链激酶（第 4 届 WHO 国际标准）

  【编号】：NIBSC16/358

  【产品名称】：链激酶（第 4 届 WHO 国际标准）

  【规格】：支

  【价格】：2600元

　　链激酶（第 4 届 WHO 国际标准）

　　编号：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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链激酶（第 4 届 WHO 国际标准）

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