硝苯地平咀嚼片的制备工艺研究

Study on the Preparation Technology of Nifedipine Chewable Tablets

目的:制备硝苯地平咀嚼片。方法:采用单因素试验对硝苯地平咀嚼片的填充剂、矫味剂、润滑剂、崩解剂及黏合剂进行优选;以外观、口感、片重差异、脆碎度、硬度和崩解时限为评价指标,采用正交试验优化咀嚼片的填充剂(甘露醇-蔗糖)、矫味剂(阿斯巴甜)、崩解剂(交联聚维酮)和润滑剂(硬脂酸镁)的用量,并进行中试验证工艺。结果:硝苯地平咀嚼片的最佳制备工艺处方(1 000片)为:硝苯地平5.0 g、甘露醇106.7 g、蔗糖53.3 g、预胶化淀粉26 g、阿斯巴甜2.0 g、聚乙烯吡咯烷酮水溶液2%、柑桔香精0.3%、交联聚维酮3.0%、硬脂酸镁1.0%;制得片剂的外观、口感、片重差异、脆碎度、硬度和崩解时限等质量指标均符合2010年版《中国药典》的有关规定。结论:硝苯地平咀嚼片制备工艺合理、可行。

OBJECTIVE： To prepare the Nifedipine chewable tablets. METHODS： The single factor test was used to optimize the fillers, flavoring agents, lubricants, disintegrating agents and adhesives; with appearance, taste, weight difference, hardness, friability and disintegration time as indexes, the orthogonal test was used to optimize the amount of fillers （mannitol-sucrose）, fla- voting agents （aspartame）, lubricants （magnesium stearate） and disintegrating agents （crosslinking polyvingypyrrolidone） ; and the pilot scale test was used to verify the preparation process of semi-works production. RESULTS： The optimized technology of Nife- dipine chewable tablets （1 000 tablets） was as follows： nifedipine 5.0 g, mannitol 106.7 g, sucrose 53.3 g, pregelatinized starch 26 g, aspartame 2.0 g, appropriate amount of aqueous solution of polyvinyl pyrrolidone 2 %, citrus flavor 0.3 %, cross-linked povi- done 3.0%, magnesium stearate 1.0% ; the appearance, taste, weight variation, friability, hardness and disintegration time and oth- er quality indicators were in line with the Chinese Pharmacopeia （2010 edition）. CONCLUSIONS： The preparation technology of Nifedipine chewable tablets is reasonable and feasible.