A gelatin-free varicella vaccine freeze-dried preparation and a preparing method thereof

Abstract

A varicella vaccine freeze-dried preparation is provided and comprises a varicella vaccine stock solution and a vaccine stabilizer. Based on the original concentration of the vaccine stock solution, the vaccine stabilizer comprises 3-10% of cane sugar and 0.01-1% of monosodium glutamate, with the balance being a buffer liquid optionally. The freeze-dried preparation is free of gelatin, dextran and / or animal-based protein. Vaccines in forms of stock solutions or freeze-dried finished products, which are prepared from the stabilizer free of the gelatin or the animal-based protein, have stability equivalent to stability of prescriptions in the prior art, and have better safety. The stabilizer is hoped to replace stabilizers containing gelatin and animal-based protein in the prior art.

Description

technical field [0001] The present invention relates to the field of vaccine manufacture. Specifically, it relates to the preparation of a high-safety gelatin-free varicella vaccine freeze-dried preparation and a preparation method thereof. Background technique [0002] Chickenpox is a highly contagious disease with obvious seasonal and periodic occurrence. Vaccination against chickenpox is currently the only way to control the spread of the virus. The VZVOka strain established by scholars from the Institute of Microbial Diseases (BIKEN) of Osaka University in Japan is currently the only vaccine strain approved by the WHO in the world. Clinical studies have proved that the Oka strain of varicella vaccine has a slight reaction and can induce a good and lasting immune response and protective effect in the body. [0003] The stabilizer used in the current live attenuated varicella vaccine is a phosphate buffer solution containing sodium glutamate, sucrose and gelatin. The ge...

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Problems solved by technology

[0003] The stabilizer used in the current live attenuated varicella vaccine is a phosphate buffer solution containing sodium glutamate, sucrose and gelatin. The gelatin component is an animal-derived excipient, which not only easily causes allergic reactions, but also has the potential to infect animal-derived viruses. Hidden danger

However, in the preparation process of the freeze-dried preparation, if there is a lack of gelatin, the freeze-dried scaffold will be insufficiently established, the preparation will be in the form of a thin film, and the water evaporation of the freeze-dried preparation will be less, which will easily lead to the death of the attenuated virus strain. Vaccine formulations prepared in this way are extremely unstable

[0004] At present, in the prior art, there are also attempts to develop various vaccine preparations to replace gelatin. However, the newly added preparations have caused more serious side effects than gelatin. For example, the combination of dextran and trehalose causes occasional allergic reactions such as Side effects such as hives, itchy skin, fever, nausea, and vomiting

Therefore, gelatin-free varicella preparations have not been available on the market so far

Therefore, there is still no varicella vaccine preparation adjuvant that can reasonably replace gelatin, which can achieve the same virus strain stability and make it safer

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