| 摘要 |
<p>PURPOSE: Provided is a new vaccine composition comprising alum, an antigen, an immunologically active saponin fraction like as QS21 that induced from cortex of Quillaja Saponaria Molina and a sterol. A manufacturing method thereof, and using method to drug are also provided. CONSTITUTION: A process for the preparation of the vaccine composition comprises of: vacuumed-drying a mixture of lipid and a cholesterol in organic solvent, adding solution(e.g., phosphate buffer saline), and shaking, fluidifying the suspension finely till the liposome size be 100nm, and sterilized-filtering through 0.2micrometer filter to get SUV(small unilamella vesicle); adding an antigen(1-500microgram) to alum in water(100-500microgram), adding water till the volume be 500μl, incubating 15-30minutes, adding MPL(3-deacylated mono-phosphoryl lipid A) 50microgram as a form of an elementary particulated MPL, leaving for 15-30minutes at room temperature, adding 10times concentrated phosphate buffer saline till the last concentration be an equal-osmosis, and incubating; adding QS21 to SUV, and adding the mixture to the alum/antigen/buffer mixture; adding bacteria-growth inhibitor like as thiomersal, if needed.</p> |
