Quality Evaluation of Banlangen Granule based on Bioassays of Anti-influenzal and Anti-inflammatory Effects

Objective: In order to control the quality better, this study aimed to develop two bioassay methods of Banlangen Granule (BLGG) based on its anti-influenza activity and antiinflammatory activity and to verify the necessity of established methods by relating the results tested by chemical methods. Methods: First, the bioassay methods for determining the biopotency of the anti-influenza effect and anti-inflammatory activity were established and applied, taking neuraminidase and cyclooxygenase- 2 as disease targets, respectively. Secondly, the ultra-high-performance liquid chromatography coupled photo-diode array detector (UPLC-PDA) technique was used to perform fingerprints and quantify chemical compounds. Finally, the correlation analysis was performed on the results of bioassay methods and chemical methods to assist in choosing the effective quality markers for the BLGG. Results: Two accurate, stable, and repeatable bioassay methods were developed and applied to the determination of 57 batches of samples. The chemical fingerprints and contents of seven quality compounds were obtained based on UPLC-PDA methods. From the results of correlation analysis, the highest intensity correlation between these quality markers was medium with a r=0.495 (P<0.01), which indicates the need for establishing a bioassay method for BLGG. Conclusion: This present work illuminated that bioassay methods can be a great means to evaluate the quality of BLGG effectively and also provided a paradigm case for the quality control of other traditional Chinese medicine preparations.