盐酸帕罗西汀分散片的制备及体外释放研究

Preparation and Dissolution Characteristics of Paroxetine Hydrochloride Dispersible Tablet

目的制备盐酸帕罗西汀分散片,并建立体外释放控制标准。方法通过崩解剂种类和用量、填充剂、片剂硬度、粘合剂等研究,确定分散片的处方和工艺。结果以交联聚乙烯吡咯烷酮为崩解剂,以淀粉、乳糖、微晶纤维素为填充剂,以5%PVPK30乙醇溶液作为粘合剂制备的分散片,盐酸帕罗西汀在15 min内,溶出达90%以上。结论崩解剂采用内外加法崩解颗粒细及均匀,能获得比较理想的分散效果。选择5%PVPK30乙醇溶液作为粘合剂可获得较理想颗粒。

Objective Preparation of Paroxetine hydrochloride dispersible tablets, and to establish the standard of in vitro dissolution. Methods Study the disintegrants type and amount, fillers, tablethardness, adhesives and so on to determine the for mulation of dispersible tablets. Results Based on thePVPP as disintegrant, starch, lactose, microcrystalline cellulose as fillers, the 5% PVPK30 ethanolsolution as the binder, the dissolution of paroxetine hydrochloride reached more than 90% in 15 minutes.Conclusion Disintegrant can be used by internal and external addition, and particles are fine and ofuniform size. 5% PVPK30 ethanol solution as binder can be used to obtain the ideal particle.