CD和FT-IR法分析重组人钙调磷酸酶B亚基冻干前后与多批产品二级结构的一致性

目的 通过测定重组人钙调磷酸酶B亚基(rhCNB)的圆二色谱(CD)和傅立叶变换红外光谱(FT-IR),来研究rhCNB冻于前、后和rhCNB多批产品之间二级结构的一致性,从而确定生产工艺是否稳定,样品是否发生变性等,达到控制产品质量的目的.方法 采用CD和FT-IR光谱法分别对3批rhCNB进行蛋白质二级结构测定,并对rhCNB冻干前与冻干后样品进行了CD和FT-IR光谱法二级结构测定.结果与结论 CD和FT-IR光谱测得3批样品谱图均达到批间一致,说明样品二级结构稳定,工艺过程较稳定,产品未发生变性.rhCNB冻干前与冻干后2种图谱均无明显变化,说明冻干工艺对rhCNB的二级结构并无改变.

Determination of Secondary Structure Concordance of Freezen Drying and Different lots of Recombinant Human Calcineurin B Subunit by CD and FT-IR Spectrum

Aim To evaluate the feasibility of manufacture process and the quality of products by determination of the stability of the secondary structure during freeze-drying and different batches of recombinant human calcineurin B subunit (rhCNB) with CD and FT-IR spectra.Methods The secondary structure of rhCNC before and after freeze-drying and 3 batches of freeze-dried rhCNB was determined by CD and FT-IR spectra. Conclusion The CD and FT-IR spectra for the different batches of rhCNB were coincident. And there were no significant differences in the spectra for rhCNB before and after freeze-drying. These results suggested that the secondary structure of rhCNB was stable during freeze-drying and the manufacture technique was workable.