黄山药提取物缓释片的研制

目的制备黄山药提取物亲水凝胶骨架缓释片。方法以羟丙基甲基纤维素(HPMC)为骨架材料制备缓释片,以体外释药试验优选处方,探讨HPMC的黏度、用量以及片剂的硬度对药物释放的影响。结果建立了高氯酸比色法测定薯蓣皂苷元含量,作为缓释片体外释放度的测定方法。该法精密度较好,RSD%为1.8%,平均回收率100.3%。制得的缓释片体外持续12 h释放药物,释药行为符合H iguchi方程,释药速率随着HPMC的黏度增大、用量增加而减慢;片剂硬度越高,释药速率越低。结论该缓释片制备工艺简单,体外缓释效果较好。

Preparation and in vitro evaluation of sustained release tablet formulations of Dioscorea panthaica Prain

Objective To prepare a sustained release tablet formulation from the extract of Dioscorea panthaica Prain.Methods Hydroxypropyl methylcellulose was used as a hydrophilic matrix of the tablet.The formulation of the tablet was optimized by in vitro drug release test.The effects of content and viscosity of hydroxypropyl methylcellulose,the hardness of the tablet,on drug release were discussed.Results Colorimetric assay for diosgenin was developed to determine the in vitro release of the tablet.The RSD was 1.8% and average recovery 100.3%.The in vitro drug release characteristics followed Higuchi equation and the drug release continued for 12 hours.The drug release rate decreased when the content and viscosity of hydroxypropyl methylcellulose,the hardness of the tablet increased.Conclusion The procedure for preparation of sustained release tablet of Dioscorea panthaica Prain is simple and feasible.