A treatment solution and a method for determining antigen content in aluminum salt-adsorbed vaccines using it

A technology of antigen content and treatment solution, applied in the biological field, can solve the problems of in vitro detection of antigen content and quality control of antigen content, etc., and achieve the effect of effective detection, high accuracy and strong durability

Active Publication Date: 2016-08-24
LIVZON GROUP VACCINE ENG
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to overcome the in vitro detection of the antigen content in the adsorbed Japanese encephalitis inactivated vaccine in the existing methods, so as to break the problem that the effective quality control of the antigen content in the vaccine cannot be directly carried out. A difficult problem, the ultimate goal is to provide an accurate and effective method to detect the antigen content in the adsorbed Japanese encephalitis inactivated vaccine

Method used

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  • A treatment solution and a method for determining antigen content in aluminum salt-adsorbed vaccines using it
  • A treatment solution and a method for determining antigen content in aluminum salt-adsorbed vaccines using it
  • A treatment solution and a method for determining antigen content in aluminum salt-adsorbed vaccines using it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Detect the antigen content of the sample processing solution, and detect the antigen content of six different concentrations of adsorbed Japanese encephalitis inactivated vaccine samples.

[0051] Take 0.702ml, 0.252ml, 0.176ml, 0.088ml, 0.044ml, and 0.022ml of the vaccine stock solution with an antigen concentration of 7.4EU / ml and add them to the test tubes, and add aluminum hydroxide adjuvant solution ( Beijing Bofengke Biotechnology Co., Ltd. ) to a final concentration of aluminum hydroxide solution / mixture = 20% (v / v), and add ultrapure water to make up the volume of each tube to 2ml. That is to say, vaccine samples with a theoretical antigen content of 0.08EU / ml, 0.16EU / ml, 0.32EU / ml, 0.65EU / ml, 1.3EU / ml, and 2.6EU / ml were prepared, and four vaccines were prepared for each concentration. These vaccine samples containing different antigen concentrations were detected according to the following steps:

[0052] (1) Detection of adsorption rate

[0053] ...

Embodiment 2

[0083] Example 2 Influence of bovine serum albumin content in sample treatment solution on the detection of antigen content in adsorbed Japanese encephalitis inactivated vaccine samples

[0084] On the basis of the sample treatment solution in (2-1) in Example 1, respectively prepare bovine serum albumin containing 5% (w / v), 10% (w / v), 15% (w / v), 20% (w / v), 30% (w / v), and 40% (w / v) sample treatment solutions were used to investigate their impact on the detection method. details as follows:

[0085] According to the method in Example 1, six samples of adsorbed Japanese encephalitis inactivated vaccine containing 1.3EU / ml JE antigen were prepared, and 5%, 10%, 15%, 20%, 30%, The sample treatment solution of 40% bovine serum albumin was processed according to the treatment method in Example 1, and then the antigen content was detected, and the result calculation method was also as described in Example 1. The implementation results are shown in Table 5.

[0086] Table 5 Examp...

Embodiment 3

[0089] Example 3 Describe the preparation ratio of the sample treatment solution and the adsorbed inactivated Japanese encephalitis vaccine sample.

[0090] According to the method in Example 1, six sticks of adsorbed Japanese encephalitis inactivated vaccine samples 1ml containing 1.3EU / ml JE antigen were prepared, and 10ml, 5ml, 1ml, 0.5ml, 0.1ml, 0.05ml of (2-1) Sample treatment solution, other steps were treated according to the treatment method in Example 1, and then the antigen content was detected, and the result calculation method was also as described in Example 1. The implementation results are shown in Table 6.

[0091] Table 6 Example 3 result summary

[0092]

[0093] Analysis: As can be seen from the results in Example 3, after the vaccine to be tested and the sample treatment solution are prepared according to the volume ratio of 1:10 to 1:0.1, the final antigen recovery rate is similar, both being 92.3%. When the volume of the sample treatment solution r...

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Abstract

The invention discloses a treatment liquid for desorbing antigens in an aluminum salt adsorption type vaccine. The treatment liquid is a phosphate buffer solution or a citrate buffer solution, wherein the buffer solution contains proteins and at least one acid and / or salts of the acids. The invention further discloses a method using the provided treatment liquid to measure the antigen content of an aluminum salt adsorption type vaccine. The provided method reduces the interference brought by the aluminum adjuvant in Japanese encephalitis vaccine, is capable of rapidly and precisely measuring the antigen content in an adsorption type Japanese encephalitis inactivated vaccine, has the characteristics of good durability, high accuracy, and high precision, and can provide references for quality control of aluminum adjuvant adsorption type Japanese encephalitis inactivated vaccines.

Description

technical field [0001] The invention belongs to the field of biotechnology. Specifically, the present invention relates to a treatment solution for desorbing antigens in adsorption-type inactivated vaccines and a method for determining the content of the antigens. Background technique [0002] Japanese encephalitis virus antigen is the main active ingredient in Japanese encephalitis inactivated vaccine, and its effective content is directly related to the protective effect after vaccination. An important test item. [0003] At present, enzyme-linked immunosorbent assay (ELISA) is mostly used for the detection of Japanese encephalitis virus antigen content. The principle is to absorb soluble Japanese encephalitis virus monoclonal antibody or high-purity polyclonal antibody The antigen to be tested in the test product is specifically bound to it, and then the enzyme-labeled antibody is added to make it combine with the antigen adsorbed on the enzyme-linked reaction plate to ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/531G01N33/569
CPCG01N33/531G01N33/56983
Inventor 罗翀李刚关欣陈小芳李云富汪恩浩
Owner LIVZON GROUP VACCINE ENG
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