溶剂对6-甲基香豆素皮肤光变态反应试验阳性结果的影响  

The Effect of Solvents on the Positive Results of 6-Methylcoumarin in Skin Photoallergy Assay

作　　者：耿雪 侯立静 赵艳霞[1] 魏霞 祝清芬 GENG Xue;HOU Lijing;ZHAO Yanxia;WEI Xia;ZHU Qingfen(Shandong Institute for Food and Drug Control/NMPA Key Laboratory for Quality Control of Cosmetics Raw Material,Jinan 250101,Shandong,China;Shandong Traditional Medicine University,Jinan 250355,Shandong,China;Shandong Academy of Chinese Medicine,Jinan 250014,Shandong,China)

机构地区：[1]山东省食品药品检验研究院/国家药品监督管理局化妆品原料质量控制重点实验室,山东济南250101 [2]山东中医药大学,山东济南250355 [3]山东省中医药研究院,山东济南250014

出　　处：《香料香精化妆品》2023年第5期93-96,97,157,共6页Flavour Fragrance Cosmetics

摘　　要：依据《化妆品安全技术规范》(2015年版),在本实验室建立化妆品新原料皮肤光变态反应检验方法,对阳性物质6-甲基香豆素适用溶剂进行筛选。分别采用乙醇、丙酮、乙醇和丙酮(体积比1∶1)、丙酮和麻油(体积比1∶1)4种溶剂对阳性物质6-甲基香豆素进行了对比研究;按照建立的方法,对化妆品新原料N-乙酰神经酰胺进行了光致敏性评价。结果表明,在质量浓度100 mg/mL、光诱导体积0.1 mL、光激发体积0.02 mL试验条件下,4种溶剂中只有使用丙酮和麻油(体积比1∶1)溶剂配制6-甲基香豆素溶液致敏率符合阳性对照要求。用建立的方法检验N-乙酰神经酰胺未见光变态反应。综上,丙酮和麻油(体积比1∶1)溶剂作为阳性对照物6-甲基香豆素的溶剂,对化妆品新原料进行皮肤光变态反应试验具有指导意义。According to Safety and Technical Standards for Cosmetics(2015),a skin photoallergy test method for new cosmetic raw materials was established in our laboratory to screen the suitable solvent for the positive substance 6-methylcoumarin in the assay.Four solvents including ethanol,acetone,ethanol and acetone(volume ratio 1:1),acetone and sesame oil(volume ratio 1:1)were chosen and compared for positive substances 6-methylcoumarin.The photosensitization of N-acetylceramide was evaluated according to the established method.The results showed that at a mass concentration of 100 mg/mL,0.1 mL photoinduced volume and 0.02 mL photostimulated volume,only 6-methylcoumarin solution prepared with solvent acetone and sesame oil(volume ratio 1:1)met the requirements of positive control in the assay.No photoallergy was observed in N-acetylceramide by the established method.Above all,6-methylcoumarin in acetone and sesame oil(volume ratio=1:1)was established to be used as the suitable positive control.The result shows guiding significance for the specific operation process of skin photoallergy test for new cosmetic raw materials.

关 键 词：毒理学 光变态反应 N-乙酰神经酰胺 化妆品新原料 溶剂 

分 类 号：TQ658[化学工程—精细化工]