秋水仙碱片质量分析研究

Quality Analysis of Colchicine Tablets

对市场上流通的秋水仙碱片的3个主要厂家的7批次产品,依据标准进行检验,对其质量进行分析与评价。按照《中国药典》2020年版进行检验,进行了性状、鉴别、含量均匀度、溶出度、含量测定等项目的检验,对结果进行统计和分析。7批次样品的检验结果均符合标准要求,但含量均匀度的测定结果存在一定差异。市场上流通的秋水仙碱片整体质量较好,但不同厂家的产品质量存在差异,制剂的处方工艺和质量标准均有较大的改进空间。

7 batches of colchicine tablets from 3 major manufacturers in the circulating market were collected for detection according to the standard,and the quality of them was analyzed and evaluated.According to Ch.P(2020),the properties,identification,content uniformity,dissolution,content determination were compared,and the test results were evaluated and analyzed.The test results of 7 batches were all in line with the standard.However,there were some differences in the results of content uniformity.The colchicine tablets circulating in the market are of good overall quality,but there are some differences in the quality from different manufacturers,much room for improvement in the preparation process and standard improvement is needed.