国产与进口盐酸吡格列酮片的质量考查

Quality Evaluation on Domestic and Imported Pioglitazone Hydrochloride Tablets

目的:考查国产与进口盐酸吡格列酮片的质量,为临床用药提供参考。方法:采用原研厂标准,对7个厂家有效期内的盐酸吡格列酮片就溶出度、有关物质、含量均匀度等项目进行测定。结果与结论:所有批次产品的各项指标基本都符合原研厂标准的要求,但各厂产品在溶出度、有关物质上有差异。

Objective： To investigate the quality of both the domestic and the imported pioglitazone hydrochloride tablets. Methods ： Dissolubility, uniformity of dosage units and related substances of different products were investigated respectively according to the specification of the imported pioglitazone hydrochloride tablets. The contents of pioglitazone hydrochloride and the related substances were determined by HPLC. The dissolution tests were carried out with paddle - stirring method. Results and Conclusion： The quality indexes of two kinds of tablets were up to the specification of the imported pioglitazone hydrochloride tablets. There were significant differences in dissolution and related substances between the domestic pioglitazone hydrochloride tablets and the imported ones.