1. Characters: White or almost white powder, odourless.
2. Extraction Source: Porcine pancreas.
3. Process: Kallidinogenase is extracted from healthy porcine pancreas.
4. Indications and uses:This product can be used for a variety of cardiovascular and cerebovascular disease, such as coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders and peripheral vascular disease. Have a better therapeutic effect on recent researches for thr prevention of early diabetic microangiopathy and diabetic nephropathy, can reduce the albumin excretion. Clinical data both at home and abroad suggest that it can increase sperm activity and production quantity, and has certain curative effect in the treatment of some male sterility.
·Produced in GMP workshop
·27 years of biological enzyme R&D history
·Raw materials are traceable
·Comply with customer standard
·Export to over 30 countries and regions
·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.
Test Items |
Company Specification |
||
CP |
JP |
||
Characters |
White or almost white powder, odourless |
White to slighty brown powder, odourless or has a faint |
|
Identification |
R (hydrolysis rate): 0.12~0.17 |
R (hydrolysis rate): 0.12~0.16 |
|
Liquid Chromatography: Conforms |
I : ≤ 0.2 |
||
Tests |
pH |
5.5~7.5(300unit/ml) |
5.5~7.5(1g/300ml) |
Clarity of solution |
Clear(2mg/ml) |
———— |
|
Fat |
≤ 5.0mg/g |
≤ 1.0mg/g |
|
Kininase |
———— |
R Value:≥ 0.8 |
|
Trypsin-like substance |
———— |
T Value:≤ 0.05 |
|
Protease |
A280 ≤ 0.2 |
A280 ≤ 0.2 |
|
Loss on drying |
≤ 5.0% (60℃ Dry in Vacuum, 4h) |
≤ 2.0% (60℃ Dry in Vacuum, 4h) |
|
Residue on ignition |
≤ 3.0% |
≤ 3.0% |
|
Kinin-releasing activity |
———— |
≥ 500ng bradykinin equivalent/min/unit per unit |
|
Purity |
≥ 75% (for oral) |
———— |
|
≥ 90% (for injection) |
|||
Bacterial endotoxin |
≤ 2.5 EU/unit (for injection) |
———— |
|
Assay |
Enzyme activity |
———— |
≥ 25 unit/mg |
Specific activity |
≥ 300 unit/mg protein (for oral) |
≥ 100 unit/mg protein |
|
≥ 600 unit/mg protein (for injection) |
|||
Microbial Impurities |
TAMC |
≤ 1000cfu/g (for oral) |
≤ 1000cfu/g |
≤ 100cfu/g (for injection) |
|||
TYMC |
≤ 100cfu/g |
≤ 100cfu/g |
|
E.coli |
Conforms |
Conforms |
|
Salmonella |
Conforms |
Conforms |