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

机译:“ iVarious”标准体系对中药质量和安全控制的整体策略

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摘要

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.
机译:有效的质量控制体系是确保中药质量,安全性和有效性的关键。但是,当前的质量标准研究缺乏顶级设计和系统设计,主要是基于特定技术或评估方法。为了解决中药质量控制面临的挑战和问题,提出了一种全新的质量标准体系“ iVarious”。该系统包含八个模块化格式的元素。通过相应的研究实例具体说明了每个元素的含义。此外,以“ iVarious”系统为基础,以乳香研究为例说明了标准和研究过程。该系统强调了中药质量,安全控制标准有效性,安全性,完整性和系统化的整体策略。 “ iVarious”的建立整合了多学科技术和进步方法,基础要素以及标准构建的重点。该系统为中药质量标准的制定提供了新颖的思路和技术示范。

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    《药物分析学报(英文)》 |2017年第005期|271-279|共9页
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