Adjuvant for HBV (hepatitis B virus) vaccine and preparation method of adjuvant

An adjuvant and vaccine technology, applied in the field of vaccines, can solve the problem of low immune promotion effect of HBV vaccine, and achieve the effect of improving immune promotion effect, easy to implement, strong cellular immunity and humoral immunity

Inactive Publication Date: 2016-07-20
邓招红
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims at the technical defects of the prior art, and provides an adjuvant for HBV vaccine and its preparation

Method used

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  • Adjuvant for HBV (hepatitis B virus) vaccine and preparation method of adjuvant
  • Adjuvant for HBV (hepatitis B virus) vaccine and preparation method of adjuvant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] (1) Preparation of adjuvant oil phase

[0022] The oil phase is to add aluminum stearate to the mixed solution formed according to the percentage (white oil: span80=17:1), and the addition amount is to add 2g aluminum stearate per 100ml mixed solution. Sterilize by high-temperature steam at 120°C for 20 minutes, and store at room temperature for later use.

[0023] (2) Preparation of adjuvant ISCOM matrix

[0024] Weigh 100 mg of QuilA, 100 mg of cholesterol, and 500 mg of levamisole, dissolve and mix with 10 ml of PBS to obtain 10-fold concentration of ISCOM matrix.

[0025] (3) Preparation of HBVC genotype inactivated virus liquid

[0026] Prepare the inactivated HBVC genotype antigen aqueous solution, and the virus content of each 0.2ml virus liquid before inactivation should be ≥ 10 7.0 LD 50 .

[0027] (4) Preparation of HBVC genotype vaccine

[0028] Under the condition of aseptic operation, put 3ml of ISCOM prepared in (2) above and 15g of HBVC genotype ina...

Embodiment 2

[0039] A kind of adjuvant for HBV vaccine, this adjuvant is divided into oily phase and ISCOM matrix two parts, wherein said oily phase is made up of following components: injection grade white oil 85% (w / w), span807% (w / w), Tween 808% (w / w); the ISCOM matrix includes the following components: QuilA 0.2 mg / ml, cholesterol 0.2 mg / ml, levamisole 3 mg / ml.

[0040] The adjuvant is prepared by the following method:

[0041] 1) Dissolve QuilA, levamisole, and cholesterol in PBS buffer to obtain ISCOM matrix;

[0042] 2) Take the formulated amount of white oil for injection, add the formulated amount of span80 to it after sterilization, stir at a speed of 60r / min for 4min, then add Tween 80 into it while stirring, and stir at a speed of 60r / min After 4 minutes, the oil phase was obtained.

Embodiment 3

[0044] A kind of adjuvant for HBV vaccine, this adjuvant is divided into oily phase and ISCOM matrix two parts, wherein said oily phase is made up of following components: injection grade white oil 84% (w / w), span808% (w / w), Tween 808% (w / w); the ISCOM matrix includes the following components: QuilA 5 mg / ml, cholesterol 5 mg / ml, levamisole 8 mg / ml.

[0045] The adjuvant is prepared by the following method:

[0046] 1) Dissolve QuilA, levamisole, and cholesterol in PBS buffer to obtain ISCOM matrix;

[0047] 2) Take the formulated amount of white oil for injection, add the formulated amount of span80 to it after sterilization, stir at a speed of 100r / min for 6min, then add Tween 80 into it while stirring, and stir at a speed of 100r / min After 6 minutes, the oil phase was obtained.

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Abstract

The invention provides an adjuvant for an HBV (hepatitis B virus) vaccine and a preparation method of the adjuvant. According to the adjuvant, an ISCOM (immunostimulating complex) matrix ingredient is creatively introduced, therefore, organisms can be stimulated to produce higher cellular immunity and humoral immunity, a better immunologic enhancement effect is achieved, and the immune protection period of the vaccine is prolonged. The adjuvant is in a water-in-oil form when used for preparing the HBV vaccine, and the HBV vaccine prepared from the adjuvant has better stability due to the rational design of ingredients and can be preserved for 18 months under the condition of 2-8 DEG C with performance kept stable. Besides, the practical application finds that no local or systemic adverse reactions are caused after inoculation with the HBV vaccine prepared from the adjuvant, the safety is reliable, and compared with an HBV vaccine prepared from an adjuvant in the prior art, a better immune effect is achieved. An outstanding technical effect is achieved through creative technological improvement; meanwhile, the cost is lower, and implementation is facilitated, so that the adjuvant has an outstanding popularization prospect.

Description

technical field [0001] The invention relates to the technical field of vaccines, in particular to an adjuvant for HBV vaccine and a preparation method thereof. Background technique [0002] Hepatitis B virus (HBV) belongs to the hepadnaviridae family, which is highly contagious and latent in humans, so the disease has serious harm to human health and economic development. The HBV antigen is volatile, so the prevention and control work is more difficult. In addition to ensuring proper sanitary conditions and isolation measures, vaccination is a key measure to control the epidemic of hepatitis B. In the prior art, although the hepatitis B vaccine has long been a product, there are still technical defects such as insufficient protective effect, multiple immunizations are required to take effect, and high cost, which makes it difficult to meet the needs of use. [0003] In order to improve the immune effect of vaccines, researchers in the prior art have made efforts in various ...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/29A61P31/20
CPCA61K39/39A61K39/12A61K2039/5252A61K2039/55577C12N2730/10134
Inventor 邓招红
Owner 邓招红
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