自身对照法测定复方甘草酸苷胶囊的溶出度

Determination of dissolution in the Compound glycyrrhizin capsules by Self-control method

目的采用自身对照法测定复方甘草酸苷胶囊的溶出度。方法用转篮法,以900 mL pH6.8磷酸盐缓冲液为溶出介质,转速100 r·min^-1,取样时间30 min;将自身对照法和对照品对照法测得的数据进行统计比较。结果在自身对照法中,4.96~49.65μg·mL^-1甘草酸苷的线性关系良好(r=0.9999),回归方程为:Y=0.0178X-2.3×10^-3,平均回收率为99.72%,RSD=1.10%(n=6);加含量值校正的自身对照法与对照品对照法的结果无显著性差异。结论自身对照法简便、准确、可行,无需使用对照品;加含量值校正后,可作为复方甘草酸苷胶囊溶出度的测定方法。

OBJECTIVE To determine the dissolution in the Compound glycyrrhizin capsules by self-control method.METHODS Basket apparatus was used at 100 r·min^-1,the dissolution medium was phosphate buffer(pH6.8,900 mL),and the dissolution time limit was 30 min.The dissolution profiles were determined with self-control method and HPLC.RESULTS The linear range of glycyrrhizin was 4.96-49.65μg·mL^-1(0.9999),and the regression equation was Y=0.0178X-2.3×10^-3.The average recovery(n=6)was 99.72%,and the RSD was 1.10%.There was no significant difference between self-control method with content correction and the HPLC method.CONCLUTION The method is convenient,accurate and practicable,and it can be applied to determine the dissolution of the compound glycyrrhizin capsules after content correction.