CN109596845A - A kind of thrombelastogram instrument quality-control product and preparation method thereof - Google Patents
A kind of thrombelastogram instrument quality-control product and preparation method thereof Download PDFInfo
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- CN109596845A CN109596845A CN201811616341.6A CN201811616341A CN109596845A CN 109596845 A CN109596845 A CN 109596845A CN 201811616341 A CN201811616341 A CN 201811616341A CN 109596845 A CN109596845 A CN 109596845A
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- control product
- thrombelastogram instrument
- blood
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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
Abstract
The invention discloses a kind of thrombelastogram instrument quality-control products and preparation method thereof; the preparation method is using animal's whole blood as raw material; using blood coagulations components such as natural subsidence technique protection coagulation factor, fibrinogen, blood platelets; to protect these ingredients not lost or activated, to improve the quality testing of thrombelastogram instrument.
Description
Technical field
The present invention relates to hemostasis examination technical fields, in particular to a kind of thrombelastogram instrument quality-control product and its system
Preparation Method.
Background technique
Thrombelastogram instrument (TEG) is that one kind monitors blood coagulation from the entire dynamic process such as platelet aggregation, blood coagulation, fibrinolytic
The analyzer of process, for monitoring and analyzing the coagulated state of blood sample.It was invented in 1948 by German Harter.
Its principle is that the final result based on coagulation process is to form blood clot, and the physical characteristic (blood clot of blood clot
Strength and stability) determine whether it has the function of normal coagulation.
Thrombelastogram instrument quality-control product, for the quality testing to thrombelastogram instrument and matched reagent.On the one hand, existing
Thrombelastogram instrument quality-control product yield it is lower and expensive, be not able to satisfy market to thrombelastogram instrument quality-control product need
It asks, on the other hand, existing thrombelastogram instrument quality-control product is through centrifugal treating, to take blood plasma using people's blood as raw material, freeze-drying is added
Protective agent, preservative, freeze-drying are prepared.
And people's blood is mainly derived from hospital or blood station, it is expensive, and amount is few, and bio-safety risk is high, is unfavorable for scale
Production, and supervise stringent.
Summary of the invention
The first object of the present invention is to provide a kind of thrombelastogram instrument quality-control product, which is original with animal blood sample
Material, and the blood coagulations component such as coagulation factor, fibrinogen, blood platelet in the quality-control product is not lost or is activated, and can be improved
The quality testing of thrombelastogram instrument.
The second object of the present invention is to provide a kind of preparation method of thrombelastogram instrument quality-control product, and the quality-control product is with dynamic
Object whole blood is raw material, using blood coagulations components such as natural subsidence technique protection coagulation factor, fibrinogen, blood platelets, with protection
These ingredients are not lost or are activated, to improve the quality testing of thrombelastogram instrument.
Another object of the present invention is to provide a kind of thrombelastogram instrument comprising has above-mentioned thrombelastogram instrument Quality Control
Product have the advantages that detection quality is high.
The present invention is implemented as follows:
A kind of thrombelastogram instrument quality-control product provided in an embodiment of the present invention comprising have anti-coagulants and animal blood plasma.
Specifically, animal blood plasma can be with are as follows: one of Swine plasma, ox blood slurry or rabbit plasma.
The embodiment of the present invention also provides a kind of preparation method of thrombelastogram instrument quality-control product comprising has following steps:
The preparation step of anti-coagulants:
According to from than, sodium citrate anticoagulant by 2~5 parts of sodium citrates, 5~10 portions of sucrose, 1~5 part of sodium chloride and
0.1~1 portion of preservative is mixed to prepare.
Further, preservative is mercuric sulphide or sodium azide or its combination.Specifically, preservative includes 0.01 part of sulphur
Change mercury and 0.5 part of sodium azide is applied directly to prevent whole blood from addling in anti-coagulants.
Mixing step:
By sodium citrate anticoagulant and the animal blood sample of acquisition according to (0.8~1.2): the volume ratio of (8.8~9.2) is mixed
It closes.Preferably, the mixed volume ratio of anti-coagulants and the animal blood sample of acquisition is 1:9.Wherein, animal blood plasma can for Swine plasma,
Ox blood slurry or rabbit plasma.
