目的 建立经典名方化肝煎物质基准的UPLC特征图谱以及HPLC多指标含量测定方法，构建其质量控制体系。方法 遵古籍并结合前期考察工艺，制备不同产地的18个批次化肝煎物质基准，采用UPLC法建立物质基准特征图谱，使用《中药色谱指纹图谱相似度评价软件》（2012版）计算相似度，并结合正交偏最小二乘判别分析，挖掘影响不同产地不同批次化肝煎物质基准质量的主要成分；将其中源自处方君药、臣药和佐药的3种指标性成分橙皮苷、芍药苷、牡丹皮作为化肝煎物质基准含测指标，建立其HPLC含量测定方法，并对18个批次样品进行含量测定。结果 特征图谱相似度均≥0.989。标定了33个共有峰，对8个共有峰进行了化学成分指认，分别为没食子酸（4号峰）、栀子苷（10号峰）、芍药苷（13号峰）、橙皮苷（22号峰）、香蜂草苷（27号峰）、丹皮酚（29号峰）、甜橙黄酮（30号峰）、3，5，6，7，8，3'，4'-七甲氧基黄酮（32号峰），找到9个影响批次间稳定性的指标性成分（峰31、20、11、13、22、33、21、29、1），最后遴选出芍药苷、橙皮苷、丹皮酚作为含测指标，其在化肝煎物质基准中的质量分数为芍药苷1.28%~1.95%、橙皮苷0.91%~1.02%、丹皮酚0.48%~0.57%。结论 通过UPLC特征图谱及HPLC指标性成分含量测定初步建立了经典名方化肝煎物质基准的质量控制方法，此方法快速简单可行，重复性、稳定性良好，可为后续制剂的开发和质量控制提供理论依据。

Objective To establish the UPLC specific chromatogram and HPLC content determination methods of multi-index components about the material reference of classical Huaganjian and build its quality control system. Methods According to the ancient books and combining with the previously inspected process, 18 batches of Huaganjian material reference from different origins were prepared. The specific chromatogram was established by using UPLC. Similarity was calculated by using TCM Chromatographic Fingerprint Similarity Evaluation Software (2012). Combining with orthogonal partial least squares discriminant analysis, we excavated the main components that affected the quality of Huaganjian material reference from different batches and origins. Three of these index components (paeoniflorin, hesperidin, paeonol) from prescription sovereign drug, minister drug, and assistant drug were selected and used as indicators for content determination of Huaganjian material reference. HPLC content determination methods were established and the content of 18 batches of samples was determined respectively. Results The similarity of the specific chromatogram was ≥ 0.989. Thirty-three common peaks were calibrated, and eight common peaks were identified by chemical composition (gallic acid, geniposide, paeoniflorin, hesperidin, didymin, paeonol, sinensetin, and 3,5,6,7,8,3',4'-heptamethoxyflavone). Nine index components that affected the stability between batches were found out (Peak 31, 20, 11, 13, 22, 33, 21, 29, 1). Paeoniflorin, hesperidin, and paeonol were selected as content determination indicators. The content range of these components in material reference was 1.28%-1.95% paeoniflorin, 0.91%-1.02% hesperidin, 0.48%-0.57% paeonol. Conclusion The quality control method of the material reference of classic prescription Huaganjian was established preliminarily through the UPLC specific chromatogram and HPLC content determination of index components. This method was rapid, simple, feasible, reproducible, stable and could provide a theoretical basis for the subsequent development and quality control of Huaganjian preparations.

R286.02

2018—2020年中国科协青年人才托举工程项目（2018QNRC1-01）