| 1.Objective:Sini decoction(SND)is a Traditional Chinese medicine(TCM)Prescription and is a representative prescription for recuperating depleted Yang in Treatise on Febrile Diseases.Sini decoction has been registered in the Chinese Pharmacopoeia.The studies in the active components alignment of the sini decoction are less,so we can’t control the quality of it from the aspect of effective substances.Under the guidance of the traditional Chinese medicine compatibility theory and the active components alignment theory,the objective of this research is studying the active components alignment(ACA)of the classical compound sini decoction,pinpointing the corresponding relation between the ACA of SND and compatibility,dosage and preparation.This research can provide experimental support for exploring the relationship between the "compatibility,dosage and preparation-the ACA" of traditional Chinese medicine compound,provide a scientific basis for establishing the quality evaluation system of the corresponding ACA of the Sini Decoction,and lay the foundation of the development of science of TCM active components alignment and component identification.2.Methods and contents:In order to study the ACA of the sini decoction,we choose the sini decoction as the research object.By means of literature searches,sort the chemical composition and pharmacological activity with corresponding functions and indications of the SND and its compatibility pieces.Screen active ingredients as reference materials,the active ingredients must conform to the characteristics of the dosage form,have clear pharmacological actions,and correspond to the efficacy of sini decoction.Compare the differences between the Aconiti Lateralis Radix Praeparata(Fuzi),Glycyrrhizae Radix et Rhizoma(Gancao)and Zingiberis Rhizoma(Ganjiang)prescriptions with the different single herbs,compatibility pieces or proportion,and prepare test samples according to the traditional method.Use HPLC-DAD wavelength multiplexing method to determinate the contents of ten different active components:6-Gingerol,8-Gingerol,6-Shogaol,liquiritin,liquiritigenin,isoliquiritin,isoliquiritigenin,glycyrrhizic acid,benzoylmesaconine and benzoylhypaconine.Analyze the influences of multiple factors on the ACA’ contents and proportion of SND.The research contents include:1)the correlation analysis of the AC A of SND and its compatibility pieces,2)the influences of multiple factors on ACA of SND:①the analysis of the influence of the compatibility pieces on the ACA of SND;②the analysis of the influence of changing the dosage of Aconiti Lateralis Radix Praeparata(Fuzi)on ACA of SND;③the analysis of the influence of changing the dosage of Glycyrrhizae Radix et Rhizoma(Gancao)on ACA of SND;④the analysis of the influence of changing the dosage of Zingiberis Rhizoma(Ganjiang)on ACA of SND;⑤the analysis of the influence of different preparation methods on ACA of SND.3.Results:(1)the correlation analysis of the ACA of SND and its compatibility piecesAfter the compatibility of raw Fuzi,honey-fried Gancao and ganjiang,the ACA of single herb are significantly changed(P<0.05).The ACA of single raw Fuzi decoction were(mg/g):benzoylmesaconine(0.425±0.022)-benzoylhypaconine(0.310±0.012).Compared with the ACA of raw Fuzi in SND,its total contents of ACA decreased by 22.72%.The ACA of single honey-fried Gancao decoction were(mg/g):liquiritin(8.872±0.21)-isoliquiritin(0.883±0.02)-liquiritigenin(0.573±0.011)-isoliquiritigenin(0.153±0.002)-glycyrrhizic acid(10.556±0.56).Compared with the ACA of honey-fried Gancao in SND,its total contents of ACA decreased by 42.50%.The ACA of single Ganjiang decoction were(mg/g):(6-gingerol)(1.128±0.012)-(8-Gingerol)(0.152±0.002)-(6-Shogaol)(0.112±0.003).Compared with the ACA of Ganjiang in SND,its total contents of ACA increased by 9.91%.The ACA of SND were:(mg/g):liquiritin(4.198±0.22)-isoliquiritin(0.517±0.01)-liquiritigenin(0.220±0.006)isoliquiritigenin(0.061±0.002)-glycyrrhizic acid(7.120±0.37)-(6-gingerol)(1.271±0.07)(8-Gingerol)(0.153±0.002)-(6-Shogaol)(0.105±0.003)-benzoylmesaconine(0.352±0.034)benzoylhypaconine(0.215±0.016).