不同厂家及批次的硝苯地平片质量分析与评价

Quality analysis and evaluation of nifedipine tablets from different manufacturers and batches

目的对收集的25批次硝苯地平片进行多项目测定,对不同厂家产品的质量进行分析与评价。方法参照《中国药典》,比较不同厂家产品的性状、有关物质、含量均匀度、溶出度、含量测定等项目,对检验结果进行统计分析和评价。结果25批次检验结果均符合《中国药典》标准,合格率为100%,但存在较大差异。结论不同厂家硝苯地平片质量存在差异,部分厂家有关物质杂质Ⅱ的控制有待提高。

Objective 25 batches of nifedipine tablets were collected for multi-item determination,and the quality of products from different manufacturers was analyzed and evaluated.Methods According to Chinese Pharmacopoeia,the properties,related substances,content uniformity,dissolution and content determination of products from different manufacturers were compared,and the results were statistically analyzed and evaluated.Results The test results of 25 batches were all in line with the standard of Chinese Pharmacopoeia,and the qualified rate was 100%,but there were great differences.Conclusion The quality of nifedipine tablets from different manufacturers is different,some manufacturers need to improve their control of related substance ImpurityⅡ.