催乳素，人類（第4屆WHO國(guó)際標(biāo)準(zhǔn)）

??【編號(hào)】：NIBSC83/573

??【產(chǎn)品名稱】：催乳素，人類（第4屆WHO國(guó)際標(biāo)準(zhǔn)）

??【規(guī)格】：個(gè)

??【價(jià)格】：2600元

　　催乳素，人類（第4屆 WHO國(guó)際標(biāo)準(zhǔn)。）

　　編號(hào)：NIBSC83/573

　　英文：Prolactin, Human (4th WHO International Standard.)

　　標(biāo)準(zhǔn)類型：國(guó)際標(biāo)準(zhǔn)品

　　規(guī)格：1個(gè)

　　描述：

1. INTENDED USE

The 3

rd International Standard (IS) for Prolactin, human, in ampoules

coded 84/500, has been widely used for the calibration of

immuoassays of Prolactin. Stocks of the 3rd IS are exhausted and the

WHO Expert Committee on Biological Standardization (ECBS) has

recognised (2015) the need for a replacement IS.

The 4th IS consists of a batch of ampoules, coded 83/573, which

contain purified prolactin of human, pituitary origin. The ampouled

preparation has been calibrated in an international collaborative study

(2016) in terms of the 3rd IS, 84/500. The 4th IS, coded 83/573, was

established at the 67th meeting of the ECBS in 2016. This material

replaces the 3rd IS which is discontinued.

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

Each ampoule contains 67 MILLI INTERNATIONAL UNITS of human

prolactin.

4. CONTENTS

Country of origin of biological material: Sweden

Each ampoule of the material contains the residue, after freeze-drying,

of a solution which contained:-

Human prolactin approximately 3.2 µg

Human albumin 1.0 mg

Lactose 5.0 mg

Ammonium formate 0.63 mg

Nitrogen gas at slightly less than atmospheric pressure

5. STORAGE

Unopened ampoules should be stored at -20°C.

Please note: because of the inherent stability of lyophilized

material, NIBSC may ship these materials at ambient temperature.

6. DIRECTIONS FOR OPENING

Tap the ampoule gently to collect the material at the bottom (labelled)

end. Ensure ampoule is scored all round at the narrow part of the

neck, with a diamond or tungsten carbide tipped glass knife file or

other suitable implement before attempting to open. Place the

ampoule in the ampoule opener, positioning the score at position 'A';

shown in the diagram below. Surround the ampoule with cloth or

layers of tissue paper. Grip the ampoule and holder in the hand and

squeeze at point 'B'. The ampoule will snap open. Take care to avoid

cuts and projectile glass fragments that enter eyes. Take care that no

material is lost from the ampoule and that no glass falls into the

ampoule.Side view of ampoule opening device containing an ampoule positioned

ready to open. 'A' is the score mark and 'B' the point of applied pressure.

7. USE OF MATERIAL

No attempt should be made to weigh out any portion of the freeze-dried

material prior to reconstitution.

For practical purposes each ampoule contains the same quantity of

human prolactin. Tap the ampoule to collect material at the base of the

ampoule and dissolve the total contents in a known volume of a suitable

diluent. Addition of a carrier protein (e.g. 0.05 - 0.1% (w/v) bovine or

human serum albumin) is recommended. Ensure all the material in

ampoule is reconstituted by using the known volume of diluent to rinse all

inner surfaces of the ampoule, collecting all the rinses to prepare the

stock concentration. Unopened ampoules of the material should be

stored below 4oC. The ampoules do not contain bacteriostat and

solutions of the material should not be assumed to be sterile.

8. PREPARATION OF AMPOULES

Ampoules were prepared as described in the ECBS report

WHO/BS/86.15201

and in Schulster2

et al. (1989), using a quantity of

highly purified extract donated by KabiVitrum, Sweden through the good

offices of Dr L. Fryklund. Prolactin content in terms of the 3rd International

Standard for Prolactin, coded 84/500, was assigned by an international

collaborative study (2016) involving ten laboratories in seven countries.

There was good agreement between laboratories giving an assigned

immunoreactivity of 67 mIU/amp (GCV 8.1%; n=18). Using a panel of

human sera containing normal and high prolactin concentratrions (n=16),

the material was shown to be commutable. Full details of the

collaborative study can be found in the ECBS report,

WHO/BS/2016.22923

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