The invention provides a method for preparing a
seasonal influenza virus split vaccine and a vaccine prepared by using the method, belonging to the technical field of vaccine preparation processes. The preparation method comprises the following steps of: preparing an original liquid from
influenza A1, A3 and B
virus strain verified as WHO (
World Health Organization) recommended
virus strain or similar strain through the procedures of working seed
bank creation through subculture, chick
embryo inoculation, virus
liquid culture and harvesting,
virus inactivation, ultrafilter concentration,
gradient centrifugation, ultrafilter
sugar removal,
column chromatography, virus splitting, secondary purification and
filtration sterilization; and carrying out semi-finished product configuration and finished product packaging to obtain the
seasonal influenza virus split vaccine. Because
gradient centrifugation purification and
molecular sieve chromatography column purification are combined and secondary purification including
gradient centrifugation purification after virus splitting is carried out, the method provided by the invention has the advantages of good concentration efficiency and
recovery rate, low cost, high efficiency and easiness for operation. The finally prepared product has low
impurity content and high HA content, and the standards of endotoxin and
ovalbumin are far better than the requirements of
Chinese Pharmacopoeia 2010 and European
Pharmacopoeia. Moreover, the product provided by the invention does not contain thiomersal,
inoculation is
safer, and inoculated
population is larger.