氟康唑注射液细菌内毒素检查法的研究  

Establishment of bacterial endotoxin test for fluconazole injection

作　　者：赖善城[1] 付丽芳[1] 卢雪梅[1] 

机构地区：[1]福建省龙岩市第二医院,龙岩364000

出　　处：《海峡药学》2007年第7期51-52,共2页Strait Pharmaceutical Journal

摘　　要：目的建立氟康唑注射液的细菌内毒素检查的方法。方法按《中国药典》2005年版(二部)附录收载的细菌内毒素检查方法进行实验。结果将氟康唑注射液经3倍稀释可消除干扰因素,用标示灵敏度为0.25EU.mL-1的鲎试剂检测细菌内毒素是有效的。结论可以用细菌内毒素检查法代替家兔法来控制氟康唑注射液的质量。OBJECTIVE To establish a method of checking bacterial endotoxin in fluconazole injection. METHODS Bacterial endotoxin test procedure and guiding principle in Chinese Pharmacopoeia were used. RESULTS The test showed that the interference elements could be excluded by diluting fluconazole injection 3 times,and it was effective that endotoxin could be tested by amebocyte lysate with accuracy of 0. 25EU · mL^-1. CONCLUSION Bacterial endotoxin test can be used in place of rabbit method for pyrogen monitoring of fluconazole injection.

关 键 词：氟康唑注射液 细菌内毒素检查法 干扰实验 

分 类 号：R927.12[医药卫生—药学]