雷美替胺片溶出度方法的建立

Estabilishment of method for dissolution test of Ramelteon Tablet

目的建立雷美替胺片体外溶出行为的评价方法。方法采用桨法,根据雷美替胺原料药在不同pH溶液中的溶解性能,选择以水、pH 1.0稀盐酸溶液、pH 6.8磷酸盐缓冲溶液及pH 4.5醋酸盐缓冲溶液为溶出介质,转速为50 rpm,用高效液相色谱法测定雷美替胺仿制制剂与原研制剂中主成分在不同时间点的累积溶出度并绘制溶出曲线,采用相似因子法评价二者体外溶出行为的相似性。结果在4种溶出介质中,仿制制剂与原研制剂的形似因子分别为72.30、64.25、78.00、68.92,表明二者体外溶出行为具有相似性。结论所建立的雷美替胺片体外溶出行为评价方法适用于评价雷美替胺片仿制制剂与原研制剂体外溶出行为相似性,并对雷美替胺片仿制制剂的处方和工艺研究具有一定的指导意义。

Objective To establish a method for the evaluation of the dissolution test of Ramelteon Tablet.Methods The paddle method was adopted with rotational speed of 50 rpm,using water,pH 1.0 hydrochloric acid solution,pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution as dissolution media,HPLC was used to determine the cumulative dissolution of main components of self-made and original preparation of Ramelteon Tablet at different time points.Dissolution profile was drew,then f2 was used to evaluate its similarity. Results In the 4 dissolution media,the of self-made and original preparation of Ramelteon Tablet was 72. 30,64. 25,78. 00,68. 92,respectively,which indicated that the dissolution profiles showed similarity. Conclusion The established ray beauty for amine piece of in vitro dissolution behavior evaluation method for evaluation of ray beauty for amine piece of generic formulation was similar to the original development agent in vitro dissolution behavior,and of the ray for amine piece of prescription and technology of the imitation preparations had a certain guiding significance.