乌苯美司口腔崩解片的研制

Study on Ubenimex Orally Disintegrating Tablets

目的探讨乌苯美司口腔崩解片的制备工艺,优化最佳处方;检测片剂的溶出度.方法以崩解时限为主要指标,通过单因素试验及正交试验设计优化乌苯美司口腔崩解片的最佳制备工艺;利用溶出仪(稍作改良)检测法检测口腔崩解片的溶出度.结果MCC∶L-HPC∶CMC-Na(9∶1∶0.75)作为崩解剂,湿法制粒压片制得的乌苯美司口腔崩解片,体外平均崩解时限为21 s,置于口腔内25 s即可崩解,无砂砾感;片剂体外溶出度10 min溶出基本完全.结论乌苯美司口腔崩解片于口腔内可迅速崩解,制备工艺简单,有效改善了药物粉末的流动性,适宜于生产.

The purpose of this paper is to discuss the prepared technique of Ubenimex orally disintegrating tablets and select the best prescription. The formulation of orally disintegrating tablet is optimized by single factor and orthogonal tests; the dissolution rates are examined by the dissolution instrument. RESULTS MCC, L-HPC and CMC-Na（9 ： 1： 0. 75）are chosen as disintegrants and the Ubenmimex orally disintegrating tablets are compressed by wetting granulating method. The mean time for complete disintegration is 21 seconds and the disintegrating time in oral cavity is within 25 seconds without any residuary rough granules,and the invitrodissolution test indicates that 100% of Ubenmimex dissolves in 10 minutes. The results show that the prepared Ubenimex orally disintegrating tablet can disintegrate rapidly in oral cavity without any residuary rough granules,and the process of preparation is feasible due to the improvent of the flow property of powders by using the wetting granulating method.