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Freeze-dried attenuated live vaccine for hepatitis A and its preparing process

A technology of live attenuated vaccines and hepatitis A, applied in antiviral agents, pharmaceutical formulas, medical preparations with non-active ingredients, etc., can solve problems such as low virus titer and large loss of vaccine activity, and achieve clear formula components , good safety and immunogenicity, good thermal stability

Active Publication Date: 2012-03-28
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when using the prior art to freeze-dry the vaccine, because the hepatitis A virus is relatively sensitive to heat, the activity of the vaccine is greatly lost during the freeze-drying process, and the virus titer is very low after freeze-drying

Method used

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  • Freeze-dried attenuated live vaccine for hepatitis A and its preparing process
  • Freeze-dried attenuated live vaccine for hepatitis A and its preparing process
  • Freeze-dried attenuated live vaccine for hepatitis A and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The lyoprotectant consists of the following ingredients: 2 grams of trehalose, 3.5 grams of glycine, dissolved in pure water to 100 ml;

[0042] According to the volume ratio of hepatitis A live attenuated vaccine: lyoprotectant = 1:0.5, add the above-mentioned lyoprotectant to the hepatitis A live attenuated vaccine, mix and pack in vials, 0.5ml per bottle , put it into the chamber of the lyophilizer after half stoppering, lower the temperature to -40°C at a rate of 0.4°C / min, and maintain it for 4 hours; then raise the temperature to -15°C at a rate of 0.8°C / min; Vacuumize for 8 hours to maintain the temperature of the partition at -15°C; then raise the temperature to 25°C at a rate of 1.4°C / min, maintain for 8 hours, and finally press the plug and take it out of the box to obtain the freeze-dried live attenuated hepatitis A vaccine.

Embodiment 2

[0044] The lyoprotectant consists of the following ingredients: 5 grams of trehalose, 9 grams of glycine, dissolved in pure water to 100 ml;

[0045] According to the volume ratio of hepatitis A live attenuated vaccine: lyoprotectant = 1:1, add the above-mentioned lyoprotectant to the hepatitis A live attenuated vaccine, mix and pack in vials, 0.5ml per bottle , put it into the chamber of the lyophilizer after half stoppering, lower the temperature to -40°C at a rate of 0.5°C / min, and maintain it for 6 hours; then raise the temperature to -15°C at a rate of 1°C / min; Vacuum the vacuum for 10 hours, and maintain the temperature of the partition at -15°C; then raise the temperature to 25°C at a rate of 1.5°C / min, and maintain it for 8 hours; finally press the plug and take it out of the box to obtain the freeze-dried live attenuated hepatitis A vaccine.

Embodiment 3

[0047] The lyoprotectant consists of the following ingredients: 10 grams of trehalose, 16 grams of glycine, dissolved in pure water to 100 ml;

[0048] According to the volume ratio of hepatitis A live attenuated vaccine: lyoprotectant = 1:1, add the above-mentioned lyoprotectant to the hepatitis A live attenuated vaccine, mix and pack in vials, 0.5ml per bottle , put it into the chamber of the lyophilizer after half stoppering, lower the temperature to -40°C at a rate of 0.5°C / min, and maintain it for 6 hours; then raise the temperature to -15°C at a rate of 1°C / min; Vacuum the vacuum for 10 hours, and maintain the temperature of the partition at -15°C; then raise the temperature to 25°C at a rate of 1.5°C / min, and maintain it for 8 hours; finally press the plug and take it out of the box to obtain the freeze-dried live attenuated hepatitis A vaccine.

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Abstract

The invention relates to a freeze-dried live attenuated hepatitis A vaccine and the preparation method thereof. The vaccine comprises the following raw materials: the live attenuated hepatitis A vaccine and a freeze-drying protective agent with the volume ratio being 1:(0.5 to 1.5), wherein the composition of the freeze-drying protective agent, namely, the mixed aqueous solution of trehalose and glycocoll, is as follows: trehalose is 2 to 10 grams / 100 milliliters, glycocoll is 3.2 to 16 grams / 100 milliliters, and the solvent is water, wherein the mass ratio between solute glycocoll and trehalose is higher than or equal to 1.6. After the vaccine and the freeze-drying protective agent are mixed, the freeze-dried live attenuated hepatitis A vaccine is prepared by adopting the freeze-dry technology. Compared with the prior aqueous vaccine, the freeze-dry live attenuated hepatitis A vaccine has the advantages that the infectious titer is not obviously changed, but the heat stability isvisibly improved, and animal experiments prove that the freeze-dry live attenuated hepatitis A vaccine has good security and immunogenicity. The effective period of the freeze-dry live attenuated hepatitis A vaccine can be prolonged to 18 months, but the effective period of the aqueous type is only 6 months, and thereby the freeze-dry live attenuated hepatitis A vaccine has great economic benefitand application value.

Description

technical field [0001] The invention relates to a freeze-dried live attenuated hepatitis A vaccine and a preparation method thereof, belonging to the technical field of biological products. Background technique [0002] Hepatitis A vaccine is an effective means of preventing hepatitis A. At present, the hepatitis A vaccines produced at home and abroad (including inactivated vaccines and live attenuated vaccines) are all in liquid dosage form, and their basic feature is that they must rely on the cold chain system to ensure their quality during storage and transportation. As a developing country with a large population, an underdeveloped economy, a complex geographical environment, and inconvenient transportation, it is difficult for the live attenuated hepatitis A vaccine in liquid dosage form to be kept in a strict cold chain environment during storage and transportation, which often affects the vaccine. the quality of. The use of freeze-drying technology to make the live...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/29A61K47/26A61K47/42A61P1/16A61P31/14A61K47/18
CPCY02A50/30
Inventor 胡云章胡凝珠任万军王海漩
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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