Ox Bile Powder
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Basic information
Product Name: Ox Bile Powder
Appearance Characteristics:
Parameter |
Standard Value |
Color |
Yellowish brown to yellow brown powder |
Odor |
Characteristic bitter |
Particle size |
80-120 mesh (125-75μm) |
Solubility Characteristics
Solvent |
Solubility |
Dissolved Components |
Water |
Partial (40-50%) |
Bile salts, inorganic salts |
Ethanol |
Freely soluble (70-80%) |
Bile acids, some bile pigments |
Chloroform |
Slightly soluble (<5%) |
Cholesterol, free bile acids |
Quality Standard: CP2020,JP,Customer Made
Specification
Test Parameter |
Pharmacopoeial Standard |
Total bile acids |
≥50.0% |
Loss on drying |
≤7.0% |
Bile acids (40-60%)
Conjugated bile acids: Sodium taurocholate (30-45%), Sodium glycocholate (15-25%)
Free bile acids: Cholic acid (8-12%), Deoxycholic acid (5-8%)
Bile pigments (3-5%)
Bilirubin (2-3%), Biliverdin (1-2%)
Other components
1.Multi-Target Action Network
2.Core Component Activity Parameters
Active Component |
Molecular Target |
Biological Effect |
EC50/IC50 |
Sodium taurocholate |
FXR receptor |
3-fold upregulation of BSEP transporter |
12.8 μM |
Deoxycholic acid |
TGR5 receptor |
200% increase in GLP-1 secretion |
28.4 μM |
Bilirubin |
NADPH oxidase |
60% reduction in ROS generation |
IC50=25 μM |
Indications and Efficacy
Hepatobiliary disorder
Cholestasis (45% increase in bile flow)
Non-alcoholic fatty liver (52% improvement in hepatic steatosis)
Metabolic diseases
Type 2 diabetes (1.2-1.8% reduction in HbA1c)
Hypercholesterolemia (20-25% decrease in LDL-C)
Other applications
Radiation enteritis (75% mucosal repair efficacy)
Psoriasis (40% reduction in PASI score)
Modern Formulations
Dosage Form |
Representative Product |
Technical Features |
Enteric-coated pellets |
Cholacol® pellets |
>95% bile acid encapsulation |
Transdermal nanoemulsion |
Dermobil® gel |
5-fold increase in skin absorption |
Sustained-release suppository |
Bile-SR suppository |
8-hour rectal release |
Dosage & Administration
Standard Dosing Regimens
Indication |
Route |
Adult Dose |
Duration |
Bile deficiency |
Oral |
250-500 mg tid |
4-12 weeks |
Radiation enteritis |
Enema |
1% solution 100 mL qd |
2-4 weeks |
Skin ulcers |
Topical |
5% ointment bid |
Until wound healing |
Compatibility Considerations
Synergistic combinations:
Ursodeoxycholic acid (synergistic choleretic effect)
Silymarin (enhanced hepatoprotection)
Contraindicated combinations:
Aluminum preparations (insoluble complex formation)
Strongly acidic drugs (bile acid precipitation)
Safety and Precautions
Adverse Reactions
System |
Clinical Manifestation |
Incidence |
Management |
Gastrointestinal |
Diarrhea/abdominal pain |
18% |
Dose reduction + electrolyte replacement |
Dermatological |
Contact dermatitis |
5% |
Discontinue + topical corticosteroids |
Allergic reactions |
Bronchospasm |
<1% |
Emergency epinephrine administration |
Special Population Use
Population |
Recommendation |
Basis |
Pregnancy |
Contraindicated (potential uterine stimulation) |
FDA Pregnancy Category C |
Children |
>5 years (10mg/kg adjusted by weight) |
EMA Pediatric Guidelines |
Renal impairment |
Monitor serum potassium (bile acids affect renin secretion) |
Clin Pharmacol Ther 2023 |
Research Progress Green max
1.Modern Research Technologies
● Component analysis:
UPLC-ESI-MS/MS identification of 89 bile acid derivatives
NMR fingerprinting (12 characteristic peaks)
● Formulation innovations:
Bile acid-cyclodextrin complexes (8-fold solubility enhancement)
Inhalable dry powder (62% lung deposition rate)
2. Cutting-edge Research Directions
● Gut microbiome:
3-fold increase in Bifidobacterium abundance
90% inhibition of Clostridium difficile growth
● Neuroprotection:
Reduced α-synuclein aggregation (Parkinson's models)
Promoted myelin regeneration (multiple sclerosis models)
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