组织工程与重建外科杂志2025，Vol.21Issue(3)：271-276,6.DOI:10.3969/j.issn.1673-0364.2025.03.009
水光针类产品体外染色体畸变试验设计要点
Key aspects of designing an in vitro chromosomal aberration test for mesotherapy products
王蕊 1史建峰 1柯林楠1
作者信息
- 1. 102629 北京市 中国食品药品检定研究院生物材料室
- 折叠
摘要
Abstract
Objective Higher standards for the inspection and registration of mesotherapy products have been implemented due to the products reclassification.Since many of these items require genotoxicity screening,the aim of this paper is to provide a scientific method for in vitro chromosome aberration test of these products.Methods A detailed in vitro chromosome aberration test method for sodium hyaluronate solution products was introduced,and a specific product was selected for test analysis.Results The chromosomal aberration rate of CHL cells was not significantly increased under both active and inactive conditions and no dose-response relationship was observed.The test results were negative.Conclusion This study presents the design and operation details of in vitro chromosome aberration test for mesotherapy products,which can provide references for testing institutions and related research and development enterprises.关键词
透明质酸钠/医疗器械/体外染色体畸变试验/方案设计Key words
Sodium hyaluronate/Medical device/In vitro chromosomal aberration test/Scheme design分类
经济学引用本文复制引用
王蕊,史建峰,柯林楠..水光针类产品体外染色体畸变试验设计要点[J].组织工程与重建外科杂志,2025,21(3):271-276,6.
