基于Plackett-Burman和G1-熵权法设计结合Box-Behnken响应面法优化中药颗粒成型工艺:以小儿热速清颗粒为例

Optimization of particle forming process of traditional Chinese medicine formulation based upon Plackett-Burman and G1-entropy weight design plus Box-Behnken response surface method:Xiao’er Resuqing Granules as an example

目的:基于Plackett-Burman和G1-熵权法设计结合Box-Behnken响应面法优化小儿热速清制粒成型工艺。方法:以二次成型率、吸湿率、休止角、溶化率为指标,通过单因素试验优选合适的因素与水平进行Plackett-Burman设计进而确定关键工艺参数,采用基于G1-熵权法结合响应面设计优化小儿热速清颗粒的成型工艺。结果:优化后处方为药辅质量比7∶3,糊精∶甘露醇质量比1∶1,矫味剂阿司帕坦质量分数0.3%、蜜桃香精质量分数0.2%;工艺:80%乙醇(2%PVP-K30)为润湿剂湿法制粒,60℃干燥1 h;综合评分的平均值为94.46。结论:该制备工艺可靠、稳定、重复性好,可用于优化小儿热速清颗粒的成型工艺。

OBJECTIVE As an important step in the production of Chinese medicine formula particles,molding process is correlated closely with the quality and efficacy of particles.In actual production researches,molding process is examined by single factor test or single factor plus orthogonal experiment.Here the authors attempted to establish an optimal molding process of Xiao’er Resuqing Granules based upon Plackett-Burman and G1-entropy weight design plus Box-Behnken response surface method.METHODS With secondary forming rate,moisture absorption rate,angle of rest and melting rate as indices,Plackett-Burman design was adopted for selecting suitable factors and levels through single factor experiment and then key process parameters were determined.The forming process of Xiao’er Resuqing Granules was optimized based upon G1-entropy weight method and response surface design.RESULTS After optimization,the mass ratio of drug-to-drug was 7∶3,mass ratio of dextrin-tomannitol 1∶1,mass fraction of aspartan 0.3%and mass fraction of peach essence 0.2%.Process:80%ethanol(2%PVP-K30)was granulated with a wetting agent and dried for 1 h at 60℃.The average comprehensive score was 94.46.CONCLUSION The above preparation process is reliable,stable and repeatable.It may be applied for optimizing the molding process of Xiao’er Resuqing Granules.