Coptis Chinensis Extract
Chinese aliases: Berberine, Berberine Hydrochloride.
Extraction source:dried rhizomes of Huanglian.
Active ingredient: Berberine hydrochloride
CAS NO: 633-65-8
Product specifications: Berberine hydrochloride 97% 98%
Color characteristics: yellow powder
Storage: Store in a cool, dry, dark, and high-temperature place.
Packaging: Double layered plastic bag inside, 1kg aluminum foil bag, 25kg cardboard drum
Shelf life: 24 months.
Pharmaceutical-Grade Berberine Hydrochloride (API)
Manufactured by Xi'an Tihealth Biotechnology Co., Ltd.
Xi'an Tihealth is a premier global B2B manufacturer of highly purified Berberine Hydrochloride (HCL). As a critical isoquinoline alkaloid, we rigorously source our botanical raw materials from the premium roots of Coptis chinensis (Huanglian) and the bark of Phellodendron amurense. Utilizing an advanced, strictly controlled acid-water extraction coupled with specific macroporous resin chromatography and low-temperature crystallization, we expertly isolate and synthesize this highly potent alkaloid salt.
Rigorously standardized to deliver an ultra-high purity of ≥ 97.0% to 98.0% Berberine HCL via HPLC validation, this yellow crystalline powder is recognized globally for its profound multi-target pharmacological profile. Historically celebrated for its potent broad-spectrum antimicrobial properties (especially against gastrointestinal pathogens), modern clinical research heavily positions our Berberine API as a master metabolic regulator. By potently activating the AMPK enzymatic pathway, it serves as the foundational raw material for advanced glycemic control (anti-diabetic) formulations, lipid-lowering nutraceuticals, and high-end cardiovascular health supplements.
Technical Data Sheet (TDS) & Analytical Control
| Analysis Item | Target Specification | Result (Typical Batch) | Methodology |
|---|---|---|---|
| Botanical Source | Coptis chinensis & Phellodendron amurense | Verified | Macroscopic ID |
| Berberine Hydrochloride Assay | ≥ 97.0%, 98.0% (Dry Basis) | 98.6% | HPLC / ChP |
| CAS / Molecular Formula | 633-65-8 / C20H18ClNO4 | Matches Profile | Spectral Analysis |
| Appearance | Yellow fine crystalline powder (Bitter taste) | Complies | Visual Assessment |
| Solubility | Soluble in hot water; slightly soluble in cold water/ethanol | Complies | Solvent Assessment |
| Loss on Drying | ≤ 12.0% | 10.5% | USP <731> |
| Residue on Ignition (Ash) | ≤ 0.2% | 0.08% | USP <281> |
| Heavy Metals (Pb, As) | ≤ 10.0 ppm / ≤ 2.0 ppm | < 5.0 ppm / < 0.5 ppm | ICP-MS |
| Solvent Residue (Ethanol) | ≤ 5000 ppm (EP/USP Limit) | < 500 ppm | GC-FID |
Manufacturing & Processing Excellence
Controlled Acid-Water Extraction
Crude extraction methods yield unstable, low-purity alkaloids. Tihealth utilizes an optimized, strictly pH-controlled acid-water extraction protocol, coupled with ultrasonic-assisted ethanol maceration. This highly specific solvent gradient ensures the maximum mobilization and structural preservation of the target isoquinoline alkaloids from the raw biomass.
Macroporous Resin & Salt Conversion
The crude extract is vacuum-concentrated and subjected to advanced macroporous resin chromatography to strip away heavy metals, non-active sugars, and chlorophyll. The purified berberine base is then reacted with Hydrochloric Acid (HCl) under controlled cooling, precipitating ultra-pure Berberine Hydrochloride crystals.
Pharmaceutical Purity Control
Our GMP-aligned protocol rigorously eliminates residual agricultural chemicals and solvent residues. The final crystals are subjected to instantaneous spray drying to yield a uniform fine powder. This guarantees an HPLC purity exceeding 98%, ensuring excellent flowability and maximum therapeutic safety for clinical applications.
Evidence-Based Pharmacological Mechanisms
Glycemic Control & Metabolic Modulation (AMPK Activation)
Berberine is clinically recognized as a master metabolic switch. It potently activates AMP-activated protein kinase (AMPK)-often referred to as the body's "metabolic master switch." This action profoundly improves cellular insulin sensitivity, significantly reduces hepatic gluconeogenesis (glucose production in the liver), and promotes the uptake of glucose into muscle tissues, providing formidable support for Type 2 Diabetes formulations.
