摘要
背景:聚乙烯醇水凝胶作为烧伤创面的修复材料具有能保持创面湿润,有利于上皮细胞的生长和修复,加速伤口愈合。目的:拟验证物理交联法制备的聚乙烯醇水凝胶的生物相容性。设计、时间及地点:体外细胞毒性、皮内反应、迟发型超敏反应实验,2007-09/11在天津市医药科学研究所细胞实验和动物实验室完成。材料:将医用纱布浸渍于一定浓度的聚乙烯醇溶液中,通过反复冷冻解冻制备水凝胶医用材料。方法:参照GB/T16886中的体外细胞毒性、皮内反应和迟发型超敏反应标准评价材料的生物相容性。主要观察指标:①计算各组细胞的相对增殖率,确定样品的细胞毒性。②计算比较实验组与阴性组的综合平均记分。③记录样品组与阴性对照组的红斑和水肿的反应等级。结果:细胞毒性试验中,样品浸提尿液组与50%浸提原液组的细胞相对增殖率分别为80.9%,94.1%,毒性反应均为1级;皮内反应试验中综合平均记分之差为0.2,于棉籽油介质中的综合平均记分之差为0.7;迟发型超敏反应试验中,样品浸提液致敏反应记分未超出阴性对照组。结论:体外细胞毒性、皮内反应和迟发型超敏反应测试结果均达到国标要求,聚乙烯醇水凝胶具有可靠的生物安全性。
BACKGROUND： Polyvinyl alcohol （PVA） hydrogel as a repair material for burn wound can maintain the wound moisture, benefit for the growth and repair of epithelial ceils as well as accelerate the healing of wound. OBJECTIVE： To verify the biocompetibility of PVA hydrogel prepared by physical crosslinking technique. DESIGN, TIME AND SETTING： These studies, a cytotoxicity test in vitro, an intradermal reaction test, and a delayed-type hypersensitivity assay, were performed at Cellular Laboratory and Animal Laboratory in Tianjin Institute of Medical and Pharmaceutical Sciences from September to November in 2007. MATERIALS： Medical gauzes were dipped in a certain concentration of PVA solution, and then frozen-thawed repeatedly to prepare hydrogel materials. METHODS： The biocompatibility of the material was evaluated according to the standards of cytotexicity test in vitro, intradermal reaction test and delayed-type hypersensitivity assay recommended in GB/T 16886. MAIN OUTCOME MEASURES： （1）The relative growth rates were calculated in each group to determine the cytotoxicity of sample. （2）The comprehensive average scores were compared between experiment group and negative group. （3）The reaction classes of erythema and edema in sample group and negative control group were recorded. RESULTS： In the cytotoxicity test, the cellular relative growth rates in sample were 80.9% in original extraction group and 94.1% in 50% dilution group. The toxicity reaction of either group was first grade. After intravenous injection of sample extraction and vehJcle blank during the Jntradermal reaction test, the differences of mean comprehensive score between test and control groups were 0.2 for saline medium and 0.7 for cottonseed oil medium. The sensitization score of test group was no more than that of the negative control group in delayed-type hypersensitivity assay. CONCLUSION： The results of cytotexicity test in vitro, intradermal reaction test and delayed-type hypersensitivity assay of hydrogel samples were all met to the requirements of state standards, therefore PVA hydrogel prepared has reliable biocompatibility.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2009年第12期2227-2231,共5页
Journal of Clinical Rehabilitative Tissue Engineering Research
基金
中国人民解放军军事医学科学院院学科培育项目
全军“十一五”重大专项项目(06D002)~~
