响应面法优选妇科IV颗粒一步制粒工艺  

Optimization of one-step pelletization technology of Fuke IV granules with response surface methodology

作　　者：刘丹[1,2,3] 何凤军[1,2,3] 刘长龙[1,2,3] 刘俊超[1,2,3] 吴云[1,2,3] 王振中[1,2,3] 萧伟[1,2,3] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]中药提取精制新技术重点研究室,江苏连云港222001

出　　处：《中国中药杂志》2016年第1期75-82,共8页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2013ZX09402203)

摘　　要：利用响应面法优选妇科IV(FKIV)颗粒一步制粒的工艺条件。以颗粒合格率为指标,利用Plackett-Burman设计实验,对影响一步制粒的6个因素进行考察,评价各因素显著水平并确定主要影响因素。在此基础上,以颗粒合格率、含水量、休止角为指标,建立3因素3水平的Box-Behnken设计,对模型进行全二次回归拟合,并利用Response Optimizer优化实验结果。确定最佳一步制粒工艺条件:浸膏相对密度1.20,进风温度88℃,雾化压力0.28 MPa。利用该优化方案制备妇科IV颗粒,测得的颗粒合格率93.65%,含水量3.76%,休止角23.19°,与模型预测值基本一致,说明优化的工艺条件符合生产要求。To optimize the one-step pelletization technology of Fuke IV（ FKIV） granules by response surface methodology. With the qualified rate of granules as evaluation indexes,6 factors affecting one-step pelletization technology were investigated,significant levels of each factor were evaluated and the primal influential factors were determined by Plackett-Burman experimental design. According to the Plackett-Burman experimental design,the qualified rates of granules,moisture capacity and angle of repose as the evaluation indexes,Box-Behnken design with three levels and three factors was established for quadratic regression fitting of the models. Then the experimental results were optimized by Response Optimizer. The best process conditions were determined as follows： the extract relative density of 1. 20,inlet air temperature of 88 ℃,and atomization pressure of 0. 28 MPa. FKIV granules were prepared by the optimized experimental scheme. The determined qualified rate,moisture capacity and angle of response were 93. 65%,3. 76% and 23. 19° respectively for the granules,basically similar to the predicted values,indicating that the optimal process conditions were in line with the manufacturing requirements.

关 键 词：妇科IV颗粒 响应面法 一步制粒 PLACKETT-BURMAN设计 BOX-BEHNKEN设计 

分 类 号：R283.6[医药卫生—中药学]