中药质量源于设计方法和应用：产品和工艺设计(1)
摘要 藥品质量源于设计(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。
关键词 中药;设计科学;产品设计;工艺设计;智能设计
Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅰ)：Products and Process Design
, http://www.100md.com
Dai Shengyun1， Xu Bing1，2，3， Shi Xinyuan1，2，3， Zhang Zhiqiang4， Zhang Yanling1， Wang Yun1，Qiao Yanjiang1，2，3
(1 Department of Chinese Medicine Information Science， Beijing University of Chinese Medicine， Beijing 102400， China; 2 Beijing
Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine， Beijing Municipal
Science &Technology Commission， Beijing 100029， China; 3 Engineering Research Center of Key Technologies for Chinese
, 百拇医药
Medicine Production and New Drug Development， Ministry of Education of People′s Republic of China， Beijing 100029，China; 4 Beijing Kangrentang Pharmaceutical Co. LTD.， Beijing 101301， China)
Abstract 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.
Key Words Chinese medicine; Design science; Product design; Process design; Intelligent design, http://www.100md.com(戴胜云 徐冰 史新元 张志强 张燕玲 王耘 乔延江)
关键词 中药;设计科学;产品设计;工艺设计;智能设计
Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅰ)：Products and Process Design
, http://www.100md.com
Dai Shengyun1， Xu Bing1，2，3， Shi Xinyuan1，2，3， Zhang Zhiqiang4， Zhang Yanling1， Wang Yun1，Qiao Yanjiang1，2，3
(1 Department of Chinese Medicine Information Science， Beijing University of Chinese Medicine， Beijing 102400， China; 2 Beijing
Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine， Beijing Municipal
Science &Technology Commission， Beijing 100029， China; 3 Engineering Research Center of Key Technologies for Chinese
, 百拇医药
Medicine Production and New Drug Development， Ministry of Education of People′s Republic of China， Beijing 100029，China; 4 Beijing Kangrentang Pharmaceutical Co. LTD.， Beijing 101301， China)
Abstract 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.
Key Words Chinese medicine; Design science; Product design; Process design; Intelligent design, http://www.100md.com(戴胜云 徐冰 史新元 张志强 张燕玲 王耘 乔延江)