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Method for detecting contents of various types of specific sugar in polyvalent pneumococcal conjugate vaccine

A pneumococcal and conjugated vaccine technology, applied in scattering characteristics measurement, biological testing, material testing, etc., can solve problems such as large fluctuation of test results and low sensitivity, eliminate component differences, improve signal-to-noise ratio, and simplify serum purification. effect of the process

Active Publication Date: 2016-10-12
BEIJING ZHIFEI LVZHU BIOPHARM +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The purpose of the present invention is to solve the problems of low sensitivity and large fluctuations in detection results of the existing detection methods for specific sugar content of various types of pneumococcal conjugate vaccines, and to provide a polysaccharide content in various types of capsular polysaccharide protein conjugates of pneumococcal conjugate vaccines. detection method

Method used

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  • Method for detecting contents of various types of specific sugar in polyvalent pneumococcal conjugate vaccine
  • Method for detecting contents of various types of specific sugar in polyvalent pneumococcal conjugate vaccine
  • Method for detecting contents of various types of specific sugar in polyvalent pneumococcal conjugate vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Detection of Type 2 Pneumococcus Polysaccharide Content in Example 1 Pneumococcal Conjugate Vaccine

[0048] Take the type 2 pneumococcal conjugate and dilute it with diluent to a solution with a polysaccharide concentration of 133 μg / mL.

[0049] Take five pneumococcal conjugate vaccines, 940 μL each, the first part without pneumococcal conjugate, the second with 15 μL of pneumococcal conjugate, the third with 30 μL of pneumococcal conjugate, and the fourth with Add 45 μL of pneumococcal conjugate to the fifth aliquot Add 60 μL of pneumococcal conjugate and dilute the five-part mixed solution to 1 mL with diluent.

[0050] Add 30 μL of 1mol / L sodium hydroxide solution to each mixed solution, mix well, add 8 μL of 1mol / L citric acid solution, mix well, and this mixed solution is the calibrator.

[0051] The reaction system is: buffer 195 μL, sample volume 20 μL, reagent volume 20 μL, reaction time 2 minutes, gain value 1.

[0052] figure 1 It is the standard curve of...

Embodiment 2

[0054] The detection of 7F type pneumococcus polysaccharide content in the pneumococcal conjugate vaccine of embodiment 2

[0055] 1. Take the 7F type pneumococcal conjugate and dilute it with a diluent to a solution with a polysaccharide concentration of 133 μg / mL.

[0056] 2. The following steps are the same as steps 2-4 in Example 1.

[0057] 3. figure 2 It is the standard curve chart of 7F pneumococcal conjugate in pneumococcal conjugate vaccine.

[0058] 4. Extrapolate the standard curve to the content axis, and the intercept on the content axis is the sugar content of the 7F pneumococcal conjugate in the pneumococcal conjugate vaccine. As can be seen from the figure, the sugar content of the 7F type pneumococcus conjugate and the reaction value are in a good linear relationship, R2=0.9895, the linear regression equation is y=0.49x+2, and the intercept of the standard curve on the content axis is 4.08, that is, the sugar content of the 7F type pneumococcal conjugate i...

Embodiment 3

[0059] The detection of 12F type pneumococcus polysaccharide content in the pneumococcal conjugate vaccine of embodiment 3

[0060] 1. Take the 12F type pneumococcal conjugate and dilute it with a diluent to a solution with a polysaccharide concentration of 133 μg / mL.

[0061] 2. The following steps are the same as steps 2-4 in Example 1.

[0062] 3. image 3 It is the standard curve chart of 12F pneumococcal conjugate in pneumococcal conjugate vaccine.

[0063] 4. Extrapolate the standard curve to the content axis, and the intercept on the content axis is the sugar content of the 12F pneumococcal conjugate in the pneumococcal conjugate vaccine. As can be seen from the figure, the sugar content of the 12F type pneumococcus conjugate and the reaction value are in a good linear relationship, R2=0.9878, the linear regression equation is y=2.9985x+14.676, and the intercept of the standard curve on the content axis is 4.89, that is, the sugar content of the 12F pneumococcal conj...

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Abstract

The invention relates to a method for detecting the contents of various types of specific sugar in polyvalent pneumococcal conjugate vaccine. The method comprises the following steps: step I: preparing solutions of certain concentrations from various types of monovalent capsular polysaccharide-protein conjugates according to sugar concentrations; step II: taking several parts of pneumococcal conjugate vaccine, adding the conjugate solutions obtained in the first step into the parts of pneumococcal conjugate vaccine except the first part, and diluting all the samples with a solvent to the same volume, wherein the volumes of the conjugate solutions added into the parts of pneumococcal conjugate vaccine increase from the second art to the last part in sequence; step III: adding alkali into each sample for desorption, and then adding acid for neutralization to obtain standards; step IV: carrying out reactions between the standards and a detection reagent, and drawing a standard curve by taking the sugar contents of the conjugate solutions as horizontal coordinates and taking reacting values as vertical coordinates; step V: pushing the standard curve outwards to the content axis, and taking the intercepts on the content axis as the sugar contents of monovalent capsular polysaccharide-protein conjugates in the polyvalent pneumococcal conjugate vaccine.

Description

technical field [0001] The invention relates to a method for detecting biological products, in particular to a method for detecting the specific sugar content of various types of multivalent pneumococcal conjugate vaccines. Background technique [0002] In the quality control of multivalent vaccines, the quantitative detection of each component is one of the important items. At present, quantitative detection methods for each component in multivalent vaccines include: [0003] chemical color [0004] Some components in the vaccine have light absorption in a specific wavelength range, or after chemical treatment, form a substance with light absorption, and the degree of light absorption is related to the content, which can be used for content detection. For example, sialic acid is one of the active components of group C polysaccharides in group A and C meningococcal polysaccharide conjugate vaccines. After extracting sialic acid from group C meningococcal polysaccharides wi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N21/49
CPCG01N21/49G01N33/68
Inventor 胡月凤朱卫华杜琳
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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