淋洗类化妆品眼刺激性评价新方法——CAMVA-ET_(50)法的建立  

Establishment of CAMVA-ET_(50) Method,A New Method for Evaluation of Eye Irritation of Rinse-off Cosmetics

作　　者：何立成 谢珍 李梦霞 黄微 匡荣 HE Licheng;XIE Zhen;LI Mengxia;HUANG Wei;KUANG Rong(Zhejiang Institute for Food and Drug Control,NMPA Key Laboratory for Animal Alternative Testing Technology of Cosmetics,Hangzhou 310052,China;Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310052,China;Hangzhou Medical College,Hangzhou 310000,China)

机构地区：[1]浙江省食品药品检验研究院,国家药品监督管理局化妆品动物替代试验技术重点实验室,杭州310052 [2]浙江省食品药品检验研究院,浙江省药品接触材料质量控制研究重点实验室,杭州310052 [3]杭州医学院,杭州310000

出　　处：《中国现代应用药学》2024年第17期2376-2380,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省药品监督管理局系统科技计划项目(2021024)。

摘　　要：目的建立一种全新的基于鸡胚绒毛膜尿囊膜血管试验的眼刺激性评价方法。方法将受试物稀释到一定浓度,涂抹在鸡胚膜血管表面暴露多个时间点后,根据每个时间点的阳性鸡胚数计算一半鸡胚阳性的暴露时间(ET50),并评价受试物的眼刺激性程度。用4批已知刺激性的样品对该方法的相关条件进行探索,选择合适的稀释浓度和暴露时间。另取清洁类产品和卸妆类产品共30批,用该方法进行测试,并与家兔法结果进行比较,确定合适的判定标准。结果条件探索测试结果表明,1%浓度有较好的区分度,且总耗时较少,30批样品的体内外一致率为86.7%(26/30)。结论本研究建立的评价方法能较好地区分淋洗类化妆品的眼刺激性。OBJECTIVE To develop a novel method for evaluating eye irritation based on the chorioallantoic membrane vascular assay.METHODS Diluted the test articles to a certain concentration,applied it to the surface of the membrane vessels of chicken embryos,and after exposure to multiple time,calculated the exposure time of half(ET_(50))according to the number of positive chicken embryos at each time point,and evaluated the degree of eye irritation of the test articles.The conditions associated with the method were explored with 4 batches of known irritation samples to select the appropriate dilution concentrations and exposure times.A total of 30 batches of skin cleansing products and makeup remover products were tested by the method and compared with the results of the Draize test to determine the appropriate determination criteria.RESULTS The results of the conditional exploration test showed that the 1%concentration had a good discrimination and the total time spent was less,and the in vitro consistency of the 30 batches was 86.7%(26/30).CONCLUSION The evaluation method established in this study can better distinguish the eye irritation of rinse-off cosmetics.

关 键 词：清洁类化妆品 眼刺激性 CAMVA-ET50 

分 类 号：R965[医药卫生—药理学]