注射用丹参多酚酸中主要成分的降解动力学分析

Degradation Kinetics Analysis of Main Ingredients in Salvianolate Lyophilized Injection

目的:探索注射用丹参多酚酸中主要活性成分(丹酚酸B和迷迭香酸)在不同pH和温度下的降解规律。方法:采用HPLC测定迷迭香酸、丹酚酸B含量,研究二者在不同pH(1～13)和温度(60,70,80,90℃)下含量变化,通过化学动力学法计算降解动力学参数。结果:丹酚酸B与迷迭香酸在不同pH和温度下降解反应均属于一级动力学反应,降解速率随pH及温度的升高而增加。丹酚酸B和迷迭香酸在水溶液中的降解活化能(Ea)分别为48.54,49.83 kJ.mol-1,在注射用丹参多酚酸中则分别为95.19,83.56 kJ.mol-1。结论:丹酚酸B与迷迭香酸在碱性条件及高温条件下易降解,与对照品相比较,二者在注射用丹参多酚酸中更为稳定。

Objective： To investigate degradation kinetics of main ingredients（salvianolic acid B and rosmarinic acid） of salvianolate lyophilized injection under different pH and temperatures.Method： HPLC was adopted to determine the content of salvianolic acid B and rosmarinic acid at different pH values and temperatures,degradation kinetic parameters of these two ingredients were evaluated by chemical kinetics.Result： Reaction of salvianolic acid B and rosmarinic acid at different pH values and temperatures were accord with the first-order kinetics,degradation rate accelerated by increasing of pH value and temperature.According to arrhenius equation,activation energy（Ea） of salvianolic acid B in aqueous solution and salvianolate lyophilized injection were 48.54,95.19 kJ.mol-1,respectively.Ea of rosmarinic acid in aqueous solution and salvianolate lyophilized injection were 49.83,83.56 kJ.mol-1,respectively.Conclusion： Salvianolic acid B and rosmarinic acid were sensitive to strong alkaline and high temperature conditions,but salvianolate lyophilized injection could obviously improve their stability.