CN109387643A - A kind of universal whole blood blood glucose quality-control product of blood sugar analyzer and preparation method thereof - Google Patents
A kind of universal whole blood blood glucose quality-control product of blood sugar analyzer and preparation method thereof Download PDFInfo
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- CN109387643A CN109387643A CN201811178015.1A CN201811178015A CN109387643A CN 109387643 A CN109387643 A CN 109387643A CN 201811178015 A CN201811178015 A CN 201811178015A CN 109387643 A CN109387643 A CN 109387643A
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- 239000008103 glucose Substances 0.000 title claims abstract description 79
- 238000003908 quality control method Methods 0.000 title claims abstract description 65
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 37
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- 230000002335 preservative effect Effects 0.000 claims abstract description 22
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims abstract description 21
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- 229930182566 Gentamicin Natural products 0.000 claims description 10
- 239000006071 cream Substances 0.000 claims description 10
- 229960002518 gentamicin Drugs 0.000 claims description 10
- 238000005406 washing Methods 0.000 claims description 8
- NDVRKEKNSBMTAX-BTVCFUMJSA-N (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal;phosphoric acid Chemical class OP(O)(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O NDVRKEKNSBMTAX-BTVCFUMJSA-N 0.000 claims description 7
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- 239000012530 fluid Substances 0.000 claims description 4
- 239000004615 ingredient Substances 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
Abstract
The present invention relates to technical field of medical examination, and in particular to a kind of universal whole blood blood glucose quality-control product of blood sugar analyzer and preparation method thereof, which includes leucocyte 4~9 × 109/ L, red blood cell 3.5~5.5 × 109/ L, 20~200mM of phosphate buffer, pH7.0-7.5, preservative mass concentration are 0.5~1.5 ‰, and antioxidant mass concentration is 0.5~1.5 ‰, and glucose mass concentration is 0.1~0.25 ‰, and glutaraldehyde mass concentration is 2~6 ‰.The universal whole blood blood glucose quality-control product of blood sugar analyzer of the invention, which is realized, simulates people's blood whole blood mode with the animal blood of inspection and quarantine qualification, quality control is carried out to portable glucose meter, accurate simulation people blood state-detection blood glucose meter and blood sugar test paper using effect, improve accuracy, the reliability of blood glucose test results.The universal whole blood blood glucose quality-control product of blood sugar analyzer of the invention is versatile, can carry out Quality Control control to the blood glucose meter of different manufacturers, different model.
Description
Technical field
The present invention relates to technical field of medical examination, and in particular to a kind of universal whole blood blood glucose quality-control product of blood sugar analyzer
And preparation method thereof.
Background technique
Contain certain density glucose in blood of human body, referred to as " blood glucose ".Human body is kept under normal circumstances " blood glucose "
The not more than 180mg/dl (10mmol/l) between 70~140mg/dl (3.9~7.8mmol/) is fluctuated in dynamic equilibrium.
After feed, the carbohydrate polysaccharide eaten digestion is hydrolyzed into monosaccharide i.e. glucose absorption and enters blood by gastrointestinal tract, makes blood glucose liter
Height is gradually reduced blood glucose again with the utilization and storage of glucose；When hungry, original is stored in intracorporal glucose and releases
Enter blood, then blood glucose rises, and maintains dynamic equilibrium.In clinical medicine inspection, the measurement of concentration of glucose is usually used in
The inspection of endocrine function；Increasing for " blood glucose " index is common in hyperthyroidism, diabetes etc.；The drop of " blood glucose " index
It is low to be common in hyperinsulinemia disease, cancer of pancreas etc..
Due to the excessively high generation that can lead to various complication of blood glucose target, and the too low easy induction of blood glucose target is cardiovascular
Disease, or even go into a coma.Therefore in the complex treatment to blood glucose target exception patient, blood sugar monitoring is such Case treatment mistake
Indispensable monitoring means in journey.
