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Aluminium phosphate adjuvant and preparation method thereof.

A technology of aluminum phosphate adjuvant and sodium dihydrogen phosphate, applied in the field of medicine, can solve problems such as defects affecting the response level of body fluids, homogeneity and encapsulation capacity, etc., and solve problems such as large differences between batches, stable properties and high stability. Effect

Inactive Publication Date: 2011-09-21
SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, the existing aluminum phosphate adjuvant has defects in uniformity and loading capacity, which affects the level of humoral response induced by this adjuvant

Method used

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  • Aluminium phosphate adjuvant and preparation method thereof.
  • Aluminium phosphate adjuvant and preparation method thereof.
  • Aluminium phosphate adjuvant and preparation method thereof.

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The preparation method of embodiment 1 aluminum phosphate adjuvant

[0025] 1. Solution preparation

[0026] 1.1 Preparation of aluminum chloride solution (0.06mol / L) and sodium dihydrogen phosphate solution (0.06mol / L)

[0027] Weigh 28.9716g of AlCl 3 .6H 2 O and 18.7212g of NaH 2 PO 4 .2H 2 O, dissolved in pure water and set the volume to 2L to obtain a solution of aluminum chloride and sodium dihydrogen phosphate with a concentration of 0.06mol / L.

[0028] 1.2 Preparation of sodium hydroxide solution (0.5mol / L)

[0029] Weigh 40g of NaOH, dissolve it in pure water and set the volume to 2L to obtain a sodium hydroxide solution with a concentration of 0.5mol / L.

[0030] 1.3 Bacteria removal and pyrogen removal: use an ultrafilter (molecular weight cut-off 8KD or 10KD) for ultrafiltration. Sterilize by filtration with a 0.22 μm capsule filter.

[0031] 2. Preparation process of aluminum phosphate adjuvant

[0032] A peristaltic pump was used to pump the mixed...

Embodiment 2

[0051] The preparation of embodiment 2HPV18L1 vaccine preparation

[0052] 1. Dilution of aluminum adjuvant

[0053] The prepared aluminum phosphate adjuvant is diluted with a special adjuvant diluent before use to obtain an aluminum phosphate adjuvant solution with a certain prescription composition.

[0054] 1.1. Composition of Aluminum Adjuvant Diluent

[0055] Component Concentration

[0056] Sodium chloride 0.308mo / L

[0057] L-histidine 0.02mol / L

[0058] Tween 80 (20% w / v) 0.02%

[0059] 1.2. Prescription composition of aluminum adjuvant after dilution

[0060] Component Concentration

[0061] Aluminum 900μg / mL

[0062] Sodium chloride 0.154mol / L

[0063] L-histidine 0.01mol / L

[0064] Tween 80 (20% w / v) 0.01%

[0065] 2. HPV18L1 protein solution dilution

[0066] 2.1. Composition of Protein Diluent

[0067] Component Concentration

[0068] Sodium chloride 0.486mo / L

[0069] L-histidine 0.01mol / L

[0070] Tween 80 (20% w / v) 0.01%

[0071] 2.2. Compositio...

Embodiment 3

[0085] Embodiment 3, the contrast of aluminum phosphate adjuvant to HPV18L1 vaccine enhancing immune effect

[0086] 1. Purpose: To compare the effect of commercial aluminum phosphate adjuvant and the aluminum phosphate adjuvant prepared in Example 1 on the effect of HPV18L1 vaccine-induced body fluid

[0087] Enhancement of the immune response.

[0088] 2. Method: Immunize mice after mixing different kinds of aluminum phosphate and HPV18L1.

[0089] 2.1 Experimental materials

[0090] 2.1.1 Experimental animals: Mice: BABL / c, non-pregnant female, 6 weeks old or 16-20g

[0091] 2.1.2 Experimental samples:

[0092] Different types of aluminum phosphate adjuvants were used to absorb the HPV 18L1 stock solution, and the HPV 18L1 monovalent vaccine 0.5ml / dose (containing 20 μg of HPV18L1) was prepared, and its composition was as follows:

[0093] Table 4

[0094] sample

The amount of aluminum adjuvant added ( / ml)

HPV18L1 added ( / ml)

I

450 μg Adju-...

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Abstract

The invention belongs to the technical field of medicaments, and in particular relates to an aluminium phosphate adjuvant and a preparation method thereof. The aluminium phosphate adjuvant disclosed by the invention is characterized in that the particle size is 200-4,500nm; the polydispersity coefficient is 0.01-1.00; and the isoelectric point is 4.0-6.0. The aluminium phosphate adjuvant has the characteristics of high stability, good uniformity and strong entrapment capacity, can be used for inducing the generation of stronger body fluid response level, and is suitable for reducing the additive amount of the adjuvant and vaccine and decreasing the toxic and side effects of the vaccine during the production process of the vaccine; and the aluminium phosphate adjuvant is superior to the existing commodity adjuvant. The method is simple in process, then the aluminium phosphate adjuvant which has the advantages of stable property, uniform dispersion and small interassay variation can be obtained, and the problem that the aluminium phosphate adjuvant has large interassay variation is solved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an aluminum phosphate adjuvant and a preparation method thereof. Background technique [0002] In recent years, with the continuous deepening of immunology research and the rapid development of genetic engineering technology, the research of new vaccines such as live vector vaccines, DNA vaccines and protein vaccines has made gratifying progress. These new vaccines have high purity and strong specificity, but their immunogenicity is weak, and the immune response induced by the body is not strong enough. Therefore, it is particularly important to use adjuvants to enhance their immunogenicity or enhance the host's protective response to antigens. [0003] With the rapid development of molecular biology, peptide vaccines and subunit vaccines are constantly emerging, and the requirements for vaccine adjuvants are getting higher and higher both in terms of quantity and qu...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/12A61P31/20
Inventor 张高峡沈琼王兰创刁美娟郭慧丽
Owner SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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