国产和进口格列吡嗪控释片的质量评价

Quality Evaluation of the Domestic and Imported Glipizide Extended Release Tablets

目的考察国产和进口格列吡嗪控释片的质量。方法采用紫外分光光度法测定含量、含量均匀度和释放度,并计算累积释放率和平均释放速率;采用薄层色谱法测定有关物质。结果2种格列吡嗪控释片的各项质量指标均符合国家质量标准。结论国产与进口格列吡嗪控释片的各项质量指标均无明显差异。

OBJECTIVE To investigate the quality of both the domestic and imported glipizide extended release tablets.METHODS The content and the content uniformity and the drug release were determined by UV Spectrophotometry,and the accumulative release percentage based on the labelled amount and the average release rates were calculated.The related substances were determinated by TL Chromatography. RESULTS The quality indexes of two kinds of extended release tablets were up to the national quality standard of glipizide extended release tablets.CONCLUSION There are no significant differences in quality indexes between the domestic glipizide extended release tablets and the imported one.