重建人类表皮模型医疗器械体外皮肤刺激试验中白细胞介素-1α和白细胞介素-8的表达变化  

Expression changes of interleukin-1αand interleukin-8 in vitro skin stimulation test of medical devices for medical devices with reconstructed human epidermis model

作　　者：刘佳 范春光 孙立魁 赵增琳 LIU Jia;FAN Chunguang;SUN Likui;ZHAO Zenglin(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,National Medical Products Administration Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan,Shandong,250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院/国家药品监督管理局材料器械安全性评价重点实验室/山东省医疗器械生物学评价重点实验室,山东济南250101

出　　处：《实用临床医药杂志》2022年第11期18-21,33,共5页Journal of Clinical Medicine in Practice

基　　金：国家重点研发计划(2016YFC1103205);山东省医疗器械产品质量检验中心内部课题基金资助项目(ZX201801)。

摘　　要：目的探讨以体外皮肤刺激试验作为家兔皮肤刺激的替代试验,检测皮肤刺激性,分析试验模型相关分子标记物。方法选取2种医疗器械产品,通过重建人类表皮模型(RhE模型)体外皮肤刺激试验检测皮肤刺激性。收集皮肤组织培养基,采用酶联免疫吸附法(ELISA)测定培养基中白细胞介素(IL)-1α、IL-8含量。结果组织病理学显示,使用4%乳酸处理,上皮细胞萎缩,角质层脱落;采用其他方式处理的上皮组织未见明显异常。氯化钠注射液配制的1%的十二烷基硫酸钠(SDS)极性阳性对照和芝麻油制备1%的SDS非极性阳性对照中,上皮细胞变性坏死。ELISA结果显示,培养基中IL-1α表达与皮肤刺激指数呈正相关,IL-8与皮肤刺激指数呈负相关。结论IL-1α可作为RhE模型体外皮肤刺激试验的分子标记物,以分析医疗器械产品的皮肤刺激性。Objective To explore the skin irritation test in vitro as a substitute test for rabbit skin irritation to detect skin irritation,and to analyze the molecular markers related to the test model.Methods Two kinds of medical devices were selected,and skin irritation was detected by reconstructing human epidermis(RhE)model in vitro skin stimulation test.Skin tissue substrates were collected,and the contents of interleukin(IL)-1αand IL-8 in the substrate were determined by enzyme-linked immunosorbent assay(ELISA).Results The histopathology showed that the epithelial cells with 4%lactate were atrophied and the cuticle was exfoliated;there was no obvious abnormality in epithelial tissue by other methods.Epithelial cells were degenerate and necrotic in 1%sodium dodecyl sulfate(SDS)polar positive control with sodium chloride injection and 1%non-polar nonpolar positive control with sesame oil.ELISA results showed that IL-1αexpression in substrate was positively correlated with skin irritation index,but IL-8 was negatively correlated with skin irritation index.Conclusion IL-1αcan be used as a molecular marker for RhE model skin irritation test in vitro to analyze skin irritation of medical devices.

关 键 词：重建人类表皮模型 白细胞介素-1Α 白细胞介素-8 皮肤刺激 医疗器械 分子标记物 

分 类 号：R197.39[医药卫生—卫生事业管理] Q81[医药卫生—公共卫生与预防医学]