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Vaccine composition and its preparation method

A vaccine composition and mixture technology, applied in the field of biomedicine, can solve the problems of long process operation time, high cost, large energy demand, etc., and achieve the effects of excellent stability, uniform particles, and excellent immune synergy

Inactive Publication Date: 2016-02-03
潘皓 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Especially influenza vaccines based on MF59 emulsion adjuvant It has been on the market for 10 years. This is a vaccine adjuvant prepared by ultra-high pressure homogenization. Long process operating times, high energy requirements and high costs

Method used

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  • Vaccine composition and its preparation method
  • Vaccine composition and its preparation method
  • Vaccine composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Preparation of nanoemulsion vaccine adjuvant

[0044] 1) Coarse milk preparation: use squalene as oil phase, mix with Tween 80 and Span 80. In addition, PBS, a buffer agent with a neutral pH, was added as the aqueous phase. The HLB is 9.5, the total amount of surfactant is 11%, the ratio of water to oil is 0.4, stirred for 15-20 minutes and heated to 55-70°C. (2) Phase transition and formation of nanoemulsion: keep the temperature at 55-70°C, continue stirring for 5-10 minutes, then quickly transfer the hot emulsion to a large amount (5 times the initial total amount) of PBS buffer at 4-8°C Dilute in solvent while stirring constantly. Continue stirring for 10-30 minutes to prepare the nanoemulsion vaccine adjuvant product. Store the product in aliquots at 2-8°C in a refrigerator.

[0045] figure 1 It is a schematic diagram of temperature, particle size and conductivity in the preparation of nanoemulsion vaccine adjuvant PIT method in this embodiment, as figure 1 A...

Embodiment 2

[0050] Product Stability Test

[0051] Stability is an important indicator of vaccine adjuvants. Table 2 shows the stability data of six batches of nanoemulsion vaccine adjuvants in Example 1 placed at 25°C for 12 months. As can be seen from Table 2, the nanoemulsion vaccine adjuvant has no significant change in particle size (the most important stability index) within 12 months, and the product quality is stable.

[0052] Table 2 The particle size of nanoemulsion vaccine adjuvant for 12 months

[0053] Batch Initial 1 3 6 9 12

[0054] number

Embodiment 3

[0056] Preparation of vaccine compositions and sensitization of vaccine adjuvants.

[0057] Rabbit experiments are used to verify that the immune effect of the vaccine composition of the present invention is better than that of no vaccine adjuvant or ordinary vaccine adjuvant, that is, the vaccine adjuvant in the vaccine composition of the present invention has sensitization. Wherein the control group is a conventional hemorrhagic fever vaccine without adjuvant (1:32 for type I antigen, 1:16 for type II), and the same hemorrhagic fever antigen is selected for the experimental group, and finally the vaccine adjuvant vaccine prepared in Example 1 is added. agent, the configuration process is the same as that of conventional non-adjuvanted vaccines. Type I antigen titers were 1:32, 1:16, 1:8, and type II antigen titers were 1:16, 1:8. A booster injection was given on the 7th day after the primary immunization, and blood was collected 21 days after the primary immunization for th...

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Abstract

The invention provides a vaccine composition and its preparation method. The vaccine composition comprises an antigen and a nanoemulsion vaccine adjuvant, wherein the nanoemulsion vaccine adjuvant has an oil phase of squalene and is mixed with two surfactants, a buffer liquid is added as an aqueous phase, in a whole system HLB value is 8-12, a total amount of the surfactants has a range of 8%-12%, and a water-oil ratio is 0.2-0.8; a mixture above is quickly stirred for initial emulsification at a temperature lower than phase inversion temperature; then preheating is carried out at a certain stirring speed to allow further emulsification; the mixture is heated to a temperature higher than the phase inversion temperature prior to being cooled, the aqueous phase fully covers the oil phase, and finally the nano-level vaccine adjuvant having uniform particles is formed. The nanoemulsion vaccine aid in the vaccine composition has uniformly distributed particles, good stability and good immunologic enhancement, so that the vaccine composition has better immune effect than vaccines without an adjuvant or with other common adjuvants.

Description

[0001] The patent application of the present invention is a divisional application of a Chinese patent application with an application date of June 18, 2014, an application number of 201410272698.2, and a nanoemulsion vaccine adjuvant. technical field [0002] The invention belongs to the field of biomedicine and relates to a vaccine composition, in particular to a vaccine composition containing a novel nanoemulsion vaccine adjuvant and a preparation method thereof. Background technique [0003] Vaccine adjuvants, also known as immune adjuvants (Adjuvant), are generally non-immunogenic when used alone, but when used in combination with antigenic substances, they can enhance the immunogenicity of antigenic substances, enhance the body's immune response, or change the type of body's immune response substance. Adjuvants are essentially a type of non-specific immune enhancer, which are usually inoculated before vaccine immunization alone or mixed with the vaccine at the same tim...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61K9/107A61P37/04
Inventor 潘皓谢小虎张岳智
Owner 潘皓
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