Quality transitivity and traceability system of herbal medicine products based on quality markers

doi:10.1016/j.phymed.2018.03.006

CORC > 上海药物研究所 > 中国科学院上海药物研究所 > 上海中药现代化研究中心

	Quality transitivity and traceability system of herbal medicine products based on quality markers
	Liu, Changxiao 2; Guo, De-an1 ; Liu, Liang 3
刊名	PHYTOMEDICINE
	2018-05-15
卷号	44 页码:247-257
关键词	Quality Transitivity Traceability Quality marker Herbal medicinal product
ISSN号	0944-7113
DOI	10.1016/j.phymed.2018.03.006
文献子类	Article
英文摘要	Background: Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. Hypothesis/purpose: To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Study design: Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Methods: Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. Results: The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. Conclusion: The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production.
资助项目	National Natural Science Foundation of China[81642011] ; National Natural Science Foundation of China[81430096]
WOS关键词	TRADITIONAL CHINESE MEDICINES ; PROCESS ANALYTICAL-CHEMISTRY ; INTERNAL TRANSCRIBED SPACER ; SALVIA-MILTIORRHIZA ; DNA BARCODES ; TANSHINONE BIOSYNTHESIS ; BIOPOTENCY ASSAYS ; HPLC ; IDENTIFICATION ; COMBINATION
WOS研究方向	Plant Sciences ; Pharmacology & Pharmacy ; Integrative & Complementary Medicine
语种	英语
出版者	ELSEVIER GMBH, URBAN & FISCHER VERLAG
WOS记录号	WOS:000436596600028
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/279757]
专题	上海中药现代化研究中心
通讯作者	Liu, Changxiao
作者单位	1.Chinese Acad Sci, Shanghai Inst Mat Med, Natl Engn Lab Standardizat Tradit Chinese Med, Shanghai 201203, Peoples R China; 2.Tianjin Inst Pharmaceut Res, Tianjin Res Ctr Drug Evaluat, Tianjin 300193, Peoples R China; 3.Macau Univ Sci & Technol, State Key Lab Qual Res Chinese Med, Macau, Peoples R China
推荐引用方式 GB/T 7714	Liu, Changxiao,Guo, De-an,Liu, Liang. Quality transitivity and traceability system of herbal medicine products based on quality markers[J]. PHYTOMEDICINE,2018,44:247-257.
APA	Liu, Changxiao,Guo, De-an,&Liu, Liang.(2018).Quality transitivity and traceability system of herbal medicine products based on quality markers.PHYTOMEDICINE,44,247-257.
MLA	Liu, Changxiao,et al."Quality transitivity and traceability system of herbal medicine products based on quality markers".PHYTOMEDICINE 44(2018):247-257.