YY/T 1416.3-2016 English PDF (YY/T1416.3-2016)

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YY/T 1416.3-2016: Test method for additive in single-use containers for human venous blood specimen collection--Part 3: Heparin
YY/T 1416.3-2016
Test method for additive in single-use containers for human venous blood specimen collection--Part 3. Heparin
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Disposable human venous blood sample collection container added
Methods for determining the dose - Part 3. Heparin
specimencolection-Part 3.Heparin
Published on.2016-07-29
2017-06-01 Implementation
The State Food and Drug Administration issued
Foreword
YY/T 1416 "Determination of additive content in a single-use human venous blood sample collection container" consists of the following parts.
--- Part 1. ethylenediaminetetraacetic acid (EDTA) salt;
--- Part 2. Sodium citrate;
---Part 3. Heparin;
--- Part 4. Fluoride.
This section is Part 3 of YY/T 1416.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This section was proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This section was drafted. Shandong Provincial Medical Device Product Quality Inspection Center, Shandong Xinhua Ande Medical Products Co., Ltd., Shengguang Medical
Products Co., Ltd.
The main drafters of this section. Shen Yong, Meng Qingsong, Huang Jianqiang.
introduction
One-time use of human venous blood sample collection containers (abbreviation. blood collection tube) is matched with one-time use of sterile venous blood sample collection needles.
Blood samples were collected for clinical testing. The use of blood collection tubes containing different additives or add-ons varies. Heparin is widely used in lung, liver, spleen, etc.
Almost all tissues and perivascular granules of mast cells and basophils. Heparin strengthens anti-thrombin III (AT-III) inactivated silk
Protease, which prevents the formation of thrombin, and has a variety of anticoagulant effects such as blocking platelet aggregation. Although heparin can keep red blood cells
Natural form, but because it often causes leukocyte aggregation, smears produce a blue background when stained with Roche, so heparin anticoagulant discomfort
Hematology general inspection. Heparin is an ideal anticoagulant for red blood cell permeability tests.
YY 0314 only gives the concentration range of heparin/heparin lithium. This part of YY/T 1416 gives the corresponding amount of various additives.
test methods.
This section recommends methylene blue spectrophotometric determination of heparin sodium/heparin lithium additive in single blood collection tubes for disposable users.
Body venous blood sample collection container quality control. Other methods of measurement may also be used, but methodological confirmation is required.
Disposable human venous blood sample collection container added
Methods for determining the dose - Part 3. Heparin
1 Scope
This part of YY/T 1416 specifies methylene blue spectrophotometric determination of disposable human blood sample collection containers (abbreviation.
Test method for the amount of additive heparin in tubes).
This section applies to blood collection tubes containing lithium heparin/heparin sodium.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
3 Test section
3.1 Test principle
This section is a methylene blue spectrophotometric method for the determination of lithium heparin/heparin titer in blood collection tubes using heparin and methylene blue solutions.
The fading reaction occurs, and the decrease in absorbance is proportional to the concentration of heparin in the solution to determine the content of lithium heparin/heparin.
3.2 Instruments and reagents
Unless otherwise specified, the reagents used should be analytically pure, and the test water should meet the requirements for secondary water specified in GB/T 6682.
a) UV-visible spectrophotometer;
b) lithium heparin standard 1);
c) Heparin sodium standards;
d) Methylene blue. biological stains.
1) There are currently no certified lithium heparin standards. After verification, heparin sodium standards are equivalent to lithium heparin standards.
3.3 Test procedure
3.3.1 Drawing of Standard Curve
Weigh the appropriate amount of lithium heparin/heparin sodium standard and prepare a lithium heparin/heparin sodium standard solution with a concentration of approximately 1 IU/mL. Take 6
In a 10 mL volumetric flask, lithium heparin/heparin sodium standard solution of 0 mL, 0.5 mL, 1.0 mL was precisely added at a concentration of approximately 1 IU/mL.
1.5 mL, 2.0 mL, and 2.5 mL, each of which was accurately added with 0.1 mL/L methylene blue solution at a concentration of 0.4 mL (before use.
Prepare now), dilute to the mark with water, shake well, and put it at room temperature for 1 hour to obtain a concentration of approximately 0 IU/mL, 0.05 IU/mL, and 0.10 IU/mL.
0.15 IU/mL, 0.20 IU/mL, 0.25 IU/mL solution of lithium heparin/heparin. Using water as a reference, measure each solution at 664nm
Absorbance. The concentration C (IU/mL) as the abscissa, absorbance as the ordinate to draw a standard curve, and find the regression equation.
3.3.2 Determination of Samples
Take one blood collection tube, inhale the test water to nominal capacity, vortex and mix it, collect it in a suitable volumetric flask, and then repeat the inhalation of the nominal
The volume of water was collected several times, and the eluate was collected in the same volumetric flask (volume V), diluted with water to the mark, and shaken to make it about every 1 mL.
1IU~2IU sample solution. Precisely take 1.0mL of the above sample solution in a 10mL volumetric flask, precisely add the concentration to 0.1g/L.
Methylene blue solution 0.4mL, diluted with water to the mark, shaken, placed at room temperature for 1h, using water as a reference, measured the absorbance of each solution at 664nm
Degree, find out on the standard curve or use the regression equation to obtain the concentration of heparin solution in each blood collection tube.
Take another blood collection tube and repeat the above procedure.
Calculate the result as follows.
W=10CV
In the formula.
W --- additive content in the blood vessel, in IU;
C --- The concentration of heparin solution in each blood collection tube detected on the standard curve, the unit is IU per milliliter (IU/mL);
V --- volume of flask, in milliliters (mL).
4 Test report
The test report should include at least the following.
a) Identification of test samples;
b) the standard number of this section;
c) test results;
d) test date;
e) Test personnel.