中国药物评价2025，Vol.42Issue(6)：421-425,5.
蟾皮定性与定量的质量控制方法研究
Study on the Qualitative and Quantitative Quality Control Methods of Bufonis Corium
摘要
Abstract
Objective:Establish a quality control research method for Bufonis corium.Methods:Based on the characteristics of Bufo-nis corium samples,formulate the characteristics of Bufonis corium.Thin layer chromatography identification was performed using Bufonis corium as a reference medicinal material and Cinobufagin.Using ethanol as the solvent,establish limits for the extract of hot leaching method.The content of cinobufagin and resibufogenin was determined by high-performance liquid chromatography,with a mobile phase of 0.5％potassium dihydrogen phosphate solution acetonitrile(50∶50)(adjusted to pH 3.2 with phosphoric acid).Column temperature 40 ℃.The chromatographic column is Sepax BR C18(4.6 mm ×250 mm,5 μm).The UV wavelength was set to 296 nm.Results:The results showed that the characterization was reasonable and could describe the characteristics of Bufonis corium.Thin layer chromatog-raphy has clear fluorescent spots for identification,good stability,and strong specificity.The linear relationship between cinobufagin and resibufogenin is good within the range of 5.69-591.50 and 5.44-504.39 μg·mL-1,respectively,with a correlation coefficient of r≥0.999 7 and an average recovery rate of ≥97.3％,RSD ≤ 1.06％.Conclusion:The qualitative and quantitative quality control methods established in this study for toad skin are simple and methodologically sound,providing expanded ideas for the quality evaluation of Bufonis corium.关键词
中华大蟾蜍/黑框蟾蜍/蟾皮/质量控制Key words
Bufo gargarizans cantor/Bufo melanostictus Schneider/Bufonis corium/Quality standards分类
医药卫生引用本文复制引用
楚贤宇,谢秋红,马依热,彭霄鹏,昝珂,赵磊..蟾皮定性与定量的质量控制方法研究[J].中国药物评价,2025,42(6):421-425,5.基金项目
吉林省中药材标准(JLYC-2020-013) （JLYC-2020-013）
海南省"南海系列"育才计划南海名家青年项目(20202075) （20202075）
