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Preparation method and application of novel oil-free adjuvant

An adjuvant, mineral oil technology, applied in antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of unclear immune mechanism, aseptic abscess and inflammatory reaction, and high viscosity of vaccines, etc. Achieve the effect of improving the quality of vaccine products, improving the effect of vaccine immunity, and reducing the probability of immunization failure

Active Publication Date: 2013-05-08
BEIJING HUAXIA XINGYANG BIOLOGICAL SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the vaccine has high viscosity, is not easy to inject, is not easy to absorb, has large side effects of the vaccine, and can cause local granulomas, aseptic abscesses and inflammatory reactions to varying degrees, and even has carcinogenic effects. It is harmful to animal carcasses and animal-derived foods. The safety impact is relatively large, and many problems have not been effectively resolved
The above-mentioned adjuvant immune enhancement effects do exist, but they also have some unavoidable shortcomings, such as weak effects, short duration of immunity, unclear immune mechanism or high product cost, unstable effect, and difficult to apply to industrial production

Method used

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  • Preparation method and application of novel oil-free adjuvant
  • Preparation method and application of novel oil-free adjuvant
  • Preparation method and application of novel oil-free adjuvant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1 The preparation method of adjuvant (605 oil-free adjuvant) of the present invention

[0016] Adjuvant group 1: disodium hydrogen phosphate 3.5g, potassium dihydrogen phosphate 0.6g, sodium chloride 7g, trehalose 7g, astragalus polysaccharide 7g, sodium glutamate 3g, gelatin 13g, polyethylene glycol 30007g, dextran 3g, 1000ml of water for injection, after ultrasonic treatment, sterilized by autoclaving at 121°C for 20min and then ready for use.

[0017] Adjuvant group 2: Weigh disodium hydrogen phosphate 5g, potassium dihydrogen phosphate 0.2g, sodium chloride 10g, trehalose 2g, astragalus polysaccharide 10g, sodium glutamate 1g, gelatin 20g, polyethylene glycol 30003g, dextran Sugar 5g, 1000ml water for injection, ultrasonic treatment, 121 ℃, autoclave for 20min, and then set aside.

[0018] Adjuvant group 3: disodium hydrogen phosphate 2g, potassium dihydrogen phosphate 1g, sodium chloride 3g, trehalose 10g, astragalus polysaccharide 2g, sodium glutamate ...

Embodiment 2

[0021] The research that embodiment 2 adjuvants are used for bird flu inactivated vaccine

[0022] Mix the qualified avian influenza virus inactivation solution with the adjuvant of the present invention in a ratio of 4:6, and stir at 500-1000 rpm for 30 minutes. Sterility test, physical properties, stability, viscosity, safety and efficacy tests were carried out according to the methods stipulated in the three parts of the current "Veterinary Pharmacopoeia of the People's Republic of China". The results show that compared with the inactivated vaccine made with the traditional oil adjuvant, the adjuvant of the present invention has significant advantages in terms of stability, viscosity, safety and vaccine preparation process. The results are shown in Table 1.

[0023] Table 1 Test results of each batch of Newcastle disease inactivated vaccine

[0024]

Embodiment 3

[0025] Example 3 The adjuvant used in the immune effect test of Newcastle disease inactivated vaccine immunized SPF chickens.

[0026] 1. Materials and methods

[0027] 1) Antigen: Newcastle disease La Sota strain antigen (toxicity is 10 9.3 ELD 50 / ml)

[0028] 2) Test animals: SPF chickens aged 1 to 2 months

[0029] 3) Antigen inactivation of ND La Sota strain: add 10% formaldehyde solution to the antigen, and shake as it is added to make it fully mixed. The final concentration of formaldehyde is 0.2%, inactivated at 37°C for 16 hours (the inactivation temperature is calculated when the temperature in the bottle reaches 37°C), shaken 3-4 times during the inactivation period, and stored at 4-8°C after inactivation .

[0030] 4) Test grouping: the test was divided into white oil control group, commercial seedling control group, adjuvant group 1, group 2, group 3, group 4 and group 5 of the present invention. The adjuvant and antigen were prepared according to the ratio ...

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Abstract

The invention relates to a preparation method of a novel oil-free adjuvant (adjuvant 605) compound and an application of the novel oil-free adjuvant in veterinary vaccines. The adjuvant prepared by using the method provided by the invention is capable of completely taking the place of mineral oil adjuvants and alumina gel adjuvants for inactivated vaccine production; the adjuvant can be completely absorbed by organisms within short time without residual; the adjuvant is low in side reaction, and capable of improving the safety of vaccines, and simultaneously simplifying the vaccine production process and reducing the vaccine production cost. The adjuvant prepared by using the method provided by the invention can be also taken as live vaccine diluting protection liquid, and has the characteristics of protecting the biological activity of the vaccine antigen, enhancing the immune effect of the vaccine, prolonging the persistent period of the vaccine antibody and the like.

Description

technical field [0001] The invention relates to a novel vaccine adjuvant and its application, belonging to the field of biology, especially the field of veterinary biological products. technical background [0002] At present, mineral oil adjuvants are widely used in the production of veterinary vaccines, that is, emulsifiers are added to the mineral oil adjuvant and the vaccine antigen respectively, and the water-in-oil or water-in-oil-in-water type is made under the action of high shear force Emulsion vaccine. This type of vaccine has unique advantages in terms of immune response and duration of immunity, and is widely recognized. However, the vaccine has high viscosity, is not easy to inject, is not easy to absorb, has large side effects of the vaccine, and can cause local granulomas, aseptic abscesses and inflammatory reactions to varying degrees, and even has carcinogenic effects. It is harmful to animal carcasses and animal-derived foods. The safety impact is relativ...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61P31/00A61P31/14A61P31/16A61P31/04
Inventor 赵卓王力江厚生
Owner BEIJING HUAXIA XINGYANG BIOLOGICAL SCI & TECH
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