目的 建立升麻饮片的高效液相色谱（HPLC）指纹图谱和分析其5种成分含量的一测多评（quantitative analysis of multicomponents by single-marker，QAMS）方法，实现对升麻饮片质量的系统评价。方法 采用HPLC法建立升麻饮片指纹图谱，运用相似度评价、聚类分析（cluster analysis，CA）、主成分分析（principal component analysis，PCA）和正交偏最小二乘-判别分析（orthogonal partial least squares discriminant analysis，OPLS-DA）等化学模式识别对指纹图谱进行分析；以异阿魏酸为内参物，建立分析咖啡酸、升麻素苷、阿魏酸、升麻素含量的QAMS法，并与外标法（external standard method，ESM）测定结果进行比较。结果 12批升麻饮片的HPLC指纹图谱中有13个共有峰，指认了该指纹图谱中的5个成分，分别为咖啡酸、升麻素苷、阿魏酸、异阿魏酸、升麻素，12批升麻饮片相似度为0.92～1.00，CA、PCA和OPLS-DA分析表明，供试升麻饮片可分为2类，差异性成分为峰2、3、4、7（阿魏酸）、8（异阿魏酸）、9（升麻素）；建立了分析所指认的5种成分含量的QAMS方法，分析结果与ESM法测定的相应成分含量无显著差异。结论 所建立的HPLC指纹图谱和QAMS法操作简便、高效、经济、可靠，可为升麻饮片及其衍生产品的质量评价提供参考和依据。

Objective A method combining high performance liquid chromatography (HPLC) fingerprint with quantitative analysis of multicomponents by single-marker (QAMS) was established to analyze the contents of five components in Shengma (Cimicifugae Rhizoma, CR) and realize the systematic evaluation of the quality of CR decoction pieces . Methods The HPLC fingerprint of CR decoction pieces was explored through HPLC analysis and comprehensively evaluated through a series of analytical methods including similarity evaluation, cluster analysis (CA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA). Isoferulic acid was selected as the internal reference standard for the exploration of the QAMS method, which was then applied to determine the content of caffeic acid, cimicifugoside, ferulic acid, and cimifugin in CR. The analytical results calculated by QAMS were subsequently compared with those from the external standard method (ESM). Results In the established fingerprints for 12 batches of CR decoction pieces, thirteen common peaks were identified and five peaks of them were confirmed, which were caffeic acid, cimicifugoside, ferulic acid, isoferulic acid, and cimifugin, respectively. The similarity scores for 12 batches of CR decoction pieces were ranged from 0.92 to 1.00. According to the further calculation of the fingerprints through CA, PCA, and OPLS-DA, the tested CR decoction pieces can be categorized into two distinct groups. The differential components among the tested samples were identified as peak 2, peak 3, peak 4, peak 7 (ferulic acid), peak 8 (isoferulic acid), and peak 9 (cimifugin), respectively. The QAMS method for quantitative analysis of five confirmed components in CR decoction pieces was established, and there were no significant difference between the analytical results through QAMS and ESM. Conclusion The established HPLC fingerprint and QAMS were found to be simple, efficient, economical and reliable, which can provide a reference and basis for quality control of CR decoction pieces and the derived products.

R286.2

2023年度国家药品标准修订研究课题（2023Z03）;国家自然科学基金资助项目（81973211/C0033375）;湖南中医药大学研究生创新课题（校行研字［2023］21号-2023CX139）;湖南中医药大学“十四五”重点学科-生物工程学科（校行发规字［2023］2号）