医用透明质酸锌凝胶临床前生物安全性研究

Biological Safety Study on Medical Used Zinc Hyaluronate Gel BeforeClinic

医用透明质酸锌凝胶可为受损的皮肤提供物理保护,并为伤口愈合提供一个最佳环境。我们根据GB/T16886《医疗器械生物学评价》系列标准对其进行临床前生物安全性研究。结果表明:医用透明质酸锌凝胶未产生皮肤刺激反应和迟发型超敏反应,有一定的细胞毒性,与同类产品相比具有良好的生物安全性。

edical used zinc hyaluronate gel can protect wounded skin and provide a perfect wound-curing surrounding.Its biological safety according to GB/T16886 《Biological Evaluation of Medical Devices 》was studied.Under the conditions of the study,medical used zinc hyaluronate gel showed no evidence of significant irritation and delayed-type hypersensitivity,but showed an evidence of significant cytotoxicity.Compared with other wound dressing,its biological safety is quite well.