Examine by the real-time test POCT of blood glucose, also referred to as bed, because have it is quick, sensitive, do not limited by place, hence it is evident that contract
The advantages that survey report time, becomes a kind of means clinical, that diabetes patient continuously monitors patient blood glucose.With the hair of science and technology
Exhibition, the blood glucose meter of prior art production, not only small volume, easy to carry, and function is also than abundant, such as body-temperature measuring function, arteries and veins
It fights and measures function etc., and measurement data is also more and more accurate, is suitble to the use of most people.But the blood glucose of prior art production
Instrument is only verified before factory, none effective monitoring means in the long-term use process, thus medical and nursing work because
This, the needs based on medical diagnosis skill and treatment technology, need to develop it is a kind of can long-term preservation and versatile quality-control product
For different blood sugar analyzers.
Summary of the invention
In order to overcome the above-mentioned deficiency of the prior art, the present invention provides a kind of universal whole blood blood glucose matter of blood sugar analyzer
Control product and preparation method thereof, the quality-control product select qualification of inspection and quarantine animal blood simulation people's blood whole blood mode, raw material at
This is low, source is sufficient, is easily obtained；And preparation process is simple, additive and modulator quantity are few.Quality-control product of the invention is general
Property it is strong, can to the blood glucose meter of different manufacturers, different model carry out Quality Control control.
To achieve the goals above, the present invention is achieved by the following technical solutions:
The first purpose of this invention is to propose a kind of universal whole blood blood glucose quality-control product of blood sugar analyzer, and feature exists
In the quality-control product ingredient are as follows:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 20~200mM, pH7.0-7.5；
Preservative: mass concentration is 0.5~1.5 ‰；
Antioxidant: mass concentration is 0.5~1.5 ‰；
Glucose: mass concentration is 0.1~0.25 ‰；
Glutaraldehyde: mass concentration is 2~6 ‰.
Further, the quality-control product ingredient are as follows:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 20~200mM, pH7.2；
Preservative: mass concentration is 1.0 ‰；
Antioxidant: mass concentration is 1.0 ‰；
Glucose: mass concentration is 0.1~0.25 ‰；
Glutaraldehyde: mass concentration is 4 ‰.
Further, the red blood cell and leucocyte both from one of blood of pig, ox, rabbit, sheep, horse, dog or
Two or more blood mixture fluids.
Further, the preservative is selected from least one of ProClin series preservative or gentamicin.
Further, the antioxidant is superoxide dismutase.
Second object of the present invention is to propose a kind of preparation side of universal whole blood blood glucose quality-control product of blood sugar analyzer
Method, comprising the following steps:
Step 1: the animal blood is divided into 2 parts by acquisition animal blood, and part 1 is used to extract leukocytic cream, the
2 parts are for extracting red blood cell layer；After the leukocytic cream and red blood cell layer are separately added into phosphate buffer washing, with penta
Dialdehyde solution fixes leucocyte and red blood cell respectively；The phosphate buffering liquid concentration is 20~200mM, pH7.0~7.5；
Step 2: glucose phosphate salt buffer of the mass concentration in 0.1 ‰~0.25 ‰ ranges is prepared, respectively to not
With being added the leucocyte and red blood cell extracted in step 1 in the glucose phosphate salt buffer of concentration, the leucocyte by 4~
The unit capacity of 9 × 109/L is added, and the red blood cell adds by the unit capacity of 3.5~5.5 × 109/L；
Step 3: adding preservative into the dextrose buffer liquid added with leucocyte and red blood cell in step 2 and resist
Oxidant obtains the universal whole blood blood glucose quality-control product of blood sugar analyzer；
Based on mass concentration, final concentration of 0.5~the 1.5 ‰ of preservative, the end of the antioxidant in the quality-control product
Concentration is 0.5~1.5 ‰, final concentration of 2~the 6 ‰ of the glutaraldehyde.
Further, the animal blood in the step 1 is selected from one of blood of pig, ox, rabbit, sheep, horse, dog or two
Kind or more blood mixture fluid.
