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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 investigate the consistency of dissolution of homemade iloperidone tablets (1 mg standard) with reference preparations. Methods The solubility of iloperidone in different pH dissolution media was determined by HPLC, and the curve of iloperidone “pH-solubility” was drawn. The self-made and reference formulations were tested in four different pH dissolution media (0.1 mol / L HCl solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, water), the dissolution profile was plotted and fitted by the similar factor method. Results In the four dissolution media selected, the f2 values of the dissolution profiles of self-developed and reference preparations were both greater than 50. Conclusion self-developed formulations and reference formulations can achieve consistent dissolution in vitro.