浓缩当归丸及当归片的HPLC指纹图谱质量初步评价

Quality Evaluation of Nongsuo Danggui Wan and Danggui Pian Based on HPLC Fingerprints Combined with Chemometric Methods

应用当归药材HPLC指纹图谱技术并结合共有峰相似度、主成分分析(PCA)、聚类分析(HCA)等化学计量学手段,对部分市售当归单味药成方制剂——浓缩当归丸和当归片进行了质量一致性和稳定性,以及与当归药材相关性的初步评价。研究结果表明,浓缩当归丸与当归片之间因制备工艺不同,其化学物质的组成与含量具有明显的差异;不同厂家生产的同类药品具有比较一致的整体色谱形貌,浓缩当归丸与当归药材图谱的相似度略高于当归片,当归片的质量稳定性和一致性略优于浓缩当归丸;同厂家不同批次同种药品的质量差异较小。此外,通过浓缩当归丸和当归片与当归药材色谱指纹图谱的对比分析,进一步探究了当归药材色谱指纹图谱中可能的药效物质信息。

The chromatographic fingerprints combined with chemometric methods including principal component analysis（PCA） and hierarchical clustering analysis （HCA） have been applied to evaluate the quality consistency and stability of Nongsuo Danggui Wan （NDW） and Danggui Pian （DP）, as well as the quality correlation with radix Angelica sinensis raw materials （Danggui）. As Chinese patent drugs containing single ingredient of Danggui, the remarkable differences between NDW and DP in the content and distribution of components in fingerprint different processing methods and techniques. However, of samples were generally ferent, and the similarity chromatograms were observed, mainly due to the chromatographic profiles of the same type consistent though the absorption intensities of some common peaks were difvalues of the NDW samples to Danggui herb were slightly higher than that of the DP samples. The quality consistency and stability of DP samples from different manufacturers and different batches were better than that of NDW. The quality differences of the different batches of NDW or DP samples from the same manufacturer were small. A few marker peaks among the 24 common peaks in chromatographic fingerprints of Danggui were pinpointed by comparing with the fingerprint chromatograms of Chinese patent drug NDW and DP, which were likely to contribute significantly to the pharmacodynamic activities of Danggui.