Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, a functional pharmaceutical excipient produced through the sol-gel process, appears as a white amorphous powder. Its defining features include a regular mesoporous channel structure with pore sizes ranging from 2 to 50nm and an ultra-large specific surface area. This material demonstrates high drug loading capacity, controlled release rates, and excellent biocompatibility, while remaining chemically inert to active pharmaceutical ingredients. As such, it serves as a core carrier material for constructing precision drug delivery systems. 1.2 Core values As a premium pharmaceutical excipient, Zhongqi Mesoporous Silica effectively addresses industry challenges such as poor targeting and short drug half-life in conventional formulations. Through precise modulation of pore structure and surface properties, it enables efficient drug loading and intelligent release, significantly enhancing bioavailability while reducing toxic side effects. The product complies with stringent global pharmaceutical excipient standards, providing core material support for innovative formulation development and the upgrade of high-end generic drugs. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Precise mesoporous structure: the pore size is continuously adjustable from 5 to 30nm, the pore size distribution is uniform (deviation ≤2nm), the BET specific surface area can reach 300-1000m²/g, and the mesoporous volume can reach 2.0cm³/g, providing sufficient loading space for drug molecules. •Intelligent release regulation: Through surface modification of pH sensitive, enzyme sensitive and other "responsive valve" structures, the specific release of drugs at targeted sites can be achieved, and the release degree can be controlled with an accuracy of ±5% in vitro. •Excellent biocompatibility: SiO₂ purity is more than 99.0%, total heavy metal content is less than 10ppm, arsenic content is less than 3ppm, and no obvious cell damage is verified by cytotoxicity test, which meets the safety standards of biomedical materials. •Highly modifiable: the surface can be covalently connected with target groups such as folic acid, PEG and peptide to realize active targeted delivery, and the targeted enrichment efficiency is 5-8 times higher than that of ordinary carriers. 2.2 Process assurance The cationic surfactant template-assisted synthesis process achieves highly uniform mesoporous structures through precise control of reaction temperature, pH, and template concentration. The production process strictly adheres to GMP standards with an integrated online pore size monitoring system, ensuring rigorous quality control through batch-by-batch testing to maintain stable and controllable parameters throughout the manufacturing cycle. 2.3 Main role 1.Flow aid: improve the flow of API powder, so that the filling weight difference of tablets is controlled within ±3%, and the tablet pressing efficiency is increased by 20%; 2.Anti-adhesive: prevent the material from sticking to the punch, reduce the phenomenon of cracking and sticking, especially suitable for high viscosity Chinese herbal extract preparation; 3.Stabilizer: adsorb the trace moisture in tablet, delay the degradation of active ingredients, and prolong the drug validity for 12-24 months; 4.Release carrier: By controlling the pore structure to adjust the drug release rate, adding 0.2% in the sustained-release tablet formulation can achieve long-term drug release. 3. Key technical parameters (KTP) Parameter items Scope of indicators testing standard SiO₂ content (after burning) ≥99.0% USP-NF <281> BET specific surface area (m²/g) 300-1000 BET multi-point adsorption method Porosity (cm³g) 0.8-2.0 BJH law mean pore size （nm） 5-30 BJH law Dry weight loss (105℃,2h) ≤6.0% gravimetric analysis Heavy metal content (ppm) ≤10 Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Drug delivery carrier: High payload chemotherapy drugs (such as doxorubicin) can be released accurately by pH/temperature response to reduce damage to normal cells; insoluble drugs (such as paclitaxel) can be wrapped to improve solubility and bioavailability. 2. Genetic/vaccine vector: protect siRNA and plasmid DNA from degradation, enhance intracellular uptake by modification to achieve targeted delivery; adsorb vaccine antigen and prolong retention time to strengthen immune response. 3. Integrated diagnosis and treatment: Load fluorescent dyes and MRI/CT contrast agents to build a diagnosis and treatment platform for simultaneous monitoring of drug delivery and lesion changes. 4. Antibacterial and tissue repair: loaded with silver ions and antibiotics to inhibit bacteria for a long time (for wound dressing); porous structure simulates extracellular matrix, supports the proliferation and differentiation of stem cells, and contributes to bone/skin repair. 5. Standards and regulations (Standards & Regulations) •Complies with multiple international pharmacopoeia standards: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and China Pharmacopoeia (ChP 2025). •Obtain relevant qualification certification: FDA inactive ingredient database inclusion, EU E551 food additive certification. •Comply with global compliance guidelines: comply with GMP production specifications and HACCP food safety system requirements. 6. Key points for handling and storage •Drug load operation: it is recommended to be carried out at room temperature (20-25℃) and humidity <50%. The soaking adsorption method is used for water-soluble drugs, and the solvent volatilization method is used for fat-soluble drugs. The loading time should be at least 2 hours. •Surface modification note: functional groups such as amino and carboxyl groups should be modified at a pH value between 5 and 8 to avoid strong acid and alkali damage mesoporous structure. •Storage conditions: Seal in a brown reagent bottle, store in a cool and dry place (15-25℃, relative humidity <50%), avoid light storage, valid for 2 years, open for use within 1 month. 7. Product Advantages (PA) •High degree of customization: the pore size and specific surface area can be precisely controlled according to the size of API molecules, providing exclusive carrier solutions. •Multidimensional functional integration: it has multiple functions of drug loading, targeted delivery and intelligent release, which simplifies the formulation design. •Global compliance assurance: all indicators meet the requirements of international pharmacopoeia, support domestic and foreign innovative drug application, accelerate the process of product marketing. •Technical service improvement: provide drug loading process development, in vitro release test and other value-added services, with professional technical team support throughout the whole process. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •Food additive production license •Feed additive production license •National high-tech enterprise •Specialized, refined and new enterprises in Guangzhou •74 patents from the State Intellectual Property Office