中药配方颗粒质量标准薄层鉴别与液相指纹图谱/特征图谱研究现状及对照提取物应用可行性探讨

中药配方颗粒是以饮片为原料，经现代生产工艺提取、浓缩、干燥、制粒得到的单味颗粒剂，其成品已经失去了原有饮片的性状和显微特征，故而有必要使用薄层色谱、指纹图谱/特征图谱、浸出物、含量测定等方法对其进行内在质量控制。本文在参考各官方发文、国家配方颗粒质量标准、各省区配方颗粒地方标准以及近年来关于配方颗粒质量标准的文献等基础上，重点对于配方颗粒标准中薄层鉴别和指纹图谱/特征图谱的应用情况进行综述讨论，针对现行标准的先进性和待完善的内容进行探讨，并针对配方颗粒对照提取物应用的可行性进行实例分析和探讨。

Research status of TLC identification and HPLC fingerprint/specificchromatograms of quality standard of traditional Chinese medicine formulagranules and discussion on feasibility of application of extractive referencesubstances

Formula granules are granules of singletraditional Chinese medicine; they are extracted, concentrated, dried, andgranulated by modern production technology and use decoction pieces as the rawmaterials. The final granule products have lost the properties and microscopiccharacteristics of the original decoction pieces. Therefore, it is necessary touse thin-layer chromatography, fingerprint/specific chromatogram, extract detection,content determination, and other methods to control their internal quality. Inthis paper, referring to official documents, national and provincial qualitystandards of formula granules, and documents on the quality standards forformula granules in recent years, we focus on the application information ofthin-layer identification and fingerprint/specific chromatogram in the standardfor formula granules, and discuss the progressiveness of the current standardand the content to be improved. The feasibility of the application of theextractive reference substances of formula granules is discussed.