国内外化妆品微生物污染现状与防腐体系构建  

Current Status of Microbial Contamination in Cosmetics at Home and Abroad and the Construction of Preservative System

作　　者：罗阿利 李辉 LUO Ali;LI Hui(Shaanxi Provincial Drug Technical Evaluation Center,Xi'an,Shaanxi,China 710065;Shaanxi Shengdetailin Biological Safety Technology Testing Co.,Ltd.,Xi'an,Shaanxi,China 710077)

机构地区：[1]陕西省药品技术审评中心,陕西西安710065 [2]陕西盛德泰林生物安全技术检测有限公司,陕西西安710077

出　　处：《中国药业》2024年第20期6-11,共6页China Pharmaceuticals

基　　金：陕西省重点研发计划项目[2022SF-390]。

摘　　要：目的为我国构建化妆品防腐体系提供参考。方法分析当前国内外化妆品微生物污染现状及其影响因素,并探讨化妆品防腐体系的构建思路。结果国内外化妆品微生物污染问题集中于需氧菌总数及霉菌和酵母菌总数,国外致病菌以铜绿假单胞菌、大肠埃希菌等革兰阴性菌较常见,国内未发现致病菌。化妆品微生物污染的影响因素包括产品设计、配方优化两部分;可基于危害分析和关键点控制(HACCP)等体系构建一级屏障,基于物理、化学因素构建二级屏障,共同形成国内化妆品防腐体系。结论设计化妆品配方时,可综合考虑包装系统、水分活度、pH、剂型、防腐剂、功能性组分、其他因素等指标,形成防腐体系,减少防腐剂的使用,降低因防腐剂单一栅栏因子导致的化妆品接触性过敏性皮炎发生风险,提高化妆品整体防腐效能。Objective To provide a reference for the construction of a cosmetic preservative system in China.Methods The current status of microbial contamination in cosmetics at home and abroad and its influencing factors were analyzed,and the construction ideas of cosmetic preservative system were explored.Results The microbial contamination in cosmetics at home and abroad mainly involved the total count of aerobic bacteria,total count of molds and yeasts.Gram-negative bacteria such as Pseudomonas aeruginosa and Escherichia coli were more common in foreign countries,while no pathogenic bacterium had been found in China.The influencing factors of microbial contamination in cosmetics included product design and formula optimization.The first-level barrier was built based on hazard analysis critical control point(HACCP)system,and the second-level barrier was built based on physical and chemical factors,which jointly formed a domestic cosmetic preservative system.Conclusion When designing cosmetic formulas,the packaging system,water activity,pH,dosage form,preservatives,functional components and other factors can be considered comprehensively to form a preservative system,which can decrease the amount of preservatives,lower the risk of cosmetic contact allergic dermatitis induced by a single fence factor of preservatives,and improve the overall preservative efficacy of cosmetics.

关 键 词：化妆品 微生物污染 防腐剂 防腐体系 防腐效能 栅栏理论 

分 类 号：R95[医药卫生—药学] TQ423[化学工程]