Objective To investigate the integral dissolution model based on biological potency in order to evaluate the dissolution of Compound Chinese materia medica（CCMM） in vitro. Methods The contents of paeoniflorin, phill...Objective To investigate the integral dissolution model based on biological potency in order to evaluate the dissolution of Compound Chinese materia medica（CCMM） in vitro. Methods The contents of paeoniflorin, phillyrin, ginsenoside Rg1, and adenosine of ten batches of Compound Biejia Ruangan Tablet（CBRT） were determined at different times. The self-defined weighting coefficient based on the contents has been created to establish the integral dissolution model. In addition, the biological potency of CBRT was measured by MTT assay. Then, the f2 similar factor was used to evaluate the similarity of the batches. Results Compared with batch a, some batches’ f2 values of paeoniflorin and adenosine were less than 50, while f2 values of ginsenoside Rg1, phillyrin, and integral component were more than 50. Likewise, ginsenoside Rg1, phillyrin, and integral component were all in good correlation with biological dissolution. Conclusion The results of the integral dissolution based on biological test of CBRT demonstrate that the bioassay method may be a promising supplement for its quality evaluation.展开更多
基金Major Scientific and Technological Specialized Project for Significant New.Formulation of New Drugs(No.2011ZX09201-201-14)National Natural Science Foundation of China(No.81073069)
文摘Objective To investigate the integral dissolution model based on biological potency in order to evaluate the dissolution of Compound Chinese materia medica（CCMM） in vitro. Methods The contents of paeoniflorin, phillyrin, ginsenoside Rg1, and adenosine of ten batches of Compound Biejia Ruangan Tablet（CBRT） were determined at different times. The self-defined weighting coefficient based on the contents has been created to establish the integral dissolution model. In addition, the biological potency of CBRT was measured by MTT assay. Then, the f2 similar factor was used to evaluate the similarity of the batches. Results Compared with batch a, some batches’ f2 values of paeoniflorin and adenosine were less than 50, while f2 values of ginsenoside Rg1, phillyrin, and integral component were more than 50. Likewise, ginsenoside Rg1, phillyrin, and integral component were all in good correlation with biological dissolution. Conclusion The results of the integral dissolution based on biological test of CBRT demonstrate that the bioassay method may be a promising supplement for its quality evaluation.
