目的 建立黄芪的高效液相色谱（HPLC）指纹图谱，评价黄芪不同类型饮片的质量一致性。方法 采用 HPLC 法建立黄芪药材对照指纹图谱，并利用黄芪药材对照指纹图谱对 3 批黄芪原料药材制备的传统饮片、煮 散饮片、破壁饮片和配方颗粒不同类型饮片进行评价分析。结果 同一黄芪原料药材制备的传统饮片、煮散饮 片、破壁饮片与原料药材的相似度为 0.925～0.994，与黄芪原料药材的成分组成一致性良好。黄芪配方颗粒与 原料药材的相似度为 0.649～0.920，与原料药材的成分组成的一致性欠佳。聚类分析结果显示，黄芪药材、黄 芪传统饮片、黄芪煮散饮片和黄芪破壁饮片聚为一类；配方颗粒单独聚为一类。结论 该研究所建立的 HPLC 指纹图谱法适用于黄芪不同类型饮片的质量一致性评价，可为中药新型饮片的质量控制提供依据，有利于指导 中药新型饮片的研制工作。

Objective To establish the high-performance liquid chromatography （HPLC） fingerprint of Astragali Radix and evaluate the quality consistency of different types of Radix Astragali decoction slices. Methods The HPLC method was used to establish the control fingerprint of Radix Astragali，and the control fingerprint of Astragali Radix was used to evaluate and analyze the different types of traditional decoction pieces，decocting powder decoction pieces， cell wall-broken decoction pieces and formula granules prepared by three batches of Astragali Radix crude materials. Results The similarity of traditional decoction pieces，decocting powder decoction pieces，cell wall-broken decoction pieces prepared from the same crude material of Astragali Radix with raw materials was 0.925-0.994，which was in good agreement with the composition of crude materials of Astragali Radix. The similarity between Astragali Radix granules and crude medicinal materials was 0.649-0.920，and the consistency with the composition of crude medicinal materials was poor. The results of cluster analysis showed that the traditional decoction pieces，decocting powder decoction，and cell wall-broken decoction pieces of Astragali Radix，were clustered into one group. The formula granules are clustered into one category alone. Conclusion The HPLC fingerprint method established in this study is suitable for the quality consistency evaluation of different types of Astragali Radix decoction pieces，which can provide a basis for the quality control of new decoction pieces of Chinese medicine，and is conducive to guiding the its development.

R284.1

广东省药品监督管理局科技创新项目（2022YDZ03）；广东省药品检验所科研项目面上项目（SN2022012）。