Research mode of quality marker research and quality evaluation of Chinese materia medica based on multi-source information fusion / 中草药

Chinese materia medica (CMM) is a complex system, which has characteristics of multiple components, diversity efficacy, and unpredictable relation among components, etc. Thus, constructing the quality evaluation and quality control model based on multi-disciplinary and multi-source information fusion is an innovative research idea for quality standards of CMM. The quality control system should been fully established to cover quality integrity and efficacy specificity of CMM based on the core concept of quality marker. Traditional quality assessment methods based on characteristic feature, chemical analysis including multiple chemical components and elementary substances, and biological evaluation were integrated by data fusion methods in this system. The correlation of the organic and elemental components with the specific effects should be established in order to verify the material basis. Finally, the Q-markers (including potential elemental Q-markers) with unique characteristics relevant to specific effect were analyzed and defined. The integrated quality indexes of Q-markers relevant to specific effect were calculated. This proposed integrated quality control system based on multi-source information fusion methods would enrich and perfect the quality evaluation of CMM.

Progress and challenges of reference standards and their new form: digital reference standards (DRS) / 中国药学杂志

The number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the companies that calibrate and use RS. This manuscript summarized the four generations of RS including physical RS, paper atlas, substitute RS, and electronic databases. The advantages and disadvantages of each generation were summarized. The concept of digital RS (DRS) was proposed based on this, and the definition, advantages, and technical architecture of DRS were summed up. The 10 characteristics of the five aspects of the DRS were discussed including digital, multi-dimensional, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of the formation and application of DRS in the holistic quality control of drugs in the era of internet plus is discussed.