人参须药材质量标准的研究

Research on Quality Standards of Ginseng Leptoradix

目的建立人参须药材质量标准。方法采用经验、显微鉴别法对该药材性状、显微特征进行描述;按照中国药典2015年版四部通则相关方法,对药材水分、总灰分进行了测定;采用薄层色谱法,分别以人参对照药材和人参皂苷(Rb_1、Re、Rf和Rg_1)对照品为对照,对该药材的脂溶性成分及皂苷类成分进行定性鉴别;采用HPLC,以人参皂苷Re、Rg_1、Rb_1和Rb_2为对照,采用Sepax BR-C_(18)色谱柱(4.6 mm×250 mm,5μm),乙腈-水为流动相,进行梯度洗脱,在203 nm波长下对各皂苷成分进行定量分析,建立该药材中皂苷类成分的含量测定方法。结果该药材性状、显微、薄层鉴别方法具有较强的专属性,水分平均值为11.0%,总灰分平均值为4.6%,人参皂苷Re与Rg_1总含量平均值为0.86%,Rb_1含量平均值为0.54%,Rb_2含量平均值为0.31%。结论本研究依据实验结果和传统经验,同时结合了吉林省人参须药材的生产现状及药用企业的应用情况,可以作为人参须药材的质量标准。

OBJECTIVE To establish quality standards of Ginseng Leptoradix. METHODS Empircal and microscopic identification methods were adopted to observe morphological and histological characters. The contents of water and total ash were analyzed according to the methods of Chinese Pharmacopoeia（2015）. Ginsenoside constituent（Rb1, Re, Rf, Rg1） and reference herbs were used to identify materia medica of Ginseng Leptoradix. The ginsenoside constituent were analyzed by HPLC, Ginsenoside constituent（Re, Rg1, Rb1, Rb2） was used as reference substances. The determination method was performed on a Sepax BR-C（18） column（4.6 mm×250 mm, 5 μm） with acetonitrile-water as the mobile phase, which was a multi-step acetonitrile-water gradient run. The detection wavelength was 203 nm. RESULTS The macroscopical identification, microscopic features and TLC methods were proper. The average congtents of water, total ash and ginsenoside constituent（Re and Rg1, Rb1, Rb2） were 11.0%, 4.6%, 0.86%, 0.54% and 0.31%, respectively. CONCLUSION The quality standards established based on the research results, traditional experience and the production status of Ginseng Leptoradix in Jilin Province, which is suitable for the quality evaluation of Ginseng Leptoradix.