聚乙烯醇明胶酯化水凝胶伤口敷料生物相容性的评价

Biocompatibility evaluation of polyvinyl alcohol-gelatin esterified hydrogel for wound dressing

背景:功能性水凝胶是一种新型的生物材料,作为伤口敷料必须通过生物学评价系列标准进行全面检测,证明材料具有良好的生物相容性后方可应用于临床。目的:对新型伤口敷料聚乙烯醇明胶酯化水凝胶的生物组织相容性进行评价。设计、时间及地点:材料学实验,于2008-04/2009-06在南华大学公共卫生学院中心实验室完成。材料:NCTCL-929小鼠成纤维细胞株由中山大学医学院细胞库提供。实验所用动物均由南华大学动物部提供。聚乙烯醇、明胶由广东省化学试剂工程技术研究开发中心提供。方法:将10g聚乙烯醇在100mL水中完全溶解后,70℃加入5g明胶,使其分散均匀,然后加入盐酸充分搅拌,进行酯化反应。将分散液浇注到模具中转化为膜状物,制成厚度为1mm的圆形薄片。按照国家标准GB/T16886的评价要求,对聚乙烯醇明胶酯化水凝胶进行细胞毒性试验、溶血试验、全身急性毒性试验和致敏试验。主要观察指标:聚乙烯醇明胶酯化水凝胶的生物组织相容性。结果:聚乙烯醇明胶酯化水凝胶浸提液的细胞毒性反应为0～1级;溶血率未超过5%;注射聚乙烯醇明胶酯化水凝胶浸提液后,小鼠无死亡、惊厥、瘫痪、呼吸抑制、腹泻和体质量下降等不良反应发生;观察72h,小鼠脊柱两侧皮肤未出现红斑、水肿等刺激反应。结论:聚乙烯醇明胶酯化水凝胶伤口敷料具有良好的组织相容性,是一种可用于临床的生物材料。

BACKGROUND：Functional hydrogel is a new biomaterial,which considered as wound dressing should be generally evaluated according to biological standard to prove the great biocompatibility prior to clinical application.OBJECTIVE：To evaluate the biocompatibility of a new kind of wound dressing,polyvinyl alcohol-gelatin esterified （PGE） hydrogel.DESIGN,TIME AND SETTING：A materials study was performed at Central Laboratory,College of Public Health,University of South China from April 2008 to June 2009.MATERIALS：Fibroblast strain of NCTC L-929 mice was provided by Medical College of Sun Yat-sen University;experimental animals were provided by Animal Faulty of Southern China University;polyvinyl alcohol and gelatin were provided by Chemical Agent Engineering Developing Center,Guangdong.METHODS：A 10-g polyvinyl alcohol was generally dissolved in 100 mL water and the mixture was added with 5 g gelatin at 70 °C.Additionally,hydrochloric acid was added and fully stirred for esterification reaction.The dispersion solution was inserted into the tooting and transformed into membrane-like products which were sectioned into 1-mm round and thin sections.Toxicity test,hemolytic test,and whole-body acute-term toxicity test,and sensitization test of PGE were performed according to national GB/T16886 standard.MAIN OUTCOME MEASURES：Biocompatibility of PGE hydrogel.RESULTS：Toxicity reaction of PGE hydrogel was grade 0-1,and hemolytic ratio was 5%.Following an injection of PGE hydrogel,mice did not have death,convulsion,paralysis,respiratory depression,diarrhea,and decreased body mass.Seventy-two hours later,erythema and edema were not observed on both sides of spine of mice.CONCLUSION：The PGE hydrogel has a good biocompatibility and can be used for wound dressing on clinic.