对于监管性皮肤吸收测试的皮肤屏障功能以及对和糖糖吸收的影响
Thomas Brackin1, Heather Gayes1, Ian Johnson1
1Dermal Technology Laboratory, Med IC4, Keele University Science & Business Park, Keele, Staffordshire ST5 5NL, UK.
概括
本研究重新评估了安全评估中人类皮肤样本的电阻 (ER) 极限. 一个新的5.0kΩ标准优化了屏障完整性测试,以进行可靠的体外皮肤吸收研究.
科学领域:
- 毒理学 毒理学 毒理学
- 皮肤吸收研究 皮肤吸收研究
- 在体外安全评估评估.
背景情况:
- 在体外人体皮肤吸收对于化学,化品和产品安全性评估至关重要.
- 屏障完整性测试可以识别受损的皮肤样本,但最佳标准需要改进.
- 以前的电阻 (ER) 极限可能会排除可行的皮肤样本.
研究的目的:
- 为了回顾地分析来自9978个人类皮肤样本的电阻 (ER) 数据.
- 在吸收研究中确定皮肤屏障完整性的最佳接受标准.
- 用和糖透数据验证新的标准.
主要方法:
- 对15年ER测量的回顾性分析 (n=9978).
- 将以前确定的10kΩ极限与新提出的5.0kΩ极限进行比较.
- 在没有初始ER标准的情况下,使用模型透剂 (,糖) 评估皮肤吸收.
主要成果:
- 以前使用的10kΩ极限发现了许多假阳性样本 (完整的皮肤具有较差的屏障功能).
- 对于2.54厘米2的扩散细胞,确定了5.0kΩ (17.5百分比) 的新接受标准.
- 这个5.0kΩ标准没有显著改变皮肤吸收研究的结果.
结论:
- 5.0 kΩ ER标准为体外吸收研究提供了更准确的适合人体皮肤样本选择.
- 优化屏障完整性测试可以提高各种产品安全评估的可靠性.
- 这种精细的方法支持皮肤吸收研究的监管要求.
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