聚乙二醇-重组人干扰素α2b结合物冻干保护剂的筛选  

Screening of Stabilizer of Freeze-dried Polyethylene Glycolylated Recombinant Human Interferon α2b Conjugate

作　　者：张雪梅[1] 石晓丽 姚为民[3] 陈云声[3] 赵大鹏[3] 关晓峰[3] 赵虹[3] 盛军[3] 孙金海[1] 

机构地区：[1]吉林大学畜牧兽医学院,长春130062 [2]成都生物制品研究所,成都610023 [3]长春生物制品研究所,长春130062

出　　处：《中国生物制品学杂志》2008年第10期887-889,共3页Chinese Journal of Biologicals

摘　　要：目的筛选聚乙二醇-重组人干扰素α2b(PEG-rhIFNα2b)结合物的冻干保护剂。方法采用两步筛选法,以氨基酸、甘露醇和糖类作为冻干保护剂,与PEG-rhIFNα2b在适宜条件下制备成冻干制剂,分别于40、25和4℃放置不同时间取样,检测其理化性质和生物学稳定性,筛选最佳保护剂配比。结果通过6～12个月的试验,证实该冻干制剂外观、pH无明显改变,但再溶解速度略慢于以人血白蛋白作保护剂的冻干制剂;采用15mmol/L精氨酸+10mmol/L谷氨酸+4%甘露醇+1%蔗糖/海藻糖的冻干保护剂配方,在4℃和25℃放置12个月后,抗病毒活性仍较好,相当于人血白蛋白的冻干保护效果。结论已筛选出不含人血白蛋白的PEG-rhIFNα2b结合物的冻干保护剂。Objective To screen the stabilizer of freeze-dried polyethylene glycolylated recombinant human interferon α2b （PEG-rhIFNα2b） conjugate. Methods Freeze-dried PEG-rhIFNα2b conjugate was prepared by using various stabilizers and stored at 40, 25 and 4℃ respectively. Take samples at various months after storage for determination of physiochemical property and biological stability, based on which the optimal formula of stabilizer was screened. Results After storage at various temperatures for 6 to 12 months, the appearance and pH value of conjugates using stabilizers consisting of amino acids, mannitol and saccharides showed no significant change, while the time for reconstitution was slightly longer than those using human serum albumin as stabilizer. After storage at 4 and 25℃ for 12 months, the PEG-rhIFNα2b conjugate using the stabilizer consisting of 15 mmol / L arginine, 10 mmol / L glutamic acid, 4% mannitol and 1% sucrose / trehalose still showed good antiviral activity, indicating that the protective effect of the stabilizer was equivalent to that of human serum albumin. Conclusion A human serum albumin-free stabilizer of freeze-dried PEG-rhIFNα2b conjugate was screened.

关 键 词：聚乙二醇 重组人干扰素Α2B 结合物 保护剂 

分 类 号：R978.7[医药卫生—药品] TQ464.7[医药卫生—药学]