基于“质-量”双标的连翘质量分析方法研究

Research on the quality analysis method of Forsythiae Fructus based on"quality-quantity"double standard

目的建立以对照药材为对照物质的定性和不依赖多种对照品定量的连翘药材“质-量”双标控制方法。方法采用高效液相色谱(HPLC)法建立连翘对照药材特征图谱,并通过质谱技术鉴定特征峰成分;通过比较对照药材和供试药材特征峰的相似度,明确药材的真伪,即“质”;其余特征峰的化学成分均通过基准物质相对定量,以区别药材的优劣,即“量”。结果建立的连翘药材“质-量”分析方法符合方法学考察要求,每批药材与对照药材相似度均在0.910以上,并规定了连翘药材特征峰化学成分的相对含量下限。结论该方法不依赖于多种对照品,能清晰、快速地判断连翘药材的真伪优劣,弥补了目前连翘药材在质量控制上的不足,完善了中药材质量控制体系,以期推动中医药事业可持续发展。

Objective To establish a dual standard control method of quality-quantity of Forsythiae Fructus herb using the control herb as the reference material for characterization and quantification without relying on multiple controls.Methods High performance liquid chromatography(HPLC)was used to establish the characteristic spectrum of Forsythiae Fructus control herbs,and the characteristic peaks were identified by mass spectrometry;The similarity of the characteristic peaks of the control herbs and the test herbs was compared to clarify the authenticity of the herbs,i.e.,the"quality";The rest of the characteristic peaks were quantified by the reference substances to distinguish the superiority and inferiority of the herbs,in other words,the"quantity".Results The established"quality-quantity"analytical method for Forsythiae Fructus complied with the requirements of methodological investigation,and the similarity between each batch of herbs and the control herbs was above 0.910,and the lower limit of the relative content of the characteristic peaks of chemical constituents of Forsythiae Fructus was stipulated.Conclusion The method does not depend on multiple controls,and it is clear and fast in judging the authenticity of Forsythiae Fructus herbs,which makes up for the current shortcomings in quality control of Forsythiae Fructus herbs and improves the quality control system of traditional Chinese medicinal materials with a view to promoting the sustainable development of traditional Chinese medicine.