A holistic strategy for quality and safety control of traditional Chinese medicines by the"iVar

• 作 者: # Lei Sun Hang Yuan Aiying Wu Jingguang Lu Shuangcheng Ma
• 机 构: #“,”National Institutes for Food and Drug Control, Beijing 100050, China“,”Xinjiang Institute for Fo
• 出 处: 药物分析学报（英文）
• 发表日期: 2017年5期
• 关键词: iVarious Quality standard system Traditional Chinese medicines (TCMs) Quality an

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 iVarious system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of iVarious 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.