UDCA is a hydrophilic, non-cytotoxic bile acid and an epimer of chenodeoxycholic acid.
Due to its choleretic, cell protective, antioxidant and immunomodulatory functions, UDCA has been widely used in the clinical treatment of a variety of hepatobiliary diseases.
It is used medically to increase bile acid secretion, reduce cholesterol and cholesterol lipids in bile, and help dissolve cholesterol in gallstones.
COA
|
Items |
Specifications |
Results |
| Reference | EP8 | |
|
Appearance |
White or off-white powder |
White powder |
|
Solubility |
Freely Soluble in ethanol(95%), Slightly Soluble in acetone , Practically insoluble in methylene chloride and water |
Complies |
|
Specific rotation |
+58.0° 〜+62.0° |
+59.5° |
|
Melting Point |
About 202.0 °C |
202.1 °C |
|
Identification |
IR : Sample spectrum corresponds to that of standard spectrum |
Complies |
|
TLC: Sample and standard exhibit the same spot |
Complies |
|
|
Colour reaction |
Complies |
|
|
Related substance |
Impurity A(CDCA)<1.0% |
0.21% |
|
Any other individual impurity<0.10% |
0.060% |
|
|
Total impurities<1.50% |
0.362% |
|
|
Loss on drying |
<1.0% |
0.040% |
|
Residual solvent |
Acetone<5 OOOppm |
0.021% |
|
Impurity C |
<0.10% |
Complies |
|
Residue on ignition |
<0.10% |
0.020% |
|
Heavy metals |
<20ppm |
Complies |
|
Assay |
99.0%〜101.0%(on dried basis) |
99.9% |
|
Conclusion |
The product conforms to the above specifications |
|
|
Storage |
Sealed preservation at room temperature |
|
1.Prevent COVID-19
In 2022, the research team of Fotios Sampaziotis at the University of Cambridge in the UK discovered that UDCA, a drug for treating liver disease, can block ACE2 receptors and thereby block infection by the new coronavirus. The results of cell experiments and animal experiments have verified the feasibility of the theory.
ACE2 is widely present on the cell membranes of various organs in the human body and is the main "channel" used by the new coronavirus to enter and infect cells.
2. Ursodeoxycholic acid can reduce the saturation of cholesterol in bile, thereby dissolving and shedding cholesterol in stones. In addition, limiting the activity of hydroxy-methylglutaryl coenzyme reduces cholesterol synthesis and secretion to prevent and dissolve cholesterol stones.
3. Ursodeoxycholic Acid is a non-toxic hydrophilic cholic acid. By activating calcium ions, protein kinase C, and cleavage-active protein kinase, it enhances the secretion capacity of cholestatic hepatocytes, thereby reducing the concentration of endogenous hydrophobic cholic acid in blood and liver cells to achieve anti-cholestasis effects.
Ursodeoxycholic Acid Capsules and Tablets
It is an important clinical drug in the treatment of gallstones, cholecystitis, liver disease and biliary tract disease.
UDCA is currently the only drug approved by the FDA for the treatment of cholestatic liver disease, especially primary biliary cholangitis. Ursodeoxycholic acid capsules are the main preparations sold, accounting for 74.61% of the market, and ursodeoxycholic acid tablets account for 20.58% of the market. This drug is not a new drug. It has been on the market for many years and its safety and stability are guaranteed.
REFERENCE
[1].Ward JBJ, Lajczak NK, Kelly OB, O'Dwyer AM, Giddam AK, Ní Gabhann J, Franco P, Tambuwala MM, Jefferies CA, Keely S, Roda A, Keely SJ. Ursodeoxycholic acid and lithocholic acid exert anti-inflammatory actions in the colon. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 01;312(6):G550-G558.
[2].Makino I, Tanaka H. From a choleretic to an immunomodulator: historical review of ursodeoxycholic acid as a medicament. J Gastroenterol Hepatol. 1998 Jun;13(6):659-64.
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