倒提壶药材质量标准研究

Research on quality specification of Herb Cynolgossum officinale

目的建立倒提壶药材的质量控制标准,为其药用植物资源的开发利用提供科学依据。方法于不同产地采集5批倒提壶样品,对倒提壶原植物进行鉴定,并对其性状进行描述;以β-谷甾醇对照品按照《中国药典》2010年版(一部)附录ⅥB对倒提壶药材进行薄层色谱鉴别;按照《中国药典》2010年版(一部)附录ⅨH和附录ⅨK测定5批倒提壶药材的水分、总灰分、酸不溶性灰分;按照《中国药典》2010年版(一部)附录ⅩA测定5批倒提壶药材的浸出物。结果倒提壶药材以环己烷-乙醚-乙酸乙酯(40:11:5)为展开剂,倒提壶中β-谷甾醇薄层色谱鉴别,分析显示检查项中暂定倒提壶药材水分不得过15%,总灰分不得过18%,酸不溶性灰分不得过1.5%。倒提壶浸出物不得少于18.00%。结论所制定倒提壶药材的质量控制标准可用于评价倒提壶药材的质量。

Objective To provide scientific basis for the utilization and development of Cynolgossum officinale by setting up the quality control specification of Cynolgossum officinale.Methods There are 5different origin batchs of Cynolgossum officinales,after identificating and describing the properties,making contrast toβ-Sitosterol on TLC according to Chinese Pharmacopoeia 2010version（VolⅠ）of appendix ⅥB;we made determination for the moisture,total ash and acid-insoluble ash of the 5batches Cynolgossum officinales according to Chinese Pharmacopoeia 2010version（VolⅠ）of appendixⅨ H and K,then the ethanol-soluble extract determination method of Cynolgossum officinale were inspected according to Chinese Pharmacopoeia 2010version（VolⅠ）of appendixⅹ A.Results The origin＇s identification of Cynolgossum officinale were described,and the TLC identification method was formulated with thiacyclo-hexane-ethyl ether-ethyl acetate（40：11：5）as developing solvent,temporarily formulating moisture was not over 15%,the total ashes was 18%,acid-insoluble ashes was 1.5%.Determined the method of ethanol-soluble extract of Cynolgossum officinale and the ethanol-soluble extract product was not less than 18.00%.Conclusion The Cynolgossum officinale quality control standard can be used to evaluate the quality of Cynolgossum officinale.