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Product Description
Ursodeoxycholic acid is a chemical preparation of natural bile acid separated from bear bile. It is an organic compound, odorless and bitter. It is used in medicine to increase the secretion of bile acid, change the composition of bile, reduce cholesterol and cholesterol ester in bile, and help the cholesterol in gallstones to gradually dissolve.
It is an epimer of chenodeoxycholic acid. Its stone-dissolving effect is similar to chenodeoxycholic acid, but the treatment course is short and the dosage is small. It combines with taurine in the body and exists in the bile. It is a hydrophilic bile acid and a cholesterol stone dissolving agent.
Product Information Table
|
Product Name |
Ursodeoxycholic acid |
|
Melting Point |
203-204°C(lit.) |
|
Solubility |
ethanol: 50 mg/mL, clear |
|
Storage Condition |
Refrigerator |
|
soluble |
practically insoluble |
Test Report
| Test Items | Specifications | Results |
|---|---|---|
| Assay | 99%–101% | 99.59% |
| Appearance | White or almost white powder | Complies |
| Melting Point | 200–204℃ | 200.2–203.3℃ |
| Bulk Density & Tapped Density | Bulk Density: 0.25–0.55g/mlTapped Density: 0.50–0.85g/ml | Complies |
| Particle Size | D90 <150μm, 100% through 60 mesh, 90% through 100 mesh | Complies |
| Chenodeoxycholic Acid | ≤1% | Complies |
| Lithocholic Acid | ≤0.1% | Complies |
| Identification | - Same IR spectrum as reference standard (RS)- Spot position similar to reference spot- Greenish-blue suspension with formaldehyde | Complies |
| HPLC Purity | ≥98.5% | 99.76% |
| Total Impurities | ≤1.5% | 0.21% |
| Any Unspecified Impurities | Each ≤0.1% | Complies |
| Chloride | <0.02% | Complies |
| Loss on Drying | <1% | 0.15% |
| Sulfated Ash | <0.1% | 0.04% |
| Heavy Metals | <10ppm | Complies |
| Specific Optical Rotation | +58.0°~+62.0° | 60.36 |
Product Function
1. Increase the secretion of bile acid, leading to changes in the composition of bile acids, increasing the content in bile, and promoting bile effects. The average value of bile acid secretion increased from 1.8mmol per hour to 2.24mmol after taking it. Long-term use can increase the content of UDCA in bile without increasing the content of bile acid.
2. It can inhibit the synthesis of cholesterol in the liver, significantly reduce the cholesterol in the bile, the amount of cholesterol ester and the saturation index of cholesterol, which is beneficial to the gradual dissolution of cholesterol in stones. UDCA can promote the formation of liquid cholesterol crystal complexes, which can accelerate the excretion of cholesterol from the gallbladder to the intestine.
3. Relax the sphincter of Oddi, which has anti-cholinergic effect.
4. Reduce liver fat, increase liver catalase activity, promote liver glycogen accumulation, and improve liver's anti-toxin and detoxification ability.
5. It can reduce the concentration of triacylglycerol in liver and serum.
6. Inhibit the secretion of digestive enzymes and digestive juices.
7. Foreign studies have shown that it has an immunomodulatory effect in chronic liver disease, can significantly reduce the expression of HLAI antigens in liver cells, and reduce the number of activated T cells. Better than chenodeoxycholic acid (CDCA) in dissolving cholesterol stones in the body
Product Application
Used as gallstone dissolving medicine. It is mainly used for cholesterol-type gallstones that are not suitable for surgical treatment, especially those with normal gallbladder function, stones with a diameter of less than 15mm, X-ray, non-calcified floating cholesterol stones with a high cure rate. It also has a certain therapeutic effect on toxic hepatitis, cholecystitis, primary sclerosing cholangitis, and primary cholestatic cirrhosis. Improve the efficacy of α-interferon in the treatment of chronic hepatitis C.
Can not dissolve other types of gallstones. Ursodeoxycholic acid is suitable for the treatment of cholesterol stones, hyperlipidemia, disorders of bile secretion, primary biliary cirrhosis, chronic hepatitis, bile reflux gastritis, and prevention of acute rejection and reaction of liver transplantation. The stone-dissolving effect of this product is slightly weaker than chenodeoxycholic acid.
Medicine Interactions
1.When used in combination with chenodeoxycholic acid, the reduction of cholesterol content and saturation in bile is greater than that of the two drugs alone, and also greater than the additive effect of the two drugs. This may be related to the different mechanisms of action of the two drugs on cholesterol synthesis, metabolism and dissolution kinetics.
2. Oral contraceptives can increase bile saturation and affect the efficacy. Other birth control measures should be taken during treatment.
3. Medicinal charcoal can bind bile acids in in vitro tests, and when combined, it will affect the absorption of the latter.
4. Aluminum-containing antacids can absorb bile acid in in vitro tests, and can reduce the absorption of ursodeoxycholic acid when used in combination.
5. Because cholestyramine and colestipol can bind bile acids in in vitro tests, they can interfere with the absorption of the latter when used in combination.
The main methods for preparing
The main methods for preparing ursodeoxycholic acid (UDCA) are chemical synthesis and biotransformation.
Chemical methods are further divided into those using animal bile acids as substrates and those using non-choleic steroidal substances as substrates. These methods are often complex, highly polluting, and involve hazardous steps such as high temperature and pressure.
Biotransformation generally uses chenodeoxycholic acid or lithocholic acid as raw materials. It utilizes whole-cell microorganisms or enzymes to specifically catalyze the oxidation and reduction reactions at specific sites on the substrate to produce UDCA. This method is green and safe.
Currently, the mainstream method for synthesizing UDCA via biotransformation uses chenodeoxycholic acid (CDCA), which is widely available, as a raw material. First, 7α-hydroxysteroid dehydrogenase (7α-HSDH) catalyzes the conversion of CDCA to 7-ketolithocholic acid (7-KLCA). Then, 7β-hydroxysteroid dehydrogenase (7β-HSDH) converts 7-KLCA to UDCA, achieving conformational inversion of CDCA to UDCA in two steps. Since 7α-HSDH and 7β-HSDH are NAD(P)H-dependent enzymes, two coenzyme regeneration enzymes need to be coupled to perform a coenzyme regeneration cycle to reduce manufacturing costs. Different microbial enzyme sources produce 7α-HSDH and 7β-HSDH with different catalytic activities; therefore, different coenzyme regeneration enzyme systems are selected for coupling catalysis to prepare UDCA based on the enzyme source.
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