世界中医药
文章摘要
引用本文:戴胜云1,徐冰1,2,3,史新元1,2,3,张志强4,张燕玲1,王耘1,乔延江1,2,3.中药质量源于设计方法和应用:产品和工艺设计[J].世界中医药,2018,(03):.  
中药质量源于设计方法和应用:产品和工艺设计
Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅰ):Products and Process Design
投稿时间:2017-12-13  
DOI:10.3969/j.issn.1673-7202.2018.03.004
中文关键词:  中药  设计科学  产品设计  工艺设计  智能设计
English Keywords:Chinese medicine  Design science  Product design  Process design  Intelligent design
基金项目:国家中药标准化项目(ZYBZH-C-QIN-45);国家自然科学基金重点项目(81430094);国家自然科学基金项目(81403112)
作者单位
戴胜云1,徐冰1,2,3,史新元1,2,3,张志强4,张燕玲1,王耘1,乔延江1,2,3 1 北京中医药大学中药信息学系北京102400 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京100029 3 教育部中药制药与新药开发关键技术工程研究中心北京100029 4 北京康仁堂药业有限公司北京101301 
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中文摘要:
      药品质量源于设计(Quality by Design,QbD)是设计科学和制造科学的总和,设计思维和方法贯穿于药品研究、开发、生产和流通的全过程,设计对药品质量具有决定作用。中药设计是在中医药理论指导下,有效使用多学科的科学原理使中药质量满足临床防病治病需求的过程。本文总结了中药方剂设计、中药药物设计和中药剂型设计等中药产品设计内容,以及药辅合一理论指导下的中药制剂处方设计、中药制药工艺路线设计和制药工程设计等中药工艺设计内容。随着数据科学和人工智能的发展,基于大数据、知识和规则的中药智能设计方法,如专家系统(ES)、工艺分类系统(MCS)和智慧中药系统(iTCM)等,提高了中药设计效率,丰富了中药质量源于设计内容。
English Summary:
      Quality by design (QbD) is the total of design science and manufacture science. The design thinking and methods run through the entire process of drug research, development, production and circulation. Moreover, design is decisive for the quality of medicinal products. Traditional Chinese Medicine (TCM) design is guided by Chinese medicine theory and combines the effective use of multidisciplinary scientific principles to ensure the quality of TCM to meet the needs of clinical disease prevention and treatment process. This article summarized the TCM product design including formula design, drug design and dosage form design, and the TCM pharmaceutical process design under the theory of “unification of medicines and excipients” including the TCM formula design, TCM manufacturing route design and pharmaceutical engineering design. With the development of data science and artificial intelligence, TCM intelligent design methods based on big data, knowledge and rules, such as expert system (ES), manufacture classification system (MCS) and intelligent traditional Chinese medicine system (iTCM), which improved the TCM design efficiency and enriched the content of Chinese medicine quality by design.
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