Methyl Hydrogen Silicone Fluid

Basic Product Information

• Product Name: Methyl hydrogen siloxane
• Appearance: Colorless to pale yellow transparent oily liquid.

TYPICAL PROPERTIES

Appearance	colorless transparent liquid
Viscosity (25℃),mm2/s	20-250
H% (wt)	0.04-1.45
Volatile content(150℃,3h),%	≤11

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Physical Properties

• Low surface tension (enables easy film formation and spreading).
• High temperature resistance (stable from –50°C to 200°C).
• Excellent hydrophobicity and breathability.

Chemical Properties

• Non-toxic and non-irritating.
• Flexible molecular chains capable of forming a cross-linked network structure through curing reactions.
• ISO 10993 biocompatibility certified (tested for biological safety).
• Non-cytotoxic and non-sensitizing (safe for human contact).
• Suitable for direct application in cosmetics and personal care products.

Product Functions

• Enhance Lubricity and Anti-Adhesion of Medical Devices

Reduce friction between devices (e.g., catheters, endoscopes) and tissues, minimizing patient discomfort.

Prevent adhesion of biomolecules (e.g., proteins, bacteria), lowering infection risks.

• Serve as a Drug Carrier for Sustained or Targeted Delivery

Load drugs via microencapsulation or nanocarriers to extend release time.

Enable tissue/cell-specific targeting through surface modifications, improving efficacy and reducing side effects.

• Promote Wound Healing and Reduce Infection in Dressings

Form a breathable, waterproof barrier to maintain a moist healing environment.

Inhibit bacterial growth via hydrophobicity and antimicrobial modifications.

• Improve Biocompatibility of Medical Silicone Rubber

Reduce immune rejection and inflammation risks.

Enhance long-term safety for tissue contact (e.g., implants, catheters).

• Enhance Precision and Flexibility of 3D-Printed Medical Models

Adjust rheological properties of printing materials as an additive, improving structural complexity.

Increase realism of models (e.g., blood vessels, organ replicas).

• Provide High-Temperature Sterilization Resistance

Maintain stability during autoclaving, ethylene oxide, or radiation sterilization, extending device lifespan.

• Impart Antimicrobial Properties

Graft antimicrobial agents (e.g., quaternary ammonium salts, silver ions) or use hydrophobic surfaces to inhibit microbial colonization, reducing hospital-acquired infections.

• Hydrophobic Coating for Microfluidic Chips

Prevent liquid residue and improve detection accuracy.

• Lubricant for Artificial Joints

Minimize wear and extend the lifespan of implants.

Applications

• Medical Devices (e.g., catheters, sutures, artificial joints)

Catheters: Lubrication and anti-biofilm formation for urinary catheters, central venous catheters, and drainage tubes.

Surgical Instruments: Lubrication for endoscopic joints, anti-adhesive coatings for electrosurgical tools.

Implants: Surface modification for artificial heart valves, orthopedic fixation materials.

Specialized Devices: Anti-mucosal adhesion treatment for endotracheal tubes, gastrointestinal decompression tubes.

• Pharmaceutical Formulations (e.g., topical gels, patches)

Transdermal Drug Delivery: Controlled-release matrix for nitroglycerin patches, fentanyl patches.

Topical Medications: Sustained-release carrier for antifungal creams, burn ointments.

Mucosal Delivery: Film-forming material for oral ulcer patches.

Ophthalmic Products: Lubricating component in artificial tears, ocular gels.

• Medical Dressings & Consumables

Wound Care: Waterproof barrier for silicone foam dressings, hydrocolloid dressings.

Surgical Protection: Coating material for anti-adhesive membranes, surgical drapes.

Ostomy Care: Skin-friendly adhesive modification for ostomy bags.

Hemostatic Materials: Surface treatment for absorbable hemostatic sponges.

• Medical Cosmetology

Injectable Fillers: Carrier material for long-lasting fillers (e.g., polycaprolactone/PCL microsphere suspension matrix).

Skin Repair: Post-laser therapy dressings, microneedling adjunct materials.

Scar Management: Silicone gel component for hypertrophic scar compression therapy.

Aesthetic Implants: Coating for tissue expanders prior to prosthetic implantation.

• Diagnostic & Assistive Devices (e.g., biosensors)

In Vitro Diagnostics: Hydrophobic channel treatment for microfluidic chips.

Implantable Sensors: Biocompatible coating for glucose sensor probes.

Imaging: Modified components for ultrasound probe coupling agents.

Rehabilitation: Anti-friction lining materials for prosthetic sockets.

• Specialized Medical Scenarios

Neonatal Care: Gentle adhesive for monitoring electrodes in preterm infant incubators.

Burn Treatment: Anti-adhesive coating for air-fluidized beds in severe burn cases.

Oncology: Coating material for radioactive seed implants.

Geriatric Care: Functionalized surfaces for anti-decubitus mattresses.

