吲哚美辛乳剂对皮肤刺激性和过敏性研究  

Study on skin irritation and allergenicity by indomethacin emulsion

作　　者：郭敏[1] 周波[1] 乔红群[1] 白文霞[1] 刘晶[1] 

机构地区：[1]南京工业大学江苏省药物研究所江苏省药物安全性评价中心,江苏南京210009

出　　处：《药学实践杂志》2016年第4期324-326,347,共4页Journal of Pharmaceutical Practice

摘　　要：目的考察吲哚美辛乳剂的皮肤刺激性和皮肤过敏性,为临床安全用药提供依据。方法采用新西兰白兔进行皮肤刺激性实验,分为完整皮肤组和破损皮肤组,每组8只。采用同体左、右侧自身对比法,左侧给予吲哚美辛乳剂0.5g,右侧给予等量空白乳剂,连续给药14d。实验期间观察皮肤刺激反应,每组6只于末次给药后72h处死,取皮肤做组织病理检查,剩余2只于末次给药后14d取皮肤做病理检查。采用豚鼠进行皮肤过敏实验,于第0、7、14天给予吲哚美辛0.5g局部诱导,第28天在未给药豚鼠的肋腹部皮肤给予吲哚美辛0.4g以局部激发。结果吲哚美辛乳剂对兔正常皮肤和破损皮肤均有轻微刺激性,但停药后可恢复,对豚鼠皮肤无过敏反应。结论吲哚美辛乳剂在临床上不宜长期使用,需重点观察皮肤刺激性。Objective Study on skin irritation and allergenicity of indomethacin emulsion, in order to provide theoretical basis for clinical safe medication. Methods New Zealand white rabbits were used to test skin irritation, given 0.5g test sub- stance for 14 days. The skin irritation was observed in the two groups wish eight rabbits each during the experiment. Six rab- bits in each group were sacrificed 72 hours after the last medication and skin tissues were taken for histopathology examination; and the skin tissues of remaining two rabbits were taken for histopathology examination in 14th day after the last medication. Guinea pigs were used to test skin allergenicity, given 0.5g test substance on day 0, 7, 14 for local induction. On day 28, the animal subjects were given 0.4g test substance on non-administration skin of guinea pigs for local excitation. Results Slight ir ritation of indomethacin emulsion on normal or damaged skin was observed but it is reversible after withdrawal for rabbits. Sen- sitization effect on the skin of guinea pig was not found. Conclusion Indomethacin emulsion is not suitable to long-term use clinically, and skin irritation need to pay more attention.

关 键 词：吲哚美辛 皮肤 刺激性 过敏性 

分 类 号：R971.1[医药卫生—药品]