Inactivated Japanese encephalitis vaccine freeze-drying preparation for injection and preparation method thereof

An inactivated vaccine, Japanese encephalitis technology, applied in the directions of biochemical equipment and methods, vaccines, freeze-dried delivery, etc., can solve problems such as poor freezing type, achieve the effect of speeding up the reconstitution speed and solving the collapse of the product

Pending Publication Date: 2019-03-01
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Changing the type of sugar will not only improve the stability of the product, but also bring about a new problem of poor frozen shape

Method used

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  • Inactivated Japanese encephalitis vaccine freeze-drying preparation for injection and preparation method thereof
  • Inactivated Japanese encephalitis vaccine freeze-drying preparation for injection and preparation method thereof
  • Inactivated Japanese encephalitis vaccine freeze-drying preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Screening experiment of process parameters for preparation of freeze-dried preparation of Japanese encephalitis inactivated vaccine.

[0025] 1. Screening experiment of carbohydrates in lyoprotectant.

[0026] (1) Preparation method: Weigh each component: 30g of human serum albumin, optionally 45g of trehalose, lactose, and maltose, and add PBS buffer to 500ml. The liquid prepared above is sterilized and filtered with a filter with a pore size of 0.22 μm to obtain the lyoprotectant of the present invention.

[0027] (2) The Japanese encephalitis inactivated vaccine strains were cultured in microcarrier suspension at 37°C for 20 days, then the virus liquid was harvested, and then the harvested liquid was concentrated and inactivated, and finally purified by molecular sieves. Mix the obtained purified solution with the prepared lyoprotectant at a ratio of 1:3, mix well, and immediately freeze-dry after dispensing according to a predetermined volume.

[0028] (...

Embodiment 2

[0055] Example 2 Formula and preparation process parameters of the optimized freeze-dried preparation of Japanese encephalitis inactivated vaccine.

[0056] 1. The optimized formula of the lyoprotectant: it is characterized by maltose 2-4g / 100ml and human serum albumin 2g / 100ml.

[0057] 2. Optimized freeze-drying process: pre-freeze at -45°C, maintain at this temperature for 4-6 hours, then anneal at -15°C for 20 minutes. After annealing, lower the temperature to -45°C, evacuate to 0.1mbar, then raise the temperature to -30°C, then raise the temperature to -20°C after 8~10 hours, then raise the temperature to 27°C after 4~6 hours and maintain it for 6~8 hours Get it later.

[0058] 3. Preparation method.

[0059] (1) Preparation method: Weigh each component: human serum albumin 30g, maltose 30g, add PBS buffer to 500ml. The liquid prepared above is sterilized and filtered with a filter with a pore size of 0.22 μm to obtain the lyoprotectant of the present invention.

[00...

Embodiment 3

[0062] Example 3 Comparison of optimized freeze-dried formulations of Japanese encephalitis inactivated vaccines and original freeze-dried formulations.

[0063] Table 9 compares the reconstitution time and thermal stability of the lyophilized preparation prepared in Example 2 and the lyophilized preparation prepared by the original process.

[0064]

[0065] It can be drawn from the results in Table 9.

[0066] (1) After the introduction of annealing process, the problem of collapse of freeze-dried products can be solved, and the frozen shape is ideal.

[0067] (2) After replacing the original dextran with maltose, the reconstitution time of Japanese encephalitis inactivated vaccine was shortened by half, from 20-30 seconds to 8-10 seconds. The drug dissolves quickly and fully, and is convenient to use.

[0068] (3) After replacing the original dextran with maltose, the protection against Japanese encephalitis inactivated vaccine was significantly improved, especially in...

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Abstract

The invention belongs to the technical field of vaccine production processes and particularly relates to an inactivated Japanese encephalitis vaccine freeze-drying preparation for injection and a preparation method thereof. The inactivated Japanese encephalitis vaccine freeze-drying preparation for injection is prepared from an inactivated Japanese encephalitis vaccine and a freeze-drying protection agent, wherein the freeze-drying protection agent is one of human serum albumin, trehalose, lactose and maltose, and a surfactant is Tween 20 or 80. The freeze-drying protection agent in an inactivated Japanese encephalitis vaccine freeze-drying product can shorten the vaccine re-dissolving time, further improve the heat stability of the inactivated Japanese encephalitis vaccine and accordinglyprolong the useful life of the inactivated Japanese encephalitis vaccine.

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 Japanese encephalitis inactivated vaccine and a preparation method thereof. Background technique [0002] The inactivated Japanese encephalitis vaccines currently on the market are mainly freeze-dried products, supplemented by water injection products. The freeze-dried protein drug is in the shape of a loose cake with low moisture content, which is conducive to the stability of the physical and chemical properties of the drug and prolongs the storage period of the protein drug. Dextran and human serum albumin were used in the control formulation of the freeze-dried product of Japanese encephalitis inactivated vaccine. Human albumin is a very good protein freeze-drying protectant, which can not only protect the activity of antigenic protein, but also play a role of skeleton support. The currently used dextran has th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/12A61K9/19A61K47/26A61K47/42A61P31/14
CPCA61K39/12A61K47/26A61K47/42A61P31/14A61K9/19A61K2039/5252A61K2039/552C12N2770/24134Y02A50/30
Inventor 李庆岸李沛阳于海吴峥曽祥伟白珠穆
Owner LIAONING CHENGDA BIOTECH
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