四种尼美舒利口服固体制剂体外溶出度的测定

Study on in vitro dissolution of four nimesulide solid oral preparations

目的测定并比较尼美舒利四种口服固体制剂的体外溶出度。方法以尼美舒利普通片剂、胶囊剂、分散片和口腔崩解片为样品,以三羟甲基氨基甲烷盐酸缓冲液(pH 9,37℃)为溶出介质,以转篮法(100 r·min-1)为溶出方法,在393 nm测定尼美舒利的溶出度。结果 4种制剂均可在规定时间内达到溶出度的要求,其中以尼美舒利口腔崩解片的溶出速度最快。结论尼美舒利口腔崩解片的体外释药速度快,是值得开发的一种新制剂。

Objective To determine and compare the in vitro dissolution of four nimesulide oral solid preparations. Methods The rotating basket method of 100 r·min-1was used to determine the in vitro dissolution of the nimesulide oridinary tablets, capsules, dispersible tablets and orally dissoluble tablets. A buffer of(pH 9.0) trometamol was used as dissolution medium and the sample was measured at 393 nm by UV spectrophotometry. Results The in vitro dissolution of all the four nimesulide solid preparations can meet the official standard. Among them, the orally disintegrating tablets presented the fastest in vitro dissolution rate. Conclusion The orally disintegrating tablets show good promise for further investigation due to its quicker in vitro dissolution.