孙昱, 徐敢, 马双成. 中药质量整体评价研究思路探讨J. 药学学报, 2021,56(7): 1749-1756. doi: 10.16438/j.0513-4870.2021-0307
引用本文: 孙昱, 徐敢, 马双成. 中药质量整体评价研究思路探讨J. 药学学报, 2021,56(7): 1749-1756. doi: 10.16438/j.0513-4870.2021-0307
SUN Yu, XU Gan, MA Shuang-cheng. Development of an overall evaluation system for traditional Chinese medicineJ. Acta Pharmaceutica Sinica, 2021,56(7): 1749-1756. doi: 10.16438/j.0513-4870.2021-0307
Citation: SUN Yu, XU Gan, MA Shuang-cheng. Development of an overall evaluation system for traditional Chinese medicineJ. Acta Pharmaceutica Sinica, 2021,56(7): 1749-1756. doi: 10.16438/j.0513-4870.2021-0307

中药质量整体评价研究思路探讨

Development of an overall evaluation system for traditional Chinese medicine

  • 摘要: 本文通过学习领会中药生产全过程质量控制的内涵要求,综述现代科学技术和传统中医药研究方法,了解中药质量的基础研究现状,探讨建立和完善以临床为导向、符合临床实际和中医药特点的中药质量整体评价体系。本文探讨了以下问题:①中药质量的整体评价如何体现中药功效;②如何量化中药功效和中药药性;③如何理解中药功效和中药药性的关联性及其应用;④中药质量整体评价中,如何体现功效成分的专属性;⑤中药质量整体评价中,如何体现功效成分在生产全过程和体内代谢过程中的量值传递。中药整体质量评价需更好地体现临床相关的安全性和有效性。建议在关注中药化学成分含量的基础上,建立临床相关的质量评价方法,即探索建立体现中药功效的符合临床实际的中药质量整体评价方法。

     

    Abstract: This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues:1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.

     

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