中国药业2025，Vol.34Issue(9)：66-70,5.DOI:10.3969/j.issn.1006-4931.2025.09.014
蒙药材扁蕾质量标准研究
Quality Standard of Mongolian Medicina Herb of Gentianopsis Barbata
摘要
Abstract
Objective To provide a reference for improving the quality standard of Gentianopsis barbata.Methods Six batches of Gentianopsis barbata samples were collected from the origin and usage areas,and qualitative identification was performed by morphological identification,microscopic identification,and thin-layer chromatography(TLC)methods.According to the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),the moisture content,total ash content,acid insoluble ash content,heavy metals and harmful elements,and extract content of Gentianopsis barbata were checked.The content of oleanolic acid in samples was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Eclipse C18 column(250 mm×4.6 mm,5 µm),the mobile phase was methanol-water-glacial acetic acid-triethylamine(87∶13∶0.04∶0.02,V/V/V/V),the flow rate was 1.0 mL/min,the detection wavelength was 210 nm,the column temperature was 30℃,and the injection volume was 10 µL.Results The roots of Gentianopsis barbata were cylindrical,the stems were quadrilateral,the leaves were opposite,the sepals were tubular and bell-shaped,the corollas were tubular and wrinkled,and the capsules were narrow and rectangular in shape.Microscopic features were obvious,including leaf epidermal cells,wood fibers,pollen grains,and fibrous lumens.The TLC spots showed clear color and good separation.In the six batches of samples,the moisture content did not exceed 5.60%,the total ash content did not exceed 5.59%,and the acid insoluble ash content did not exceed 2.72%;the contents of lead,cadmium,arsenic,mercury,and copper were lower than or equal to 0.70×10-6,0.20×10-6,0.20×10-6,0.05×10-6,and 8×10-6,respectively;the content of ethanol thermal extract did not exceed 21.45%.The linear range of oleanolic acid was 0.979 0-5.874 0 µg(r=0.999 9,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of oleanolic acid was 100.44%with an RSD of 1.45%(n=6).The content of oleanolic acid in the six batches of samples was 16.29,16.82,16.52,12.44,12.06,and 13.27 mg/g,respectively.Conclusion This method is simple,with strong specificity,good reproducibility,and accurate results,which can be used for quality control of Gentianopsis barbata.The moisture content,total ash content,and acid-insoluble ash content in Gentianopsis barbata should be lower than or equal to 7.0%,6.5%,and 3.0%,respectively.The ethanol hot extract and dried oleanolic acid content should be higher than or equal to 17.0%and 1.1%,respectively.关键词
扁蕾/性状鉴别法/显微鉴别法/薄层色谱法/高效液相色谱法/质量控制Key words
Gentianopsis barbata/characteristic identification method/microscopic identification method/TLC/HPLC/quality control分类
药学引用本文复制引用
朝鲁门,娜仁图雅,李妍,白妍,韩塔娜..蒙药材扁蕾质量标准研究[J].中国药业,2025,34(9):66-70,5.基金项目
国家药品标准提高研究课题[446]. （）
