Studies On The Preparation Technology And Quality Standard Of Zizhu Danmu Capsules

Li medicine is a valuable cultural heritage of Li nationality,and also an important part of Chinese medicine.Li nationality is an indigenous people in Hainan Island.Living on Hainan Island 3000 years ago.Li doctors have rich experience in medication and simple prescription.For example,the folk prescription Zizhu Danmu decoction,which is often used to treat all kinds of upper respiratory tract infections,is only composed of two kinds of medicinal materials,Callicarpa.nudiflora and Nauclea officinalis.The two drugs can also be used alone,and have been developed into patent medicine,but the compound is only used in clinical prescriptions,not developed into patent medicine.This paper focuses on the research of the preparation development of Li medicine prescription medical institutions,and plans to carry out the research on the extraction and preparation process,chemical composition and pharmacological activity analysis,and quality standard of Zizhu Danmu capsule.In this paper,the extraction and preparation technology of Zizhu Danmu capsule was studied.According to the experience of folk medicine,the powder of Callicarpa nudiflora and Nauclea officinalis was refluxed with water as solvent according to the ratio of 4:1.In order to optimize the extraction process,the L9(34)orthogonal experiment was used to investigate the three factors of water addition(A),extraction time(B)and extraction times(C),and three levels were selected for each factor.The best extraction process of Zizhu Danmu extract was as follows:the amount of water was 20 times of the quality of the medicinal material,extracted three times,0.5h each time;the dry extract was obtained by the process of extraction,concentration and drying,and then directly packed into capsules after crushing.In order to elucidate the main chemical constituents of Zizhu Danmu capsule,UPLC-QTOF-MS/MS was used to qualitatively analyze the chemical constituents of Zizhu Danmu capsule,water extract of Callicarpa nudiflora and water extract of Nauclea officinalis.59 compounds were identified from Zizhu Danmu capsule,which were all from water extract of Callicarpa nudiflora and water extract ofNauclea officinalis,mainly acteoside and strictosamide,cynaroside,pumiloside,etc.At the same time,the anti-inflammatory effect of Zizhu Danmu capsule was verified by acute lung injury mouse model,and the anti-inflammatory mechanism of Zizhu Danmu Capsule on acute lung injury in mice was explored by pathological changes of lung tissue,wet dry weight ratio of lung tissue,expression of TNF-α,IL-1β,IL-6 and other indicators.The results showed that compared with the model group,the pathological changes of lung tissue,inflammatory cell infiltration,pulmonary septum and alveoli of mice treated with 400 mg/kg Zizhu Danmu capsule by gavage were significantly reduced;compared with the model group,the wet/dry weight ratio(W/D)of lung tissue in the experimental group was significantly decreased(p<0.05).It can be seen that Zizhu Danmu capsule can significantly reduce the expression of TNF-α,IL-1β(p<0.01)and IL-6(p<0.05).Therefore,Zizhu Danmu capsule can significantly reduce the pulmonary edema caused by acute lung injury,and improve the inflammatory response of lung tissue by regulating the expression of pro-inflammatory factors.Finally,this paper studies the character,identification,inspection and content determination of Zizhu Danmu capsule.According to the Chinese pharmacopoeia in 2020,the characteristics of the content and shell of Zizhu Danmu capsule were described.The product is a hard capsule,the content is brown powder,with slightly fragrant gas,slightly sweet taste and slightly bitter.Objective:To establish a TLC identification method for Zizhu Danmu capsule.Methods:The capsule shell was clean,without adhesion,deformation,capsule shell rupture and other phenomena.The contents of acteoside and strictosamide in Zizhu Danmu capsule were determined by HPLC.The linear equations for the determination of acteoside and strictosamide were Y=6897368.2035x-26246.3229,R2=0.9999;Y=15802909.4072x-8903.1596,R2=0.9997,respectively.The precision,stability and repeatability were not more than 3%,and both acteoside and strictosamide were stable within 24 hours.The recovery of acteoside was 99.2%～104.5%,RSD was 1.71%.The recoveries of strictosamide ranged from 97.0%～101.1%with RSD of 1.54%.Finally,the quality standard draft of Zizhu Danmu capsule was formulated,and three batches of Zizhu Danmu capsule samples were tested,and the results were in line with the provisions of the draft standard.In conclusion,based on the Li medicine prescription Zizhu Danmu decoction,Zizhu Danmu capsule was prepared by optimizing the extraction and preparation process of the prescription and using the conventional method.The acute lung injury model of mice was used to verify that Zizhu Danmu capsule can significantly reduce the pulmonary edema caused by acute lung injury,and improve the anti-inflammatory effect of lung tissue by regulating the expression of proinflammatory factors and anti-inflammatory factors Should.At the same time,UPLC-Q-TOFMS/MS was used to clarify that the main components of Zizhu Danmu capsule were acteoside and strictosamide,cynaroside,pumiloside,etc.Finally,the quality standard of Zizhu Danmu capsule was established.This study can provide scientific basis for the development of Zizhu Danmu Decoction and the preparation of medical institutions.