Quality Evaluate of Betamethasone Tablet by Establishing a Mathematical Model / 中国药房

ABSTRACT

OBJECTIVE:To investigate the quality differences of Betamethasone tablet from different enterprises,and provide reference for the eventual establishment of the drug relative quality evaluation system. METHODS:According to the principle and steps of the ideal point method,a mathematical model was established. And the perfect point of the 3 inspection parameters (content,content uniformity and dissolution)of Betamethasone tablet was regarded as the upper limit theoretically,and the permis-sible point as the prescribed minimum in the model. After homogenizing the initial data or ones to be quantifiable were translated in-to evaluation parameters;and the evaluation parameters were calculated by ideal point method to receive comprehensive evaluation results. RESULTS:According to variance analysis,there was no significant difference in the comprehensive evaluation results of Betamethasone tablet from different enterprises(P=0.54>0.05),indicating that the overall quality of Betamehasone tablet was good. CONCLUSIONS:The mathematical model of quality evaluation with different drug has certain feasibility and operability.