Stand step:
Mixed animal blood plasma is stored at room temperature to layering, time of repose is 5~12h.Specifically, time of repose can be with
For 5h, 6h, 7h, 8h, 9h, 10h, 11h or 12h.It should be noted that room temperature is 15 DEG C, 16 DEG C, 17 DEG C, 18 DEG C, 19 DEG C, 20
DEG C, 21 DEG C, 22 DEG C, 23 DEG C, 24 DEG C or 25 degrees Celsius.
Relative to the blood plasma of centrifugal treating, coagulation factor, coagulation factor, fibrin can be protected using natural subsidence
The blood coagulations such as original, blood platelet component is not lost or is activated.
Extraction step:
Being rich in after extracting stratification has the animal blood plasma (supernatant blood plasma) of blood platelet to extract, and is sub-packed in reagent bottle
Or in Reagent Tube.
Freezing step:
The animal blood plasma of extraction is freezed into 11~13h, cryogenic temperature is -30 DEG C~-60 DEG C.Specifically, cooling time can
Think 11h, 11.5h, 12h, 12.5h or 13h, cryogenic temperature can be -30 DEG C, -35 DEG C, -40 DEG C, -45 DEG C, -50 DEG C, -55
DEG C or -60 DEG C.
Vacuum step:
Start vacuum freeze drier, 2h be pre-chilled, by after freezing equipped with animal blood plasma Reagent Tube or reagent bottle be placed in
It in drying machine, vacuumizes 24 hours, vacuum degree is less than 30pa.
In addition, the present invention also provides a kind of thrombelastogram instrument comprising have above-mentioned thrombelastogram instrument quality-control product or by
Thrombelastogram instrument quality-control product made from above-mentioned preparation method.
The invention has the following advantages:
The embodiment of the invention provides a kind of thrombelastogram instrument quality-control product, the quality-control product using animal blood sample as raw material, and
The blood coagulations components such as coagulation factor, fibrinogen, blood platelet in its quality-control product are not lost or are activated, and can be improved thrombus bullet
Try hard to the quality testing of instrument.
The embodiment of the invention provides a kind of preparation method of thrombelastogram instrument quality-control product, the preparation method is complete with animal
Blood is raw material, using blood coagulations components such as natural subsidence technique protection coagulation factor, fibrinogen, blood platelets, to protect these
Ingredient is not lost or is activated, to improve the quality testing of thrombelastogram instrument.
In addition, the embodiment of the invention also provides a kind of thrombelastogram instrument comprising there is above-mentioned thrombelastogram instrument matter
Control product have the advantages that detection quality is high.
Specific embodiment
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds
The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase
Product.
Feature and performance of the invention are described in further detail with reference to embodiments.
Embodiment 1
The preparation method of thrombelastogram instrument quality-control product provided in this embodiment comprising following steps:
The preparation step of anti-coagulants:
It is according to mass parts ratio, 3 parts of sodium citrates, 7 portions of sucrose, 3 parts of sodium chloride, 0.01 part of mercuric sulphide and 0.5 part is folded
Sodium nitride mixing.
Mixing step:
Sodium citrate anticoagulant is mixed with the animal blood sample of acquisition according to the volume ratio of 1:9.Wherein, animal blood plasma is pig
Blood plasma.
Stand step:
Mixed animal blood plasma is stored at room temperature to layering, time of repose 10h, room temperature is 15 DEG C.
Relative to the blood plasma of centrifugal treating, coagulation factor, coagulation factor, fibrin can be protected using natural subsidence
The blood coagulations such as original, blood platelet component is not lost or is activated.
Extraction step:
Being rich in after extracting stratification has the animal blood plasma (supernatant blood plasma) of blood platelet to extract, and is sub-packed in reagent bottle
Or in Reagent Tube.
Freezing step:
The animal blood plasma of extraction is freezed into 12h, cryogenic temperature is -45 DEG C.
Vacuum step:
Start vacuum freeze drier, 2h be pre-chilled, by after freezing equipped with animal blood plasma Reagent Tube or reagent bottle be placed in
In drying machine, vacuumize.
