伊潘立酮片溶出度一致性评价研究

Evaluation of dissolution consistency of Iloperidone Tablets

目的考察自制伊潘立酮片(1 mg规格)与参比制剂的溶出度一致性。方法用HPLC法测定伊潘立酮在不同pH溶出介质中的溶解度,绘制伊潘立酮"pH-溶解度"曲线,测定自研制剂与参比制剂在4种不同pH溶出介质(0.1 mol/L HCl溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水)中的溶出度,绘制溶出曲线,用相似因子法进行拟合。结果在所选4种溶出介质下,自研制剂与参比制剂的溶出曲线相似因子f2值均大于50。结论自研制剂与参比制剂能够达到体外溶出一致。

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.