Herbal Extract Mixing Process for Osthol Stabilization
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Solution Overview
Problem
The existing production methods for Iberogast, a plant-based medicine, face challenges in maintaining a constant active ingredient content and consistent quality due to precipitation/crystal formation in the angelica root extract, leading to inhomogeneities and unacceptable fluctuations in the Osthol content.
Innovation Solution
A specific manufacturing process is developed where Angelicae radix extract and Liquiritiae radix extract are mixed in a 1:6 to 3:1 volume ratio, followed by the sequential addition of other extracts, stabilizing Osthol and preventing crystal formation through the use of saponins and mucus-containing drugs, ensuring reproducible production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If angelica root extract is produced and stored, then the extract contains active ingredients, but precipitation and crystal formation occur leading to inhomogeneities and fluctuations in Osthol content
Solution Approach 1:
The patent applies preliminary action by mixing the angelica root extract with licorice root extract and other herbal extracts immediately after extraction, before precipitation and crystal formation can occur. This proactive mixing approach prevents the development of inhomogeneities rather than addressing them after they form, thereby maintaining constant Osthol content and extract homogeneity throughout storage.
2Reliability
If extracts are mixed in arbitrary order, then production is simple, but quality consistency and reproducibility cannot be maintained
Solution Approach 1:
The patent applies segmentation by dividing the mixing process into specific sequential steps with defined mixing ratios. Instead of mixing all extracts simultaneously or in arbitrary order, the process segments the extraction and mixing operations into distinct stages, where each extract is mixed in a predetermined sequence and proportion. This segmented approach ensures quality reproducibility while maintaining manageable process complexity through clear procedural steps.
3Manufacturing precision
If sediment formation occurs in angelica root extract, then active ingredients precipitate, but this leads to unacceptable fluctuations in Osthol content and batch inhomogeneity
Solution Approach 1:
The patent applies the intermediary principle by introducing licorice root extract and other herbal extracts as mediating substances that prevent crystal formation in the angelica root extract. These intermediary extracts contain compounds that interfere with the precipitation process, acting as protective agents that maintain Osthol in solution and prevent the formation of sediments and crystals, thereby ensuring batch homogeneity.
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 described process ensures consistent and reproducible quality of Iberogast by suppressing crystal formation, maintaining Osthol content within permissible tolerance, and ensuring batch homogeneity, as demonstrated by Examples 1, 2, and 3.
Implementation Method 1
stabilizing Osthol and preventing crystal formation through the use of saponins
Implementation Method 2
the mucus-containing drugs such as milk thistle prevent sedimentation
Implementation Method 3
The mixing order (addition sequence) prevents the formation of crystals of the ingredients (secondary plant substances) of the herbal extracts
Data Source
Figure 1~2
AI summary
The present invention relates to a method for producing a herbal medicinal product containing Iberis amara, Menthae piperitae folium, Matricariae flos, Carvi fructus, Melissae folium, Angelicae radix, Liquiritiae radix, Cardui mariae fructus and Chelidonii herba in the form of alcoholic extracts, and to a medicinal product produced according to this method and its use.