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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 investigate the dissolution status of baicalin in Sanhuang Tablets from different manufacturers. Methods The content was determined by high performance liquid chromatography. The chromatographic conditions were as follows: column: Dimansil C18 column (250 mm×4.6 mm, 5 μm), mobile phase: CH3OH-0.1% H3PO4 (51∶49); detection wavelength: 280 nm. The flow rate was 1 mL/min. The dissolution measurement conditions were selected. The cumulative dissolution curves of baicalin were calculated and plotted, and the similarity factors were compared for each curve. Results The dissolution was determined by using a slurry method with a speed of 100 r/min and a pH 7.2 phosphate buffer solution as a dissolution medium. The results showed that the similarity factor f2 of the baicalin dissolution curve in different Sanhuang tablets was less than 50. Conclusion There are significant differences in the dissolution of baicalin in Sanhuang tablets from different manufacturers.