阿司匹林口腔崩解片的研制  

Preparation of aspirin orally disintegrating tablets

作　　者：王文喜[1] 翟剑峰 黄云[3] 顾浩[1] 

机构地区：[1]浙江工业大学药学院,杭州310014 [2]浙江万马药业有限公司,杭州310011 [3]浙江大学医学院附属儿童医院,杭州310003

出　　处：《中国新药杂志》2005年第8期1014-1016,共3页Chinese Journal of New Drugs

摘　　要：目的:研究阿司匹林口腔崩解片的最佳处方和制备工艺。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,正交试验优化处方,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:优选处方的口腔崩解片的体外崩解时间为(9.26±0.06)s,口腔内的崩解时间为(31.82±2.17)s,体外释放非常迅速,2min之内释放76.9%。结论:本研究所得的处方和工艺可以制备性能优良的阿司匹林口腔崩解片。Objective：To develop the optimal formula and preparation for aspirin orally disintegrating tablets. Methods： Microcrystaline cellulose and low-substituted hydroxypropylcellulose were employed as disintegrants. The tablets were prepared by wet process compression method, and the optimal formula was obtained by orthogonal test according to disintegrating time in vitro. The properties of the tablets, such as disintegrating time both in vitro also in mouth and the release profile, were determined. Results： The tablets prepared by the optimal formula were disintegrated within （9.26 ± 0.06） s in vitro, while （31.82 ± 2.17） s in mouth. Aspirin in the tablets was released so quickly that it arrived 76.9% within 2 min. Conclusion： The preparation and formula presented in the paper appears a promising future in aspirin orally disintegrating tablets with pretty properties.

关 键 词：阿司匹林 口腔崩解片 正交设计 

分 类 号：R971.1[医药卫生—药品] R944.2[医药卫生—药学]