半边莲药材质量标准研究

Quality standard of Lobeliae Chinensis Herba

依据《中国药典》2020年版四部通则,对半边莲进行系统研究,建立药材质量标准。采用硅胶GF;薄层板,以地奥司明、蒙花苷对照品及对照药材为对照,建立薄层色谱鉴别方法;按四部通则方法对半边莲药材的水分、总灰分、酸不溶性灰分进行检查,测定醇溶性浸出物的含量;采用高效液相色谱法,建立半边莲药材的特征图谱,同时以地奥司明、党参炔苷和蒙花苷为质控指标,建立多成分含量测定方法。利用所建方法对不同产地批次的18批样品进行测定,综合评价,起草质量标准,为丰富该药材质量控制内容和药典修订提出建议。

In light of related methods in Chinese Pharmacopoeia(2020 edition),this study established the quality standard for Lobeliae Chinensis Herba.The TLC identification method was established with silica gel GF;thin layer plate,diosmin standard,linarin standard,and the reference material of Lobeliae Chinensis Herba.The loss on drying,total ash,acid-insoluble ash,and ethanol-soluble extracts of 18 batches of Lobeliae Chinensis Herba samples were determined according to the general principles in Chinese Pharmacopoeia.Then,HPLC was adopted in the establishment of characteristic chromatogram and content determination.The results showed that the established method can achieve good separation for diosmin,linarin,and lobetyolin.Based on the results of detection for 18 batches of Lobeliae Chinensis Herba samples,the draft quality standard was established,which was expected to provide reference for the revision of this medicinal herb in Chinese Pharmacopoeia.