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

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。

Objective： To improve the specifications of Rifapentine and Rifapentine Capsules. Methods： The test i- tems 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 chromato- graphic conditions for related substances and assay were optimized. Meanwhile, the TLC method was added in iden- tification. Conclusion： The quality of Rifapentine and Rifapentine Capsules can be better controlled with the improved specifications.