Study On Quality Control Method Of Chinese Medicine Compound Yuquan Pills

Objectives In order to provide a scientific basis for the quality control of Yuquan Pills,the chemical composition of Yuquan Pills was characterized,the high performance liquid chromatography?HPLC?fingerprint was established and the multi-components quantitative analysis was conducted simultaneously.Methods 1 Yuquan Pills exclusive database was built through the literature research.The chemical components of Yuquan Pills were qualitatively analyzed by using the technology of ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry?UPLC-Q-TOF-MS?,and the compounds were identified by comparing the standard products and Yuquan Pills exclusive database.2 The fingerprint of Yuquan Pills was established by using HPLC and similarity evaluation system of traditional Chinese medicine chromatographic fingerprint?2012A?.The common peaks were found and their similarity was evaluated.The quality of Yuquan Pills was studied by cluster analysis and principal component analysis.3 HPLC with double-wavelength switching was used to establish quantitative analysis method for multi-components in Yuquan Pills.Results 1 UPLC-Q-TOF-MS was used to extract and separate the sample of Yuquan Pills.The Waters ACQUITY BEH^TM C18 column?1.7 ?m,2.1×100 mm?was used.The mobile was consisted of 0.2% formic acid-acetonitrile.The sample was collected based on Mass spectrometry^Energy?MS^E? in positive and negative ion modes.Based on Mass Lynx V4.1 data processing platform,standard products and exclusive database,qualitative analysis in Yuquan Pills was carried out.A total of 82 components were identified,including 39 flavonoids,10 saponins,3 nucleosides,3 organic acids,4 terpenes,21 phenylpropanes,1 amino acid,1 aldehyde.puerarin,verbascoside,liquiritin,daidzein,glycyrrhizin and schisandrin were identified by standard products.2 The HPLC with double-wavelength switching analysis was performed on Symmetery C18 column?250mm×4.6 mm,5 ?m?,using acetonitrile and 0.1% phosphoric acid solution as the mobile phase.Fingerprints of Yuquan Pills were established,and verified by the methodology.12 peaks were identified and the similarity of each batch was above 0.9.Six of them were identified by standard products,namely puerarin,verbascoside,liquiritin,daidzein,glycyrrhizic and schisandrin.Through CA and PCA analysis,enterprises should pay more attention to the quality changes of glycyrrhizin and daidzein components in production,so as to more effectively control the quality of drug batches.3 HPLC with double-wavelength switching was used to determine the content of 6 major chemical components in Yuquan Pills,including puerarin,verbascoside,liquiritin,daidzein,glycyrrhizin and schisandrin,and verified by the methodology.Conclusions UPLC-Q-TOF-MS and HPLC were used to establish qualitative and quantitative analysis method for Yuquan Pills.The method is efficient,convenient and repeatable,which can provide methodological reference for the quality control of Yuquan Pills.Figure 23;Table 27;Reference 94...