黄芩Scutellariae Radix作为传统中药材，其提取物及主要活性成分黄芩苷已成为现代中药制剂中不可或缺的重要原料。综述黄芩提取物与黄芩苷的制备工艺、质量标准、监管政策及在中成药中的应用现状。黄芩提取物按中药提取物备案管理，仅能用于口服中成药；黄芩苷则作为化学原料药进行关联审评，其应用范围更广，除口服中成药外，还可用于注射剂、滴眼液等剂型。黄芩提取物和黄芩苷原料药均是以黄芩苷为主要成分的混合物，但质量标准均以单一黄芩苷为质控指标。含黄芩提取物、黄芩苷的中成药很多纳入医保目录和非处方药目录，说明了黄芩苷作为中成药原料的重要性。为了保证用药安全有效，尤其是针对注射用黄芩苷原料，未来应进一步强化外源污染物控制并建立多组分全面质量控制体系。

Huangqin (Scutellaria Radix) is a traditional Chinese medicine. Scutellaria extract and main active ingredient baicalin have become an indispensable and important raw material in modern Chinese medicine preparations. The preparation technology, quality standards, regulatory policies and application status of Scutellaria extract and baicalin in Chinese patent medicine were reviewed. Scutellaria extract is managed as a traditional Chinese medicine extract and can only be used for oral Chinese patent medicine; Baicalin is used as a chemical raw material for association review. Its application scope is wider. In addition to oral Chinese patent medicine, it can also be used in injection, eye drops and other dosage forms. Scutellaria extract and baicalin are mixtures with baicalin as the main component, but the quality standard is a single baicalin as the quality control index. Many Chinese patent medicines containing Scutellaria extract and baicalin have been included in the medical insurance catalog and the list of over-the-counter drugs, indicating the importance of baicalin as a raw material of Chinese patent medicines. In order to ensure the safety and effectiveness of drug use, especially for baicalin for injection, we should further strengthen the control of exogenous pollutants and establish a multi-component total quality control system in the future.

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山西省中医药科技创新工程项目（2025kjzy005）；山西省卫生健康委中医药科研课题（2025YYAD33）