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引用本文:桑晶,陈舒怀,蒙宏,谢珍,匡荣,李杨.体外人源细胞激活试验法应用于4种染发剂的皮肤变态反应研究[J].中国现代应用药学,2018,35(4):484-487.
SANG Jing,CHEN Shuhuai,MENG Hong,XIE Zhen,KUANG Rong,LI Yang.Study of the Application of in Vitro Human Cell Line Activation Test with Four Hair Dyes[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(4):484-487.
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体外人源细胞激活试验法应用于4种染发剂的皮肤变态反应研究
桑晶, 陈舒怀, 蒙宏, 谢珍, 匡荣, 李杨
浙江省食品药品检验研究院, 杭州 310004
摘要:
目的 研究体外人源细胞激活试验h-CLAT法应用在染发剂的皮肤变态反应检测中的可行性,通过和现行化妆品标准中体内皮肤变态反应法的比较,评价体外人源细胞激活试验应用在染发剂皮肤变态反应试验上的优劣。方法 参考OECD指导原则442E的体外人源细胞系激活试验方法,应用流式细胞仪技术在类树突样的人源白血病细胞系THP-1上对4种染发剂进行体外皮肤变态反应检查,并与体内皮肤变态反应法的检测结果相比较。结果 体外h-CLAT试验表明,4种染发剂中#2,#3和#4染发剂的CD54RFI都 < 200且CD86RFI < 150,即体外试验结果为阴性与体内皮肤变态反应试验比较,结果一致;而#1染发剂为体外结果阳性,且有效致敏浓度为315 μg·mL-1,与体内变态反应阴性结果不同。结论 与体内皮肤变态反应试验相比,体外人源细胞系激活试验在对染发剂的检验上有周期短、测试方法简便、评价结果客观等优点。缺点是无法反映整个过敏反应的过程,存在假阳性的可能。
关键词:  人源激活系实验  皮肤变态反应  替代方法
DOI:10.13748/j.cnki.issn1007-7693.2018.04.006
分类号:R965.2
基金项目:浙江省药品接触材料质量控制研究重点实验室(2014E10006)
Study of the Application of in Vitro Human Cell Line Activation Test with Four Hair Dyes
SANG Jing, CHEN Shuhuai, MENG Hong, XIE Zhen, KUANG Rong, LI Yang
Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
Abstract:
OBJECTIVE To discuss the possibility of applying human cell line activation test in vitro to skin sensitization test for hair dyes. Compared with skin sensitization test in vivo, it was evaluated that advantages and disadvantages to apply human cell line activation test in vitro to skin sensitization test with hair dyes. METHODS In terms of OECD guideline 442E, 4 different shampoos were tested in human cell line activation test with human leukemia THP-1 cells by flow cytometer. And this result was compared with result from Buehler test in vivo. RESULTS From human cell line activation test in vitro, it showed that #2, #3 and #4 hair dyes got the same negative results, from which showed all the CD54RFI were < 200 and CD86RFI were < 150, compared with the traditional skin sensitization test in vivo. However, #1 hair dye got the positive result from human cell line activation test, which were different from the result in Buehler test in vivo. CONCLUSION It has advantages of short test cycle, simple test method and objective evaluation in human cell line activation test in vitro for skin sensitization test with hair dyes, and disadvantages of reflecting part of process of skin sensitization, existing the possibility of false positive.
Key words:  human cell line activation(h-CLAT)  skin sensitization  alternative methods
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