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

Anzhen Chen, Lei Sun, Hang Yuan, Aiying Wu, Jingguang Lu, Shuangcheng Ma
2017 Journal of Pharmaceutical Analysis  
A B S T R A C T 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.
more » ... ning 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. Elements of "iVarious" standard system The "iVarious" standard system comprises eight elements: i, V, a, r, i, o, u, and s standing for information, variety, alternative, rapidity, ion (mass spectrum), overall, uniformity, and substitute and safety, respectively (Fig. 1) . The element of information (i) involving "digitization", "artificial intelligence", and "Internet" is the digital form of quality standard. The other seven research elements represent sample collection (V), the set of items (a), the choice of methods (r, u and i), holistic quality evaluation (o and s), and safety (s) test, respectively. The seven http://dx.
doi:10.1016/j.jpha.2017.07.008 pmid:29404049 pmcid:PMC5790695 fatcat:mt3z4uba35e5rme7qaocwtjpia