基于UPLC指纹图谱的西洋参饮片、标准汤剂、配方颗粒的质量相关性研究

为了实现西洋参配方颗粒全生产过程的质量控制，采用超高效液相色谱法(UPLC)对其饮片、标准汤剂和配方颗粒的指纹图谱和量质传递进行了相关性研究。采用UPLC法测定18批西洋参饮片、标准汤剂、3批配方颗粒的指纹图谱、人参皂苷Rg₁,Re, Rb₁总量，以K值和各已知成分的转移率作为量值传递的评价指标，结合相似度评价法研究三者的相关性。结果表明：西洋参饮片、标准汤剂、配方颗粒指纹图谱均呈现8个共有特征峰，并指认出5个成分，三者的指纹图谱与相应对照指纹图谱及三者对照指纹图谱的相似度均大于0.95,人参皂苷Rg₁,Re, Rb₁的转移率及K值趋势一致，量值传递稳定。西洋参饮片、标准汤剂、配方颗粒的化学成分基本一致，三者具有良好的相关性。研究所得可对西洋参配方颗粒的质量标准研究提供实验及理论支持，并为后续以标准汤剂为基准的配方颗粒或经典方制剂质量控制提供了参考依据。

Study on the quality correlation of American Ginseng decoction pieces, standard decoctions and formula granules based on UPLC fingerprint

In order to achieve the quality control of American Ginseng formula granules in the whole production process, ultra-high performance liquid chromatography (UPLC) method was used to study the correlation between the fingerprint and the quantity-quality-transfer of the decoction pieces, standard decoctions and formula granules. UPLC was used to determine the fingerprints of eighteen batches of American Ginseng decoction pieces, standard decoctions and three batches of formula granules and the total amount of ginsenoside Rg1, Re and Rb1. The value of K and the transfer rate of each known component were taken as the evaluation index of quantity transfer, and the correlation among the three was studied by combining with similarity evaluation method. The results show that there are eight common characteristic peaks in the fingerprints of American Ginseng decoction pieces, standard decoctions and formula granules, and five components are identified. The similarity between the three fingerprints and the corresponding control fingerprints and the three control fingerprints is greater than 095. The trend of ginsenoside Rg1, Re, Rb1 transfer rates and K values is consistent, and the quantitative value transfer is stable. The chemical composition of American Ginseng decoction pieces, standard decoction and formula granule is basically the same, and the three have a good correlation. This study can provide experimental and theoretical support for the research on the quality standards of American Ginseng formula granules, and it can also provide reference for the quality control of standard decoction-based granules or classical preparations.