地塞米松磷酸钠注射液的细菌内毒素检查法  

Bacterial endotoxin test in dexamethasone sodium phosphate injection

作　　者：吴露露[1] 居红枫[1] 

机构地区：[1]江苏省药品检验所,南京210008

出　　处：《药学与临床研究》2007年第5期415-417,共3页Pharmaceutical and Clinical Research

摘　　要：目的:探讨地塞米松磷酸钠注射液对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准。方法:参照《中国药典》2005年版二部附录X I E细菌内毒素检查法,用两个厂家的鲎试剂对两个厂家的地塞米松磷酸钠注射液进行干扰试验。结果:地塞米松磷酸钠注射液对细菌内毒素检查有干扰作用,但通过细菌内毒素检查用水稀释可消除干扰。结论:该制剂可以用细菌内毒素检查法(凝胶法)代替兔热原检查法。Objective ：To study the interferential effect of dexamethasone sodium phosphate injection on bacterial endotoxin test and to establish bacterial endotoxin test method. Methods： According to China Pharmacopoeia 2005, inhibition and enhancement test was performed with Amebocyte Lysate manufactured by two different com- panies in dexamethasone sodium phosphate injection manufactured by two different companies. Results： The in- jection can interfere with the bacterial endotoxins test, but the inhibition effect can be eliminated by appropriate dilution with BET water. Conclusions： The results suggest that bacterial endotoxins test （gel-clot method） can be used as an alternative method for the rabbit pyrogen test for Dexamethasone Sodium Phosphate Injection.

关 键 词：地塞米松磷酸钠注射液 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]