重组猪α干扰素冻干保护剂的筛选

Screening of freeze-drying stabilization additives for recombinant porcine interferon- α preparation

关键词:  重组猪α干扰素  冻干保护剂  筛选

Key words:  recombinant porcine interferon- α, freeze dry stabilizer, screen

摘要:

为了使重组猪α干扰素(rPoIFN-α)制品更好地应用于生产实践之中，本文采用保守的冻干工艺重点对rPoIFN-α制品的冻干保护剂进行筛选。通过外观检测、水分含量、活性检测对十四种冻干保护剂进行了比较和筛选。研究结果表明终浓度2%、4%和5%的甘露醇的保护效果较好，活性保持率分别为102.8%，95.1%，108.3%。然后将活性好的这三个配方再冻干三批制品进行放置40℃加速稳定性实验。结果表明，在40℃放置三个月后，三个保护剂制品效价基本没变化，稳定性良好，有效期暂定为两年。本研究初步探索了rPoIFN-α的冻干配方，为rPoIFN-α的产业化打下基础。

Abstract:

Screening of freeze-drying stabilization additives of recombinant porcine interferon-α (rPoIFN-α) preparation was carried out in the study. 14 freezing protection protocols were screened by judging three indexes of physical appearance, residue moisture and bioactivity of the preparations after freeze-drying with conservative method. Three protocols, which had mannitol concentrations of 2%, 4% and 5%, could retain preparation bioactivity at 102.8±5.6%, 95.1±2.5% and 108.3±2.3%, respectively. Freeze-dried preparations of rPoIFN-α with the three protocols were employed for accelerating stability test at 40℃. The test result showed that the bioactivity of all preparations did not change significantly during the test period of 3 months. The expiration time of 24 months was deduced with the freeze-drying rPoIFN-α preparations.