| Huangying Kechuan Syrup is a compound preparation composed of 9 traditional Chinese medicines:ephedra,almond,gypsum,licorice,platycodon grandiflorum,scutellaria,dandelion,poppy shell and menthol.The results of modern clinical research and pharmacodynamics research showed that this formula can be used in the treatment of cough,asthma and bronchitis caused by wind-heat,wind-cold,lung heat and pulmonary qi deficiency,which has rather remarkable effects.Current quality standards for the product only include the TLC identification of baicalein,almonds,poppy shell,licorice and menthol,and the content determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in ephedra.The standard is relatively simple,unable to fully reflect the quality of the compound and ensure its efficacy.Therefore,this paper determined the basis of pharmacodynamic substances of Huangying Kechuan Syrup through the systematic analysis of its chemical profile in vitro and blood components.On this basis,the quality control index was added,the content determination method of the new index and the fingerprint of Huangying Kechuan Syrup were established by high performance liquid chromatography,and the quality standard of the product was improved.The main research contents of this topic are as follows:1.Analysis of chemical components of Huangying Kechuan SyrupUPLC-Q-TOF-MS~E technology was used to detect the extract of Huangying Kechuan Syrup in positive and negative ion mode.The analysis was assisted by UNIFI software.A total of 93 compounds were identified,including 9 alkaloids,41flavonoids,22 triterpenoids and triterpenoid saponins,13 organic acids,2 cyanogen glycosides and 6 other compounds,the result inference process of main compounds was also summarized.It lays a foundation for the basic research of pharmacodynamic substances and the improvement of quality standards.2.Research on the effective material basis and mechanism of Huangying Kechuan Syrup based on targeted network pharmacology methodThrough the collection of drug-containing plasma from Huangying Kechuan Syrup after intragastric administration,the UPLC-Q-TOF-MS~E technology was used to detect the samples.By comparing the blank and administered plasma and identifying with the assistance of UNIFI software,a total of 25 prototype components were identified.Through targeted network pharmacology research,the"in vivo component-target-disease"network of Huangying Kechuan Syrup was established,the main medicinal ingredients were screened out,and the medicinal mechanism was explained.The results showed that codeine,pseudoephedrine,morphine,glycyrrhizic acid and platycodonin D could play a pharmacodynamic role through sphingolipid signaling pathway,TNF signaling pathway and c AMP signaling pathway in the treatment of cough and asthma by Huangying Kechuan Syrup,and could be used as the index components of quality standard.3.Study on HPLC fingerprint of Huangying Kechuan SyrupA HPLC method for fingerprint analysis of 10 batches of Huangying Kechuan Syrup was established by using high performance liquid chromatography(HPLC).Combined with the results of chemical composition analysis above,18 common peaks were calibrated in the fingerprint,and the similarity was found to be between 0.99-1.The method was stable,feasible and met the requirements.The established fingerprint could be used for the overall quality control of Huangying Kechuan Syrup.Combining cluster analysis and principal component analysis,the peak 9(baicalin)and peak 13(Wogonoside)components that cause differences between batches are used as the indicator components of the quality standard.4.Study on the determination method of the index components of Huangying Kechuan SyrupBased on the results of in vitro and in vivo chemical composition analysis and fingerprint analysis,the quality control components were determined.According to the chemical properties of these components,three content determination methods were established:(1)HPLC-UV method was established to determine the contents of morphine,ephedrine hydrochloride,pseudoephedrine hydrochloride and codeine phosphate.(2)HPLC-ELSD method was established to determine the content of Platycodon D.(3)HPLC-UV method was established to determine the content of baicalin,baicalin and glycyrrhizic acid.Through systematic test and methodological investigation,it was confirmed that the three methods were stable and feasible,and could be used for the quality control of Huangying Kechuan Syrup,which provided the basis for improving the quality standard. |
PDF Full Text Request