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目的建立利咽分散片的制备工艺。方法采用单因素实验法和正交设计法,以崩解时间、硬度以及片剂表面情况为综合指标,对填充剂、崩解剂、润滑剂的种类以及用量和润湿剂种类进行考察。结果优选处方为25%微晶纤维素作填充剂,12%交联聚乙烯吡咯烷酮与6%交联羧甲基纤维素纳作联合崩解剂,内外加入比例为5∶1,30%乙醇溶液作润湿剂,1%微粉硅胶作润滑剂。结论利咽微粉分散片硬度适中、崩解时间短、分散均匀,该分散片处方合理可行、经济方便,符合分散片的质量要求。
Objective To establish the preparation process of Liyan dispersible tablets. Methods The single factor experiment method and orthogonal design method were used to investigate the types of the filler, disintegrant, lubricant, dosage and type of wetting agent based on the disintegration time, hardness and the surface of the tablet. Results The optimal prescription was 25% microcrystalline cellulose as filler, 12% crospovidone and 6% croscarmellose sodium as disintegrating agent, the ratio of 5: 1, 30% ethanol solution For wetting agent, 1% silica gel as a lubricant. Conclusion Liyan powder dispersible tablets moderate hardness, disintegration time is short, evenly dispersed, the dispersible tablets prescription is reasonable and feasible, economical and convenient, in line with the quality requirements of dispersible tablets.