Mumps vaccine freeze-drying protective agent without gelatin and human serum albumin components

Abstract

The invention discloses a mumps vaccine freeze-drying protective agent without gelatin and human serum albumin components, and a formula and a preparation process of the mumps vaccine freeze-drying protective agent are provided. By adopting a technical scheme that the mumps vaccine freeze-drying protective agent is prepared from cane sugar, mycose, dextran, sodium glutamate, urea, arginine, a 199 culture medium, mannitol and sterile water for injection, a mumps live-attenuated vaccine freeze-drying preparation can avoid the defects of gelatin and human serum albumin, and the purposes of eliminating allergic reaction, removing hidden dangers of hepatitis infection and reducing cost can be achieved.

Description

technical field [0001] The invention relates to a freeze-drying protectant, in particular to a freeze-dried mumps freeze-drying agent without gelatin and human serum albumin components, which is used for making the freeze-dried preparation of the live attenuated mumps vaccine. Background technique [0002] Freeze-dried protective agent, referred to as cryoprotectant, is a protective agent added to the vaccine to prevent the sex change of the vaccine due to freeze-drying when the vaccine is made into a freeze-dried preparation; it is used to make a freeze-dried preparation of the live attenuated mumps vaccine Freeze-dried protective agent, referred to as gill vaccine cryoprotectant. [0003] The prior art mumps cryoprotectant contains gelatin and human serum albumin components, and the mumps attenuated live vaccine freeze-dried preparation prepared with the prior art mumps freeze-dried preparation is referred to as the existing mumps freeze-dried preparation; biomedical techn...

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Problems solved by technology

[0003] The prior art mumps cryoprotectant contains gelatin and human serum albumin components, and the mumps attenuated live vaccine freeze-dried preparation prepared with the prior art mumps freeze-dried preparation is referred to as the existing mumps freeze-dried preparation; biomedical technology Studies have found that some vaccinated people, especially children, who have been vaccinated with the existing lyophilized vaccine preparations will have strong allergic reactions to the gelatin and human albumin components, or have a risk of hepatitis infection; the mechanism leads to allergic reactions The most important thing is that gelatin or gelatin derivatives can cause some vaccinated people to produce IgE antibodies against gelatin molecules. Gelatin can cause both cell-mediated and non-cell-mediated immune responses; in addition, gelatin contains other bacterial species The endotoxin in the vaccine can also cause some of the vaccinated persons to have a fever reaction; in addition, causing some of the vaccinated persons to be infected with hepatitis is due to the fact that the human serum albumin in the vaccine cryoprotectant in the prior art carries the source of hepatitis, although the human serum albumin The protein is derived from healthy human blood that has passed the test, but limited by the existing detection technology, the source of hepatitis carried in human serum albumin will cause hidden contamination to the vaccine; in addition, the supply of human serum albumin is tight and expensive, and the cost High; therefore, there are problems and deficiencies in the prior art such as allergic reactions, hidden dangers of hepatitis infection, and high cost

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