Further, phosphate buffering liquid concentration is 20~200mM, pH7.2 in the step 1；Based on mass concentration, institute
State final concentration of 1.0 ‰ of preservative in quality-control product, final concentration of the 1.0 ‰ of the antioxidant, the end of the glutaraldehyde is dense
Degree is 4 ‰.
Further, the preservative is selected from least one of ProClin series preservative or gentamicin.
Further, the antioxidant is superoxide dismutase.
Compared with prior art, the beneficial effects of the present invention are:
(1) quality-control product provided by the invention is centrifuged by acquiring anticoagulant animal blood and obtains leucocyte and red thin
Born of the same parents save through the buffer containing glutaraldehyde is fixed respectively to leucocyte and red blood cell；Animal haemocyte, phosphoric acid in quality-control product
Salt buffer system, glucose, antioxidant, preservative, glutaraldehyde etc. at be grouped as reach simulation people's normal blood state, guarantee
Cell can save steadily in the long term, and wherein glucose is both energy source and the concentration index of blood glucose of cell in quality-control product；
Phosphate buffer guarantees that cell is preferably working within the scope of PH, while will not cause to damage to cellular morphology；It is anti-oxidant
Agent (superoxide dismutase) can prevent blood glucose caused by oxidation unstable and stablize cellular morphology；Preservative make cell,
Buffer system etc. is not influenced by microorganisms such as bacteriums；Glutaraldehyde can be keyed to form friendship with the amino and peptide of protein molecule
Even, the activity of enzyme and protein is kept.Therefore, the universal whole blood blood glucose quality-control product of blood sugar analyzer of the invention, which realizes, has examined
The qualified animal blood simulation people's blood whole blood mode of quarantine is tested, quality control, accurate simulation people are carried out to portable glucose meter
Blood state-detection blood glucose meter and blood sugar test paper using effect improve accuracy, the reliability of blood glucose test results.
(2) quality-control product cost of material of the invention is low, source is sufficient, is easily obtained, and quality-control product is easy to save.
(3) whole blood blood glucose quality-control product of the invention is versatile, can carry out matter to the blood glucose meter of different manufacturers, different model
Control control.
(4) quality-control product preparation process of the invention is simple, additive and modulation property quantity are few.
Specific embodiment
It shows that example illustrates certain embodiments of the present invention, and should not be construed as limiting model of the invention
It encloses.Present disclosure can be improved from material, method and reaction condition simultaneously, all these improvement should all
It falls within spirit and scope of the invention.
Embodiment 1
The preparation of the universal whole blood blood glucose quality-control product of blood sugar analyzer:
1. the quality-control product of the present embodiment includes following component:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 20~200mM, pH7.0-7.5；
Preservative: mass concentration is 0.5~1.5 ‰；
Antioxidant: mass concentration is 0.5~1.5 ‰；
Glucose: mass concentration is 0.1 ‰, 0.25 ‰；
Glutaraldehyde: mass concentration is 2~6 ‰.
2. preparation method
(1) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, collect blood plasma with
Tunica albuginea layer among separating liquid；The leukocytic cream includes lymphocyte, monocyte, neutrophil leucocyte, blood platelet, by collection
Leukocytic cream is added 20ml phosphate buffer (20mM, pH7.0) and carries out washing 2 times, the glutaraldehyde for being 25% with mass concentration
Solution is as the fixed cell of fixer.
(2) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, abandon blood plasma with point
Tunica albuginea layer, blood platelet, blood plasma among chaotropic collect red blood cell, and 20ml phosphate buffer is added in the red blood cell layer of collection
(20mM, pH7.0) carries out washing 2 times, and using mass concentration is that 25% glutaraldehyde solution fixes cell as fixer.
