背景:目前基于植物油体(油体)的SPF产品的体外SPF筛选方法在SPF等级上具有明显的不一致性和低可靠性。
目的:本研究的主要目的是评估分光光度法测定的基于油脂体的SPF产品的防晒系数(SPF)的可靠性和重现性。次要目标是分光光度测量与体内SPF测试的数据比较,以建立可靠的体外测试方法作为筛选测定法。
方法:将甲氧基肉桂酸辛酯(UVB过滤器)和阿伏苯宗(UVA过滤器)装入红花油体中,并配制成水包油乳液基成品。为了评估体内和分光光度测试方法之间的可靠性,样本被送往临床实验室,并将报告的SPF值与分光光度测试结果进行比较。
结果:从体内和分光光度测试结果观察到的SPF证明了与SPF30产品的高度相关性。对于SPF15和50产品,观察到两种评估方法之间的比例相关性,准确性稍低,在临床研究中测试的人群数量较少。
结论:以两种广泛使用的有机紫外防晒活性物质为例,开发了一种可靠的油体SPF配方分光光度筛选方法。与美国FDA指导的体内SPF测试方法相比,结果具有较高的可重复性和可靠性。
BACKGROUND: Current in vitro SPF screening method for plant oil body (oleosome)-based SPF products possesses significant inconsistency and low reliability in the SPF rating.
OBJECTIVE: The primary objective of this study was to evaluate the reliability and reproducibility of spectrophotometrically determined sun protection factor (SPF) from oleosome-based SPF products. The secondary objective was the data comparison of the spectrophotometric measurements against in vivo SPF testing to establish a reliable in vitro test method as a screening assay.
METHODS: Octyl methoxycinnamate (UVB filter) and avobenzone (UVA filter) were loaded into safflower oil bodies and formulated into oil-in-water emulsion-based finished products. To evaluate the reliability between in vivo and spectrophotometric test methods, samples were dispatched to a clinical laboratory, and the reported SPF values were compared with spectrophotometric test results.
RESULTS: The observed SPF from the in vivo and spectrophotometric test results demonstrated a high correlation for SPF 30 products. Proportional correlation between the two evaluation methods was observed for SPF 15 and 50 products with slightly lesser accuracy with a smaller number of population tested in the clinical studies.
CONCLUSIONS: A reliable spectrophotometric screening method for oil body-based SPF formulas has been developed using two broadly used organic UV sunscreen actives as a
case study. The results demonstrated a high level of reproducibility and reliability compared to the US FDA-guided in vivo SPF testing method.