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A kind of freeze-dried preparation of Japanese encephalitis vaccine

A technology of freeze-dried preparations and vaccines, which is applied in the field of virus biology, can solve problems such as the impact on product safety, and achieve the effect of simple composition and good stability

Active Publication Date: 2021-08-03
GUANGZHOU GALAXY SUN BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of preparing freeze-dried human JE vaccine, in addition to the above-mentioned excipients, gelatin, trehalose and surfactants need to be added to enhance the protective effect during freeze-drying and storage and reduce the loss of vaccine potency rate, but the ingredients introduced thereby will have a greater impact on the safety of the product

Method used

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  • A kind of freeze-dried preparation of Japanese encephalitis vaccine
  • A kind of freeze-dried preparation of Japanese encephalitis vaccine
  • A kind of freeze-dried preparation of Japanese encephalitis vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1.1 Prepare the vaccine semi-finished product according to the following formula, and test its freeze-drying effect:

[0026] Human serum albumin 0.5(w / w)%;

[0027] Mannitol 5.0(w / w)%;

[0028] JE virus antigen stock solution 50mL;

[0029] Supplement the pH7.2~8.0 phosphate buffer to 100mL.

[0030] 1.2 Preparation method of Japanese encephalitis vaccine

[0031] The purified Japanese encephalitis virus antigen stock solution is prepared into a semi-finished product according to the above formula;

[0032] The semi-finished product is divided into 2ml vials, 0.5ml per tube, and placed in a small lyophilizer for freeze-drying.

[0033] 1.3 Vaccine testing method

[0034] Potency determination: according to "Chinese Pharmacopoeia" 2010 edition three freeze-dried Japanese encephalitis inactivated vaccine (Vero cell) potency determination method;

[0035] Moisture: Measured according to the method VIID of the third appendix of "Chinese Pharmacopoeia" 2010 edition; ...

Embodiment 2

[0064] 2.1. Effect of different dosages of mannitol on vaccine preparations

[0065] Set the concentration of human serum albumin to 0.5%, and adjust the concentration of mannitol therein, and observe the influence of the concentration of mannitol on the vaccine. The specific comparison results are shown in Table 5:

[0066] The influence of table 5 different mannitol concentrations on freeze-drying effect

[0067]

[0068] The data in Table 5 shows that within the concentration range of 1.0-10% mannitol, the appearance, reconstitution time and water content all meet the relevant requirements of "Chinese Pharmacopoeia" three (2010 editions) to freeze-dried JE vaccine, but in 3 Both the appearance and the reconstitution time performed best in the concentration range of ~6% mannitol.

[0069] 2.2 Effects of different dosages of human serum albumin on vaccine preparations

[0070] Set the concentration of mannitol to 5%, adjust the concentration of human serum albumin therein...

Embodiment 3

[0074] The impact of the vaccine stabilizer of embodiment 3 different combinations on the vaccine preparation

[0075]

[0076]

[0077] The above experiments show that the vaccine stabilizer of the present invention effectively controls the loss rate of vaccine activity in the freeze-drying process.

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Abstract

The invention discloses a freeze-dried preparation of JE vaccine. The preparation contains JE vaccine stock solution and a vaccine stabilizer, and the vaccine stabilizer is composed of human serum albumin and mannitol. The beneficial effects of the present invention are: (1) The ingredients in the auxiliary materials are simple in composition, without ingredients derived from animal sources, and the risk is lower. (2) The vaccine activity loss rate in the freeze-drying process is effectively controlled. (3) After the preparation is made into a finished product, the product shows good stability through stability research.

Description

technical field [0001] The invention belongs to the technical field of virus biology, and in particular relates to a freeze-dried preparation of Japanese encephalitis vaccine. Background technique [0002] Epidemic encephalitis JE, referred to as JE for short, is an acute infectious disease that infects the central nervous system caused by an arbovirus of the Flaviviridae family - JE virus. Often cause death or leave neurological sequelae. JE is a zoonotic disease transmitted by mosquitoes. People and many animals (livestock, poultry and birds) can become the source of JE infection after being infected with JE virus. JE is mainly transmitted through mosquito bites. Japanese encephalitis vaccine is an effective measure to prevent epidemic Japanese encephalitis. [0003] Inactivated whole virus vaccine products are usually administered subcutaneously or intramuscularly, using the abundant immune cells in these parts, especially antigen presenting cells (Antigen Presenting c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12A61K9/19A61K47/42A61K47/26A61P31/14
CPCA61K9/19A61K39/12A61K47/10A61K47/42C12N2770/24134C12N2770/36034Y02A50/30
Inventor 艾文刘钿莲沈名锋艾譞
Owner GUANGZHOU GALAXY SUN BIOLOGICAL PROD CO LTD
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