Establishment of Feedforward Control Model for Dry Granulation of Polysaccharide Components Based on Quality by Design
10.13422/j.cnki.syfjx.20211762
- VernacularTitle:基于质量源于设计理念构建多糖组分干法制粒前馈控制模型
- Author:
Zan-yang HUANG
1
;
Ya-jing WANG
1
;
Dong-li QI
1
;
Di GAO
1
;
Xiao-yu WANG
1
;
Yu WANG
1
;
Yan-wen WANG
1
;
Xiang-yin YE
1
Author Information
1. Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique， Ministry of Education，Tianjin University of Traditional Chinese Medicine，Tianjin 301617，China
- Publication Type:Journal Article
- Keywords:
quality by design （QbD）;
dry granulation;
principal component analysis （PCA）;
radial basis function neural network （RBFNN）;
polysaccharide components of Astragali Radix;
powder properties;
critical quality attribute （CQA）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(4):130-137
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveA feedforward control model for dry granulation of polysaccharide components was established to guide the adjustment and optimization of critical process parameters （CPPs） in the design space， so as to reduce the impact of fluctuations in raw materials properties on the quality of medicines. MethodTaking Astragali Radix extract powder as the model drug， the design space of dry granulation CPPs was determined by Box-Behnken design. Astragali Radix mixed powder with different powder properties were prepared by mixture design， the variance inflation factor （VIF） was used to diagnose the multicollinearity of the powder properties， and principal component analysis （PCA） was used to extract the characteristic data of the model. Radial basis function neural network （RBFNN） was used to establish a feedforward control model for reflecting the relationship between the powder properties of polysaccharide components， dry granulation CPPs and one-time molding rate. ResultThe design space for dry granulation CPPs of polysaccharide components was 16-35 Hz for feeding speed， 10-23 Hz for roller speed， and 10-46 kg·cm-2 for roller pressure. The established RBFNN feedforward control model had a good predictive effect on the one-time molding rate of dry granulation of polysaccharide components， which could be used to guide the adjustment and optimization of CPPs in the design space， the relative error was 0.38%-6.73%， and the average relative error was 3.42%. ConclusionThe established feedforward control model can well reflect the relationship between the powder properties of the polysaccharide components， the dry granulation CPPs and the one-time molding rate of the granules， which can be used to guide the adjustment and optimization of CPPs in the design space， reduce the impact of material property fluctuation on product quality， and provide ideas for promoting the quality of traditional Chinese medicine from passive control to active control.
