羌活中挥发油和异欧前胡素的含量测定

Quantitative analysis of volatile oils and isoimperatorin in Rhizoma et Radix Notopterygii

目的:研究目前羌活药材的质量现状,为制订羌活合理的质量标准提供科学依据。方法:采用药典方法和HPLC分别对22个羌活主产地的29份商品药材样品进行挥发油和异欧前胡素含量的检测和统计学分析。结果:29份样品中仅3份的挥发油含量能达到2005年版药典的含量标准,产新药材中的不达标的比例达87.0%;统计结果显示,欲达到80%以上合格率的控制指标的挥发油含量应为1.63%,异欧前胡素为0.17%;样品的2种定量检测指标成分含量在采收年份间差异不显著,异欧前胡素在羌活和宽叶羌活间差异显著。结论:2005年版药典羌活挥发油含量标准过高,建议标准为不低于1.6%(mL.g-1);建议增加异欧前胡素为羌活药材质量的定量指标含量之一,标准为不低于0.2%(mg.g-1)。

Objective： To establish scientific and efficient quality control standard of Rhizoma et Radix Notopterygii through two quantitative parameters. Method： The contents of isoimperatorin and volatile oils in 29 commercial samples from 22 localities of Rhizoma et Radix Notopterygii were determined by HPLC and the method in the pharmacopoeia respectively. The data were statistically analyzed. Result： Only 3 of 29 samples met the required standard in the Chinese Pharmacopoeia （2005 edition）, 87% of samples newly produced in 2005 not met the standard. Statistics showed that the contents of volatile oils and isoimperatorin should reach 1.63% and 0. 17% respectively when the samples meet requirement of criterion with more than 80% probability. The contents of volatile oil and isoimperatorin were not significantly different （P 〈 0. 05 ） in the samples of 2005 and 2003, while the contents of isoimperatorin were significantly different between Notopterygium incisum and N. forbesii samples. Conclusion： Since the criterion of volatile oils in the Chinese Pharmacopoeia （2005 version） for Rhizoma et Radix Notopterygii is too high to satisfy for most Rhizoma et Radix Notopterygii samples, it is suggested to reduce it to 1.6% （mL · g^-1 ）. The content of isoimperatorin is proposed to add to the quality standard of Rhizoma et Radix Notopterygii as above 0. 2% （ mg · g^- 1 ）.