Quality analysis of the domestic roxithromycin preparation
Objective A comprehensive quality analysis and evaluation of roxithromycin preparations(tablets,dispersed tablets,capsules,granules and dry suspensions)listed in China were conducted in the present study from the perspectives of effectiveness,rationality and quality control.Methods Based on the current statutory quality standards,the roxithromycin preparation was subjected to standard inspection to analyze the overall level of the quality of roxithromycin tablets in China,to compare the quality of products in different enterprises,and to carry out exploratory studies,which are analyzed using the Chinese Pharmacopoeia version 2020,ep 10.8,and the roxithromycin method as received by the corporate standard for consistency assessment of generic drugs.Results This sampling involved 337 batches of samples from 79 manufacturing enterprises for roxithromycin preparation,which involved 31 provinces,municipalities and autonomous regions throughout the country.Of these,61 batches of roxithromycin tablets,83 batches of dispersive tablets,149 batches of capsules,32 batches of granules and 12 batches of dry suspension were drawn and examined according to legal standards,all of which were found to be in compliance with the regulations with a pass rate of 100.0％.Compared with the dissolution behavior of the reference formulation,the dissolution rate of the formulation had significantly improved compared to the last national drug sampling quality.Conclusion The current quality standard of roxithromycin preparation was feasible and the quality status was good.
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