Study on In Vitro Dissolution Behavior of Xuesaitong Tablets
Objective To establish a method for determination of dissolution of Xuesaitong Tablets and determine the integrated dissolution of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1 and ginsenoside Rd in Xuesaitong Tablets.Methods The small cup method was used and the dissolution of five index components were determined by HPLC.The dissolution was integrated by the mass fraction weight coefficient method.The dissolution curves were drawn and f2 similarity factor method was used to compare the similarity between the dissolution curve of each index component and the integrated dissolution curve.The model fitting of the integrated dissolution data was carried out,and the dissolution parameters including T50,Td and T85 were calculated.Results Water was selected as the dissolution medium.The samples were collected at a speed of 50 r/min during 60 min of dissolution.The f2 similarity factors between the dissolution curve of each component and the integrated dissolution curve were 64.5,61.6,79.8,60.0 and 68.2,respectively.The Weibull model was the best model to fit the dissolution data.The dissolution parameters T50,Td and T85 were 12.29 min,18.09 min and 56.09 min,respectively.Conclusion The method for determination of dissolution was accurate and feasible.The in vitro dissolution of Xuesaitong Tablets can be well characterized by integrating dissolution using mass fraction weight coefficient method,which can be used as a technical reference for quality consistency evaluation and quality control of Xuesaitong Tablets.
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