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2025
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Medical Grade Silica Dioxide: A Key Excipient Driving the Upgrade of Pharmaceutical Preparation Technology
With the development of the pharmaceutical industry towards refinement and high efficiency, medical grade silica dioxide, relying on its versatility and safety, has become an important support for the innovation of preparation technology, helping pharmaceuticals upgrade from "administrable" to "high-quality administrable".
With the development of the pharmaceutical industry towards refinement and high efficiency, medical grade silica dioxide, relying on its versatility and safety, has become an important support for the innovation of preparation technology, helping pharmaceuticals upgrade from "administrable" to "high-quality administrable".
1. Technical Advantages: Adapting to Modern Preparation Needs
- Controllable Performance: By adjusting the production process, medical grade silica dioxide with different specific surface areas and particle sizes can be prepared to meet the personalized needs of different pharmaceutical preparations. For example, products with high specific surface areas are suitable for promoting the dissolution of poorly soluble drugs.
- Strong Compatibility: It has no incompatibility with most active pharmaceutical ingredients (APIs) and other excipients (such as microcrystalline cellulose and lactose). It can be flexibly integrated into various preparation formulas without the need for additional adjustments to the production process.
- Environmental Friendliness: No toxic or harmful substances are emitted during the production process, and the product is biocompatible and will not remain in the body. It conforms to the development concept of "green production and safe medication" in modern medicine.
2. Quality Control: Ensuring Medication Safety Throughout the Chain
- Raw Material Control: High-purity quartz sand is selected as the raw material, and chemical synthesis methods (such as vapor phase method and precipitation method) are used for production to eliminate the introduction of impurities from the source.
- Process Supervision: The production process strictly follows the Good Manufacturing Practice (GMP) for pharmaceuticals. Key parameters such as temperature, humidity, and particle size distribution are monitored in real time to ensure consistent quality of each batch of products.
- Terminal Testing: Before leaving the factory, comprehensive testing must be conducted using equipment such as infrared spectrometers, particle size analyzers, and heavy metal detectors. Only products that meet the pharmacopoeia standards can enter the market.
3. Market Trends: Steady Growth in Demand Driven by the Pharmaceutical Industry
- Global Market: According to industry data, the global market size of medical grade silica dioxide exceeded 1.5 billion US dollars in 2024, with an annual growth rate of 5%-8%. The main driving force comes from the capacity expansion of generic drugs and innovative drugs.
- Domestic Development: China has achieved independent control over the production capacity of medical grade silica dioxide. Products from local enterprises not only meet domestic demand but also are exported to Europe, America, Southeast Asia, and other regions, promoting the stability of the global pharmaceutical excipient supply chain.
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