经典名方达原饮基准样品关键质量属性量值传递研究

Quantitative value transfer research of key quality attributes of benchmark samples of classical prescription Dayuan Decoction

目的建立经典名方达原饮基准样品的HPLC特征图谱,并对其关键质量属性量值传递进行研究。方法按照古代工艺制备15批达原饮基准样品,建立其特征图谱,明确其特征峰并对其进行特征峰归属分析;对达原饮基准样品进行多成分含量测定,分析主要成分从饮片到基准样品的传递规律。结果15批达原饮基准样品的特征图谱相似度均大于0.97,特征图谱相似度良好,共指认20个共有峰,其中4号峰来自槟榔,3、11、19、20号峰来自厚朴,12~16、18号峰来自黄芩,1、7、8、10号峰来自白芍,2、6号峰来自知母,5、17号峰来自甘草,9号峰为厚朴和白芍共有;全处方干膏率范围和平均转移率为12.88%~16.42%和72.41%。各指标成分的含量范围及饮片到基准样品的平均转移率分别为槟榔碱0.08%~0.19%和17.48%,厚朴酚与和厚朴酚0.0215%~0.0522%和15.85%,黄芩苷22.12%~28.72%和59.36%,芍药苷0.84%~1.32%和38.88%,芒果苷0.08%~0.13%和21.58%,甘草酸铵0.15%~0.25%和10.39%。结论特征图谱结合出膏率和多指标成分含量测定对达原饮基准样品的量值传递规律进行研究,为达原饮的质量控制和制剂开发提供了科学依据。

Objective The HPLC characteristic chromatogram of the benchmark samples of the classic prescription Dayuan Decoction(DYD,达原饮)was established,and the quantitative value transfer of its key quality attributes was studied.Methods According to the ancient process,a total of 15 batches of DYD benchmark samples were prepared,their characteristic spectra were established,their characteristic peaks were identified and analyzed.The multi-component content of the benchmark samples of DYD was determined,and the transfer law of the main components from the decoction pieces to the benchmark samples was analyzed.Results The similarity of the characteristic spectra of 15 batches of DYD benchmark samples was greater than 0.97,and the similarity of the characteristic spectra was good.A total of 20 common peaks were identified,including peak 4 was from Binglang(Arecae Semen),peaks 3,11,19 and 20 were from Houpo(Magnoliae Officinalis Cortex,MOC),peaks 12—16 and 18 were from Huangqin(Scutellariae Radix),peaks 1,7,8 and 10 were from Baishao(Paeoniae Radix Alba,PRA),peaks 2 and 6 were from Zhimu(Anemarrhenae Rhizoma),peaks 5 and 17 were from Gancao(Glycyrrhizae Radix et Rhizoma),peak 9 was the common peak of MOC and PRA.The dry extract rate range and average transfer rate of the whole prescription were 12.88%—16.42%and 72.41%.The content range of each index component and the average transfer rate from the decoction pieces to the benchmark samples were 0.08%—0.19%and 17.48%for arecoline,0.0215%—0.0522%and 15.85%for magnolol and honokiol,22.12%—28.72%and 59.36%for baicalin,0.84%—1.32%and 38.88%for paeoniflorin,0.08%—0.13%and 21.58%for mangiferin,0.15%—0.25%and 10.39%for ammonium glycyrrhetate.Conclusion The characteristic chromatogram combined with the extraction rate and the content determination of multiindex components was used to study the value transfer law of the benchmark samples of DYD,which provided a scientific basis for the quality control and preparation development of DYD.