基于双波长HPLC指纹谱的一级系统指纹定量法鉴定木香顺气丸质量

Identifying MXSQP Quality by the Firstly Systematically Quantified Fingerprint Method Based on Dual Wavelength HPLC Fingerprints

建立木香顺气丸(Muxiangshunqi pills,MXSQP)双波长HPLC指纹图谱,用一级系统指纹定量法鉴定其质量.采用RP-HPLC法,以橙皮苷(HI)为参照物峰,在265和326nm下分别检测获得60和56个共有指纹峰.以Sm和Pm为指标用系统聚类分析分别确定其中11批和12批样品指纹图谱生成265和326nm对照指纹图谱(RFP),并以此二个RFP为标准用一级系统指纹定量法分别评价16批样品.分别用权重法、均值法和投影参数法整合双波长指纹谱的宏定性和宏定量信息,用一级系统指纹定量法鉴定MXSQPs质量.上述五种方法鉴别出12批质量基本合格,4批含量明显不合格.基于不同波长及双波长整合谱的一级系统指纹定量法能够对中药系统的化学指纹进行整体定性分析和整体定量分析,是评价中药质量的便捷有效方法.

To develop the dual wavelength HPLC fingerprints of Muxiangshunqi pills （MXSQP） and iden- tify their quality by firstly systematically quantified fingerprint method （FSQFM）. The chromatographic fingerprints （CFPs） were determined by reversed-phase HPLC,in which the CFPs containing 60 and 56 co-possessing peaks in the wavelength of 265 and 326 nm respectively when the Hesperidin （HI） peak was marked as the referential peak. Sixteen batches of MXSQPs were identified with the hierarchical clustering analyses by using macro qualitative similarity Sm and macro quantitative similarity Pm as the variables. According to the results of classification,the referential fingerprint （RFP） was synthesized from 11 and 12 batches of MXSQPs in 265 and 326 nm respectively. Taking the RFP for the qualified model, the whole 16 batches of them were evaluated by FSQFM, respectively. According Sm and Pm and α of the two RFPs to calculate the weights as the weighted method, the average method to calculate the mean of Sm and Pf for two groups, the project parameter method to calculate the overall Sm and Pf, respectively, we unified the different chemical information from the dual wavelength fingerprints and identified the authentically quality of 16 batches of MXSQPs, among which 12 batches were completely qualified except the other 4 batches were obviously unqualified. The FSQFM based on the dual wavelength fingerprints excellently performed the overall qualitatively and overall quantitatively determining the Traditional Chinese Medicine （TCM）, which can briefly and effectively identify the authentical quality of TCM.