Study On The Method Of Quality Control Of Reduning Injection By Chromatogram Fingerprint

Quality control of traditional Chinese medicine injection is one of the core issues of the modernization of traditional Chinese medicine research. In this thesis, a traditional Chinese medicine Reduning injection as the research object, the main components from Reduning injection were analysed and identified by high-performance liquid chromatography (HPLC) and ultra-high pressure liquid chromatography time-of-flight mass spectrometry (UPLC/Q-TOF/MS).The main components also were separated, in order to provide reference for quality control of Reduning injection and extracts from the production process.First of all, the fingerprints of Reduning injection and its intermediates were established by HPLC, and three original materials were also analyzed by HPLC.The chromatographic conditions were C18(250mm×4.6mm,5μm) column, acetonitrile-0.1%formic acid in water as mobile phase gradient elution, detection wavelength238nm, injection volume of20μL, a flow rate of1.0mL/min. Fringerprints of Reduning injection and its intermediates and its medicinal materials were compared and the origination study of the main chromatographic peaks were performed.22common peaks in the Reduning injection are all existed in the raw herbs, and we determined the ascription of21of them in the two intermediates,which indicated that composition of the main components of Reduning injection in the production process were stable. Stability of relative content of components were studied by calculating the relative retention time(RRT) and relative peak area(RPA) of the peaks in the10batches Reduning injection and9batches the intermediates. The RSDs of RRT of the common peaks in injection and the intermediates were less than1.00%and the RSDs of RPA of the common peaks were2.18%～8.48%,1.00%～5.90%,1.17%～6.38%.Using the UPLC-ESI/TOF/MS identified and characterized and the main chemical components from the Reduning injection and raw herbs, and14compounds were identified and characterized by UPLC-ESI/TOF/MS, in addition to the4compounds as the quinic acid derivative.The compounds cis-4-O-caffeoylquinic acid and cis-5-O-caffeoyl-quinic acid were first reported in Reduning injection. The components from intermediates of Lonicera japonica Thunb-Artemisia annua L (Ⅰ) and Gardenia jasminoides Ellis(Ⅱ) were separated, and6compounds of the injection,such as chlorogenic acid and geniposide with purity of more than94%, were extracted from the intermediates.Composition of the components of Reduning injection in production process and stability of the relative contents of the components were studied by the HPLC fingerprints.The method was simple and results was stable and reliable.Using UPLC/Q-TOF/MS identification and characterization the main compounds of Reduning injectionb to analyse the main compounds in injection,qualitatively. Fingerprint and UPLC-MS technique are important method for quality evaluation of modern Chinese medicine injection.