ABSTRACT
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.