| Traditional Chinese medicine(TCM)quality ensures the security and effect of clinical use,but the component of Chinese medicine formulae is complex and the effective composition is not explicit.So choosing a single index component as the standard of quality control can not fully reflect the medicine quality.The TCM fingerprint technology can provide abundant information and has strong characteristic,which can reflect the whole characteristics of the complicated components,and has been applied to the quality control of TCM.Qingqing granule(QQG)is the Chinese medicine formulae that consists of 9 medicinal materials including Coptidis Rhizoma(CR),Scutellariae Radix(SR),Paeoniae Radix Alba(PRA),Glycyrrhizae Radix et Rhizoma(GRR),Zingiberis Rhizoma(ZR),Aucklandiae Radix(AR)etc.HPLC-DAD/MS method was used to establish the fingerprint quality evaluation system of QQG on this study.The HPLC-DAD fingerprints of herbs,herbal extract,intermediate and granule were established,and the ingredients were analyzed and compared in 4 processes respectively combined with MS.So that the quality of QQG was controlled comprehensively from the raw materials to production process to granule products,which provide a scientific reference for the safety and effect of clinical medication.The specific research contents were as follows.1.To establish the HPLC-DAD fingerprints of CR,herbal extract,intermediate and granule.9 common peaks were marked respectively in herbs and herbal extract that the retention times were corresponding.Moreover.12 corresponding common peaks were marked in intermediate and granule respectively,in which 8 peaks belonged to CR.8 components were identified both in herbs and herbal extract combined with MS,and it were identified in intermediate and granule.The results indicated that the main ingredients of CR were retained in the finished granule.2.To establish the HPLC-DAD fingerprints of SR,herbal extract,intermediate and granule.14 common peaks were marked respectively in herbs and herbal extract that the retention times were corresponding.Furthermore,25 corresponding common peaks were marked in intennediate and granule respectively,in which 12 peaks belonged to SR.14 components were identified both in herbs and herbal extract in combination with MS,and 12 compositions were identified both in intermediate and granule that corresponding to herbs.The results illustrated that the main ingredients of SR were retained in the finished granule.3.To establish the HPLC-DAD fingerprints of PRA,herbal extract intermediate and granule.15 common peaks were marked in herbs,14 corresponding common peaks were marked in herbal extract.In addition,23 corresponding common peaks were marked in intermediate and granule respectively,in which 2 peaks belonged to PRA.13 components were identified both in herbs and herbal extract combined with MS,and 10 compositions were found both in intermediate and granule that corresponding to herbs and herbal extract.8 of which(1 unknown component of PRA)were not directly detected in intermediate and granule due to the low content.4.To establish the HPLC-DAD fingerprints of GRR.herbal extract,intermediate and granule.24 common peaks were marked respectively in herbs and herbal extract that the retention times were corresponding.Moreover,32 corresponding common peaks were marked in intermediate and granule respectively,in which 14 peaks belonged to GRR.22 components were identified both in herbs and herbal extract in combination with MS,and 18 compositions were found both in intermediate and granule that corresponding to herbs,4 of which(1 unknown component of GRR)were not directly detected in intermediate and granule due to the low content.5.To establish the HPLC-DAD fingerprints of ZR,herbal extract,intermediate and granule.10 common peaks were marked in herbs,6 corresponding common peaks were marked in herbal extract.Furthermore,20 corresponding common peaks were marked in intermediate and granule respectively,in which 1 peaks belonged to ZR.8 components were identified in herbs and 6 corresponding components were identified in herbal extract in combination with MS,and 2 compositions were identified both in intermediate and granule that corresponding to herbs and herbal extract,1 of which were not directly detected in intermediate and granule due to the low content.6.To establish the HPLC-DAD fingerprints of AR,herbal extract and granule.13 common peaks were marked in herbs,9 corresponding common peaks were marked in herbal extract.In addition,24 common peaks were marked in granule,in which 1 peaks belonged to AR.7 components were identified both in herbs and herbal extract in combination with MS,and 2 compositions were identified in granule that corresponding to herbs and herbal extract.1 of which were not directly detected in granule due to the low content.The results indicated that the volatile oil could increase the content of the characteristic components of AR in the finished granules.We research and establish the fingerprint quality evaluation system of QQG by HPLC-DAD/MS on this experiment,and the method is accurate and reproducible.The sensitivity of MS is higher,it can further provide specific information of the compounds as a supplementary analysis method,which will offer more comprehensive and scientific reference for the quality control and evaluation of QQG. |
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