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

A flu vaccine, drying technology, applied in antiviral agents, freeze-dried delivery, pharmaceutical formulations, etc., can solve the problem of difficult storage of multiple flu HA vaccines, and achieve the effect of stable supply

Inactive Publication Date: 2018-07-17
NITTO DENKO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the amino acid sequence and three-dimensional structure are different according to the virus type, so it is difficult to store multiple influenza HA vaccines stably in the form of a single pharmaceutical composition in the existing vaccine preparation technology

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 1～40

[0084] (freeze-dried influenza HA vaccine preparation)

[0085] For influenza HA antigens (A H1N1: A / California / 7 / 2009, A H3N2: A / Victoria / 361 / 2011, B Yamagata system: B / Wisconsin / 1 / 2010 and B Victoria system: B / Brisbane / 60 / 2008, manufactured by the Osaka University Microbial Disease Research Association), as shown in Tables 1 to 4, trehalose (manufactured by Hayashibara) or sucrose (manufactured by Wako Pure Chemical Industries) was added as a disaccharide, and L(+ )-arginine hydrochloride (manufactured by Wako Pure Chemical Industries), L-lysine hydrochloride (manufactured by Wako Pure Chemical Industries), L(-)-proline (manufactured by Wako Pure Chemical Industries), L- After threonine (manufactured by Wako Pure Chemical Industries) or L(+)-arginine (manufactured by Wako Pure Chemical Industries), PBS (phosphate-buffered sodium chloride solution) with the following composition was added, and the above-mentioned disaccharide The content is 10% by mass / volume, the content o...

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PUM

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Abstract

Provided is a dried influenza vaccine preparation that can be supplied stably and in which the influenza vaccine activity can be maintained stably even when stored without strict temperature control.Also provided is a method for producing said dried influenza vaccine preparation. This dried influenza vaccine preparation comprises an influenza vaccine antigen, a disaccharide, and an amino acid.

Description

technical field [0001] The invention relates to dry formulations containing influenza vaccines. More specifically, the present invention relates to a dried influenza vaccine preparation capable of stably maintaining the activity of the influenza vaccine even without storage under strict temperature control, and enabling stable supply. 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 infection with influenza virus until the onset of influenza is usually 1 to 2 days. At the time of onset, in addition to general symptoms such as fever above 38 degrees Celsius, general malaise, headache, joint pain, and muscle pain, symptoms such as sore throat, cough, and runny nose may also appear. Usually recovers within 1 week. When the elderly, infants, pregnant women, patients with chronic diseases of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61K39/00A61K47/18A61K47/26A61K9/19A61P31/16
CPCA61K39/00A61K47/26A61K9/19A61K47/183A61P31/16A61K39/145A61K47/18A61K2039/5252A61K2039/55511
Inventor 清远英司堀光彦浅利大介大久保胜之宍户卓矢深坂昌弘松下恭平
Owner NITTO DENKO CORP
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