A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system  

作　　者：Anzhen Chen Lei Sun Hang Yuan Aiying Wu Jingguang Lu Shuangcheng Ma 

机构地区：[1]Qingdao Institute for Food and Drug Control [2]National Institutes for Food and Drug Control [3]Xinjiang Institute for Food and Drug Control

出　　处：《Journal of Pharmaceutical Analysis》2017年第5期271-279,共9页药物分析学报（英文版）

基　　金：financial support from National Major Scientific and Technological Special Project for "Significant New Drugs Development" (2014ZX09304307-002);Youth Development Research Foundation of NIFDC (2013WA8);the National Natural Foundation of China (81303214)

摘　　要：An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named 'iVarious', was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the 'i Various' system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of'i Various' integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

关 键 词：iVarious QUALITY standard system TRADITIONAL CHINESE MEDICINES (TCMs) QUALITY and safety control HOLISTIC STRATEGY 

分 类 号：R288[医药卫生—中药学]