Abstract:
OBJECTIVE To investigate the dissolution behavior of notoginsenoside R
1, ginsenoside Rg
1, ginsenoside Re,ginsenoside Rb
1 and ginsenoside Rd in Xuesaitong dropping pills in different dissolution mediums.
METHODS The small cup method was adopted with 200 mL water, pH 4.5 acetate buffer and pH 6.8 phosphate buffer as dissolution medium at a rotate speed of 50 r⋅min
–1. The cumulative dissolution of 5 components in Xuesaitong dropping pills was determined by HPLC. The dissolution curves were drawn and the dissolution rates was evaluated by
f2 similarity factor. The dissolution data were fitted to determine the optimal dissolution model of Xuesaitong dropping pills.
RESULTS The dissolution behavior in water had little difference in the dissolution behavior of 5 components in Xuesaitong drop pills from different manufacturers and batches, and reached equilibrium in 15 minutes. The dissolution of 5 index components in the same sample was synchronous. In pH 4.5 acetate buffer solution, there was little difference between batches of the same component. The contents of ginsenoside Rb
1 and ginsenoside Rd in the same sample were lower than those of the other three components. In pH 6.8 phosphate buffer solution,there were significant differences in the dissolution behavior. The dissolution data fitting results of Xuesaitong dropping pills from different manufacturers and batches were slightly different and the best one was Weibull model.
CONCLUSION Xuesaitong dropping pills in water was more conducive to the dissolution of indicators. The partial alkaline solution has a great influence on the dissolution of index components. The study was accurate and reliable, and can be used for the quality control of Xuesaitong dropping pills. It also provided a data base for the study of quality consistency evaluation and process improvement.