甲磺酸酚妥拉明泡腾片的处方及制备工艺研究

摘要

Objective: To prepare phentolamine mesylate effervescent tablets, which have advantages of taking conveniently and acting quickly, by a common preparation technique. Methods: The excipients and their proportion in phentolamine mesylate effervescent tablets were optimized by experiments. The quality of preparation was preliminarily evaluated. Results-. All the indexes of phentolamine mesylate effervescent tablets, such as disintegration time, tablet weight variation and hardness, accorded with or better than the correlative requirements in the appendix of Chinese Pharmacopoeia (2005 edition) . Conclusion: The formula and preparation methods of phentolamine mesylate effervescent tablets are effective and feasible, and the preparation can be developed as a new phentolamine mesylate formulation.%目的:利用普通制剂技术制备起效快、服用方便的甲磺酸酚妥拉明泡腾片.方法:通过实验优化筛选甲磺酸酚妥拉明泡腾片的辅料及其配比,并对制剂进行初步的质量评价.结果:优化处方的甲磺酸酚妥拉明泡腾片的崩解时限、片重差异、硬度等指标均符合或优于中国药典2005版附录的相关要求.结论:本品处方和制备方法有效可行,可作为甲磺酸酚妥拉明的一种新剂型开发.