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胰岛素溶液化学稳定性研究
引用本文:安富荣,张景海,刘刚,苏德森. 胰岛素溶液化学稳定性研究[J]. 沈阳药科大学学报, 1993, 0(3)
作者姓名:安富荣  张景海  刘刚  苏德森
作者单位:沈阳药学院物理药学研究室,沈阳药学院物理药学研究室,上海宝钢廿冶医院,沈阳药学院物理药学研究室 上海医药工业研究院制剂室
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。

关 键 词:胰岛素  反相高效液相色谱法  高效液相凝胶层析法  化学稳定性  pH值

A STUDY ON THE CHEMICAL STABILITY OF INSULIN SOLUTION
An Furong Zhang Jinghai Liu Gang Su Desen Res.Dept.of Phy.Pharm.. A STUDY ON THE CHEMICAL STABILITY OF INSULIN SOLUTION[J]. Journal of Shenyang Pharmaceutical University, 1993, 0(3)
Authors:An Furong Zhang Jinghai Liu Gang Su Desen Res.Dept.of Phy.Pharm.
Affiliation:An Furong Zhang Jinghai Liu Gang Su Desen Res.Dept.of Phy.Pharm.
Abstract: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.
Keywords:Insulin  RP-HPLC  GF-HPLC  Chemical stability  pH value  
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