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2025
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Medical Grade Silica Dioxide: The "Invisible Stabilizer" in Pharmaceutical Preparations
Its core value lies in enhancing the stability and administration safety of pharmaceuticals, making it an indispensable component in most solid preparations.
As a key excipient in the pharmaceutical industry, medical grade silica dioxide is widely used in the field of pharmaceutical preparations. Its core value lies in enhancing the stability and administration safety of pharmaceuticals, making it an indispensable component in most solid preparations.
1. Core Functions: Safeguarding Pharmaceutical Quality and Efficacy
- Anti-adhesion and Glidant Property: In the production of tablets and capsules, medical grade silica dioxide can adhere to the surface of drug particles, reducing adhesion between particles. This ensures smooth tableting and filling processes, and prevents issues such as tablet lamination and uneven capsule filling.
- Adsorption and Stabilization: It can adsorb trace moisture or oil in drugs, preventing drugs from absorbing moisture, caking, oxidizing, and deteriorating. This extends the shelf life of pharmaceuticals, and is particularly effective for moisture-sensitive drugs such as vitamins and antibiotics.
- Dispersion and Dissolution: It can refine drug particles, increase the contact area between drugs and body fluids, promote rapid dissolution and absorption of drugs in the body, improve the bioavailability of pharmaceuticals, and ensure the stable exertion of efficacy.
2. Safety Standards: Strictly Complying with Pharmaceutical-Grade Specifications
The production and use of medical grade silica dioxide must comply with the Pharmacopoeia of the People's Republic of China and the standards of the International Pharmaceutical Excipients Council (IPEC). The core requirements include:
- Purity: The content of silica dioxide must reach over 99.0%, and harmful impurities such as heavy metals and arsenic salts must not be detected to ensure medication safety.
- Sterility: When used in sterile pharmaceuticals such as injections and ophthalmic preparations, it must undergo high-temperature sterilization or radiation sterilization to avoid microbial contamination.
- Compliance: Manufacturers must hold a Pharmaceutical Production License, and each batch of products must be accompanied by a quality inspection report to ensure traceability of the source.
3. Application Scenarios: Covering Multiple Types of Pharmaceutical Preparations
- Oral Solid Preparations: It is a common excipient in tablets, capsules, and powders. For example, it is added to cold medicines, antihypertensive drugs, and hypoglycemic drugs, with a dosage usually accounting for 0.1%-2% of the total weight of the pharmaceutical.
- Topical Preparations: In ointments and creams, it acts as a thickener and stabilizer, improving the texture of the preparation, preventing oil-water separation, and enhancing the user experience.
- Special Preparations: It is used in targeted drugs and sustained/controlled-release preparations to assist in controlling the drug release rate, achieving precise drug administration, and reducing the frequency of medication.
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