不同厂家三黄片中大黄素、大黄酚的溶出度

目的:建立三黄片中大黄素、大黄酚溶出度测定方法以及考察市售不同厂家的三黄片中大黄素、大黄酚的溶出度情况.方法:采用高效液相色谱方法进行含量测定,色谱条件为Grace C18色谱柱(4.6 mm×250 mm,5μm),流动相CH3 OH-0.1％ H3PO4(85∶ 15),检测波长254 nm,流速1 mL·min-1；筛选出溶出度测定条件,计算并分别绘制大黄素与大黄酚的累积溶出曲线,且对各曲线进行相似因子的比较及溶出模型拟合.结果:溶出度测定条件为采用桨法,转速100 r·min-1,以0.1 mol·L-1盐酸溶液加0.5％十二烷基硫酸钠为溶出介质.不同厂家三黄片中大黄素和大黄酚的溶出曲线相似因子f2值大多小于50,且两成分的体外溶出的模型拟合不统一.结论:不同厂家的三黄片中大黄素、大黄酚的溶出度存在显著性差异,应将中成药主要成分的溶出度增加至质量控制体系中,且应寻求适宜描述中药制剂成分的溶出机制模型.

Dissolution of Emodin and Rheic Acid in Sanhuang Tablets of Different Pharmaceutical Factory

Objective: To establish the dissolution method of emodin and rheic acid in Sanhuang Tablets and research the dissolution behavior of emodin and rheic acid in Sanhuang Tablets of different pharmaceutical factory.Method: The content of emodin and rheic acid was determined by HPLC.The Grace-C18(4.5 mm×250 mm,5 μm)column was used,the mobile phase was CH3OH-0.1% H3PO4(85∶ 15),the detection wavelength was 254 nm and flow velocity was 1 mL·min-1.The determination conditions of dissolution were selected,accumulation dissolution curves were calculated,drawn and compared by similarity factor values(f2) and do the model simulation.Result: The determination conditions of dissolution included paddle method with the rotating speed of 100 r·min-1 and 0.1 mol·L-1 hydrochloric acid plus 0.5% sodium dodecyl sulfate as dissolution medium.The result of determination showed that the similarity factor values(f2) of emodin and rheic acid dissolution curves of different pharmaceutical factory of Sanhuang tablets were mostly less than 50.And the dissolution model simulations of this two components are not uniform.Conclusion: There was significant difference in emodin and rheic acid dissolution among Sanhuang tablets of different pharmaceutical factory.The dissolution of the main components should be added to the quality control systems of Chinese patent medicines,and should seek appropriate dissolution mechanism model to describe the dissolution behavior of traditional Chinese medicine.