仙桃草药材质量标准研究

Study on the Quality Standard of Xiantao Herbal Medicine

目的:建立仙桃草药材质量标准。方法:对仙桃草药材粉末进行显微鉴别,采用薄层色谱法(TLC)对药材进行定性鉴别,以原儿茶酸作为质量标志物建立高效液相色谱(HPLC)测定方法,根据2020年版《中国药典》方法检查其水分、总灰分、酸不溶性灰分、浸出物含量。结果:药材显微结构明显,与现有描述一致。薄层色谱法鉴别斑点清晰且分离度好。高效液相色谱法定量方法线性关系较好,重复性良好,回收率符合要求。依据《中国药典》相关方法及原则,确定原儿茶酸(C_(7)H_(6)O_(4))为仙桃草药材的主要成分且不得少于0.02%,仙桃草药材水分含量不得超过12.0%,总灰分不得超过15.0%,酸不溶性灰分不得过5.0%,浸出物限度为不得低于26.0%。结论:该方法简便准确,完善了仙桃草药材的质量检测方法,为药材的质量控制及药典的修订提供了参考。

Objective To establish the quality standard of Xiantao herbal medicine.Methods The powder of Cynodon grandiflorum herbs was identified microscopically and qualitatively by thin-layer chromatography(TLC),and a high-performance liquid chromatography(HPLC)method was established for the determination of protocatechuic acid as a quality marker,and the contents of moisture,total ash,acid-insoluble ash,and leachate were examined according to the methods of 2020 edition of the Chinese Pharmacopoeia.Results The microstructure of the herb was evident and consistent with the existing description.The identification spots were clear and well separated by thin-layer chromatography.The quantitative method of HPLC showed good linearity and reproducibility,and the recovery was in accordance with the requirements.According to the relevant methods and principles of the Chinese Pharmacopoeia,it was determined that protocatechuic acid(C_(7)H_(6)O_(4))was the main constituent of Cynanchum officinale and should not be less than 0.02%,the moisture content of Cynanchum officinale should not be more than 12.0%,the total ash should not be more than 15.0%,acid-insoluble ash should not be more than 5.0%,and the limit of leachate should not be less than 26.0%.Conclusion The method is simple and accurate,which improves the quality testing method of Cynodon grandiflorum herbs and provides a reference for the quality control of herbs and the revision of pharmacopoeia.