世界中医药
文章摘要
引用本文:石国琳1,徐冰1,2,3,林兆洲4,5,史新元1,2,3,戴幸星1,2,3,乔延江1,2,3.中药质量源于设计方法和应用:工艺建模[J].世界中医药,2018,(03):.  
中药质量源于设计方法和应用:工艺建模
Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅲ):Process Modeling
投稿时间:2017-12-13  
DOI:10.3969/j.issn.1673-7202.2018.03.003
中文关键词:  质量源于设计  中药  系统建模  质量传递规律  质量预测
English Keywords:Quality by Design (QbD)  Chinese medicine  System modeling  Quality transfer rules  Quality prediction
基金项目:国家中药标准化项目(ZYBZH-C-QIN-45);国家自然科学基金项目(81403112);国家自然科学基金重点项目(81430094)
作者单位
石国琳1,徐冰1,2,3,林兆洲4,5,史新元1,2,3,戴幸星1,2,3,乔延江1,2,3 1 北京中医药大学中药信息系北京102400 2 北京市科委中药生产过程控制与质量评价北京市重点实验室北京102400 3 教育部中药制药与新药开发关键技术工程研究中心北京102400 4 首都医科大学附属北京中医医院北京100010 5 北京市卫生局临床药学研究所北京100035 
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中文摘要:
      药品质量源于设计(Quality by Design,QbD)强调对制药过程的透彻理解,即理解原料、工艺和产品质量之间的多维组合和相互作用关系。数学模型以函数关系的形式表征所研究工艺系统或过程“输入-输出”量对的集合,是解释制药质量传递规律,实现产品关键质量属性(CQAs)预测的重要工具。本文提出依据数学模型对终产品质量的影响程度将工艺模型分为高、中、低3类。为规范建模过程、提高建模效率,提出工艺建模质量管理规范(GMoP)。总结了机理建模、统计建模和混合建模方法,并介绍了数学模型在中药提取、干燥、制粒、粉体压缩、制药过程质量监控和工艺系统表征中的应用。
English Summary:
      Pharmaceutical Quality by Design (QbD) emphasizes comprehensive understandings of multidimensional combinations and interactions among raw materials, process and product quality during the pharmaceutical manufacturing processes. Such understandings could be realized by mathematical models, which characterize the “input-output” relationships of process systems and are important tools for explaining the laws of pharmaceutical quality transfer and predicting final product critical quality attributes (CQAs). Based on the quality risk management principles and the influence of mathematical models on the final product quality, process models were divided into high, medium and low risk categories. And good modeling practice (GMoP) was introduced to standardize the modeling process and to improve the efficiency of process modeling. This paper also summarized the methods of mechanistic model, statistical model and hybrid model, and reviews the applications of mathematical models to the extraction, drying, granulation, powder compression, process monitoring and control, and application of process system characterization.
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