杜仲木香散的质量标准研究

Study on the quality standard of Duzhong Muxiang San

目的建立杜仲木香散的质量标准。方法采用显微观察法建立杜仲和木香的鉴别方法;以木香烃内酯和京尼平苷酸为质量控制指标,建立鉴定杜仲木香散的高效液相色谱法(high performance liquid chromatography,HPLC)。结果显微鉴别专属性良好;经HPLC法测得木香烃内酯和京尼平苷酸质量浓度分别在10.00~100.00、10.00~60.00μg·mL^(-1)范围内,线性关系良好;加样回收率分别在96.98%~103.87%、98.93%~103.21%范围内,RSD值均小于3.00%。结论该方法简单、快速、准确,为杜仲木香散的质量标准研究提供依据。

Objective To establish a quality standard of Duzhong Muxiang San.Methods The microscopic identification of Eucommiae cortex and Aucklandiae radix was established.The content determination with high performance liquid chromatography(HPLC) for Duzhong Muxiang San was established by taking costunolide and geniposidic acid as the quality control index.Results The microscopic identification showed good specificity;the calibration curves were linear within the ranges of 10.00-100.00 μg•mL^(-1) for costunolide, and 10.00-60.00 μg•mL^(-1) for geniposidic acid.The average recoveries were ranged from 96.98% to 103.87%,and 98.93% to 103.21% respectively with RSDs below 3.00%.Conclusion The method is simple, fast and accurate, which provides suggestions for the study of the quality standard of Duzhong Muxiang San.