痹祺胶囊为中药大品种，具有益气养血、祛风除湿、活血止痛的功效，临床用于风湿、类风湿性关节炎等属气血不足、风湿瘀阻之证者，疗效确切；但其基础研究相对薄弱，现行质量标准仅对君药马钱子Strychni Semen中士的宁和马钱子碱进行含量测定，难以科学评价和有效控制药品整体质量。在系统总结痹祺胶囊化学物质组研究、药效及作用机制、配伍规律及多成分质控方法等研究的基础上，基于中药质量标志物（quality markers，Q-Marker）“五原则”，对其Q-Marker进行系统预测与分析，确定马钱子碱、士的宁、党参炔苷、白术内酯III、茯苓酸、丹参素、丹参酮IIA、丹酚酸B、迷迭香酸、三七皂苷R₁、人参皂苷Rg₁、人参皂苷Rb₁、阿魏酸、藁本内酯、蜕皮甾酮、牛膝皂苷D、次黄嘌呤、甘草次酸、甘草苷19个化学成分为痹祺胶囊的Q-Marker。为建立科学的痹祺胶囊质量评价体系提供了理论和实验依据，也为同类中药复方制剂的Q-Marker研究提供了思路借鉴。

Biqi Capsule (痹祺胶囊), a major Chinese patent medicine with confirmed therapeutic efficacy, exerts the effects of replenishing qi and nourishing blood, dispelling wind-dampness, and activating blood circulation to relieve pain. It is clinically indicated for rheumatic and rheumatoid arthritis manifesting as qi-blood deficiency complicated by wind-dampness obstruction. However, limited fundamental research has been conducted on this preparation, and its current quality standard merely quantifies strychnine and brucine derived from the sovereign drug Maqianzi (Strychni Semen), which is insufficient for the scientific evaluation and effective control of the overall quality of the product. Based on the systematic studies of Biqi Capsule including chemical profiling of the material basis, pharmacodynamics and mechanism, compatibility regularity, and multi-component quality control methods, the quality marker (Q-Marker) of Biqi Capsule were systematically predicted and analyzed following the five principles for Q-Marker determination. Consequently, nineteen components, namely brucine, strychnine, lobetyolin, atractylenolide III, pachymic acid, danshensu, tanshinone II_A, salvianolic acid B, rosmarinic acid, notoginsenoside R₁, ginsenoside Rg₁, ginsenoside Rb₁, ferulic acid, ligustilide, ecdysterone, achyranthoside D, hypoxanthine, glycyrrhetinic acid, and liquiritin, were identified as the Q-Markers of Biqi Capsule. This study provides both theoretical and experimental evidence for constructing a scientific quality evaluation system for Biqi Capsule, and offers a methodological reference for Q-Marker investigation of compound preparations of traditional Chinese medicine in general.

R285

国家科技重大专项（2025ZD05497000）