世界中医药2023，Vol.18Issue(22)：3172-3179,8.DOI:10.3969/j.issn.1673-7202.2023.22.003
经典名方芍药甘草汤物质基准质量标准研究
Quality Value Transfer for Substance Benchmark of Classical Famous Prescription Shaoyao Gancao Decoction
摘要
Abstract
Objective:To establish thin-layer chromatography(TLC)identification method and ultra-high performance liquid chro-matography(UHPLC)characteristic chromatogram for the substance benchmark of Shaoyao Gancao Decoction(SGD),and to deter-mine its multi-component content and study the law of value transfer.Additionally,combined with the extraction yield and moisture,the quality standard of SGD was discussed.Methods:A total of 18 batches of SGD substance benchmarks and corresponding objects were prepared.TLC identification:1％sodium hydroxide(NaOH)for preparation of silica gel plate,ethyl acetate:formic acid:gla-cial acetic acid:water at the ratio of 15∶1∶1∶2 as the developing sol vent,and 10％sulfuric acid/ethanol solution as the visualiza-tion reagent.Ultra-high-performance liquid chromatography method with diode array detection(UHPLC-DAD)method was em-ployed to establish the characteristic chromatograms for SGD substance benchmarks and corresponding objects,and identify and the characteristic peaks.The multi-component contents of decoction pieces,substance benchmarks and corresponding objects were de-termined,and the transfer law of the index components from decoction pieces to substance reference to corresponding material was analyzed.Results:The spots in TLC were clear and easy to be identified,and the negative control showed no interference.Both the similarity of substance benchmarks and corresponding objects were greater than 0.9,and 14 characteristic peaks were matched,with 6 identified.The index component test indicated that paeoniflorin,liquiritin,and glycyrrhizic acid in the substance benchmarks were 0.48 to 0.83 mg/mL,0.13 to 0.32 mg/mL,and 0.31 to 0.60 mg/mL,respectively,and 2.21％to 3.40％,0.64％to 1.59％,and 1.56％to 3.00％,respectively in the corresponding objects.The average transfer rates from decoction pieces to substance benchmarks were paeoniflorin 51.15％,liquiritin 36.65％,and glycyrrhizic acid 37.03％,and those from substance benchmarks to corresponding objects were paeoniflorin 100.19％,liquiritin 99.55％,and glycyrrhizic acid 100.49％.Conclusion:Through vari-ous studies,it is possible to comprehensively control the quality of SGD substance benchmarks and corresponding objects and thus achieve the whole-process quality control in the development and research of SGD.关键词
经典名方/芍药甘草汤/物质基准/对应实物/质量控制/超高效液相色谱-二极管阵列检测器/芍药苷/甘草苷/甘草酸Key words
Classical famous prescription/Shaoyao Gancao Decoction/Substance benchmark/Corresponding object/Quality con-trol/Ultra-high-performance liquid chromatography method with diode array detection(UHPLC-DAD)/Paeoniflorin/Liquiritin/Glycyrrhizic acid分类
医药卫生引用本文复制引用
曲缘章,朱广伟,李丹,刘佳萌,马生军,孙博,李宝国,李刚,杨林勇,刘岩..经典名方芍药甘草汤物质基准质量标准研究[J].世界中医药,2023,18(22):3172-3179,8.基金项目
"重大新药创制"国家科技重大专项(2018ZX09721005) （2018ZX09721005）
中国中医科学院科技创新工程项目(CI2021A04506) （CI2021A04506）
