为探究含烟酰胺化妆品可能引起人体皮肤刺激性反应的主要原因,开展了健康志愿者烟酸、烟酰胺斑贴试验及含烟酰胺化妆品稳定性试验研究.首先选取含烟酰胺化妆品进行斑贴试验,同时测定烟酸、烟酰胺含量水平;随后进行了不同含量烟酸溶液(0.000 5%,0.001%,0.01%,0.025%)和3%烟酰胺溶液斑贴试验,并开展了含烟酰胺化妆品稳定性试验.结果发现:45个含烟酰胺化妆品中,17个会引起皮肤反应(占总数的37.8%),41个检出烟酸(占总数的91.1%),含量为0.000 15%~0.026 6%;采用自建皮肤反应评分方法进行评分,皮肤反应评分总和与烟酸含量正相关具有统计学意义(r=0.406,P=0.006),与烟酰胺含量相关无统计学意义(r=0.099,P=0.517).0.000 5%烟酸、0.001%烟酸、3%烟酰胺溶液对皮肤刺激性与阴性对照的差异无统计学意义(P>0.05);0.025%烟酸、0.01%烟酸对皮肤刺激性与阴性对照的差异具有统计学意义(P<0.05).含烟酰胺化妆品在25℃放置8周烟酸含量稳定,在55℃放置8周烟酸含量呈现逐渐增加趋势.
To investigate the main causes of skin adverse reactions caused by niacinamide cosmetics,niacin and niacinamide patch test in healthy volunteers,and niacinamide cosmetics stability test were conducted.Niacinamide cosmetics were selected to perform patch test on healthy volunteers,and the content of niacin and niacinamide were measured.Subsequently,patch tests of niacin solution with different content(0.000 5%,0.001%,0.01%,0.025%)and 3%niacinamide solution were carried out,and the stability test of niacinamide cosmetics was carried out.The results are shown as following:among 45 kinds of niacinamide cosmetics selected,17 kinds of them cause skin reactions by patch test(accounting for 37.8%of the total),and niacin is detected in 41 kinds(accounting for 91.1%)with the content of 0.000 15%-0.026 6%.Self-established skin reaction scoring method is used for scoring,and the total score of skin reaction is significantly positively correlated with the niacin content(r=0.406,P=0.006),but not significantly correlated with the niacinamide content(r=0.099,P=0.517).There are no significant differences among skin irritation of 0.000 5%niacin solution,0.001%niacin solution,3%niacinamide solution and the negative control(P>0.05).There are significant differences between skin irritation of 0.025%niacin and the negative control,or between skin irritation of 0.01%niacin and the negative control(P<0.05).Niacinamide cosmetics are placed at 25℃ for 8 weeks and the content of niacin are stable,while niacin content are gradually increased at 55℃ for 8 weeks.Hence,niacin is potentially irritating to healthy human skin,and the degree of irritation worsens with the increase of the content.In addition,for niacinamide cosmetics,part of niacinamide slowly hydrolyze to niacin under high temperature,which may cause adverse reactions on the skin of the sensitive consumers.