CAS No.: 80449-31-6
Complies with CP2020, JP18
Ulinastatin |
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Source |
Fresh human urine |
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Process description |
Ulinastatin is solution of a glycoprotein having trypsin inhibiting activity, which is separated and purified from human urine. This product is a glycoprotein solution extracted from fresh human urine that can inhibit the activity of various proteolytic enzymes | ||||||
Manufacturing requirements |
This product should be extracted from healthy human urine. The production process should conform with the requirements of current version of Good Manufacturing Practice. This product should have virus safety control measures in the production process, and the process needs to be heated at 60℃ for 10 hours to inactivate the virus. |
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Pharmacopoeia standard |
CP |
JP |
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Solution |
Powder |
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Character |
Colorless to yellow clear liquid. Odorless. | An almost white to light brown powder. Odorless. | Occurs as a light brown to brown,clear liquid. | ||||
Identification |
(1) The solution is orange-yellow | (1)An orange to red-orange color develops. | |||||
(2)The solution should be yellow. | (2)Both spectra exhibit similar intensities of absorption at the same wavelengths. | ||||||
(3)There is a maximum absorption at a wavelength of 277nm. | (3) The solution obtained with the sample solution develops no color while that obtained with the control solution develops a yellow color | ||||||
(4)A clear precipitin line appears between the wells. | (4)A clear precipitin line appears between the wells. | ||||||
Tests |
pH |
6.0-7.5 |
6.0-8.0 |
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Appearance of solution |
Clear and colorless |
Occurs as a light brown to brown,clear liquid. |
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Loss on drying |
_________ |
≤6.0% |
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Thromboplastic contaminants |
The clotting time of the sample solution is not shorter than that of the standard solution. |
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Purity |
Heavy metal |
≤10ug/ml |
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Not more than 1ppm |
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Related substances |
If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area should not be greater than 4 times (2.0%) of the main peak area of the control solution. |
The bands other than the principal band obtained from the sample solution are not more intense than the band from the standard solution in the electrophoretogram. |
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Kallidinogenase |
Absorbance not exceed 0.03 |
The difference is not more than 0.050. |
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Molecular mass |
37000~43000 (SDS-PAGE) |
67000±5000(HPLC) |
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Antigenicity |
_________ |
The animals of the first group exhibit none of the signs mentioned above, and all the animals of the second group exhibit symptoms of respiratory distress or collapse and not less than 3 animals are killed. |
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Abnormal toxicity |
All the animals survive for 48 hours. |
All the animals survive for 48 hours. |
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Bacterial endotoxin |
≤0.625 EU/10000units |
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Potency |
Assay |
Not less than 100,000IU/ml |
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Not less than 45,000IU/ml. |
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Specific activity |
Not less than 3500IU/mg.pr |
Not less than 2500IU/mg.pr |
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Microbial limit |
TAMC |
≤100CFU/ml |
≤103CFU/g |
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TYMC |
≤10CFU/ml |
≤102CFU/g |
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Escherichia coli |
Should not be detected |
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Virus |
Hbs Ag |
Should be negative |
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Storage |
Store in an airtight container, at a temperature exceeding -20°C or lower. |
Containers—Tight containers. Storage—Not exceeding -20°C. |
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Category |
Protease inhibitors drug |
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Preparation |
Ulinastatin for injection |
Acute pancreatitis (including traumatic, postoperative and postoperative acute pancreatitis after endoscopic retrograde cholangiopancreatography), acute exacerbation of chronic recurrent pancreatitis, acute circulatory collapse (hemorrhagic shock, bacterial shock, traumatic shock, burn shock). This product is also widely used in thoracic surgery, digestive system surgery, tumor surgery, organ transplantation, organ resection surgery and CPB surgery. This product is also used to treat and prevent renal dysfunction caused by tumor chemotherapy.