36批何首乌药材质量的HPLC指纹图谱评价研究

 目的建立评价何首乌药材质量优劣的指纹图谱分析方法。方法采用高效液相色谱分析,LiChro CART C₁₈柱(4 mm×250mm,5μm),乙腈-水梯度洗脱,检测波长亦梯度变化,流速为1.0 mL·min^-1,柱温30℃。数据分析采用“计算机辅助相似性评价系统”软件。结果测定了36批何首乌药材的HPLC指纹图谱,建立了36批药材的总共有模式,计算得到各批药材的相似度,其中30批药材的相似度介于0.859 7～0.998 2,6批药材介于0.328 2～0.471 5。结论以相似度0.85为界,大于0.85认定为合格药材,小于0.85为不合格药材。本方法的评价结果与根据药典标准的划分结果一致,但更合理、直观、可操作性更强。

Study on Quality Evaluation for 36 Samples of Radix Polygonui Multiflori by HPLC-Fingerprints

OBJECTIVE To establish a HPLC-fingerprint method for evaluating the quality of Radix Polygoni Multiflori.METHODS A separation was performed on a LiChro CART C_(18) chromatographic column(4 mm×250 mm,5 μm) with gradient elution.The mobile phase consisted of acetonitrile-water and detection was performed with different UV wavelength.The flow rate was 1.0 mL·min^-1,and the column temperature was 30 ℃.The data from HPLC were analyzed by the software of "Computer-aided Similarity Evaluation".RESULTS The thirty-six samples of the crude drug of Radix Polygoni Multiflori were determined.The mutual model of 36 samples was established and the similarity degrees of 36 samples were also calculated.There were 30 samples whose similarity degrees were between 0.859 7～0.998 2 and 6 samplesbetween 0.328 2～0.471 5.CONCLUSION The limit of similarity degree for Radix Polygoni Multiflori was set at 0.85.If the similarity degree was greater than 0.85,it was qualified crude drug,otherwise it was unqualified.The evaluation results from this method were the same as the results from the method published in the Chinese Pharmacopoeia(2005 ed.),but this method is more reasonable,intuitionistic and operable.