吴燕虹;孙清萍;陈素珍;曾秋敏;李瑾翡;颜林;
WU Yanhong;SUN Qingping;CHEN Suzhen;ZENG Qiumin;LI Jinfei;YAN Lin;Institute of Drug Control in Guangdong Provice;

• 1:广东省药品检验所

摘要(Abstract)：

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? 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 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? 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 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? 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? 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.

关键词(KeyWords)： 苯扎氯铵;EpiKutis~? RHE表皮皮肤模型;动物试验;皮肤刺激性
benzalkonium chloride;Epikutis~? RHE skin model;animal test;skin irritation

Abstract:

Keywords:

基金项目(Foundation): 广东省食品药品监督管理局2018年科技创新项目（2018ZDB02）;; 广州市科技计划项目（201707010410）

作者(Authors): 吴燕虹;孙清萍;陈素珍;曾秋敏;李瑾翡;颜林;
WU Yanhong;SUN Qingping;CHEN Suzhen;ZENG Qiumin;LI Jinfei;YAN Lin;Institute of Drug Control in Guangdong Provice;

参考文献(References)：

• [1]Barroso J M.Regulation(EC)No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products,Belgium,2009[C].Brussels,Official Journal of the European Union,2009.
• [2]化学品体外皮肤刺激性:重组人表皮试验[S].SN/T 3948-2014,2014:1.
• [3]化妆品皮肤刺激性检测重建人体表皮模型体外检测方法[S].SN/T 4577-2016,2016:1.
• [4]化妆品皮肤刺激性检测:体外重组3D表皮模型多时间点测试方法(ET50)[S]. Q/SXBX 002-2016,2016:8.
• [5]药物刺激性、过敏性和溶血性研究技术指导原则[S].国家食品药品监督管理局,2014.
• [6]张艳云,李润芝,姜珊,等.三维表皮模型Epikutis~?参考品的研制[J].药物分析杂志,2019,39(12):2117-2125.
• [7]Poumay Y,Coquette A.Modelling the human epidermis in vitro:tools for basic and applied research[J].Arch Dermatol Res,2007,298(8):361-369.
• [8]杨毅,宋健.体外皮肤刺激性试验在化妆品安全评价中的应用[J].中国药理学与毒理学杂志,2013,11(27):341-342.
• [9]何立成,孙叶丹,瞿霖吉,等.重组人皮肤模型用于评价外用液体药用高密度聚乙烯瓶的原发性皮肤刺激性研究[J].中国现代应用药学,2018,35(6):801-804.
• [10]何立成,张劲松,朱社敏,等.重组人皮肤模型用于评价药品包装材料原发性皮肤刺激质量标准的建立[J].中国药品标准,2018,19(6):442-447.
• [11]In Vitro Skin Irritation:Reconstructed Human Epidermis Test Method,OECD Guideline for the Testing of Chemicals,439[S].2015.
• [12]张劲松,何立成,桑晶,等.EpiSkinTM和Epikutis~?模型在体外皮肤刺激性和腐蚀性检测应用中的比较[J].中国现代应用药学,2017,34(4):524-526.