藏药细叶亚菊的质量标准研究

Study on the Quality Standard of Tibetan Medicine Ajania tenuifolia

目的建立细叶亚菊的质量标准,为其质量控制和合理开发利用提供科学参考。方法采用性状鉴别、显微鉴别、薄层色谱法(TLC)对细叶亚菊进行定性分析;参照《中国药典》(2020年版)通则方法对细叶亚菊水分、总灰分、酸不溶性灰分、水溶性浸出物进行含量检查;利用高效液相色谱法(HPLC)测定细叶亚菊中绿原酸、异绿原酸A的含量。结果确定了细叶亚菊的药材性状及显微特征。TLC鉴别显示,供试品(细叶亚菊药材)与对照品(绿原酸、异绿原酸A)在相应位置上均显示相同颜色的荧光斑点。13批细叶亚菊水分、总灰分、酸不溶性灰分、浸出物的含量分别为8.55%-13.07%、6.81%-12.68%、1.11%-3.53%、8.41%-11.64%;绿原酸、异绿原酸A的含量范围分别为0.072%-0.440%、0.283%-1.324%(n=3)。结论本研究建立的方法准确稳定,可为细叶亚菊的质量控制提供参考。暂规定细叶亚菊水分不得过12.0%,总灰分不得过10.0%,酸不溶性灰分不得过2.5%,水溶性浸出物不得少于8.0%,绿原酸不得少于0.2%,异绿原酸A不得少于0.6%。

Objective To establish the quality standard of Ajania tenuifolia and provide scientific reference for its quality control and rational development and utilization.Methods Morphological identification,microscopic identification and TLC identification were used for qualitative analysis of A.tenuifolia;The contents of moisture,total ash,acid insoluble ash and water-soluble extract of A.tenuifolia were checked according to the methods stated in the 2020 Edition of Chinese Pharmacopoeia;The contents of chlorogenic acid and isochlorogenic acid A in A.tenuifolia were determined by HPLC.Results The medicinal properties and microscopic characteristics of A.tenuifolia were determined.TLC identification showed that the test sample(A.tenuifolia)and the control sample(chlorogenic acid,isochlorogenic acid A)showed fluorescent spots of the same color at the corresponding positions.The contents of water,total ash,acid insoluble ash and extract of 13 batches of A.tenuifolia were 8.55%-13.07%,6.81%-12.68%,1.11%-3.53%and 8.41%-11.64%respectively;The contents of chlorogenic acid and isochlorogenic acid A were 0.072%-0.440%,0.283%-1.324%(n=3)respectively.Conclusion The method established in this study is stable and accurate,and can provide a reference for the quality control of A.tenuifolia.It is preliminarily proposed that moisture,total ash,acid insoluble should not exceed 12.0%,10.0%and 2.5%;extract,chlorogenic acid and chlorogenic acid A content should not be less than 8.0%,0.2%and 0.6%respectively.