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Split encephalitis B virus vaccine and method for preparing the same

A technology of Japanese encephalitis virus and Japanese encephalitis, applied in the field of preparation of virus split vaccine

Active Publication Date: 2007-03-21
复星安特金(成都)生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The live attenuated vaccine uses non-clean primary hamster kidney cells as the vaccine culture substrate, which is difficult to avoid the contamination of exogenous factors of mouse origin, and this possible contamination is difficult to detect with current biological methods

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Lysis, Extraction and Purification of Japanese Encephalitis Virus Particles and Preparation of Vaccine

[0038] Type SA 14 ,P 3 strain. The Vero cells were cultured at 37°C and passed through four consecutive passages. After the 4th passage cells are cultured for 3-5 days, they are rinsed with phosphate buffer, and the inoculation virus titer is not less than 7.5LgLD 50 / ml Japanese encephalitis virus, and added to the cell maintenance solution at 35 ℃, cultured for 24 hours. Replace with fresh cell maintenance solution, and continue culturing for 2-4 days according to the above conditions. When the cytopathic pathology (CPE) reaches ++~+++, harvest and combine the virus solution. After the sample was reserved, 20% formaldehyde was added to make the final concentration 0.05%, and the virus was inactivated at 22°C for 8 days. After passing the inactivation test, it was concentrated by ultrafiltration with a 100KD filter membrane. 10 mg / ml protamine sulfate was adde...

Embodiment 2

[0040] Lysis, Extraction and Purification of Japanese Encephalitis Virus Particles and Preparation of Vaccine

[0041] Type SA 14 ,P 3 strain. The Vero cells were cultured at 37°C and passed through four consecutive passages. After the 4th passage cells are cultured for 3-5 days, they are rinsed with phosphate buffer, and the inoculation virus titer is not less than 7.5LgLD 50 / ml Japanese encephalitis virus, and added to the cell maintenance solution at 35 ℃, cultured for 24 hours. Replace with fresh cell maintenance solution, and continue culturing for 24 days according to the above conditions. When the cytopathic pathology (CPE) reaches ++~+++, harvest and combine the virus solution. After the sample was reserved, 20% formaldehyde was added to make the final concentration 0.05%, and the virus was inactivated at 22°C for 8 days. After passing the inactivation test, it was concentrated by ultrafiltration with a 300KD filter membrane. Add 10 mg / ml protamine sulfate to th...

Embodiment 3

[0043] Preparation of Japanese Encephalitis Virus Split Vaccine Absorbed by Aluminum Adjuvant

[0044] According to the virus protein content of Japanese encephalitis virus split vaccine stock solution, add sterilized non-pyrogenic aluminum hydroxide adjuvant to the vaccine stock solution. Add slowly and mix well to form a uniformly distributed suspension, pH 7.0-8.0. Each dose contains 70 μg of viral protein, aluminum hydroxide ≤ 0.70 mg, 0.5 ml per dose, and the vaccine is divided into packages.

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Abstract

The invention relates to a Japanese B encephalitis virus split vaccine and its preparation process. The method includes the steps: splitting the whole Japanese B encephalitis virus powder by chemical method, extracting and purifying virus envelope and spike containing fragment, adding aluminim adjuvant.

Description

technical field [0001] The invention relates to a split vaccine of Japanese encephalitis virus. Specifically, the present invention relates to a Japanese encephalitis virus split vaccine that is extracted by chemically splitting the whole virus particle of Japanese encephalitis, and then adding an adjuvant such as aluminum salt to a fragment containing the virus envelope and spikes. . The split virus vaccine can prevent Japanese encephalitis disease caused by Japanese encephalitis virus infection in infants, children, teenagers and adults. The invention also relates to the preparation method of the virus split vaccine. Background technique [0002] Japanese encephalitis is an infectious disease caused by acute viral infection of the central nervous system. The annual incidence rate in endemic areas is as high as 100-100 / 100,000. Nearly 3 billion people live in Japanese encephalitis endemic areas. In this area, more than 100,000 newborns are born every year. 70 million. A...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/12A61P31/12
CPCY02A50/30
Inventor 薛平
Owner 复星安特金(成都)生物制药有限公司