经典名方当归四逆汤物质基准的关键质量属性传递规律分析

Analysis on transfer law of critical quality attributes of Danggui Sini Decoction material benchmarks

[目的]探究当归四逆汤(DSD)物质基准关键质量属性的传递规律。[方法]制备15批DSD冻干粉作为物质基准样品,测定多指标性成分含量、特征图谱及干膏率,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]指标性成分藁本内酯、桂皮醛、肉桂酸、芍药苷、细辛脂素和甘草酸在药材-物质基准中转移率范围分别为:0.65%~1.18%、0.08%~0.30%、10.40%~37.05%、23.96%~48.18%、0.83%~1.32%、4.94%~11.83%;特征图谱共指认20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平均值的70%~130%范围;15批物质基准的干膏率转移率为47.87%~61.53%。[结论]DSD物质基准的关键质量属性可在药材-饮片-水煎液-物质基准中稳定传递,文章初步构建了DSD物质基准的全过程质量控制体系,为后续复方制剂的开发提供数据支撑。

[Objective]To explore the transfer law of critical quality attributes of Danggui Sini Decoction(DSD)material benchmarks.[Methods]The 15 batches of lyophilized powder samples of DSD were prepared as the material benchmarks.Index component contents,specific chromatograms and dry extract rates were determined and the transfer rates of the above indexes in the process of medicinal material-decoction piece-decoction-material benchmarks were calculated.[Results]The transfer rates from medicinal material to material benchmarks of ligustilide,cinnamaldehyde,paeoniflorin,asarcin and glycyrrhizin were 0.65%~1.18%,0.08%~0.30%,10.40%~37.05%,23.96%~48.18%,0.83%~1.32%,4.94%~11.83%,respectively.The 20 characteristic peaks originated from the characteristic spectrums were 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 transfer rates of the dry extract rates from decoction piece to material benchmarks were 47.87%~61.53%.[Conclusion]The critical quality attributes of DSD material benchmarks can be transmitted stably across the process of medicinal material-decoction pieces-decoction-material benchmarks.This study preliminarily constructed the whole process quality control system of DSD,which provided data support for the development of subsequent compound preparations.