Method for preparing tetanus toxoid vaccine

A tetanus toxoid and tetanus technology, applied in the direction of bacterial antigen components, antibacterial drugs, etc., can solve the problems of inconvenient refining operation, process that does not meet the requirements of GMP, and easy blockage of filter plates, so as to reduce antigen damage and shorten preparation Time, reduce the effect of channel clogging

A tetanus toxoid and tetanus technology, applied in the direction of bacterial antigen components, antibacterial drugs, etc., can solve the problems of inconvenient refining operation, process that does not meet the requirements of GMP, and easy blockage of filter plates, so as to reduce antigen damage and shorten preparation Time, reduce the effect of channel clogging

CN102961741AActive Publication Date: 2013-03-13WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Method for preparing tetanus toxoid vaccine
  • Method for preparing tetanus toxoid vaccine
  • Method for preparing tetanus toxoid vaccine

Examples

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Comparison scheme
Effect test

Embodiment 1

[0016] A preparation method of tetanus toxoid vaccine, comprising the following steps:

[0017] 1) Tetanus toxoid culture

[0018] The bacterial classification adopted is Clostridium tetani, derived from China Food and Drug Control Research Institute, and the bacterial number is CMCC64008, which is used after passing the test. Means to ferment the strain, cultivate it in a seed tank at 34-36°C for 40 hours, the size of the seed tank is 50L, and then transfer it to a large tank for cultivation, adopt a 1000L fermentation system, culture at a temperature of 34-36°C, and cultivate 67 The culture was stopped after 1 hour. After the fermentation is completed, add formaldehyde solution until the final concentration of formaldehyde is 0.35% (V / V), and keep warm for 30 minutes at 30~35°C.

[0019] 2) Separation of bacterial liquid

[0020] Take 50L of tetanus toxoid culture solution (73Lf / ml), with NaHCO 3 Adjust the pH to 6.9, and press filter with a plate and frame filter (model...

Embodiment 2

[0035] A preparation method of tetanus toxoid vaccine, comprising the following steps:

[0036] 1) Tetanus toxoid culture

[0037] The culture method is the same as in Example 1.

[0038] 2) Separation of bacterial liquid

[0039] Get 50L tetanus toxoid culture fluid (68Lf / ml), with NaHCO 3 Adjust the pH to 7.5, and use a filter press to remove bacteria under the condition that the pressure is not greater than 0.1Mp.

[0040] 3) Concentration by ultrafiltration

[0041] The filtrate is collected, and the filtrate is concentrated by tangential flow ultrafiltration with an ultrafiltration system of a 40KD ultrafiltration membrane. The steps of the ultrafiltration concentration are:

[0042] Connect the ultrafiltration system and the refining tank, connect the inlet of the ultrafiltration system, the return port and the waste liquid port respectively, and open the ultrafiltration system;

[0043] Confirm that all the valves of the system are open, adjust the frequency conver...

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Abstract

The invention discloses a method for preparing a tetanus toxoid vaccine. According to the process, with clostridium tetani strains as raw materials, the tetanus toxoid vaccine is prepared through the following steps of: culturing of tetanus toxoid, bacterium liquid separation, ultrafiltration and concentration, salting out, ultrafiltration desalting and the like. According to the method, firstly culture liquid is subjected to virus-free treatment and then refined, so that the porous channel plugging caused by accumulation of thalli and other impurity segments at a plate and frame membrane package during plate and frame filtering to remove thalli is reduced, and the smoothness during filtration is increased; toxoid protein and other allergens in the culture liquid are removed by changing the salting-out method; and as the desalting methods of the culture liquid after concentration and salting out adopt the tangential flow ultrafiltration method, the destruction of antigen caused by shearing of toxoid protein is reduced, and the protein precipitation is avoided. By utilizing the method, the time for preparing the tetanus toxoid vaccine is shortened, and the production efficiency is improved.

Description

technical field [0001] The invention relates to a preparation method of a tetanus toxoid vaccine. Background technique [0002] Tetanus toxoid is a protein produced by Clostridium tetani and secreted outside the bacteria. It consists of 1315 amino acids and has a molecular weight of 150-700Da. The original tetanus toxoid was originally used for human immunization. This toxoid has a good immune effect, but the side effects after vaccination are very large, and there are even cases of death from anaphylactic shock. This is mainly due to the existence of a large number of incompletely hydrolyzed protein components in the original toxoid, which cause allergic reactions. In order to reduce the side effects of vaccination, Ramon refined and purified the original tetanus toxoid in 1923, and prepared a refined tetanus toxoid. Observations by use showed that the side effects of the refined tetanus toxoid were significantly less than those of the original toxoid after vaccination. ...

Claims

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Application Information

Patent Timeline
13 Mar 2013
Publication
CN102961741A
IPC
A61K39/08; A61P31/04
Inventors
李佩珊; 陈亮