开心散是治疗“好忘”的经典名方，现收录于《古代经典名方目录（第一批）》，可治疗心失所养、痰阻心窍、心肾不交所致之善忘。临床常用于改善记忆力衰退、语言障碍、认知功能障碍、人格改变等神经精神疾病的症状。通过梳理开心散的化学成分、质量控制、药动学、药理作用以及临床应用等相关文献，基于“五原则”对开心散的中药质量标志物（quality marker，Q-Marker）进行预测分析，人参皂苷Rb₁、人参皂苷Re、人参皂苷Rg₁、细叶远志皂苷、3,6'-二芥子酰基蔗糖、远志𠮿酮III、茯苓酸、β-细辛醚、α-细辛醚的专属性高、可测性强，可作为开心散的Q-Marker，为其质量控制研究提供参考。

Kaixin Powder, a famous classical formula with definite clinical efficacy in treatment of amnesia, was included in the Catalogue of Ancient Famous Classical Formulas (The First Batch). Kaixin Powder has the effects of heart losing nourishment, mental confusion due to phlegm stagnation, and amnesia by heart-kidney imbalance and its main indications include improving symptoms of neurological and psychotic disorders, such as loss of memory, language and cognitive disorders and personality change. The relevant references of Kaixin Powder on chemical constituents, quality control, pharmacokinetics, pharmacological actions, and clinical application were searched and analyzed. According to the results, ginsenoside Rb₁, ginsenoside Re, ginsenoside Rg₁, tenuifolin, 3,6'-disinapoyl sucrose, polygalaxanthone Ⅲ, pachymic acid, β-asarone and α-asarone were considered quality markers (Q-Marker) because of their good specificity and testability, in order to provide scientific basis for quality control research of Kaixin Powder.

R282.710.5

国家重点研发计划项目(2019YFC1711205);临沂市兰山区科技发展计划项目(2026)