经典名方苓桂术甘汤的物质基准量值传递分析

Analysis on quality value transmitting of substance benchmarks of Linggui Zhugan Decoction

通过制备10批物质基准,建立苓桂术甘汤物质基准特征图谱的检测方法,明确其特征图谱的峰归属,相似度范围,出膏率范围,桂皮醛、甘草苷和甘草酸的含量范围以及转移率范围,阐明苓桂术甘汤物质基准的关键质量属性。结果表明,10批苓桂术甘汤物质基准特征图谱相似度良好(>0.9);进一步汇总特征峰信息可知,茯苓有2个特征峰,桂枝有6个特征峰,白术有2个特征峰,甘草有11个特征峰;10批物质基准的出膏率为(12.13±0.35)%;桂皮醛的平均质量分数为0.32%,平均转移率为10.69%,不同批次物质基准的桂皮醛质量分数均在0.22%~0.42%,转移率均在7.48%~13.90%;甘草苷的平均质量分数为0.84%,平均转移率为50.39%,不同批次物质基准的甘草苷质量分数均在0.42%~1.26%,转移率均在35.27%~65.51%;甘草酸的平均质量分数为1.88%,平均转移率为40.74%,不同批次物质基准的甘草酸质量分数均在0.94%~2.82%,转移率均在28.52%~52.96%。该文采用特征图谱、出膏率及指标性成分含量相结合的模式,对经典名方苓桂术甘汤物质基准的量值传递过程进行分析,初步建立了科学稳定的物质基准质量评价方法,为经典名方苓桂术甘汤的后续开发及相关制剂的质量控制提供依据。

By preparing 10 batches of the material reference of Linggui Zhugan Decoction,the methodology of the characteristic spectrum of the material reference was created.The creaming rate range,the contents and the transfer rate range of cinnamaldehyde,glycyrrhizin and glycyrrhizic acid,the characteristic peaks and the similarity range of the characteristic spectrum of Linggui Zhugan Decoction were determined to clarify key quality attributes of the material reference of Linggui Zhugan Decoction.In the 10 batches of the material reference of Linggui Zhugan Decoction,the similarity of characteristic spectrum was higher than 0.9.Furthermore,after summarizing the characteristic peak information,we knew that Fuling had two characteristic peaks,Guizhi had six characteristic peaks,Baizhu had two characteristic peaks and Gancao had 11 characteristic peaks.The average creaming rate of the material reference of the ten batches was(12.13±0.35)%.The average content of cinnamaldehyde was 0.32%,the average transfer rate was 10.69%,the content of cinnamaldehyde in the different batches was between 0.22%and 0.42%,and the transfer rate was between 7.48%and13.90%.The average content of glycyrrhizin was 0.84%,the average transfer rate was 50.39%,the content of glycyrrhizin in the different batches was between 0.42%and 1.26%,and the transfer rate was between 35.27%and 65.51%.The average content of glycyrrhizic was 1.88%,the average transfer rate was 40.74%,the content of glycyrrhizic in the different batches was between 0.94%and2.82%,and the transfer rate was between 28.52%and 52.96%.In this paper,the quality value transmitting of substance benchmarks of Linggui Zhugan Decoction was analyzed by the combination of characteristic spectrum,creaming rate and the content of index component.A scientific and stable method was preliminarily established,which provided scientific basis for the quality control and formulation development of Linggui Zhugan Decoction.