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Vaccine composition liquid preparation used for nose and preparation method thereof

A technology of vaccine composition and liquid preparation, which is applied in the field of nasal vaccine composition liquid preparation and its preparation, which can solve the problems of poor stability and cumbersome preparation, and achieve the effect of improving the ability of uptake and presentation

Inactive Publication Date: 2014-12-17
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to provide a liquid formulation of a nasal vaccine composition in order to overcome the defects of cumbersome preparation and poor stability of the existing nasal vaccine preparations

Method used

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  • Vaccine composition liquid preparation used for nose and preparation method thereof
  • Vaccine composition liquid preparation used for nose and preparation method thereof
  • Vaccine composition liquid preparation used for nose and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051]Weigh 1g of squalene, 1g of medium-chain triglyceride, 1.5g of Solutol HS15, 0.5g of egg yolk lecithin, and stir to obtain the oil phase / surfactant mixture; weigh 2g of citric acid, 0.01g of thimerosal, and add 60mL In water for injection, stir to dissolve; under stirring, slowly add the above aqueous solution into the oil phase / surfactant mixture to obtain an opalescent solution; add 7500μg HA influenza antigen (B / Brisbane / 60 / 2008), add water to 100mL, stir well, and filter through a 0.22μm filter membrane; fill it into a nasal spray device at 0.2ml / dose (ie 15μg / dose) to obtain the vaccine composition.

Embodiment 2

[0053] Weigh 4g of squalene, 4g of medium-chain triglyceride, 156g of Solutol HS, 2g of egg yolk lecithin, stir to obtain the oil phase / surfactant mixture; weigh 0.2g of potassium dihydrogen phosphate, 0.01g of phenol, add to 60mL injection In water; under stirring, slowly add the above aqueous solution into the oil phase / surfactant mixture to obtain an opalescent solution; add 50000 μg HA of influenza antigen (B / Brisbane / 60 / 2008), add water to 100 mL; add 0.01 g of sodium chloride, adjusted to an isotonic solution of nasal mucus, stirred evenly, filtered through a 0.22 μm filter membrane; filled in a nasal spray device at 0.2 ml / dose (ie 100 μg / dose), to obtain the vaccine composition.

Embodiment 3

[0055] Weigh squalene 3g, medium chain triglyceride 7g, Solutol HS1515g, stir to obtain oil phase / surfactant mixture; weigh benzalkonium chloride 0.016g, add in 60mL water for injection; under stirring, the aqueous solution Slowly add to the oil phase / surfactant mixture to obtain an opalescent solution; add 30,000 μg of HA influenza antigen (B / Brisbane / 60 / 2008), add water to 100 mL, stir well, and filter through a 0.22 μm filter; ml / dose (ie 15 μg / dose) is filled in a nasal spray device to obtain the vaccine composition.

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Abstract

The invention discloses a vaccine composition liquid preparation used for nose and a preparation method thereof. The vaccine composition liquid preparation comprises the following raw materials by mass percentage: 1)0.002-0.2% of antigen, 2)0.1-15% of oil phase, 3)70-99.7% of water phase and 4)0.1-15% of surfactant, the percentage expresses the gram of each raw material in 100mL of raw material bulk volume. The preparation method comprises the following steps: 1) mixing oil phase and the surfactant, mixing with the water phase to obtain an adjuvant; and 2)mixing the prepared adjuvant in the step 1) with antigen, and performing freeze drying to obtain the powder. The vaccine composition liquid preparation used for nose is nasal mucosa immunization, the preparation method is simple, stability is high, operation is convenient during a practical application process, inoculation rate can be greatly increased, and the vaccine composition powder preparation has good application prospect.

Description

technical field [0001] The invention belongs to the field of pharmaceuticals, and in particular relates to a liquid formulation of a nasal vaccine composition and a preparation method thereof. Background technique [0002] Vaccines are the most cost-effective means of preventing and treating viral infections. Take the influenza vaccine as an example. In developed countries, if the antigen of the influenza vaccine matches the circulating influenza virus well, it can protect 70-90% of healthy adults from clinical disease. At present, the main means of immunization in China is still the traditional injection, but there are many defects in the intramuscular injection, including the inconvenience of injection, obvious pain (especially for infants and children), and the possible unsafe factors of injection. Wait. [0003] Oral influenza vaccine needs to overcome the acidic environment of the gastrointestinal tract, and deliver the sensitive antigenic protein intact to the microf...

Claims

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Application Information

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IPC IPC(8): A61K39/00A61K39/145A61K39/29A61K39/08A61K9/12A61P31/16A61P31/20A61P31/04
Inventor 金方蔡伟惠王颖
Owner SHANGHAI INST OF PHARMA IND