热毒宁注射液中绿原酸的降解动力学研究.docVIP

  热毒宁注射液中绿原酸的降解动力学研究# 邱喜龙1，任晓亮1，张慧杰1，萧伟2，戚爱棣1** （1. 天津中医药大学中药学院，天津 300193； 5 10 15 20 25 30 35 40 2. 江苏康缘药业股份有限公司，江苏 连云港 222001） 摘要：目的：研究热毒宁注射液中绿原酸(chlorogenic acid, CHA)在不同 pH 和温度条件下降 解反应的动力学特征。方法：采用高效液相色谱法(HPLC)考察不同 pH 和温度下绿原酸对照 品水溶液及热毒宁注射液中绿原酸的含量变化，利用化学反应动力学的方法计算绿原酸在不 同环境下的降解反应动力学参数,用阿仑尼乌斯公式预测其有效期(t0.9)、半衰期(t0.5)和活化 能(energy of activation, Ea)。结果：绿原酸在不同 pH 和温度下的降解反应均遵循一级动力学 规律，在 pH7 水溶液中绿原酸的 t0.9 = 22d、t0.5 = 104d、Ea = 90.89 kJ·mol-1；在热毒宁注射 液中绿原酸的 t0.9 = 31d、t0.5 = 203d、Ea = 140.49 kJ·mol-1。结论：绿原酸在水溶液及热毒 宁注射液中均在酸性、低温条件下较稳定。同样条件下，绿原酸在热毒宁注射液中的稳定性 都要高于绿原酸水溶液。可根据绿原酸降解动力学模型，用于热毒宁注射液有效性和安全性 的评价。 关键词：绿原酸；热毒宁注射液；水溶液；pH；温度；降解动力学 中图分类号：R917 Studies on degradation kinetics of chlorogenic acid in reduning injection QIU Xilong1, REN Xiaoliang1, ZHANG Huijie1, XIAO Wei2, QI Aidi1 (1. College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, TianJin 300193; 2. Jiangsu Kanion Parmaceutical CO. LTD, JiangSu LianYunGang 222001) Abstract: Objective: To investigate the degradation kinetic characteristics of chlorogenic acid (CHA) in reduning injection under different pH and temperatures. Methods: The concentration changes of CHA in aqueous solution and reduning injection were determined by HPLC under different pH conditions and temperatures. Base on the chemical reaction kinetic, the parameters of degradation kinetics were calculated under different conditions. The activation energy and shelf life were evaluated with Arrhenius equation. Results: Our experiment results indicated that thermal degradation kinetic model of CHA in aqueous solution and reduning injection was a first-order degradation kinetic process. The period of validity (t0.9) were 22 and 31 days; the half - life period (t0.5) were 104 and 203 days under pH7 in aqueous solution and reduning injection. The energy of activation (Ea) was 90.89 kJ·mol-1 in aqueous solution and 140.49 kJ·mol-1 in reduning injection. Conclusions: CHA was more stable in acidic and low temperature condit