Study On Material Basis And Quality Standard Improvement Of Si Ji Gan Mao Tablets

Si Ji Gan Mao Tablets is a traditional Chinese medicine composed of nine herbal ingredients,including Perillae Folium,Forsythiae Fructus,Isatidis Folium,Citri Reticulatae Pericarpium,Cyperi Rhizoma,Saposhnikoviae Radix,Schizonepetae Herba,Platycodonis Radix and Licorice.The medication has a mild nature and stable efficacy which used to treat seasonal colds and flu.At present,the current quality standards for Si Ji Gan Mao Tablets cannot fully reflect the overall quality of the medication and guarantee its therapeutic effects.In order to improve the quality standards of the medication,this paper analyzed the chemical composition in Si Ji Gan Mao Tablets,and combined with targeted network pharmacology research to clarify the pharmacological material basis of the medication.A high-performance liquid chromatography method was established to determine the content of its index components.Meanwhile,the fingerprint of Si Ji Gan Mao Tablets was studied.By improving the effectiveness and integrity of the medication,the quality standards of Si Ji Gan Mao Tablets were enhanced to ensure its quality.The main research contents are as follows:1.Chemical composition analysis of Si Ji Gan Mao TabletsBased on UPLC-Q-TOF-MS technology,the chemical composition of Si Ji Gan Mao Tablets was analyzed and identified.A total of 131 compounds were identified,including 5 alkaloids,47 flavonoids,22 triterpenoids and triterpenoid saponins,14 phenylpropanoids,16 phenylethanoid glycosides,8 anthraquinones,and 19 other compounds.The mass spectrometry fragmentation patterns of the main compounds were summarized and the sources of medicinal materials were attributed to the chemical composition,which laid the foundation for the study of pharmacological material basis and the improvement of quality standards.2.Study on pharmacological material basis and mechanism of Si Ji Gan Mao Tablets based on targeted network pharmacologyUsing UPLC-Q-TOF-MS technology,41 blood-derived original components were identified in rat plasma samples after administration of Si Ji Gan Mao Tablets.Combining with targeted network pharmacology,a "herbs-in vivo components-key targets" network of Si Ji Gan Mao Tablets was constructed to elucidate the therapeutic targets and mechanisms of Si Ji Gan Mao Tablets in treating colds.Effective pharmacological ingredients were screened,and the results showed that 11 compounds,including α-cyperone,rosmarinic acid,platycodin D,phillyrin,indirubin,glycyrrhizic acid,prim-o-glucosylcimifugin,4-o-beta-d-gulcosyl-5-o-methylvisamminol,deapioplatycodin D,forsythoside A and hesperidin,played a crucial role in the treatment of colds with Si Ji Gan Mao Tablets and could serve as index components for quality standard research.3.Study on the content determination method of Si Ji Gan Mao TabletsHPLC-UV and HPLC-ELSD methods were respectively established to quantitatively determine 11 index components.To ensure the specificity and reliability of the methods,analytical method validation was performed according to the guidelines of Chinese Pharmacopoeia.The results showed that the methods were suitable for the quality research of Si Ji Gan Mao Tablets.Meanwhile,quantitative analysis of multi-components by single-marker was established,with forsythoside A as the internal reference substance,and the content of rosmarinic acid,α-cyperone,phillyrin,glycyrrhizic acid,hesperidin,prim-oglucosylcimifugin,4-o-beta-d-gulcosyl-5-o-methylvisamminol and indirubin was detected simultaneously in Si Ji Gan Mao Tablets.The results showed that no significant difference with the external standard method,and it could overcome the problem of insufficient reference substance quantity.This method is stable and feasible,and can be used for the determination of index components in Si Ji Gan Mao Tablets.4.Study on fingerprint of Si Ji Gan Mao TabletsHPLC-UV was used to study 20 batches of Si Ji Gan Mao Tablets and a fingerprint was established.In the fingerprint,20 common peaks were identified and assigned.At the same time,it was found that the similarity of the 20 batches medication was between0.9-1.0 with similarity evaluation.The established fingerprint can be used for the overall quality control of Si Ji Gan Mao Tablets.Combined with cluster analysis and principal component analysis,Si Ji Gan Mao Tablets were comprehensively evaluated to further improve the quality standards of Si Ji Gan Mao Tablets and control their quality in all aspects.