Improvement Study Of Quality Standard Of Qige Granules

Qige Granules is composed of eight herbs of Astragali radix,Puerariae lobatae radix,Paeoniae radi.x alba,Ligusticum chuanxiong,Cinnamomi Ralumiis,Curcumae longae rhizome,Clematidis radix et rhizome and Chrysanthemi flos.It is used for neck,shoulder and back pain,et,which were caused by cervical spodylotic radiculopathy(CS R).At present,due to the fact that the existing quality standard control components of the Qige Granules are relatively simple,it is necessary to carry out the researches on the improvement of quality standard.In this study,the chemical constituents and the main absorbed components of Qige Granules were analyzed by liquid chromatography coupled with mass spectrometry technology(LC-MS).The index components of improving the quality standards of Qige Granules were idenfied by the study results of chemical constituents and absorbed components in rats.The main contents are as follows:1.Qualitative analysis of the chemical components of Qige GranulesThe chemical constituents of Qige Granules were analyzed systematically by RRLC-Q-TOF-MS/MS.First,according to the exact molecular weight obtained by MS,82 poten tial compounds were preliminarily inferred.A total of 78 compounds were successfully identified from Qige Granules on the basis of the reference comparison,secondary mass spectrometry fragmentation and literature data for structural identification,including 46 flavonoids,11 organic acids,11 phenylpropanoids and their dimers and 10 saponins.2.Study on the absorbed components in rats after administration of Qige GranulesRat plasma samples were analyzed by RRLC-Q-TOF-MS/MS technique after single intragastric administration.A total of 31 compounds were detected in rat plasma samples by comparing with the results blank plasma and chemical constituents,including 8 prototype compounds(5 flavonoids,1 saponin,2 phenylpropanoids)and 23 possible metabolites(Glucuronic acid,sulfuric acid and amino acid combinations).3.Study on the quality standard promotion of Qige Granules(1)Study of Thin-layer chromatography(TLC)In this study,the preparation of the solution and the developer in the TLC of Puerariae lobatae radix,Paeoniae radix alba,and Ligusticum chuanxiong were optimized,and Cinnamomi Ralumus of TLC was established.The Investigation results of different temperature,humidity and thin plates showed that the established methods were stable and reliable.And the results of 10 batch experiments showed that the method could be used for quality control of Qige Granules.(2)Study of determinationCombined the results of the chemical composition spectrum and blood composition spectrum of Qige Granules,3’-hydroxy puerarin,puerarin,3’-methoxy puerarin,puerarin glucoside and daidzin were used as the marker components.A HPLC method was established for determination of 5 compounds in Qige Granules.The methodological study showed good-precision,repeatability and accuracy,which could be used for the quality evaluation of Qige Granules.(3)Study of the HPLC FingerprintA method was established for fingerprint by HPLC.A total of 28 common peaks were cloned with fingerprints of 17 batches of samples and were identified by prescription medicinal materials and chemical composition spectrum study results.At the same time,the main components affecting the quality of Qige Granules were analyzed by Principal component analysis(PCA)and Orthogonal partial least squares discriminant analysis(OPLS-DA),including ligustilide,3’-methoxydaidzin,ferulic acid,kakkalide,3’-hydroxy puerarin,Daidzein-6-C-glucoside and a unknown component.The methodological study showed good precision and repeatability,and which could be used for the fingerprint of evaluation of Qige Granules.