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Dried influenza vaccine preparation and method for producing dried influenza vaccine preparation

A technology for influenza vaccine and manufacturing method, applied in biochemical equipment and methods, antiviral agents, freeze-dried delivery, etc., can solve the problem that the dried influenza vaccine preparation is not on the market, and achieve the effect of easy circulation and preservation

Inactive Publication Date: 2016-04-27
NITTO DENKO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, currently, dry preparations of influenza vaccines with excellent stability are not on the market, and further improvement in stability is required

Method used

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  • Dried influenza vaccine preparation and method for producing dried influenza vaccine preparation
  • Dried influenza vaccine preparation and method for producing dried influenza vaccine preparation
  • Dried influenza vaccine preparation and method for producing dried influenza vaccine preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] (freeze-dried influenza HA vaccine preparation)

[0055] Sucrose (manufactured by Wako Pure Chemical Industries, Ltd.) listed in Table 1 was added to influenza HA antigen (type A H1N1: A / California / 07 / 2009, manufactured by Osaka University Institute of Microbial Diseases), and PBS with the following composition was added (Phosphate-buffered sodium chloride solution), an aqueous solution containing influenza vaccine antigen was prepared in such a way that it became 20w / v% sucrose, 500 μg HA / mL influenza HA antigen (400 parts by weight of sucrose relative to 1 part by weight of influenza HA antigen). 10 μL of the obtained aqueous solution containing influenza vaccine antigen was dispensed into a 1.5 mL centrifuge tube (safe-lock tube) (manufactured by Eppendorf), and freeze-dried.

[0056] PBS for preparation

[0057]

Embodiment 2～17

[0076] (freeze-dried influenza HA vaccine preparation)

[0077] A freeze-dried influenza HA vaccine preparation was obtained in the same manner as in Example 1, except that the type and content of the disaccharide, or the liquid volume before freeze-drying were changed as shown in Table 2.

Embodiment 18～21

[0085] (freeze-dried influenza HA vaccine preparation)

[0086] A freeze-dried influenza HA vaccine preparation was obtained in the same manner as in Example 1 except that the content of the influenza HA antigen was changed as shown in Table 5.

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PUM

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Abstract

The purpose of the present invention is to provide the following: a dried influenza vaccine preparation with which stable retention of the activity of influenza vaccine antigen is possible, even when the preparation is stored without strict low-temperature management, and with which a stable supply is possible; and a method for producing the dried influenza vaccine preparation. The present invention provides a dried influenza vaccine preparation comprising influenza vaccine antigen and a disaccharide, wherein the disaccharide is one or more selected from the group consisting of sucrose, maltose, palatinose, melibiose, isomalt, cellobiose, allolactose, isomaltose, sophorose, lactobionic acid, laminaribiose, xylobiose, turanose, gentiobiose, rutinose, kojibiose, nigerose, robinose, neohesperidose, sucralose, and maltitol.

Description

technical field [0001] The present invention relates to dry formulations containing influenza vaccine antigens. More specifically, the present invention relates to a dried influenza vaccine preparation capable of stably maintaining the activity of influenza vaccine antigens even when stored without strict low temperature control, and capable of being supplied stably. Moreover, this invention relates to the manufacturing method of this influenza vaccine dry preparation. Background technique [0002] Influenza is a kind of acute infectious disease caused by influenza virus. The incubation period from influenza virus infection until the onset of influenza is usually 1 to 2 days. When you get sick, you will have a fever of 38 degrees or higher, and in addition to general symptoms such as general fatigue, headache, joint pain, and muscle pain, you will also have symptoms such as sore throat, cough, and nasal discharge. Usually recovers within 1 week. For influenza, the elderl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61K9/19A61K47/26A61P31/16
CPCA61K47/26A61K9/19A61K39/12C12N2760/16134A61K31/7016A61P31/16A61K2300/00A61K39/145A61K2039/525A61K2039/55511C12N7/00C12N2760/16034
Inventor 清远英司堀光彦浅利大介冈崎有道深坂昌弘
Owner NITTO DENKO CORP
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