目的 考察自制伊潘立酮片（1 mg規(guī)格）與參比制劑的溶出度一致性。方法 用HPLC法測定伊潘立酮在不同pH溶出介質(zhì)中的溶解度，繪制伊潘立酮“pH-溶解度”曲線，測定自研制劑與參比制劑在4種不同pH溶出介質(zhì)（0.1 mol/L HCl溶液、pH 4.5醋酸鹽緩沖液、pH 6.8磷酸鹽緩沖液、水）中的溶出度，繪制溶出曲線，用相似因子法進(jìn)行擬合。結(jié)果 在所選4種溶出介質(zhì)下，自研制劑與參比制劑的溶出曲線相似因子f₂值均大于50。結(jié)論 自研制劑與參比制劑能夠達(dá)到體外溶出一致。

Objective To compare the dissolution curves of reference preparation and self-prepared Iloperidone Tablets in four different pH dissolution media (0.1 mol/L HCl solution, pH 4.5 acetate buffer solution, pH 6.8 phosphate buffer solution, and water).Methods The solubility of Iloperidone in different pH solutions was measured, the dissolution curves of two preparations in four different pH dissolution media were determined by HPLC, and the similarity was investigated according to the f₂ factor method.Results The f₂ factors between reference preparation and self-prepared Iloperidone Tablets in four different media were more than 50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro.