Dry Lipase Analytical Element Using Hydrophilic Polymer Stabilization
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Solution Overview
Problem
Current dry analytical elements for pancreatic lipase measurement face challenges such as low specificity, substrate instability, and contamination issues due to triglyceride transcription on supports, leading to production difficulties and inaccurate results.
Innovation Solution
A dry multilayer analytical element with a hydrophilic polymer ratio of 1.8:1 or greater to triglyceride, incorporating monoglyceride lipase and a glycerin measurement reagent, and a water-impermeable support to prevent triglyceride transcription and ensure stable production and accurate analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If triglyceride is used as a substrate for pancreatic lipase measurement, then measurement accuracy is improved, but substrate stability deteriorates due to disintegration
Solution Approach 1:
The patent introduces a protective colloid as an intermediary substance that stabilizes the triglyceride substrate and prevents its disintegration. The protective colloid forms a protective environment around the triglyceride molecules, allowing them to maintain their structural integrity while still being accessible to pancreatic lipase for accurate measurement.
Solution Approach 2:
The patent creates a composite system combining triglyceride substrate with protective colloid and other reagents in a multilayer structure. This composite approach allows the substrate to maintain stability while preserving its reactivity with pancreatic lipase, resolving the contradiction between stability and measurement accuracy.
2Measurement precision
If triglyceride is incorporated into dry analytical element, then pancreatic lipase measurement is enabled, but transcription on support occurs causing contamination
Solution Approach 1:
The patent extracts or removes the problematic transcription issue by using a protective colloid system that prevents triglyceride from adhering to the support surface. The protective colloid creates a barrier that eliminates the harmful transcription effect while preserving the necessary measurement functionality.
Solution Approach 2:
The protective colloid acts as an intermediary between the triglyceride substrate and the support surface, preventing direct contact and thus preventing transcription and contamination. This intermediary layer allows the triglyceride to remain stable and functional without causing harmful effects.
3Manufacturing precision
If emulsification dispersion method is used for substrate incorporation, then substrate uniformity is improved, but production difficulty increases due to reproducibility requirements
Solution Approach 1:
The patent employs a protective colloid system that simplifies the manufacturing process by eliminating the need for complex emulsification and dispersion steps. This approach uses readily available materials and straightforward procedures, making production easier while still achieving uniform substrate distribution.
Solution Approach 2:
The patent changes the physical and chemical parameters of the substrate system by introducing protective colloid, which alters the behavior of triglyceride from requiring complex emulsification to allowing simpler incorporation methods. This parameter change maintains substrate uniformity while significantly easing manufacturing requirements.
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 solution reduces triglyceride transcription, prevents contamination, and ensures stable production, enhancing the accuracy and reliability of pancreatic lipase measurement while maintaining the specificity and reactivity of the analytical element.
Implementation Method 1
a hydrophilic polymer at a weight ratio of 1.8:1 or greater with respect to the triglyceride is contained
Implementation Method 2
a water-impermeable support to prevent triglyceride transcription
Implementation Method 3
incorporating monoglyceride lipase and a glycerin measurement reagent
Implementation Method 4
measuring pancreatic lipase under conditions in which a micellar substrate is dispersed in water
Implementation Method 5
a glycerin measurement reagent
Implementation Method 6
converted into a dye
Data Source
AI summary
It is an object of the present invention to provide: a dry analytical element for analyzing pancreatic lipase wherein the triglyceride is not transcribed on the support to contaminate a transportation slip or other analytical elements and wherein an additive solution of the triglyceride neither reaggregates nor precipitate, so that the dry analytical element is stable and is compatible with production. The present invention provides a dry analytical element for measuring pancreatic lipase contained in body fluid, which comprises triglyceride of long chain alkyl fatty acid having 12 to 22 carbon atoms, monoglyceride lipase, and a glycerin measurement reagent, and which comprises a water-impermeable support and at least one spreading or reagent layer, wherein a hydrophilic polymer at a weight ratio of 1.8:1 or greater with respect to the triglyceride is contained.