SLS人体单次斑贴试验阳性对照物基准模型的建立  

Establishment of positive control for benchmark in human single patch test

作　　者：杨丽洁 胡蔚毅 马亚峰 袁超 YANG Lijie HU Weiyi MA Yafeng YUAN Chao(Research Laboratory of cosmetics and skin, Shanghai Dermatology Hospital, Shanghai 200443, China Department of Dermatology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou 210002, China)

机构地区：[1]上海市皮肤病医院,皮肤与化妆品研究室,上海200443 [2]徐州医科大学附属医院皮肤科,江苏徐州221002

出　　处：《中国麻风皮肤病杂志》2017年第2期88-91,共4页China Journal of Leprosy and Skin Diseases

摘　　要：目的:建立十二烷基磺酸钠(SLS)人体单次斑贴试验阳性基准模型。方法:60名健康受试者使用0.01%、0.05%、0.10%、0.50%和1.00%SLS进行第一阶段皮肤单次斑贴试验,确定阳性对照物的初步合适浓度区间。然后再选取60名健康受试者根据第一阶段合适浓度范围设计浓度进行第二阶段试验,进一步确定合适浓度。结果:第一阶段的试验提示,阳性基准物的浓度在0.01%~0.05%之间,第二阶段确定0.02%SLS的1级皮肤反应人数≤5例,2级皮肤反应人数<2例,该反应率与标准中的阳性结果最为接近。结论:建议以0.02%SLS作为人体单次斑贴试验的阳性对照物基准模型。Objective：To establish the positive control for benchmark model of human asingle patch test. Methods：In the first stage, sixty healthy subjects were tested by different concentrations （ 0. 01%、0. 05%、0.10%、0.50% and 1.00%） of sodium lauryl sulphate （ SLS） in single patch test in order to determine the proper concentration. In the second stage, the results obtained from the first stage of the experiment was used to determine the test concentration in 60 study subjects. Results： The positive benchmark concentration was between 0.01%-0.05% in the first study stage. When the concentration of SLS was 0.02%, there was less than 5 subjects in level 1 skin reaction and less than 2 subjects in level 2 skin reaction, which was most close to the positive standard according to the Cosmetics Health Standards 2007. Conclusion：0.02% SLS is appli-cable as a positive control for benchmark in human single patch test.

关 键 词：皮肤斑贴试验 刺激反应 基准模型 十二烷基磺酸钠 

分 类 号：R-332[医药卫生] TQ658[化学工程—精细化工]