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基于L.、L.和L.活性成分的多重水包油包水型乳液的体外和临床安全性评估

In Vitro and Clinical Safety Assessment of the Multiple W/O/W Emulsion Based on the Active Ingredients from L., L. and L.

作者信息

Zlabiene Ugne, Baranauskaite Juste, Kopustinskiene Dalia M, Bernatoniene Jurga

机构信息

Institute of Pharmaceutical Technology, Faculty of Pharmacy, Medical Academy, Lithuanian University of Health Sciences, Sukileliu pr. 13, LT-50161 Kaunas, Lithuania.

Department of Analytical and Toxicological Chemistry, Faculty of Pharmacy, Medical Academy, Lithuanian University of Health Sciences, Sukileliu pr. 13, LT-50161 Kaunas, Lithuania.

出版信息

Pharmaceutics. 2021 May 16;13(5):732. doi: 10.3390/pharmaceutics13050732.

Abstract

The multiple W/O/W emulsion supplemented with the extracts of L., L. and L. was prepared in the study, its active compounds were determined by HPLC and its safety was evaluated in vitro by the means of reconstituted human skin model EpiDerm™ for the assessment of its irritation, phototoxicity and early skin inflammation effects and by the 48 h human skin patch test for its skin irritation and allergenic potential. The microbiological challenge test of W/O/W emulsion was performed to ensure its preservation efficiency. The results showed that the W/O/W emulsion loaded with self-preserving plant-based bio-actives had no irritant potential, was not phototoxic and did not provoke skin inflammation or sensitization and thus could be used as a safe base for cosmetic products. Furthermore, our results demonstrate that the safety evaluation of cosmetic ingredients of natural or organic origin could be easily performed using reconstructed human skin model EpiDerm™ similar to the well-defined chemicals used in the cosmetics industry.

摘要

本研究制备了添加了薰衣草、迷迭香和柠檬香蜂草提取物的多重水包油包水乳液,通过高效液相色谱法测定其活性成分,并通过重组人皮模型EpiDerm™体外评估其刺激性、光毒性和早期皮肤炎症效应,以及通过48小时人体皮肤斑贴试验评估其皮肤刺激性和致敏潜力,从而对其安全性进行评估。进行了水包油包水乳液的微生物挑战试验以确保其防腐效率。结果表明,负载具有自防腐功能植物源生物活性成分的水包油包水乳液无刺激潜力,无光毒性,不会引发皮肤炎症或致敏,因此可作为化妆品的安全基质。此外,我们的结果表明,使用重组人皮模型EpiDerm™可以轻松地对天然或有机来源的化妆品成分进行安全性评估,这与化妆品行业中使用的明确化学品类似。

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