经典名方桃核承气汤物质基准关键质量属性传递规律分析

Analysis on transmission law of critical quality attributes of classical prescription Taohe Chengqi Decoction substance benchmarks

目的探究桃核承气汤物质基准关键质量属性的传递规律。方法制备15批桃核承气汤冻干粉作为物质基准,测定其特征图谱、指标成分含量及干膏率,并计算上述指标在药材-饮片-水煎液-物质基准传递过程中的转移率。结果15批桃核承气汤特征图谱选取的48个特征峰在传递过程中无丢失,多数特征峰相对峰面积的转移率在均值的70%~130%,饮片-物质基准中苦杏仁苷、甘草酸、肉桂酸、大黄总游离蒽醌的平均转移率分别为(21.03±6.83)%、(21.16±2.60)%、(35.96±14.04)%和(6.01±2.05)%,干膏率平均传递率为78.68%。结论桃核承气汤物质基准的关键质量属性均可在药材-饮片-水煎液-物质基准中稳定传递。初步构建桃核承气汤物质基准制备全过程质量控制体系,为后续复方制剂的开发提供了方法参考。

Objective To explore the transfer law of critical quality attributes of Taohe Chengqi Decoction(TCD,桃核承气汤)substance benchmarks.Methods A total of 15 batches of TCD lyophilized powder samples were prepared as the substance benchmarks.Specific chromatograms,index component contents and dry extract rates were determined and the transfer rates of the above indexes in the process of medicinal material-decoction piece-decoction-substance benchmarks were calculated.Results The 48 characteristic peaks originated from the specific chromatogram did not lost across the whole process,and most of the transfer rates of relative areas of characteristic peaks were in the range of 70%—130%of the mean.The average transfer rates from decoction pieces to substance benchmarks of amygdalin,glycyrrhizic acid,cinnamic acid and rhubarb total free anthraquinone were(21.03±6.83)%,(21.16±2.60)%,(35.96±14.04)%,(6.01±2.05)%,respectively.The average transfer rate of dry extract rate of 15 batches of TCD was 78.68%.Conclusion The critical quality attributes of TCD substance benchmarks can be stably transferred from medicinal material to decoction piece to decoction finally to substance benchmarks.This study preliminarily constructs the quality control system of the whole process of substance benchmarks preparation of TCD,which provides a method reference for the development of subsequent compound preparations.