参芪扶正注射液细菌内毒素检测方法的研究  

Study of test for bacterial endotoxins in Shenqifuzheng injection

作　　者：邓云锋[1] 

机构地区：[1]广东广州医学院第二附属医院药学部,广州510260

出　　处：《海峡药学》2011年第2期34-35,共2页Strait Pharmaceutical Journal

摘　　要：目的考察参芪扶正注射液进行细菌内毒素检查的可行性,建立检测参芪扶正注射液中细菌内毒素实验方法。方法应用凝胶法鲎试验对样品进行细菌内毒素的检测。结果参芪扶正注射液稀释至40倍时为最佳浓度,对细菌内毒素检查无干扰作用。结论参芪扶正注射液的细菌内毒素限值可定为1.2EU.mL-1,日常细菌内毒素检查时可将样品稀释至40倍以排除其干扰作用。OBJECTIVE To inspect the feasibility of bacterial endotoxins test and establish a bacterial endotoxins test for Shenqifuzheng injection.METHODS Gel-clot limulus test was applied to detect the bacterial endotoxins in samples.RESULTS The experiment shows that Shenqifuzheng injection has no interference in 1∶40 dilution.CONCLUSION The bacterial endotoxin limit of Shenqifuzheng injection is 1.2EU·mL-1,samples can be diluted to 1∶40 to avoid their interfering effects on routine bacterial endotoxins test.

关 键 词：参芪扶正注射液 细菌内毒素 干扰试验 

分 类 号：R927.2[医药卫生—药学]