Core-Shell Ion Exchange Filler for Low-Pressure HbA1c Separation
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Solution Overview
Problem
Existing ion exchange chromatography packing materials face challenges in achieving high separation performance at low column pressure and require more efficient production methods, particularly for hemoglobin components like HbA1c.
Innovation Solution
A packing material comprising core-shell particles with a cation exchange group on the shell surface, having a CV value of 18% or less, an average particle size of 3.0 to 10.0 µm, and a cation exchange capacity of 0.1 to 150 µeq/gel mL, produced through seeded polymerization, enhances separation performance and ease of production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional packing materials are used for ion exchange chromatography, then the column pressure is reduced, but the separation performance is insufficient
Solution Approach 1:
The patent applies parameter changes by precisely controlling the particle size distribution (CV value ≤ 18%) and average particle size (3.0-10.0 µm) of the core-shell particles. This parameter optimization allows the packing material to achieve high separation performance while maintaining low column pressure, resolving the contradiction between measurement precision and stress.
Solution Approach 2:
The patent uses composite materials by creating core-shell particles with a core containing a crosslinked polymer and a shell containing a hydrophilic polymer with ion exchange groups. This composite structure combines the advantages of both materials to achieve both high separation performance and low column pressure.
2Manufacturing precision
If complex multi-step production methods are used, then the packing material properties can be controlled, but the production efficiency is low
Solution Approach 1:
The patent applies preliminary action by preparing seed particles with controlled properties before the main polymerization process. The seed particles serve as a foundation that determines the final particle size distribution, allowing precise control of manufacturing parameters while simplifying the overall production process and improving efficiency.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The packing material achieves very high separation performance at reduced column pressure, allowing accurate measurement of hemoglobins such as HbA1c and HbF with improved production efficiency.
Implementation Method 1
Ion exchange liquid chromatography is widely used for analyzing components in analytes... separates a target substance utilizing the electrostatic interactions between ion exchange groups in a packing material and ions in the target substance
Implementation Method 2
separates a target substance utilizing the electrostatic interactions between ion exchange groups in a packing material and ions in the target substance
Implementation Method 3
a core-shell particle obtained by polymerization of a monomer in the presence of a seed particle
Data Source
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AI summary
The disclosure provides a packing material for ion exchange chromatography that has very high separation performance even at reduced column pressure and is useful for measurement of hemoglobins, particularly hemoglobin A1c and the like, and a production method that enables efficient and easy production of the packing material. The disclosure also provides a hemoglobin measurement method that enables measurement of hemoglobins with very high accuracy. The packing material of the disclosure is used for ion exchange chromatography, the packing material including core-shell particles, each core-shell particle including a core and a shell covering at least part of the core, and including a cation exchange group on a surface of the shell, the packing material having a CV value (%) of 18% or less, where the CV value is represented by the following formula (1): CV value (%) = (standard deviation of particle size/average particle size) × 100.