红景天分散片的研制及质量控制

Preparation and quality control of Rhodiola dispersible tablets

目的:探讨红景天分散片制备工艺及质量标准。方法:采用正交设计法对红景天分散片的辅料进行了筛选,并对质量控制方法进行了研究。结果:选择2%低取代羟丙基纤维素(L-HPC)、10%羧甲基淀粉钠(CMS-Na)为崩解剂,2%聚乙烯吡咯烷酮(PVPK-30)的20%乙醇溶液为黏合剂,0.2%硬脂酸镁为润滑剂,进行湿法制粒压片。制备的分散片每片含红景天多糖0.1 g,崩解时限为35 s,45 min溶出量为标示量的76.73%,符合中华人民共和国药典(2005年版)对分散片的要求。结论:所制备的红景天分散片制备工艺简单,溶出度高,性质稳定,具有实用价值。

Objective： To study the preparation and quality control of Rhodiola dispersible tab- lets. Methods： The formulation of Rhodiola dispersible tablets was optimized by an orthogonal design. The quality control was evaluated. Results： The optimal formulation was consisted of 0.1 g polysaccha- rides from Rhodiola sachalinensis A. Bor. , 2% L-HPC and 10% CMS-Na as disintegrator, PVPK30 sol- vent （20% ethanol） as adhesive, 0.2% magnesium stearate as lubricant. The tablets were prepared by a wet granulation. The tablets showed the disintegration time for 35 seconds and the dissolution rate of 76.73% within 45 minutes. Conclusion： The Rhodiola dispersible tablets with the high dissolution rate were achievable.