中药制剂质量的均一、稳定是保障其发挥临床疗效的关键，也是患者安全用药的前提。然而，由于中药材质量的波动、制剂制造工序繁多、工艺影响因素复杂，中药制剂质量均一稳定性易受到影响。基于传统中医药理论与现代研究进展，聚焦于中药制剂质量均一性“控什么”及“如何控”2点，思考总结中药质量均一性评价指标、均一性调控策略与技术，并探讨未来的研究发展趋势，为提高中药制剂质量均一性提供研究思路。

The quality uniformity and stability of traditional Chinese medicine (TCM) preparations is the key to ensuring clinical efficacy and prerequisite for their safe use. However, due to the fluctuation in TCM quality, complex manufacturing processes, and multifaceted process-influencing factors, the quality uniformity and stability of TCM are easily affected. Based on the TCM theory and modern research progress, this article focuses on the two points of “what” and “how” to control the quality uniformity of TCM. It systematically summarizes evaluation metrics, regulatory strategies, and techniques for uniformity enhancement, while also discussing future research trends, so as to provide research ideas for improving the quality uniformity of TCM preparations.

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国家重点研发计划（2023YFC3504504）；江西省科技＋中医药”联合项目（2023KZI01009）；国家自然科学基金资助项目（82260768）；国家自然科学基金资助项目（82460773）；江西省主要学科学术与技术带头人项目（20225BCJ23002）；江西省自然科学基金面上项目（20252BAC240461）