消渴清颗粒UPLC-PDA-ELSD指纹图谱的建立及5个主要成分的测定

目的 建立消渴清颗粒的UPLC-PDA-ELSD指纹图谱研究方法，并对新芒果苷、芒果苷、知母皂苷BII、巴马汀和小檗碱进行定量测定，为消渴清颗粒的质量控制提供依据。方法 采用RP-UPLC-PDA-ELSD法，分别以芒果苷和知母皂苷BII为参照峰，确定了23个紫外检测共有指纹峰和10个蒸发光检测共有指纹峰，建立了消渴清颗粒的数字化定量指纹图谱，并以三级系统指纹定量法鉴定28批消渴清样品的质量等级。采用外标法，测定了28批样品中新芒果苷、芒果苷、知母皂苷BII、巴马汀和小檗碱的量。结果 19批消渴清颗粒合格，9批不合格；8批消渴清颗粒中5个主要成分的量有异常，定量测定与指纹图谱结果具有一致性。结论 UPLC指纹图谱和5个成分的定量测定方法准确、稳定、简便，可作为消渴清颗粒的质量控制依据。

Establishment of UPLC-PDA-ELSD fingerprints of Xiaokeqing Granules and determination of its five main constituents

Objective To establish a UPLC-PDA-ELSD method for the fingerprint of Xiaokeqing Granules (XG) and to determine the contents of neomangiferin, mangiferin, timosaponin BII, palmatine, and berberine so as to provide the basis for the quality control of XG. Methods The chromatographic fingerprints were determined by UPLC-PDA-ELSD using mangiferin and timosaponin BII peaks as the reference peaks, 23 PDA and 10 ELSD common peaks were selected, and the digital quantitative fingerprint of XG was established. Using the third systematic quantified fingerprint method, the quality levels of 28 batches of XG were assessed. The contents of neomangiferin, mangiferin, timosaponin BII, palmatine, and berberine in the 28 batches of samples were determined using external standard method. Results Twenty batches of XG were identified as qualified and eight batches were unqualified, in which there were differences in the five main consitituents. The quantitative results were consistent with the fingerprint. Conclusion The method is accurate, stable, and simple, which could be applied to the quality control of XG.