【摘要】 目的在冻干重组碱性成纤维细胞生长因子制剂中引入一种无人血清白蛋白保护剂。方法采用 3种药用辅料按一定比例配制保护剂。结果加入无人血清白蛋白保护剂的 3批供试品 ,成品各项检查均合格。生物效价在 (40± 2 )℃、(2 5± 2 )℃、2℃～ 8℃保存分别达 6、12、3 0个月。结论在重组碱性成纤维细胞生长因子冻干制剂中无人血清白蛋白保护剂可以替代人血清白蛋白更多还原

【Abstract】 PurposeIntroduction a new protective agent w ithout human serum albumin in lyophilized recombinant basic fibroblast gr owth factor product.MethodsBased on definition proportio n dispensing to make protective agent of three kinds pharma-accessories.ResultsThe bioactivity of three lost exponent of protect ive agent without human serum albumin keeping 6 months(storage in 40℃±2℃)、k eeping 12 months (storage in 25℃±2℃) and keeping 30 months (storage in 2℃～8 ℃),final products all qualified.ConclusionThe new prot ective agent could replace human serum albumin completely in lyophilized recombi nant basic fibroblast growth factor products.更多还原