[关键词]
[摘要]
目的:建立当归破壁饮片(成品)、破壁粉体(中间体)及传统饮片(原料)的HPLC指纹图谱,并测定三者的阿魏酸含量,为当归破壁饮片的质量评价提供依据。方法:采用高效液相色谱法,Aglient-ZORBAX SB色谱柱,以乙腈-1%醋酸溶液为流动相进行梯度洗脱,流速为1.0mL·min-1,检测波长为254nm,柱温为30℃。采用2015版《中国药典》HPLC含量测定方法测定阿魏酸含量。结果:建立了当归破壁饮片-破壁粉体-传统饮片的HPLC指纹图谱,10批当归破壁饮片、10批破壁粉体及10批传统饮片的指纹图谱共有模式中均有14个共有特征峰,各批次破壁饮片、破壁粉体及传统饮片的图谱基本一致,相似度均大于0.96;当归破壁饮片中阿魏酸含量略高于当归药材。结论:本文所建立的方法稳定、可靠、重复性好,可用于当归破壁饮片的质量控制和综合评价。
[Key word]
[Abstract]
This study aimed to establish an effective measurement to exam the quality of three formulations,ultrafine granular powder,ultrafine powder and decoction pieces made from Angelicae sinensis Radix through determining the content of ferulic acid by HPLC fingerprints.RP-HPLC method was performed on an Agilent ZORBAX SB column with a gradient elution using acetonitrile-1% acetic acid at the flow rate of 1 mL·min-1.The column temperature was 30℃,and the detective wavelength was 254nm.In addition,the contents of ferulic acid of the samples were detected according to Chinese Pharmacopoeia(2015 Edition).As a result,the fingerprints of the three formulations of Angelicae sinensis Radix were analyzed.The common pattern of chromatographic fingerprints in which fourteen mutual peaks were marked, was established with 30 batches of samples with 10 batches for each formulation of Angelicae sinensis Radix.The similarity among the fingerprints of the ultrafine granular powder,the granular powder and the decoction pieces were higher than 0.96.The content of ferulic acid in the ultrafine granular powder of Angelicae sinensis Radix was slightly higher than that in its decoction pieces.In conclusion,this method was reliable and stable and with good reproducibility,which was feasible in the area of drug quality control of ultrafine granular powder of Angelicae sinensis Radix.
[中图分类号]
[基金项目]
广东省中山市科学技术局资助项目(2008CXY004):丹参等四味中药超微饮片的色谱指纹图谱研究及应用,负责人:成金乐。