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Ursodeoxycholic acid
Cholic acid series Products
Ursodeoxycholic acid.jpg
CAS No.​ 128-13-2.jpg

Ursodeoxycholic acid

Ursodeoxycholic acid (UDCA, CAS: 128-13-2) is a hydrophilic bile acid with the chemical formula C₂₄H₄₀O₄ and molecular weight 392.572 g/mol. As the primary active component of bear bile (1-3% of bile acid pool), it is FDA-approved for treating primary biliary cholangitis (PBC) (brand name: Urso®). The 2023 EASL guidelines designate it as first-line therapy for PBC (Evidence Level: 1A), while China's PBC Diagnosis and Treatment Guidelines (2023) recommend a dosage of 13-15 mg/kg/d.

Product Name: Ursodeoxycholic acid

CAS No.​: 128-13-2

Molecular Formula: C₂₄H₄₀O₄

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    CAS No

    Basic information

    Product Name: Ursodeoxycholic acid

    CAS No.​: 128-13-2

    Molecular Formula: C₂₄H₄₀O₄

    IUPAC Name: (3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid

    Appearance & Solubility:

    Property​

    ​Specification​

    Appearance

    White crystalline powder

    Melting Point

    203-206°C

     Solubility

    Soluble in ethanol, insoluble in chloroform; Easy to dissolve in glacial acetic acid, soluble in sodium hydroxide solution

    Quality Standard: CP2020,JP,Customer Made

    Specification

    Test Items

    Standard

    Ursodeoxycholic acid(CAS: 128-13-2)

    98.5% by titration

    Loss on drying

    ≤1.0%

    Residue on ignition

    ≤0.2%

    Key Features

    index_10-7

    Structural Uniqueness

    7β-hydroxyl configuration (vs. human bile acid's 7α-hydroxyl)

    index_10-7

    Functional Advantages

    Stimulates bile secretion (↑40% bile flow)

    Anti-apoptotic effect (↓50% hepatocyte apoptosis)

    index_10-7

    Pharmacopoeial Standards

    USP-NF, EP 11.0, and ChP 2020 require ≥99.0% purity

    Applications

    Therapeutic Uses​

    Hepatobiliary Diseases:
    Primary biliary cholangitis (↑30% 5-year survival rate)
    Cholesterol gallstones (50-70% dissolution rate at 6 months)

    Metabolic Disorders:Non-alcoholic fatty liver disease (↓40% ALT levels)

    Industrial Applications​

    Field​

    ​Application​

    ​Representative Products​

    Pharmaceutical Excipients

    Solubilizer for lipophilic drugs

    Cyclosporine soft capsules

    Cosmetics

    Skin barrier repair agent

    Medical repair serums

    Pharmacological Mechanisms

    1. Hepatoprotective Mechanism

    Hepatoprotective Mechanism

    2. Molecular Targets​

    Target​

    ​Effect​

    ​EC50​

    FXR Nuclear Receptor

    Upregulates BSEP transporter expression

    20 μM

    EGFR Signaling Pathway

    Promotes hepatocyte regeneration

    50 μM

    Clinical Applications​

    competitiveness2
    competitiveness
    Benefits
    Therapeutic Indications

    PBC:Standard dose: 13-15 mg/kg/d (long-term use required)

    Gallstones:8-10 mg/kg/d (treatment duration: 6-24 months)
    competitiveness2
    competitiveness
    Benefits
    Contraindications​

    Complete biliary obstruction

    Acute cholecystitis

    Dosage & Administration

    Formulations​

    Form​

    ​Specification​

    ​Features​

    Capsules

    250mg/capsule

    Enteric-coated

    Tablets

    150mg/tablet

    Contains disintegrant (rapid release)

    Dosing Regimens​

    Indication​

    ​Dose​

    ​Duration​

    PBC

    13-15 mg/kg/d

    Long-term

    Gallstones

    8-10 mg/kg/d

    6-24 months

    Safety Profile

    Adverse Reactions​

    ​System​

    ​Effect (Incidence)​​

    ​Management​

    Gastrointestinal

    Diarrhea (10%)

    Dose reduction/split dosing

    Hepatobiliary

    ALT elevation (3%)

    Usually no discontinuation needed

    Drug Interactions​

    Enhanced Effects: Requires 30% dose reduction when combined with obeticholic acid

    Contraindicated Combinations: Cholestyramine (>90% adsorption)

    Research Progress Green max

    1. Novel Formulations​

    Nanosuspensions:Phospholipid complexes (↑50% bioavailability)

    Sustained-Release Microspheres:PLGA carriers (24-hour release)

    2.New Indication Exploration

    COVID-19:Inhibits ACE2 internalization (Phase II trials ongoing)

    Alzheimer's Disease:Reduces β-amyloid aggregation (↓40% plaques in animal models)

    Ursodeoxycholic acid

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