Method To Evaluate The Release Characteristics Of The Sustained-release Pellets Of Sedum Sarmentosum Compound In Vitro Based On Materiome Theory And Real-Time Cell-based Assay

As the Traditional Chinese medicine(TCM)with integrity and multi-component,its release properties can not be fully evaluated with reference to the evaluation method of chemical agents.As the subject of research,the sustained-release pellets of Sedum Sarmentosum compound is prepared in advance.In view of the bottleneck of TCM evaluation,Real-Time Cell-based Assay is applied in the study of the TCM sustained-release formulations release characteristics.Cell lines sensitive to the sustained-release pellets of Sedum Sarmentosum compound are screened,and cell index-time(CI-T)graphs and cell index release kinetics model are established based on the cell index(CI)monitored.In addition,the materiome of TCM compound is detected based on the materiome theory,and the materiome release kinetics model is established.Then,the correlation of materiome release kinetcs model and cell index release kinetcs model is surveyed.The overall effect of the sustained-release pellets of Sedum Sarmentosum compound as an indicator,the method to evaluate the sustained-release property is established,which is validated by the overall pharmacodynamic animal experiments.The study not only is a new idea and method to evaluate TCM sustained-release formulations,but also lay a solid foundation for the research and development of the TCM sustained-release formulations,and it have an important significance for TCM formulations to meet modern clinical needs.The research contents are:(1)The materiome of Sedum Sarmentosum compound sustained-release pellets is defined and materiome release kinetics model is established.The extract of Sedum Sarmentosum compound sustained-release pellets as materiome,by determination of multi-component in the release medium,materiome standard spectrum is established,and then materiome release kinetics model is established,when the accumulative release rate is calculated by the determination of the materiome concentration of release solution at different time point.(2)The cell index-time profiles of samples is obtained and cell index release kinetics model of the sustained-release pellets of Sedum Sarmentosum compound sustained-release pellets is established.Cell lines sensitive to the sustained-release pellets of Sedum Sarmentosum compound are screened,and cellular signals of Sedum Sarmentosum compound sustained-release pellets are monitored by using real-time cell electronic analyzer cell signals inde.Then,cell index-time curve is obtained and cell index kinetics model is established.(3)The correlation of materiome release kinetcs model and cell index release kinetcs model is surveyed and the validation of the overall pharmacodynamic animal experimentsThe correlation of both kinetics models is studed by Mathematical statistical theory and Statistica software.In order to obtain the materiome-cell index-pharmacological effects model and overall evaluation of the sustained-release pellets,the study is validated by efficacy indicators.