【摘要】 目的用定量指纹图谱结合一线多评法评价复方甘草片质量一致性。方法色谱柱为COSMOSIL C₁₈-MS-Ⅱ柱（250 mm×4.6 mm,5μm）,以0.2%磷酸水溶液(含0.005 mol·L^-1庚烷磺酸钠)为流动相A,乙腈-甲醇（9∶1,V/V）溶液为流动相B,洗脱程序为0～10min,96%～79%A;10～20 min,79%～65%A;20～32 min,65%～47%A;32～45min,47%～18%A;45～50 min,18%～15%A;50～55 min,15%～96%A,流速为1.0m L·min^-1,检测波长220 nm,柱温35℃,进样量5μL。结果 9个厂家共145批样品的S_m均大于0.9,P_m均在80%～120%,质量均符合规定,但不同厂家样品之间的P_m值存在显著差异,用标准曲线法和一线多评法分别测定的5个指标含量无显著差异。结论一线多评法操作简便,节省对照品,在定量指纹图谱校正前提下结果可靠、误差小,与定量指纹图谱联合可对复方甘草片质量进行一致性评价。更多还原

【Abstract】 Objective To evaluate the quality consistency of compound licorice tablets with the quantitative fingerprints combined with multi-markers assay by monolinear method.Methods Chromatographic separations were conducted on a COSMOSIL C₁₈-MS-Ⅱcolumn （250mm×4.6 mm,5μm）.The 0.2%phosphoric acid solution (containing 0.005 mol·L^-1 sodium1-heptanesulfonate) was taken as the mobile phase A and acetonitrile-methanol=9∶1 as the mobile phase B.Gradient program was set as 96%-79%A at 0-10 min;79%-65%A at 10-20 min;65%-47%A at 20-32 min;47%-18%A at 32-45 min;18%-15%A at 45-50 min;15%-96%A at 50-55 min,with the flow rate at 1.0 m L·min^-1.The detection wavelength was220 nm and the column temperature was 35℃.The injection volume was 5μL.Results The S_m of145 batches of samples from nine manufacturers were all greater than 0.9,and the P_m was between80%and 120%.The quality of all samples met the requirements,but with differences in P_m values among samples from different manufacturers.There was no significant difference in the content of the five markers by the standard curve method and the multi-markers assay by monolinear method.Conclusion The method is easy to operate,saves reference standard with reliable results and minor errors after quantitative fingerprint correction.更多还原