重组可溶性TRAIL冻干保护剂的初步筛选

Preliminary Screening of Protective Medium of Recombinant Human Soluble Tumor Necrosis Factor-related Apoptosis-inducing Ligand

目的筛选出适合肿瘤坏死因子相关凋亡诱导配体(TRAIL)冻干制剂的保护剂。方法在TRAIL蛋白中加入不同浓度配方的甘露醇、清蛋白和乳糖,经过冷冻干燥,观察冻干制剂的色泽、外观、溶解度和澄明度,并且测定冻干制品的水分和生物学活性,筛选出最佳保护剂。结果初步筛选出2%甘露醇+3%乳糖作为TRAIL蛋白的保护剂。结论TRAIL蛋白药物加入该保护剂后,外观、溶解度、澄明度及生物活性都比较好。在不同温度,对TRAIL蛋白生物活性有很好的稳定作用。

Objective To screen the protective mediums of recombinant human soluble tumor necrosis factor-related apoptosis-inducing ligand（rsTRAIL） . Methods With different concentrations of protective mediums, such an mannitol, human albumin and lactose, added to TRAIL, the physical appearance, solubility, and transparency of freeze-dried TRAIL were observed,and its residual moisture and biologic activity were determined for screening the optimal protective medium. Results Mannitol 2% ＋ lactose 3% was shown to be the best protective medium. Conclusion Freeze-dried TRAIL added with 2% mannitol and 3% lactose has good physical appearance, solubility, transparency and bioactivity .