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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-1α and interleukin-8 in vitro skin stimulation test of medical devices for medical devices with reconstructed human epidermis model

    摘要
  • 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。

     

    Abstract:
    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) -1α and 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-1α expression in substrate was positively correlated with skin irritation index, but IL-8 was negatively correlated with skin irritation index.
    Conclusion  IL-1α can be used as a molecular marker for RhE model skin irritation test in vitro to analyze skin irritation of medical devices.

     

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