目的 建立北柴胡Bupleurum chinense及醋北柴胡标准汤剂质量评价方法，比较二者质量的差异性。方法 制备北柴胡及醋北柴胡标准汤剂各20批，对醋制前后标准汤剂的pH值及出膏率进行考察；建立北柴胡醋制前后标准汤剂HPLC指纹图谱方法和多指标成分含量测定方法，并结合化学计量学和统计学方法对二者差异进行分析。结果 北柴胡醋制后标准汤剂pH值降低，出膏率降低；建立了北柴胡及其醋制品标准汤剂指纹图谱，分别确定了16个共有峰，指认了其中5个共有峰；北柴胡标准汤剂相似度为0.976～0.995，醋北柴胡标准汤剂相似度为0.946～0.996。主成分分析将北柴胡及其醋制品标准汤剂归为2类，正交偏最小二乘法-判别分析找出二者共7个差异色谱峰，分别为峰1、4（柴胡皂苷c）、6、7（柴胡皂苷a）、9（柴胡皂苷b₂）、10（柴胡皂苷b₁）及13（柴胡皂苷d），为北柴胡及醋北柴胡标准汤剂差异化合物。多指标成分含量测定结果表明北柴胡醋制前后指标成分含量具有显著差异（P＜0.05），北柴胡醋制后标准汤剂中柴胡皂苷a、柴胡皂苷c及柴胡皂苷d含量较低，柴胡皂苷b₁及柴胡皂苷b₂含量较高。结论 建立了科学和实用的北柴胡及醋北柴胡标准汤剂质量评价方法，也为北柴胡与其醋制品相关制剂的鉴别和质量控制提供参考。

Objective To establish the quality evaluation method and investigate the quality differences of standard decoction of Chaihu (Bupleurum chinense) (CHD) and vinegar-processed Bupleurum chinense (VCHD). Methods Twenty batches of CHD and VCHD samples were prepared, the extract rates and pH were determined, respectively. Chromatographic fingerprints and multi-index content determination method of CHD and VCHD were generated from thehigh performance liquid chromatography (HPLC) and the quality differences were analyzed using the method of chemometrics and statistics. Results The extract rates and pH value of VCHD standard decoction was decreased. The fingerprints of the CHD and VCHD were established, a total of 16 common peaks were determined respectively, and five peaks were identified; The similarity of CHD and VCHD were 0.976—0.995 and 0.946—0.996, respectively. A clear classification among CHD and VCHD sample was observed in the score plot of the principal component analysis (PCA), then seven marker compounds were selected and identified by orthogonal partial least square discriminant analysis (OPLS-DA), including peaks 1, 4 (saikosaponin c), peaks 6, 7 (saikosaponin a), peak 9 (saikosaponin b₂), peak 10 (saikosaponin b₁), and peak 13 (saikosaponin d). Multiple-index content determination results showed that there was significant difference in the content of index components before and after vinegar processing of CHD (P < 0.05). The contents of saikosaponin a, saikosaponin c and saikosaponin d were lower. Besides, saikosaponin b₁ and saikosaponin b₂ was higher in the standard decoction of VCHD. Conclusion A scientific and practical quality evaluation method of CHD and VCHD was established, which also provided a reference for the identification and quality control of related preparations of B. chinense and its vinegar-processed products.

R283.6

国家中药标准化项目（ZYBZH-Y-JL-25）；吉林省科技发展计划项目（20210204078YY）