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

作　　者：黄淑惠[1] 倪健[1] 冯丽君[1] 林龙飞[1] 张晋[1] 曹飒丽[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国实验方剂学杂志》2012年第16期12-13,共2页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药管理局公益性行业科研专项(200807038)

摘　　要：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.

关 键 词：健胃消食片 辅料 溶出度 相似因子 溶出机制 

分 类 号：R283.6[医药卫生—中药学]