(3) the glucose phosphate salt buffer that mass concentration is respectively 0.1 ‰, 0.25 ‰ is prepared, respectively to two kinds of grapes
The leucocyte and red blood cell of extraction are added in sugared phosphate buffer.According to normal person's ratio of blood, leucocyte presses 4~9
The unit capacity of × 109/L is added, and red blood cell adds by the unit capacity of 3.5~5.5 × 109/L.To added with white thin
Gentamicin and superoxide dismutase are added in two kinds of dextrose buffer liquid of born of the same parents and red blood cell, keeps the end of gentamicin dense
Degree is 0.5 ‰, final concentration of the 0.5 ‰ of superoxide dismutase, to obtain the universal whole blood blood glucose Quality Control of blood sugar analyzer
Product.
Embodiment 2:
The preparation of the universal whole blood blood glucose quality-control product of blood sugar analyzer:
1. the quality-control product of the present embodiment includes following component:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 100mM, pH7.2；
Preservative: mass concentration is 1.0 ‰；
Antioxidant: mass concentration is 1.0 ‰；
Glucose: mass concentration is 0.1 ‰, 0.25 ‰；
Glutaraldehyde: mass concentration is 4 ‰.
2. preparation method
(1) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, collect blood plasma with
Tunica albuginea layer among separating liquid；The leukocytic cream includes lymphocyte, monocyte, neutrophil leucocyte, blood platelet, by collection
Leukocytic cream is added 20ml phosphate buffer (100mM, pH7.2) and carries out washing 2 times, the glutaraldehyde for being 25% with mass concentration
Solution is as the fixed cell of fixer.
(2) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, abandon blood plasma with point
Tunica albuginea layer, blood platelet, blood plasma among chaotropic collect red blood cell, and 20ml phosphate buffer is added in the red blood cell layer of collection
(100mM, pH7.2) carries out washing 2 times, and using mass concentration is that 25% glutaraldehyde solution fixes cell as fixer.
(3) the glucose phosphate salt buffer that mass concentration is respectively 0.1 ‰, 0.25 ‰ is prepared, respectively to two kinds of grapes
The leucocyte and red blood cell of extraction are added in sugared phosphate buffer.According to normal person's ratio of blood, leucocyte presses 4~9
The unit capacity of × 109/L is added, and red blood cell adds by the unit capacity of 3.5~5.5 × 109/L.To added with white thin
Gentamicin and superoxide dismutase are added in two kinds of dextrose buffer liquid of born of the same parents and red blood cell, keeps the end of gentamicin dense
Degree is 1.0 ‰, final concentration of the 1.0 ‰ of superoxide dismutase, to obtain the universal whole blood blood glucose Quality Control of blood sugar analyzer
Product.
Embodiment 3:
The preparation of the universal whole blood blood glucose quality-control product of blood sugar analyzer:
1. the quality-control product of the present embodiment includes following component:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 200mM, pH7.5；
Preservative: mass concentration is 1.5 ‰；
Antioxidant: mass concentration is 1.5 ‰；
Glucose: mass concentration is 0.1 ‰, 0.25 ‰；
Glutaraldehyde: mass concentration is 6 ‰.
2. preparation method
(1) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, collect blood plasma with
Tunica albuginea layer among separating liquid；The leukocytic cream includes lymphocyte, monocyte, neutrophil leucocyte, blood platelet, by collection
Leukocytic cream is added 20ml phosphate buffer (200mM, pH7.5) and carries out washing 2 times, the glutaraldehyde for being 25% with mass concentration
Solution is as the fixed cell of fixer.
(2) it takes animal anticoagulation: 10ml pig blood is imported containing 20ml separating liquid (the virtue Pacific Ocean (Tianjin) biology section
The human lymphocyte separating liquid of skill limited liability company) Centrifuge Cup in, low-speed centrifugal 15 minutes in centrifuge, abandon blood plasma with point
Tunica albuginea layer, blood platelet, blood plasma among chaotropic collect red blood cell, and 20ml phosphate buffer is added in the red blood cell layer of collection
(200mM, pH7.5) carries out washing 2 times, and using mass concentration is that 25% glutaraldehyde solution fixes cell as fixer.
