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日用化学工业 ›› 2020, Vol. 50 ›› Issue (10): 698-703.doi: 10.3969/j.issn.1001-1803.2020.10.008

• 开发与应用 • 上一篇    下一篇

化妆品微生物污染状况及其防腐剂使用情况分析

张静(),刘绪平,易路遥,张春华,章瑛()   

  1. 江西省药品检验检测研究院 国家药品监督管理局中成药质量评价重点实验室 江西省药品与医疗器械质量工程技术研究中心,江西 南昌 330029
  • 收稿日期:2020-01-10 修回日期:2020-09-17 出版日期:2020-10-22 发布日期:2020-10-22
  • 通讯作者: 章瑛
  • 作者简介:张 静(1981-),女,江西人,主管药师,硕士,电话:(0791)88158675,E-mail: 330906434@qq.com
  • 基金资助:
    江西省科技厅资助项目(20192BBGL70052);江西省药品监督管理局资助项目(2019JS03)

Analysis of microbial contamination and preservative use in cosmetics

ZHANG Jing(),LIU Xu-ping,YI Lu-yao,ZHANG Chun-hua,ZHANG Ying()   

  1. Jiangxi Provincial Engineering Research Center for Drugand Medical Device Quality, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine, Jiangxi Provincial Institute for Drug Control, Nanchang, Jiangxi 330029, China
  • Received:2020-01-10 Revised:2020-09-17 Online:2020-10-22 Published:2020-10-22
  • Contact: Ying ZHANG

摘要:

通过对化妆品的微生物污染状况及其防腐剂使用情况进行分析,评价其防腐体系对微生物污染的控制能力。按《化妆品安全技术规范》(2015年版)(以下简称《规范》)对38批次市售化妆品的微生物和防腐剂进行检测,对检出情况进行整理汇总;参照《中国药典》(2015年版)四部通则1121抑菌效力检查法进行抑菌性实验。检验结果显示3批次检出微生物指标不合格,不符合《规范》的要求,检出污染菌经鉴定有豕链球菌、玫瑰色考克氏菌、成团泛菌;防腐剂种类及使用浓度均在《规范》要求范围内,7批使用4-羟基苯甲酸酯类,3批使用苯氧乙醇,1批使用甲基异噻唑啉酮,23批使用复合防腐剂;38批次化妆品均通过抑菌效力挑战实验。结果表明:化妆品微生物指标控制不能完全依赖于防腐剂,生产企业应严格控制防腐剂的使用范围及用量,并应对生产工艺和生产环境进行控制,加强生产环节中的微生物控制,提高产品质量。

关键词: 化妆品, 微生物污染, 防腐剂, 抑菌性实验, 分析

Abstract:

The microbial contamination of cosmetics and the use of preservatives were analyzed, and the control ability of the preservative system to microbial contamination was evaluated. According to “Safety and Technical Standards for Cosmetic” (2015th Edition) (hereinafter referred to as “Standards”), 38 batches of microorganisms and preservatives of commercial cosmetics were detected, and the detection conditions were summarized; the bacteriostatic test was carried out according to the general rule 1121 of the fourth part of Chinese Pharmacopoeia (2015th Edition). The results show that the microbiological indexes of three batches are unqualified, which does not meet the requirements of the “Standards”. The contaminating bacteria are identified as Streptococcus porcinus, Kocuria rosea, and Pantoea agglomerans. The type and concentration of preservatives are within the requirements of the “Standards”. 7 batches use 4-hydroxybenzoates, 3 batches use phenoxyethanol,1 batch use methyl isothiazolinone, and 23 batches use composite preservative. 38 batches of cosmetics all pass the antibacterial efficacy challenge experiment. The results show that the control of microbiological index in cosmetics cannot be completely dependent on preservatives. Manufacturers should strictly control the scope and dosage of preservatives, control the production process and production environment, strengthen the microbiological control in the production process, and improve the product quality.

Key words: cosmetics, microbial contamination, preservatives, bacteriostatic experiment, analysis

中图分类号: 

  • TQ658