Squalene Purification via Segmented Distillation Temperatures

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Solution Overview

Problem

Current methods for producing squalene from shark liver oil often result in contaminated products due to the risk of pathogens, human toxins, and allergens, making it unsuitable for pharmaceutical use without rigorous manufacturing standards.

Innovation Solution

A method involving purification and denaturing distillation at specific temperatures (T1 and T2) to produce squalene with high purity, removing impurities and allergens like parvalbumin, ensuring the product is safe for pharmaceutical applications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If squalene is extracted from shark liver oil using conventional methods, then the production cost is low and the process is simple, but the product contains contaminants, pathogens, and allergens making it unsuitable for pharmaceutical use

Engineering Contradiction:
Improveproduct safetyVSAvoidprocess complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The purification process is divided into multiple distinct stages: initial extraction, purification distillation at temperature T1, and denaturing distillation at temperature T2. Each stage targets specific contaminants, progressively improving product safety while maintaining manageable process complexity through systematic breakdown of the purification task.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The process utilizes temperature parameter changes to achieve different purification objectives. Purification distillation occurs at temperature T1 to remove volatile contaminants, while denaturing distillation occurs at higher temperature T2 to denature proteins and remove non-volatile contaminants. This parameter-based approach ensures pharmaceutical-grade purity without requiring overly complex equipment.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If purification distillation is carried out at temperature T1, then volatile impurities are removed, but non-volatile contaminants remain in the product

Engineering Contradiction:
ImprovepurityVSAvoidsqualene loss
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The process employs two distinct temperature parameters: T1 for purification distillation to remove volatile impurities, and T2 (where T2 > T1 and T2 ≥ 200°C) for denaturing distillation to remove non-volatile contaminants. This staged parameter approach maximizes purity while minimizing squalene loss by optimizing each distillation stage for its specific contaminant type.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The method exploits phase transition differences between squalene and various contaminants at different temperatures. At temperature T1, volatile contaminants transition to vapor phase and are removed. At temperature T2, proteins and non-volatile contaminants undergo denaturation and phase separation, enabling their removal while retaining squalene in the desired phase.

Inventive Principle:
Principle #36Phase transitions

3Reliability

If denaturing distillation is carried out at temperature T2 ≥ 200°C, then proteins and non-volatile contaminants are removed, but energy consumption increases

Engineering Contradiction:
Improveproduct safetyVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The process performs preliminary purification distillation at the lower temperature T1 before conducting denaturing distillation at the higher temperature T2. This preliminary action removes volatile contaminants first, reducing the overall energy burden of the subsequent high-temperature denaturing step while ensuring comprehensive contaminant removal for pharmaceutical-grade safety.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The method utilizes controlled temperature parameter changes with T2 ≥ 200°C specifically for denaturing distillation. This parameter is optimized to achieve protein denaturation and removal of non-volatile contaminants while minimizing unnecessary energy consumption. The staged approach allows energy-intensive high-temperature processing to be applied only when necessary for specific contaminant types.

Inventive Principle:
Principle #35Parameter changes

4Ease of manufacture

If shark liver oil is used as the source, then squalene can be obtained at low cost, but the product contains pathogens, toxins, and allergens

Engineering Contradiction:
Improvemanufacturing easeVSAvoidcontaminants
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The manufacturing process segments contaminant removal into targeted stages: purification distillation at T1 addresses volatile contaminants, while denaturing distillation at T2 addresses proteins and non-volatile contaminants including allergens like parvalbumin. This segmented approach maintains ease of manufacture with conventional equipment while systematically eliminating harmful factors to achieve pharmaceutical-grade safety.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The process employs parameter changes in temperature (T1 and T2 ≥ 200°C) to selectively remove different types of harmful contaminants from shark liver oil-derived squalene. This approach maintains manufacturing simplicity while effectively addressing pathogens, toxins, and allergens through thermally-based separation and denaturation mechanisms.

Inventive Principle:
Principle #35Parameter changes

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 method effectively purifies squalene, achieving a product with at least 99% purity and reducing contaminants, pathogens, and allergens, making it suitable for pharmaceutical use and safe for human administration.

Implementation Method 1

a purification distillation carried out at a temperature T1

Methodology Applied
Scientific EffectDistillation: Distillation

Implementation Method 2

a denaturing distillation carried out at a temperature T2

Methodology Applied
Scientific EffectDistillation: Distillation

Implementation Method 3

a denaturing distillation carried out at a temperature T2 wherein T2≥200° C.

Methodology Applied
Scientific EffectProtein denaturation:

Implementation Method 4

T1 and T2 are sufficient to cause squalene to boil

Methodology Applied
Scientific EffectHeating: Heating

Data Source

PatentUS11077186B2Methods for preparing squalene
Publication Date: 2021.08.03 SEQIRUS UK LTD
  • US11077186B2 patent drawing

AI summary

An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T1 (b) a denaturing distillation carried out at a temperature T2; wherein steps (a) and (b) may be performed in either order; T1 and T2 are sufficient to cause squalene to boil; T2>T1; and T2>200° C.