Research On The Preparation And Characterization Of Propofol Emulsion With Soybean Oil As The Carrier

In this research,we aimed to investigate the preparation process and characterization of water-soluble propofol fat emulsion.And explore the method of industrial production stability propofol.First,we measure the diameter of the fat emulsion particles,centrifugal stability and propofol content from the formulations of different proportions.Then determine the best formulation and lay the foundation for the follow-up test.Secondly,we research the emulsification temperature,pH value,the composition and proportions of the additive,working pressure of homogenizer and the number of homogeneous.In order to select the best and stability of preparation process,we choose a range of different conditions for gradient test and orthogonal experiment.After the success of a small pilot test,we began to study the optimized process of water-soluble propofol fat emulsion of enlarge.Investigate the requirements of producing process equipment from small test to pilot test.Research the industrialized feasible process and equipment selection,to provide a basis for industrial design and make propofol fat emulsion preparation to industrialization.Finally,we systematic study the characteristic of water-soluble propofol fat emulsion.The stability of emulsions related with the particle size and its distribution.The smaller the particle size and the more narrow the particle size,would lead to the more stability of emulsion.We use laser particle size analyzer detect the particle diameter of water-soluble propofol fat emulsion.Then we determine the particle diameter of the emulsion,and investigate the stability of the emulsion.Detect the centrifugal stability of propofol fat emulsion by UV spectrophotometer and centrifuge.Measure the concentration of propofol in emulsion by high performance liquid chromatography.On the particle size distribution of the potentials,electron microscope observation,revealing the excellent stability of propofol fat emulsion physicochemical characteristics.Results:1.By measuring the particle diameter of water-soluble propofol fat emulsion,centrifugal stability and propofol content from the formulations of different proportions.We determine the best formula as follows:oil phase:soybean oil 10%,lecithin 1.2%,oleic 0.2%,propofol 1%VE0.01%;aqueous phase:glycerol 1.8%,the poloxamers 0.2%.2.By researching the emulsification temperature,the colostrum of homogeneous time,pH value,the composition and proportions of the additive,working pressure of homogenizer and the number of homogeneous.We determine the best and stability of preparation process as follows:colostrum temperature 60?,pH 11,homogenization pressure 800Pa,homogeneous 6,sterilization time 12min.3.Through the above conditions of initial drug lipid emulsion particle size can be up to 200 nm,0.5913 centrifugal stability,propofol content is 1%.Long-term retention samples after observing particle size can reach around 250 nm,0.6777 centrifugal stability,propofol content is 1%.