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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。
In this paper, the effect of pH on the chemical stability of insulin solution was studied by reversed-phase high performance liquid chromatography (RP-HPLC) and high performance liquid chromatography (GF-HPLC). Stability experiments using classical thermostat method. The experimental results show that pH value is an important factor affecting the chemical stability of insulin solution. The degradation rate in acidic solution increases with the decrease of pH value, but decreases with the decrease of pH value in alkaline solution, ie, the solution Its pH is best when it is near the isoelectric point of insulin. Insulin solution heat degradation reaction law in line with the first-order kinetics equation.