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Hydrophobia vaccine freezing drying preparations for stable human beings and the preparations thereof

A technology of rabies vaccine and freeze-dried preparation, which is applied in the field of freeze-dried preparation of human rabies vaccine and its preparation, achieving excellent stability, prevention of rabies, and low incidence of side effects

Active Publication Date: 2011-01-26
LIAONING CHENGDA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no relevant report on replacing the routinely used human serum albumin stabilizer in rabies vaccine preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A phosphate buffer system with a pH of 7.2 is used, the concentration of sodium chloride is 0.8%, then 2% trehalose, 2% sucrose, and 3% dextran are added to make the freeze-drying excipient, and then 0.1-0.2 um filter membrane to filter and sterilize, then add inactivated rabies virus antigen (derived from pv2061 strain) to 12IU / ml, mix well and divide into 0.5ml preparations per bottle, freeze-dry to make human serum albumin-free The lyophilized preparation of rabies vaccine was used to determine the immune potency of the preparation.

Embodiment 2

[0020] According to Example 1, 1% maltose was used instead of trehalose, and 3% dextran was used instead of dextran as excipients to prepare a freeze-dried preparation of rabies vaccine without human serum albumin, and its immune potency was determined.

Embodiment 3

[0022] According to Example 1, 3% gelatin was used instead of trehalose to prepare a freeze-dried preparation of rabies vaccine without human serum albumin, and its immune potency was determined.

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PUM

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Abstract

The invention relates to a kind of hydrophobia vaccine for human, which in detail relates to a freeze-drying hydrophobia vaccine for human and its preparation method. It is contained in physiological soluble buffer solution with pH being 7-8, the sodium chloride weight proportion is 0.4-1.0%, one or several from mycose, sucrose, gelatin, maltose and dextran is used as stabilizing agent, the concentration is 0.5-5%; the weight proportion of shaping agent for freeze-drying agent is 1-5%, and the purified hydrophobia viral antigen concentration is 4-20 IU per ml.

Description

technical field [0001] The invention relates to a human rabies vaccine preparation, in particular to a freeze-dried human albumin-free, compatible and storage-stable rabies vaccine preparation and its preparation. Background technique [0002] Rabies vaccine is the application of cell culture engineering to cultivate and harvest rabies virus. After special purification and inactivation, a certain concentration of human albumin is added to make various liquid and freeze-dried preparations. It is a kind of vaccine used for prevention and treatment. Immunization vaccines after exposure to rabies virus can effectively stimulate the body to produce anti-rabies virus antibodies and prevent rabies clinically. [0003] Stable rabies vaccine preparations have corresponding products on the market at home and abroad, which all contain human serum albumin as a stabilizer, and the use of human serum albumin as a stabilizer complicates the production process. As a blood product, human ser...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/205A61K9/19A61P31/14
Inventor 杨旭高军查力白珠穆李旭侯剑英杨俊伟
Owner LIAONING CHENGDA BIOTECH
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