基于多成分定量测定的六味地黄浓缩丸质量分析

Quality analysis of Liuwei Dihuang Concentrated Pills based on multi-index components

目的建立同时测定六味地黄浓缩丸中多成分的定量分析方法。方法以六味地黄浓缩丸中没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、芍药苷、丹皮酚、熊果酸的量为考察指标,采用RP-HPLC法,Agilent TC-C18（250 mm×4.6 mm,5μm）为色谱柱,以乙腈-0.02%三氟乙酸为流动相,梯度洗脱,体积流量为1.0 m L/min,柱温为30℃;检测波长：0~60 min,238 nm,60~70 min,210 nm;并结合聚类分析法,比较了20个不同厂家六味地黄浓缩丸之间的质量差异。结果不同厂家的六味地黄浓缩丸中的7种成分均有检出,且其量存在差异,其中芍药苷差异较大。聚类分析结果显示,该20个厂家产品被分为2类,2类产品所测成分之间存在着较为明显的差异,其中编号4、6、8、9、11、14和16的厂家样品被归为一类,质量差异相对较小;其余厂家产品被归为一类,产品之间7个成分的量差异不大。结论方法学考察结果表明该方法符合测定要求,并提出通过多成分测定控制六味地黄浓缩丸质量的建议,可以为其质量评价提供参考。

Objective To establish a determination method for the simultaneous determination of the multiple components in Liuwei Dihuang Concentrated Pills（LDCP）. Methods The contents of gallic acid, 5-hydroxymethyl furfural, morroniside, loganin, paeoniflorin, paeonol, and ursolic acid were used as observing indexes. HPLC method, Agilent TC-C18（250 mm × 4.6 mm, 5 μm） column using acetonitrile-0.02% TFA as mobile phase, gradient elution volume flow was 1.0 m L/min, column temperature was 30 ℃; Detection wavelengths were 0—60 min, 238 nm, 60—70 min, and 210 nm; Cluster analysis method was used to compare the differences of LDCP among 20 different manufacturers. Results The seven ingredients in LDCP from different manufacturers were determined. There was difference among them, the contents of paeoniflorin showed appreciable difference. The products from 20 manufacturers were divided into two categories by the cluster analysis, and showed obvious difference between them. The numbers 4, 6, 8, 9, 11, 14 and 16 were classified into one group, which quality difference was relatively minor; The products from other manufacturers belonged to one category and there were little differences among the seven components. Conclusion The methodology research shows that this methed could fit the demand of determination and provides some guidance to advance the quality evaluation of LDCP.