含苯扎氯铵消毒液体内外皮肤刺激性的对比研究

Comparative Study on Skin Irritation of Disinfectant Containing Benzalkonium Chloride in Vitro and in Vivo

目的 比较几种含苯扎氯铵消毒液对EpiKutis^(■) RHE表皮皮肤模型和传统动物模型的皮肤刺激性实验结果。判断EpiKutis^(■) RHE表皮皮肤模型是否适用于评定含苯扎氯铵消毒液皮肤刺激性。方法 参照国家食品药品监督管理局《药物刺激性、过敏性和溶血性研究技术指导原则》2014年版进行含苯扎氯铵消毒液皮肤刺激性实验,应用EpiKutis^(■) RHE表皮皮肤模型检测含苯扎氯铵消毒液体外皮肤刺激性。结果 动物实验结果显示,完整皮肤组刺激性强度:苯扎氯铵D溶液>B溶液>A溶液>E溶液>C溶液;破损皮肤组:苯扎氯铵A溶液>B溶液>D溶液>E溶液>C溶液。消毒液刺激EpiKutis^(■) RHE表皮皮肤模型实验结果显示,苯扎氯铵A溶液>D溶液>E溶液>B溶液>C溶液。结论 几种含苯扎氯铵消毒液在EpiKutis^(■) RHE表皮皮肤模型与传统动物模型的皮肤刺激性实验结果基本一致,表明EpiKutis^(■) RHE表皮皮肤模型可以用于判断含苯扎氯铵消毒液的皮肤刺激性。

OBJECTIVE To compare the effects of several disinfectants containing benzalkonium chloride on the skin irritation test results of epikutis^(■) HHE skin model and traditional animal model test,to determine whether epikutis^(■) HHE skin model is suitable for the evaluation of skin irritation of disinfectant containing benzalkonium chloride.METHODS The skin irritation tests of several disinfectants containing benzalkonium chloride were carried out according to the technical guidelines for the study of drug irritation,anaphylaxis and hemolysis(2014 version) issued by the State Food and Drug Administration,and the skin irritation in vitro of several disinfectants containing benzalkonium chloride was carried out according to the epikutis^(■) RHE skin model manual.RESULTS The traditional animal skin irritation test showed that the irritation intensity of several disinfectants were as follows:in complete skin group,benzalkonium chloride solution D>solution B>solution A>solution E>solution C,in damaged skin group:benzalkonium chloride solution A>solution B>solution D>solutionE>solution C.Epikutis^(■) RHE skin model test showed that the irritant intensity of several disinfectants were as follows:solution A>solution D>solution E>solution B>solution C.CONCLUSION The skin irritation test results of several disinfectants containing benzalkonium chloride on epikutis^(■) HHE skin model test are basically consistent with the traditional animal test.It shows that epikutis^(■) RHE skin model can be used to judge the skin irritation of disinfectant containing benzalkonium chloride.