Study On Quality Control And Compatibility Of Huangqi Shengmai Decoction

Huangqi Shengmai Decoction is composed of Astragalus membranaceus,Codonopsis pilosula,Schisandra chinensis,Ophiopogon japonicus.It has the effects of nourishing qi and nourishing yin,nourishing the heart and nourishing the lungs.It is mainly used to treat patients with coronary heart disease,which is due to deficiency of both qi and yin,but with palpitations and shortness of breath.In recent years,Huangqi Shengmai Decoction has been widely used clinically to treat viral myocarditis,chronic heart failure,diabetic nephropathy and other diseases,However,the compatibility law and compatibility mechanism of Huangqi Shengmai Decoction are still unclear,and in the "Medicine Standards of the Ministry of Health of the People’s Republic of China·Prescriptions of Traditional Chinese Medicine(Volume 16)",only the relative density of Huangqi Shengmai Decoction is measured,but not the qualitative and quantitative research of its active ingredients,so cannot reflect the quality of the preparation as a whole.Therefore,it is necessary to clarify the effective material basis of the compound prescription,and then improve the quality control level,and clarifying the compatibility law.This project is based on UPLC-Q-TOF/MS to establish the fingerprint of Huangqi Shengmai Decoction,and identify and analyze its chemical components.UPLC-PDA is used to determine the content of various components of Huangqi Shengmai Decoction.Based on UPLC-Q-TOF/MS to establish the in vivo and in vitro analysis methods of Astragalus membranaceus-Codonopsis pilosula and Schisandra chinensis-Ophiopogon japonicus in Huangqi Shengmai Decoction,the chemical components changes before and after in vitro compatibility were investigated,identification and analysis of the chemical components of the drug pairs in rat serum,urine and feces.It is more practical to study the effective material basis from the blood components and metabolites.The main research methods and results are as follows:(1)UPLC-Q-TOF/MS was used to establish the quality control method of Huangqi Shengmai Decoction,and the fingerprints of 10 batches of Huangqi Shengmai Decoction were established,and the similarity evaluation was carried out.The experimental method meets the requirements of the establishment of fingerprint atlas.In order to clarify the chemical components in Huangqi Shengmai Decoction,UPLC-Q-TOF/MS was used to identify and analyze the chemical components in Huangqi Shengmai Decoction.A total of thirty-eight chemical components,including Formononetin,Lobetyolin,Schisandrin A,and Ophiopogonin D have been identified.(2)Taking Huangqi Shengmai Decoction as the research object,using UPLC-PDA to establish a research method for the content determination of Huangqi Shengmai Decoction,and methodological investigation and content determination of the three active ingredients(Formononetin,Schisandrin,Schisandrin A)in Huangqi Shengmai Decoction were carried out.The results of the methodological investigation all met the standards of content determination.The average contents of the three components in the three batches of samples were 0.0543 mg/mL,0.4463 mg/mL,0.2691 mg/mL,respectively.This research provides experimental basis for the quality control research of Huangqi Shengmai Decoction.(3)Taking the Astragalus membranaceus-Codonopsis pilosula and Schisandra chinensisOphiopogon japonicus in Huangqi Shengmai Decoction as the research object,UPLC-QTOF/MS was used to establish the research methods of Astragalus membranaceus,Codonopsis pilosula drug pair and Schisandra chinensis,Ophiopogon japonicus drug pair in vitro.A total of 25 chemical components were identified in the mixed decoction and single decoction of Astragalus membranaceus and Codonopsis pilosula,and 26 chemical components were identified in the mixed decoction and single decoction of Schisandra chinensis and Ophiopogon japonicus.By using PCA and PLS-DA analysis to find out the chemical components with significant changes before and after the compatibility.After the compatibility of Astragalus membranaceus and Codonopsis pilosula,the content of components increased,including Calycosin and Acetytastragalosid I in Astragalus membranaceus,tangshenoside V,pentacarboxyl-glucose-hexanolside and Lobetyolin in Codonopsis pilosula.After the compatibility of Schisandra chinensis and Ophiopogon japonicus,the components with increased content are Schisantherin A in Schisandra chinensis and Ophiopogonin D in Ophiopogon japonicus.The decreased content is Gomisin G in Schisandra chinensis and methylophiopogonanone B in Ophiopogon japonicus.(4)The chemical components in rat serum,urine,and feces after the compatibility of Astragalus membranaceus-Codonopsis pilosula and Schisandra chinensis-Ophiopogon japonicus are identified by UPLC-Q-TOF/MS technology.A total of 10 chemical components were identified in serum samples,28 in urine samples and 15 in feces samples from the mixed and single decoction of Astragalus membranaceus-Codonopsis pilosula.Before and after the compatibility of Astragalus membranaceus and Codonopsis pilosula,the rats were given intragastric administration respectively,and there were 11 kinds of body components changed.A total of 12 chemical components were identified in serum samples,14 in urine samples and 20 in feces samples from the mixed and single decoction of Schisandra chinensis and Ophiopogon japonicus.Before and after the compatibility of Schisandra chinensis and Ophiopogon japonicus,the rats were given intragastric administration respectively,and there were 7 kinds of body components changed.