对利福平及其制剂2005版质量标准的建议

Suggestion for quality standard of Rifampicin and its preparation on Chinese Pharmacopoeia 2005 Edition

目的对2005版药典中利福平及其制剂质量标准中存在的问题进行探讨。方法采用高效液相色谱法进行系统适应性试验的考察。结果实验中利福平主要组分的出峰顺序与2005年版《中国药典》规定的出峰顺序不同。结论实际质量控制中,很难达到《中国药典》2005年版标准规定,建议修改利福平及其制剂的含量测定方法标准。

Objective To discuss the problem in quality standard of Rifampicin and its preparation on Chinese Pharmacopoeia 2005 Edition. Methods The systematic adaptability test was performed by high performance liquid chromatography method. Results The experiment proved that order of the peak in the main ingredient of Rifampicin had discrepancy with that of Chinese Pharmacopoeia 2005 Edition. Conclusion It is difficult to reach the standard of Chinese Pharmacopoeia 2005 Edition in actual quality control of Rifampicin. To control the quality of Rifampicin and its preparation, the revision should be made for future reference.