检查法。方法按《中国药典》2010年版(二部)附录细菌内毒素检查法,采用2个厂家的鲎试剂对国内3个生产厂家的柴胡注射液进行干扰试验的研究。结果柴胡注射液对内毒素检查无干扰。结论该方法简单快速,柴胡注射液细菌内毒素检查法,其限值为75 EU.mL-1。

Objective To establish a bacterial endotoxin test method of Chaihu Injection. Methods Interference tests of Chaihu Injections which producted by 3 domestic manufacturers were performed with TAL from 2 manufacturers according to bac-terial endotoxin test method in appendix of Chinese Pharmacopoeia （2010 Edition）. Results No interference was found in the test. Conclution The method was simple,rapid,sensitive,and the endotoxin limit of Chaihu Injection was 75EU·mL^-1.