注射用伏立康唑细菌内毒素检查方法研究  

Study on bacterial endotoxins detection method of voriconazole for injection

作　　者：王红平 黄梅梅 荣祖元 

机构地区：[1]四川省食品药品检验检测院,成都610097

出　　处：《现代医药卫生》2017年第13期1948-1950,共3页Journal of Modern Medicine & Health

摘　　要：目的建立统一的注射用伏立康唑(VRC)细菌内毒素检查方法。方法按2015的版《中华人民共和国药典:四部》通则1 143细菌内毒素检查凝胶法,使用2个厂家的鲎试剂对5个生产厂家的13批VRC样品进行细菌内毒素检查的方法学研究。结果不同厂家注射用VRC稀释至0.67 mg/m L均可排除干扰作用。结论建议将注射用VRC细菌内毒素检查项限值统一为0.75 EU/mg。Objective To establish a unified detection method for bacterial endotoxins of voriconazole for injection （VRC）. Methods According to the gel-clot technique for bacterial endotoxins inspection method and the related regulations of the Chinese Pharmacopoeia 2015 volume IV 1 143, tachypleus amebocyte lysate （TAL） produced by two different manufacturers was used to conduct the methodological research on 13 batches of VRC samples from 5 manufacturers. Results VRC from differ- ent manufacturers diluting to 0.57 mg/mL could exclude interference effect. Conclusion It is suggested that the limiting value in VRC bacterial endotoxin detection is unified to be 0.75 EU/mg.

关 键 词：三唑类 嘧啶类 注射剂 内毒素类 细菌毒素类 鲎试验 

分 类 号：R978.1[医药卫生—药品]