水溶性化妆品霉菌和酵母菌快速检测替代方法  

An alternative method for the rapid detection of mold and yeast in water-soluble cosmetic

作　　者：安丽康 武晓青 李聪 周玉岩 赵振霞 AN Likang;WU Xiaoqing;LI Cong;ZHOU Yuyan;ZHAO Zhenxia(Hebei Institute for Drug and Medical Device Control,Shijiazhuang Hebei 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050227

出　　处：《河北省科学院学报》2024年第4期54-59,共6页Journal of The Hebei Academy of Sciences

基　　金：河北省药品监督管理局科技计划项目(2022ZC1018)。

摘　　要：本文旨在研究采用测试片法进行水溶性化妆品霉菌和酵母菌快速检测的可行性。选取了6批化妆品面膜,参照《中国药典》2020年版非无菌产品微生物限度检查的微生物计数法,从专属性、定量限、重现性和耐用性几个方面对测试片法进行考察,并进行6批面膜测试片法的方法适用性试验。结果显示,测试片法与《化妆品安全技术规范》(2015年版)中平皿法在专属性、定量限、重现性和耐用性等方面无明显差异,6批面膜测试片法方法适用性试验结果回收率均在0.7~1.1之间,表明测试片法可作为快速检测法对水溶性化妆品中霉菌和酵母菌进行检测。In this paper,the feasibility of rapid detection of mold and yeast in water-soluble cosmetics by test tablets is studied.Six batches of cosmetic masks are selected,and referring to the ″Guidelines for Validation of Alternative Methods for Microbial Testing of Drugs″ in the ″Pharmacopoeia of the People′s Republic of China″(2020 edition),Part IV,General Rule 9201,and ″Microbial Limits Test for non-Sterile Products:Microbial Counting Method″,General Rule 1105,the test table method is evaluated in terms of specificity,limit of quantitation,reproducibility,and robustness.Additionally,method applicability trials for the test table method are conducted on six batches of masks.The results show that there is no obvious difference between the test tablet method and the flat plate method in the ″Cosmetic Technical Specifications″(2015 edition) in terms of specificity,quantitative limit,reproducibility,durability and other aspects.The recovery rate of the applicability test results of six batches of face masks for the test table method is between 0.7 and 1.1.The test tablet method can be used as a rapid test for mold and yeast detection in water-soluble cosmetics.

关 键 词：水溶性化妆品 霉菌和酵母菌 测试片法 快速检测 

分 类 号：TQ658[化学工程—精细化工]