OBJECTIVE:To investigate the similarity of the dissolution of self-made preparations and original preparations (25 mg per tablet) in 4 kinds of mediums with different pH in vitro.METHODS:Paddle method was used to determine dissolution of the sample in pH 1.0 hydrochloric acid,pH 4.5 acetic acid and sodium acetate buffer solution,pH 6.8 phosphate buffer solution and water,using oversea listed Agomelatine tablets as reference preparation.UV spectrophotometry was used to determine the content of the tablets.Similarity factor (f2) was used to evaluate the similarity of dissolution curves.RESULTS:In 4 different dissolution mediums,f2 of agomelatine from self-prepared preparation and reference preparation were all more than 50.CONCLUSIONS:The dissolution behavior of self-prepared preparation and reference preparation are similar in 4 dissolution mediums.%目的:考察自研制剂与原研制剂(均为每片25 mg)在4种不同pH值的溶出介质中体外溶出行为的相似性.方法:以国外上市的阿戈美拉汀片作为参比制剂,采用桨法进行溶出试验.溶出介质分别为pH 1.0盐酸溶液、pH 4.5醋酸-醋酸钠缓冲液、pH6.8磷酸盐缓冲液和水,紫外分光光度法检测含量,相似因子(f2)法对溶出曲线的相似性进行评价.结果:在4种不同pH值的溶出介质中,自研制剂与参比制剂比较f2均大于50.结论:自研制剂和参比制剂在4种不同溶出介质中的体外溶出行为相似.
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