Sun Fei, Zhan Shu-Yi, Guo Ning, Liang Sheng-Wang, Qiao Yan-Jiang, Wang Shu-Mei
School of Traditional Chinese Medicine， Guangdong Pharmaceutical University， Guangzhou 510006， China.
Key Laboratory of Digital Quality Evaluation of Chinese Materia Medica of State Administration of Traditional Chinese Medicine， Guangzhou 510006， China.
Zhongguo Zhong Yao Za Zhi. 2018 Aug;43(16):3270-3278. doi: 10.19540/j.cnki.cjcmm.20180611.008.
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 sections of the process. By taking the wet granulation-tableting process as the research object and using the Panax notoginsengs sapions (PNS) as a model drug, multi-block partial least squares method (MBPLS) was used in this article to build the system model of Chinese herbal medicine process, analyze the mass transmission rules in the process and improve the understanding on pharmaceutical process system of Chinese medicine. According to the process flow, the quality attributes of raw materials, granules and tablets collected in the process were divided into different data blocks, and the MBPLS method was used to establish system model. 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 raw materials and quality attributes of PNS granules were the key factors to affect the quality of PNS tablets. The particle size, bulk density and tapped density of PNS raw materials 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.
中药生产过程系统模型是提高制药过程精度和确保过程不同环节间质量稳定传递的基础。本文以湿法制粒-压片过程为研究对象，以三七总皂苷（PNS）为模型药物，采用多块偏最小二乘法（MBPLS）构建中药生产过程系统模型，分析该过程中的质量传递规律，加深对中药制药过程系统的理解。根据工艺流程，将该过程中收集的原料、颗粒和片剂的质量属性划分为不同的数据块，采用MBPLS方法建立系统模型。MBPLS模型的R²Y和Q²Y分别为89.1%和65.5%，表明该模型性能良好。通过分析MBPLS模型参数，确定PNS原料的物理质量属性和PNS颗粒的质量属性是影响PNS片剂质量的关键因素。PNS原料的粒度、堆密度和振实密度是导致PNS颗粒和PNS片剂质量变化的关键质量属性。MBPLS通过将质量属性划分为不同单元来量化各单元对产品质量的贡献。这有助于分析中药过程单元之间的相互作用，可应用于构建其他中药制剂过程的系统模型。
