盐酸达泊西汀片的体外溶出曲线相似性评价

Similarity evaluation of in vitro dissolution profiles of dapoxetine hydrochloride tablets

目的采用相似因子(ƒ2)法,考察自制的盐酸达泊西汀片与原研片的体外溶出曲线,并进行体外溶出行为相似性评价。方法采用浆法,转速为50 r/min,介质体积为900 ml,溶出介质分别为pH 1.0盐酸溶液、pH 4.5醋酸盐缓冲液、pH 5.5醋酸盐缓冲液、pH 5.8磷酸盐缓冲液、pH 6.8磷酸盐缓冲液和水,紫外分光光度法测定累积溶出度,绘制体外溶出曲线,并评价在6种介质中自制片与原研片的溶出曲线相似性。结果自制盐酸达泊西汀片与原研片的ƒ2因子值分别为69.9、67.5、67.9、68.9、68.3、67.0,结果均大于50。结论在6种溶出介质中自制盐酸达泊西汀片的溶出曲线相似。

Objective To investigate the in vitro dissolution profiles of self-made dapoxetine hydrochloride tablets and the originator tablets by using the similarity factor(ƒ2)method,and to evaluate the similarity of dissolution behavior in vitro.Methods With the paddle method,the rotating speed was 50 r/min,the medium volume was 900 ml,and the dissolution media were hydrochloric acid solution at pH 1.0,acetate buffer at pH 4.5,acetate buffer at pH 5.5,phosphate buffer at pH 5.8,phosphate buffer at pH 6.8 and water.The cumulative dissolution was determined by UV spectrophotometry,and the in vitro dissolution profile was drawn.The similarity of the dissolution profiles between the self-made tablets and the originator tablets in the six media was evaluated.Results Theƒ2 factor values of self-made dapoxetine hydrochloride tablets and originator tablets were 69.9,67.5,67.9,68.9,68.3 and 67.0 respectively,and the results were more than 50.Conclusion The dissolution profiles of self-made dapoxetine hydrochloride tablets were similar in 6 dissolution media.