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

A technology for freeze-dried preparations and vaccines, which can be used in freeze-dried transportation, antiviral agents, and pharmaceutical formulations, and can solve problems such as insufficient establishment of freeze-dried scaffolds, easy allergic reactions, and potential safety hazards of animal-derived viruses.

Inactive Publication Date: 2016-05-18
SHANGHAI INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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

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preparation example Construction

[0064] The preparation of the vaccine stabilizer of the present invention can be carried out according to pharmaceutically acceptable conventional methods. For example, each component in the vaccine stabilizer is mixed according to its specific acceptable concentration, and the pH value is adjusted, so that the pH value of the vaccine preparation is maintained at 7 after reconstitution of the lyophilized preparation.

[0065] buffer

[0066] The buffer that can be used in the lyophilized formulation of the varicella vaccine of the present invention is not particularly limited, and can be any buffer that makes the lyophilized formulation of the varicella vaccine of the present invention have a pH of 7.0 after reconstitution. Preferably, the buffer that can be used in the present invention is PBS (phosphate) buffer. Contains sodium chloride, potassium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phospha...

Embodiment 1

[0095] Embodiment 1 No gelatin stabilizer to the protective effect of vaccine stock solution

[0096] 1.1 Relevant quality indicators of vaccine stock solution

[0097] Table 2 shows that the virus titer of the stock solution of varicella live attenuated vaccine prepared with 4 kinds of gelatin-free stabilizers (B, C, D, E formula) is basically the same as that of the vaccine stock solution prepared with gelatin stabilizer (A formula), both It meets the requirements of the regulations; the identification test, abnormal toxicity test, sterility test and mycoplasma test of the five vaccine stock solutions are all qualified. Studies have shown that 4 gelatin-free stabilizer formulations have protective effects on the stock solution of live attenuated varicella vaccine.

[0098] The test results of relevant quality indicators of 25 kinds of varicella live attenuated vaccine stock solutions

[0099]

[0100] 1.2 Virus stability test of vaccine stock solution

[0101] The vacc...

Embodiment 2

[0106] Embodiment 2 No gelatin stabilizer to the protective effect of vaccine finished product

[0107] 2.1 Relevant quality indicators of finished vaccine products

[0108] 2.1.1 Appearance

[0109] According to the "Registration Standards for Varicella Live Attenuated Vaccines", the inspection of 5 kinds of finished vaccines shows that ( figure 1 ), the appearance of five kinds of vaccines after freeze-drying was white loose body, smooth surface, no shrinkage, foaming and swelling. After adding sterilized water for injection, it dissolves rapidly, and no foreign matter appears. Except for the use of gelatin-containing stabilizer, vaccine A was pale yellow after dissolving, and the rest of the vaccines were slightly white after dissolving due to the use of no gelatin stabilizer.

[0110] 2.1.2 Short-term thermal stability of finished product

[0111] The thermal stability test results (Table 4) of short-term storage at room temperature show that the virus titers of the fi...

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PUM

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/25A61K9/19A61P31/22
Inventor 马相虎王亮杨月莲周锋谢蕾
Owner SHANGHAI INST OF BIOLOGICAL PROD CO LTD
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