指纹定量法测定通宣理肺丸指纹归属度和药效物质工艺收率

Determination of fingerprint attribution ratio and process recovery of medicinally effective components for TLPs by quantified fingerprint method

目的建立通宣理肺丸(TLPs)HPLC指纹图谱,研究其化学指纹成分归属度和药效物质工艺收率。方法以水煎混合样品指纹图谱为评价标准,采用归属度pi、逸出度qi、宏定性相似度Sm和宏定量相似度Pm进行指纹归属的整体定性定量分析,用指纹定量法测定TLPs药效物质工艺收率。结果评价出S8黄芩为君药、S13枳壳为臣药、S6陈皮和S11甘草为佐药,其余为辅药。14批市售TLPs药效物质工艺收率的Pm较高,但Sm很低,说明其化学指纹分布比例与对照指纹图谱差异很大。结论指纹定量法能够客观、准确地定量描述单味药对TLPs化学指纹的贡献大小和整体定性定量评价药效物质工艺收率,为TLPs质量控制提供了新方法。

Objective To establish HPLC fingerprint of TLPs and to investigate the fingerprint attribution ratio and process recovery of medicinally effective components.Methods The overall qualitative and quantitative analyses of the attribution ratio were performed by outlier ratio qi,attribution ratio pi,macro qualitative similarity Sm,and macro quantitative similarity Pm,in which the HPLC fingerprints of the decoction samples were considered as the evaluating criteria.The process recovery of medicinally effective components in TLPs were investigated using the quantified fingerprint method.Results S8（Radix Scutellariae） was assessed to be the dominating drug in the compound,S13（Fructus Aurantii） was the minister drug,S6（Pericarpium Citri Reticulatae） and S11（Radix Et Rhizoma Glycyrrhizae） were junior drugs and others were auxiliary drugs.The process recovery of the medicinally effective components for 14 batches of market preparations with high Pm and low Sm disclosed great differences from the reference fingerprint in chemical constituents constituents distribution ratio.Conclusion Quantified fingerprint method can objectively and accurately reflect the contribution of single crude drug to the compound,and quantitatively evaluate the process recovery of TLPs.