Objective To establish a new dissolution determination method for Aspirin Enteric-Coated Tablets,and to investigate the differences in dissolution behavior between the generic drug and reference formulation.Methods The open-loop system of flow-through cell was used with pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.0 and pH 6.8 phosphate buffer as the dissolution media;the flow rate was 4 mL/min,and the samples were taken at specified time points to determine the dissolution of Aspirin Enteric-Coated Tablets.The model-dependent mean squared deviation(MSD)method was used to evaluate the similarity between the dissolution curves of generic drug and reference formulation after fitting,and the f2-bootstrap method was used to evaluate the consistency of inter-batch dissolution behavior.Results The commercial products of only one of five domestic manufacturers showed a similar dissolution curve to the reference formulation.The commercial products of two of six manufacturers involved in the test showed a similar inter-batch dissolution behavior.Conclusion The established method conforms to the physiological characteristics of the human body,which can be used for determining the dissolution of Aspirin Enteric-Coated Tablets.
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