关白附薄膜包衣片的处方和制备工艺研究  

The formulation and preparation process of Aconitum coreanum film-coating tablets

作　　者：陈梁[1] 刘建平[1] 王广基[2] 孙建国[2] 刘静涵[3] 杨春华[4] 

机构地区：[1]中国药科大学药物制剂研究所,南京210009 [2]中国药科大学药物代谢动力学重点实验室,南京210009 [3]中国药科大学天然药物化学教研室,南京210009 [4]中国药科大学分析测试中心,南京210009

出　　处：《药学服务与研究》2011年第5期359-362,共4页Pharmaceutical Care and Research

基　　金：重大新药创制国家科技重大专项资助项目(No.2009ZX09103-345)

摘　　要：目的:研制关白附薄膜包衣片,为临床提供服用方便、疗效明显的抗房颤口服新药。方法:使用新型的直接压片辅料,筛选可压性和流动性良好的处方,运用全粉末直接压片技术制备关白附总碱盐片,并对其进行薄膜包衣。结果:优化后的处方流动性良好,片剂外观色泽均匀,硬度、片重差异、崩解时限等指标均符合《中华人民共和国药典》2010年版的要求,包衣后药物的引湿性有明显的改善。结论:采用全粉末压片技术制备关白附总碱盐片并用欧巴代进行包衣,有效地降低了药物的吸湿性,该工艺操作简单可行,适合工业化生产。Objective： To prepare the Aconitum coreanum film-coating tablets,in order to provide a more convenient and effective formulation for treatment of atrial fibrillation.Methods：New direct compression excipients were used to screen a formulation with good flowability and compressibility.Aconitum coreanum alkaloids salt tablets were prepared by direct powder compression process,and then coated with thin film.Results： The optimized formulation displays a good flowability.The appearance,hardness,weight difference and disintegration time of the tablets were in line with the relevant requirements of Pharmacopoeia of the People＇s Republic of China（2010 edition）.The hygroscopicity of the tablet was significantly decreased after film-coating.Conclusion： The hygroscopicity of Aconitum coreanum alkaloids salt tablets prepared by direct compression process and coated with opadry is decreased significantly.The preparation process is simple,practical,and suitable for industrial production.

关 键 词：关白附总碱盐 全粉末直接压片 薄膜包衣 引湿性 

分 类 号：R943[医药卫生—药剂学] R972.2[医药卫生—药学]