Core Advantages

Advantage	Medical Value	Data/Certification
Biocompatibility	ISO 10993 certified for safe implantation in the body.	Grade 0 cytotoxicity, no sensitization observed.
Lubrication & Anti-Adhesion	Reduces tissue friction damage from endoscopic tools.	60% lower friction coefficient vs. conventional materials.
Sustained-Release Drug Carrier	Enhances drug stability and prolongs release duration.	40% improvement in sustained-release efficiency.
Wound Care Performance	Waterproof, breathable, and accelerates healing.	30% reduction in healing time.
High-Temperature Sterilization Resistance	Compatible with autoclaving/ethylene oxide sterilization.	No performance degradation after 10 sterilization cycles.
Antimicrobial Function	Inhibits bacterial adhesion and biofilm formation.	≥90% inhibition rate against E. coli.

Market Value

Core Value Proposition

Hydrogen-containing silicone oil holds irreplaceable value in medical applications due to its unique biocompatibility and chemical stability:

• Medical-Grade Performance Standards

Ultra-high purity requirements: Metal impurities <0.1 ppm.

Sterilization stability: Resistant to gamma radiation and ethylene oxide (EO) sterilization.

Long-term implant safety: Compliant with ISO 10993 series testing.

• Functional Advantages

Ultra-low surface tension (22–24 mN/m) enhances drug wettability.

Rheological stability across extreme temperatures (–50°C to 250°C).

Tunable gas permeability: O₂ transmission rate of 200–500 cm³/m²/day.

Market Segmentation

• Medical Devices (Dominant Market)

Market size: $280 million globally in 2023 (accounting for 78% of medical applications).

Key applications:

Catheter/intubation surface treatment (reduces friction coefficient to 0.05–0.1).

FDA 510(k)-certified respiratory mask sealing materials.

Anti-adhesive coatings for surgical tools (60% reduction in adhesion rates).

Pharmaceuticals (Fastest-Growing Sector)

Growth rate: 18.7% CAGR (2023–2030 forecast).

Innovative applications:

Ophthalmic drug carriers (extends drug retention time by 3–5×).

Transdermal penetration enhancers (boosts permeation efficiency by 40–80%).

Moisture-resistant coatings for oral drugs (reduces humidity sensitivity by 90%).

• Implantable Devices (High-Value Niche)

Long-term durability (>10 years in vivo stability).

Anti-calcification treatment (annual deposition rate <5%).

Market Drivers

• Clinical Demand Evolution

Minimally invasive surgery: 12% annual growth in catheter demand.

Chronic disease management: Drives demand for long-acting formulations.

Aging population: Accelerates implantable device market expansion.

• Regulatory Tailwinds

China’s Innovative Medical Device Fast-Track Approval Program.

Stricter material safety requirements under the EU Medical Device Regulation (MDR).

Updated FDA 21 CFR 177.2600 standards (US).

• Technology Replacement Opportunities

Displacing PTFE in interventional devices.

Upgrading traditional silicone gel implants.

Revolutionizing wound care product performance.

Experimental Data & Case Studies

Medical Devices (Catheters, Artificial Joints, etc.)

• Experimental Data
• Lubricity Testing (ASTM D1894 Standard):

Friction coefficient of hydrogen-containing silicone oil-coated catheters reduced to 0.05–0.1 (vs. 0.3–0.5 for uncoated catheters).

Case Study: Cook Medical’s silicone-coated urinary catheters (USA) showed 40% reduction in patient discomfort and 25% lower urinary tract infection rates (Journal of Urology, 2018).

• Anti-Adhesion Performance:

In vitro tests demonstrated 90% reduction in bacterial adhesion (E. coli, ISO 22196 standard) on hydrogen-containing silicone oil-treated catheter surfaces.

Pharmaceutical Formulations (Gels, Patches)

• Experimental Data
• Sustained-Release Performance:

Nitroglycerin patches (72-hour release) using hydrogen-containing silicone oil matrix exhibited zero-order kinetics (R² >0.98) and 50% reduction in blood concentration fluctuations vs. traditional patches.

Case Study: Hisamitsu Pharmaceutical’s (Japan) silicone-based ketoprofen patches achieved 30% higher transdermal efficiency.

• Skin Permeability:

Hydrogen-containing silicone oil increased percutaneous permeation of flurbiprofen from 12 μg/cm²/h to 28 μg/cm²/h (Franz diffusion cell test).

Medical Dressings (Wound Care)

• Experimental Data
• Healing Acceleration:

Animal studies (rat full-thickness skin defects): Hydrogen-containing silicone dressings reduced healing time to 14 days (vs. 21 days control) with 35% increased collagen deposition (H&E staining).

Case Study: Smith & Nephew’s ALLEVYN™ silicone foam dressings (UK) demonstrated 60% lower infection rates (Wound Repair and Regeneration, 2020).

