摘要
以Ⅰ型胶原蛋白、酸性成纤维细胞生长因子(acidFibroblastGrowthFactor,aFGF)为主要原料,研制一种新型的创伤敷料,并对其进行了临床试验。制备高纯度的Ⅰ型胶原蛋白溶液,透析至中性,加入aFGF溶液冷冻干燥成为海绵体。再进行生物安全性评价试验,包括急性毒性试验、刺激性试验、致敏试验、溶血性试验、细胞毒性试验以及动物体内埋植试验;在临床上选取开放性创面进行贴敷,评价其治疗效果。结果:aFGF胶原海绵的毒理学试验结果均呈阴性,在兔肝埋植试验中未见异常反应,8周内降解;临床上应用具有促进创面愈合,阻止渗液溢出的效果。所研制的aFGF胶原海绵无毒副作用,具有良好的临床疗效,具备推广应用的前景。
The purpose is to prepare a wound dressing made from aFGF and collagen. The biocompatibility tests and clinical curative effects were detected to evaluate its biological security and clinical effect. aFGF solution was put into purified collagen solution, then becoming sponge by freeze-drying, followed by the biocompatibility tests, including acute toxicity, stimulation, allergy, hemolysis and cell toxicology, as well as the test of implanting in rabbits liver. Then the clinical test of trauma was done.All of biocompatibility tests were negative. The result of implanting test was in gear, and the aFGF-collagen sponge could degrade completely in liver in 8 weeks. The clinical test showed that the aFGF-collagen sponge could not only accelerate the speed of curing but also restrain the trauma extravasation. The aFGF-collagen sponge had good biocompatibility and clinical curative effects. It was suggested to be a security biomaterial for medical use.
出处
《药物生物技术》
CAS
CSCD
2005年第3期171-174,共4页
Pharmaceutical Biotechnology
关键词
酸性成纤维细胞生长因子
胶原
创伤敷料
Acid Fibroblast Growth Factor(aFGF), Collagen, Wound dressing
