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High-performance liquid chromatography detection method for residual CDAP in polysaccharide conjugate vaccine

A high-performance liquid chromatography combined with vaccine technology, which is applied in the field of high-performance liquid chromatography to measure CDAP, can solve problems such as CDAP measurement, and achieve the effect of simple method, convenient operation and high accuracy

Active Publication Date: 2016-02-03
北京成大天和生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, thin-layer chromatography (TLC) is used abroad, which can only be used to measure the purity of CDAP. There is no domestic literature report on the determination method of CDAP residues in polysaccharide conjugate vaccines. is a technical difficulty

Method used

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  • High-performance liquid chromatography detection method for residual CDAP in polysaccharide conjugate vaccine
  • High-performance liquid chromatography detection method for residual CDAP in polysaccharide conjugate vaccine
  • High-performance liquid chromatography detection method for residual CDAP in polysaccharide conjugate vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Determination of CDAP residues in group A meningococcal polysaccharide derivatives:

[0030] 1. Precisely prepare 2000ng / ml CDAP standard solution as sample 1;

[0031] 2. Group A meningococcal polysaccharide derivatives use 3K D Ultrafiltration tube 5000g centrifugal 20 minutes, collect filtrate and filter with 0.45 μ m membrane as need testing solution; Measure the sugar concentration of group A meningococcal polysaccharide derivative sample, be 4.67mg / ml (C 0 ), take the polysaccharide derivative of group A meningococcal meningitis to be tested as sample 2;

[0032] 3. Sample 1 and sample 2 were loaded and detected according to the chromatographic conditions;

[0033] Setting of chromatographic conditions:

[0034] 3.1 Mobile phase: acetonitrile-water-trifluoroacetic acid (60:40:0.1);

[0035] 3.2 Chromatographic column: C18, TSKgelODS-100V (4.6mm×250mm, 5μm), purchased from Tosoh Biotechnology Co., Ltd.;

[0036] 3.3 Detector: PDA detector;

[0037] 3.4 Detect...

Embodiment 2

[0047] Determination of CDAP residual in group A meningococcal meningitis polysaccharide conjugate stock solution:

[0048] 1. Precisely prepare 2000ng / ml CDAP standard solution as sample 1;

[0049] 2. 3K is used for group A meningococcal meningitis polysaccharide conjugate stock solution D Ultrafiltration tube 5000g centrifugal 20 minutes, collect filtrate and use 0.45 μ m membrane filtration as need testing solution; Measure the sugar concentration of group A meningococcal meningitis polysaccharide conjugate stoste sample, be 0.24mg / ml (C 0 ), take the stock solution of polysaccharide conjugate of group A meningococcal meningitis to be tested as sample 2;

[0050] 3. Sample 1 and sample 2 were loaded and detected according to the chromatographic conditions;

[0051] Setting of chromatographic conditions:

[0052] 3.1 Mobile phase: acetonitrile-water-trifluoroacetic acid (60:40:0.1);

[0053] 3.2 Chromatographic column: C18, TSKgelODS-100V (4.6mm×250mm, 5μm), purchased f...

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Abstract

1-cyano-4-dimethylamino-pyridinium tetrafluoroborate (CDAP) can activate polysaccharide to form cyanate ester, so that CDAP is applied to a preparation process of a polysaccharide conjugate vaccine. The invention provides a high-performance liquid chromatography detection method for residual CDAP in the polysaccharide conjugate vaccine. The method comprises the following steps: preparing a reference substance solution by using standard CDAP; centrifuging a sample to be detected by using an ultrafiltration centrifuge tube, and filtering the collected filtrate through a filtering membrane of 0.45 [mu]m so as to be used as a test sample solution; respectively loading the test sample solution and the reference substance solution CDAP on high-performance liquid chromatography columns, eluting after sample loading and recoding chromatograms; calculating the concentration of CDAP in the sample by adopting an external standard method according to the concentration and chromatographic peak area of the reference substance solution CDAP and the chromatographic peak area of the test sample solution CDAP. The method provided by the invention is simple, convenient to operate and high in accuracy, and can accurately and quickly realize effective monitoring on residual CDAP in the polysaccharide conjugate vaccine.

Description

technical field [0001] The invention belongs to the field of testing and analysis, in particular to a method for measuring CDAP by using high-performance liquid chromatography. Background technique [0002] Polysaccharide conjugate vaccine is a covalent combination of polysaccharide antigen and carrier protein by chemical method, and the antigen type is changed from thymus-independent antigen to thymus-dependent antigen, which can stimulate effective immunity in children under 2 years old, the elderly and immunodeficiency The protective antibody induced is mainly immunoglobulin (Ig) G, which is more effective than the IgM induced by polysaccharide vaccine and can last for a long time, which has incomparable advantages of polysaccharide vaccine. [0003] In the preparation process of polysaccharide-conjugated vaccines, activators such as cyanogen bromide are usually used to activate bacterial polysaccharides. Like cyanogen bromide, 1-cyano-4-dimethylamino-pyridine boron tetr...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 张晓华孙述学王震褚自青周荔葆王振业刘晓磊李晓帆
Owner 北京成大天和生物科技有限公司
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