重组碱性成纤维细胞生长因子凝胶剂的制备

目的制备重组碱性成纤维细胞生长因子(bFGF)凝胶剂。方法以卡波姆940、甘油、1,2丙二醇为基质,加入复方保护剂(肝素钠、人血白蛋白、甘露醇和HP-β-CD),制成bFGF凝胶剂,观察25和4℃保存的稳定性,并进行家兔局部刺激试验、急性毒性试验、促烧伤创面愈合试验。结果bFGF凝胶剂在25℃保存18个月、4℃保存24个月,效价维持在原效价的80%以上;局部用药未见皮肤刺激反应和急性毒性反应;促家兔烧伤创面愈合的效果明显优于水溶液剂。结论制备的bFGF凝胶剂安全有效,具有缓释作用,稳定性良好,具有广阔的临床应用前景。

Preparation of Recombinant Basic Fibroblast Growth Factor Gel

Objective To prepare recombinant basic fibroblast growth factor(bFGF)gel.Methods Recombinant bFGF gel was prepared by using a matrix consisting of carbomer 940,glycerol and 1,2-propylene glycol and a compound protective agent consisting of heparin sodium,human serum albumin,mannitol and HP-β-CD and observed for stability at 25 and 4℃,then subjected to local stimulation test in rabbits,acute toxicity test and burn surface healing test.Results After storage at 25℃ for 18 months or at 4℃ for 24 months,the titer of prepared bFGF was more than 80% of the original titer.The curative effect of bFGF gel on burn surface of rabbits was superior to that of liquid bFGF,and no skin stimulation or acute toxicity was observed.Conclusion The prepared recombinant bFGF is safe,effective and may be control-released,thus may be used widely in clinic.