重组人酸性成纤维细胞生长因子滴眼液的制备及其稳定性  

Preparation of Recombinant Human Acid Fibroblast Growth Factor Eye Drops

作　　者：冯秀萍[1] 曲红艳[2] 田海山[3] 张弛[3] 李校堃[3] 

机构地区：[1]吉林大学白求恩医学院免疫教研室,长春130021 [2]广州暨南大学医药生物技术研究开发公司,广州510632 [3]生物反应器与药物开发教育部工程研究中心,长春130118

出　　处：《中国生物制品学杂志》2008年第10期884-886,共3页Chinese Journal of Biologicals

摘　　要：目的制备重组人酸性成纤维细胞生长因子(rhaFGF)滴眼液,并进行稳定性检测。方法在rhaFGF中添加复方保护剂,并以透明质酸钠作为保湿剂,制备rhaFGF滴眼液,对其进行鉴定和体外药效学检测,并进行稳定性试验。结果制备的3批滴眼液各项质量指标均合格,可促进碱烧伤家兔角膜细胞和鸡胚绒毛膜血管增殖。在4℃保存12个月,-20℃保存18个月,(25±2)℃保存6个月,滴眼液各项质量指标与0月基本一致。结论制备的rhaFGF滴眼液稳定性良好,可促进损伤角膜细胞修复。Objective To prepare recombinant human acid fibroblast growth factor （rhaFGF） eye drops and study its stability. Methods Prepare 3 lots of rhaFGF eye drops with a compound protective agent consisting of heparin sodium, mannitol, human serum albumin, dextran and trehalose, using sodium hyaluronate as a moisture-holding agent. The prepared eye drops were identified, then tested for pharmacodynamics in vitro and stability. Results All the quality indexes of the 3 lots of rhaFGF eye drops met the relevant requirements, and showed no significant change after storage at 4℃ for 12 months, at -20℃ for 18 months or at（25 ± 2）℃ for 6 months. The eye drops promoted the proliferations of corneal cells of rabbits with base burn and the chorion blood vessel of chick embryo. Conclusion The prepared rhaFGF eye drops showed good stability and promoted the repair of injured cornea cells.

关 键 词：重组人酸性成纤维细胞生长因子 滴眼液 角膜修复 稳定性 

分 类 号：R977.6[医药卫生—药品] R392.33[医药卫生—药学]