Embodiment 2
The preparation method of thrombelastogram instrument quality-control product provided in this embodiment, the preparation method provided with embodiment 1
Roughly the same, difference is the difference of parameter, distinguishes as follows:
The preparation step of anti-coagulants:
It is according to mass parts ratio, 4 parts of sodium citrates, 8 portions of sucrose, 3 parts of sodium chloride, 0.01 part of mercuric sulphide and 0.5 part is folded
Sodium nitride mixing.
Mixing step:
Sodium citrate anticoagulant is mixed with the animal blood sample of acquisition according to the volume ratio of 1:9.Wherein, animal blood plasma is pig
Blood plasma.
Stand step:
Mixed animal blood plasma is stored at room temperature to layering, time of repose 12h, room temperature is 15 DEG C.
Extraction step:
Being rich in after extracting stratification has the animal blood plasma (supernatant blood plasma) of blood platelet to extract, and is sub-packed in the west 3mL
In woods bottle.
Freezing step:
The animal blood plasma of extraction is freezed into 12h, cryogenic temperature is -60 DEG C.
Vacuum step:
Start vacuum freeze drier, 2h be pre-chilled, by after freezing equipped with animal blood plasma Reagent Tube or reagent bottle be placed in
It in drying machine, vacuumizes 24 hours, vacuum degree is less than 30pa.
Embodiment 3
The preparation method of thrombelastogram instrument quality-control product provided in this embodiment, the preparation side provided with embodiment 1,2
Method is roughly the same, and difference is the difference of parameter, distinguishes as follows:
The preparation step of anti-coagulants:
It is according to mass parts ratio, 5 parts of sodium citrates, 10 portions of sucrose, 3 parts of sodium chloride, 0.01 part of mercuric sulphide and 0.5 part is folded
Sodium nitride mixing.
Mixing step:
Sodium citrate anticoagulant is mixed with the animal blood sample of acquisition according to the volume ratio of 1:9.Wherein, animal blood plasma is pig
Blood plasma.
Stand step:
Mixed animal blood plasma is stored at room temperature to layering, time of repose 11h, room temperature is 20 DEG C.
Extraction step:
Being rich in after extracting stratification has the animal blood plasma (supernatant blood plasma) of blood platelet to extract, and is sub-packed in the west 3mL
In woods bottle.
Freezing step:
The animal blood plasma of extraction is freezed into 12h, cryogenic temperature is -60 DEG C.
Vacuum step:
Start vacuum freeze drier, 2h be pre-chilled, by after freezing equipped with animal blood plasma Reagent Tube or reagent bottle be placed in
It in drying machine, vacuumizes 24 hours, vacuum degree is less than 30pa.
Comparative example 1
Verify the stability of thrombelastogram instrument quality-control product provided by the invention.
Quality-control product obtained in Examples 1 to 3 is saved under the conditions of room temperature (2-8 DEG C), timing sampling it is primary (0 month,
3 months, 6 months, 9 months, 12 months, 15 months and 18 months), detect four coagulation parameters.Shown in testing result table 1.
1 coagulation parameters of table
The MA value of thrombelastogram instrument quality-control product test is 40 or so in the prior art, by table as it can be seen that the present invention is implemented
The MA mean value for the thrombelastogram instrument quality-control product that example provides is more than 60 Zuo You, and test result is stablized.Quality-control product in the market is also
There is no MA value 60 or more.
To sum up, the embodiment of the invention provides a kind of thrombelastogram instrument quality-control product, which is original with animal blood sample
Material, and the blood coagulations component such as coagulation factor, fibrinogen, blood platelet in its quality-control product is not lost or is activated, and can be improved
The quality testing of thrombelastogram instrument.
The embodiment of the invention provides a kind of preparation method of thrombelastogram instrument quality-control product, the preparation method is complete with animal
Blood is raw material, using blood coagulations components such as natural subsidence technique protection coagulation factor, fibrinogen, blood platelets, to protect these
Ingredient is not lost or is activated, to improve the quality testing of thrombelastogram instrument.
