鸡重组α-干扰素冻干粉剂的冻干保护剂的筛选

Screening of the lyophilized protectant for recombinant chicken alpha- interferon preparation

以获得适宜于制备鸡重组α-干扰素冻干粉剂的冻干保护剂为目标,通过冻干保护剂的筛选及冻干保护剂浓度的优化,确定了最优的冻干保护剂配方和装液量等工艺参数。结果显示:在最优配方(甘露醇(3%)+PEG(3%))和最佳的装液量(40%)条件下,冻干粉剂外观呈海绵状、表面平整、体积与冻结时的体积基本一致,颜色均匀,无起泡现象,复水迅速而完全。通过生物活性稳定性实验,证明在最优条件下制备的鸡重组α-干扰素冻干粉的生物学效价较为稳定(40℃条件下贮藏12个月,生物活性无变化)。最终获得的冻干保护工艺,对鸡重组α-干扰素冻干粉剂工业化生产具有一定的指导和借鉴意义。

In order to achieve excellent component of lyophilized protectant for chicken alpha- interferon production,lyophilized protectants were screened at first. Secondly,the concentration of protectants and the medium volume were optimized. As the results showed,the mannitol and PEG were selected as the best lyophilized multi-protectants and the concentrations were defined as 3% and 3% respectively. And with the optimized medium volume of 40%,the physical appearance was sponginess and uniform,tabulated,bubble- free and quickly soluble.Under the optimized conditions,the lyophilized recombinant chicken alpha interferon was harvested.The anti- virus activity of alpha- interferon showed no significant difference after 12 months under the temperature at about 40 ℃.This process was successfully established and could be advantageous to its application for chicken alpha interferon production.