Pyrroloquinoline Quinone Sodium Salt Crystal Forms
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Solution Overview
Problem
Existing crystal forms of pyrroloquinoline quinone sodium salt exhibit high hygroscopicity and instability, making them unsuitable for processing and storage in pharmaceutical, cosmetic, and food applications, with previous modifications not fully addressing the need for low hygroscopicity and high crystallinity.
Innovation Solution
Development of new crystal forms (I, II, III, IV) of pyrroloquinoline quinone sodium salt with specific X-ray diffraction and infrared absorption spectra, characterized by low hygroscopicity (<0.3% at 75% RH) and improved stability, achieved through controlled pH adjustment and solvent-based crystallization methods, facilitating easier filtering, drying, and storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If prior art crystallization methods are used to obtain pyrroloquinoline quinone sodium salt, then the crystal form can be obtained, but the crystal form exhibits high hygroscopicity and instability
Solution Approach 1:
The patent applies parameter changes by systematically varying crystallization conditions including pH (adjusted to specific ranges), temperature (controlled during dissolution and crystallization), and solvent composition (using ethanol-water mixtures with specific ratios) to obtain new crystal forms with reduced hygroscopicity and improved stability compared to prior art methods
Solution Approach 2:
The patent utilizes phase transitions through controlled crystallization processes where the pyrroloquinoline quinone sodium salt transitions from dissolved state to crystalline state under specific conditions (pH adjustment, temperature control, solvent evaporation), resulting in new crystal forms with different physical and chemical properties including lower hygroscopicity
2Manufacturing precision
If prior art crystal forms are used, then the product can be obtained, but the crystallinity is low and residual solvent content is high
Solution Approach 1:
The patent improves crystallinity and reduces residual solvent by optimizing crystallization parameters including using specific ethanol-water solvent ratios, controlling pH to precise ranges, and managing temperature profiles during the crystallization process, resulting in high crystallinity products with minimal residual solvent
Solution Approach 2:
The patent applies extraction principles by using solvent-based crystallization where the choice of ethanol-water mixture allows for selective dissolution and crystallization, effectively separating the product from residual solvents and impurities, achieving high purity and low residual solvent content
3Ease of manufacture
If prior art crystal forms are used, then the product can be obtained, but the processing adaptability (filtering, drying, tabletting) is poor
Solution Approach 1:
The patent enhances processing adaptability by obtaining crystal forms with optimized physical properties through controlled crystallization parameters (pH, temperature, solvent composition), resulting in products with better filtration characteristics, drying performance, and tabletting properties while maintaining solid state stability
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 new crystal forms demonstrate enhanced chemical and physical stability, high purity, and reduced hygroscopicity, enabling improved processing and storage, with applications in medicines, cosmetics, and functional foods, while being environmentally friendly and cost-effective.
Implementation Method 1
achieved through controlled pH adjustment and solvent-based crystallization methods
Data Source
AI summary
Provided are crystal forms I, II, III and IV of a pyrroloquinoline quinone sodium salt and a preparation method thereof. Also provided are a pharmaceutical composition, a cosmetic composition, a functional food or a nutritional agent containing the above-mentioned crystal forms. The crystal forms have excellent properties in terms of solubility, crystal stability, hygroscopicity and the like.