Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations f...Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development 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 summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.展开更多
In this study, we developed a novel and simple HPLC-DAD method for simultaneous qualitative and quantitative determination of five major components of Glycyrrhizae Radix et Rhizoma （GRR） in Xiaoer Zhike Tangjiang （...In this study, we developed a novel and simple HPLC-DAD method for simultaneous qualitative and quantitative determination of five major components of Glycyrrhizae Radix et Rhizoma （GRR） in Xiaoer Zhike Tangjiang （XEZKTJ） with standardized reference extract （SRE）. The five analytes （liquiritin apioside, liquiritin, isoliquiritin apioside, liquirigenin and glycyrrhizic acid） were well separated with good linearity, precision, stability and repeatability. The recovery rates ranged from 95.69% to 100.80%. The content of the five compounds in 34 batches of commercial XEZKTJ products was determined using standardized GRR extract （SRE method） and individual chemical reference standards （CRS method）. Highly similar results were obtained from the two methods, demonstrating the feasibility of the proposed SRE method. Taken together, we proposed an efficient and low-cost way to perform multi-component quality control of XEZKTJ in this study.展开更多
文摘Number and quantities of reference standards (RS) needed for the quality control of drugs are increasing, bringing great pressure to the calibration and using company. This manuscript summarized the four generations for the development 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 summed up the definition, advantages, and technical architecture of DRS. The 10 characteristics of five aspects of the DRS were discussed including digital, multi-dimension, big data, cloud computing, internet, internet of things, sharing, multi-terminal, intelligence, and compliance certification. Then, the necessity of its formation and application in the medicine holistic quality control of internet plus era was discussed in this manuscript.
基金Drug Standards Improvement Project of Chinese Pharmacopoeia Commission
文摘In this study, we developed a novel and simple HPLC-DAD method for simultaneous qualitative and quantitative determination of five major components of Glycyrrhizae Radix et Rhizoma （GRR） in Xiaoer Zhike Tangjiang （XEZKTJ） with standardized reference extract （SRE）. The five analytes （liquiritin apioside, liquiritin, isoliquiritin apioside, liquirigenin and glycyrrhizic acid） were well separated with good linearity, precision, stability and repeatability. The recovery rates ranged from 95.69% to 100.80%. The content of the five compounds in 34 batches of commercial XEZKTJ products was determined using standardized GRR extract （SRE method） and individual chemical reference standards （CRS method）. Highly similar results were obtained from the two methods, demonstrating the feasibility of the proposed SRE method. Taken together, we proposed an efficient and low-cost way to perform multi-component quality control of XEZKTJ in this study.
