A kind of immunoenhancing composition, preparation method and application thereof

A technology of immune enhancement and composition, applied in the field of medical biomaterials, can solve the problems of local abscess, severe reaction, short duration, etc., and achieve the effect of enhancing immune response, controllable degradation process, and long action period

Active Publication Date: 2020-11-03
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although these materials can better strengthen the immune response, they have different disadvantages, such as the formation of granulomas, local abscesses, short duration, and easy to cause fever and inflammation.
At present, the only immunopotentiator approved by the FDA for human immunity is aluminum salt adjuvant, and due to the high heterogeneity of the material, it is difficult to achieve a unified standard in the production process of the immunopotentiator, and subcutaneous injection is likely to cause severe reactions (such as erythema, subcutaneous nodules, contact allergy, and granulomatous inflammation)

Method used

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  • A kind of immunoenhancing composition, preparation method and application thereof
  • A kind of immunoenhancing composition, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The novel immune-enhancing composition of the present embodiment is prepared through the following steps:

[0046] (1) Organizational preprocessing:

[0047] The small intestinal submucosa tissue material was divided into 10cm wide and 15cm long predetermined size, the lymphoid tissue was removed, rinsed three times with tap water, and then rinsed with purified water until the surface was free of stains, and the water was drained.

[0048] (2) Virus inactivation:

[0049] Use peracetic acid-ethanol solution to soak small intestinal submucosa tissue material for virus inactivation, and this process can be carried out in a stainless steel barrel; the concentration of peracetic acid in the peracetic acid-ethanol solution is 1% (volume percent), the concentration of ethanol is 24% (volume percentage), the ratio (volume ratio) of peracetic acid-ethanol solution to small intestinal submucosa tissue material is 9:1, the inactivation time is 2 hours, and the temperature range ...

Embodiment 2

[0060] The performance test is carried out to the sample in Example 1, and the test items and results are as follows:

[0061] 1) Identification of collagen subtypes: I, III, IV and VI collagens were detected by immunohistochemical staining, 3 μm thick serial sections, dewaxed in xylene, and dehydrated in graded ethanol. Move the slices into a rice cooker water bath (containing 0.01 mol / L, pH 6.0 trisodium citrate buffer), keep the temperature at 95-100 °C, cook for 20 min, carry out antigen retrieval, and then naturally cool at room temperature after taking out. Wash with phosphate buffered saline (PBS), 5 min×3 times. Two-step immunohistochemistry: primary antibodies of collagen I, III, IV and VI were added dropwise at a concentration of 1:100, incubated at 4°C overnight at room temperature for 60 min, and washed 3 times with PBS. Add the Envision reaction solution dropwise and incubate at room temperature for 30 min. Washed 3 times with PBS. 0.05% 3,3-diaminobenzidine + ...

Embodiment 3

[0072] The biocompatibility test was carried out on the sample in Example 1, and the test items included: pyrogen, cytotoxicity, delayed type hypersensitivity reaction, intradermal reaction, acute systemic toxicity, Ames test, mouse lymphoma cell mutation test, chromosomal aberration , implantation, subchronic toxicity

[0073] 1) Pyrogen

[0074] Prepare the test solution according to the mass ratio of 1:5 leaching medium, 37±1℃, 72±2hr, leaching medium: physiological saline. According to the method specified in GB / T 14233.2-2005, the product has no pyrogen reaction.

[0075] 2) Cytotoxicity

[0076] Prepare the test solution according to the mass ratio of 1:5 leaching medium, 37±1℃, 24±2hr, leaching medium: MEM medium containing serum. Take the test solution and conduct the test according to the test method specified in GB / T16886.5-2003. The result shows that the cytotoxicity of the product is not greater than grade 1.

[0077] 3) Delayed type hypersensitivity

[0078] ...

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Abstract

The invention provides an immunoenhanced composition, a preparation method and application. The composition is characterized by comprising collagens which are free of immunogenicity and can be degraded in vivo, polysaccharide substances and loose particles of active factors. The immunoenhanced composition applied to vaccination can intensity the immunoreactions of an antigen, and reduce side effects of inflammation, granuloma and abscess in the immunoreactions.

Description

technical field [0001] The invention relates to the technical field of medical biological materials, in particular to an immune-enhancing composition, which has no immune response itself, but can be compatible with antigens to enhance the immune response of the human body. Background technique [0002] Vaccination is currently the most cost-effective way to prevent disease. After the vaccine is inactivated and lysed, it is no longer a live antigen and will not cause infection. In the process of vaccine use, in order to reduce the amount of antigen and relatively expand the vaccine production, it is also necessary to add an appropriate immune enhancer for the ratio. Immune enhancers are non-specific immune enhancers that, when injected with antigens or pre-injected into the body, can enhance the body's immune response to antigens or change the type of immune response. Vaccines with immune enhancers are more helpful than vaccines without immune enhancers Stimulate the body to...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/39A61P37/04
CPCA61K39/39A61K2039/55516A61K2039/55522A61K2039/55583A61K2039/55588A61K2039/57
Inventor 赵博夏磊磊王洪权赵延瑞李学军张晋辉
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH
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