Lipid Profile Management & Cardiovascular Health
Through distinct pathways (independent of statin mechanisms), Berberine increases the expression of hepatic LDL receptors, actively clearing low-density lipoprotein (LDL-C) and triglycerides from the bloodstream. Furthermore, it prolongs myocardial action potentials, demonstrating distinct antiarrhythmic properties and improving overall cardiovascular hemodynamics.
Broad-Spectrum Antimicrobial & GI Defense
Historically and clinically proven, Berberine strongly inhibits a wide array of pathogenic microorganisms, including Staphylococcus aureus, Shigella flexneri, and Escherichia coli. It acts by directly disrupting their cellular integrity and inhibiting microbial adherence to epithelial cells, offering highly effective, non-antibiotic relief for acute gastroenteritis and bacterial dysentery.
Cellular Anti-Inflammatory & Oncology Support
Significantly downregulates pro-inflammatory cytokines, mitigating acute and chronic inflammatory responses at the cellular level. In advanced oncology R&D, Berberine demonstrates significant efficacy in inhibiting tumor cell proliferation and angiogenesis while showing potential in reversing multidrug resistance in specific cancer cell lines.
Industrial Formulation Applications
Metabolic Dietary Supplements
The foundational API in premium nutraceuticals targeting pre-diabetes and metabolic syndrome, safely utilized globally to regulate blood glucose and lipid metabolism without the harsh side effects of synthetic drugs.
Gastrointestinal Pharmaceuticals
Formulated heavily into OTC tablets and hard capsules as a primary clinical treatment for severe bacterial dysentery, acute gastroenteritis, and infectious diarrhea.
Cardiovascular Formulations
Incorporated into specialized medical regimens for managing essential hypertension, reducing systemic cholesterol, and improving overall myocardial hemodynamics.
Topical & Dental Care
Applied in advanced oral care formulations (mouthwashes) and dermatological creams to leverage its powerful localized antibacterial and anti-inflammatory properties.
Contract Manufacturing & Global Supply Chain
♦ Stable High-Purity Supply
As a direct factory, we guarantee a stable, large-scale supply of Berberine Hydrochloride. Our strict crystallization process ensures a consistent HPLC purity of ≥97.0% to 98.0%, perfectly matching your pharmaceutical and high-end nutraceutical requirements.
♦ Traceable Quality Control
Quality is mathematically verifiable. Every batch undergoes strict cGMP-aligned analysis via HPLC. We provide full COAs and MSDS documentation, ensuring heavy metals, pathogens, and solvent residues strictly comply with ChP, EP, and USP pharmacopeial standards.
♦ Secure Export Bulk Fulfillment
We specialize in global botanical logistics. We offer blind shipping, bulk private label packaging (from 1kg foil bags to 25kg sterile drums), and full regulatory documentation support for rapid global customs clearance without delays.
Packaging, Logistics & Secure Payment
Reliable B2B Supply Chain Solutions
We provide pharmaceutical-grade aseptic packaging, efficient global logistics (Air/Sea freight with dual customs clearance), and secure multi-currency payment methods to ensure seamless, moisture-free cross-border transit for our B2B procurement partners.
Formulator & Procurement FAQ
01. Do you supply Berberine HCL in bulk quantities?
Yes. As a direct manufacturer, we supply bulk Berberine Hydrochloride powder packaged in standard 25kg heavy-duty cardboard drums with double-layer sterile PE liners, ensuring absolute molecular stability and moisture protection during international transit.
02. What testing methods do you use to verify purity?
We do not rely on basic UV methods. Every batch is strictly verified using High-Performance Liquid Chromatography (HPLC) against verified analytical standards to guarantee an assay of ≥ 97.0%. Comprehensive third-party lab reports and COAs are available upon request.
03. Does the extraction process use harsh chemical solvents?
We strictly control our solvent usage. We employ an optimized acid-water extraction followed by specific macroporous resin purification. This ensures the structural integrity of the alkaloid while guaranteeing that any residual solvents (like Ethanol) remain strictly ≤ 5000 ppm, fully complying with EP/USP limits.
04. Is the powder suitable for solid dosage forms like capsules and tablets?
Absolutely. Our Berberine HCL powder is meticulously crystallized and milled to ensure excellent flowability, low hygroscopicity, and uniform dispersion. It is perfectly optimized for high-speed capsule filling and tablet compression machines in pharmaceutical environments.
05. What is the Minimum Order Quantity (MOQ) and lead time?
Our standard MOQ for mass commercial production is 25kg. To support your R&D efforts, we also supply 1kg bespoke foil bags for pilot manufacturing and stability trials. Standard global dispatch via air or sea freight is within 7-10 days.
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