| Objective: Chaihu Guizhi Decoction comes from Zhang Zhongjing's "Treatise on Febrile Diseases",which is composed of Bupleurum,Guizhi,Astragalus,Peony,Licorice,Pinellia,Ginseng,Jujube,and Ginger Jiuwei.According to "Jun,Chen,Zuo,Zhi",It is mainly suitable for fever,aversion to cold and limb pain caused by sun deficiency and yang.It is effective in the treatment of various diseases in clinical practice,so it is highly necessary to make it into granules.Based on the content of the active ingredients of the various herbs and the yield of dry extract,optimize the preparation process of Chaihu Guizhi Granules,establish the preparation system of Jingfang Granules,preliminarily explore its quality standards,and establish a firewood based on LC-QQQ-MS technology.The research method of pharmacokinetics of Chaihuguizhi granules.Methods: 1.To establish a method for the determination of six active constituents(saikosaponin A,cinnamaldehyde,baicalin,paeoniflorin,baicalin and glycyrrhizin)in the middle of Chaihu Guizhi Decoction,and to study the method.Conduct a single factor study to determine the factors and levels of orthogonal test design.Finally,the amount of water added,the time of extraction,and the number of boiling times are taken as the factors,and the content of ingredients and the yield of dry extract are added with different weights as indicators to establish L9(34).)Orthogonal test to optimize the process.2.Optimize the molding process of the preparation,select the molding rate,particle melting,angle of repose and particle as the index,and gradually optimize the type,proportion and ratio of the best excipients,and establish the molding process of Chaihu Guizhi pellets.3.Qualitative identification of Bupleurum,Guizhi,Astragalus,Radix Glycyrrhizae and Radix Paeoniae Alba by TLC;HPLC method for determination of baicalin and paeoniflorin in Chaihu Guizhi Decoction;HPLC-QQQ-MS method for determination of ginsenoside A method of Rb1,ginsenoside Re,and ginsenoside Rg1.4.Establishment of 15 components of Chaihu Guizhi Decoction based on LC-MS/MS technology(sauroside A,cinnamic acid,baicalin,baicalin,glycyrrhizin,glycyrrhizin,isoliquiritin,isoliquiritin,Determination of glycyrrhizic acid,glycyrrhetinic acid,wogonin,lamellar A,paeoniflorin,paeoniflorin and gallic acid,and pharmacokinetic analysis.Results: The HPLC analysis method was determined by methodological investigation to be fast,accurate and stable.The optimal extraction process for orthogonal test optimization was as follows: 10 times water soaking for 60 min,extraction 3 times,40 min each time,through verification test The method is stable and feasible.The results of optimizing the particle forming process are: lactose: a mixture of dextrin 1:2,excipient: the powder is 1:4,and the production and storage environment should be controlled below 72.5%.TLC showed that the spots were clear,the specificity was strong,and there was no negative interference.The determination method of baicalin,paeoniflorin and ginsenoside was high in precision,stability and reproducibility.The established methods for simultaneous determination of 15 active components in rats are within an acceptable range of specificity,precision,accuracy,etc.The method is stable and reliable.Analysis by pharmacokinetic software showed that some components had obvious peaks of secondary blood drug;structurally similar components had similar pharmacokinetic curves;the pharmacokinetic curve of saikosaponin A was consistent with the reported results;It was found for the first time that cinnamic acid had a significant secondary demand peak,presumably due to the compatibility of traditional Chinese medicine compound;it was confirmed that glycyrrhetinic acid was metabolized by glycyrrhizic acid and absorbed by the body.Conclusion: This experiment studied the extraction and preparation process of Chaihu Guizhi granules.The obtained process is stable and feasible.The qualitative and quantitative methods are simple and accurate,and the quality can be controlled quickly and effectively.The established pharmacokinetic method is stable and reliable.The results can provide important experimental evidence for preclinical research. |
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