Ursodeoxycholic acid is an organic compound, odorless and bitter. Medically, it is used to increase the secretion of bile acids, change the composition of bile, reduce cholesterol and cholesterol lipids in bile, and is conducive to the gradual dissolution of cholesterol in gallstones.
Ursodeoxycholic acid is an organic compound, odorless and bitter in taste.
1. It is suitable for non-calcified stones with normal gallbladder function, light transmission, and diameter of 10-15mm.
2. Prevent the formation of gallstones: Patients who need long-term use of drugs that are easy to form cholesterol stones, those who eat a high-cholesterol diet for a long time, or those who are susceptible to genetic factors, can take ursodeoxycholic acid to prevent gallstone formation.
3. Treatment of cholecystitis, cholangitis, biliary dyspepsia, jaundice, etc.
4. Treatment of steatorrhea, hypertriglyceridemia, hepatomegaly, and chronic hepatitis after ileectomy. It can also be used for bile reflux gastritis.
5. It is also used for primary biliary cirrhosis and primary sclerosing cholangitis.
| Test item | Test standard | Test result |
| Appearance | White or almost white crystalline powder,
taste bitter, without stink. | Complied |
| Identification | Enterprise Standard | Complied |
| Related Substance | Lithocholic Acid ≤0.1% Cholic Acid ≤0.5%
Chenodeoxycholic Acid ≤1.0%
Unidentified Impurity ≤0.25% Total Impurity ≤2.0% | Complied |
| Specific Optical Rotation | +58°- +62° | +59.3° |
| Melting Point | 200ºC -204ºC | 202.8ºC-203.8ºC |
| Loss on Drying | ≤ 1.0% | 0.3% |
| Ignition Residue | ≤ 0.1% | 0.07% |
| Assay (TITRATION) | ≥ 99.2%-101% | 99.4% |
| Heavy Mental | ≤ 10ppm | Complied |
| Microorganism | Aerobic Bacteria Amount ≤ 1000cfu/g
Mould and Yeast Amount ≤ 100cfu/g | Aerobic Bacteria Amount ≤ 100cfu/g
Mould and Yeast Amount ≤ 10cfu/g |
China
