摘要
本文用反相高效液相色谱法(RP-HPLC)和高效液相凝胶层析法(GF-HPLC)研究了pH值对胰岛素溶液化学稳定性的影响。稳定性实验采用经典恒温法。实验结果表明pH值是影响胰岛素溶液化学稳定性的重要因素,在酸性溶液中降解反应速率随pH值的降低而增大;而在碱性溶液中则随pH值的降低而减小,即溶液pH值接近胰岛素等电点时其稳定性最好。胰岛素溶液加热降解反应规律符合一级动力学方程。
The effect of pH values on the chemical stability of insulin solution was investigated by reversed-phase high performance liquid chromatography (RP-HPLC)and gel filtration chromatography with HPLC(GF-HPLC).The results obtained indicated that pH value was an important factor affecting the chemical stability of insulin solutions. The decomposition of insulin followed a good first order reaction. The degradation rate of insulin in acidic solution increased as pH decreased, and in alkaline solution it decreased as pH decreased. The degradation rate of insulin was minimal at pH values near the isoelectric point.
关键词
胰岛素
高效液相色谱
化学稳定性
Insulin
RP-HPLC
GF-HPLC
Chemical stability
pH value