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Avian influenza H5N1 subtype Re-5 strain hemagglutination inhibition antigen standard substance and preparation method

A technology of avian influenza virus and H5N1, which is applied in the field of hemagglutination-inhibiting antigen standard material and preparation of avian influenza virus H5N1 subtype Re-5 strain, and can solve problems such as lack of technical specifications to follow.

Inactive Publication Date: 2011-04-13
HARBIN VETERINARY RES INST CHINESE ACADEMY OF AGRI SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the development of reference materials in my country mainly refers to and follows the "Management Measures for Standard Materials" issued and implemented by the National Bureau of Metrology on July 10, 1987, and the technical specifications for primary standard materials (JJG 1006-94), but this technical specification is applicable to chemical Composition, physical and chemical characteristics and engineering technical characteristics of the development of primary reference materials, there is currently no technical specification for the development of reference materials for biological products, especially reference materials for veterinary biological products

Method used

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  • Avian influenza H5N1 subtype Re-5 strain hemagglutination inhibition antigen standard substance and preparation method
  • Avian influenza H5N1 subtype Re-5 strain hemagglutination inhibition antigen standard substance and preparation method
  • Avian influenza H5N1 subtype Re-5 strain hemagglutination inhibition antigen standard substance and preparation method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Antigen manufacturing and inspection of semi-finished products

[0096] 1 Preparation of poisonous seeds for production

[0097] (1) Propagation of virus seeds: make 10-fold serial dilution of virus seeds with sterilized physiological saline, get 10 -4 Dilution: Inoculate 10-day-old SPF chicken embryos into the allantoic cavity, 0.1ml per embryo, seal the pinhole, and continue to incubate at 36°C without turning the eggs. After 24 hours of inoculation, the eggs were illuminated once every 12 hours. The dead chicken embryos were taken out and discarded at any time. At 72 hours, all live embryos were collected and cooled at 2-8°C. Take out the chicken embryos that have been cooled for 4-24 hours, disinfect the air chamber with tincture of iodine, then use aseptic surgery to remove the egg shells in the air chamber, remove the yolk shell membrane, cut the chorioallantoic membrane and amniotic membrane (do not break the yolk) , Aspirate the chicken embryo fluid (allantoic...

Embodiment 2

[0113] Product testing

[0114] 1. Physical properties White or off-white spongy loose lumps, easy to separate from the bottle wall, and dissolve quickly after adding diluent.

[0115] 2. Sterility test Sampling test, no bacteria or mold growth. The test results are shown in Table 1, and all freeze-dried products were all negative.

[0116] Table 1 Sterility test statistics table

[0117]

[0118] 3. Potency determination: Samples were randomly selected from different parts during freeze-drying for hemagglutination determination (according to the "Appendix"). The measurement results are shown in Table 2. The results show that the agglutination value of 1% chicken red blood cells is 8log2.

[0119] Table 201 Antigen titer test results

[0120]

[0121] Note: "#" in the table indicates complete agglutination, "++" indicates partial agglutination, and "-" indicates no agglutination.

[0122] 4. The specificity test adopts the method of hemagglutination inhibition test ...

Embodiment 3

[0131] 1. Valuation of standard substance potency

[0132] (1) Fixed value method

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Abstract

The invention relates to an avian influenza H5N1 subtype Re-5 strain hemagglutination inhibition antigen standard substance and a preparation method thereof. The standard substance is prepared by performing the following series of steps of: preparing and inspecting liquid of avian influenza H5N1 subtype Re-5 strain viruses; inactivating the liquid of the viruses and inspecting a semi-finished product; freeze-drying, inspecting a finished product, homogeneity and stability, demarcating the standard substance, valuing and the like. The standard substance is fundamental guarantee of accurately diagnosing avian influenza H5N1 subtype, performing immune monitoring of an H5N1 subtype Re-5 strain hemagglutination inhibition antibody and accurately evaluating the immune effect of vaccine and improves the prevention and control level of the avian influenza.

Description

technical field [0001] The invention relates to an avian influenza virus H5N1 subtype Re-5 strain hemagglutination inhibiting antigen standard substance and a preparation method, belonging to the field of veterinary biological products. Background technique [0002] The chemical reference substances of the British Pharmacopoeia (BP) were only proposed in 1963. Since the WHO established an international biological standard substance center in the United Kingdom, the United Kingdom has always used international standard substances, while its own national standard substances were established later, after 1970. , the European Pharmacopoeia came out. In addition to citing international standard substances, the UK also used European Pharmacopoeia standard substances, and used its own standard substances in a small amount. Even so, the BP1968 edition and its supplement plus the British Pharmacopoeia (1968) included more than 260, the 1980 edition exceeded 300, and the BP1993 editio...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/531
Inventor 孙建宏刘景利田国彬胡井雷韩正博张从禄曾显营杨帆徐姗姗
Owner HARBIN VETERINARY RES INST CHINESE ACADEMY OF AGRI SCI
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