稳定性研究是评价中药质量的重要依据，也是中药质量控制研究的重要工作。中药制剂大多具有成分复杂、有效成分和作用机制不明确等特点，其稳定性的相关基础研究薄弱，给科学合理地研究与评价中药制剂的稳定性带来了挑战。基于中药制剂特点、中药制剂质量控制研究成果和认识，通过借鉴化学药物稳定性研究要求、国际植物药稳定性研究的认识，研究思考中药制剂稳定性研究评价指标和评价方法、结果评价，对中药制剂稳定性研究中业界关注的问题进行讨论分析。认为目前阶段，中药制剂稳定性研究的考察指标、结果评价及研究要求等应具有与其相适应的考虑和要求，应鼓励药品上市许可持有人发挥主体责任，加强相关基础研究，多角度、多维度选择考察指标反映中药制剂的整体质量以及制剂质量变化，积极研究建立反映中药制剂质量的指标，并开展有针对性研究，控制其潜在的风险，更好地促进中药质量提高，真正发挥和体现中药制剂稳定性研究的价值和意义。

Stability studies serve as a critical foundation for evaluating the quality of traditional Chinese medicine (TCM) and constitute an indispensable component in quality control research for TCM. Most TCM preparations are characterized by complex components, undefined active ingredients, and unclear mechanisms of action, compounded by insufficient fundamental stability research, poses significant challenges to the scientific and rational evaluation of TCM preparations stability. Given the unique attributes of TCM preparations and integrating current achievements in quality control research on TCM preparations, this paper investigates the evaluation indicators, evaluation methods and result evaluation of the stability studies on TCM preparations by referencing the stability study requirements for chemical drugs and international understanding of botanical drug stability testing. Furthermore, it discusses and analyzes the key issues of widespread concern in the industry within the field of TCM preparation stability research. The analysis indicates that stability studies of TCM preparations necessitate specialized considerations in the selection of test indicators, evaluation criteria, and study requirements at the current stage. Marketing Authorization Holders (MAHs) should be encouraged to assume primary responsibility to strengthening fundamental research at this stage, adopting multi-perspective and multi-dimensional selection of test items to comprehensively reflect the overall quality of TCM preparations and monitor their quality variations. Proactive efforts should focus on establishing indicators reflecting the quality of TCM preparations, conducting targeted studies to mitigate potential risks, so as to better promote the improvement of TCM quality and truly exert and reflect the value and significance of TCM preparation stability studies.

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2023年药品监管科学全国重点实验室第一批课题（2023SKLDRS0132）；2024年药品监管科学全国重点实验室第二批课题（2024SKLDRS0221