中药质量控制未来发展方向的思考

马双成, 王莹, 魏锋

中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1273-1281.

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中国药学杂志
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中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1273-1281. DOI: 10.11669/cpj.2021.16.001
综述

中药质量控制未来发展方向的思考

  • 马双成, 王莹, 魏锋
作者信息 +

Ideas on Future Development Direction of Quality Control of Traditional Chinese Medicine

  • MA Shuang-cheng, WANG Ying, WEI Feng
Author information +
文章历史 +

摘要

中医药是中华民族的重要财富,古往今来在保障人民健康上发挥着不可替代的作用。加强中药的质量控制,对于保证民众用药安全、促进中药产业发展具有重要意义。本研究对近些年来中药材及饮片、中成药市场抽验情况进行总结,并对检测结果分析,归纳出中药质量目前存在的主要问题。同时,针对这些问题,对中药质量控制未来应关注的重点方向进行展望,主要包括中药质控新型标准物质研究、中药质量等级评价新模式、中药质控重点关注品种(多糖、内源性毒性成分、动物药及发酵类中药材)以及有毒有害物质的风险评价。通过对以上中药质控方向的阐述,旨在从中药质量实际存在问题出发,为中药质量监管及制定监管决策提供有益参考。

Abstract

Traditional Chinese medicine (TCM) is an important wealth of Chinese people, which plays an irreplaceable role in protecting people's health. Strengthening the quality control of TCM is of great significance to ensure drug safety and promote the development of TCM industry. In this study, we summarized the quality situation of Chinese medicinal materials and Chinese patent medicine according to the RESULTS of drug inspection in recent years, and summarized the main problems existing in the quality of TCM. At the same time, the key directions of quality control of TCM were proposed, including the research of new reference materials for quality control of traditional Chinese medicine, new models of quality grade evaluation of traditional Chinese medicine, the key research varieties (polysaccharides, endogenous toxic components, animal drugs and fermented traditional Chinese medicine), and the risk assessment of toxic and harmful substances. The OBJECTIVE of this article is to provide a useful reference for the quality supervision and regulatory decision-making of TCM.

关键词

中药 / 质量控制 / 质量现状 / 标准物质 / 等级评价

Key words

traditional Chinese medicine (TCM) / quality control / quality situation / reference substance / grade evaluation

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导出引用
马双成, 王莹, 魏锋. 中药质量控制未来发展方向的思考[J]. 中国药学杂志, 2021, 56(16): 1273-1281 https://doi.org/10.11669/cpj.2021.16.001
MA Shuang-cheng, WANG Ying, WEI Feng. Ideas on Future Development Direction of Quality Control of Traditional Chinese Medicine[J]. Chinese Pharmaceutical Journal, 2021, 56(16): 1273-1281 https://doi.org/10.11669/cpj.2021.16.001
中图分类号： R284   

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