| 崔学文,孙雪奇,罗慧萍.利福喷丁及其胶囊质量标准提高的研究[J].中国药品标准,2017,18(4):252-257 |
| 利福喷丁及其胶囊质量标准提高的研究 |
| Study on Specifications Improvement for Rifapentine and Rifapentine Capsules |
| 投稿时间：2017-04-24 修订日期：2017-08-04 |
| DOI： |
| 中文关键词: 利福喷丁 胶囊 溶解度 鉴别 有关物质 含量测定 |
| 英文关键词: Rifapentine capsules solubility identification related substances assay |
| 基金项目: |
|
| 摘要点击次数: 886 |
| 全文下载次数: 134 |
| 中文摘要: |
| 目的：提高利福喷丁及其胶囊的质量标准。方法：按照《中国药典》2015年版的相关规定，参考现行标准及研究文献，考察本品的性状、鉴别、有关物质及含量。结果：修订了溶解度、有关物质和含量测定色谱条件，增订了薄层色谱鉴别方法。结论：改进的标准可以更好地控制利福喷丁原料和胶囊的质量。 |
| 英文摘要: |
| Abstract Objective: To improve the specifications of Rifapentine and Rifapentine Capsules. Methods: The test items of description, identification, related substances and assay were studied based on Chinese Pharmacopoeia 2015, current specifications and some relevant literatures. Results: The solubility is revised and the chromatographic conditions for related substances and assay were optimized. Meanwhile, the TLC method was added in identification. Conclusion: The quality of Rifapentine and Rifapentine Capsules can be better controlled with the improved specifications. |
|
查看/发表评论 下载PDF阅读器 |
| 关闭 |