Preparation method of nano-aluminium adjuvant capable of raising vaccine effect and its use

A nano-aluminum and vaccine technology, used in medical preparations containing active ingredients, antiviral agents, pharmaceutical formulations, etc., can solve the problems of weak vaccine adjuvant effect, granulomatous inflammation, contact allergic reaction, etc., and achieve rapid activation Effects of immune response, inflammatory nodule reduction, inflammatory response reduction

Inactive Publication Date: 2006-08-30
THE THIRD AFFILIATED HOSPITAL OF THIRD MILITARY MEDICAL UNIV OF PLA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] ①Long use time: It has been used since 1926; ②Safe and effective; ③Inexpensive; ④Widely used; ⑤Weak adjuvant effect or no adjuvant activity for some vaccines; ⑥Easy to induce the expression of IgE; Erythema, subcutaneous nodules, contact allergic reactions, granulomatous inflammation, etc., and some even have serious local reactions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1, the preparation method of the nano aluminum adjuvant involved in the present invention

[0023] Take a certain amount of AlCl3, cyclohexane and distilled water in a beaker, add benzalkonium bromide-n-octanol-cyclohexane-AlCl3 solution system, and then stir with a high-speed dispersing homogenizer to emulsify it into a microemulsion. Pour into a reaction bottle with a cover, heat and stir, slowly add excess ammonia water drop by drop, cover the lid, and react for 3 hours to form Al(OH)3 sol, which is dissolved in water by freeze-drying or vacuum drying, and then ultrasonically Dispersion, in a dispersed state in aqueous solution. The electron microscope observation and measurement method is used to determine the diameter of nanoparticles.

Embodiment 2

[0024] Embodiment 2, the preparation method of novel human hepatitis B vaccine

[0025] Prepare the prepared nano-aluminum adjuvant at 0.1-5.0 mg / ml (with water as solvent), the optimal working concentration is 2.0 mg / ml, ultrasonically disperse the nano-aluminum adjuvant solution for 20 minutes, add commercially available adjuvant-free human The dose of hepatitis B vaccine is 5.0-60 micrograms per tube, and the optimal dose is 10.0 micrograms per tube. Mix human rabies vaccine and nano-aluminum adjuvant at a volume of 3:1, absorb at 4°C for one week, and centrifuge at 15,000 rpm for 30 Minutes, the concentration of Rabies v antigen in the supernatant was detected by ELISA double antibody sandwich method. According to the method described above, the amount of the novel human hepatitis B vaccine adsorbed on the nano-aluminum adjuvant per unit mass is 10-20 times higher than that of the conventional aluminum adjuvant.

Embodiment 3

[0026] Embodiment 3, the preparation method of novel human rabies vaccine

[0027]Prepare the prepared nano-aluminum adjuvant at 0.1-5.0 mg / ml (with water as solvent), the optimal working concentration is 2.0 mg / ml, ultrasonically disperse the nano-aluminum adjuvant solution for 20 minutes, add commercially available adjuvant-free human The dose of rabies vaccine is 5.0-60 micrograms per bottle, and the optimal dose is 10.0 micrograms per bottle. Mix the human rabies vaccine and nano-aluminum adjuvant in a volume of 3:1, absorb at 4°C for one week, and centrifuge at 15,000 rpm for 30 Minutes, the concentration of Rabies v antigen in the supernatant was detected by ELISA double antibody sandwich method. According to the method described above, according to the new type of human rabies vaccine, the quantity adsorbed on the unit mass of nano aluminum adjuvant is 10-20 times higher than that of conventional aluminum adjuvant.

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Abstract

A nano-class aluminum adjuvant for improving the effect of vaccine is prepared from the aluminum hydroxide nanoparticles. It has high purity and dispersity. Said aluminum adjuvant is suitable for the substances prepared from virus or viroid component (protein, DNA, or RNA). Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a nano-aluminum adjuvant for human vaccines and a preparation method thereof, as well as a vaccine composition containing the nano-aluminum adjuvant and a preparation method thereof. technical background [0002] Vaccines usually mainly use the following methods: inoculating virus seeds in cells; harvesting virus liquid; inactivating virus liquid; clarifying ultrafiltration; purifying; diluting and subpackaging. Most of these vaccines require the addition of aluminum adjuvants. It mainly plays an adsorption role. [0003] The main mechanism of antigen adsorption by aluminum adjuvant includes: electrostatic force, hydrophobic interaction and group exchange [Vogel FR, Hem SL. In: Plotkin SA, Orenstein MD, editors.Vaccines.4th ed. New York: Sanders]. Phosphate and aluminum form the surface of the inner sphere under the action of inorganic equivalent exchange of covalent bonds. The phosphate group is stronger than the hydroxide ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61P31/12
Inventor 吕凤林何萍胡承香何凤慈
Owner THE THIRD AFFILIATED HOSPITAL OF THIRD MILITARY MEDICAL UNIV OF PLA
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