关键词: 中药配方颗粒, 薄层鉴别, 指纹图谱, 特征图谱, 对照提取物

Abstract: Formula granules are granules of single traditional Chinese medicine; they are extracted, concentrated, dried, and granulated by modern production technology and use decoction pieces as the raw materials. The final granule products have lost the properties and microscopic characteristics of the original decoction pieces. Therefore, it is necessary to use thin-layer chromatography, fingerprint/specific chromatogram, extract detection, content determination, and other methods to control their internal quality. In this paper, referring to official documents, national and provincial quality standards of formula granules, and documents on the quality standards for formula granules in recent years, we focus on the application information of thin-layer identification and fingerprint/specific chromatogram in the standard for formula granules, and discuss the progressiveness of the current standard and the content to be improved. The feasibility of the application of the extractive reference substances of formula granules is discussed.

Key words: Traditional Chinese medicine formula granules, Thin layer chromatography identification, Fingerprint, Specific chromatogram, Extractive Reference Substance