(3) the glucose phosphate salt buffer that mass concentration is respectively 0.1 ‰, 0.25 ‰ is prepared, respectively to two kinds of grapes
The leucocyte and red blood cell of extraction are added in sugared phosphate buffer.According to normal person's ratio of blood, leucocyte presses 4~9
The unit capacity of × 109/L is added, and red blood cell adds by the unit capacity of 3.5~5.5 × 109/L.To added with white thin
Gentamicin and superoxide dismutase are added in two kinds of dextrose buffer liquid of born of the same parents and red blood cell, keeps the end of gentamicin dense
Degree is 1.5 ‰, final concentration of the 1.5 ‰ of superoxide dismutase, to obtain the universal whole blood blood glucose Quality Control of blood sugar analyzer
Product.
Embodiment 4:
The reliable portable blood sugar analyzer of quality-control product and one or Biochemical Analyzer pair in the present embodiment Example 1-3
Than calculating the calculated value of concentration of glucose 0.1 ‰ in quality-control product as concentration of glucose 0.25 ‰ in 5.5mmol/L, quality-control product
Calculated value be 13.8mmol/L.Quality-control product prepared by embodiment 1-3 is placed 6 months at 4 DEG C, its stability of tracking and monitoring,
As a result as shown in the table.
The quality-control product long-time stability tracking and monitoring result of 1 embodiment 1-3 of table
From the data in table 1 it is found that can be stabilized 6 months under the conditions of 4 DEG C of whole blood blood glucose quality-control product of the invention, therefore
It can long-term preservation.
Embodiment 5:
Quality-control product in the present embodiment Example 1-3 detects Rett Rightest blood glucose meter respectively, Ai Yintan only likes blood
Whether sugar analyzer detection system works normally.
1. first by the universal whole blood blood glucose quality-control product of blood sugar analyzer and a reliable Portable blood in embodiment 1-3
Sugar analyzer or Biochemical Analyzer comparison, the calculated value for calculating concentration of glucose 0.1 ‰ in quality-control product is 5.5mmol/L, matter
The calculated value of concentration of glucose 0.25 ‰ is 13.8mmol/L in control product.
2. blood sugar test paper to be inserted into Rett Rightest blood glucose meter, Ai Yintan respectively only to like on blood sugar analyzer, reality is shaken up
Apply the universal whole blood blood glucose quality-control product in a 1-3, and drip respectively on blood sugar test paper, by the chip that is implanted into advance in instrument into
The direct scaling results of row are simultaneously shown on portable blood sugar analyzer, wait the testing result of quality-control product, the detection knot of quality-control product
Fruit is as shown in the table:
The testing result of quality-control product in 2 embodiment 1-3 of table
By data in table 2 it is found that the fluctuation of the actually detected result of the quality-control product in embodiment 1-3, which is no more than, calculates concentration
10%, show that the Rett Rightest blood glucose meter in the present embodiment, Ai Yintan only like that blood sugar analyzer functional operation is normal.
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto,
Anyone skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its
Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (10)
1. a kind of universal whole blood blood glucose quality-control product of blood sugar analyzer, which is characterized in that the quality-control product ingredient are as follows:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 20~200mM, pH7.0-7.5；
Preservative: mass concentration is 0.5~1.5 ‰；
Antioxidant: mass concentration is 0.5~1.5 ‰；
Glucose: mass concentration is 0.1~0.25 ‰；
Glutaraldehyde: mass concentration is 2~6 ‰.
2. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 1, which is characterized in that the matter
Control product ingredient are as follows:
Leucocyte: 4~9 × 109/L；
Red blood cell: 3.5~5.5 × 109/L；
Phosphate buffer: 20~200mM, pH7.2；
Preservative: mass concentration is 1.0 ‰；
Antioxidant: mass concentration is 1.0 ‰；
Glucose: mass concentration is 0.1~0.25 ‰；
Glutaraldehyde: mass concentration is 4 ‰.
3. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 1, which is characterized in that described red
The blood mixture fluid of cell and leucocyte both from one or more of the blood of pig, ox, rabbit, sheep, horse, dog.
4. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 1, which is characterized in that described anti-
Rotten agent is selected from least one of ProClin series preservative or gentamicin.
5. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 1, which is characterized in that described anti-
Oxidant is superoxide dismutase.
6. a kind of preparation method of the universal whole blood blood glucose quality-control product of blood sugar analyzer, which comprises the following steps:
Step 1: the animal blood is divided into 2 parts by acquisition animal blood, and part 1 is for extracting leukocytic cream, and the 2nd
Divide for extracting red blood cell layer；After the leukocytic cream and red blood cell layer are separately added into phosphate buffer washing, with penta 2
Aldehyde solution fixes leucocyte and red blood cell respectively；The phosphate buffering liquid concentration is 20~200mM, pH7.0~7.5；
Step 2: the glucose phosphate salt buffer that mass concentration is 0.1 ‰~0.25 ‰ ranges is prepared, respectively to various concentration
Glucose phosphate salt buffer in be added the leucocyte and red blood cell extracted in step 1, the leucocyte by 4~9 ×
109The unit capacity of/L is added, and the red blood cell presses 3.5~5.5 × 109The unit capacity of/L is added；
Step 3: preservative and anti-oxidant is added into the dextrose buffer liquid added with leucocyte and red blood cell in step 2
Agent obtains the universal whole blood blood glucose quality-control product of blood sugar analyzer；
Based on mass concentration, final concentration of 0.5~the 1.5 ‰ of preservative, the final concentration of the antioxidant in the quality-control product
It is 0.5~1.5 ‰, final concentration of 2~the 6 ‰ of the glutaraldehyde.
7. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 6, it is characterised in that: the step
Animal blood in rapid 1 is selected from the blood mixture fluid of one or more of blood of pig, ox, rabbit, sheep, horse, dog.
8. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 6, it is characterised in that: the step
Phosphate buffering liquid concentration is 20~200mM, pH7.2 in rapid 1；Based on mass concentration, the end of preservative is dense in the quality-control product
Degree is 1.0 ‰, final concentration of the 1.0 ‰ of the antioxidant, final concentration of the 4 ‰ of the glutaraldehyde.
9. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 6, it is characterised in that: described anti-
Rotten agent is selected from least one of ProClin series preservative or gentamicin.
10. the universal whole blood blood glucose quality-control product of a kind of blood sugar analyzer according to claim 6, it is characterised in that: described
Antioxidant is superoxide dismutase.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112697557A (en) * | 2020-12-30 | 2021-04-23 | 郑州普湾医疗技术有限公司 | Quality control product of 2-level thrombus elastogram, preparation method and application thereof |
| CN115327139A (en) * | 2022-09-16 | 2022-11-11 | 杭州同创医学检验实验室有限公司 | Blood quality control product for portable glucometer and preparation method thereof |
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Cited By (2)
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| CN112697557A (en) * | 2020-12-30 | 2021-04-23 | 郑州普湾医疗技术有限公司 | Quality control product of 2-level thrombus elastogram, preparation method and application thereof |
| CN115327139A (en) * | 2022-09-16 | 2022-11-11 | 杭州同创医学检验实验室有限公司 | Blood quality control product for portable glucometer and preparation method thereof |
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Effective date of registration: 20231103 Address after: 519000 room 1301, building 3, scientific research incubation building, phase II, Tsinghua Science Park, 101 University Road, Tangjiawan Town, high tech Zone, Zhuhai, Guangdong Patentee after: Zhuhai Langtai Biotechnology Co.,Ltd. Address before: 430000 floors 1-2, plant 2, economic development zone, Hannan District, Wuhan City, Hubei Province (Wuhan Gaoyuan Biotechnology Development Co., Ltd.) Patentee before: WUHAN DONGFANG HUAKANG TECHNOLOGY Co.,Ltd. |