不同厂家复方黄连素片的溶出曲线研究

目的比较不同企业的复方黄连素片在4种溶出介质中的溶出曲线,为该制剂的质量评价提供参考。方法分别在水、0.1 mol.L-1盐酸、pH 5.9和pH 7.4磷酸盐缓冲液中,测定15个厂家复方黄连素片的溶出曲线,并用f2因子法分析结果。结果在水中有4个厂家的样品与参比制剂溶出过程一致,在0.1 mol.L-1盐酸中有3个厂家与参比制剂一致,在pH 5.9和pH 7.4缓冲液中分别仅有1个厂家与参比制剂一致。结论多数厂家与参比制剂的溶出曲线有显著差异,建议对溶出度进行规定以提高该药品质量。

Research on dissolution profiles of Compound Huangliansu Tablets from different manufacturers

Objective To research the dissolution profiles of Compound Huangliansu Tablets from 15 manufacturers in 4 dissolution media and provide references for the quality evaluation of the above-mentioned drug.Methods The dissolution profiles were determined in water,0.1 mol·L-1 HCl,pH 5.9 and pH 7.4 phosphate buffer solution.Then,the results were analyzed by the method of f2 factor.Results In water,the dissolution profiles of 4 manufacturers were similar to that of the reference preparation(f2≥50).In 0.1 mol·L-1 HCl,3 manufacturers were similar to the reference preparation.However,in pH 5.9 and pH 7.4 phosphate buffer solution,only one manufacturer was similar to the reference preparation,respectively.Conclusion The dissolution profiles of most of the manufacturers were significantly different from that of the reference preparation,which suggested that dissolution of the drug should be prescribed for the quality control.