Influenza vaccine sucked or sprayed through nasal cavity, preparation method
An influenza vaccine and nasal technology, which is applied in the field of nasal inhalation or nasal spray influenza vaccine and preparation thereof, and can solve the problems of reducing immunogenicity and the like
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Embodiment 1
[0107] 1. Use the A drug recommended by WHO in 2003 3 (H 3 N 2 ): A 3 / Moscow / 10 / 99;A 1 (H 1 N 1 ): A 1 / NewCaledonis / 20 / 99, type B: B / Johannesburg / 99 three strains of influenza virus were inoculated into 8-11-year-old chicken embryos, cultured at 34°C-35°C for 48-72 hours, harvested allantoic fluid, concentrated by ultrafiltration , Purified by ultracentrifugation, which is the whole influenza virus suspension. After the semi-finished product is tested and qualified, the virus suspension is packed into 1000 ml of soft plastic blood collection agent and sealed, and stored in a refrigerator at 2-8°C for future use.
[0108] 2. A sealed soft plastic blood collection bag with a capacity of 1000ml of qualified influenza trivalent full virus suspension produced according to the quality standards and processes stipulated by the state, placed in a medium-sized hydrostatic press, and processed with a hydrostatic press at a pressure of 250Mp2 for 30 minutes. After being process...
Embodiment 2
[0110] Get the virus suspension after the inactivation of the whole influenza virus, check that the titer of hemagglutinin is 180000 micrograms of the suspension several milliliters (hemagglutinin per milliliter is greater than 70 micrograms), calculate the addition amount of the suspension of the whole influenza virus inactivation, and prepare a refined large Add 500 grams of soybean oil, 40 grams of refined soybean lecithin, 300 grams of Tween, 60 grams of glycerin, add water for injection to 2000 ml, put it in a glass container and mix thoroughly for later use.
Embodiment 3
[0112] 1. Put the qualified influenza trivalent inactivated whole virus and fat emulsion mixture together in a high-speed mixer for 15 minutes, make it fully mixed, put it into the debugged medium-sized nano collider, and inactivate the whole influenza virus and fat emulsion. The fat emulsion mixture is processed by a nano-collider, and the voltage, pressure, and flow are adjusted to crack the virus and fat emulsion mixture into particles of 10-12nm size. After being processed by a nano-collider, put it in a refrigerator at 4-8°C .
[0113] 2. After nanotechnology treatment, the influenza virus and fat emulsion are both 10nm in size. After passing the inspection according to the influenza vaccine quality inspection regulations, the hemagglutinin content per milliliter of the mixed solution must be greater than 70 micrograms. Then it is divided into standard nasal cavity inhalation bottles, freeze-dried, and the hemagglutinin of each person (one bottle) of frozen powder must be...
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