Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Novel freeze-drying protective additive for duck virus hepatitis live vaccines

A technology of duck viral hepatitis and freeze-drying protective agent, which is applied to antiviral agents, freeze-dried delivery, and medical preparations of non-active ingredients, etc., which can solve the problems of large loss of antigenic activity, difficulties in vaccine storage and transportation, and thermal stability of vaccines Sexuality and antigenic activity protection ability is not strong

Active Publication Date: 2013-12-04
兆丰华生物科技(南京)有限公司
View PDF1 Cites 6 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the main components of freeze-dried protective agents for live animal vaccines in China are milk, sucrose, gelatin, etc. Although the products prepared by using them as protective agents have stable appearance, good solubility, and low cost, they are harmful to the thermal stability and antigenic activity of vaccines. The protective ability is not strong. For some vaccines, the antigenic activity is greatly lost during the freeze-drying process. Most of the products need to be stored below -15°C, and the storage period is only about 1 year, which brings great difficulties to the storage and transportation of vaccines.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Novel freeze-drying protective additive for duck virus hepatitis live vaccines
  • Novel freeze-drying protective additive for duck virus hepatitis live vaccines
  • Novel freeze-drying protective additive for duck virus hepatitis live vaccines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] ——Preparation of antigen for duck viral hepatitis live vaccine (A66 strain)

[0036] Take the virus seed of duck hepatitis virus A66 strain used for production and dilute it 100 times with sterilized physiological saline, inoculate the allantoic cavity of well-developed 9-10-day-old SPF chicken embryos, 0.2ml per embryo, seal the holes, and place at 36-37°C Continue to incubate, and discard the chicken embryos that died before 36 hours. After 36 hours, light the eggs every 4-8 hours, take out the dead chicken embryos within 72 hours at any time, and cool them at 4-8°C. Take out the chicken embryos that have been cooled for 4 to 24 hours, disinfect the air chamber with tincture of iodine, remove the eggshells with aseptic surgery, and collect the chorioallantoic membrane, embryo fluid (allantoic fluid and amniotic fluid) and fetuses from diseased chicken embryos. Chicken embryos were mixed into one group, homogenized at high speed to make a suspension, placed in a steri...

Embodiment 2

[0038] ——Preparation of protective agent and preparation of vaccine (1)

[0039] The new lyoprotectant consists of the following components in terms of weight percentage: trehalose 2, glucose 1%, glycine 3%, D-sorbitol 1%, polyvinylpyrrolidone (PVP-k30) 1%, gelatin 0.8%, the balance For injection water. Dissolve the above substances completely, and sterilize by autoclaving at 116°C for 30 minutes.

[0040] Take the new lyoprotectant and the 5% sucrose skimmed milk protectant used for the control, mix them with the qualified duck viral hepatitis antigen solution at a volume ratio of 1:1, and pack them into 7ml vials, 2ml per bottle , half stoppered with butyl rubber three-pronged plug, put it into a freeze dryer box pre-cooled to 5°C, lower the temperature to -45°C at a speed of 0.5°C / min, keep the vaccine for 4 hours to freeze the vaccine, and vacuum to 5Pa Then, raise the temperature to 15°C at a rate of 1°C / min and maintain at this temperature for 12 hours, then raise the ...

Embodiment 3

[0042] ——Preparation of protective agent and preparation of vaccine (2)

[0043] The new lyoprotectant consists of the following components in terms of weight percentage: trehalose 3.5%, glucose 2%, glycine 5.5%, D-sorbitol 2%, polyvinylpyrrolidone (PVP-k30) 2%, gelatin 1%, plus Water for injection to 100%. Dissolve the above substances completely, and sterilize by autoclaving at 116°C for 30 minutes.

[0044] Take the new lyoprotectant and the 5% sucrose skimmed milk protectant used for the control, mix them with the qualified duck viral hepatitis antigen solution at a volume ratio of 1:1, and pack them into 7ml vials, 3ml per bottle , half-stopped with butyl rubber three-pronged plug, put it into a freeze dryer box pre-cooled to 5°C, lower the temperature to -45°C at a rate of 0.75°C / min, keep it for 5 hours to freeze the vaccine, and then vacuum to 5Pa Afterwards, raise the temperature to 15°C at a rate of 1°C / min, maintain at this temperature for 13.5 hours, then raise t...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to a novel freeze-drying protective additive for duck virus hepatitis live vaccines. The novel freeze-drying protective additive has the advantages that the vaccine is low in loss of antigen activity during freeze drying, and the problem that the duck hepatitis virus is sensitive to the freeze drying is effectively solved; the duck virus hepatitis vaccines freeze-dried by the protective additive are good in heat resistance, and storage life thereof is longer than 24 months at the temperature of 2-8 DEG C, good activity is still maintained in ten days after a resistance aging test at the temperature of 37 DEG C, so that the problem of a strict low-temperature cold chain of the vaccines upon storage and transportation is solved, and meanwhile vaccine storage and transportation costs are greatly lowered.

Description

technical field [0001] The invention relates to a novel freeze-drying protectant for duck viral hepatitis live vaccine, which belongs to the technical field of veterinary biological product manufacturing. Background technique [0002] Duck viral hepatitis (DVH) is an acute, severe and highly fatal infectious disease of ducklings caused by duck hepatitis virus (DHV), characterized by hemorrhagic inflammation of the liver. Duck hepatitis mainly occurs in ducklings less than 3 weeks old. The onset is sudden and the spread is rapid. The morbidity and mortality can reach more than 90%. Since Levine and Fabricant first isolated type 1 duck hepatitis virus from Long Island diseased ducklings in New York in 1950, there are currently three known viruses that cause duck hepatitis, namely type 1, type 2 and type 3 duck hepatitis virus. Among them, duck hepatitis virus type 1 belongs to Picornaviridae, and duck hepatitis virus types 2 and 3 belong to Astroviridae. The three viruses ar...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K47/42A61K47/26A61K47/18A61K47/10A61K47/32A61K39/29A61K39/125A61K9/19A61P31/14
Inventor 张小飞黄显明
Owner 兆丰华生物科技(南京)有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products