[摘要]目的: 研究马来酸伊索拉啶口腔崩解片的最佳处方和工艺。 方法: 选用微晶纤维素和低取代羟丙基纤维素作为崩解剂，通过湿法制粒压片制备，以体外崩解时间为指标，采用改进单纯形法优化处方，并测定体外和人体口腔内的崩解时间及体外溶出度等质量评价指标。 结果: 按照优选处方制得的口腔崩解片的体外崩解时间为(9.30±1.06)s，人体口腔内的崩解时间为(53.86±7.43)s，体外释放迅速，5min之内释放近70%。 结论: 本研究所得的处方和工艺可以制备性能优良的伊索拉啶口腔崩解片。

     [关键词] 口腔崩解片;改进单纯形法;伊索拉啶

    Preparation of orally disintegrating tablets of irsogladine maleate

    HUANG Yun，WANG Jue，WANG Wen-xi，et al

    (The Children's Hospital，College of Medical Science，Zhejiang University，Zhe-jiang Hangzhou 310003，China;Zhejiang University of Technology，Zhejiang Hangzhou 310032，China)

    [Abstract] Objective:To develop the optimal formula and preparation for orally disintegrating tablets of irsogladine maleate.Methods:Microcrys-taline cellulose and low-substituted hydroxypropylcellulose were employed as disintegrants.The tablets were prepared by wet granulation compres-sion method ......