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Ulinastatin |
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| Source | Fresh human urine | ||||
| 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.This product should be extracted from the urine of healthy people, and the production process should meet the requirements of the current version of the Good Manufacturing Practice for Drugs. During the production process of this product, there should be measures to control the virus safety. In the process, it needs to be heated at 60 ℃ for 10 hours to inactivate the virus.（solution） | ||||
| Pharmacopoeia standard |
CP |
JP |
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Character |
Colorless to yellow clear liquid. Odorless（solution） | Occurs as a almost white to light brown powder. Odorless. | Occurs as a light brown to brown,clear liquid. | ||
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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)Should form a distinct precipitation line with rabbit antiulinastatin serum. | (4)A clear precipitin line appears between the wells. | ||||
|
Tests |
pH |
6.0-7.5 | 6.0-7.5 | 6.0-8.0 | |
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Appearance of solution |
Clear and colorless | 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 initial cloting time of the test tube should not be less than the initial cloting time of the blank . | The initial cloting time of the test tube should not be less than the initial cloting time of the blank . | _________ | ||
| Purity |
Heavy metal |
≤10ug/mL | _________ | Not more than 1ppm | |
| Related substances | The sum of the peak area of impurities in each test solution shall not be greater than 4 times (2.0%) of the main peak area of the control solution. | The sum of the peak area of impurities in each test solution shall 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. | ||
| Kallidinogenase | Absorbance not exceed 0.03 | Absorbance not exceed 0.03 | The difference is not more than 0.050. | ||
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Molecular mass |
37000~43000 | 37000~43000 | 67000±5000 | ||
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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 sym-ptoms of respiratory distress or collapse and not less than 3 animals are killed. | ||
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Abnormal toxicity |
Conform with regulation | Conform with regulation | All the animals survive for 48 hours. | ||
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Bacterial endotoxin |
≤0.625 EU/10000units | ≤0.625 EU/10000units | __________ | ||
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Potency |
Assay |
_________ | _________ | Not less than 45000IU/mL. | |
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Specific activity |
Not less than 3500IU/mg.pr | Not less than 3500IU/mg.pr | Not less than 2500IU/mg.pr | ||
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Microbial limit |
TAMC |
≤103CFU/g | ≤103CFU/g | ≤103CFU/g | |
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TYMC |
≤102CFU/g | ≤102CFU/g | ≤102CFU/g | ||
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Virus |
Hbs Ag |
Should be negative（10 0000 unit/ml） | Should be negative | _________ | |
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HCV antibodies |
_________ | _________ | _________ | ||
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HIV I+II |
_________ | _________ | _________ | ||
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Storage |
Store in an airtight container, at a temperature exceeding -20°C or lower. | Containers- Tight containers.Storage- Preserve at - 20°C or lower. | |||
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Category |
Protease inhibitors drug | ||||
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Preparation |
Ulinastatin for injection | ||||