Study on the Qualitative and Quantitative Quality Control Methods of Bufonis Corium
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1.Jilin Normal University College of Chemistry， Jilin Siping 136000， China； 2.Siping Central Hospital， Jilin Siping 136000， China； 3.Jilin Normal University College of Chemistry， Jilin Siping 136000， China； 4.State Key Laboratory of Tree Genetics and Breeding， Key Laboratory of Tree Breeding and Cultivation of the National Forestry and Grassland Administration， Research Institute of Forestry， Chinese Academy of Forestry， Beijing 100091， China； 5.National Institutes for Food and Drug Control， Beijing 102629， China； 6.Jilin Normal University College of Life Sciences， Jilin Siping 136000， China
Objective： Establish a quality control research method for Bufonis corium. Methods： Based on the characteristics of Bufonis 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 chromatography 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.
