指纹图谱与特征图谱技术在中药配方颗粒国家标准中的应用回顾性分析

Retrospective Analysis on the Application of Fingerprint and Characteristic Chromatography Technology in the National Standards of Traditional Chinese Medicine Dispensing Granules

关键词:  中药配方颗粒  国家标准  指纹图谱  特征图谱  质量控制

Key words:  traditional Chinese medicine dispensing granules  national standard  fingerprint chromatography  characteristic chromatography  quality control

摘要:

指纹图谱与特征图谱技术在中药质量控制方面具有十分重要的作用,与中药饮片、中成药相比,中药配方颗粒国家标准均按照"中药配方颗粒质量控制与标准制定技术要求"规定建立了指纹图谱或特征图谱。本文通过回顾性分析指纹图谱与特征图谱技术在196个已发布中药配方颗粒国家标准中的应用情况,发现部分中药配方颗粒的国家标准存在物质基础研究薄弱,指纹图谱或特征图谱分析时间过长、对照品使用数量过多等问题。中药配方颗粒生产企业应当落实标准维护主体责任,践行绿色标准理念,持续开展中药标准汤剂物质基础研究,优化指纹图谱与特征图谱色谱条件,深入挖掘指纹图谱与特征图谱信息,通过相对保留时间定位或者设置相对峰面积规定,尽可能地建立可以区分多基原、生品与炮制品、伪品及易混淆品的中药配方颗粒国家标准,保障中药配方颗粒临床使用安全性和有效性。

Abstract:

Fingerprint and characteristic chromatography technology plays a very important role in the quality control of traditional Chinese Medicine(TCM). Compared with the national standards of Chinese medicine decoction pieces and proprietary Chinese medicine, the fingerprint or characteristic chromatography of TCM dispensing granules have been established in accordance with the "technical requirements for quality control and standard formulation of TCM dispensing granules". By reviewing and analyzing the application of fingerprint and characteristic chromatography technology in 196 national standards of TCM formula granules, it was found that some national standard of TCM formula granules had problems such as weak material basic research, too long analysis time and too many reference materials of fingerprint and characteristic chromatography technology. Enterprises producing traditional Chinese medicine formula granules should implement the main responsibility of standard maintenance, practice the concept of green standards, continue to conduct research on the material basis of traditional Chinese medicine standard decoction, optimize the chromatographic conditions of fingerprint and characteristic chromatography, and deeply explore the information of fingerprint and characteristic chromatography. By locating the relative retention time or setting relative peak area regulations, to establish national standards of TCM dispensing granules that can distinguish multiple sources, raw and processed products, counterfeit and easily confused products to ensure the safety and effectiveness of clinical use of TCM dispensing granules.