指纹图谱技术在中药配方颗粒质量评价及过程控制中的应用

Application of fingerprint technology in quality evaluation and process control of traditional Chinese medicine formula granules

指纹图谱技术能全面反映中药饮片或制剂的内在化学特征,具有"整体性"和"模糊性"特点,适用于评价中药配方颗粒在生产过程中各环节中间体及成品的质量。该文综述了近年来高效液相色谱(HPLC)、薄层色谱(TLC)、气相色谱(GC)及红外光谱(IR)指纹图谱技术在中药配方颗粒过程控制及质量评价中的应用,并对各自的优缺点进行剖析。旨在加强多种指纹图谱技术在中药配方颗粒中的联合应用,优势互补,为实现中药配方颗粒生产工艺的稳定性及整体质量评价提供一定参考依据。

The fingerprint technology could reflect the internal chemical characteristics of Chinese herbal medicine or preparation, which has the characteristics of "wholeness" and "fuzziness". It is suitable for evaluating the quality of intermediate and finished products in the production process of traditional Chinese medicine formula granules. In this paper, the applications of high performance liquid chromatography(HPLC), thin layer chromatography(TLC), gas chromatography(GC) and infrared spectrum(IR) fingerprint technology in the quality control of traditional Chinese medicine formula granules were reviewed, and their advantages and disadvantages were analyzed. The aim of this article is to enhance the combined application of various fingerprint technologies in traditional Chinese medicine formula granules. It could provide technical reference for realizing the stability of production process and improving the overall quality of formula granules.