目的：本研究以没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、芍药苷5个成分的含量为溶出指标，建立多成分指标评价六味地黄浓缩丸溶出度的方法。方法：测定条件为浆法，以900mL 0.1mol·L^-1盐酸作为溶出介质，转速100r·min^{-1,/sup>，温度（37.0±0.5）℃。采用RP-HPLC外标法定量，Agilent TC-C₁₈色谱柱（250mm×4.6mm，5μm），以乙腈-0.02%三氟乙酸溶液为流动相，梯度洗脱；流速为1.0mL·min-1；柱温为30℃；检测波长：238 nm。结果：该厂家10个批次的六味地黄浓缩丸中5个成分的溶出曲线相似因子?₂大部分高于50，表明该厂家不同批次间六味地黄浓缩丸的溶出度差异性较小。结论：该方法简便，重复性良好，适用于六味地黄浓缩丸中5个成分的溶出度测定。}

This study aimed to establish a dissolution determination method for multi-index components in Liuwei Dihuang concentrated pills with the content of gallic acid, 5-hydroxymethyl furfural,morroniside,loganin and paeoniflorin as indexes.The paddle method was adopted with 900mL of 0.1mol·L^-1 hydrochloric acid as the dissolution medium at a rotation rate of 100r·min^-1 and the temperature of 37.0±0.5℃. Adopting RP-HPLC method(an external standard method)was applied for quantitative,while Agilent TC-C₁₈(250mm×4.6mm,5μm)column was with acetonitrile-0.02% TFA as mobile phase gradient elution volume flow of 1.0mL·min^-1,column temperature at 30℃,and detection wavelength at 238nm.It was found that similarity factors f₂ of the dissolution curve of the five main components of different batches of Liuwei Dihuang concentrated pills were mostly higher than 50,which referred to the dissolution of a smaller difference between these samples.It was demonstrated that this method was simple,reproducible,applicable for measuring the five components dissolution of Liuwei Dihuang concentrated pills.

国家科技部“重大新药创制“科技重大专项（2013ZX09402203）：现代中药创新集群与数字制药技术平台，负责人：王振中。