Evonik的药用级AEROSIL 200 Pharma：全球药品和食品行业的纳米级载体创新

Utworzono 04.12

Evonik's Pharmaceutical-Grade AEROSIL  200 Pharma: Nano-Scale Carrier Innovation for Global Drug and Food Industries

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April 10, 2025, Hanau, Germany – Evonik, a global leader in specialty chemicals, today announced that its pharmaceutical-grade product AEROSIL  200 Pharma (CAS No.: 112945-52-5) has obtained regulatory approvals in 12 countries, including the EU, U.S., and Japan, positioning it as the preferred carrier material for solid/liquid pharmaceuticals and food additives worldwide. This high-purity colloidal silica offers breakthrough solutions for drug stability and food safety through its nano-porous structure and multi-pharmacopeia compliance.
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I. Product Highlights: 质量药品级 & 多功能性能

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AEROSIL  200 Pharma 是一种通过火焰水解法生产的无定形无水胶体二氧化硅，具有：

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- Ultra-High Purity: SiO₂ content ≥99.0% (Ph. Eur. standard), with strict control of heavy metals (≤25ppm), arsenic (≤8ppm), and other impurities, compliant with EU E551 food additive requirements.

- Nano-Scale Network Structure: Specific surface area of 175-225 m²/g and tamped density of 50 g/L ensure efficient adsorption and uniform dispersion, enhancing drug bioavailability.

- 多药典合规性：获得欧洲药典（Ph. Eur.）、美国药典（USP/NF）、日本药典（JP）和印度药典（IP）认证，支持全球药物注册。

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II. 技术参数与性能比较

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Indicator AEROSIL  200 Pharma Tradisjonelle farmasøytiske bærere

Specific Surface Area (BET) 175-225 m²/g 50-100 m²/g

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Loss on Drying (105℃, 2h) ≤2.5% ≤5.0%
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pH 值（水相系统） 3.5-5.5 6.0-7.0

Microbial Limits (TAMC/TYMC) ≤1000 CFU/g ≤1000 CFU/g

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III. 应用场景与行业价值

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1. Industria Farmacéutica

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- Solid Dosages:

- Tablets/Capsules: Mejora la fluidez del polvo (reduciendo el ángulo de reposo en un 20-30%), previene la aglomeración y mejora la dureza de la tableta (en un 15-20%) y la resistencia a la desintegración.

- Direct Compression: Reduces lubricant usage and shortens production cycles.

- Liquid Formulations:

- Suspensions/Emulsions: Actúa como un espesante y agente tixotrópico para prevenir la sedimentación del fármaco (relación de volumen de sedimentación >95%).

- Injectables: Conforme a los estándares IPEC-GMP para la fabricación aséptica.

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msgid "2. Food & Nutraceuticals"
msgstr "2. 食品与营养保健品"

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- Anti-Caking Agent: Maintains flowability in powdered foods (e.g., milk powder, protein powder) without caking for 6+ months under ≤60% humidity.

- Active Ingredient Carrier: Adsorbe vitaminas, probióticos, etc., extendiendo la vida útil (retención de bioactividad aumentada en un 30%).

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IV. 全球足迹与可持续性

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Evonik确保通过位于德国哈瑙和中国上海的生产设施本地化供应AEROSIL 200 Pharma，年产能力为5,000公吨。制造过程遵循GMP和HACCP体系，同时可持续发展倡议包括：

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- Energy Recycling: Utilizes waste heat for power generation, reducing fossil fuel consumption.

- Packaging Optimization: Utiliza bolsas de papel multicapa reciclables (10 kg/bolsa) para minimizar los desechos plásticos.

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V. 客户支持与成功案例

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- Technical Services: A global team of 200+ experts provides full-cycle support, including:

- Dispersion guidance (recommended high-shear mixing ≥30 minutes).

- Compatibility testing (adsorption isotherm data with APIs).

- Key Clients:

- Multinational Pharmaceutical Companies: Implementado en tabletas de liberación sostenida, logrando uniformidad de disolución (RSD <5%).

- Food Conglomerates: Prolonged shelf life of probiotics from 6 to 12 months as a carrier.

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VI. 联系信息

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- Global Website: www.silica-specialist.com

- Technical Inquiries: technical.service.aerosil@evonik.com

- China Hotline: +86 21 6119-1151

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About Evonik

Evonik es una empresa líder global en productos químicos especiales con 50 años de experiencia en portadores farmacéuticos, sirviendo a 18 de las 20 principales empresas farmacéuticas del mundo. Su serie AEROSIL tiene una participación de mercado global del 35% en sílice de grado farmacéutico, impulsando la innovación continua en tecnologías de entrega de medicamentos.

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注意：产品性能可能因配方和工艺条件而有所不同。建议在使用前进行兼容性测试。Evonik保留在不事先通知的情况下修改技术参数的权利。
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