| As a fat-soluble vitamin, Vitamin E can be prepared to venous millimicron emulsion to strengthen the stability of medicine and increase the biology profitability of medicine, including boosting up its target location to lymph. In this dissertation, the author investigates the prescription and preparation technics of Vitamin E venous millimicron emulsion, and estimate its stability and character of physics and chemistry. Condign equilibrium constant of hydrophile and lipophile is very important to ensure the stability of venous millimicron emulsion to be emulsion. However, HLB value of the emulsion that water is wrapped by fat is from 8 to 16.Through the serious the method of constant of centrifuge stability, the author ascertains that the optimal value is 11. Among the factors in the preparation of primary emulsion, according to influence intensity, the first is the dosage of emulsion that is 0.071,the second is the time of mixture that is 0.052,the third is the temperature of emulsification which is 0.022.This article uses orthogonal method to filtrate the optimal prescription and method of the preparation of emulsion avoiding the unstable phenomenon that is made by the traditional emulsion preparation. Under different pressure, with the same time to emulsificate, the diameter of emulsion will decrease along with the pressure increasing, and the distribution of diameter will concentrate along with the pressure increasing. In order to make the diameter of emulsion according with the criterion of Chinese Codex(2000), taking into account the diameter and its distribution, we choose 1000bar pressure to manufacture emulsion. Under the same pressure of 1000bar,the diameter of emulsion decreases along with the time of homogenizing, and the distribution concentrates along with the pressure increasing. However, when the time of emulsification is beyond 4,the diameter and distribution can not be improved any more. Therefore, the time of emulsification is confirmed to 4 times. Hot-press sterilizing under 121 ℃for 20 minutes can not affect diameter and its distribution. Only the PH of emulsion whose PH is 5.0 increases after sterilizing, but others` PH decrease after sterilizing. The decreasing of PH reflects that fatty acid is produced after phospholipids and fat is hydrolyzed. According to the optimal prescription, we prepare Vitamin E venous millimicron emulsion, and take stock of its character of physics and chemistry. The result indicates that the character of Vitamin E venous millimicron emulsion accords with criterion of Chinese Codex. Agglomeration of emulsion is aroused by gravity, and this phenomenon is reversible. Vibrating the emulsion under different temperature, then, we mensurate its conductance and find out that it is the same as that not Vibrating. Based on prediction, the emulsion will lead to distributive balance under gravity, and the emulsion dripping of different diameter will distribute in the different part of emulsion. However, the emulsion dripping will exclude each other with electrostatic force that is about 35mv,so it isnot easy for the emulsion dripping to combinate, and they will equably distribute after shaking. In the water shaker with a constant temperature of 25 ℃,which is shaking at 100rpm,sampling after 12 hours,24 hours,48 hours,72hours,and mensurate centrifugal stabilization parameter of different time and the number of dripping that is bigger than 2um under the 1600 times oil microscope. The result indicates that continuously shaking hardly influences the centrifugal stabilization parameter, but the emulsion should not be continuously shaked. Filled with nitrogen, airproofed, under 40℃,60℃,45001X for ten days, observe the appearance,diameter,and viscosimeter after 0,5,10 days. Placed in different experimental conditions, the diameter and viscosimeter of the emulsion doesn`t change much. Placed at 60 ℃for nine days, the color of the emulsion will become yellow, and the phospholipid or oil will hydrolyze. Therefore, Reserving the emulsion should avoid high temperature. Irradiation of ray aroses ranciditing of lipin, and accelerates hydrolyzing of phospholipids and lipin. Although we can not observe many changes in experimental conditions, reserving for a long time should avoid light. According to the criterion of Chinese Codex, emulsion belongs to thermodynamic unstable system, so acceleratory experiment should be done under 30 ℃. Simulating the condition of transportation and storage, using KangLaite emulsion,duck`s gallbladder emulsion,Intralipos fatty emulsion in control experiment, observing the centrifugal stability of vitamin E venous... |
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