Improvement Study Of Quality Standard Of Glycosides And Liuwei Dihuang Gantang Tablets

Rhmanniae decoction of six ingredients is a classic prescription of traditional Chinese medicine to nourish Yin and kidney.It is composed of Rehmannia Radix Praeparata,liquor cornus,Mutan Cortex,Dioscoreae Rhizoma,Poria cocos and Alismatis Rhizoma.Liuwei Dihuang Gantang Tablets are based on a large number of basic research and development of Liuwei Dihuang Decoction for the treatment of climacteric syndrome.After the study of Liuwei Dihuang Decoction,the active components that play immunomodulatory role were traced and separated.After two steps of alcohol precipitation and two steps of chromatography,the glycosides,polysaccharides and oligosaccharides were obtained.On this basis,the Liuwei dihuang gantang tablets were obtained.At present,due to the fact that the existing quality standard control components of the Liuwei dihuang gantang tablets are relatively single,it is difficult to reflect quality status of the preparations,and it is necessary to carry out the research on the improvement of quality standard.In this study,the chemical constituents and the main absorbed component of Liuwei dihuang gantang tablets were analyzed by liquid chromatography coupled with mass spectrometry technology(LC-MS).The index components of improving the quality standards of Liuwei dihuang gantang tablets were defined by the study results of chemical constituents and absorbed components in rats.The specific research contents are as follow:1.Qualitative analysis of the chemical components of Liuwei dihuang gantang tabletsThe chemical constituents of Liuwei dihuang gantang tablets were analyzed systematically by UPLC-Q-TOF-MS.First,according to the exact molecular weight obtained by MS,possible compounds were preliminarily inferred,A total of 71 compounds were successfully identified from Liuwei dihuang gantang tables on the basis of reference comparison,secondary mass spectronmetry fragmentation and literature data from structural identification,The chemical constituents of Liuwei dihuang gantang tablets were established.2.Study on the absorbed components in rats after administration of Liuwei dihuang gantang tabletsRat plasma samples were analyzed by UPLC-Q-TOF-MS technique after single intragastric administration.A total of 3 prototype compounds with high content were detected in rat plasma samples by comparing with the results blank plasma and chemical constituents,namely morroniside,loganin and paeoniflorin.3.Study on the quality standard promotion of Liuwei dihuang gantang tablets(1)Study of determinationCombined the results of the chemical composition spectrum and blood composition spectrum of Liuwei dihuang gantang tablets,5-hydroxymethyl furaldehyde,morroniside,paenonlide,loganin and paeoniflorin were used as marker components.A HPLC method was established for determination of 5 compounds in Liuwei dihuang gantang tablets.The methodological study result showed good linearity,precision,stability,epeatability and accuracy,and could be used for the quality evaluation of Liuwei dihuang gantang tablets.(2)Study of the HPLC FingerprintA method was established for Fingerprint by HPLC.A total of 8 common peaks were cloned with fingerprints of 10 batches of samples and were identified by prescription medicinal matericals and chemical composition spectrum study results.THE methodological study result showed good precision,stability and repeatability,and could be used for the fingerprint of evaluation of Liuwei dihuang gantang tablets.