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Analytical method development and percutaneous absorption of propylidene phthalide, a cosmetic ingredient
Journal of Toxicology and Environmental Health, Part A ( IF 2.6 ) Pub Date : 2021-06-30 , DOI: 10.1080/15287394.2021.1944941
Ji-Young Kim 1, 2 , Jueng Eun Im 1, 3 , Jung Dae Lee 1 , Kyu-Bong Kim 1
Affiliation  

ABSTRACT

Propylidene phthalide (PP) is a cosmetic ingredient used in the fragrance industry and regulated for the limited content of 0.01% in cosmetic products in Korea. The aim of this study was to determine PP dermal absorption rate according to the Korea Ministry of Food and Drug Safety (MFDS) guidelines using in vitro Franz diffusion system. An analytical method in assessing PP was developed through method validation using LC–MS/MS. Linearity, precision, and accuracy were acceptable based upon MFDS guidelines. The stability of PP in receptor fluid (50% ethanol) at 32°C was sufficient up to 24 hr. Cream formulation (o/w) was topically applied to excised rat skin at a dose of 113 mg/cm2 containing 0.7% PP. The time points for receptor fluid collection were set at 0, 1, 2, 4, 8, 12, and 24 hr. After 24 hr, the remaining formulation on the skin and stratum corneum (SC) were collected through swabbing with an alcohol cotton and tape stripping, respectively. The collected samples (swabbed-remained formulation, SC, and skin) were extracted using acetonitrile for 24 hr. Total dermal absorption rate of PP was approximately 24% in cream formulation. These findings may be used for further exposure evaluation of PP in human consumers.



中文翻译:

化妆品成分丙叉苯酞的分析方法开发和经皮吸收

摘要

丙二苯酞 (PP) 是一种用于香水行业的化妆品成分,在韩国化妆品中的含量限制为 0.01%。本研究的目的是根据韩国食品药品安全部 (MFDS​​) 指南,使用体外Franz 扩散系统确定 PP 皮肤吸收率。通过使用 LC-MS/MS 的方法验证开发了一种评估 PP 的分析方法。根据 MFDS 指南,线性、精密度和准确度是可以接受的。PP 在受体液(50% 乙醇)中在 32°C 下的稳定性足以维持长达 24 小时。乳膏制剂 (o/w) 以 113 mg/cm 2的剂量局部施用于离体的大鼠皮肤含 0.7% PP。接收液收集的时间点设置为 0、1、2、4、8、12 和 24 小时。24 小时后,分别通过用酒精棉擦拭和胶带剥离收集皮肤和角质层 (SC) 上的剩余制剂。收集的样品(擦拭残留的制剂、SC 和皮肤)使用乙腈提取 24 小时。在乳膏配方中,PP 的总皮肤吸收率约为 24%。这些发现可用于进一步评估人类消费者中 PP 的暴露情况。

更新日期:2021-08-09
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