【摘要】 目的研究重组人酸性成纤维细胞生长因子(rhaFGF)在不同温度下的存放稳定性。方法rhaFGF冻干粉和溶媒在4,25和37℃分别保存30个月;rhaFGF液体在4℃保存56d,在25和37℃分别保存35d。采用MTT法测定rhaFGF的生物活性,同时进行外观性状、水分含量、pH值的测量和无菌试验。结果4℃时,rhaFGF冻干粉、液体和溶媒的各项性质在观察期内都无变化。25℃时,rhaFGF冻干粉、液体的生物活性分别在存放18个月和35d有下降趋势。37℃时,rhaFGF冻干粉、液体的生物活性分别在存放12个月和35d有下降趋势。结论rhaFGF冻干粉在4℃时可有效保存2年;rhaFGF冻干粉溶解后于4℃时保存28d内使用有效;溶媒在4℃时保存2年质量稳定。更多还原

【Abstract】 OBJECTIVE To study the stability of recombinant human acid fibroblast growth factor(rhaFGF) deposited at 4℃,25℃ or 37℃.METHODS The freeze-dried powder of rhaFGF and dissolvent were deposited at 4℃,25℃ and 37℃ for 36 months.The solution of rhaFGF powder was deposited for 56 days at 4℃ and for 35 days at 25℃ and 37℃ respectively.The bioactivity of rhaFGF was determined by MTT method,and the appearance,water content,pH and sterility test were also observed.RESULTS All properties of rhaFGF freeze-dried powder,rhaFGF solution and dissolvent were not altered during the observation period at 4℃.However,the bioactivity of rhaFGF freeze-dried powder and its solution decreased after storage for 18 months or 35 days at 25℃ respectively.The bioactivity of rhaFGF freeze-dried powder and its solution decreased after storage for 12 months or 35 days at 37℃ respectively.CONCLUSION The freeze-dried powder rhaFGF and dissolvent can be deposited effectively for 2 years at 4℃.The solution of rhaFGF freeze-dried powder can be deposited effectively for 28 days at 4℃.更多还原