经典名方清经散物质基准关键质量属性量值传递研究

Quantity Transfer of Index Components in Material Benchmark of Qingjing Powder

目的:建立经典名方清经散物质基准,并对其关键质量属性量值传递进行研究。方法:制备15批清经散对应实物,建立物质基准高效液相色谱法(HPLC)特征图谱,进行特征峰归属分析;建立物质基准指标性成分含量测定方法,对指标成分从饮片到对应实物的转移率进行分析研究。结果:物质基准HPLC特征图谱共指认了6个特征峰,峰1、2(S)、3、5、9、11分别为芍药内酯苷、芍药苷、东莨菪内酯、毛蕊花糖苷、丹皮酚和盐酸小檗碱;共归属了12个特征峰,分别来自白芍(峰1),白芍、牡丹皮(峰2、6),地骨皮(峰3、8、10),牡丹皮(峰4、9、12),熟地黄(峰5),青蒿(峰7),盐黄柏(峰11),芍药苷、东莨菪内酯、丹皮酚从饮片到对应实物的转移率分别为67.57%~79.69%、57.29%~77.57%、68.13%~73.11%。结论:采用HPLC特征图谱结合多指标性成分含量测定对清经散物质基准进行量值传递研究,该方法科学合理,可为清经散物质基准的建立及复方制剂的研究开发提供参考。

Objective:To establish the material benchmark of Qingjing Powder and study the quantity transfer of key index components.Methods:Fifteen batches of Qingjing Powder were prepared.The high performance liquid chromatography(HPLC)chromatograms were established,and the characteristic peaks were analyzed.The content determination method of index components was established,and the transfer rates of index components from decoction pieces to Qingjing Powder samples were analyzed.Results:Six characteristic peaks were identified by comparison of the HPLC chromatograms between the material benchmark and the reference materials.Peaks 1,2(S),3,5,9,and 11 were albiflorin,paeoniflorin,scopoletin,verbascoside,paeonol,and berberine hydrochloride respectively.A total of 12 characteristic peaks were identified by comparison of the HPLC chromatograms between the material benchmark and decoction pieces.The compounds corresponding to the 12 peaks were from Paeoniae Radix Alba(peak 1),Moutan Cortex(peaks 2 and 6),Lycii Cortex(peaks 3,8,and 10),Moutan Cortex(peaks 4,9,and 12),Rehmanniae Radix Praeparata(peak 5),Artemisiae Annuae Herba(peak 7),and Phellodendri Chinensis Cortex processed with salt(peak 11).The transfer rates of paeoniflorin,scopoletin,and paeonol were 67.57%-79.69%,57.29%-77.57%,and 68.13%-73.11%,respectively.Conclusion:HPLC characteristic chromatogram combined with multi-index component content determination can be used to study the quantity transfer of index components in Qingjing Powder.The method was scientific and reasonable and provided a basis for the establishment of Qingjing Powder material benchmark and the research and development of compound preparations.