Study On Chemical Composition And Fingerprint Of Huoxuezhitong Capsule

Huoxue Zhitong Capsule is a variety of OTC produced by Jiangxi Bai Shen Chang Nuo Pharmaceutical.The prescription was composed of Angelicae Sinensis Radix,Parmx notoginseng(Burk),Boszvellia carterii Bird,Eupolyphag a sinensis Walker,borneolum syntheticum and Pyritum.It has the functions of promoting blood circulation,removing blood stasis,swelling and relieving pain.It is mainly used for the treatment of acute and chronic soft tissue injuries.The current standard of Huoxue Zhitong Capsule was published in the first volume of 2015 edition of Chinese Pharmacopoeia.The chemical composition of this product is complex,and the chemical composition research only stays at the level of single medicinal material chemical composition research.There is no report on the basic system research of chemical substances of Huoxue Zhitong Capsule.The quality standard is simple,which can not reflect the characteristics of multi-component overall efficacy of traditional Chinese medicine,and seriously restricts the market expansion of this product,clinical application and internationalization process.In this paper,the material basis and quality standard of Huoxuezhitong capsule were systematically studied,including the following aspects:(1)In view of the non-volatile chemical components in the formula,using UPLC-Q / TOF-MS technology to collect the samples of Huoxuezhitong capsule and the information of single medicinal materials,a total of 113 chemical components were identified,including 40 saponins,33 triterpenoids,22 phthalides and 13 organic acids,and the corresponding cracking rules of each component were summarized with examples.The source of the compound was identified by the method of controlled peak chromatogram.Among 113 chromatographic peaks.There are 42 peaks come from Parmx notoginseng(Burk)and 38 peaks of Angelicae Sinensis Radix,and 33 peaks come from Boszvellia carterii Bird,and 1 peaks come from Eupolyphag a sinensis Walker.Provide basis for improving quality control standard.(2)By using GC-MS,hp-5ms quartz capillary column(30 m × 250 ? m × 0.25 ? m),programmed temperature rise,split ratio: 5:1,EI source electronic energy: 70 ev,quality scanning range: 15-550 amu and other methods to collect the information of samples and single medicinal materials,69 components were identified and identified in Huoxuezhitong capsule through retrieval of standard mass spectrometry library,The main components were isoborneol(26.52%),borneol(25.32%),ligustilide(10.61%),(+)-ramulene(6.89%)and 3,14,15-trimethoxyprogesterone-16-ene-20-one(5.06%).According to the data of GC-MS,19 components are from Angelicae Sinensis Radix,17 from Boszvellia carterii Bird,and 2 from borneolum syntheticum.(3)By using UPLC-Q / TOF-MS technology,the migrating components in the blood of rats were compared and identified after the administration of Huoxue Zhitong Capsule by gavage,and the incoming components and their possible metabolic rules were analyzed.Through the comparison and analysis of the liquid quality data of Huoxuezhitong capsule and the plasma samples,26 absorption prototype drug components were identified in the plasma of rats which were given Huoxuezhitong capsule.Compared with the theoretical value,the error of the accurate mass number of TOF-MS is less than 10 ppm.Through the quality defect filter(MDF)technology in matabolynxtm software,the metabolites were effectively searched and screened in the complex biological matrix.Through the selection of ion signals only appearing in the plasma samples of drug administration,21 metabolites were finally identified in the rat plasma.The main metabolic pathways were hydroxylation,isomerization,glucuronization and sulfation.From the point of view of the original component of Huoxue Zhitong Capsule-the blood entering component-the metabolism component,the main chemical substances group and the chemical substance basis of Huoxue Zhitong Capsule were clarified,which provided the research basis for the further study of the mechanism of action.(4)Based on the characterization and identification of the chemical group of Huoxuezhitong capsule and the study of the blood transfiguration components,using the ultra-high performance liquid chromatography(UPLC),the waters equity UPLC BEH C18(2.1 × 100 m m,1.7 ? m)column,the detection wavelength is 203 nm,the fingerprint of Huoxuezhitong capsule is established,combined with the similarity evaluation system of traditional Chinese medicine fingerprint(2012 version)the similarity of 10 batches of Huoxue Zhitong capsules was evaluated.The similarity results of 10 batches were all greater than 0.984.A total of 13 common peaks were determined and they were attributed to each single medicinal material.Through the comparison of standards,ferulic acid,Ginsenoside Rg1,ginsenoside Rb1,ligustilide,11-keto-?-boswellic acid and 11-keto-?-acetyl-boswellic acid can be determined.In conclusion,this study first used UPLC-Q / TOF-MS to study the non-volatile chemical components of Huoxue Zhitong Capsule,then used GC-MS technology to characterize and identify the volatile components in the prescription,and defined the chemical basis of the preparation.On this basis,the serum drug method was used to compare and identify the main blood transitional components of Huoxue Zhitong Capsule,and clarified the blood intake On the basis of chemical substance group and blood entering substance group,the quality control method of Huoxue Zhitong Capsule based on holographic chemical contour was established,and the fingerprint spectrum and pattern recognition of multiple batches of Huoxue Zhitong Capsule were studied by the established method,and the standard fingerprint of Huoxue Zhitong Capsule was established and the fingerprint peak was carried out Identification and attribution,to ensure its quality stability and uniformity,safety and effectiveness to lay the foundation.