碱性成纤维细胞生长因子凝胶的无菌检查

Sterility Test of Basic Fibroblast Growth Factor Gel

目的建立碱性成纤维细胞生长因子(bFGF)凝胶剂的无菌检查方法。方法依据《中国药典》2010年版三部要求,采用直接接种法进行bFGF凝胶剂无菌检查并进行方法学验证。结果与结论通过方法学验证说明建立的无菌检查法适用于bFGF凝胶剂的无菌检查。

Objective To establish a method for sterile test of recombinant growth factor （bFGF） gel. Methods The direct inoculation method was used for t gel according to relevant requests in ChP 2010, volume Ⅲ and methodology valid this study. Results and Conclusion The methodology validation demonstrated that was suitable for sterile test of bFGF gel. h b uman basic fibroblast e sterile test of bFGF ation was performed in the established method