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目的:制备马来酸氟吡汀干混悬剂并制定其质量控制方法。方法:采用干粉直接混匀法制备干混悬剂;以沉降体积比、再分散性为考察指标,考察助悬剂羟丙基甲基纤维素和羧甲基纤维素钠对干混悬剂的影响,筛选出干混悬剂的处方;采用NDJ-4型旋转式黏度计测定其黏度;高效液相荧光色谱法测定制剂中主药的含量。结果:制得的马来酸氟吡汀干混悬剂3h内的沉降体积比等于1,再分散性好,流动性良好。30 min时体外溶出百分率达80%以上。结论:制得的马来酸氟吡汀干混悬剂质量稳定可控,工艺可行,为新制剂的研发提供依据。
Objective: To prepare flupirtine maleate suspension and to develop its quality control method. Methods: The dry suspension was prepared by direct mixing with dry powder. Taking sedimentation volume ratio and redispersibility as index, the effect of suspending agent hydroxypropylmethylcellulose and sodium carboxymethylcellulose on dry suspension Influence, screening out the prescription of dry suspension; using NDJ-4 rotary viscometer to measure the viscosity; HPLC determination of the main drug content in the preparation. Results: Flupdine maleate suspension obtained within 3h sedimentation volume ratio equal to 1, redispersibility, good fluidity. 30 min in vitro dissolution percentage of more than 80%. Conclusion: The prepared flupirtine maleate suspension has stable quality and feasible technology, and provides the basis for the research and development of new formulations.