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Type-B encephalitis virus antibody titer standard serum and preparation method thereof

A technology of Japanese encephalitis virus and antibody titer, which is applied in the field of Japanese encephalitis virus antibody titer standard serum and its preparation, can solve problems such as unusability, and achieve the effect of broad application prospects

Active Publication Date: 2010-09-22
SICHUAN YUANDASHUYANG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Mouse-derived reference serum was used to determine the potency of Japanese encephalitis inactivated vaccine by cell plaque reduction neutralization method. Due to heterogeneity, enzyme-linked immunosorbent reagents were used to detect IgG antibodies to Japanese encephalitis virus in human serum. China National Reference Reagent for Serum of Japanese Encephalitis Virus with No. 250008 in Catalog of Standard Substances for Biological Products

Method used

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  • Type-B encephalitis virus antibody titer standard serum and preparation method thereof
  • Type-B encephalitis virus antibody titer standard serum and preparation method thereof
  • Type-B encephalitis virus antibody titer standard serum and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037] Embodiment 1 The preparation of Japanese encephalitis virus antibody titer standard serum of the present invention

[0038] Vaccine immunization method: take freeze-dried live attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products, China Biotechnology Group, batch number: 200612A095-2, 1 serving each) freeze-dried live attenuated Japanese encephalitis vaccine plus sterile water for injection 0.5 After reconstitution in ml, the skin at the attachment point of the deltoid muscle on the outer side of the upper arm was disinfected with alcohol, and 0.5 ml was injected subcutaneously. Primary immunization and booster immunization The interval between primary immunization and booster immunization is 3 months.

[0039] Standard serum: 14 days after the vaccine booster immunization, venous blood was collected to separate the serum, and the diagnostic kit for IgG antibody to Japanese encephalitis virus was used to detect it. 450nm Value ≥ normal seru...

Embodiment 2

[0042] Example 2 Using the Japanese Encephalitis IgG Antibody Quantitative Diagnostic Kit to Detect Japanese Encephalitis IgG Antibody

[0043] This example is made by substituting the Japanese encephalitis virus antibody titer standard serum of the present invention for the positive control part in the Japanese encephalitis IgG antibody diagnostic kit with batch number 20080428 produced by Beijing Jinhao Pharmaceutical Co., Ltd. A new Japanese encephalitis IgG antibody quantitative diagnostic kit was developed for detection. The kit consists of: ELISA plate for detecting JE IgG antibody, sample diluent, enzyme conjugate, Japanese encephalitis virus antibody titer standard serum of the present invention as JE IgG antibody positive control, JE IgG antibody negative Control, chromogenic agent A, chromogenic agent B (using TMB chromogenic system).

[0044] The specific detection steps are as follows:

[0045] 1. The sample was diluted 1:100. Reserve a blank well on the enzyme-...

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Abstract

The invention relates to a type-B encephalitis virus antibody titer standard serum and a preparation method thereof, which belong to the field of standard substances of biological products. The invention solves the technical problem of providing the type-B encephalitis virus antibody titer standard serum which serves as a reference standard for measuring a type-B encephalitis human immune globulin titer value. The type-B encephalitis virus antibody titer standard serum is characterized in that the OD450nm value of the type-B encephalitis virus antibody titer standard serum is 1.019+ / -0.051 by detecting the serum with a type-B encephalitis virus IgG antibody diagnostic reagent kit. The type-B encephalitis virus antibody titer standard serum provides a reference for pharmaceutical research on type-B encephalitis human immune globulin, can be used for quantitatively judging the preventing and treating effect of the type-B encephalitis human immune globulin, and has a wide application prospect.

Description

technical field [0001] The invention relates to Japanese encephalitis virus antibody titer standard serum and a preparation method thereof, belonging to the field of biological product standard substances. Background technique [0002] Epidemic encephalitis B (JE) for short is an acute insect-borne infectious disease with high mortality and disability rates. With the improvement of living environment and the application of vaccines, the incidence rate has increased significantly. However, the mortality rate of the disease is still high, and it is the second-ranked infectious disease after tuberculosis. Human encephalitis B Immunoglobulin (Human encephalitis B Immunoglobulin) is referred to as HEIG. It has been reported that HEIG has the prospect of treating Japanese encephalitis. However, in terms of pharmaceutical research, there is no reference or standard serum, and there is no comparable product of the same kind. , how to develop and calibrate the HEIG titer in internat...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/543
Inventor 魏宪义陈光清高玲
Owner SICHUAN YUANDASHUYANG PHARM CO LTD
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