基于多模块偏最小二乘的中药制药过程系统建模研究
投稿时间:2018-04-25  修订日期:2018-05-14  责任编辑:  点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
孙飞 Sun Fei 广东药科大学 Guangdong Pharmaceutical University sunfeiky2011@126.com 
詹书怡 Zhan shuyi 广东药科大学 Guangdong pharmaceutical university  
郭宁 Guo ning 广东药科大学 Guangdong pharmaceutical university  
梁生旺 Liang shengwang 广东药科大学 Guangdong pharmaceutical university  
乔延江 Qiao yanjiang 北京中医药大学 Beijing university of Chinese medicine yjqiao@263.net 
王淑美* Wang Shumei 广东药科大学 Guangdong Pharmaceutical University 2395903468@qq.com 
基金项目:广东省医学科学基金项目
中文摘要:中药制药过程系统建模是提高中药制药工艺精密度,确保质量在工艺各环节稳定传递的基础。本文以湿法制粒-压片成型工艺过程为研究对象,以三七总皂苷(PNS)为模型药物,应用多模块偏最小二乘法(MBPLS)建立中药制药过程系统模型,解析过程质量传递规律,提高对中药制药过程系统的理解。根据工艺流程,将过程中采集的原料、颗粒和片剂质量属性参数划分为不同的数据块,采用MBPLS建立系统模型。MBPLS模型的R2Y和Q2Y分别为89.1 %和65.5 %,表明所建立的MBPLS模型性能较好。通过对MBPLS模型建模参数进行解析,确定PNS原料物理质量属性和颗粒质量属性是影响PNS片质量的关键因素,其中,PNS原料粒径、松装密度和振实密度变异是引起颗粒和片剂质量变异的关键来源。MBPLS通过对不同单元质量属性参数进行划分,量化了各个工艺单元对产品质量的贡献,有利于解析中药制药过程单元之间的相互作用,可推广应用于建立其他中药制剂过程系统模型。
中文关键词:多模块偏最小二乘  三七总皂苷  质量传递  质量源于设计
 
System modeling on Chinese herbal medicine process with the multi-block projection to the latent structures method
Abstract:The system model of Chinese herbal medicine process is the basis for improving the precision of pharmaceutical process and ensuring the stable transmission of quality between different units of the process. Taking the wet granulation-tableting process as the research object and using the Panax notoginsengs sapions (PNS) as a model drug, this article applied multi-block partial least squares method to build the system model of Chinese herbal medicine process. According to the flowsheet of process, the quality attributes of raw materials, granules and tablets collected in the process were divided into different data blocks, and the MBPLS model was built. The R2Y and Q2Y of MBPLS model were 89.1% and 65.5%, respectively, indicating that the performance of the MBPLS model was good. By analyzing the parameters of MBPLS model, it was determined that the physical quality attributes of PNS powders and quality attributes of PNS granules were significance to affect the quality of PNS tablets. The particle size, bulk density and tapped density of PNS powders were the critical quality attributes which caused the quality variations of PNS granules and PNS tablets. MBPLS can quantify the contributions of each unit to the product quality by dividing the quality attributes into different units. It was helpful to analyze the interactions between the process units of Chinese herbal medicine and it could be applied to build system model of other Chinese herbal preparations processes.
keywords:multi-block partial least squares  Panax notoginseng saponins  quality transfer  quality by design
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