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Preparation method of aluminum hydroxide adjuvant

An aluminum hydroxide and adjuvant technology, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, antibody medical components, etc., can solve the problems of reporting aluminum hydroxide adjuvant preparation methods, etc., and achieve the effect of high adsorption capacity

Active Publication Date: 2015-02-25
WUHAN INST OF BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are currently two major aluminum hydroxide adjuvant manufacturers in the world (Brenntag Biosector and General Chemical, the trade name is and the aluminum hydroxide adjuvant of Rehydragel LV) can produce the aluminum hydroxide adjuvant that meets the above parameters, but because it involves its technical secrets, there are no published literature and patent reports on the preparation method of its aluminum hydroxide adjuvant

Method used

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  • Preparation method of aluminum hydroxide adjuvant
  • Preparation method of aluminum hydroxide adjuvant
  • Preparation method of aluminum hydroxide adjuvant

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Embodiment 1. Preparation of aluminum hydroxide adjuvant

[0029] (1) Weigh AlCl3·6H2O and dissolve it in water for injection to prepare an aluminum salt solution with an aluminum ion content of 0.25 mol / L. Weigh NaOH and dissolve it with water for injection to prepare an alkaline solution with a NaOH content of 0.265 mol / L.

[0030] (2) First add the aluminum salt solution into the reactor, then add 2 times the volume of water for injection, start stirring and mix evenly, and raise the temperature to 60°C. Use a peristaltic pump to add the alkali solution dropwise. When the dropwise addition reaches pH 4.0, add the aluminum salt solution dropwise at the same time, and keep the pH constant by adjusting the drop rate of the aluminum salt solution. The constant pH drop continued for about 40 minutes, stopped the drop of the aluminum salt solution, and continued to drop the alkali solution to pH 4.8.

[0031] (3) After the above solution is centrifuged, it is washed once...

Embodiment 2

[0035] Embodiment 2. Preparation of aluminum hydroxide adjuvant

[0036] (1) Weigh AlCl3·6H2O and dissolve it in water for injection to prepare an aluminum salt solution with an aluminum ion content of 0.25 mol / L. Weigh NaOH and dissolve it with water for injection to prepare an alkaline solution with a NaOH content of 0.265 mol / L.

[0037] (2) First add the aluminum salt solution into the reactor, then add 2 times the volume of water for injection, start stirring and mix evenly, and raise the temperature to 60°C. Use a peristaltic pump to add the alkali solution dropwise. When the dropwise addition reaches pH 3.5, add the aluminum salt solution dropwise at the same time, and keep the pH constant by adjusting the drop rate of the aluminum salt solution. The dropwise addition of constant pH continued for about 35 minutes, stopped the dropwise addition of the aluminum salt solution, and continued the dropwise addition of the alkali solution to pH 4.5.

[0038] (3) After the ab...

Embodiment 3

[0042] Embodiment 3. Preparation of aluminum hydroxide adjuvant

[0043] (1) Weigh AlCl3·6H2O and dissolve it in water for injection to prepare an aluminum salt solution with an aluminum ion content of 0.25 mol / L. Weigh NaOH and dissolve it with water for injection to prepare an alkaline solution with a NaOH content of 0.265 mol / L.

[0044](2) First add the aluminum salt solution into the reactor, then add 2 times the volume of water for injection, start stirring and mix evenly, and raise the temperature to 60°C. Use a peristaltic pump to add the alkali solution dropwise. When the dropwise addition reaches pH 3.5, add the aluminum salt solution dropwise at the same time, and keep the pH constant by adjusting the drop rate of the aluminum salt solution. The dropwise addition of constant pH lasted for about 40 minutes, stopped the dropwise addition of the aluminum salt solution, and continued the dropwise addition of the alkali solution to pH 5.2.

[0045] (3) After the above ...

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Abstract

The invention relates to a preparation method of an aluminum hydroxide adjuvant. The aluminum hydroxide adjuvant comprises the following steps: (1) preparing an aluminum salt solution and an alkali solution; (2) dropwise adding the alkali solution into the aluminum salt solution; (3) centrifuging the reaction product in the step (2), and re-dissolving the reaction product by virtue of a 0.1%-0.5% NaCl solution; (4) heating the washed product solution; (5) washing; and (6) carrying out sterilization and sub-packaging.

Description

technical field [0001] The invention belongs to the field of vaccine preparations, and in particular relates to a preparation method of aluminum hydroxide adjuvant. Background technique [0002] Aluminum adjuvant has been used as an immune adjuvant for a long time, and its safety and immune enhancing effect have long been confirmed by people. Glenny and his colleagues first discovered the aluminum salt (KAl(SO 4 ) 2 12H 2 O) co-precipitates with diphtheria toxoid, which can significantly increase its potency. The current aluminum salt adjuvants mainly include aluminum potassium sulfate, aluminum phosphate, and aluminum hydroxide. Among them, aluminum hydroxide adjuvant is the most widely used. [0003] The aluminum hydroxide adjuvant is poorly-crystalline boehmite (PCB), which has the chemical formula AlO(OH), and is aluminum partial hydroxide. X-ray diffraction showed that the aluminum hydroxide adjuvant in PCB crystal form had relatively broad characteristic peaks at...

Claims

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Application Information

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IPC IPC(8): A61K39/39
Inventor 艾绪露薛红刚陈少华孙晓艳胡业勤
Owner WUHAN INST OF BIOLOGICAL PROD CO LTD