可吸收多糖微球的制备及生物相容性研究  

Preparation and Biocompatibility Investigation of the Absorbable Polysaccharide Microspheres

作　　者：姜丽娟[1] 李玲[1] 张春霞[1] 宋祥[1] 张林林[1] 刘长凤[1] 

机构地区：[1]山东赛克赛斯药业科技有限公司,山东济南250000

出　　处：《生物医学工程研究》2014年第1期32-34,共3页Journal Of Biomedical Engineering Research

摘　　要：采用淀粉为主要原料经乳化交联制备一种具有微孔结构的新型可降解止血材料。并根据GB/T16886医疗器械生物学评价标准规定的皮内反应试验、致敏试验、全身急性毒性试验和植入试验方法评价可吸收多糖微球的生物相容性,同时与进口微球作对比,以验证其安全性。试验结果显示无皮内反应、无致敏、无全身急性毒性、肌肉植入2周后未见固形物,无明显组织反应。可吸收多糖微球具有良好的生物相容性,符合临床使用要求。The absorbable polysaccharide microspheres is made of potato starch by emulsion and cross-linking,which is a kind of novel biodegradable hemostatic materials with microporous structure. The absorbable polysaccharide microspheres was studied by using the subcutaneous reactivity,sensitization,acute systemic toxicity,intramuscular implantation tests described in GB / T16886. The experimental results showed that the microporous polysaccharide microspheres had no subcutaneous reactivity,no sensitization,no acute systemic reaction,no solids and obvious tissue reaction observed after 2 weeks implantation. It is concluded that the absorbable polysaccharide microspheres has excellent biocompatibility and meets the requirement for clinical application.

关 键 词：微球 皮内反应 致敏 植入试验 生物相容性 

分 类 号：R318[医药卫生—生物医学工程]