【目的】 明确加味温胆片的质量标志物，并探讨该制剂工艺步骤中主要质量标志物的稳定性。【方法】 采用薄层色谱 （TLC）方法鉴别加味温胆片制剂中的枳实、化橘红、五指毛桃、毛冬青，采用高效液相色谱（HPLC）法测定制剂及各工艺步 骤样品中柚皮苷与新橙皮苷的含量，并以这2种成分的保留率为指标，评价工艺稳定性。【结果】 制剂中枳实与化橘红的黄酮 类、枳实的生物碱类、五指毛桃的香豆素类、毛冬青皂苷类等成分的 TLC鉴别方法可行、耐用性良好；柚皮苷与新橙皮苷 含量测定方法学符合要求；饮片→清膏→醇沉液→稠膏→干浸膏→素片→薄膜衣片等制剂工艺步骤相邻两环节的柚皮苷与 新橙皮苷保留率在79%以上，说明该质量标志物能相对稳定在一定范围内。【结论】 该制剂工艺及评价方法准确、可靠、重 复性好，为加味温胆片的工艺及质量评价提供了实验依据。

Objective To identify the quality markers of Jiawei Wendan Tablets and to evaluate the stability of its primary quality markers throughout the manufacturing process. Methods Thin-layer chromatography （TLC） was employed to identify Aurantii Fructus Immaturus， Exocarpium Citri Grandis， Fici Hirtae Radix， and Ilicis Pubescentis Radix in the preparation. The contents of naringin and neohesperidin in the final preparation and in samples collected from various manufacturing steps were determined using high-performance liquid chromatography （HPLC）. The retention rates of these two components were used as indicators to evaluate process stability. Results The established TLC methods for identifying flavonoids from Aurantii Fructus Immaturus and Exocarpium Citri Grandis，alkaloids from Aurantii Fructus Immaturus，coumarins from Fici Hirtae Radix，and triterpenoid saponins from Ilicis Pubescentis Radix in the preparation were feasible and demonstrated good durability. The methodological validation for the content determination of naringin and neohesperidin met the required standards. The retention rates of naringin and neohesperidin between adjacent steps in the manufacturing process （including decoction pieces → herbal extract → alcohol-precipitated solution → thick paste → dry extract → uncoated tablets → film-coated tablets） were all above 79%， indicating that the quality markers remained relatively stable within a specific range throughout the process. Conclusion The established methods are accurate， reliable， and reproducible， providing an experimental basis for the process control and quality evaluation of Jiawei Wendan Tablets.

R282.5

广州市科技计划项目—市校（院）企联合资助专项（编号：2023A03J0296）；2023年度广东省工程技术研究中心，粤科函产字[2024] 346号（编号：2023A170）；2023年度广东省工程研究中心，广东省发改委员会[2380（] 编号：23）