动物药作为传统中药的主要来源之一，自古被称为“血肉有情之品”“行走通窜之物”，功效显著独特，临床应用具有不可替代性。但由于动物药成分复杂，多数动物药的药效物质基础尚不完全明确，且目前规定的质量控制内容难以体现专属性与整体性，以致动物药质量参差不齐，严重影响其临床用药的安全有效。基于《中国药典》2020年版记载动物类药材及制剂的质量控制内容，对目前动物药质量控制现状进行分析，并针对质控现状提出“专属性-安全性-有效性”三维一体化质控策略，旨在对症举措，为完善动物药的质控体系提供一定的参考。

As one of the main sources of traditional Chinese medicine (TCM), animal-derived TCM has been known since ancient times as “flesh and blood with emotions” and “things that can move and circulate”. It has remarkable and unique effects and is irreplaceable in clinical application. However, due to the complex composition of animal-derived TCM, the material basis of the efficacy of most animal-derived TCM is not yet fully clear. Moreover, the current stipulated quality control contents are difficult to reflect specificity and integrity, resulting in uneven quality of animal-derived TCM and seriously affecting the safety and effectiveness of their clinical use. Based on the quality control contents of animal-based medicinal materials and preparations recorded in the 2020 edition of Chinese Pharmacopoeia, this article analyzes the current status of quality control of animal-derived TCM and proposes a three-dimensional integrated quality control strategy of “specificity-safety-efficacy” in view of the current quality control status. The aim is to take targeted measures and provide certain references for improving the quality control system of animal-derived TCM.

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国家自然科学基金资助项目(U21A20409); 四川省科技计划重点研发项目(2020YFS0567); 四川省科技厅四川省科技计划项目(2021YJ0251); 四川省中医药管理局科学技术研究专项(2023MS600); 成都中医药大学杏林学者青基人才专项(QJRC2022027)