咪达那新口腔崩解片的制备及处方优化  

Preparation and Optimized Formation of Orally Disintegrating Tablets of Imidafenacin

作　　者：李丽然[1,2] 郭红[2] 王成港[2] 任晓文[2] 

机构地区：[1]天津中医药大学,300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,300193

出　　处：《医药导报》2012年第10期1350-1354,共5页Herald of Medicine

基　　金：国家重点基础研究发展计划项目(973计划)(2010CB735602)

摘　　要：目的研究咪达那新口腔崩解片的处方与制备工艺。方法采用粉末直压-升华干燥制备法,以崩解剂的种类与用量、助崩解剂用量、升华剂用量等为考察因素,以物料休止角、片剂润湿时间、崩解时间等为考察指标,通过单因素试验进行处方筛选,确定最优处方。在最优处方的基础上考察片剂硬度对口崩片崩解时间的影响,从而制得孔隙率较高脆碎度较好的咪达那新口腔崩解片。结果处方以甘露醇为填充剂,微晶纤维素40%、交联聚维酮5%为崩解剂,另加入10%的碳酸氢铵为升华剂,压制硬度4.0～6.0 kg的咪达那新口腔崩解片,于60℃真空恒温干燥箱干燥90 min。结论该优选的制备工艺简单可行。Objective To investigate the preparation and formulation of orally disintegrating tablets of Imidafenacin.Methods The orally disintegrating tablets of imidafenacin were prepared by using the technology of direct compression and sublimation drying.The formulation was optimized by single factor test,in which,the kind of disintegrants,amount of disintegrants and sublimation agent were investigated.All formulations were evaluated by flow properties,wetting time,and in vitro disintegration time（DT）.Based on the established formulation,the relationship between tablet hardness and disintegration time was studied.The best prescription and the orally disintegrating tablets with high porosity and good hardness were obtained.Results The tablets were composed of mnnitol,40% MCC,5% PVPP,and 10% Ammonium bicarbonate,with the hardness of 4.0-6.0 kg,the optimal product was prepared after drying in vacuum oven at 60 ℃ for 90 min.Conclusion The method is simple and accurate in preparation.

关 键 词：咪达那新 口崩片 升华干燥 崩解剂 

分 类 号：R971.92[医药卫生—药品] R460.6[医药卫生—药学]