基于中药炮制特色的饮片质量标准研究现状与问题探析  

Exploration of the current status and issues in the research on the quality standard of decoction pieces based on the characteristics of traditional Chinese medicine processing

作　　者：郭玥 康显杰 叶佩 李小宁 李昌煜[1] 杜伟锋[1,2,3] 葛卫红[1,2,3] GUO Yue;KANG Xianjie;YE Pei;LI Xiaoning;LI Changyu;DU Weifeng;GE Weihong(School of Pharmaceutical Sciences,Zhejiang Chinese Medical University,Hangzhou 311402,China;Research Center of TCM Processing Technology,Zhejiang Chinese Medical University,Hangzhou 311401,China;Chinese Herbal Pieces Co.,Ltd.,Zhejiang Chinese Medical University,Hangzhou 311401,China)

机构地区：[1]浙江中医药大学药学院,杭州311402 [2]浙江中医药大学中药炮制技术研究中心,杭州311401 [3]浙江中医药大学中药饮片有限公司,杭州311401

出　　处：《中华中医药杂志》2024年第11期6163-6167,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2018YFC1707001);杭州市农业与社会发展科研重点项目(No.202204A06);浙江省基础公益研究计划项目(No.LTG N23H280001);浙江中医药大学科研项目(No.2023JKZKTS28);浙江省“三农九方”科技协作计划(No.2023SNJF031)。

摘　　要：中药饮片作为中医临床及中成药生产的核心物质基础,其质量控制直接关系到临床疗效与患者安全。然而,当前市场上中药饮片质量参差不齐,主要由于缺乏明确的特征成分作为质量控制标准。文章基于中药炮制特色,深入探讨了中药饮片质量标准研究现状与问题。通过分析《中华人民共和国药典》及其他相关文献,指出当前中药饮片质量标准存在炮制品收录不全、质量控制指标不完善等问题。进一步探析了炮制机制、谱效关系、质量标志物及代谢组学等研究方法在中药饮片质量标准制定中的应用。通过对中药饮片日后质量标准的构建进行展望,旨在构建更为科学、系统的炮制中药饮片质量标准体系,推动中医药事业的积极与健康发展。Traditional Chinese medicine(TCM)decoction pieces serve as the core material basis for TCM clinical practice and the production of prepared TCM medicines,and their quality control is directly related to clinical efficacy and patient safety.However,the quality of TCM decoction pieces on the current market is inconsistent,mainly due to the lack of clear characteristic components as quality control standards.This article,based on the characteristics of TCM processing,deeply explores the current status and issues in the research on the quality standards of TCM decoction pieces.By analyzing the Pharmacopoeia of The People’s Republic of China and other relevant literature,it points out that there are problems with the current quality standards for TCM decoction pieces,such as incomplete collection of processed products and imperfect quality control indicators.The article further explores the application of research methods such as processing mechanisms,spectrum-effect relationships,quality markers,and metabolomics in the formulation of quality standards for TCM decoction pieces.By looking forward to the construction of future quality standards for TCM decoction pieces,the aim is to build a more scientific and systematic quality standard system for processed TCM decoction pieces,and to promote the positive and healthy development of the TCM cause.

关 键 词：中药炮制 中药饮片 质量标准 炮制机制 谱效关系 质量标志物 代谢组学 

分 类 号：R288[医药卫生—中药学]