(2)The influences of multiple factors on ACA of SND1)Analysis of the influence of compatibility pieces on ACA of SND.When compatibility dosage is fixed at raw Fuzi:honey-fried Gancao:Ganjiang 15g:6g:9g,changed the compatibility pieces,the ACA of raw Fuzi,honey-fried Gancao,Ganjiang and SND were changed significantly(P<0.05),where in the variation of the total amount of ACA were:raw Fuzi:honey-fried Gancao:Ganjiang>baked Fuzi:honey-fried Gancao:Ganjian>raw Fuzi:raw Gancao:Ganjiang>raw Fuzi:honey-fried Gancao:baked Ganjiang>raw Fuzi:honey-fried Gancao:raw Ganjiang>Fuzi(cooked with salt,dyed with dyes):honey-fried Gancao:Ganjiang>Fuzi(cooked with salt):honey-fried Gancao:Ganjiang.2)Analysis of the influence of compatibility dosage on ACA of SND.①Compatible dosage of single factor raw Fuzi changed,the ACA of raw Fuzi,Ganjiang,honey-fried Gancao and the total content were changed significantly(P<0.05).When compatible dose of honey-fried Gancao and Ganjiang fixed 6g-9g unchanged,dosage of raw Fuzi were 6g,9g,12g,15g,18g,21g,24g,the total content of ACA in raw Fuzi and ganjiang increased and the total content of ACA in honey fried Gancao decreased.The total content of ACA ratio of raw Fuzi,honey-fried Gancao and Ganjiang were changed from 1:35:5 to 1:4:1.The total content of ACA of the SND were(mg/g):4.574±0.055,4.021±0.023,3.559±0.01,3.181±0.012,2.868±0.031,2.644±0.048,2.456±0.018.②Compatible dosage of single factor honey-feied Gancao changed,the ACA of honey-fried Gancao,raw Fuzi,Ganjiang and the total content were changed significantly(P<0.05).When compatible dosage of raw Fuzi and Ganjiang fixed 15g-9g unchanged,dosage of honey-fried Gancao were 0.3g,1g,3g,6g,9g,12g,15g,the total content of ACA in ganjiang decreased and in honey fried Gancao increased.The total content of ACA in raw Fuzi first increased and the decreased.The total content of ACA ratio of raw Fuzi,honey-fried Gancao and Ganjiang were changed from 1:0.05:2 to 1:28:1.5.The total content of ACA of the SND were(mg/g):0.971±0.002,1.035±0.018,1.576±0.013,3.154±0.032,4.072±0.024,5.033±0.01,5.949±0.023.③Compatible dosage of single factor Ganjiang changed,the ACA of honey-fried Gancao,raw Fuzi,Ganjiang and the total content were changed significantly(P<0.05).Compatible dosage of raw Fuzi and honey-fried Gancao fixed 15g-6g unchanged,when dosage of Ganjiang were 1g,3g,6g,9g,12g,15g,18g,the total content of ACA in ganjiang increased and in honey fried Gancao decreased.The total content of ACA in raw Fuzi first increased and the decreased.The total content of ACA ratio of raw Fuzi,honey-fried Gancao and Ganjiang were changed from 1:14:0.11 to 1:7:4.The total content of ACA of the SND were(mg/g):4.176±0.023,3.752±0.013,3.359±0.034,3.163±0.029,2.855±0.064,2.494±0.012,2.339±0.014.3)Analysis of the influence of different preparation methods on ACA of SND.The AC A of SND obtained by Chinese Pharmacopoeia(2015 version)method were:(mg/g):liquiritin(3.569±0.004)-isoliquiritin(0.523±0.002)-liquiritigenin(0.276±0.001)isoliquiritigenin(0.037±0.001)-glycyrrhizicacid(4.127±0.02)-(6-gingerol)(0.801±0.003)-(8-Gi ngerol)(0.068±0.002)-(6-Shogaol)(0.038±0.001)-benzoylmesaconine(0.302±0.004)-benzoylhypaconine(0.292±0.002).Compared with traditional decoction(P<0.05),the content of ACA of ganjiang decreased by 28.75%;raw Fuzi’s decreased by 15.49%and honey-fried Gancao’s decreased by 25.50%.4.Summary and discussion(1)Summary1)the correlation analysis of the AC A of SND and its compatibility pieces①The ACA of SND for restoring yang were:(mg/g):liquiritin(4.198±0.22)-isoliquiritin(0.517±0.01)-liquiritigenin(0.220±0.006)-isoliquiritigenin(0.061±0.002)-glycyrrhizic acid(7.120±0.37)-(6-gingerol)(1.271±0.07)-(8-Gingerol)(0.153±0.002)-(6-Shogaol)(0.105±0.003)-benzoylmesaconine(0.352±0.034)-benzoylhypaconine(0.215±0.016).The result shows that if remove any compatibility pieces will have a significant impact on ACA of SND(P<0.05).②The ACA of single raw Fuzi decoction were(mg/g):benzoylmesaconine(0.425±0.022)-benzoylhypaconine(0.310±0.012).It is significantly different from the ACA of raw Fuzi in SND(P<0.05).The ACA of raw Fuzi for restoring yang is related to compatibility of honey-fried Gancao and ganjiang.The efficacy of raw Fuzi for restoring yang is achieved through medical compatibility.③The ACA of single honey-fried Gancao decoction were(mg/g):liquiritin(8.872±0.21)-isoliquiritin(0.883±0.02)-liquiritigenin(0.573±0.011)-isoliquiritigenin(0.153±0.002)-glycyrrhizic acid(10.556±0.56).The ACA of honey-fried Gancao for restoring yang is related to compatibility of raw Fuzi and ganjiang.The efficacy of honey-fried Gancao for restoring yang is achieved through medical compatibility.