目的 基于质量标志物（Q-Marker）“五原则”，整合超高效液相色谱-四极杆飞行时间质谱（UPLC-Q-TOF-MS）、血清药物化学与网络药理学技术，筛选散寒解热口服液Q-Marker，建立UPLC指纹图谱及多指标含量测定方法，完善其质量评价体系。方法 采用UPLC-Q-TOF-MS技术系统解析散寒解热口服液的体外化学成分与入血原型成分；结合网络药理学与分子对接技术初步筛选与治疗风寒感冒相关的潜在Q-Marker；建立14批制剂的UPLC指纹图谱，标定共有峰并开展批次相似度评价；建立多指标UPLC定量测定方法。结果 共鉴定得到151个体外化学成分与35个入血原型成分，筛选获得15个靶向治疗风寒感冒的潜在Q-Marker。结合“点-线-面-体”综合评价模式与UPLC可测性验证，最终确立9个核心QMarker，包括葛根素、3'-甲氧基葛根素、葛根素芹菜糖苷、芍药苷、葛根素-6 "-O-木糖苷、大豆苷、甘草酸、D-苦杏仁苷、肉桂酸；同时确定葛根素-4'-β-D-葡萄糖苷、3'-羟基葛根素2个高含量成分为指示性Q-Marker。所建UPLC指纹图谱共标定21个共有峰，结合对照品指认其中13个成分，14批样品相似度均大于0.99，批次质量一致性良好。多指标定量方法符合药典分析要求，可用于制剂样品的含量测定。结论 明确了散寒解热口服液治疗风寒感冒的药效物质基础，建立的UPLC指纹图谱及11个Q-Marker多指标定量检测方法准确、可靠，可为该制剂的质量标准提升及临床应用提供实验依据。

Objective To identify quality markers (Q-Marker) of Sanhan Jiere Oral Liquid based on the “five principles” of Q-Marker, integrating ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS), serum pharmacochemistry, and network pharmacology techniques; to establish a UPLC fingerprint profile and a multi-component quantitative analysis method, thereby improving its quality evaluation system. Methods The in vitro chemical constituents and blood-borne parent compounds of Sanhan Jiere Oral Liquid were systematically analyzed using UPLC-Q-TOF-MS. Potential Q-Marker related to the treatment of wind-cold common cold were preliminarily screened by combining network pharmacology with molecular docking. A UPLC fingerprint profile was established for 14 batches of samples, common peaks were identified, and batch-to-batch similarity was evaluated. A multi-component UPLC quantitative method was also developed. Results A total of 151 in vitro chemical components and 35 blood-borne parent compounds were identified, from which 15 potential Q-Marker targeting wind-cold common cold treatment were selected. Based on an integrated evaluation model of “point-line-surface-body” and UPLC detectability verification, nine core QMarker were finally confirmed: puerarin, 3'-methoxy puerarin, puerarin apioside, paeoniflorin, puerarin-6"-O-xyloside, daidzin, glycyrrhizic acid, D-amygdalin, and cinnamic acid. Additionally, two high-abundance components—puerarin-4'-β-D-glucoside and 3'-hydroxypuerarin—were identified as indicator Q-Marker. The established UPLC fingerprint profile revealed 21 common peaks, among which 13 were tentatively identified using reference standards. Similarity values for all 14 batches exceeded 0.99, indicating excellent consistency across batches. The multi-component quantitative method met pharmacopoeia analytical requirements and can be applied to content determination of the formulation. Conclusion The study clarified the material basis for the therapeutic effects of Sanhan Jiere Oral Liquid in treating wind-cold common cold. The established UPLC fingerprint profile and the multi-component quantitative method involving 11 Q-Marker are accurate and reliable, providing experimental support for enhancing the quality standard and clinical application of this preparation.

R286.0;R284.1