金玄痔科熏洗散及其有效部位新制剂的HPLC指纹图谱比较

Comparison on the HPLC Fingerprint of Jinxuan Zhike Xunxisan and Its Active Ingredients Group

目的:建立金玄痔科熏洗散有效部位新制剂的非挥发性成分的指纹图谱测定方法,指认主要色谱峰,分析比较其与原制剂有效成分的差异,从而为金玄痔科熏洗散传统制剂的二次开发提供依据。方法:采用RP-HPLC,流动相甲醇-0.4%磷酸水溶液梯度洗脱,检测波长335 nm,流速为1.0 mL.min-1,柱温35℃,以指纹图谱计算软件计算相似度并进行图谱的比较及指认。结果:建立了金玄痔科熏洗散及其有效部位新制剂的HPLC标准指纹图谱,各10批次样品的相似度大于0.945,并指认了5个色谱峰。结论:指纹图谱方法可靠、重复性好,能有效比较金玄痔科熏洗散与其新制剂的数量关系,新制剂有效成分的数和量均优于原制剂。

Objective：To establish the HPLC fingerprint method and compare the changes of chemical consitituents of Jinxuan Zhike Xunxisan and its active ingredients group.Method： Chromatographic was investigated by RP-HPLC and the procedure analysis was performed at 35 ℃ with the methanol-0.4% phosphoric acid in gradient elution as the mobil phase.The detection wavelength was set at 335 nm and the flow rate was 1.0 mL·min-1.Result：The standard HPLC fingerprint and five main chromatographic peaks with the isolated compounds was obtained and the average similarities among the processed products of an active ingredients group were over 0.945.Conclusion：The method is reliable,accurate and provides a reference for the quality control of an active ingredients group.