目的 建立人参健脾丸（Renshen Jianpi Pills，RJP）中11个成分的HPLC含量测定方法，并对测定结果进行化学计量学分析。方法 采用Kromasil 100-5-C₁₈色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%甲酸水溶液为流动相梯度洗脱，体积流量1.0 mL/min，柱温35℃，进样体积10 μL；采用切换波长法测定52批RJP中隐绿原酸、香草酸、斯皮诺素、毛蕊异黄酮葡萄糖苷、阿魏酸、芸香柚皮苷、3，6'-二芥子酰基蔗糖、川陈皮素、橘皮素、藁本内酯、白术内酯I的含量，结合层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）和正交偏最小二乘法-判别分析（orthogonal partial least squares-discriminant analysis，OPLS-DA）对含量测定结果进行综合分析。结果 隐绿原酸、香草酸、斯皮诺素、毛蕊异黄酮葡萄糖苷、阿魏酸、芸香柚皮苷、3，6'-二芥子酰基蔗糖、川陈皮素、橘皮素、藁本内酯、白术内酯I分别在0.18～17.75、0.20～20.02、0.20～19.96、0.31～30.81、0.21～21.07、0.84～84.14、0.44～44.24、0.18～17.63、0.17～17.17、1.62～162.48、0.17～17.28 μg/mL线性关系良好（r≥0.999 7），平均加样回收率分别为97.46%、101.61%、103.02%、96.49%、102.88%、96.97%、97.92%、99.13%、94.29%、92.16%、95.57%，RSD分别为0.78%、0.57%、1.12%、1.65%、0.73%、0.91%、1.23%、1.34%、1.54%、1.92%、1.76%。化学计量学分析结果显示，52批RJP样品聚为3类，不同生产企业样品质量存在一定差异；芸香柚皮苷、藁本内酯和川陈皮素是影响RJP样品质量的主要潜在标志物。结论 建立的HPLC含量测定方法简单、可行，结合化学计量学方法可用于RJP的质量的综合评价。

Objective To establish an HPLC content determination method of 11 components in Renshen Jianpi Pills (人参健脾丸, RJP), and analyze the content determination results by chemometrics method. Methods The analysis was carried out on Kromasil 100-5-C₁₈ column (250 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile-0.1% formic acid with gradient elution. The column temperature was 35℃, the volume flow was 1.0 mL/min, and the injection volume was 10 μL. Measuring the content of cryptochlorogenic acid, vanillic acid, spinosin, calycoflavone glucoside, ferulic acid, naringin, 3,6'-disinaloyl sucrose, nobiletin, hesperetin, ligustilide and atractylenolide I in 52 batches of RJP by wavelength switching method. The content determination results were comprehensively analyzed using hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA). Results Cryptochlorogenic acid, vanillic acid, spinosin, calycoflavone glucoside, ferulic acid, naringin, 3,6'-disinaloyl sucrose, nobiletin, hesperetin, ligustilide and atractylenolide I showed good linear relationship (r ≥ 0.999 7) within the ranges of 0.18-17.75, 0.20-20.02, 0.20-19.96, 0.31-30.81, 0.21-21.07, 0.84-84.14, 0.44-44.24, 0.18-17.63, 0.17-17.17, 1.62-162.48, and 0.17-17.28 μg/mL, whose average recoveries were 97.46%, 101.61%, 103.02%, 96.49%, 102.88%, 96.97%, 97.92%, 99.13%, 94.29%, 92.16%, and 95.57% with RSD values of 0.78%, 0.57%, 1.12%, 1.65%, 0.73%, 0.91%, 1.23%, 1.34%, 1.54%, 1.92%, 1.76%, respectively. The chemometrics analysis results showed that 52 batches of RJP could be clustered into three categories, and there were some differences in sample quality among different manufacturers. Naringin, ligustilid and nobiletin were the main potential markers affecting the quality of RJP. Conclusion The established content determination method by HPLC is simple and feasible, and could be used for the comprehensive evaluation of the quality of RJP combined with chemometrics method.

R283.6

山东省重点研发计划（重大科技创新工程）项目（2021CXGC010511）；山东省重点研发计划（重大科技创新工程）项目（2021SFGC1202）；山东省人文社会科学课题（2021-YYGL-44）；泉城产业领军人才支持计划创新团队项目（MRJT2105）；中药材及饮片质量控制重点实验室项目（2022GSMPA-KL12）；“新高校20条”科研带头人工作室项目（202228096）