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Title:: The preparation and biological safety evaluation for ultra smooth antibacterial coating for new catheter

作者:: 李育强1; 智倩倩1△; 王晓丽1; 王南南1; 韩超1; 孔晓颖2; 1.青岛明药堂医疗股份有限公司，青岛 266111；2.青岛农业大学，青岛 266109

Author(s):: LI Yuqiang1; ZHI Qianqian1; WANG Xiaoli1; WANG Nannan1; HAN Chao1; KONG Xiaoying2; 1.Qingdao Miuton Medical Share CO., LTD., Qingdao 266111，China；2.Qingdao Agricultural University, Qingdao 266109

Keywords:: Rubber catheter; Coating; Antibacterial; Photografting; Preparation; Biological safety

摘要:: 以硅胶导管为基体材料，将丙烯酸单体进行紫外接枝，制备得到一种具有较高生物安全性的超滑抗菌导管，探讨了单体浓度、体系温度、紫外接枝时间等重要因素对超滑涂层的影响。依据《医用器械生物学评价国家标准》GB/T 16886体系，采用细胞毒性MTT法、皮下刺激、黏膜刺激试验对新型超滑抗菌涂层的安全性进行研究。结果表明，超滑涂层厚度随丙烯酸单体浓度增加而先增后降，优化浓度为95 mM；随体系温度升高、紫外接枝时间延长，涂层厚度增加，优化温度及紫外接枝时间分别为35℃、7 min。新型硅胶超滑抗菌导尿管与普通硅胶导尿管相对增殖率（RGH）均值间无显著性差异，细胞毒性均为1级，皮下刺激评分为0，对阴道黏膜无刺激。新型超滑抗菌涂层符合医疗器械生物学评价标准要求，为其临床应用提供理论依据。

Abstract:: To use ultraviolet graft of acrylic monomer as the substrate material to prepare an ultra-slippery antibacterial catheter with high biological safety. The influence of monomer concentration, system temperature, UV graft time on the superslip coating was discussed. In this article, the biological safety of ultra smooth antimicrobial coating was studied by MTT of cytotoxicity, subcutaneous stimulation and vaginal mucosa stimulation test, which was based on the national standard of biological evaluation of medical instruments GB/T 16886. Ultra smooth antimicrobia coating was prepared on silica rubber catheters. The results showed that there was no significant difference in the relative proliferation rate (RGH) between the new ultra smooth antimicrobial silicone rubber catheters and the ordinary ones. The cytotoxicity was grade 1. The subcutaneous stimulation score was 0, and the vaginal mucosa was not stimulated. The new ultra smooth antimicrobial coatings meets the requirements of biological evaluation standard for medical devices, it provides theoretical basis for its clinical application.