精制卵黄磷脂的安全试验及其制剂静脉脂肪乳的不良反应  

SAFETY TESTS OF PURIFIED EGG LECITHIN AND CLINICAL OBSERVATIONS OF FAT EMULSION

作　　者：辛顺妹[1] 宋磊[1] 马竹卿[1] 

机构地区：[1]上海市长宁区中心医院,上海200051

出　　处：《中国临床药学杂志》1997年第3期119-121,共3页Chinese Journal of Clinical Pharmacy

摘　　要：精制卵黄磷脂的动物毒性试验表明:精制卵黄磷脂给小鼠5g/kg iv不产生毒性反应和死亡;给猫0.44,1.1g/kg iv gtt对BP、HR、ECG、R均无影响;给小鼠0.6,1.0,2.0g/kg iv对精神系统无明显影响;给家兔0.45g/kg iv不引起热原反应;给猫0.01,0.02g/kg iv不产生降压反应;10%的本品给豚鼠0.5ml致敏,1ml激发,未见过敏反应.临床对102例应用本品制成的静脉脂肪孔的病人进行不良反应观察显示:连续用药3d和连续用药21d以上者均未产生不良反应.与市售的10%英脱利匹特无明显差异.The results of toxicity and safety tests showed that purified egg lecithin given iv 5g/kg to mice caused no toxicity and death,given iv 0. 44,1. lg/kg to cats caused no obvi-ous effects on blood pressure,heart rate,electrocardiogram and respiration,given iv 0. 6,1. 0, 2.0g/kg to mice caused no obvious effects on nervous system,given iv 0. 45g/kg to rabbits caused no pyrogen reaction,given iv 0. 01,0. 02g/kg to cats didn't cause blood pressure de-pressed. It also had no allergic reaction. Fat emulsions prepared from purified egg lecithin ap-plied to 102 patients for 3 days and over 21 days showed no adverse reactions and no signifi-cant difference compared with 10% Intralipid.

关 键 词：卵黄磷脂 静脉脂肪乳剂 毒性 安全试验 

分 类 号：R977.6[医药卫生—药品] R965.3[医药卫生—药学]