强的松龙纳米微球缓释膜的生物安全性  

Biosafety of prednisolone implantable film

作　　者：汤育森[1] 李强[1] 齐鹏[1] 练克俭[1] 

机构地区：[1]解放军第175医院骨科,福建省漳州市363000

出　　处：《中国组织工程研究》2013年第51期8849-8855,共7页Chinese Journal of Tissue Engineering Research

基　　金：漳州市科技基金(Z2010086)~~

摘　　要：背景:如何用药物去抑制神经修复后瘢痕的生长成为周围神经损伤后功能恢复的关键。课题组以往研究借鉴广泛应用于抗肿瘤药物局部释放的纳米微球缓释技术设计了一种强的松龙纳米微球缓释膜,取得了良好的体外药物缓释效果。目的:制备强的松龙纳米微球缓释膜,观察该膜的生物相容性及安全性。方法:采用反胶束乳化溶剂挥发法和球膜结合的方法制备强的松龙纳米微球缓释膜,用细胞毒性实验、溶血实验、急慢性全身毒性实验对药膜的生物安全性进行初步评价。结果与结论:培养第7天,L929小鼠成纤维细胞相对增殖率为92.6%,证实此膜无细胞毒性;该膜对新鲜的抗凝兔血溶血率为0.59%,无明显的溶血作用;此缓释膜的浸提液腹腔注射小鼠未见明显的生物学行为的异常,对大鼠肝肾功能无明显影响。结果证实,强的松龙纳米微球缓释膜具有良好的生物相容性,安全无毒性。BACKGROUND： After peripheral nerve injury, to inhibit scar formation by drugs is the key to functional recovery. To reduce the amount of scar formation we designed a prednis01one-loaded film which can sustain drug release and good achievement in in vitro drug release test. OBJECTWE To prepare the prednisolone implantable film and investigate its in vivo biocompatibility and safety. METHODS： Prednisolone-loaded nanoparticles were first prepared with reverse micellar emulsion-solvent evaporation method, and the composite film and drug-loaded film were further prepared. Then, we investigated the in vivo biocompatibility of drug-loaded film through cell toxicity test, hemolysis test, acute systemic toxicity test chronic systemic toxicity test. RESULTS AND CONCLUSION： After cultured for 7 days, the relative growth rate of L929 mouse fibroblasts was 92.6%, showing no cytotoxicity. The hemolysis rate of the film was 0.59%, indicating that the material had no hemolysis action. No abnormal biological behaviors were seen in mice after intraperitoneal injection of film extracts, and there were no changes in liver and renal functions in rats. As illustrated above, we can safely come to a conclusion that prednisolone-loaded film possesses good biocompatibility and can be safely used in the experiment of reducing the scar at sites of peripheral nerve repair.

关 键 词：生物材料 纳米生物材料 强的松龙 纳米微球 缓释膜 周围神经 生物安全性 

分 类 号：R318[医药卫生—生物医学工程]