Abstract
Objective: To perform a preliminary study on the quality evaluation of compound Danshen preparations based on the xCELLigence Real-Time Cell-based Assay (RTCA) system and make a pharmacodynamics verification. Methods: The compound Danshen was discussed as a methodological example, and the bioactivity of the compound Danshen preparations were evaluated by real-time cell electronic analysis technology. Meanwhile, an in vivo experiment on an acute blood stasis rat model was performed in order to verify this novel evaluation through the curative effect of dissipating blood stasis. Results: We determined the cell index (CI) and IC50 of the compound Danshen preparations and produced time/dose-dependent cell response profiles (TCRPs). The quality of the three kinds of compound Danshen preparations was evaluated through the RTCA data. The trend of CI and TCRPs reflected the effect of drugs on the cell (promoting or inhibiting), and it was verified that the results correlated with the biological activity of the drugs using a pharmacodynamics experiment. Conclusion: The RTCA system can be used to evaluate the quality of compound Danshen Preparations, and it can provide a new idea and new method for quantitatively characterizing the biological activity of traditional Chinese medicines (TCMs).
Highlights
The quality control for and evaluation of traditional Chinese medicines (TCMs) have always been a difficult and focal point in the progress of TCMs’ modernization [1]
The corresponding clinical indications were the same, so the selected drugs of the screening cells are Compound Danshen Dripping Pills (CDDPs). It indicated that the time/dose-dependent cell response profiles (TCRPs) of the same sample acting on different cell lines were quite different with Real-Time Cell-based Assay (RTCA)
According to the TCRPs results, CDDPs significantly inhibited the proliferation of these four kinds of cells
Summary
The quality control for and evaluation of traditional Chinese medicines (TCMs) have always been a difficult and focal point in the progress of TCMs’ modernization [1]. The current pattern and method of quality control for and evaluation of TCMs are mainly based on the methods and theory of chemical medicines. The concept of “Only Component” for TCMs can hardly control and reflect the safety and efficacy of TCM preparations [2]. It is difficult to guarantee both the intrinsic quality of real stability and controllability and promise a practical clinical application. Biological activity (potency) evaluation is a quality control method that directly inspects the safety and effectiveness of drugs in one step [3].
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