Biosafety of prednisolone implantable film

Tang Yu-sen; Li Qiang; Qi Peng; Lian Ke-jian

doi:10.3969/j.issn.2095-4344.2013.51.011

Abstract：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 prednisolone-loaded film which can sustain drug release and good achievement in in vitro drug release test. <br> OBJECTIVE:To prepare the prednisolone implantable film and investigate its in vivo biocompatibility and safety. <br> 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 celltoxicity test, hemolysis test, acute systemic toxicity test, chronic systemic toxicity test. <br> 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 il ustrated 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.