中国中药杂志

2021, v.46(19) 4969-4977

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中药高剪切湿法制粒过程物料可制造性分类研究
Material manufacturability classification in high shear wet granulation process of Chinese medicine

王政;王雅雯;曹君杰;李婉婷;张燕玲;罗赣;乔延江;徐冰;
WANG Zheng;WANG Ya-wen;CAO Jun-jie;LI Wan-ting;ZHANG Yan-ling;LUO Gan;QIAO Yan-jiang;XU Bing;Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine;Beijing Key Laboratory of Chinese Medicine Manufacturing Process Control and Quality Evaluation, Beijing Municipal Science & Technology Commission;Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education;

摘要(Abstract):

中药高剪切湿法制粒(HSWG)过程机制复杂、影响因素多。为总结不同物料在HSWG过程的可制造性,该文构建了由11种物料组成的小型物料库,包括4种中药浸膏粉和7种药用辅料,每种物料用22种物性参数进行描述。设计了具有不同流体力学性质的黏合剂,进行了密度、黏度和表面张力参数表征。结合经验约束条件和随机化原则,安排21次制粒试验和8次验证试验。采用偏最小二乘(PLS)算法建立了基于物料和黏合剂性质、接触参数和工艺参数预测颗粒中值粒径的过程模型。通过模型辨识了黏合剂的表面张力和密度,以及过程无量纲参数最大孔隙饱和度为关键变量。在优选得到的HSWG过程模型的潜变量空间内,按照物料分布特征,将物料分为3类,即中药浸膏粉、稀释剂和崩解剂。中药浸膏粉制粒要求低黏度、低用量的黏合剂,制得颗粒粒径偏小;稀释剂粉末的物性空间大,可通过调节黏合剂性质制成不同粒径的颗粒;崩解剂在含水黏合剂条件下易制成大粒径颗粒。物料库结合多变量建模的方法有利于中药湿法制粒工艺知识的归纳,为基于物料性质的制剂处方和工艺设计提供了依据。
The high shear wet granulation(HSWG) process of Chinese medicine has a complicated mechanism. There are many influencing factors that contribute to this process. In order to summarize the manufacturability of different kinds of materials in HSWG, this paper constructed a material library composed of 11 materials, including 4 Chinese medicine extracts and 7 pharmaceutical excipients. Each material was described by 22 physical parameters. Several binders were employed, and their density, viscosity and surface tension were characterized. Combining empirical constraints and the principle of randomization, 21 designed experiments and 8 verification experiments were arranged. The partial least squares(PLS) algorithm was used to establish a process model in prediction of the median granule size based on properties of raw materials and binders, and process parameters. The surface tension and density of binders, as well as the maximum pore saturation were identified as key variables. In the latent variable space of the HSWG process model, all materials could be divided into three categories, namely the Chinese medicine extracts, the diluents and the disintegrants. The granulation of Chinese medicine extracts required low viscosity and low amount of binder, and the resulted granule sizes were small. The diluent powders occupied a large physical space, and could be made into granules with different granule sizes by adjusting the properties of binders. The disintegrants tended to be made into large granules under the condition of aqueous binder. The combination use of material database and multivariate modeling method is conducive to innovate the knowledge discovery of the wet granulation process of Chinese medicine, and provides a basis for the formulation and process design based on material attributes.

关键词(KeyWords): 高剪切湿法制粒;物料库;可制造性;偏最小二乘;质量源于设计
high shear wet granulation;material library;manufacturability;partial least squares;quality by design

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金面上项目(82074033);; 中华中医药学会青年人才托举工程项目(2019-QNRC2-C11);; 创新药物与高效节能降耗制药设备国家重点实验室开放基金项目(GZSYS202007)

作者(Author): 王政;王雅雯;曹君杰;李婉婷;张燕玲;罗赣;乔延江;徐冰;
WANG Zheng;WANG Ya-wen;CAO Jun-jie;LI Wan-ting;ZHANG Yan-ling;LUO Gan;QIAO Yan-jiang;XU Bing;Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine;Beijing Key Laboratory of Chinese Medicine Manufacturing Process Control and Quality Evaluation, Beijing Municipal Science & Technology Commission;Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education;

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