【摘要】 小金丸是中医临床治疗乳腺增生的首选中成药。近年来，随着对小金丸研究的不断深入，有关其质量控制问题及不良反应的报道逐渐增多。复杂的药物来源、多变的药材质量、不同的物料性质与特殊的生产工艺多因素综合叠加，严重影响小金丸质量的稳定可控性、均一性、一致性与临床应用的安全性、有效性，这也是传统中药制剂品质提升面临的共性瓶颈问题。文章基于理论分析与生产实践，从组方药物质量与生产工艺过程控制两大视角对小金丸的质量影响因素与风险控制点进行分析与总结，并提出改进策略与建议，以期为小金丸的品质保障提供科学依据，也为其他传统丸剂的精细制造与创新提升提供思路参考。更多还原

【Abstract】 Xiaojin Pills is the first choice of Chinese patent medicine for the clinical treatment of mammary glands hyperplasia in Chinese medicine. In recent years, with the in-depth study of Xiaojin Pills, reports on quality control problems and adverse reactions have gradually increased. The comprehensive superposition of multiple factors, such as complex drug sources, variable medicinal material quality, different material properties and special production processes, seriously affects the stability, controllability, uniformity and consistency of Xiaojin Pills’ quality and the safety and efficacy of clinical application.This is also a common bottleneck problem in the quality improvement of traditional Chinese medicine preparations. Based on theoretical analysis and production process, this article analyzes and summarizes the quality influencing factors and control risk points of Xiaojin Pills from the two perspectives of drug quality in prescriptions and process control of production, and proposes improvement strategiesand suggestions. It is expected to provide a scientific basis for the quality assurance of Xiaojin Pills and a reference for the fine manufacturing and innovation of other traditional pills.更多还原