国家药品监督管理局查询系统的“药妆”质量研究

Quality Analysis of“Cosmeceuticals”Based on the Inquiry System of National Medicine Administration and Enlightenment

该研究采用国家药品监督管理局查询系统于2017—2019年发布的“药妆”品抽检记录数据,分析其中的不合格化妆品的类别、质量问题类别、产品产地。采用卡方检验进行分析,为药监人员实施精准监管提供科学依据。结果显示,95%的不合格化妆品为烫(染)发类、防晒类、面膜类、美白/祛斑类、祛痘/抗粉刺类。不同化妆品的不合格比例差异有显著意义(p<0.01)。广东、浙江、上海、江苏不合格化妆品占比90%。启示:结果既可为中国化妆品生产制造商提供有针对性的改进生产质量的循证依据和建议,也可为监管部门应加强对高风险产品的监管力度,靶向性地开展特定产品类别、重点产地整治工作,以进一步提高“药妆”质量。

According to the sampling data of“cosmeceuticals”published by the query system of the State Drug Administration from 2017 to 2019 were used.The categories of unqualified cosmetics,the categories of quality problems and the origin of products were analyzed.Chi square test was used for analysis,which provided scientific basis for drug supervision personnel to implement precise supervision.The results showed that 95%of the unqualified cosmetics were hair,sunscreen,facial mask,whitening freckle,acne anti acne.The unqualified proportion of different cosmetics was significantly different(p<0.01).Guangdong,Zhejiang,Shanghai and Jiangsu accounted for 90%of the unqualified cosmetics.Enlightenment:the results can not only provide evidence-based basis and suggestions for domestic cosmetics manufacturers to improve production quality,but also provide regulatory authorities with the need to strengthen the supervision of high-risk products and carry out targeted rectification of specific product categories and key production areas,so as to further improve the quality of cosmeceuticals.