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日用化学工业(中英文) ›› 2026, Vol. 56 ›› Issue (10): 1419-1425.doi: 10.3969/j.issn.2097-2806.2026.10.015

• 分析与检测 • 上一篇    下一篇

高效液相色谱法测定化妆品中类视黄醇及产品风险评价研究

刘慧锦1,王海燕1,冯克然1,邢宇2,张伟清1,*()   

  1. 1 中国药品检定研究院, 北京 100050
    2 安捷伦科技(中国)有限公司, 北京 100102
  • 收稿日期:2025-12-04 修回日期:2026-09-15 出版日期:2026-10-22 发布日期:2026-10-30

Determination of retinoids in cosmetics by high-performance liquid chromatography and product risk assessment

Huijin Liu1,Haiyan Wang1,Keran Feng1,Yu Xing2,Weiqing Zhang1,*()   

  1. 1 National Institutes for Drug Control, Beijing 100050, China
    2 Agilent Technologies, Beijing 100102, China
  • Received:2025-12-04 Revised:2026-09-15 Online:2026-10-22 Published:2026-10-30
  • Contact: E-mail: zhangweiqing@nidc.org.cn

摘要:

建立了化妆品中9种类视黄醇的高效液相色谱检测方法,对样品前处理条件及色谱条件进行优化,并用该方法对市售56批含类视黄醇化妆品开展质量安全风险评价。样品采用四氢呋喃分散,乙腈超声提取,经C18色谱柱分离,以乙腈-5 mmol/L乙酸铵水溶液-四氢呋喃梯度洗脱。结果表明,9种类视黄醇化合物在相应质量浓度范围内线性关系良好,相关系数均大于0.998。选取水剂、膏霜、乳液、油剂、凝胶等5种基质进行加标回收试验,平均回收率为86.96%~109.63%,RSD为0.30%~8.55%,适用性广泛。56批市售化妆品检验结果显示,29批样品检验结果与标签标识不符,其中8批样品将类视黄醇作为特定宣称原料功效进行备案但未检出,涉及虚假功效宣传。另有3批样品检出禁用原料视黄酸、异视黄酸,存在一定的安全风险。建议药品监管部门持续关注类视黄醇原料及相关化妆品的使用安全性,督促企业规范化生产,进一步完善产品标签标识及功效宣称管理体系的建设。

关键词: 化妆品, 类视黄醇, 高效液相色谱法, 标签标识, 功效宣称

Abstract:

A high-performance liquid chromatography (HPLC) method was established for the determination of 9 retinoids in cosmetics. The sample pretreatment and chromatographic conditions were optimized, and this method was used to assess quality and safety risks of 56 batches of cosmetics containing retinoids. The samples were dissolved in tetrahydrofuran (THF) and ultrasonically extracted with acetonitrile. The nine retinoids were separated on a C18 chromatographic column, and eluted with a gradient of acetonitrile-aqueous ammonium acetate solution (5 mmol/L) -THF. The results show that the nine retinoids exhibit good linearity with the correlation coefficients exceeding 0.998. Five cosmetic matrices are selected for spiked recovery tests, yielding average recoveries ranging from 86.96% to 109.63%, with RSDs between 0.30% and 8.55%. The detection results of the 56 batches of samples show that retinoids in 29 batches of samples do not conform to their labels. Among them, eight batches that claim specific retinoid ingredients on their registration contain no detectable levels, indicating false efficacy claims. Additionally, three batches contain prohibited ingredients, specifically retinoic acid and isotretinoin, posing substantial safety risks. Therefore, regulatory authorities should continuously monitor the safety of retinoid ingredients and related cosmetics, urge enterprises to standardize production. Furthermore, comprehensive supervision of cosmetic labeling and efficacy claims remains imperative.

Key words: cosmetic, retinoid, high-performance liquid chromatography, product label, efficacy claims

中图分类号: 

  • TQ658