口腔崩解片体外崩解评价方法探讨.pdfVIP

口腔崩解片体外崩解评价方法探讨 ( ) 姚方耀 ,刘欢 ,刘衡 ,张鹏威 ,阎卉 ,王春龙 天津药物研究院制剂中心 ,天津 300 193 摘要 : 目的　改进设计口腔崩解片体外崩解的评价方法 。方法 　制备了利培酮 口腔崩解片和茶苯海明口腔崩解片 ,改进设计 了 4种口腔崩解片体外崩解的测定方法 。分别采用这些方法测定了两种口崩片的体外崩解 ,并且考查了体内外相关性 。结果 ( ) 　对于利培酮口崩片 ,采用滴定管液滴法测定崩解具有较好的重现性和较好的体内外崩解时间相关性 ,而且砂砾感 粒度 控 ( ) 制准确 ;对于茶苯海明口崩片 ,则以日本药典 JP 溶出度改良法较为适合 。结论 　用于 口崩片体外崩解评价 ,滴定管液滴法 和 JP溶出度改良法为两种可取的方法 。 关键词 :利培酮 ;茶苯海明; 口腔崩解片 ;崩解测定 中图分类号 : R9444　　　文献标识码 : A 　　　文章编号 : 100 1 - 2494 (2007) 04 - 0276 - 04 Study on D isin tegra ting M ethod for O ra lly D isin tegra ting Tablets YAO Fangyao, L IU Huan , L IU H eng, ZHAN G Pengwei, YAN Hu i ,WAN G Chunlong ( T ianj in Ins titu te of P ha rm aceu tica l R esea rch, T ianj in 300 193 , Ch ina) A BSTRACT : O BJECT IVE 　To de sign and imp rove disin tegrating equ ipm ents for orally disin tegrating tab lets (OD T) M ETHOD S 　R isp eridone OD T and dim enhydrinate OD T were p rep ared They were re sp ectively tested w ith fou r k ind s of disintegrating equ ip m en ts Then the relation sh ip between in vivo and in vitro disintegrating re su lts of these two OD T wa s studiedRESUL TS 　Buret liq u id drop let disintegrating m ethod is su itab le for testing risp eridone OD T w ith good rep roducib ility, in vivo in vitro relation sh ip and effec tive control of p article size Imp rovedJP disso lu tion disin tegrating m ethod was op timum for the m ea su rem ent dim enhydrinate OD TCO NCL US IO N 　Bu ret liqu id drop let disin tegrating m ethod and imp rovedJP disso lu tion disin tegrating m ethod are good disin tegrating m ethod s to evaluate OD T KEY W O RD S: risp eridone; dim enhydrinate; orally disin tegrating tab lets; disintegrating m ethod ( ) 　　口腔崩解片 orall