关键词: 透明质酸钠, &emsp, 医疗器械, &emsp, 体外染色体畸变试验, &emsp, 方案设计

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.

Key words: Sodium hyaluronate, &emsp, Medical device, &emsp, In vitro chromosomal aberration test, &emsp, Scheme design