流化床制粒法制备速释硝苯地平片及其体外溶出度研究

目的:研制具有速释性的硝苯地平(NFP)片并考察其体外溶出度。方法:对NFP原料药先进行微粒化,再加入辅料采用流化床制粒,经压片、包衣制备NFP片。依据2005年版《中国药典》溶出度第2法及高效液相色谱法测定NFP的累积溶出度,并与2种市售NFP片进行比较。结果:所制NFP片为薄膜衣片,其中NFP粒径小于15μm;其10、60min时累积溶出度分别约为85%、99%,而市售样品1约为30%、78%,市售样品2约为70%、93%。结论:采用流化床法制备NFP片方法简单,工艺可行,所制制剂具有速释作用,优于市售片。

Preparation of Rapid- release Nifedipine Tablet by Fluidized Bed Granulation and Study on Its in Vitro Dissolution

OBJECTIVE： To prepare rapid - release nifedipine（NFP） tablet and investigate its dissolution rate in vitro. METHODS： The NFP crude drug was micronized and then added with excipients to prepare NFP tablets by means of tabletting and coating. The accumulative dissolution of NFP was determined by dissolution method 2 recorded by Chinese Pharmacopeia （2005 Edition） and HPLC, and the results were compared with those of other 2 NFP tablets available on the market, RESULTS： The prepared NFP tablets were film - coated with particle size of less than 15/＊m; The accumulative dissolution of NFP at 10 min and 60 min were about 85% and 99%, respectively, versus 30% and 78%, respectively for market sample 1 and 70% and 93%, respectively for market sample 2. CONCLUSION： The fluidized bed process is simple and feasible for the preparation of NFP tablets, and the prepared tablets characterized by rapid - release are proved to be better than the market NFP tablets