蒙药五味清浊丸HPLC指纹图谱建立与多成分含量分析

Study on HPLC fingerprints of Wuweqinzhuo Pills and determination of four major components

目的:建立五味清浊丸的HPLC指纹图谱,并同时测定其中4种成分的含量。方法:采用依利特Hypersil-C18柱(4.6 mm×250 mm,5μm),洗脱体系为乙腈-0.1%甲酸,流速为1.0 mL/min,柱温为35℃,在310nm波长下建立指纹图谱。同时在310nm波长下测定鞣花酸、桂皮醛、胡椒碱的含量,在403nm波长下测定羟基红花黄色素A含量。结果:通过对10批五味清浊丸样品的分析建立了指纹图谱,并确定了20个共有峰,各样品图谱与对照图谱比较相似度均大于0.915;20个共有峰中5、12、17、19号峰分别为羟基红花黄色素A、鞣花酸、桂皮醛、胡椒碱。含量测定结果显示五味清浊丸中羟基红花黄色素A含量在0.04%~0.27%、鞣花酸含量在0.15%~0.33%、桂皮醛含量在0.02%~0.11%、胡椒碱含量在0.11%~0.19%。结论:首次通过HPLC法建立五味清浊丸指纹图谱,并同时对其中4种成分进行含量测定,该法准确可靠,重复性好,可用于五味清浊丸的质量评价。

Objective:To establish the HPLC fingerprints of Wuweiqinzhuo(WWQZ)pills and to determine the contents of four constituents.Methods:HPLC fingerprint was performed on Elliott Hypersil-C18 column(250 mm×4.6 mm,5μm)with the mobile phase comprising of acetonitrile-0.1%formic acid,flowing at 1.0 mL/min in a gradient elution manner.The column temperature was 35℃.And the detection wavelength was 310nm.Results:20 common peaks with the similarities of more than 0.915 were observed in the ten batches of samples of HPLC fingerprints.By comparing with standards,the components of hydroxysafflor yellow A,ellagic acid,cinnamaldehyde and piperine were detected.The results of content determination were respectively 0.04%~0.27%,0.15%~0.33%,0.02%~0.11%and 0.11%~0.19%.Conclusion:HPLC is used to establish the fingerprints of Wuweiqinzhuo pills and determine the contents of the four constituents.The method is highly accurate,reliable and reproducible,and it can be used for the quality control of Wuweiqingzhuo pills.