A kind of freeze-drying method of live vaccine

A drying method, vacuum freeze-drying technology, applied in the direction of drying solid materials, drying solid materials without heating, drying, etc., can solve the problems of unstable quality, large loss of potency, high rejection rate, and achieve uniform sublimation rate. Effect

Active Publication Date: 2019-04-26
SICHUAN HUAPAI BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the above-mentioned deficiencies in the prior art, the present invention provides a freeze-drying method for live vaccines, which can effectively solve the problems of poor physical properties, large potency loss, unstable quality, waste products, etc. High rate defects

Method used

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  • A kind of freeze-drying method of live vaccine
  • A kind of freeze-drying method of live vaccine
  • A kind of freeze-drying method of live vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of freeze-drying method of porcine transmissible gastroenteritis, epidemic diarrhea virus dual live vaccine, comprises the following steps: the porcine transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) two Add the seed virus liquid into the seedling matching tank, control the temperature in the tank at 10°C, stir evenly, add heat-resistant protective agent, continue stirring evenly, and then divide it into 10ml vials, 2.6ml per bottle. While filling, the temperature of the plate layer is controlled at about 0°C; after the filling is completed, the machine will automatically half stopper, then put the filled product into the suction chassis and send it to the freeze-drying box in time, close the box door, and use 10min Time to reduce the temperature of the plate fluid of the vacuum freeze dryer to -43°C, keep it for 5 hours, and then start vacuuming, when the vacuum degree reaches below 15Pa, start to heat up; when the temper...

Embodiment 2

[0033] A kind of freeze-drying method of porcine transmissible gastroenteritis, epidemic diarrhea virus dual live vaccine, comprises the following steps: the porcine transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) two Add the seed virus liquid into the seedling matching tank, control the temperature in the tank at 10°C, stir evenly, add heat-resistant protective agent, continue stirring evenly, and then divide it into 10ml vials, 2.6ml per bottle. While filling, the temperature of the plate layer is controlled at about 0°C; after the filling is completed, the machine will automatically half stopper, then put the filled product into the suction chassis and send it to the freeze-drying box in time, close the box door, and use 10min Time to reduce the temperature of the plate fluid of the vacuum freeze dryer to -23°C and keep it for 1.5h; cool the product at a rate of 1°C / h and drop it to -25°C; adjust the temperature in the vacuum freeze ...

Embodiment 3

[0036]A kind of freeze-drying method of porcine transmissible gastroenteritis, epidemic diarrhea virus dual live vaccine, comprises the following steps: the porcine transmissible gastroenteritis (SCJY-1 strain) and epidemic diarrhea virus (SCSZ-1 strain) two Add the seed virus liquid into the seedling matching tank, control the temperature in the tank at 10°C, stir evenly, add heat-resistant protective agent, continue stirring evenly, and then divide it into 10ml vials, 2.6ml per bottle. While filling, the temperature of the plate layer is controlled at about 0°C; after the filling is completed, the machine will automatically half stopper, then put the filled product into the suction chassis and send it to the freeze-drying box in time, close the box door, and use 10min Time to reduce the temperature of the plate fluid of the vacuum freeze dryer to -16°C and keep it for 2 hours; then lower the temperature of the product at a rate of 1°C / h to -25°C; adjust the temperature in the...

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Abstract

The invention discloses a freezing-drying method for live vaccine. The freezing-drying method comprises the steps that the eutectic point range of a to-be-frozen and to-be-dried vaccine is tested, then, the live vaccine is placed in a vacuum freezing-drying machine pre-cooled to 0+ / -1 DEG C, when the temperature of a plate layer of the vacuum freezing-drying machine is reduced to be higher than the eutectic point of the live vaccine by 1-2 DEG C, the current state is kept for 1-2 h, and continuous cooling is conducted with the rate of 1 DEG C / h till all vaccine is frozen; and cooling is immediately conducted to the temperature needed for sublimation, and finally vacuum sublimation is conducted according to the normal procedure. The product obtained through the method is not provided with large ice crystals, sublimation is easy, and after freezing-drying, a good product physical behavior can be obtained, and the freezing-drying titer losses are minimal.

Description

technical field [0001] The invention belongs to the technical field of cryoprotection of vaccines, and in particular relates to a freeze-drying method of live vaccines. Background technique [0002] Porcine epidemic diarrhea and porcine transmissible gastroenteritis are widespread worldwide, especially in Asian countries such as Korea, Japan and China. Porcine epidemic diarrhea and porcine transmissible gastroenteritis can reduce the survival rate of pigs, poor uniformity, slow growth, reduce weight gain, delay the time to market, reduce feed utilization, increase additional consumption, and reduce their immunity. Increase the susceptibility to bacteria and virus, increase the incidence rate, make it dehydrated, shock and even die, etc., which have brought serious economic losses to the pig industry. [0003] In order to effectively control porcine epidemic diarrhea and porcine transmissible gastroenteritis, my country has developed a dual live vaccine for the prevention an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): F26B5/06A61K39/225A61K39/215A61P31/14
Inventor 吴越李宇周应辉万成燕池波邱良栋
Owner SICHUAN HUAPAI BIO PHARMA
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