The Preparation Process And Preliminary Research On Quality Control Of New Artemisia Argyi Hot Moxibustion Plaster

Objective:To prepare a new type of portable hot moxibustion plaster using the total flavonoids from artemisia leaf as the main raw material and investigated its quality stability,safety,release and transdermal properties in vitro to provide new drug experimental study of the development of hot moxibustion plaster.Methods:?1?UV spectrophotometry was adopted to establish the content determination method of total flavonoid content in artemisia argyi levl by using NaNO₂-AlNO₃-NaOH as color development;?2?Single factor tests were employed and then the factor such as ethanol concentration,dosage of solvent and extraction time was used to carry out L₉?3³?response surface experiments to optimize the extraction process parameters by using the extraction rate of total flavonoids from artemisia argyi levl as a response value.adsorption and elution behavior of polyamide resin for total flavonoids was investigated under static and dynamic conditions to select optimum technology parameters of purification technology.?3?Establishing a comprehensive evaluation method for gel plaster,the formulations were optimized by combining plackett-burman design with orthogonal design test;The heating temperature and heating time of self-heating bag were measured to optimize preparation technology by using single factor tests;?4?According to the method of"Chinese Pharmacopoeia",the quality indexes and transdermal characteristics of hot moxibustion plaster in vitro was checked and tested.Results:?1?The linear regression equation of rutin is y=0.0099x-0.0026,R₂=0.9998,with a good linear relationship in the range of7.5?75ug/ml;?2?The extraction and purification process conditions of total flavonoids from artemisia argyi levl were respectively:the defatted artemisia leaf plus 60 times the amount of 60%ethanol and heated at 100?for 1.5h with water bath,its extraction rate is 11.17%;PH=3,2.6BV total flavonoids concentration of 0.2g/ml,which was applied to a polyamide column at a flow rate of 1.0ml/min,Absorbed for 120min,washed with 3BV water to remove impurities,and eluted with 6BV60%ethanol.The eluate was collected.The retention rate and purity of total flavonoids were 83.26%and 73.22%,respectively.?3?The self-heating package and gel paste formula were:6.5g of reduced iron powder,1.5g of activated carbon,1.2g of sodium chloride,0.6g of vermiculite and 1.0g of water;0.13g of aluminum glycolate,1.5g of polyacrylic resin?NP-800?,15ml of total flavonoid solution,1.4g of polyvinylpyrrolidone?PVP?,0.18 g of agar and 6g of glycerol,respectively.?4?The quality indicators specified by the gel patch including appearance characteristics,adhesion,heat resistance,excipients,ointment content,total flavonoid content,and skin irritation meet the requirements of the Pharmacopoeia and have good Drug release,transdermal properties in vitro.Conclusion:The ultraviolet spectrophotometric method for the determination of total flavonoids of artemisia leaf established in the study is fast,sensitive,simple,and accurate.The extraction process of total flavonoids from artemisia leaf is economical,simple,easy to operate,and repeatable.Total flavonoids;polyamide purified total flavones have high retention and good purity;the heating temperature of the self-heating package is high and continuously stable,which meets the"heat"requirements in thermal moxibustion therapy,and the quality of the prepared gel paste is stable,safe and reliable.The drug release and transdermal properties are good in vitro,which can provide experimental reference materials for the development of new drugs for wormwood gel patch.