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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 the molding process of brain-derived dispersible tablets and evaluate its in vitro release. Methods: According to the disintegration time and the formability as the index, single factor test and orthogonal experiment were used to screen the kinds and proportions of the excipients of Naodesheng dispersible tablets. Taking puerarin as the detection index, Comparison of the in vitro release of tablets and brain derived ordinary tablets. Results: The best preparation process was calcium sulfate as filler, 95% ethanol as binder, disintegrating agent as 5% microcrystalline cellulose-5% cross-linked polyvinylpyrrolidone-5% croscarmellose Sodium 0.5% hydroxypropyl cellulose, the hardness of 6 ~ 7 kg appropriate; brain dispersible tablets within 10 min dissolution rate of> 80%, 15 min dissolution rate has reached 90%, the brain ordinary tablets dissolved within 10 min The rate of <50%, 45 min has not yet reached 80%, while the brain dispersible tablets 45 min in vitro release of 94.65%. Conclusion: The preparation process of Naodesheng dispersible tablets is stable and easy to operate, and its in vitro release effect is obviously better than that of Naodesheng tablets.