透皮吸收实验推导皮肤吸收值的规范化研究

Standardization study of deriving dermal absorption value from experiments

考虑到相当数量的化学物质主要通过皮肤途径暴露,将毒理学经口染毒的试验方法和试验结果外推到透皮吸收实验,建立统一的皮肤吸收值的设置规范已逐步成为当下的研究热点。透皮吸收试验方法可分为体内和体外两种,各有其优缺点和适用范围。为了减少实验变异并提高体内外研究数据解释的一致性,研究方案的标准化非常重要,而在进行风险评估时对皮肤吸收值的设置也应走向规范化。在实验数据待定时,应依据制剂类型选择相应的皮肤吸收值,如果需要确定皮肤吸收的制剂是密切相关的,则可使用另一种制剂的皮肤吸收数据作为参考,在必要的情况下须逐案进行判断。

Considering that a significant number of chemicals are exposed mainly through the skin pathway,it has become a research hotspot to extrapolate the test method and result of toxicological oral exposure to dermal absorption experiments so that the standard of setting dermal absorption value can be established.Dermal absorption test method can be divided into in vivo and in vitro,each of which has its advantages and disadvantages and the scope of application.In order to reduce experimental variation and improve consistency in the interpretation of data,it is important to standardize research programmes and the setting of dermal absorption value in risk assessment.When the experimental data are to be timed,the corresponding skin absorption values should be selected according to the type of formulation.Dermal absorption data on another formulation can be used if the formulation which dermal absorption needs to be determined is closely related.Case-by-case judgement will be needed in some instances.