不同辅料对健胃消食片质量参数的影响

Effect of Different Excipients on Quality Parameters of Jianwei Xiaoshi Tablet

目的:研究不同辅料对健胃消食片质量参数的影响,为实际生产工艺的优化提供科学依据。方法:采用湿法制粒压片,改用不同辅料研制4种健胃消食片,采用小杯法测定累积溶出度,进行溶出曲线相似因子拟合,溶出机制模型拟合。结果:4种不同辅料制得健胃消食片中,样品Ⅰ与Ⅱ,Ⅲ,Ⅳ中橙皮苷溶出曲线存在显著性差异,样品Ⅱ,Ⅲ,Ⅳ相互间不存在显著性差异;样品Ⅱ中橙皮苷溶出最快,累积溶出度最高;橙皮苷溶出行为都最接近一级动力学方程。结论:采用糊精、蔗糖和硬脂酸镁等辅料制备的健胃消食片质量最佳。

Objective： To study effect of different excipients on quality parameters of Jianwei Xiaoshi tablet, in order to provide a scientific basis on process optimization of actual productiong Method： Four kinds of Jianwei Xiaoshi tablet were developed by wet granulation and tableting with different accessories, cumulative dissolution was determined by small glass method, similar factor of dissolution curve was fitted, model of dissolution mechanism was fitted. Result： In 4 kinds of different Jianwei Xiaoshi tablet, there were significant differences between sample Ⅰ and Ⅱ, Ⅲ , Ⅳof hesperidin dissolutio.n curve, there are no significant differences among Ⅱ , Ⅲ and Ⅳ ; dissolution of hesperidin was fastest of sample Ⅱ, and cumulative dissolution was highest; Dissolution behavior of hesperidin was closest to the kinetic equation. Conclusion： The best accessories of Jianwei Xiaoshi tablet was dextrin, sucrose, magnesium stearate and so on.