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Freeze-dried preparation of vaccine containing aluminum adjuvant, and preparation method and application of freeze-dried preparation

A technology of freeze-dried preparations and aluminum adjuvants, which is applied in the field of vaccine production technology, can solve the problems of high cost, broken cold chain, inconvenient storage and transportation of vaccines, etc., and achieve the effect of low finished product, mild conditions, and simple and rapid preparation method

Pending Publication Date: 2020-09-15
SICHUAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But all the vaccines containing aluminum adjuvants on the market at present cannot be frozen or freeze-dried ("Vaccine (6th Edition)", Stanley Hem et al, People's Health Publishing House, Volume 1, Chapter 5, Chapter 85 Page, 2017), lingering coagulums form after freezing, destroying vaccine structure and immunogenicity
Therefore, the product must be stored at 2-8°C, which brings inconvenience to the storage and transportation of the vaccine
[0005] my country has a vast territory, and the climate difference between the north and the south is large, which brings many challenges to the long-distance cold chain transportation. In addition, the influence of factors such as the condition of the refrigerated truck, the external ambient temperature, road conditions, and flight arrangements during the cold chain transportation will cause the transportation link to appear. Cold chain "broken chain" and other issues, which directly affect the stability and effectiveness of vaccines
Moreover, this high-cost and high-risk transportation method also severely limits the use of vaccines in remote areas such as rural areas

Method used

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  • Freeze-dried preparation of vaccine containing aluminum adjuvant, and preparation method and application of freeze-dried preparation
  • Freeze-dried preparation of vaccine containing aluminum adjuvant, and preparation method and application of freeze-dried preparation
  • Freeze-dried preparation of vaccine containing aluminum adjuvant, and preparation method and application of freeze-dried preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0088] Preparation of semi-finished products of aluminum hydroxide-chondroitin sulfate-chicken ovalbumin (OVA) nanoparticles: add 60μl of 28mg / ml chondroitin sulfate to 320μl of 100mmol / LPH of 7.7 Hepes buffer, and mix well as phase A; draw 400μl 10mmol / L aluminum sulfate solution, 40μl 1000μg / ml OVA solution, 40μl 100μg / ml oligodeoxynucleotide adjuvant CpG1826 solution mixed uniformly as phase B, add phase B to phase A dropwise under vortexing conditions In the middle, vortex for 30s; add 45mg glucose to the nanoparticle solution to fully dissolve.

Embodiment 2

[0090] Preparation of semi-finished products of aluminum hydroxide-chondroitin sulfate-HBsAg nanoparticles: add 60μl of 30mg / ml chondroitin sulfate to 400μl of 1000mmol / L Hepes buffer with a pH of 7.6, and mix well as phase A; draw 400μl of 10 mmol / L The aluminum sulfate solution and 400μl of 50μg / ml hepatitis B surface antigen solution are mixed uniformly as phase B. Under vortexing condition, add phase B dropwise to phase A, vortex for 30s; add 63mg trehalose to the nanoparticle solution In, fully dissolved.

Embodiment 3

[0092] Preparation of semi-finished products of aluminum hydroxide-chondroitin sulfate-HBsAg nanoparticles: Add 60μl 28mg / ml chondroitin sulfate to 320μl 90mmol / L Hepes buffer with a pH of 7.6, and mix well as phase A; draw 400μl 10mmol / L Mix the aluminum sulfate solution with 350μl 50μg / ml hepatitis B surface antigen solution and use it as phase B. Add phase B to phase A drop by drop under vortexing conditions, vortex for 30s; add 60mg glucose to the nanoparticle solution, fully Dissolve.

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Abstract

The invention discloses a freeze-dried preparation of a vaccine containing an aluminum adjuvant, and a preparation method and application of the freeze-dried preparation. The aluminum salt vaccine freeze-dried preparation contains nanoparticles or microparticles formed by compounding anionic polymers or derivatives thereof and aluminum salt, a vaccine antigen, an adjuvant and a freeze-dried protective agent; and a freeze-drying method provided by the invention avoids the massive aggregation of aluminum hydroxide in the vaccine, and reduces the damage to the activity of the antigen. The stability of the vaccine in the freeze-drying process and the storage process can be improved; the vaccine can get rid of cold-chain transportation; the cost is reduced; energy is saved; and particularly, the technical problem that a low-temperature cold chain in a remote area is difficult to guarantee is solved.

Description

Technical field [0001] The invention belongs to the technical field of vaccine production technology, and in particular relates to a freeze-dried preparation of an aluminum-containing adjuvant vaccine, a preparation method and application thereof. Background technique [0002] The application of vaccines has greatly reduced the morbidity and mortality of common epidemic infectious diseases, so that many epidemic infectious diseases have been effectively controlled. In recent years, with a deeper understanding of the relevant mechanisms of the immune system, the development of vaccines has made considerable progress. Not only has its performance in the traditional field of prevention and treatment become more prominent, but it has also begun to emerge in HIV, cancer and other diseases. Nowadays, vaccines have become an indispensable medicine in human health care. [0003] As the application of vaccines becomes more and more widespread, the stability problems in its production, tran...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K47/36A61K39/39
CPCA61K9/19A61K39/39A61K47/26A61K47/36A61K2039/55505A61K2039/55511
Inventor 孙逊张志荣龚涛白淑婷侯盈盈
Owner SICHUAN UNIV
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