• Antimicrobial Efficacy:

Silver ion-modified silicone dressings showed 15 mm inhibition zone diameter against Staphylococcus aureus (ISO 20743 standard).

Medical Cosmetology (Fillers, Scar Management)

• Experimental Data
• Filler Longevity:

Hydrogen-containing silicone oil-modified polycaprolactone (PCL) microspheres (Ellansé®) stimulated 150% more collagen production vs. unmodified groups, with effects lasting 24 months (histological data).

• Scar Reduction:

Silicone gel scar sheets (e.g., Dermatix®) reduced hypertrophic scar thickness by 47% (ultrasound measurement, 12-week follow-up).

Diagnostic Devices (Biosensors)

• Experimental Data
• Stability Enhancement:

Glucose sensors with hydrogen-containing silicone oil coatings (implantable) extended in vivo operational lifespan from 7 days to 21 days (MARD <10%).

Case Study: Medtronic’s Guardian™ sensors with silicone-modified membranes achieved 80% improvement in anti-protein adsorption.

Specialized Medical Scenarios (Neonatal Care)

• Experimental Data
• Skin Safety:

Hydrogen-containing silicone oil-treated NICU electrodes reduced adverse skin reactions in preterm infants from 18% to 3% (RCT, n=120).

Case Study: GE Healthcare’s Giraffe™ incubator monitoring electrodes with silicone adhesives received FDA neonatal-specific certification.

Key Experimental Methods & Data

Test Parameter    Standard/Method Typical Data

Biocompatibility ISO 10993-5 (Cytotoxicity)    Cell viability >90%

Antimicrobial Activity     ISO 20743 (Inhibition Zone)   Inhibition zone diameter: 10–18 mm

Drug Release      USP <724> Dissolution Test   Sustained release >95% over 72 hours

Mechanical Lubricity ASTM D1894 (Friction Coefficient)    0.05–0.1 (post-coating)

Industry Application Cases

Johnson & Johnson Ethicon: Coating surgical sutures with hydrogen-containing silicone oil reduced 30% tissue drag force.

Medtronic: Silicone-coated pacemaker leads showed reduced fibrotic encapsulation in 5-year follow-ups.

Fuerjia (China): CFDA-certified medical silicone scar gel achieved 88.7% clinical efficacy.

Preparation Methods, Core Technologies & Precautions

Preparation Methods

• Medical-Grade Hydrogen-Containing Silicone Oil: Preparation and Specifications
• Ultra-High Purity Raw Material Synthesis

Electronics-grade silane raw materials (purity ≥99.99%).

Multi-stage molecular distillation (temperature control precision: ±0.5°C).

Nanoscale filtration system (0.1 μm PTFE membrane).

• Sterile Polymerization Process

Closed stainless steel reaction system (ISO Class 5 cleanliness).

Low-temperature plasma-initiated polymerization (40–60°C mild conditions).

Real-time FTIR monitoring of molecular weight distribution.

• Medical-Specific Modification Technologies

Zwitterionic surface grafting (sulfonic acid groups/quaternary ammonium salts for balanced modification).

Bioactive molecule conjugation (e.g., heparin, collagen).

Controlled degradation design (enzyme-responsive siloxane bonds).

Core Technological Breakthroughs

• Ultra-Low Impurity Control

Heavy metal chelation purification (residues <0.05 ppm).

VOC removal (<50 μg/g).

Endotoxin removal (<0.25 EU/mL).

• Biocompatibility Enhancement

Surface topology regulation (nano-pillar array fabrication).

Protein anti-adsorption layer (phosphorylcholine modification).

Cell-selective interface design (RGD peptide modification).

• Medical Functionalization

Drug sustained-release microencapsulation (encapsulation efficiency >95%).

Antimicrobial silver ion loading (sustained release for 30+ days).

Conductive-insulative switchable coating (impedance range: 10³–10⁸ Ω).

Special Process Requirements

• Medical Device Coating Processes

Plasma-assisted deposition (film thickness precision: ±0.1 μm).

UV-curing crosslinking technology (optimized at 365 nm wavelength).

Multi-layer gradient coating (interfacial bonding strength >5 N/cm).

• Implant Material Preparation

Supercritical CO₂ foaming (porosity: 85% ±2%).

3D printing compatibility modification (viscosity: 3,000–5,000 cP).

In vivo degradation rate control (0.1–2 mm/year).

• Drug Carrier Systems

Microfluidic emulsification (particle size CV <5%).

Phase transition encapsulation (drug loading: 30–60%).

Stimuli-responsive shell (pH/enzyme dual-trigger).

Key Considerations

• Storage:Store in dark, cool conditions (≤25°C) with airtight sealing.
• Handling:Wear gloves; avoid eye contact.
• Compatibility:Keep away from strong acids/bases.

Packaging & Ordering

Packaging: 200kg/1000kg plastic drums (customizable).