目的 建立10个不同批次金泽排石颗粒的HPLC指纹图谱，并初步建立其抗炎生物活性效价检测方法，构建环氧合酶-2（COX-2）与金泽排石颗粒的量效关系，科学评价并有效控制颗粒的质量。方法 采用HPLC法分析10个不同批次金泽排石颗粒共有峰的相似度，并将19个共有峰归属到药材，将相似度结合SPSS统计软件聚类分析以及主成分分析结果评价10批次颗粒；用酶免疫法测定金泽排石颗粒对COX-2的半数抑制浓度（IC₅₀）。结果 10个批次金泽排石颗粒的HPLC指纹图谱的相似度均≥0.955，聚类分析和主成分分析结果与相似度结果具有一致性。金泽排石颗粒对COX-2有明显的抑制作用，IC₅₀为10.272 mg/mL，具有明显的量效关系。结论 采用化学指纹图谱与生物活性检测多元质控体系，具有高效、快速、准确、灵敏、重现性好等特点，可以有效地评价金泽排石颗粒的抗炎生物活性，更加科学合理地控制其质量，也为其他中药制剂建立更加科学的质量控制标准提供了参考。

Objective To establish HPLC fingerprints of Jinzepaishi Granules from ten different batches and a preliminary method for its anti-inflammatory biological activity titer detection, and construct a dose-effect relationship between cyclooxygenase-2 (COX-2) and Jinzepaishi Granules for scientific evaluation and effective control of granules quality. Methods The HPLC method was used to analyze the similarity of common peaks in different batches of granules and assigned 19 common peaks to herbs. The fingerprints were further analyzed by the chemometric method of hierarchical clustering analysis and principal component analysis (PCA). The EIA method was used to determine the half-inhibitory concentration (IC₅₀) of Jinzepaishi Granules. Results The similarity of HPLC fingerprints of all the ten batches was ≥ 0.955, which were consistent with the results of cluster analysis and PCA. Jinzepaishi Granules had a significant inhibitory effects on COX-2 with a IC₅₀ of 10.272 mg/mL, which demonstrated a significant dose-effect relationship. Conclusion The multiple quality control system of chemical fingerprinting and biological activity detection has the characteristics of high efficiency, rapidness, accuracy, sensitivity, and good reproducibility. It can effectively evaluate the anti-inflammatory biological activity of Jinzepaishi Granules and achieve more scientific and reasonable control of its quality. It also provides a reference for the establishment of more scientific quality control for other Chinese materia medica preparations.