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Aluminum hydroxide adjuvant and preparation method and application thereof

A technology of aluminum hydroxide and sodium hydroxide, applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, antibody medical ingredients, etc., can solve the problem of affecting the adsorption rate and sedimentation rate of adjuvants, high equipment and energy requirements, high temperature repeated Dealing with and other issues to achieve the effects of reducing production costs, reducing energy consumption, and simplifying the preparation process

Pending Publication Date: 2020-04-14
SHENZHEN KANGTAI BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the inventor found in the process of implementing the present invention that the preparation process of the aluminum hydroxide adjuvant in the prior art is relatively complicated, and the preparation process requires repeated high-temperature treatment, which requires high equipment and energy.
And the aluminum hydroxide adjuvant is an amorphous weak crystal boehmite, high temperature is easy to make it deprotonated and dehydrated, which in turn affects its specific surface area, thus affecting the adsorption rate and sedimentation rate of the adjuvant

Method used

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  • Aluminum hydroxide adjuvant and preparation method and application thereof
  • Aluminum hydroxide adjuvant and preparation method and application thereof
  • Aluminum hydroxide adjuvant and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0043] Weigh disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and sodium chloride and dissolve them in water for injection, adjust the pH to 7.0, filter and subpackage to obtain pH7.0 phosphate buffer; weigh KAl(SO 4 )·12H 2 O was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.21mol / L aluminum potassium sulfate solution; weighed sodium hydroxide was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.5mol / L sodium hydroxide solution. Prepare tanks for CIP and SIP, and cool to 2-8°C under temperature control.

[0044] Add 160kg pH7.0 phosphate buffer solution into the preparation tank, stir at 80rpm, add 56.5kg of 0.21mol / L aluminum potassium sulfate solution at a speed of 4kg / min, and add 0.5mol / L sodium hydroxide at a speed of 4.0kg / min Solution 54.5kg; adjust the pH to 6.5-7.2, and continue stirring for no less than 30 minutes.

[0045] After standing under controlled pressure, remove the su...

Embodiment 2

[0050] Weigh disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and sodium chloride and dissolve them in water for injection, adjust the pH to 7.0, filter and subpackage to obtain pH7.0 phosphate buffer; weigh KAl(SO 4 )·12H 2O was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.21mol / L aluminum potassium sulfate solution; weighed sodium hydroxide was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.5mol / L sodium hydroxide solution. Prepare tanks for CIP and SIP, and cool to 2-8°C under temperature control.

[0051] Add 170kg pH7.0 phosphate buffer solution into the preparation tank, stir at 80rpm, add 60kg of 0.21mol / L aluminum potassium sulfate solution at a speed of 3.9kg / min, and add 0.5mol / L sodium hydroxide solution at a speed of 4kg / min 58kg; adjust the pH to 6.5-7.2, and continue stirring for no less than 30 minutes.

[0052] After standing under controlled pressure, remove the superna...

Embodiment 3

[0057] Weigh disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and sodium chloride and dissolve them in water for injection, adjust the pH to 7.0, filter and subpackage to obtain pH7.0 phosphate buffer; weigh KAl(SO 4 )·12H 2 O was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.21mol / L aluminum potassium sulfate solution; weighed sodium hydroxide was dissolved in water for injection, sterile filtered and subpackaged to obtain a 0.5mol / L sodium hydroxide solution. Prepare tanks for CIP and SIP, and cool to 2-8°C under temperature control.

[0058] Add 170kg pH7.0 phosphate buffer solution into the preparation tank, stir at 80rpm, add 60kg of 0.21mol / L aluminum potassium sulfate solution at a speed of 6.1kg / min, and add 0.5mol / L sodium hydroxide solution at a speed of 4kg / min 58kg; adjust the pH to 6.5-7.2, and continue stirring for no less than 30 minutes.

[0059] After standing under controlled pressure, remove the supern...

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Abstract

The embodiment of the invention discloses an aluminum hydroxide adjuvant and a preparation method and application thereof. The preparation method comprises the following steps: controlling the temperature in a preparation tank to be 1-10 DEG C after sterilizing the tank; adding 50-200 parts by weight of a phosphate buffer solution into the preparation tank, adding 10-80 parts by weight of an aluminum salt solution under a stirring condition, and adding a sodium hydroxide solution to adjust the pH value to 6.5-7.2; standing and discarding a supernatant after stopping stirring, and changing theliquid for at least one time; and adjusting the pH value to 6.8-7.2, and carrying out aseptic subpackaging to obtain the aluminum hydroxide adjuvant. The preparation process can be remarkably simplified, the production cost is reduced, the energy loss is reduced, and the adsorption rate and the sedimentation rate are increased.

Description

technical field [0001] The invention relates to the field of vaccine preparation technology, in particular to an aluminum hydroxide adjuvant and its preparation method and application. Background technique [0002] Aluminum hydroxide adjuvant, as an aluminum adjuvant widely used in vaccine preparations, can greatly improve the immunogenicity of vaccines. Aluminum hydroxide adjuvant The adsorption capacity of aluminum hydroxide adjuvant is one of the key indicators in vaccine preparation. The higher the adsorption rate, the more antigens can be absorbed per unit area, and the more obvious the immune effect will be. [0003] However, the inventors found in the process of implementing the present invention that the preparation process of the aluminum hydroxide adjuvant in the prior art is relatively complicated, and the preparation process requires repeated high-temperature treatment, which requires high equipment and energy. And the aluminum hydroxide adjuvant is an amorphous...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61P37/04
CPCA61K39/39A61P37/04A61K2039/55505
Inventor 刘鹏祝孟杰李进唐敏钟晓勇辛集包刘海涛
Owner SHENZHEN KANGTAI BIOLOGICAL PROD
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