标准物质的发展和挑战与数字化新形式

Progress and Challenges of Reference Standards and their New Form:Digital Reference Standards(DRS)

药品质量控制所需的标准物质种类和数量越来越多,这给发放方和使用方都带来了巨大压力。本文归纳了标准物质的发展历史,包括实物标准物质、纸质图谱集、替代标准物质、电子数据库大致四代,对每一代的优缺点进行了总结。并在此基础上提出了数字标准物质的概念,总结出数字标准物质的定义、优势与技术架构,深入探讨了数字标准物质五个方面的十个特性,包括数字化、多维、大数据、云计算、互联网、物联网、共享、多终端、智能化、认证合规。并对其在互联网+时代的药品整体质量控制中形成和应用的必然性进行了探讨。

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.