| Fufang Xianzhuli Ye is a traditional Chinese patent medicine composed up of Succus Bambusae,Houttuyniae herba,Eriobotrya japonica Lindl,Platycodon grandiflorum,Zingiber officinale Rosc,Pinellia ternata Breit,Peppermint Oil,with the traditional effect of relieving cough and resolving phlegm.The current prescription quality standard only establishes the TLC identification of Pinelliae Rhizoma,Pinelliae Rhizoma and Zingiberis Rhizoma Recens,and lacks qualitative quality control indicators for volatile components such as ginger juice,Houttuynia cordata distillate,and mint oil.When the volatile components in Fufang Xianzhuli Ye were analyzed and identified by GC-MS in this project,it was discovered that the types and contents of volatile components differed significantly between the commercially available preparations and the reference drugs of Fufang Xianzhuli Ye.Therefore,it is necessary to improve its current quality standard.Based on the GCMS volatile component identification of reference drugs of Fufang Xianzhuli Ye,the aim of this study is to improve the quality standard of Fufang Xianzhuli Ye in terms of thin-layer identification,fingerprinting,and multi-component content determination.The thesis is divided into main sections as follows:1.The components identification of Fufang Xianzhuli Ye by GC-MSThe volatile components of the commercial preparations of Fufang Xianzhuli Ye were analyzed by GC-MS,and its quality was evaluated with reference drugs as accompanying control.A total of 64 chemical components were identified,including24 phenols,2 furans,6 alcohols,4 aromatic aldehydes,6 ketones,4 terpenes,12 esters,and 5 other compounds.The main differences between the commercial preparations and reference drugs are phenolic compounds such as phenol and 4-ethylguaiacol.The reference drugs has 8 more phenolic compounds than the commercial preparation,and their relative percentage content is much higher than that of commercially available preparations.2 The TLC identification of Fufang Xianzhuli YeIn this study,the TLC identification of Succus Bambusae was added,and the TLC identification of Platycodon grandiflorum was optimized,based on the current quality standard of Fufang Xianzhuli Ye.The TLC identification method for the two medicinal materials has high specificity,no negative interference,and the results of the durability inspection are in accordance with the regulations.3 The HPLC fingerprint of Fufang Xianzhuli YeThe HPLC fingerprint of 28 batches of Fufang Xianzhuli Ye commercially available preparations was established,16 common peaks were calibrated and 13 characteristic peaks were identified.Compared with reference drugs,all commercially available preparations lacked the No.16 peak(2,6-dimethoxyphenol).The similarity between 9 samples and reference drugs was above 0.75 among 28 samples.Based on the orthogonal partial least squares method-discriminant analysis,5 components with large differences,such as protocatechuic acid and salicylic acid were screened out.4 The content determination of Fufang Xianzhuli YeThe contents of six compounds such as protocatechuic acid,furoic acid,phydroxybenzoic acid,salicylic acid,2,6-dimethoxyphenol and(+)-lyonirenisol-3α-O-β-D-glucopyranoside in Fufang Xianzhuli Ye were determined by HPLC.UHPLCMS was used to determine the content of 9 components,including p-coumaric acid,succinic acid,chlorogenic acid,neochlorogenic acid,cryptochlorogenic acid,5-hydroxymethylfurfural,eugenol,vanillin and protocatechualdehyde.The content differences of these 15 components in commercial preparations and reference drugs were compared.The contents of chlorogenic acid,cryptochlorogenic acid,neochlorogenic acid,p-coumaric acid and succinic acid in most commercial preparations are much higher than those in the reference drugs,and the contents of(+)-lyonirenisol-3α-O-β-D-glucopyranoside are similar to those in the reference drugs,while the contents of other 9 components are much lower than those in the reference drugs. |
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