In Vitro Dissolution and Consistency Evaluation of Compound Danshen Tablets Based on RTCA Technology

OBJECTIVE  Based on real-time cell-based assay (RTCA), the feasibility of evaluating the in vitro dissolution of Compound Danshen Tablets by cell biological effect was investigated.METHODS  According to the concentration gradient dependence of rat cardiomyocytes (H9C2) on the dissolution of Compound Danshen Tablets at different times, RTCA was used to monitor the dynamic changes of cells in different time. Thus, a dissolution kinetic model based on cell index (CI) was established. At the same time, the dissolution rate was calculated to evaluate the correlation and consistency with the dissolution curve determined by traditional UV spectrophotometry. Finally, DDSolver software was used for correlation analysis.RESULTS  Taking the dissolution curve obtained by UV spectrophotometry as a reference, the difference factor f₁ of the dissolution curve of Compound Danshen Tablets from three different manufacturers was less than 15, and the similarity factor f₂ was greater than 50. Under the two evaluation methods, the best fitting model of dissolution curves of Compound Danshen Tablets from the same manufacturer were consistent.CONCLUSION  This result showed that the cell biological effect evaluation method based on RTCA could basically reflect the characteristics of in vitro dissolution of Compound Danshen Tablets. The dissolution evaluation method based on the cell index is expected to become a new detection method for the in vitro dissolution of solid preparations of traditional Chinese medicine.