化妆品中防腐剂苯甲醇检测能力验证质量控制措施及结果分析  

Analysis of Quality Control Measures and Outcomes for Benzyl Alcohol Preservative Detection in Cosmetics

作　　者：严倩云 韩晓萍 李玉丽 李亚楠 王启林 YAN Qianyun;HAN Xiaoping;LI Yuli;LI Yanan;WANG Qilin(Drug inspection and testing Institute of Qinghai Provincial,Xi'ning,Qinghai 810016,China;Key Laboratory of Quality Control of Traditional Chinese Medicine(Tibetan Medicine)State Medical Products Administration,Xi'ning,Qinghai 810016,China)

机构地区：[1]青海省药品检验检测院青海省中藏药现代化研究重点实验室,青海西宁810016 [2]国家药品监督管理局中药(藏药)质量控制重点实验室,青海西宁810016

出　　处：《中国洗涤用品工业》2025年第3期91-96,共6页China Cleaning Industry

摘　　要：通过参加“化妆品中防腐剂苯甲醇的测定”(NIFDC-PT-499)能力验证,验证实验室检测化妆品中苯甲醇的技术能力和水平,提高实验人员对化妆品防腐剂项目检测的技术能力,促进实验室化妆品检测能力和技术水平的提升。根据中国食品药品检定研究院提供的NIFDC-PT-499《化妆品中防腐剂的测定》作业指导书和《化妆品安全技术规范》(2015年版)第四章4.1甲基异噻唑啉酮等23个组分检验方法,采用高效液相色谱法对能力验证样品中苯甲醇的含量进行测定,并且通过加标回收、精密度、标准物质核查、质控样核查、仪器比对、人员比对以及实验结果比对等多重质量控制措施,对结果的准确度进行控制。苯甲醇在浓度范围内与峰面积呈良好线性关系,相关系数(R^(2))在0.999以上,回收率为90%。能力验证结果中Z值为0.10,结果为满意,检测结果未离群。能力验证结果表明实验室对化妆品中防腐剂苯甲醇定量测定能力较好。To verify the laboratory's technical competence in detecting benzyl alcohol in cosmetics and enhance the personnel's proficiency in preservative detection,ultimately promoting the lab's overall technical capability in cosmetics analysis.Methods:Following the NDC-PT-499"Determination of Preservatives in Cosmetics"work instruction and the"Cosmetic Safety Technical Specification"(2015 edition)provided by the National Institute for Food and Drug Control,high-performance liquid chromatography(HPLC)was employed to determine benzyl alcohol content in proficiency testing samples.Multiple quality control measures,including added standard recovery,precision assessment,standard material verification,quality control sample verification,instrument comparison,personnel comparison,and experimental results comparison,were implemented to ensure the accuracy of results.Benzyl alcohol exhibited a strong linear relationship with peak area within the concentration range,with a correlation coefficient(R^(2))exceeding 0.999 and a recovery rate of 90%.The capability verification result yielded a Z-value of 0.10,indicating satisfactory performance,and the detection result was not an outlier.Conclusion:The proficiency test results demonstrate that the laboratory possesses excellent capability for the quantitative determination of benzyl alcohol in cosmetics.

关 键 词：能力验证 苯甲醇 防腐剂 化妆品 质量控制 

分 类 号：TQ047.6[化学工程]