摘要
目的:优选脑得生分散片的成型工艺并对其体外释放度进行评价。方法:以崩解时间、成型性为指标,采用单因素试验和正交试验筛选脑得生分散片的辅料种类及配比;以葛根素为检测指标,采用溶出度测定法对脑得生分散片和脑得生普通片的体外释放进行对比评价。结果:最佳制备工艺为以硫酸钙为填充剂,95%乙醇为黏合剂,联合崩解剂为5%微晶纤维素-5%交联聚乙烯吡咯烷酮-5%交联羧甲基纤维素钠-0.5%羟丙基纤维素,硬度6～7 kg适宜;脑得生分散片10 min内溶出率>80%,15 min左右溶出率已达90%,脑得生普通片10 min内溶出率<50%,45 min尚未达到80%,而脑得生分散片45 min体外释放度94.65%。结论:脑得生分散片制备工艺稳定、操作简便可行,且其体外释放效果明显优于脑得生普通片。
Objective： To optimize molding process of Naodesheng dispersible tablet, and to evaluate its in vitro release. Method： With disintegration time and formability as indexes, kind and ratio of accessories from Naodesheng dispersible tablet were screened by single factor test and orthogonal test; With puerarin as detection index, in vitro release comparative evaluation of Naodesheng dispersible tablet and Naodesheng ordinary tablet was determined by dissolution method. Result： Optimum preparation technology was as follows： with CaSO4 as filler, 95% ethanol as adhesive, combined disintegrating agent of 5% microcrystalline cellulose-5% PVPP-5% croscarmellose sodium and 0. 5% HPC, hardness of 6-7 kg was suitable for this dispersible tablet; Dissolution rate of Naodesheng dispersible tablet was more than 80% in 10 min and 90% in 15 min, dissolution rate of Naodesheng ordinary tablet was far below 50% within 10 min and less than 80% in 45 min, but dissolution rate of Naodesheng dispersible tablet was 94.65% in 45 min. Conclusion： Preparation process of Naodesheng dispersible tablet was stable, simple and feasible, its in vitro release effect was significantly better than Naodesheng ordinary tablet.
出处
《中国实验方剂学杂志》
CAS
北大核心
2012年第21期31-34,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
黑龙江中医药大学面上基金项目(2010006)
黑龙江省中医药管理局项目(ZHY12-2073)
关键词
脑得生
分散片
制备工艺
体外释放
葛根素
Naodesheng
dispersible tablet
preparation process
in vitro release
puerarin
