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鏈激酶（第 4 屆 WHO 國際標準）
??【編號】：NIBSC16/358

??【產品名稱】：鏈激酶（第 4 屆 WHO 國際標準）

??【規(guī)格】：支

??【價格】：2600元

　　鏈激酶（第 4 屆 WHO 國際標準）

　　編號：NIBSC16/358
　　英文：Streptokinase (4th WHO International Standard)
　　描述：
　　1. INTENDED USE
Streptokinase is a plasminogen activator derived from Streptococcus
haemolyticus. Streptokinase possesses no proteolytic or esterolytic
activity itself and must form a 1:1 complex with plasminogen resulting in a
plasminogen activator complex able to generate plasmin from free
plasminogen. The plasmin generated in this way is able to digest fibrin
and hence dissolve blood clots.
2. CAUTION
This preparation is not for administration to humans or animals in
the human food chain.
The preparation contains material of human origin, and either the final
product or the source materials, from which it is derived, have been
tested and found negative for HBsAg, anti-HIV and HCV RNA. As with
all materials of biological origin, this preparation should be regarded as
potentially hazardous to health. It should be used and discarded
according to your own laboratory's safety procedures. Such safety
procedures should include the wearing of protective gloves and
avoiding the generation of aerosols. Care should be exercised in
opening ampoules or vials, to avoid cuts.
3. UNITAGE
Bulk Streptokinase was dissolved in 7.5 L of 10 mM Hepes buffer, pH 7.4,
containing 0.15 M NaCl and 5 mg/ml Human Albumin. This solution was
dispensed in 1 ml aliquots into ampoules before freeze drying. The mean
weight of solution dispensed into ampoules before drying was 1.008g (%
cv = 0.17). The mean residual moisture remaining after freeze drying was
0.63 %. The contents of the ampoules should be reconstituted in 1 ml of
distilled water. The activity of the solution thus formed was determined in
an International Collaborative Study involving 15 laboratories from 9
countries and was found to be 1013 International Units (IU) per ampoule.
The Standard was established by the Expert Committee on Biological
Standardisation of the World Health Organisation (WHO) in October 2019
and designated the 4th International Standard for Streptokinase code
16/358.
4. CONTENTS
Country of origin of biological material: United Kingdom.
5. STORAGE
Unopened ampoules should be stored in the dark at or below -20ºC.
Please note: because of the inherent stability of lyophilized
material, NIBSC may ship these materials at ambient temperature.
6. DIRECTIONS FOR OPENING
DIN ampoules have an 'easy-open' coloured stress point, where the
narrow ampoule stem joins the wider ampoule body. Various types of
ampoule breaker are available commercially. To open the ampoule,
tap the ampoule gently to collect material at the bottom (labelled) end
and follow manufactures instructions provided with the ampoule
breaker.
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the freeze-dried
material prior to reconstitution
Ampoules are shipped at ambient temperatures and should be stored
unopened in the dark at –20 °C upon arrival. To reconstitute, allow the
ampoule to warm to room temperature and ensure that the lyophilised material is all in the base of the ampoule before carefully snapping off the top
of the ampoule. The contents should be reconstituted using 1 ml of distilled
water and mixed gently to produce a clear, colourless solution. This solution
should be stored on ice and used as soon as possible by dilution into
appropriate assay buffer under conditions defined for your assay. Following
reconstitution, the activity is stable for several hours when the solution is
maintained on ice. However, the potency is not guaranteed after further
freezing and thawing of the reconstituted solution.
8. STABILITY
Reference materials are held at NIBSC within assured, temperaturecontrolled
storage facilities. Reference Materials should be stored on
receipt as indicated on the label.
NIBSC follows the policy of WHO with respect to its reference materials.
It is the policy of WHO not to assign an expiry date to their international
reference materials and they remain valid with the assigned potency until
withdrawn or amended.
Predictions on long term stability are made by monitoring ampoules
stored under accelerated degradation conditions over time.
9. REFERENCES
A report of the collaborative study to calibrate the standard is availble from
WHO, reference WHO/BS/2019.2364.
10. ACKNOWLEDGEMENTS
We are grateful to all the participants that took part in the collaborative study,
and to the Fibrinolysis Subcommittee of the Scientific and Standardization
Committee (SSC) of the International Society on Thrombosis and
Haemostasis (ISTH).
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