摘要
取同一批重组人干扰素α2a原液 ,分别加入A、B、C、D、E五种冻干保护剂 ,按《中国生物制品规程》方法进行冻干 ,检测其效价、外观、水分含量、内毒素含量 ,以现行干扰素生产使用的人血白蛋白C保护剂作为对照 ,结果显示 ,使用A、D、E保护剂制品在 40℃放置 4个月 ,效价降低了 45 %～ 6 0 % ,使用B保护剂的制品稳定性最好 ,在 40℃放置 4个月 ,效价仅下降了 35 % 。
Five kinds of stabilizer (A,B,C,D and E)were screened out.In this study,C of the five kinds is the current stabilizer used as a cotrol.The rest 4 kinds were compared with C separatively.Inspect the potency, physical appearance, residul moisture and endotoxin content after lypholization. The results showed that the bioactivity of product containing stabilizer B decreased by 35% after being stored at 40℃ for 4 months;however,the bioactivity of product containing the rest kinds A,C,D,E decreased by 45%～60%.Therefor,B is the optimum candidate of stabilizer used for freeze-dried interferon.
出处
《微生物学免疫学进展》
2002年第4期40-43,共4页
Progress In Microbiology and Immunology
