摘要
研发新一代液体创口贴,获得国家医疗器械注册证。通过研究成膜材料选择、液体制剂处方筛选、工艺及性能对比研究、性能指标及检验方法完善,优化配方工艺,建立产品检验和验证方法,制定医疗器械生产企业质量体系文件,建成了年产48万支(10,m L)的生产线,产品开始进入市场。产品涂于创面,溶剂蒸发后即形成薄膜敷料,具有防水、透气、阻菌、保护创面、促进伤口愈合等作用。
A new generation of liquid bandage was developed with the national medical device registration certificate.Main research includes film-forming material selection, liquid formulation screening, process and performance contrast research,performance index and test methods research.The formulation process was optimized,product inspection and verification method was established, the medical device manufacturing enterprise quality system documents were developed.A production line with annual capacity of 480,000 tubes(10,m L/tube)was built and products began to enter into the market.After applied to the wound,the product can form a thin film after solvent evaporation.The film uses waterproof,breathable and bacteria resistant materials and can protect the wound and promote wound healing.
作者
杜璇
杨政
DU Xuan;YANG Zheng(Shanghai Center of Medicine Development,Shanghai 201203,China;Jiangsu High-wit Medical Ltd.,Nanjing 210061,Jiangsu Province,China)
出处
《天津科技》
2018年第5期51-55,58,共6页
Tianjin Science & Technology
关键词
医疗器械
液体创口贴
丙烯酸类树脂
制备工艺
medical equipment
liquid bandage
acrylic resin
preparation technique