基于UPLC结合比色法的葛桑降糖胶囊质量控制研究

目的构建葛桑降糖胶囊的质量控制方法。方法采用比色法测定葛桑降糖胶囊粗多糖、总皂苷和总黄酮含量;采用UPLC建立葛桑降糖胶囊的指纹图谱,测定了10个批次产品;并利用中药色谱指纹图谱相似度评价系统(2012版本)进行相似度评价,确定共有峰。结果 3批次葛桑降糖胶囊中粗多糖平均质量分数为4.56%,总皂苷平均质量分数为2.97%,总黄酮平均质量分数为2.61%;建立了10批次葛桑降糖胶囊的UPLC指纹图谱,确立15个共有峰,经对照品指认出7个共有峰,分别是葛根素、芦丁、三七皂苷R1、人参皂苷Rg1、商陆苷、人参皂苷Rb1、商陆黄素,对应1、5、8、10、12、14、15号峰。结论此方法可用于葛桑降糖胶囊的质量控制。

Quality control research of Gesang Jiangtang Capsules based on UPLC fingerprint combined with colorimetry

Objective To establish the determination and fingerprint of Gesang Jiangtang Capsules (GJC) for its quality control. Methods UV spectrophotometric method was used for determining polysaccharides, total saponins, and total flavonoids of GJC. Ten batches of GJC were detected and recorded by UPLC. Similarity evaluation was performed by using Similarity Evaluation System for Fingerprint Chromatogram of TCM (2012) to confirm the common peaks. Results In three batches of GJC, average polysaccharides content, average total saponins content, and average total flavonoids content were 4.56%, 2.97%, and 2.61%, respectively. UPLC fingerprints of 10 batches of GJC were established and 15 common peaks were confirmed. Puerarin, rutin, notoginsenoside R₁, ginsenoside Rg₁, ombuoside, ginsenoside Rb₁, and ombuin were identified by chemical identification of the reference substance, corresponding to peaks 1, 5, 8, 10, 12, 14, and 15. Conclusion The methods can be used for the quality control of GJC with good precision, accuracy, and reproducibility.