五波长高效液相色谱指纹图谱和红外指纹图谱联合鉴定复方丹参片质量

目的建立复方丹参片（compound Danshen tablet,CDST）五波长HPLC指纹图谱（HPLC-FP）,测定其红外定量指纹图谱（IR-FP）和一阶导数定量指纹图谱（D-IR-FP）,先把五波长HPLC-FP整合后再与IR-FP进行等权整合用以综合评价其质量。方法采用RP-HPLC法,记录254、265、280、290和326 nm 5个波长下色谱图,以丹酚酸B为参照物峰,确立40个共有指纹峰。以系统指纹定量法全面鉴定其质量,将五波长测得100个指纹图谱按均值法生成对照指纹图谱评价样品质量,分别在每个波长下进行评价,再按方均开方值法整合5个波长下的Sm和Pm及α,并重新评价20批CDST质量。用IR-FP和一阶导数定量指纹图谱基于系统指纹定量法进行质量评级。最后把HPLC-FP和IR-FP等权整合。结果 HPLC-FP和IR-FP等权整合后鉴定20批CDSTs的S9质量（1级）极好;S8,S13和S18质量（2级）很好;S4、S6和S16质量（4级）较好;其余13批质量（3级）均好。结论多波长HPLC-FP结合IR-FP联合鉴定中药质量即能突出紫外吸收化学成分也能表达饱和化学键成分对质量评价的贡献作用。

Combination of 5 wavelength high performance liquid chromatographic fingerprints with infrared spectral fingerprints for the quality of compound Danshen tablets

Objective To establish 5 wavelength HPLC fingerprints and infrared fingerprints of compound Danshen tablets（CDST）,which were merged to comprehensively identify CDST quality by the systematically quantified fingerprint method（SQFM）.Methods The chromatographic fingerprints（CFPs） of 20 batches of CDSTs were determined by reversed-phase HPLC under 254,265,280,290 and 326 nm simultaneously.A total of 40 common peaks were confirmed while the salvianolic acid B peak was chosen as the referential peak.All data were assessed by SQFM.We firstly averaged the 100 fingerprint signals to set up the standard fingerprint and calculated Sm,Pm and α under 5 wavelengths to evaluate the quality of 20 batches of CDSTs.Then we averaged the 20 fingerprint signals to set up the reference fingerprint and calculated Sm,Pmand α under each of the 5 wavelengths to evaluate those of the 20 batches of CDSTs,and finally the 5 parameters were all taken the root of the sum of squaring variable to reassess the quality.The infrared fingerprint and their derivative fingerprints were obtained and assessed by SQFM.We integrated the HPLC-FPs with the IR-FPs by equal weight combination.Results The 20 batches of CDSTs were identified as follows： the quality of S9 was best（grade 1）;that of S8,S13 and S18 was better（grade2）;that of S4,S6 and S16 was fine（grade 4）;that of the others was good（grade 3）.Conclusion The multiple wavelength fingerprints combined with the infrared fingerprints can strongly display both the ultraviolet components and the contribution of the saturated chemicals in quality evaluation.