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Preparation method of aluminum hydroxide adjuvant

A technology of aluminum hydroxide and adjuvant, applied in the field of preparation of aluminum hydroxide adjuvant, can solve the problems of affecting immune effect, weakening antigen presentation, and unfavorable batch-to-batch consistency control.

Pending Publication Date: 2021-10-29
CHENGDU INST OF BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The production of adjuvants by the sodium hydroxide method is mainly the reaction of sodium hydroxide and aluminum trichloride solution. The adjuvant produced by the commercial sodium hydroxide method has a large particle size, which is formed by the aggregation of fibrous primary particles of 4.5×2.2×10nm 1-10um secondary particles, studies have reported that when the particle size of the adjuvant and antigen conjugate becomes larger, the presentation of the antigen by the antigen-presenting cells is weakened, which affects the immune effect
The particle size of the aluminum hydroxide adjuvant produced by the ammonia method is small, which is nano-scale. However, in the production of the ammonia method adjuvant, ammonia water is added to the aluminum chloride solution in a flow-feed manner, and many large particles will be generated at the moment of contact. Particulate matter, after dialysis and high pressure, the precipitation of non-alumina hydroxide is formed, which leads to large differences in the appearance and particle size of the adjuvant between batches, which affects the quality of the adjuvant and is not conducive to the consistency control between batches

Method used

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  • Preparation method of aluminum hydroxide adjuvant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1, the preparation of aluminum trichloride adjuvant of the present invention

[0028] 1) Preparation of aluminum chloride solution: take AlCl 3 ·6H 2 O was dissolved in water for injection to make a concentration of 0.04g / ml aluminum chloride solution, which was poured into the preparation container through a filter.

[0029] 2) Preparation of ammonia solution: take ammonia solution with a concentration of 25-28%, add 3 times the volume of water for injection to dilute, and mix well;

[0030] 3) Take the aluminum chloride solution prepared in step 1), heat it to 60° C., stir at a speed of 200 rpm, and simultaneously add the ammonia solution in step 2) in the form of a spray, wherein the speed of the pump in the spray equipment is 20 rpm, when three When the pH value of the aluminum chloride solution exceeds 4.4, adjust the rotating speed of the pump in the spray equipment to be 9rpm until the pH value of the aluminum chloride solution is 6.50, leave it for ...

Embodiment 2

[0031] Embodiment 2, the preparation of aluminum trichloride adjuvant of the present invention

[0032] 1) Preparation of aluminum chloride solution: take AlCl 3 ·6H 2 O is dissolved in water for injection, and making concentration is the aluminum trichloride solution of 0.04g / ml, squeezes in the preparation container by filter;

[0033] 2) Preparation of ammonia solution: take ammonia solution with a concentration of 25-28%, add 3 times the volume of water for injection to dilute, and mix well;

[0034] 3) Take the aluminum chloride solution prepared in step 1), heat it to 60° C., stir at a speed of 200 rpm, and simultaneously add the ammonia solution in step 2) in the form of a spray, wherein the speed of the pump in the spray equipment is 20 rpm, when three When the pH value of the aluminum chloride solution exceeds 4.4, adjust the rotating speed of the pump in the spray equipment to be 9rpm until the pH value of the aluminum chloride solution is 6.60, leave it for 21 hou...

Embodiment 3

[0035] Embodiment 3, the preparation of aluminum trichloride adjuvant of the present invention

[0036] 1) Preparation of aluminum chloride solution: take AlCl 3 ·6H 2 O is dissolved in water for injection, and making concentration is the aluminum trichloride solution of 0.04g / ml, squeezes in the preparation container by filter;

[0037] 2) Preparation of ammonia solution: take ammonia solution with a concentration of 25-28%, add 3 times the volume of water for injection to dilute, and mix well;

[0038] 3) Take the aluminum chloride solution prepared in step 1), heat it to 60° C., stir at a rotating speed of 200 rpm, and simultaneously add the aqueous ammonia solution in step 2) in a spray form, wherein the rotating speed of the pump in the spraying device is 20 rpm, when three When the pH value of the aluminum chloride solution exceeds 4.4, adjust the rotating speed of the pump in the spray equipment to be 9rpm until the pH value of the aluminum chloride solution is 6.78, ...

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Abstract

The invention discloses a preparation method of an aluminum hydroxide adjuvant. The preparation method comprises the step of: adding ammonia water into an aluminum trichloride solution in a spray form until the pH value of the solution is 6.4-6.8. According to the method for preparing the aluminum hydroxide adjuvant, which is disclosed by the invention, the ammonia water is added into the aluminum trichloride solution in a spray form, so that the reaction of the ammonia water and the aluminum trichloride is more uniform, and the formed non-hydroxyl aluminum oxide large-particle substances are obviously reduced; meanwhile, the ammonia water and the aluminum trichloride solution fully react with each other by controlling the terminal point online pH of the adjuvant to be 6.4-6.8; and the consistency of important quality indexes such as appearance, pH, particle size and the like of the aluminum hydroxide adjuvant prepared after the dialysis high pressure operation is better than that of an adjuvant in the prior art.

Description

technical field [0001] The invention specifically relates to a preparation method of aluminum hydroxide adjuvant. Background technique [0002] Aluminum hydroxide adjuvant is an important component of vaccines, which mainly absorbs antigens through group exchange and electrostatic attraction to improve the efficacy of vaccines. Aluminum hydroxide has a variety of morphological structures, including amorphous and crystalline forms, wherein the crystalline forms include bayerite, gibbsite, etc. X-ray diffraction (XRD) shows that the structure of aluminum hydroxide adjuvant is different from bayerite and gibbsite, it is weakly crystalline boehmite (poorly-crystalline boehmite, PCB), also known as aluminum monohydrate Stone, aluminum oxyhydroxide, chemical formula AlO(OH), has small particle size and large specific surface area (about 500m 2 / g), strong adsorption capacity. [0003] The existing production methods of aluminum hydroxide adjuvant mainly contain two kinds of sod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39C01F7/02C01F7/34
CPCA61K39/39C01F7/02C01F7/34A61K2039/55505
Inventor 张飞伟刘少祥杨希飞胡高翔张华杨勇
Owner CHENGDU INST OF BIOLOGICAL PROD
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