In addition, the embodiment of the invention also provides a kind of thrombelastogram instrument comprising there is above-mentioned thrombelastogram instrument matter
Control product have the advantages that detection quality is high.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of thrombelastogram instrument quality-control product, which is characterized in that it includes anti-coagulants and animal blood plasma；The anti-coagulants is Chinese holly
Rafter acid sodium anti-coagulants.
2. thrombelastogram instrument quality-control product according to claim 1, which is characterized in that described anti-according to mass parts ratio
Solidifying agent includes: 2~5 parts of sodium citrates, 5~10 portions of sucrose, 1~5 part of sodium chloride and 0.1~1 portion of preservative；
The animal blood plasma is Swine plasma, ox blood slurry or rabbit plasma rich in blood platelet.
3. thrombelastogram instrument quality-control product according to claim 2, which is characterized in that the blood plasma and the anti-coagulants
Volume ratio is (0.8~1.2): (8.8~9.2).
4. thrombelastogram instrument quality-control product according to claim 2 or 3, which is characterized in that the preservative is mercuric sulphide
Or sodium azide.
5. a kind of preparation method of thrombelastogram instrument quality-control product, which is characterized in that it includes extraction step and freezing step；
The extraction step is the animal blood plasma for extracting the animal blood sample mixed with sodium citrate anticoagulant；
The freezing step includes 11~13h of plasma freezing after extracting, and cryogenic temperature is -30 DEG C~-60 DEG C.
6. preparation method according to claim 5, which is characterized in that the sodium citrate anticoagulant is by 2~5 parts of citric acids
Sodium, 5~10 portions of sucrose, 1~5 part of sodium chloride and 0.1~1 portion of preservative are mixed to prepare.
7. preparation method according to claim 6, which is characterized in that the animal blood plasma is the pig blood rich in blood platelet
Slurry, ox blood slurry or rabbit plasma.
8. according to the described in any item preparation methods of claim 5~7, which is characterized in that the preparation method is in the extraction
It successively include mixing step and standing step before step；
The mixing step includes by sodium citrate anticoagulant and the animal blood sample of acquisition according to (0.8~1.2): (8.8~9.2)
Volume ratio mixing；
Mixed blood sample is stored at room temperature to layering by the standing step, and time of repose is 5~12h.
9. according to the described in any item preparation methods of claim 5~7, which is characterized in that the preparation method is in the freezing
It include vacuum step after step；
The vacuum step includes vacuumizing the animal blood plasma after freezing using vacuum freeze drier.
10. a kind of thrombelastogram instrument, which is characterized in that it includes the described in any item thrombelastogram instrument of Claims 1 to 4
Quality-control product or the thrombelastogram instrument quality-control product as made from claim 5~9 described in any item preparation methods.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111551414A (en) * | 2020-06-03 | 2020-08-18 | 上海原科实业发展有限公司 | Preparation method of platelet quality control product and application of prepared platelet quality control product |
| 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 |
| CN112841171A (en) * | 2021-01-12 | 2021-05-28 | 广州鸿泉生物科技有限公司 | Preparation method and application of anticoagulated pig blood and pig plasma used in thrombus test |
| CN113848332A (en) * | 2021-09-17 | 2021-12-28 | 广州徕西姆医学诊断技术有限公司 | Thrombus elastogram detection reagent and preparation method and application thereof |
| CN113848332B (en) * | 2021-09-17 | 2024-04-19 | 广州徕西姆医学诊断技术有限公司 | Thrombus elastography detection reagent and preparation method and application thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111551414A (en) * | 2020-06-03 | 2020-08-18 | 上海原科实业发展有限公司 | Preparation method of platelet quality control product and application of prepared platelet quality control product |
| 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 |
| CN112841171A (en) * | 2021-01-12 | 2021-05-28 | 广州鸿泉生物科技有限公司 | Preparation method and application of anticoagulated pig blood and pig plasma used in thrombus test |
| CN113848332A (en) * | 2021-09-17 | 2021-12-28 | 广州徕西姆医学诊断技术有限公司 | Thrombus elastogram detection reagent and preparation method and application thereof |
| CN113848332B (en) * | 2021-09-17 | 2024-04-19 | 广州徕西姆医学诊断技术有限公司 | Thrombus elastography detection reagent and preparation method and application thereof |
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