④The ACA of single Ganjiang decoction were(mg/g):(6-gingerol)(1.128±0.012)(8-Gingerol)(0.152±0.002)-(6-Shogaol)(0.112±0.003),The ACA of Ganjiang for restoring yang is related to compatibility of raw Fuzi and honey-fried Gancao.The efficacy of Ganjiang for restoring yang is achieved through medical compatibility.2)The influences of multiple factors on AC A of SND①Compatibility pieces:As the compatibility pieces in SND is changed,its ACA changed accordingly.The compatibility of SND in Treatise on Febrile Diseases is scientific.Different Chinese traditional medicine processed products derived from the same Chinese medicine are different drugs.Do not change the compatibility pieces in prescriptions at will.②Compatibility dosage:As the compatibility dosage in SND is changed,its ACA changed accordingly.The dosage of Compatibility pieces in SND in Treatise on Febrile Diseases is scientific.Do not change the compatibility dosage in prescriptions at will.③Preparation methods:As the Preparation method of SND is changed,its ACA changed accordingly.The preparation method of SND in Treatise on Febrile Diseases is scientific.The ACA of SND for restoring yang is related to compatibility pieces,compatibility dosage,and preparation method and so on.The ACA of SND is coincided with clinical curative effect and it’s the primary standard substance for SND quality standard.And it is the intermediate of active components alignment new drugs for restoring yang.(2)Discussion:1)the correlation analysis of the ACA of SND and its compatibility piecesThe compatibility have significant impact on the Content and proportion of ACA.The clinical curative effect of SND is determined together by raw Fuizi,honey-fried Gancao and Ganjiang.If remove any compatibility pieces in SND will have a significant impact on its ACA,which shows that the combination of ACA in decoction are following the natural laws.After compatibility with each other,the ACA of raw Fuzi,honey-fried Gancao and Ganjiang are significantly changed.Compatibility has changed the ACA of single traditional Chinese medicine.The efficacy of single traditional Chinese medicine is achieved through medical compatibility.2)The influences of multiple factors on ACA of SNDCompatibility has significant impact on the content,proportion and the total content of ACA of the SND.The compatibility pieces play a part in the ACA,after the compatibility of Fuzi,Gancao and Ganjiang,the content and proportion of their ACA changed significantly,this proved that ACA of Chinese medicine compound are not a superposition of ACA of its compatibility pieces,there exists physical or chemical interaction between its compatibility constituent,and the interaction changed the dissolution of ACA.When the compatibility proportions were the same and the compatibility pieces were different,the content of ACA was different.When the compatibility pieces were raw Fuzi,honey-fried Gancao and Ganjiang,content of ACA was the highest,proved the science of classical prescription.When compatibility pieces were the same,changed the compatibility doses and proportions,the content of ACA were also different,there is one-to-one relationship between ACA and compatibility proportion.The clinical efficacy will change when ACA is not the same,suggesting that we should pay attention to varieties,processed products and doses of compatibility pieces,and be cautious when prescription and dispensing.When compatibility pieces and proportion are certain,the ACA of Chinese medicine compound is also certain,proving that using the ACA with specific content and proportion of the SND as reference materials for its evaluation and quality control on clinic is scientific.3)Determination methodThis research established the HPLC-DAD multi-wavelength components determination method of 10 kinds of ACA of the SND and its compatibility pieces(liquiritin,liquiritigenin,isoliquiritin,isoliquiritigenin,glycyrrhizic acid,6-Gingerol,8-Gingerol,6-Shogaol,benzoylmesaconine and benzoylhypaconine).The method is easy to operate,has good reproducibility and specificity,and has scientific and feasible when used for the quality control of the SND. |
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