热毒宁注射液由青蒿Artemisiae Annuae Herba、金银花Lonicerae Japonicae Flos和栀子Gardeniae Fructus组成，具有清热、疏风、解毒的功效。临床上常用于治疗外感风热所致感冒、咳嗽等疾病。对热毒宁注射液的化学成分、药理作用及临床应用的研究进展进行系统归纳总结，并基于中药功效物质的“三要素”与中药质量标志物的“五原则”对热毒宁注射液与质量相关的功效物质进行预测分析。结果显示，41个成分可作为质量相关功效物质，为提升质控的可操作性，进一步将其分为3级：核心功效物质（10个）包括绿原酸、新绿原酸、隐绿原酸、异绿原酸A、异绿原酸B等；辅助功效物质（29个）包括山栀苷、马钱苷、断马钱子酸、咖啡酸、獐牙菜苷等；药材溯源特征性物质（2个）包括东莨菪内酯和滨蒿内酯。该分级策略为热毒宁注射液的质量控制及相关制剂开发提供科学参考。

Reduning Injection (热毒宁注射液, RDN), composed of three traditional Chinese medicines—Qinghao (Artemisiae Annuae Herba), Jinyinhua (Lonicerae Japonicae Flos), and Zhizi (Gardeniae Fructus)—exhibits heat-clearing, wind-dispersing, and detoxifying effects. It is clinically used for treating conditions such as common cold and cough caused by external wind-heat. This article reviews recent advances in the chemical composition, pharmacological actions, and clinical applications of RDN. Furthermore, based on the “three key elements” of effective components in Chinese medicine and the “five principles” of quality marker (Q-Marker), a predictive analysis was conducted on quality-related effective components of RDN. The analytical findings revealed that a total of 41 compounds could be designated as the quality-correlated effective components. To facilitate the operability of quality control, these effective components were stratified into three tiers: the core effective components, comprising 10 constituents, namely chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, etc.; the auxiliary effective components, consisting of 29 constituents, including shanzhiside, loganin, secologanic acid, caffeic acid, sweroside, etc.; and two characteristic substances for medicinal material traceability, namely scopoletin and 6,7-dimethoxycoumarin. This tiered classification strategy provides a scientific reference for the quality control of RDN and development of its relevant pharmaceutical formulations.

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国家长三角科技创新共同体联合攻关项目（2023CSJGG1700）；国家自然科学青年基金（82404828）；江苏省院士工作站（BM2024101，BM2023118）