肠外营养用海豹油脂肪乳安全性的初步评价  

Preliminary Safety Evaluation of Seal Oil Based Lipid Emulsion for Parenteral Nutrition

作　　者：苏健芬[1,2] 吴琳娜[1] 王周华[1] 章正赞[1] 吴传斌[1] 

机构地区：[1]中山大学药学院,广东省创新药物制剂工程技术研究开发中心,广东广州510006 [2]广州市番禺区中心医院药学部,广东广州511400

出　　处：《中国医药工业杂志》2014年第1期56-59,共4页Chinese Journal of Pharmaceuticals

基　　金：科技部国际科技合作与交流专项项目(2008DFA31080)

摘　　要：从兔热原试验、体内外溶血试验和血管刺激性试验豚鼠过敏性试验,以及小鼠急性毒性试验等方面初步考察了自制肠外营养用海豹油脂肪乳的安全性。结果显示,兔静注本品后未见热原反应,体内外试验未见溶血,对兔耳缘静脉血管刺激性轻微;豚鼠静注本品后无过敏反应;小鼠按最大耐受量(0.04 ml/g)静脉注射,间隔12 h再次给药,连续7 d未见急性中毒症状。The safety of seal oil based lipid emulsion （SOLE） was preliminary evaluated comprehensively through pyrogen test, in vitro and in vivo haemolysis and stimulation test in blood vessel in rabbits, allergic test in guinea pigs and acute toxicity in mice. The results showed that except slight stimulation caused by SOLE reasonably, neither pyrogen-induced fever nor haemolysis was observed. There was no allergic reaction in guinea pigs induced by SOLE, and no death was found in a week after intravenous injection of SOLE at the maximum tolerated dose of 0.04 ml/g to mice per 12 h for one day.

关 键 词：海豹油 脂肪乳 安全性 溶血 刺激性 过敏性 急性毒性 

分 类 号：R944.1[医药卫生—药剂学]