Tianjin Research Centre for Drug Evaluation, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China.
National Engineering Laboratory for Standardization of Traditional Chinese Medicine, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
Phytomedicine. 2018 May 15;44:247-257. doi: 10.1016/j.phymed.2018.03.006. Epub 2018 Mar 6.
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.
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.
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.
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.
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.
由于多种因素会影响草药质量，现有的质量管理模式无法对过程控制进行评估。“质量标志物”（Q-marker）概念的提出为建立草药产品独立的过程质量控制系统奠定了基础。
假说/目的：为确保草药产品的安全性、有效性和过程控制达到最高水平，旨在从原材料到成品草药产品建立质量传递和过程控制的质量可追溯性系统。
基于质量评估的关键问题和挑战，分析了药典中从原材料到草药药品的质量和过程控制的现状，并设计了包括 Q-标志物的发现和鉴定、风险评估的分析和质量管理在内的研究模型。
作者介绍了一些新技术和方法，如 DNA 条形码、色谱技术、指纹分析、化学标志物、生物反应、风险管理以及质量过程控制的解决方案。
提出了草药药品的质量和过程控制模型，并构建了从原材料到成品的可追溯性系统，以从整个供应和生产链提高草药质量。
基于质量标志物建立了可追溯性系统，特别是如何在良好工程规范下控制生产过程，以及在草药生产中实施质量和过程控制的风险管理。
