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Recombinant adenovirus vaccine preparation and preparation method thereof

A technology for recombinant adenoviruses and preparations, applied in botany equipment and methods, biochemical equipment and methods, pharmaceutical formulations, etc., can solve the problems of limited application, transportation, storage difficulties, temperature sensitivity, etc., and achieve long validity period and stability Good and stable effect

Inactive Publication Date: 2016-01-27
亚宝药业太原制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, even liquid recombinant adenovirus preparations containing stabilizers are sensitive to temperature, which brings great difficulties to transportation and storage, which largely limits their clinical application

Method used

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  • Recombinant adenovirus vaccine preparation and preparation method thereof
  • Recombinant adenovirus vaccine preparation and preparation method thereof
  • Recombinant adenovirus vaccine preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Cryoprotectant formula: trimethylolaminomethane: 1.5g, sodium chloride 9.1g, sucrose 75g, magnesium chloride 0.15g, Tween-800.2g, ethylenediaminetetraacetic acid 0.02g, L-histidine 1.3g, Absolute ethanol 1g.

[0012] preparation:

[0013] Mix the components according to the formula, add water for injection cooled to 4°C to 200ml, stir to dissolve, mix well, and then add the recombinant adenovirus stock solution 2*10 14 Add the amount of VP, mix evenly, add water for injection to 1000ml, stir and mix evenly, sterile filter, fill, fill with nitrogen, press stopper, cover, after light inspection, store in -20°C freezer.

Embodiment 2

[0015] Cryoprotectant formula: trimethylolaminomethane: 1.0g, sodium chloride 5.6g, sucrose 10g, magnesium chloride 0.2g, Tween-800.3g, edetate 0.04g, L-histidine 4.5g, Absolute ethanol 5g.

[0016] preparation:

[0017] Mix the components according to the formula, add water for injection cooled to 4°C to 200ml, stir to dissolve, mix well, and then add the recombinant adenovirus stock solution 2*10 14 Add the amount of VP, mix evenly, add water for injection to 1000ml, stir and mix evenly, sterile filter, fill, fill with nitrogen, press stopper, cover, after light inspection, store in -20°C freezer.

Embodiment 3

[0019] Cryoprotectant formula: tris-methylaminomethane: 1.3g, sodium chloride 4.5g, sucrose 50g, magnesium chloride 0.1g, Tween-800.1g, edetate 0.015g, L-histidine 3g, no Water ethanol 7.5g.

[0020] preparation:

[0021] Mix the components according to the formula, add water for injection cooled to 4°C to 200ml, stir to dissolve, mix well, and then add the recombinant adenovirus stock solution 2*10 14 Add the amount of VP, mix evenly, add water for injection to 1000ml, stir and mix evenly, sterile filter, fill, fill with nitrogen, press stopper, cover, after light inspection, store in -20°C freezer.

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Abstract

The invention relates to a preparation method of a recombinant adenovirus vaccine preparation in the field of biotechnology. The invention aims to provide a recombinant adenovirus vaccine preparation. According to the technical scheme, the recombinant adenovirus vaccine preparation contains a recombinant adenovirus stock solution and a preparation prescription. The method for producing the above recombinant adenovirus vaccine preparation comprises the following steps: (1) preparing a buffer solution according to the preparation prescription, finally adding the virus stock solution, uniformly mixing, carrying out aseptic filtration, and subpackaging in penicillin bottles; filling nitrogen and tamponing and capping; and (2) carrying out light inspection on the subpackaged recombinant adenovirus vaccine preparation, and preserving the recombinant adenovirus vaccine preparation at minus 20 DEG C. The recombinant adenovirus vaccine preparation can be preserved for at least 24 months.

Description

technical field [0001] The invention relates to a recombinant adenovirus vaccine preparation and a preparation method thereof in the field of biotechnology. Background technique [0002] Adenoviruses are widely distributed in nature, and are found in many mammals and birds; because of their low pathogenicity to humans, no induction of cancer, large loading capacity, wide host cells, and high reproductive titers, they have become viral vectors in recent years. Research hotspots. However, even liquid recombinant adenovirus preparations containing stabilizers are sensitive to temperature, which brings great difficulties to transportation and storage, which largely limits their clinical application. So far, long-term storage of recombinant adenovirus preparations is basically stored at -20°C. Contents of the invention [0003] The purpose of the present invention is to provide a recombinant adenovirus vaccine preparation with safety, good stability and long validity period a...

Claims

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Application Information

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IPC IPC(8): A61K39/235A61K47/34A61K48/00C12N15/861
Inventor 戴东升安俊杨仁佳焦进安王星星陈婧周鹏王斐
Owner 亚宝药业太原制药有限公司
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