马来酸伊索拉啶口腔崩解片的研制  

Preparation of orally disintegrating tablets of irsogladine maleate

作　　者：黄云[1] 王珏[1] 王文喜[2] 蔡燕[2] 

机构地区：[1]浙江大学医学院附属儿童医院,浙江杭州310003 [2]浙江工业大学,浙江杭州310032

出　　处：《儿科药学杂志》2006年第3期7-9,共3页Journal of Pediatric Pharmacy

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,5 min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。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 compression method, and the optimal formula was obtained by modified simplex method according to disintegrating time in vitro. The properties of the tablets, such as the time of disintegrating both in vitro and in mouth, and of the dissolution in vitro were determined. Results： The tablets prepared with the optimal formula disintegrate within （9.30±1.06） seconds in vitro, while （53.86±7.43） seconds in mouth. Irsngladine was dissoluted so quickly from the tablets that it almost reached 70% within 5 minutes. Conclusions：The preparation and formula presented in this article brings a promising future in orally disintegrating tablets with favorable properties.

关 键 词：口腔崩解片 改进单纯形法 伊索拉啶 

分 类 号：R944.4[医药卫生—药剂学] R975[医药卫生—药学]