芍药苷在疏经防痛胶囊水提液和浓缩液中热稳定性考察

Thermal Stability of Paeoniflorin in Water Extract and Concentrated Solution of Shujing Fangtong Capsules

目的:考察不同因素对疏经防痛方水提液和浓缩液中芍药苷含量的影响,通过分析芍药苷的热降解动力学优化工艺条件。方法:采用HPLC测定芍药苷含量,流动相0.05%磷酸二氢钾-乙腈(85∶15),检测波长230 nm。考察不同影响因素对疏经防痛胶囊水提液和浓缩液中芍药苷含量的影响。结果:疏经防痛胶囊制剂工艺过程中加热温度及时间是影响芍药苷含量的主要因素。芍药苷在水提液中热降解反应符合热力学一级反应方程,热降解速率常数随温度的升高显著增大;在浓缩液水浴80℃中降解反应符合一级反应方程lg C=-0.002t+1.345(r=0.990 4),速率常数4.606×10-3,有效期22.88 h,半衰期150.46 h。结论:疏经防痛胶囊制备工艺过程应避免高温及长时间受热,在浓缩和干燥工艺中应采用减压浓缩法及真空干燥法以降低芍药苷的降解速率。

Objective： To investigate effects of different factors on the content of paeoniflorin in water extract and concentrated solution of Shujing Fangtong prescription, to optimize process conditions by analyzing thermal degradation kinetics of paeoniflorin. Method ： HPLC was employed to determine the content of paeoniflorin with mobile phase of 0.05% potassium dihydrogen phosphate-acetonitrile （85： 15） and detection wavelength at 230 nm. Effects of different factors on the content of paeoniflorin in water extract and concentrated solution of Shujing Fangtong capsules. Result： Main factors affecting the content of paeoniflorin were heating temperature and time in preparation process of Shujing Fangtong capsules. Thermal degradation reaction of paeoniflorin in water extract accorded with thermodynamic first-order reaction equation, thermal degradation rate constant （K） increased significantly with increasing of temperature; its thermal degradation reaction accorded with thermodynamic first- order reaction equation of lgC = - 0. 002t ＋ 1. 345 （r = 0. 990 4） in concentrated solution at 80 ℃ , K was 4. 606 ×10^-3, validity was 22.88 h, half-life was 150.46 h. Conclusion： High temperature and long time heating should avoid in preparation process of Shujing Fangtong capsules, vacuum concentration method and vacuum drying method should be adopted to reduce degradation rate of paeoniflorin.