赋形剂—甘露醇粉剂细菌内毒素检查法的研究  

The endotoxin inspection of excipient mannitol powder.

作　　者：李华[1] 柯华昕[1] 龙润乡[1] 崔萍芳[1] 丁雪凤[1] 谢忠平[1] 

机构地区：[1]中国医学科学院中国协和医科大学医学生物学研究所,云南昆明650118

出　　处：《云南医药》2005年第5期475-477,共3页Medicine and Pharmacy of Yunnan

摘　　要：Objective To establish the inspection method of endotoxin in mannitol powder.Methods The experiment was implemented according to the endotoxin inspection in China Pharmacopoeia(II,2000ED).Results The mannitol power did not interfere with the agglutination reaction of TAL.The mannitol powder was assayed by TAL labeled the sensitivity of 0.25EU/mL for endotoxin.The results were proved by the endotoxin inspection of transfer factor(TF).Conclusion The endotoxin inspection method can be used for mannitol powder.Objective To establish the inspection method of endotoxin in mannitol powder. Methods The experiment was implemented according to the endotoxin inspection in China Pharmacopoeia （II, 2000ED）. Results The mannitol power did not interfere with the agglutination reaction of TAL. The mannitol powder was assayed by TAL labeled the sensitivity of O. 25EU/mL for endotoxin. The results were proved by the endotoxin inspection of transfer factor （TF）. Conclusion The endotoxin inspection method can be used for mannitol powder.

关 键 词：赋形剂 甘露醇粉剂 细菌内毒素 鲎试剂 

分 类 号：R927.12[医药卫生—药学]