三黄片中黄芩苷的溶出度研究

Dissolution of baicalin from Sanhuang Tablets

目的考察市售不同厂家不同批次的三黄片中黄芩苷的溶出度现状。方法采用高效液相色谱方法进行含量测定,色谱条件为色谱柱:Dimansil C18柱(250 mm×4.6 mm,5μm),流动相:CH3OH-0.1%H3PO4(51∶49);检测波长:280 nm,流速1 mL/min;筛选出溶出度测定条件;计算并绘制黄芩苷的累积溶出曲线,且对各曲线进行相似因子的比较。结果溶出度测定条件为:采用浆法,转速100 r/min,以pH7.2磷酸盐缓冲液为溶出介质。测定结果显示,不同三黄片中黄芩苷的溶出曲线相似因子f2值均小于50。结论不同厂家不同批次的三黄片中黄芩苷的溶出度存在显著性差异。

Objective To review the dissolution behavior of baicalin from Sanhuang Tablets of different batches produced by different producers in market. Method The content of baicalin was determined by using HPLC. The procedure of HPLC was performed on the chromatographic column of Dimansil C18 （250 mm×4. 6 mm, 5μm）. The mobile phase was CH3OH -0. 1% H3PO4 （51： 49）, the detection wavelength was 280 nm and flow velocity was 1 mL/min. The determination conditions of dissolution were selected, accumulation dissolution curves were calculated, drawn and compared by similarity factor values （f2）- Result The determination conditions of dissolution included paddle method with the rotating speed of 100 r/min and phosphate buffer （pH =7.2） as dissolution medium. The result of determination showed that the similarity factor values （f2） of baicalin dissolution curves of different batches of Sanhuang Tablets were all less than 50. Conclusion There was significant difference in baicalin dissolution among Sanhuang Tablets of different batches produced by different producers.