中药口服液是以中药材为原料，经提取、浓缩、纯化等工序加工制成的口服液体制剂，是常用的液体制剂之一。具有易于吸收、作用迅速、服用便利等优势，在临床上得到广泛应用。但中药口服液成分复杂，在生产和储存过程中易受温度、光照等因素影响，发生氧化、降解、络合等反应出现沉降、浑浊、絮凝、分层等不稳定现象，这些现象对产品质量和用药安全造成了不利影响。如何通过环境控制、澄清工艺优化、附加剂添加和新型制剂技术应用调控中药口服液稳定性是一个关键问题。基于此，在中药口服液药效成分基础上，深入分析影响中药口服液稳定性的因素及药效成分转变机制，进而总结控制策略，为中药口服液的研发和生产提供理论参考。

Traditional Chinese medicine (TCM) oral liquid is an oral liquid preparation made from Chinese medicinal materials through processes such as extraction, concentration and purification, and it is one of the commonly used liquid preparations. It has the advantages of easy absorption, rapid action and convenient administration, and is widely used in clinical practice. However, TCM oral liquid has a complex composition. During production and storage, it is easily affected by factors such as temperature and light, and undergoes oxidation, degradation, complexation and other reactions, resulting in unstable phenomena such as sedimentation, turbidity, flocculation and stratification. These phenomena have adverse effects on product quality and medication safety. How to regulate the stability of TCM oral liquid through environmental control, clarification process optimization, additive addition and application of advanced formulation technologies is a key issue. Based on this, this paper aims to deeply analyze the factors affecting the stability of TCM oral liquid and the transformation mechanism of its active ingredients on the basis of the active ingredients of TCM oral liquid, and then summarize the control strategies, with the aim of providing theoretical references for research and development and production of TCM oral liquid.

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江西省科技创新平台（20222BCD43008）；国家级人才创新创业项目