响应面法优化马来酸曲美布汀缓释片处方工艺  

Optimizing the preparation of trimebutine maleate sustained release tablet using response surface methodology

作　　者：徐璐[1] 王永禄[1,2] 韩杰[1] 王栋[1] 叶雯[1] 李学明[1] 

机构地区：[1]南京工业大学药学院,江苏南京211816 [2]东南大学医学院,江苏南京210009

出　　处：《中国生化药物杂志》2014年第6期163-167,170,共6页Chinese Journal of Biochemical Pharmaceutics

基　　金：国家自然科学基金资助项目(81170492);江苏省博士后科研资助计划(1301012A);江苏政府留学奖学金(2013)

摘　　要：目的利用响应面分析法优化马来酸曲美布汀缓释片处方工艺。方法通过单因素考察确定对释放度影响较大的3个因素:HPMC K4M和HPMC K100-LV的比例、酒石酸的用量、粘合剂PVP-K30的浓度,以释放度综合评分作为响应值,利用BoxBenhnken中心组合实验设计原理,采用3因素3水平的响应面分析法,确定各处方的用量。结果筛选得到优化的处方及工艺为:骨架材料HPMC K4M和HPMC K100-LV的比例为6∶10、酒石酸的用量为22%、PVP-K30的浓度为15%,其体外释药行为较理想。结论筛选所得的马来酸曲美布汀缓释片处方工艺稳定可行。Objective In this article,Response Surface Analysis( RSA) was applied to optimize the formulation of trimebutine maleate sustained release tablet. Methods Single factor exploration was used to determine the three factors which have the greatest impact on the release rate. Composite score of the release behaviour was taken as the response value. Box-Benhnke design principles and 3 factors and 3 levels was used to the dosage of the ingredients. Results The optimized formulation and process was as follows: HPMC was selected as framework material,and the ratio of HPMC K4 M and HPMC K100-LV is 6: 10,the dosage of the tartaric acid in the total weight of the tablet was 13. 5%,still 15% for PVP-K30. The release behavior in vitro was ideal. Conclusion The optimized preparation process of trimebutine maleate sustained release tablet is stable,highly efficient and suitable for industrial production.

关 键 词：马来酸曲美布汀 缓释片 响应面法 体外释放度 

分 类 号：R94[医药卫生—药剂学]